Addendum to the Corrective Action Decision Document/Closure Report for Corrective Action Unit 321: Area 22 Weather Station Fuel Storage Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the August 2001, Corrective Action Decision Document / Closure Report for Corrective Action Unit 321: Area 22 Weather Station Fuel Storage as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modificationmore » document, this addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the UR for CAS 22-99-05, Fuel Storage Area. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

PubMed Central

Sumathipala, Athula; Siribaddana, Sisira; Hewege, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

2008-01-01

Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. PMID:18267015

Increased Access to Professional Interpreters in the Hospital Improves Informed Consent for Patients with Limited English Proficiency.

PubMed

Lee, Jonathan S; Pérez-Stable, Eliseo J; Gregorich, Steven E; Crawford, Michael H; Green, Adrienne; Livaudais-Toman, Jennifer; Karliner, Leah S

2017-08-01

Language barriers disrupt communication and impede informed consent for patients with limited English proficiency (LEP) undergoing healthcare procedures. Effective interventions for this disparity remain unclear. Assess the impact of a bedside interpreter phone system intervention on informed consent for patients with LEP and compare outcomes to those of English speakers. Prospective, pre-post intervention implementation study using propensity analysis. Hospitalized patients undergoing invasive procedures on the cardiovascular, general surgery or orthopedic surgery floors. Installation of dual-handset interpreter phones at every bedside enabling 24-h immediate access to professional interpreters. Primary predictor: pre- vs. post-implementation group; secondary predictor: post-implementation patients with LEP vs. English speakers. Primary outcomes: three central informed consent elements, patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered. We considered consent adequately informed when all three elements were met. We enrolled 152 Chinese- and Spanish-speaking patients with LEP (84 pre- and 68 post-implementation) and 86 English speakers. Post-implementation (vs. pre-implementation) patients with LEP were more likely to meet criteria for adequately informed consent (54% vs. 29%, p = 0.001) and, after propensity score adjustment, had significantly higher odds of adequately informed consent (AOR 2.56; 95% CI, 1.15-5.72) as well as of each consent element individually. However, compared to post-implementation English speakers, post-implementation patients with LEP had significantly lower adjusted odds of adequately informed consent (AOR, 0.38; 95% CI, 0.16-0.91). A bedside interpreter phone system intervention to increase rapid access to professional interpreters was associated with improvements in patient-reported informed consent and should be considered by hospitals seeking to improve care for patients with LEP; however, these improvements did not eliminate the language-based disparity. Additional clinician educational interventions and more language-concordant care may be necessary for informed consent to equal that for English speakers.

Addendum to the Closure Report for Corrective Action Unit 427: Area 3 Septic Waste Systems 2, 6, Tonopah Test Range, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the April 1999, Closure Report for Corrective Action Unit 427: Area 3 Septic Waste Systems 2, 6, Tonopah Test Range, Nevada as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modificationmore » document, this addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 03-05-002-SW02, Septic Waste System • CAS 03-05-002-SW06, Septic Waste System These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum to the Streamlined Approach for Environmental Restoration Closure Report for Corrective Action Unit 454: Historical Undrground Storage Tank Release Sites, Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the April 1998, Streamlined Approach for Environmental Restoration Closure Report for Corrective Action Unit 454: Historical Underground Storage Tank Release Sites as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modificationmore » document, this addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the UR for CAS 12-25-09, Spill 960722-02 (from UST 12-B-3). This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum to the Closure Report for Corrective Action Unit 335: Area 6 Injection Well and Drain Pit Nevada Test Site, Nevada, Revison 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the June 2003, Closure Report for Corrective Action Unit 335: Area 6 Injection Well and Drain Pit as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consistsmore » of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 06-20-02, 20-inch Cased Hole • CAS 06-23-03, Drain Pit These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum to the Closure Report for Corrective Action Unit 356: Mud Pits and Disposal Sites Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the November 2002, Closure Report for Corrective Action Unit 356: Mud Pits and Disposal Sites as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of: •more » This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 03-04-01, Area 3 Change House Septic System • CAS 03-09-04, Mud Pit These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum to the Closure Report for Corrective Action Unit 398: Area 25 Spill Sites, Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the April 2003, Closure Report for Corrective Action Unit 398: Area 25 Spill Sites as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of: • Thismore » cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the UR for CAS 25-25-17, Subsurface Hydraulic Oil Spill. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum to the Closure Report for Corrective Action Unit 423: Area 3 Building 03-60 Underground Discharge Point, Tonopah Test Range, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the July 1999, Closure Report for Corrective Action Unit 423: Area 3 Building 0360 Underground Discharge Point, Tonopah Test Range, Nevada as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modificationmore » document, this addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the UR for CAS 03-02-002-0308, Underground Discharge Point. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum to the Closure Report for Corrective Action Unit 214: Bunkers and Storage Areas Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the September 2006, Closure Report for Corrective Action Unit 214: Bunkers and Storage Areas as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of: • Thismore » cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 25-23-01, Contaminated Materials • CAS 25-23-19, Radioactive Material Storage These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum to the Closure Report for Corrective Action Unit 342: Area 23 Mercury Fire Training Pit Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the April 2000, Closure Report for Corrective Action Unit 342: Area 23 Mercury Fire Training Pit as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of:more » • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the UR for CAS 23-56-01, Former Mercury Fire Training Pit. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum to the Closure Report for Corrective Action Unit 322: Areas 1 & 3 Release Sites and Injection Wells Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the June 2006, Closure Report for Corrective Action Unit 322: Areas 1 & 3 Release Sites and Injection Wells as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, thismore » addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 01-25-01, AST Release • CAS 03-25-03, Mud Plant AST Diesel Release These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

Readability of Informed Consent Documents at University Counseling Centers

ERIC Educational Resources Information Center

Lustgarten, Samuel D.; Elchert, Daniel M.; Cederberg, Charles; Garrison, Yunkyoung L.; Ho, Y. C. S.

2017-01-01

The extent to which clients understand the nature and anticipated course of therapy is referred to as informed consent. Counseling psychologists often provide informed consent documents to enhance the education of services and for liability purposes. Professionals in numerous health care settings have evaluated the readability of their informed…

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

PubMed Central

Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.; Sprumont, D.; Zalcberg, J.

2017-01-01

Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. PMID:28453700

Architecture of a consent management suite and integration into IHE-based Regional Health Information Networks.

PubMed

Heinze, Oliver; Birkle, Markus; Köster, Lennart; Bergh, Björn

2011-10-04

The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents. Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general.

Architecture of a consent management suite and integration into IHE-based regional health information networks

PubMed Central

2011-01-01

Background The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Methods Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. Results The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents. Conclusions Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general. PMID:21970788

On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

PubMed

Kara, Mahmut A; Aksoy, Sahin

2006-09-01

Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

PubMed

Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

2017-05-01

In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

PubMed Central

Madeira, Jody Lyneé; Andraka-Christou, Barbara

2016-01-01

Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

Addendum to the Closure Report for Corrective Action Unit 271: Areas 25, 26, and 27 Septic Systems Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the August 2004, Closure Report for Corrective Action Unit 271, Areas 25, 26, and 27 Septic Systems as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consistsmore » of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the modification of the UR for CAS 27-05-02, Leachfield. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to modify the UR to an administrative UR. Administrative URs differ from standard URs in that they do not require onsite postings (i.e., signs) or other physical barriers (e.g., fencing, monuments), and they do not require periodic inspections (see Section 6.2 of the Industrial Sites Project Establishment of Final Action Levels [NNSA/NSO, 2006c]). This Administrative UR was based on an “Occasional Use Area” future land use scenario that was used to calculate the FAL. The administrative UR will protect workers from an exposure exceeding that used in the calculation of the FAL (i.e., 400 total work hours). Any proposed activity within this use restricted area that would potentially cause an exposure exceeding this exposure limit would require approval from the Nevada Division of Environmental Protection (NDEP). Requirements for inspecting and maintaining postings at this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Do surgeons and patients discuss what they document on consent forms?

PubMed

Hall, Daniel E; Hanusa, Barbara H; Fine, Michael J; Arnold, Robert M

2015-07-01

Previous studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms. We enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed. Of 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure. The patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need. Published by Elsevier Inc.

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

PubMed Central

Matsui, Kenji; Lie, Reidar K.; Turin, Tanvir C.; Kita, Yoshikuni

2012-01-01

Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Methods Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Results Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. Conclusions A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research. PMID:22447213

46 CFR 67.509 - Application for approval of exchange of Certificate of Documentation requiring mortgagee consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Application for approval of exchange of Certificate of Documentation requiring mortgagee consent. 67.509 Section 67.509 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DOCUMENTATION AND MEASUREMENT OF VESSELS DOCUMENTATION OF VESSELS Fees § 67.509 Application for approval of exchange of...

Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record?

PubMed

Fenton, S H; Manion, F; Hsieh, K; Harris, M

2015-01-01

Despite efforts to provide standard definitions of terms such as "medical record", "computer-based patient record", "electronic medical record" and "electronic health record", the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process - patients, information technology and regulatory staff, and the investigative team - fully understand what data and information they are asking to obtain and agreeing to share. This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question "Does the use of the term "medical record" in the context of a research informed consent document accurately represent the scope of the data involved?" Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine's (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. "Medical record", a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context of contemporary information management and governance.

Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials.

PubMed

Reinert, Christiane; Kremmler, Lukas; Burock, Susen; Bogdahn, Ulrich; Wick, Wolfgang; Gleiter, Christoph H; Koller, Michael; Hau, Peter

2014-01-01

In randomised controlled trials (RCTs), patient informed consent documents are an essential cornerstone of the study flow. However, these documents are often oversized in format and content. Clinical experience suggests that study information sheets are often not used as an aid to decision-making due to their complexity. We analysed nine patient informed consent documents from clinical neuro-oncological phase III-studies running at a German Brain Tumour Centre with the objective to investigate the quality of these documents. Text length, formal layout, readability, application of ethical and legal requirements, scientific evidence and social aspects were used as rating categories. Results were assessed quantitatively by two independents investigators and were depicted using net diagrams. All patient informed consent documents were of insufficient quality in all categories except that ethical and legal requirements were fulfilled. Notably, graduate levels were required to read and understand five of nine consent documents. Quality deficits were consistent between the individual study information texts. Irrespective of formal aspects, a document that is intended to inform and motivate patients to participate in a study needs to be well-structured and understandable. We therefore strongly mandate to re-design patient informed consent documents in a patient-friendly way. Specifically, standardised components with a scientific foundation should be provided that could be retrieved at various times, adapted to the mode of treatment and the patient's knowledge, and could weigh information dependent of the stage of treatment decision. Copyright © 2013 Elsevier Ltd. All rights reserved.

Addendum to the Closure Report for Corrective Action Unit 358: Areas 18, 19, 20 Cellars/Mud Pits Nevada Test Site, Nevada

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the January 2004, Closure Report for Corrective Action Unit 358: Areas 18, 19, 20 Cellars/Mud Pits as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of:more » • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 20-23-02, Postshot Cellar • CAS 20-23-03, Cellar • CAS 20-23-04, Postshot Cellar • CAS 20-23-05, Postshot Cellar • CAS 20-23-06, Cellar • CAS 20-37-01, Cellar & Mud Pit • CAS 20-37-05, Cellar These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum to the Closure Report for Corrective Action Unit 394: Areas 12, 18, and 29 Spill/Release Sites Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the September 2003, Closure Report for Corrective Action Unit 394: Areas 12, 18, and 29 Spill/Release Sites as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consistsmore » of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 12-25-04, UST 12-16-2 Waste Oil Release • CAS 18-25-01, Oil Spills • CAS 18-25-02, Oil Spills • CAS 18-25-03, Oil Spill • CAS 29-44-01, Fuel Spill These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

46 CFR 67.145 - Restrictions on exchange; requirement and procedure for mortgagee consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Restrictions on exchange; requirement and procedure for mortgagee consent. 67.145 Section 67.145 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DOCUMENTATION AND MEASUREMENT OF VESSELS DOCUMENTATION OF VESSELS Application for Documentation, Exchange or Replacement of Certificate of...

What emergency physicians should know about informed consent: legal scenarios, cases, and caveats.

PubMed

Moore, Gregory P; Moffett, Peter M; Fider, Cyril; Moore, Malia J

2014-08-01

The basic concept of obtaining informed consent is familiar to emergency physicians, and many consider themselves well versed on the topic; however, lack of obtaining proper informed consent is a frequent source of lawsuits. The legal definitions and nuances of informed consent might surprise even the most experienced physician. This article will detail the historical legal evolution of the concept of informed consent. It will also report defining and recent court cases that illustrate the current medical-legal status of informed consent. Special scenarios, caveats, and documentation recommendations are discussed. After reading this article the emergency physician will know how to practice and document the appropriate aspects of informed consent in emergency medicine, as well as understand available legal defenses if a lawsuit should arise. © 2014 by the Society for Academic Emergency Medicine.

Informed consent: Part II.

PubMed

Murphy, E K

1988-05-01

Although the legal responsibility to inform and obtain the patient's consent lies with the surgeon, the agency may have a duty to ensure that the patient's consent has been obtained. Agency liability is limited to those cases in which the agency knew (or should have known) that informed consent was not obtained. It is still unclear whether agencies have an affirmative duty to ensure that consent has been obtained. If this duty does exist, it appears that a policy requiring documentation in the medical record of the patient's consent meets this requirement. It is clear that whatever the extent of the agency's duty, it does not include the duty to give the patient information or assess his or her level of understanding. Court opinions discourage anyone but the physician from doing so. A nurse's legal responsibility is limited to following agency policy. Courts have not recognized any independent nurse duty beyond that which accrues to them as employees of the agency. Perioperative nurses often provide the final checkpoint that consent has been obtained and documented before the procedure begins. This unique position raises additional legal concerns if the agency's policy is not followed or if the premedicated patient arrives without proper consent documentation in the record. Perioperative nursing concerns will be discussed next month in Part III.

[The post-mortal right of privacy].

PubMed

Jansen, Christoph

2008-01-01

Regarding the post-mortal right of privacy a distinction must be made between post-mortal protection of the personality, the post-mortal duty of confidentiality and the problems associated with the necessity to consent to a clinical post-mortem. The post-mortal protection of the personality both grants the post-mortal right to respect for privacy, which can be asserted by rights holder, and entitles to claim damages resulting from breach of any proprietary elements of the right to post-mortal privacy. The post-mortal duty of confidentiality protects against the unauthorized disclosure of confidential information about the patient even after his death. The physician has to decide whether the consent of the deceased may be presumed; however, he/she has to state the reasons why, due to medical confidentiality, he/she feels unable to disclose such information. Basically, the consent for clinical post-mortem can be effectively declared by way of a refusal clause in the hospital admission contract.

National Comparative Audit of Blood Transfusion: report on the 2014 audit of patient information and consent.

PubMed

Booth, C; Grant-Casey, J; Lowe, D; Court, E L; Allard, S

2017-11-28

The aim of this study was to assess current practices around obtaining consent for blood transfusion and provision of patient information in hospitals across the UK and identify areas for improvement. Recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) (2011) state that valid consent should be obtained for blood transfusion and documented in clinical records. A standardised source of information should be available to patients. Practices in relation to this have historically been inconsistent. The consent process was studied in hospitals across the UK over a 3-month period in 2014 by means of an audit of case notes and simultaneous surveys of patients and staff. In total, 2784 transfusion episodes were reviewed across 164 hospital sites. 85% of sites had a policy on consent for transfusion. Consent was documented in 43% of case notes. 68% of patients recalled being given information on benefits of transfusion, 38% on risks and 8% on alternatives and 28% reported receiving an information leaflet. In total, 85% of staff stated they had explained the reason for transfusion, but only 65% had documented this. 41% of staff had received training specifically on transfusion consent in the last 2 years. There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened. © 2017 British Blood Transfusion Society.

Applying a sociolinguistic model to the analysis of informed consent documents.

PubMed

Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

2009-11-01

Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

Addendum to the Corrective Action Decision Document/Closure Report for Corrective Action Unit 406: Area 3 Building 03-74 & Building 03-58 Underground Discharge Points and Corrective Action Unit 429: Area 3 Building 03-55 & Area 9 Building 09-52 Underground Discharge Points, Tonopah Test Range, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the March 2000, Corrective Action Decision Document / Closure Report for Corrective Action Unit 406: Area 3 Building 03-74 & 03-58 Underground Discharge Points and Corrective Action Unit 429: Area 3 Building 03-55 & Area 9 Building 09-52 Underground Discharge Points (TTR) as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. Themore » approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the UR for CAS 03-51-001-0355 – Photo Shop UDP, Drains in CAU 429. It should be noted that there are no changes to CAU 406. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

PubMed

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P < 0.0005), highest in infection (96.1%) and lowest in recurrence (52.3%). For patient recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients <65 years old recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to <2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

[The informed consent in international clinical trials including developing countries].

PubMed

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 1 2011-07-01 2011-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 1 2012-07-01 2012-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

40 CFR 26.1117 - Documentation of informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Documentation of informed consent. 26.1117 Section 26.1117 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving...

Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms.

PubMed

St John, E R; Scott, A J; Irvine, T E; Pakzad, F; Leff, D R; Layer, G T

2017-08-01

Completion of hand-written consent forms for surgical procedures may suffer from missing or inaccurate information, poor legibility and high variability. We audited the completion of hand-written consent forms and trialled a web-based application to generate modifiable, procedure-specific consent forms. The investigation comprised two phases at separate UK hospitals. In phase one, the completion of individual responses in hand-written consent forms for a variety of procedures were prospectively audited. Responses were categorised into three domains (patient details, procedure details and patient sign-off) that were considered "failed" if a contained element was not correct and legible. Phase two was confined to a breast surgical unit where hand-written consent forms were assessed as for phase one and interrogated for missing complications by two independent experts. An electronic consent platform was introduced and electronically-produced consent forms assessed. In phase one, 99 hand-written consent forms were assessed and the domain failure rates were: patient details 10%; procedure details 30%; and patient sign-off 27%. Laparoscopic cholecystectomy was the most common procedure (7/99) but there was significant variability in the documentation of complications: 12 in total, a median of 6 and a range of 2-9. In phase two, 44% (27/61) of hand-written forms were missing essential complications. There were no domain failures amongst 29 electronically-produced consent forms and no variability in the documentation of potential complications. Completion of hand-written consent forms suffers from wide variation and is frequently suboptimal. Electronically-produced, procedure-specific consent forms can improve the quality and consistency of consent documentation. Copyright © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

34 CFR 97.117 - Documentation of informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Documentation of informed consent. 97.117 Section 97.117 Education Office of the Secretary, Department of Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects...

45 CFR 690.117 - Documentation of informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to...: (1) That the only record linking the subject and the research would be the consent document and the...

45 CFR 690.117 - Documentation of informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 690.117 Public Welfare Regulations Relating to Public Welfare (Continued) NATIONAL SCIENCE FOUNDATION... witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to...: (1) That the only record linking the subject and the research would be the consent document and the...

Beyond informed consent.

PubMed Central

Bhutta, Zulfiqar A.

2004-01-01

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings. PMID:15643799

Addendum to the Closure Report for Corrective Action Unit 404: Roller Coaster Sewage Lagoons and North Disposal Trench, Tonopah Test Range, Nevada, Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the September 1998, Closure Report for Corrective Action Unit 404: Roller Coaster Lagoons and Trench, Tonopah Test Range, Nevada as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, thismore » addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the modification of the UR for CAS TA-03-001-TARC Roller Coaster Lagoons. This UR was established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and was based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This reevaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to modify the UR for CAS TA-03-001-TARC to an administrative UR. Administrative URs differ from standard URs in that they do not require onsite postings (i.e., signs) or other physical barriers (e.g., fencing, monuments), and they do not require periodic inspections (see Section 6.2 of the Industrial Sites Project Establishment of Final Action Levels [NNSA/NSO, 2006c]). This Administrative UR was based on a “Remote Work Sites” future land use scenario that was used to calculate the FAL. The administrative UR will protect workers from an exposure exceeding that used in the calculation of the FAL (i.e., 336 hours per year). Any proposed activity within these use restricted areas that would potentially cause an exposure exceeding this exposure limit would require approval from the Nevada Division of Environmental Protection (NDEP). Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum to the Closure Report for Corrective Action Unit 404: Roller Coaster Lagoons and Trench, Tonopah Test Range, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the September 1998, Closure Report for Corrective Action Unit 404: Roller Coaster Lagoons and Trench, Tonopah Test Range, Nevada as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, thismore » addendum consists of: • This cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS TA-03-001-TARC Roller Coaster Lagoons • CAS TA-21-001-TARC Roller Coaster N. Disposal Trench These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to modify these URs to administrative URs. Administrative URs differ from standard URs in that they do not require onsite postings (i.e., signs) or other physical barriers (e.g., fencing, monuments), and they do not require periodic inspections (see Section 6.2 of the Industrial Sites Project Establishment of Final Action Levels [NNSA/NSO, 2006c]). These Administrative URs were based on a “Remote Work Sites” future land use scenario that was used to calculate the FAL. The administrative UR will protect workers from an exposure exceeding that used in the calculation of the FAL (i.e., 336 hours per year). Any proposed activity within these use restricted areas that would potentially cause an exposure exceeding this exposure limit would require approval from the Nevada Division of Environmental Protection (NDEP). Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

County of Hawai’i: Administrative Order on Consent; Docket No. SDWA-UIC-AOC-2017-0002

EPA Pesticide Factsheets

Documents related to the Administrative Order on Consent (“Consent Order”) between the U.S. Environmental Protection Agency Region 9 (“EPA”) and the County of Hawai‘i. Docket No. SDWA-UIC-AOC-2017-0002.

1,2-Ethylene Dichloride; Final Enforceable Consent Agreement and Testing Consent Order

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable testing Consent Order with the Dow Chemical Co, Vulcan Materials Co, Occidental Chemical Corp, Oxy Vinyls, LP, Georgia Gulf Corp, Westlake Chemical Corp, PPG Industries, Inc., and Formosa Plastics.

Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery.

PubMed

Zarnegar, Roxaneh; Brown, Matthew R D; Henley, Matthew; Tidman, Victoria; Pathmanathan, Ahilan

2015-11-01

In Britain, consent for surgery is documented using a Department of Health form signed by the surgeon and the patient. In contrast, anaesthetic procedures have no formalised consent process. Evidence on the process of consent for regional anaesthesia, and patient perceptions of this, is scarce outside obstetric practice. We aimed to determine patient recall and perceptions of consent for interscalene brachial plexus block and compared this to surgical consent for shoulder arthroplasty. Prospective observational survey. A specialist musculoskeletal centre, UK. Forty-six patients (female:male 30:16, mean age 61 years) undergoing shoulder arthroplasty with interscalene brachial plexus block. Recall and understanding of consent for regional anaesthesia and surgery was examined using a semi-structured questionnaire 1-2 days after arthroplasty. Surgical consent forms and discussions recorded by the anaesthetist were examined in participants' medical notes to compare against the level of recall. Analysis to determine statistical significance was conducted using McNemar's test. Recall of surgical risks was overall significantly better than recall of brachial plexus block risks. Compared to their recollections of surgical risk, patients remembered fewer specific risks for brachial plexus block (p < 0.001). There were more patients unable to recall any risks when questioned about brachial plexus block than about their surgery (p < 0.05). One-third of patients did not regard the consent discussion about regional anaesthesia as important as consent for surgery and over one-quarter had not recognised the preoperative discussion about the brachial plexus block as a consent process similar to that conducted for surgery. Fundamental misunderstandings about the consent process are prevalent. Future work in this area should seek to investigate how documentation of the consent process and patients' understanding of consent for regional anaesthesia can be improved. © The Royal Society of Medicine.

Informed consent document improvement does not increase patients' comprehension in biomedical research

PubMed Central

Paris, Adeline; Brandt, Christian; Cornu, Catherine; Maison, Patrick; Thalamas, Claire; Cracowski, Jean-Luc

2010-01-01

AIMS International guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained. A written document describing the research, the informed consent (IC) document, must be given to all participants by the investigator. Most IC documents are long, containing much information. The aim of the present study was to determine whether the modification of the IC document by a working group or systematic improvement in its lexicosyntactic readability can improve comprehension of the written information given to patients participating in biomedical research. METHODS One hundred and fifty-nine patients were randomized to read one of the three versions of the IC document: unchanged document, document modified using systematic improvement of lexicosyntactic readability and document modified by a working group. RESULTS Neither the improvement in the lexicosyntactic readability, nor the intervention of the working group significantly improved the score of objective comprehension for the subjects included in this study: it was 66.6 (95% confidence interval 64.0, 69.2) for the control group, 68.8 (66.2, 71.4) for the group with the document improved for lexicosyntactic readability and 69.2 (66.0, 72.4) for the group who read the document improved by the working group (P= 0.38). CONCLUSIONS We failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension. PMID:20233193

Informed consent for genetic research.

PubMed

Hamvas, Aaron; Madden, Katherine K; Nogee, Lawrence M; Trusgnich, Michelle A; Wegner, Daniel J; Heins, Hillary B; Cole, F Sessions

2004-06-01

Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome. Survey conducted between February 1, 2002, and March 31, 2003. Academic, tertiary free-standing children's hospital. A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed. Reasons for refusal. Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study. The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.

Addendum to the Closure Report for Corrective Action Unit 355: Area 2 Cellars/Mud Pits Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

This document constitutes an addendum to the November 2003, Closure Report for Corrective Action Unit 355: Area 2 Cellars/Mud Pits as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications. In conformance with the UR Modification document, this addendum consists of: • Thismore » cover page that refers the reader to the UR Modification document for additional information • The cover and signature pages of the UR Modification document • The NDEP approval letter • The corresponding section of the UR Modification document This addendum provides the documentation justifying the cancellation of the URs for: • CAS 02-37-01, Cellar & Mud Pit • CAS 02-37-03, Cellar & Mud Pit • CAS 02-37-04, Cellar & Mud Pit • CAS 02-37-05, Cellar & Mud Pit • CAS 02-37-06, Cellar & Mud Pit • CAS 02-37-07, Cellar & Mud Pit • CAS 02-37-10, Cellar & Mud Pit • CAS 02-37-11, Cellar & Mud Pit • CAS 02-37-12, Cellar & Mud Pit • CAS 02-37-13, Cellar & Mud Pit • CAS 02-37-14, Cellar & Mud Pit • CAS 02-37-15, Cellar & Mud Pit • CAS 02-37-16, Cellar & Mud Pit • CAS 02-37-17, Cellar • CAS 02-37-18, Cellar & Tanks These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996; as amended August 2006). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006c). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004f). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Bioethics and power: Informed consent procedures in post-socialist Latvia.

PubMed

Putniņa, Aivita

2013-12-01

This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two. Copyright © 2013 Elsevier Ltd. All rights reserved.

Using computer agents to explain medical documents to patients with low health literacy.

PubMed

Bickmore, Timothy W; Pfeifer, Laura M; Paasche-Orlow, Michael K

2009-06-01

Patients are commonly presented with complex documents that they have difficulty understanding. The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants. Subjects were invited to participate in a simulated consent process for a study involving a genetic repository. Explanation of the research consent form by the computer agent was compared to explanation by a human and a self-study condition in a randomized trial. Responses were compared according to level of health literacy. Participants were most satisfied with the consent process and most likely to sign the consent form when it was explained by the computer agent, regardless of health literacy level. Participants with adequate health literacy demonstrated the highest level of comprehension with the computer agent-based explanation compared to the other two conditions. However, participants with limited health literacy showed poor comprehension levels in all three conditions. Participants with limited health literacy reported several reasons, such as lack of time constraints, ability to re-ask questions, and lack of bias, for preferring the computer agent-based explanation over a human-based one. Animated computer agents can perform as well as or better than humans in the administration of informed consent. Animated computer agents represent a viable method for explaining health documents to patients.

Time to address the problem of post-mortem procurement of organs for transplantation occurring without proper pre-mortem consent.

PubMed

Garwood-Gowers, Austen

2013-09-01

Current cadaveric organ transplant systems allow individuals to be classified as donors after death where they registered wishes in favour of this prior to death. However, systems for registering wishes pertaining to donation fall woefully short of securing proper consent. Furthermore, even jurisdictions which technically require consent to be obtained in order to treat an individual as a donor, allow that consent to be given by next of kin after death in circumstances where there is no evidence of the individual having refused prior to death. This article explores these and related issues with current systems from the perspectives of health law norms, ethics and human rights. It concludes that proper pre-mortem consent ought to be a pre-requisite for post-mortem organ transplantation.

Good eggs? Evaluating consent forms for egg donation.

PubMed

Cattapan, Alana Rose

2016-07-01

Beyond gaps in the provision of information, the informed consent process for egg donation is complicated by conflicts of interest, payment and a lack of longitudinal data about physiological and psychological risks. Recent scholarship has suggested that egg donation programmes could improve the informed consent process by revising consent documents. At a minimum, these documents should include information about eight key criteria: the nature and objectives of treatment; the benefits, risks and inconveniences of egg donation; the privacy of donors and their anonymity (where applicable); disclosure that participation is voluntary (withdrawal); the availability of counselling; financial considerations; the possibility of an unsuccessful cycle and potential uses of the eggs retrieved. This study evaluates the incorporation of these minimum criteria in consent forms for egg donation, obtained through requests to Canadian fertility clinics. Even when clinics were considered to have met criteria simply by mentioning them, among the eight consent forms assessed, none met the minimum standards. Only half of clinics addressed privacy/anonymity concerns, financial issues and the possibility of a future cycle. Improving the quality of consent documentation to meet the minimum standards established by this study may not be an onerous task. For some, this will include re-evaluating how they include one or two elements of disclosure, and for others, this will require a substantial overhaul. Using the criteria provided by this study as the minimum standard for consent could ensure that donors have the basic information they need to make informed decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

How IRBs View and Make Decisions About Consent Forms

PubMed Central

Klitzman, Robert L.

2013-01-01

IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn’t been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how “perfect” forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also “nitpick” these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research. PMID:23485667

A Rural Community's Involvement in the Design and Usability Testing of a Computer-Based Informed Consent Process for the Personalized Medicine Research Project

PubMed Central

Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

2014-01-01

Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants’ understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, such as genetic clinical trials consents. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time. PMID:24273095

[Formal quality assessment of informed consent documents in 9 hospitals].

PubMed

Calle-Urra, J E; Parra-Hidalgo, P; Saturno-Hernández, P J; Martínez-Martínez, M J; Navarro-Moya, F J

2013-01-01

Informed consent forms are very important in the process of medical information. The aim of this study is to design reliable formal quality criteria of these documents and their application in the evaluation of those used in the hospitals of a regional health service. Criteria have been designed from the analysis of existing regulations, previous studies and consultation with key experts. The interobserver concordance was assessed using the kappa index. Criteria evaluation was performed on 1425 documents of 9 hospitals. A total of 19 criteria used in the evaluation of the quality of informed consent forms have been obtained. Kappa values were higher than 0,60 in 17 of them and higher than 0,52 in the other 2. The average number of defects per document was 7.6, with a high-low ratio among hospitals of 1.84. More than 90% of the documents had defects in the information on consequences and contraindications, and in about 90% it did not mention the copy to the patient. More than 60% did not comply with stating the purpose of the procedure, a statement of having understood and clarified doubts, and the treatment options. A tool has been obtained to reliably assess the formal quality of the informed consent forms. The documents assessed have a wide margin for improvement related to giving a copy to the patient, and some aspects of the specific information that patients should receive. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.

PubMed

Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

2014-01-01

Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants' understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, including those for trials involving treatment of genetic disorders. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time. © 2013 Wiley Periodicals, Inc.

Testing Consent Order On 4 Nonylphenol, Branched

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable testing Consent Order with GAF Chemicals Corporation, GE Specialty Chemicals Incorporated, Kalama Chemicals Incorporated, Monsanto Company, Rohm & Haas Company, Schenectady Chemicals Incorporated.

Mandated monitoring of post-project impacts in the Czech EIA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Branis, Martin; Christopoulos, Stamatios

2005-04-15

Altogether, 801 documents of consent (50% of all) issued under the EIA Act No. 244/1992 by the competent authorities in the Czech Republic between 1993 and 2001 were studied. The aim of the analysis was to find and characterize conditions prescribing to the developer to perform ex-ante and ex-post monitoring of potential impacts of projects submitted for approval. It was found that each of the studied documents (standpoints) contained on average three to four conditions prescribing to collect data on various environmental factors during the preparation, implementation and/or operation phase of the development in question. The number of monitoring conditionsmore » contained in the standpoints issued by the Ministry of Environment as well as by the District Offices increased during the period studied from about two to five per project indicating a growing interest in and/or need to obtaining such data. Even though there is a good legal background for collecting monitoring data from implementation and operation phase of new developments, the Czech EIA Act (similarly as EIA acts in other countries) does not provide any practical background for this activity. Without relevant institutional, personal and financial support the possibility to impose post-project monitoring to the developer remains rather a challenge to, not advantage of the Czech EIA Act.« less

Audit of the informed consent process as a part of a clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2014-06-01

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

Testing Consent Order on Alkyl Phthalates

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable testing Consent Order with Aristech Chemical Corporation (Aristech), BASF Corporation (BASF), Exxon Chemical Company (Exxon), Eastman Kodak Company (Kodak), and Witco Corporation, Humko Chemical.

Testing Consent Order for Acrylic Acid

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable testing Consent Order with BASF Corporation, Dow Chemical U.S.A., Hoechst Celanese Chemical Group, Rohm and Haas Company, and Union Carbide Chemicals and Plastics, Inc.

A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process.

PubMed

Strech, D; Bein, S; Brumhard, M; Eisenmenger, W; Glinicke, C; Herbst, T; Jahns, R; von Kielmansegg, S; Schmidt, G; Taupitz, J; Tröger, H D

2016-06-01

Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank governance framework. Recent reviews demonstrated high variability in what issues these documents mention or not and how the issues are explained. This might undermine the protection of sample donors, complicate networked biobank research, create research waste and impact on public trust. A systematic analysis of international research guidelines and existing broad consent templates was performed. Based on this information an interdisciplinary expert group from the AKMEK (Permanent Working Party of German RECs) developed a draft template and organized a comprehensive stakeholder consultation. After revision the final template was consented by all 53 German RECs. This paper briefly explores the spectrum of potentially relevant issues for broad consent forms. It then elaborates the template and how it was designed to be applicable in different types of biobanks. To further improve the validity and applicability of broad consent forms in biobank and other big data research, practice evaluations are needed. We hope that in this regard the presented template supports the development of new consent forms as well as the evaluation and revision of existing ones. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Using digital multimedia to improve parents' and children's understanding of clinical trials.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Levine, Robert

2015-06-01

Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents' and children's understanding of clinical trial concepts and participation. Parents (n=148) and children (n=135) were each randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process. Regardless of the mode of information delivery, all participants demonstrated improved pretest to post-test understanding. While there were no statistical differences in parents' post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65 (4.1) vs 8.85 (4.1) (2.8, 1.4, 4.2) 0-18 scale where 18=complete understanding). Furthermore, the IP was found to be significantly 'easier to follow' and 'more effective' in presenting information compared with the TF. Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Re-evaluating ethical concerns in planned emergency research involving critically ill patients: an interpretation of the guidance document from the United States Food and Drug Administration.

PubMed

Smischney, Nathan J; Onigkeit, James A; Hinds, Richard F; Nicholson, Wayne T

2015-01-01

U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Review of the 2011 and updated FDA guidance document on exemption from informed consent. The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Testing Consent Order for Sodium Cyanide

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable testing Consent Order with E.I. du Pont de Nemours and Company (DuPont), FMC Corporation (FMC), Degussa Corporation (Degussa), ICI Americas Incorporated (ICI), and Cyanco Company (Cyanco).

24 CFR 5.502 - Requirements concerning documents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Requirements concerning documents... § 5.502 Requirements concerning documents. For any notice or document (decision, declaration, consent... regulations for requirements concerning communications with persons with disabilities.) ...

Testing Consent Order on Mesityl Oxide

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable testing Consent Order with four of the manufacturers of mesityl oxide (MO; CAS No, 141—79—7), who have agreed to perform certain health effects tests with MO.

Testing Consent Order on 3,4-Dichlorobenzotrifluoride (DCBTF) and Response to the Interagency Testing Committee

EPA Pesticide Factsheets

This document announces that EPA has signed an enforceable Testing Consent Order with Occidental Chemical Corp. to perform certain chemical fate and environmental effects tests on 3,4-dichlorobenzotrifluoride (DCBTF).

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

PubMed

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred

PubMed Central

2014-01-01

Background Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes. Methods We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”. Results Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). Conclusions 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients. PMID:24406020

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... investigation, including research development, testing and evaluation, designed to develop or contribute to... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms..., questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB; (3) Documentation of...

Assessment of Impact of Consent Decree Annual Tonnage Limits on Transport Rule Allocations

EPA Pesticide Factsheets

This Technical Support Document (TSD) provides information that supports EPA’s analysis of the impact of emission constraints specified in existing federally-enforceable judicial consent decrees on allowance allocations under the Transport Rule.

Informed consent: it is more than just a document.

PubMed

Wilhite, C Leigh

2010-01-01

With litigation in the forefront of the minds of most healthcare professionals today, obtaining valid, fully informed consent from patients means that no recovery should be allowed in a court of law against that provider for treating, examining, or operating on a patient without his or her informed consent when (1) the action of the provider in obtaining the consent of the patient, or person authorized to give consent, was in accordance with an accepted standard of practice and/or (2) a reasonable individual with information provided by the practitioner, under the circumstances, would have a general understanding of the procedure, the medically acceptable alternative procedures or treatments, and the substantial risks and hazards inherent in the proposed treatment or procedures, which are recognized among providers, in the same or similar community, who perform similar treatments. Most courts do not permit recovery against a provider if the patient would reasonably, under all the surrounding circumstances, have undergone such treatment or procedure as he or she had been advised by the provider. A consent that is evidenced in writing and meets requirements, if validly signed by the patient or another authorized person, raises a rebuttable presumption of a valid consent. A valid signature is the one that is given by a person who under all the surrounding circumstances is mentally and physically competent to give consent. Armed with this knowledge, the plastic surgical nurse will understand that informed consent is far more than just a document signed by the patient that becomes part of his or her medical record.

Developing competency in post-graduate students of anaesthesiology for taking informed consent for elective caesarean section.

PubMed

Mehta, Kamla Harshad; Shah, Vandana Saurin; Patel, Kirti Dhirajlal

2017-02-01

Post-graduate medical students (residents) generally lack effective communication skills required to obtain informed consent. The aim of this study was to assess role play and group discussion as teaching/learning tools for improving residents' knowledge on informed consent and competency in communicating while taking informed consent. This prospective, observational study was conducted on 30 anaesthesia residents. They were first observed while obtaining informed consent and their basic knowledge regarding communication skills was checked with a pre-test questionnaire. Then, lecture and group discussion were carried out to increase the knowledge base, and their knowledge gain was checked by the same questionnaire as a post-test. Communication skills were demonstrated by role play and residents were assessed by direct unobtrusive observation using a checklist. Feedback regarding effectiveness of programme was taken from students. Statistical analyses were done using Microsoft Office Excel and SPSS software. Percentage gain was 122.37% for knowledge domain. For communication skills, mean ± standard deviation for checklist was 8.93 ± 1.43 before role play and it improved to 17.96 ± 1.29 after role play. Regarding effectiveness of role play as a teaching/learning tool, 76.66% of residents said they strongly agreed and 23.33% of residents said they agreed. Likert scale for evaluation of programme was graded 4 or 5 by all residents. The knowledge and communication skills required for obtaining informed consent was improved significantly after role playing.

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

PubMed

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-04

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications, and Consent

PubMed Central

Horst, Jeremy A; Ellenikiotis, Hellene; Milgrom, Peter M

2016-01-01

The Food and Drug Administration recently cleared silver diamine fluoride for reducing tooth sensitivity. Clinical trials document arrest and prevention of dental caries by silver diamine fluoride; this off-label use is now permissible and appropriate under U.S. law. A CDT code was approved for caries arresting medicaments for 2016 to facilitate documentation and billing. We present a systematic review, clinical indications, clinical protocol, and consent procedure to guide application for caries arrest treatment. PMID:26897901

Decisional Capacity for Research Participation in Individuals with Mild Cognitive Impairment

PubMed Central

Jefferson, Angela L.; Lambe, Susan; Moser, David J.; Byerly, Laura K.; Ozonoff, Al; Karlawish, Jason H.

2009-01-01

OBJECTIVES To assess decisional capacity performance and the neuropsychological correlates of such performance to better understand higher-level instrumental activities of daily living in individuals with mild cognitive impairment (MCI). DESIGN Cross-sectional. SETTING Research center, medical center, or patient’s home. PARTICIPANTS Forty participants with MCI and 40 cognitively normal older controls (NCs) aged 60 to 90 (mean age ± standard deviation 73.3 ± 6.6; 54% female). MEASUREMENTS Capacity to provide informed consent for a hypothetical, but ecologically valid, clinical trial was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Neuropsychological functioning was assessed using a comprehensive protocol. RESULTS Adjusted between-group comparisons yielded significant differences for most decisional capacity indices examined, including Understanding (P = .001; NC>MCI) and Reasoning (P = .002; NC>MCI). Post hoc analyses revealed that participants with MCI who were categorized as capable of providing informed consent according to expert raters had higher levels of education than those who were categorized as incapable. CONCLUSION The findings suggest that many individuals with MCI perform differently on a measure of decisional capacity than their NC peers and that participants with MCI who are incapable of providing informed consent on a hypothetical and complex clinical trial are less educated. These findings are consistent with prior studies documenting functional and financial skill difficulties in individuals with MCI. PMID:18482298

Improving readability of informed consents for research at an academic medical institution.

PubMed

Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

2017-12-01

The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

Governing the postmortem procurement of human body material for research.

PubMed

Van Assche, Kristof; Capitaine, Laura; Pennings, Guido; Sterckx, Sigrid

2015-03-01

Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent.

42 CFR 486.346 - Condition: Organ preparation and transport.

Code of Federal Regulations, 2010 CFR

2010-10-01

... with the identification number, specific contents, and donor's blood type. ... complete documentation of donor information to the transplant center with the organ, including donor evaluation, the complete record of the donor's management, documentation of consent, documentation of the...

Blockchain protocols in clinical trials: Transparency and traceability of consent.

PubMed

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2017-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

Blockchain protocols in clinical trials: Transparency and traceability of consent

PubMed Central

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2018-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility. PMID:29167732

Addendum to the Closure Report for Corrective Action Unit 326: Areas 6 and 27 Release Sites, Nevada Test Site, Nevada, Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grant Evenson

This document constitutes an addendum to the Closure Report for Corrective Action Unit 326: Areas 6 and 27 Release Sites, Nevada Test Site, Nevada (Revision 1), December 2002 as described in the document Supplemental Investigation Report for FFACO Use Restrictions, Nevada Test Site, Nevada (SIR) dated November 2008. The SIR document was approved by NDEP on December 5, 2008. The approval of the SIR document constituted approval of each of the recommended UR removals. In conformance with the SIR document, this addendum consists of: • This page that refers the reader to the SIR document for additional information • Themore » cover, title, and signature pages of the SIR document • The NDEP approval letter • The corresponding section of the SIR document This addendum provides the documentation justifying the cancellation of the UR for CAS 06-25-01, CP-1 Heating Oil Release. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was reevaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum to the Closure Report for Corrective Action Unit 403: Second Gas Station, Tonopah Test Range, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grant Evenson

This document constitutes an addendum to the Closure Report for Corrective Action Unit 403: Second Gas Station, Tonopah Test Range, Nevada, September 1998 as described in the document Supplemental Investigation Report for FFACO Use Restrictions, Nevada Test Site, Nevada (SIR) dated November 2008. The SIR document was approved by NDEP on December 5, 2008. The approval of the SIR document constituted approval of each of the recommended UR removals. In conformance with the SIR document, this addendum consists of: • This page that refers the reader to the SIR document for additional information • The cover, title, and signature pagesmore » of the SIR document • The NDEP approval letter • The corresponding section of the SIR document This addendum provides the documentation justifying the cancellation of the UR for CAS 03-02-004-0360, Underground Storage Tanks. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was reevaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum to the Closure Report for Corrective Action Unit 339: Area 12 Fleet Operations Steam Cleaning Discharge Area, Nevada Test Site, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grant Evenson

This document constitutes an addendum to the Closure Report for CAU 339: Area 12 Fleet Operations Steam Cleaning Discharge Area Nevada Test Site, December 1997 as described in the document Supplemental Investigation Report for FFACO Use Restrictions, Nevada Test Site, Nevada (SIR) dated November 2008. The SIR document was approved by NDEP on December 5, 2008. The approval of the SIR document constituted approval of each of the recommended UR removals. In conformance with the SIR document, this addendum consists of: • This page that refers the reader to the SIR document for additional information • The cover, title, andmore » signature pages of the SIR document • The NDEP approval letter • The corresponding section of the SIR document This addendum provides the documentation justifying the cancellation of the UR for CAS 12-19-01, A12 Fleet Ops Steam Cleaning Efflu. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was reevaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Addendum 2 to the Closure Report for Corrective Action Unit 358: Areas 18, 19, 20 Cellars/Mud Pits, Nevada Test Site, Nevada, Revison 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grant Evenson

This document constitutes an addendum to the Closure Report for Corrective Action Unit 358: Areas 18, 19, 20 Cellars/Mud Pits, Nevada Test Site, Nevada, January 2004 as described in the document Supplemental Investigation Report for FFACO Use Restrictions, Nevada Test Site, Nevada (SIR) dated November 2008. The SIR document was approved by NDEP on December 5, 2008. The approval of the SIR document constituted approval of each of the recommended UR removals. In conformance with the SIR document, this addendum consists of: • This page that refers the reader to the SIR document for additional information • The cover, title,more » and signature pages of the SIR document • The NDEP approval letter • The corresponding section of the SIR document This addendum provides the documentation justifying the cancellation of the UR for CAS 19-09-05, Mud Pit. This UR was established as part of a Federal Facility Agreement and Consent Order (FFACO) corrective action and is based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996). Since this UR was established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, this UR was reevaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006). This re-evaluation consisted of comparing the original data (used to define the need for the UR) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove the UR because contamination is not present at the site above the risk-based FALs. Requirements for inspecting and maintaining this UR will be canceled, and the postings and signage at this site will be removed. Fencing and posting may be present at this site that are unrelated to the FFACO UR such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at this site.« less

Informed Consent Conversations and Documents: A Quantitative Comparison

PubMed Central

Koyfman, Shlomo A.; Reddy, Chandana A.; Hizlan, Sabahat; Leek, Angela C.; Kodish, Eric

2015-01-01

Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease Score (FRES) of ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Conclusions Clinicians use more understandable language during ICCs than the corresponding ICD, but less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation. PMID:26505269

Family and community concerns about post-mortem needle biopsies in a Muslim society

PubMed Central

2011-01-01

Background Post-mortem needle biopsies have been used in resource-poor settings to determine cause of death and there is interest in using them in Bangladesh. However, we did not know how families and communities would perceive this procedure or how they would decide whether or not to consent to a post-mortem needle biopsy. The goal of this study was to better understand family and community concerns and decision-making about post-mortem needle biopsies in this low-income, predominantly Muslim country in order to design an informed consent process. Methods We conducted 16 group discussions with family members of persons who died during an outbreak of Nipah virus illness during 2004-2008 and 11 key informant interviews with their community and religious leaders. Qualitative researchers first described the post-mortem needle biopsy procedure and asked participants whether they would have agreed to this procedure during the outbreak. Researchers probed participants about the circumstances under which the procedure would be acceptable, if any, their concerns about the procedure, and how they would decide whether or not to consent to the procedure. Results Overall, most participants agreed that post-mortem needle biopsies would be acceptable in some situations, particularly if they benefitted society. This procedure was deemed more acceptable than full autopsy because it would not require major delays in burial or remove organs, and did not require cutting or stitching of the body. It could be performed before the ritual bathing of the body in either the community or hospital setting. However, before consent would be granted for such a procedure, the research team must gain the trust of the family and community which could be difficult. Although consent may only be provided by the guardians of the body, decisions about consent for the procedure would involve extended family and community and religious leaders. Conclusions The possible acceptability of this procedure during outbreaks represents an important opportunity to better characterize cause of death in Bangladesh which could lead to improved public health interventions to prevent these deaths. Obstacles for research teams will include engaging all major stakeholders in decision-making and quickly building a trusting relationship with the family and community, which will be difficult given the short window of time prior to the ritual bathing of the body. PMID:21668979

Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Malviya, Shobha; Philipson, Sandra J

2005-04-01

To examine whether a consent document modified to conform with the federal guidelines for readability and processability would result in greater parental understanding compared with a standard form. Randomized clinical study. The preoperative waiting area of a larger tertiary care children's hospital. A total of 305 parents of children scheduled for minor elective surgical procedures. Parents were randomized to receive information about a clinical study in 1 of 4 ways: (1) standard consent form alone, (2) standard consent form with verbal disclosure, (3) modified form alone (standard form modified to meet the federal guidelines for readability and processability), and (4) modified form with verbal disclosure. Parents were interviewed to determine their understanding of 11 elements of consent, including study purpose, protocol, risks, benefits to child (direct), benefit to others (indirect), freedom to withdraw, alternatives, duration of study, voluntariness, confidentiality, and whom to contact. Their responses were scored by 2 independent assessors. Understanding of the protocol, study duration, risks, and direct benefits, together with overall understanding, was greater among parents who received the modified form (P<.001). Additionally, parents reported that the modified form had greater clarity (P = .009) and improved layout compared with the standard form (P<.001). When parents were shown both forms, 81.2% preferred the modified version. Results suggest that a consent form written according to federal guidelines for readability and processability can improve parent understanding and thus will be important in enhancing the informed consent process.

Research subject privacy protection in otolaryngology.

PubMed

Noone, Michael C; Walters, K Christian; Gillespie, M Boyd

2004-03-01

Health Insurance Portability and Accountability Act regulations, which took effect on April 14, 2003, placed new constraints on the use of protected health information for research purposes. To review practices of research subject privacy protection in otolaryngology in order to determine steps necessary to achieve compliance with Health Insurance Portability and Accountability Act regulations. Literature review. Articles appearing in 2001 in 3 widely circulated otolaryngology journals were classified according to study design. The "Methods" section of each article was reviewed to determine whether the informed consent and institutional review board processes were clearly documented. Descriptive studies involving case reports and case series were more common than observational studies that include a control group (66% vs 11%). Few case series documented the consent process (18%) and institutional review board process (19%). Observational designs demonstrated better documentation of the consent process (P<.001) and the institutional review board exemption and approval process (P<.001). Methods used to protect subject privacy are not commonly documented in case series in otolaryngology. More attention needs to be given to research subject privacy concerns in the otolaryngology literature in order to comply with Health Insurance Portability and Accountability Act regulations.

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment trial

PubMed Central

Denning, Eileen; Sharma, Shweta; Smolskis, Mary; Touloumi, Giota; Walker, Sarah; Babiker, Abdel; Clewett, Megan; Emanuel, Ezekiel; Florence, Eric; Papadopoulos, Antonios; Sánchez, Adriana; Tavel, Jorge; Grady, Christine

2014-01-01

Objectives Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Methods Interested START sites were randomised to use either the standard consent form or the concise consent form for all of the site’s participants. Results A total of 4473 HIV-positive participants at 154 sites worldwide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. Conclusions These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. PMID:25711320

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

PubMed

Denning, E; Sharma, S; Smolskis, M; Touloumi, G; Walker, S; Babiker, A; Clewett, M; Emanuel, E; Florence, E; Papadopoulos, A; Sánchez, A; Tavel, J; Grady, C

2015-04-01

Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants. A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. © 2015 British HIV Association.

Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

PubMed Central

Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

2017-01-01

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

7 CFR 283.10 - Consent decision.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 4 2010-01-01 2010-01-01 false Consent decision. 283.10 Section 283.10 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE... of the document. Such decision shall be final and shall take effect 30 days after the date of the...

7 CFR 283.10 - Consent decision.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 4 2011-01-01 2011-01-01 false Consent decision. 283.10 Section 283.10 Agriculture Regulations of the Department of Agriculture (Continued) FOOD AND NUTRITION SERVICE, DEPARTMENT OF AGRICULTURE... of the document. Such decision shall be final and shall take effect 30 days after the date of the...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2011 CFR

2011-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2014 CFR

2014-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2012 CFR

2012-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2013 CFR

2013-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

When good news is bad news: psychological impact of false positive diagnosis of HIV.

PubMed

Bhattacharya, Rahul; Barton, Simon; Catalan, Jose

2008-05-01

HIV testing is known to be stressful, however the impact of false positive HIV results on individuals is not well documented. This is a series of four case who developed psychological difficulties and psychiatric morbidities after being informed they had been misdiagnosed with HIV-positive status. We look into documented cases of misdiagnosis and potential risks of misdiagnosis. The case series highlights the implications a false diagnosis HIV-positive status can have, even when the diagnosis is rectified. Impact of misdiagnosis of HIV can lead to psychosocial difficulties and psychiatric morbidity, have public health and epidemiological implications and can lead to medico-legal conflict. This further reiterates the importance of HIV testing carried out ethically and sensitively, and in line with guidelines, respecting confidentiality and consent, and offering counselling pre-test and post-test, being mindful of the reality of erroneous and false positive HIV test results. The implications of misdiagnosis are for the individual, their partners and social contacts, as well as for the community.

76 FR 70722 - Healthcare Technology Holdings, Inc.; Analysis of Proposed Agreement Containing Consent Orders To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-15

... FEDERAL TRADE COMMISSION [File No. 111 0097] Healthcare Technology Holdings, Inc.; Analysis of Proposed Agreement Containing Consent Orders To Aid Public Comment Correction In notice document 2011-28497 appearing on pages 68189-68191 in the issue of Thursday, November 3, 2011, make the following corrections: 1...

An audit cycle of consent form completion: A useful tool to improve junior doctor training.

PubMed

Leng, Catherine; Sharma, Kavita

2016-01-01

Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008) and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91-100%) and additional procedures (0-7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.

Informed consent and standard of care: what must be disclosed.

PubMed

Macklin, Ruth; Shepherd, Lois

2013-01-01

The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (2) the meaning and application of the concept of "standard of care" in the context of research; and (3) the proper role of OHRP. Examination of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of "standard of care" may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements.

Improving the informed consent process in international collaborative rare disease research: effective consent for effective research

PubMed Central

Gainotti, Sabina; Turner, Cathy; Woods, Simon; Kole, Anna; McCormack, Pauline; Lochmüller, Hanns; Riess, Olaf; Straub, Volker; Posada, Manuel; Taruscio, Domenica; Mascalzoni, Deborah

2016-01-01

The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia – a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects. PMID:26860059

A Randomized Controlled Trial of a Cardiopulmonary Resuscitation Video in Advance Care Planning for Progressive Pancreas and Hepatobiliary Cancer Patients

PubMed Central

Volandes, Angelo E.; Chen, Ling Y.; Gary, Kristen A.; Li, Yuelin; Agre, Patricia; Levin, Tomer T.; Reidy, Diane L.; Meng, Raymond D.; Segal, Neil H.; Yu, Kenneth H.; Abou-Alfa, Ghassan K.; Janjigian, Yelena Y.; Kelsen, David P.; O'Reilly, Eileen M.

2013-01-01

Abstract Background Cardiopulmonary resuscitation (CPR) is an important advance directive (AD) topic in patients with progressive cancer; however such discussions are challenging. Objective This study investigates whether video educational information about CPR engenders broader advance care planning (ACP) discourse. Methods Patients with progressive pancreas or hepatobiliary cancer were randomized to an educational CPR video or a similar CPR narrative. The primary end-point was the difference in ACP documentation one month posttest between arms. Secondary end-points included study impressions; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation; and longitudinal patient outcomes. Results Fifty-six subjects were consented and analyzed. Rates of ACP documentation (either formal ADs or documented discussions) were 40% in the video arm (12/30) compared to 15% in the narrative arm (4/26), OR=3.6 [95% CI: 0.9–18.0], p=0.07. Post-intervention knowledge was higher in both arms. Posttest, preferences for CPR had changed in the video arm but not in the narrative arm. Preferences regarding mechanical ventilation did not change in either arm. The majority of subjects in both arms reported the information as helpful and comfortable to discuss, and they recommended it to others. More deaths occurred in the video arm compared to the narrative arm, and more subjects died in hospice settings in the video arm. Conclusions This pilot randomized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects. This trend, as well as other video effects, is the subject of ongoing study. PMID:23725233

Improving the Quality of Informed Consent in Clinical Research with Information Technology.

PubMed

Taber, Celia; Warren, Jim; Day, Karen

2016-01-01

The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

Addendum to the Streamlined Approach for Environmental Restoration Closure Report for Corrective Action Unit 452: Historical Underground Storage Tank Release Sites, Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grant Evenson

This document constitutes an addendum to the Streamlined Approach for Environmental Restoration Closure Report for Corrective Action Unit 452: Historical Underground Storage Tank Release Sites, Nevada Test Site, Nevada, April 1998 as described in the document Supplemental Investigation Report for FFACO Use Restrictions, Nevada Test Site, Nevada (SIR) dated November 2008. The SIR document was approved by NDEP on December 5, 2008. The approval of the SIR document constituted approval of each of the recommended UR removals. In conformance with the SIR document, this addendum consists of: • This page that refers the reader to the SIR document for additionalmore » information • The cover, title, and signature pages of the SIR document • The NDEP approval letter • The corresponding section of the SIR document This addendum provides the documentation justifying the cancellation of the URs for CASs: • 25-25-09, Spill H940825C (from UST 25-3101-1) • 25-25-14, Spill H940314E (from UST 25-3102-3) • 25-25-15, Spill H941020E (from UST 25-3152-1) These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Addendum 2 to the Streamlined Approach for Environmental Restoration Closure Report for Corrective Action Unit 454: Historical Underground Storage Tank Release Sites, Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grant Evenson

This document constitutes an addendum to the Streamlined Approach for Environmental Restoration Closure Report for Corrective Action Unit 454: Historical Underground Storage Tank Release Sites, Nevada Test Site, Nevada, April 1998 as described in the document Supplemental Investigation Report for FFACO Use Restrictions, Nevada Test Site, Nevada (SIR) dated November 2008. The SIR document was approved by NDEP on December 5, 2008. The approval of the SIR document constituted approval of each of the recommended UR removals. In conformance with the SIR document, this addendum consists of: • This page that refers the reader to the SIR document for additionalmore » information • The cover, title, and signature pages of the SIR document • The NDEP approval letter • The corresponding section of the SIR document This addendum provides the documentation justifying the cancellation of the URs for CASs: • 12-25-08, Spill H950524F (from UST 12-B-1) • 12-25-10, Spill H950919A (from UST 12-COMM-1) These URs were established as part of Federal Facility Agreement and Consent Order (FFACO) corrective actions and were based on the presence of contaminants at concentrations greater than the action levels established at the time of the initial investigation (FFACO, 1996). Since these URs were established, practices and procedures relating to the implementation of risk-based corrective actions (RBCA) have changed. Therefore, these URs were re-evaluated against the current RBCA criteria as defined in the Industrial Sites Project Establishment of Final Action Levels (NNSA/NSO, 2006). This re-evaluation consisted of comparing the original data (used to define the need for the URs) to risk-based final action levels (FALs) developed using the current Industrial Sites RBCA process. The re-evaluation resulted in a recommendation to remove these URs because contamination is not present at these sites above the risk-based FALs. Requirements for inspecting and maintaining these URs will be canceled, and the postings and signage at each site will be removed. Fencing and posting may be present at these sites that are unrelated to the FFACO URs such as for radiological control purposes as required by the NV/YMP Radiological Control Manual (NNSA/NSO, 2004). This modification will not affect or modify any non-FFACO requirements for fencing, posting, or monitoring at these sites.« less

Integration of clinical research documentation in electronic health records.

PubMed

Broach, Debra

2015-04-01

Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration.

The Frequency of Reporting Ethical Issues in Human Subject Articles Published in Iranian Medical Journals: 2009-2013.

PubMed

Astaneh, Behrooz; Khani, Parisa

2017-11-10

Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups. Data collection was carried out by assessing articles, focusing on the documentation "ethics committee approval", patients' "informed consent", "financial support", "confidentiality", and "conflict of interest". Of 1460 evaluated articles, 443 (30.3%) reported "ethics committee approval", 686 (47.0%) reported "informed consent", 594 (40.7%) reported "financial support", and 341 (23.4%) reported "conflict of interest". 13% of the articles referred to patients' confidentiality in their text. There was a significant association between these ethical documentations and the year of publication. Articles published in English language journals reported "ethics committee approval", "financial support", and "conflict of interest" significantly more than Persian language journals, but the frequency of "informed consent" was similar. Ethical documentation rate in Iranian medical journals is not up to the expected standards of reputable journals which might be related to a lack of awareness and the education of the authors and the journal's editors. Precise reporting of ethical considerations in medical articles by authors are recommended. It is suggested journals and policymakers pay more attention to reporting this issue while providing standard guidelines in this regard.

Absence of significant dissent should be sufficient for deceased donor organ procurement in New Zealand.

PubMed

Douglas, Thomas M; Douglas, Nicholas M

2009-10-01

New Zealand's organ donation rates are among the lowest in the OECD. In a bid to increase organ availability, the New Zealand Human Tissue Act 2008 introduces new consent arrangements for deceased donor organ procurement. This article assesses these new arrangements and presents the case for further reform. Our assessment and arguments are based on philosophical analysis informed by empirical data on the effectiveness of alternative consent systems. We: 1) Identify widely held ethical judgments about policies and practices relevant to organ donation (e.g. those relating to coronial post-mortems), 2) Assess the implications of these judgments for the Human Tissue Act and the assumptions that underpin it, and 3) Derive policy recommendations that are consistent with the judgments. The Human Tissue Act 2008 retains a strong consent requirement for organ procurement: organs may not be transplanted unless either the deceased or the family consents. We argue that organ availability could and should be increased by shifting from a model that requires consent to one that requires the absence of significant dissent. We recommend that New Zealand adopt either 1) an organ donation system similar to the existing system for ordering coronial post-mortems, or 2) a variant of the 'opt-out' system already in place in several other countries.

[Ethics committees bear a responsibility for patient information. Informed consent implies that the patient understands what he has consented to].

PubMed

Werkö, Lars

2002-03-19

A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Directives defining informed consent in relation to clinical trials have been issued by The EU Commission. The Department of Health and Social Security in England has also published several documents governing patient consent. Even if information is given to the patient it is not always comprehended. In one study of cancer treatment about one third of the patients had misunderstood the information in certain respects.

38 CFR 16.115 - IRB records.

Code of Federal Regulations, 2011 CFR

2011-07-01

... adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents... basis for requiring changes in or disapproving research; and a written summary of the discussion of...

38 CFR 16.115 - IRB records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents... basis for requiring changes in or disapproving research; and a written summary of the discussion of...

45 CFR 690.115 - IRB records.

Code of Federal Regulations, 2011 CFR

2011-10-01

... adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents... basis for requiring changes in or disapproving research; and a written summary of the discussion of...

Call-Center Based Disease Management of Pediatric Asthmatics

DTIC Science & Technology

2005-04-01

study locations. Purchase peak flow meters. Prepare and reproduce patient education materials, and informed consent work sheets. Contract Oracle data...identified. Electronic peak flow meters have been purchased. Patient education materials and informed consent documents have been reproduced. A web-based...Research Center * Study population identified via military and Foundation Health databases * Electronic peak flow meters purchased * Patient education materials

Call-Center Based Disease Management of Pediatric Asthmatics

DTIC Science & Technology

2006-04-01

This study will measure the impact of CBDMP, which promotes patient education and empowerment, on multiple factors to include; patient/caregiver quality...Prepare and reproduce patient education materials, and informed consent work sheets. Contract Oracle data base administrator to establish database for... Patient education materials and informed consent documents were reproduced. A web-based Oracle data-base was determined to be both prohibitively

Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

PubMed Central

2011-01-01

Background Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards. Methods We examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs). Results We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites. Conclusion The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. PMID:21235768

Personality, sex of participant, and face-to-face interaction affect reading of informed consent forms.

PubMed

Knepp, Michael M

2014-02-01

Students (N = 183) participated in a study designed to determine if each student read the informed consent form. Approximately 12% of students in the online condition followed the procedure compared with 38% in the laboratory phase. Participants with higher trait worry and those with lower emotion reappraisal were more likely to follow the procedure, while women were more likely to read the form than men. Across conditions, most students do not read informed consent documents, particularly in online formats. These findings of this research support the idea that women tend to be more information-seeking than men in health and research settings and those with higher trait worry tend to read the consent forms to alleviate uncertainty and trust concerns.

Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

PubMed

Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

2013-11-25

In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects' right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects' right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed.

How to achieve informed consent for research from Spanish-speaking individuals with low literacy: a qualitative report.

PubMed

Cortés, Dharma E; Drainoni, Mari-Lynn; Henault, Lori E; Paasche-Orlow, Michael K

2010-01-01

Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, since the majority of the general population has limited or no familiarity with research studies. These challenges are further magnified when obtaining consent from individuals with low literacy levels and who speak languages other than English. In this article we present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process. While the text of the consent and authorization documents can be simplified using plain language principles, comprehension of several fundamental ideas such as risk and privacy need to be safeguarded with a consent process that confirms comprehension. Recommendations are provided to address the informational needs of individuals with low literacy levels and limited or no experience with research participation.

But is this really the ‘parent’ or ‘guardian’? Practical strategies for consent to child research in South Africa

PubMed Central

Slack, C M; Strode, A E

2018-01-01

Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value, probe assertions that are made, or even call for supporting documentation? In this article we set out the facts research staff should possess, propose key questions they could ask, and recommend practical steps for uncertain cases. We recognise that a parental/guardianship consent strategy may not be appropriate in all instances, but do not debate that issue in this article. This article is confined to practical advice for researchers wishing to implement a parental or guardianship consent approach. PMID:29887973

14 CFR 1230.115 - IRB records.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true IRB records. 1230.115 Section 1230.115... documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress...

14 CFR 1230.115 - IRB records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 5 2010-01-01 2010-01-01 false IRB records. 1230.115 Section 1230.115... documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress...

Ill-informed consent? A content analysis of physical risk disclosure in school-based HPV vaccine programs.

PubMed

Steenbeek, Audrey; Macdonald, Noni; Downie, Jocelyn; Appleton, Mary; Baylis, Françoise

2012-01-01

This study examines the accuracy, completeness, and consistency of human papilloma virus (HPV) vaccine related physical risks disclosed in documents available to parents, legal guardians, and girls in Canadian jurisdictions with school-based HPV vaccine programs. We conducted an online search for program related HPV vaccine risk/benefit documents for all 13 Canadian jurisdictions between July 2008 and May 2009 including follow-up by e-mail and telephone requests for relevant documents from the respective Ministries or Departments of Health. The physical risks listed in the documents were compared across jurisdictions and against documents prepared by the vaccine manufacturer (Merck Frosst Canada), the National Advisory Committee on Immunization (NACI), the Society of Obstetricians and Gynecologists of Canada (SOGC), and a 2007 article in Maclean's Magazine. No jurisdiction provided the same list of vaccine related physical risks as any other jurisdiction. Major discrepancies were identified. Inaccurate, incomplete, and inconsistent information can threaten the validity of consent/authorization and potentially undermine trust in the vaccine program and the vaccine itself. Efforts are needed to improve the quality, clarity, and standardization of the content of written documents used in school-based HPV vaccine programs across Canada. © 2011 Wiley Periodicals, Inc.

Principles and practice of external digital photography in ophthalmology

PubMed Central

Mukherjee, Bipasha; Nair, Akshay Gopinathan

2012-01-01

It is mandatory to incorporate clinical photography in an ophthalmic practice. Patient photographs are routinely used in teaching, presentations, documenting surgical outcomes and marketing. Standardized clinical photographs are part of an armamentarium for any ophthalmologist interested in enhancing his or her practice. Unfortunately, many clinicians still avoid taking patient photographs for want of basic knowledge or inclination. The ubiquitous presence of the digital camera and digital technology has made it extremely easy and affordable to take high-quality images. It is not compulsory to employ a professional photographer or invest in expensive equipment any longer for this purpose. Any ophthalmologist should be able to take clinical photographs in his/her office settings with minimal technical skill. The purpose of this article is to provide an ophthalmic surgeon with guidelines to achieve standardized photographic views for specific procedures, to achieve consistency, to help in pre-operative planning and to produce accurate pre-operative and post-operative comparisons, which will aid in self-improvement, patient education, medicolegal documentation and publications. This review also discusses editing, storage, patient consent, medicolegal issues and importance of maintenance of patient confidentiality. PMID:22446907

Principles and practice of external digital photography in ophthalmology.

PubMed

Mukherjee, Bipasha; Nair, Akshay Gopinathan

2012-01-01

It is mandatory to incorporate clinical photography in an ophthalmic practice. Patient photographs are routinely used in teaching, presentations, documenting surgical outcomes and marketing. Standardized clinical photographs are part of an armamentarium for any ophthalmologist interested in enhancing his or her practice. Unfortunately, many clinicians still avoid taking patient photographs for want of basic knowledge or inclination. The ubiquitous presence of the digital camera and digital technology has made it extremely easy and affordable to take high-quality images. It is not compulsory to employ a professional photographer or invest in expensive equipment any longer for this purpose. Any ophthalmologist should be able to take clinical photographs in his/her office settings with minimal technical skill. The purpose of this article is to provide an ophthalmic surgeon with guidelines to achieve standardized photographic views for specific procedures, to achieve consistency, to help in pre-operative planning and to produce accurate pre-operative and post-operative comparisons, which will aid in self-improvement, patient education, medicolegal documentation and publications. This review also discusses editing, storage, patient consent, medicolegal issues and importance of maintenance of patient confidentiality.

Effects of informed consent for individual genome sequencing on relevant knowledge.

PubMed

Kaphingst, K A; Facio, F M; Cheng, M-R; Brooks, S; Eidem, H; Linn, A; Biesecker, B B; Biesecker, L G

2012-11-01

Increasing availability of individual genomic information suggests that patients will need knowledge about genome sequencing to make informed decisions, but prior research is limited. In this study, we examined genome sequencing knowledge before and after informed consent among 311 participants enrolled in the ClinSeq™ sequencing study. An exploratory factor analysis of knowledge items yielded two factors (sequencing limitations knowledge; sequencing benefits knowledge). In multivariable analysis, high pre-consent sequencing limitations knowledge scores were significantly related to education [odds ratio (OR): 8.7, 95% confidence interval (CI): 2.45-31.10 for post-graduate education, and OR: 3.9; 95% CI: 1.05, 14.61 for college degree compared with less than college degree] and race/ethnicity (OR: 2.4, 95% CI: 1.09, 5.38 for non-Hispanic Whites compared with other racial/ethnic groups). Mean values increased significantly between pre- and post-consent for the sequencing limitations knowledge subscale (6.9-7.7, p < 0.0001) and sequencing benefits knowledge subscale (7.0-7.5, p < 0.0001); increase in knowledge did not differ by sociodemographic characteristics. This study highlights gaps in genome sequencing knowledge and underscores the need to target educational efforts toward participants with less education or from minority racial/ethnic groups. The informed consent process improved genome sequencing knowledge. Future studies could examine how genome sequencing knowledge influences informed decision making. © 2012 John Wiley & Sons A/S.

Guideline for obtaining valid consent for gastrointestinal endoscopy procedures.

PubMed

Everett, Simon M; Griffiths, Helen; Nandasoma, U; Ayres, Katie; Bell, Graham; Cohen, Mike; Thomas-Gibson, Siwan; Thomson, Mike; Naylor, Kevin M T

2016-10-01

Much has changed since the last guideline of 2008, both in endoscopy and in the practice of obtaining informed consent, and it is vital that all endoscopists who are responsible for performing invasive and increasingly risky procedures are aware of the requirements for obtaining valid consent. This guideline is restricted to GI endoscopy but we cover elective and acute or emergency procedures. Few clinical trials have been carried out in relation to informed consent but most areas are informed by guidance from the General Medical Counsel (GMC) and/or are enshrined in legislation. Following an iterative voting process a series of recommendations have been drawn up that cover the majority of situations that will be encountered by endoscopists. This is not exhaustive and where doubt exists we have described where legal advice is likely to be required. This document relates to the law and endoscopy practice in the UK-where there is variation between the four devolved countries this is pointed out and endoscopists must be aware of the law where they practice. The recommendations are divided into consent for patients with and without capacity and we provide sections on provision of information and the consent process for patients in a variety of situations. This guideline is intended for use by all practitioners who request or perform GI endoscopy, or are involved in the pathway of such patients. If followed, we hope this document will enhance the experience of patients attending for endoscopy in UK units. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Enhancing clinician provision of informed consent and counseling: some pedagogical strategies.

PubMed

Wear, S

1999-02-01

Although long touted as an ethical and legal requirement, some clinicians still seem to offer less than fully adequate informed consent processes; similarly the counseling of patients and families, particularly about post-intervention scenarios, is often perfunctory at best. Keyed to a narrative of a patient's experience with surgery for a deviated septum, this article reflects on why such less than adequate clinician behaviors tend to occur and what might be done about them. Certain legal misconceptions about informed consent are highlighted in this reflection, as well as why certain clinicians seem to take such a narrow view of their responsibilities to patients. Further reference in this regard is also made to a recently constructed module on informed consent for medical residents. In it, though legal requirements for informed consent are reviewed, the basic perspective taken regards informed consent as a clinical intervention that pursues certain basic goods and values, only one of which lies in determining when legal closure for such processes has occurred.

Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial

PubMed Central

Jeste, Dilip V.; Palmer, Barton W.; Golshan, Shahrokh; Eyler, Lisa T.; Dunn, Laura B.; Meeks, Thomas; Glorioso, Danielle; Fellows, Ian; Kraemer, Helena; Appelbaum, Paul S.

2009-01-01

Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols. PMID:18245061

Readability of patient information and consent documents in rheumatological studies.

PubMed

Hamnes, Bente; van Eijk-Hustings, Yvonne; Primdahl, Jette

2016-07-16

Before participation in medical research an informed consent must be obtained. This study investigates whether the readability of patient information and consent documents (PICDs) corresponds to the average educational level of participants in rheumatological studies in the Netherlands, Denmark, and Norway. 24 PICDs from studies were collected and readability was assessed independently using the Gunning's Fog Index (FOG) and Simple Measure of Gobbledygook (SMOG) grading. The mean score for the FOG and SMOG grades were 14.2 (9.0-19.0) and 14.2 (12-17) respectively. The mean FOG and SMOG grades were 12.7 and 13.3 in the Dutch studies, 15.0 and 14.9 in the Danish studies, and 14.6 and 14.3 in the Norwegian studies, respectively. Out of the 2865 participants, more than 57 % had a lower educational level than the highest readability score calculated in the individual study. As the readability level of the PICDs did not match the participants' educational level, consent may not have been valid, as the participants may have had a limited understanding of what they agreed to participate in. There should be more focus on the readability of PICDs. National guidelines for how to write clear and unambiguous PICDs in simple and easily understandable language could increase the focus on the readability of PICD.

Tesoro (BP Amoco) Consent Decree

EPA Pesticide Factsheets

This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies

PubMed Central

2015-01-01

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications – US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved. PMID:26225759

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies.

PubMed

Hanrahan, Donna; Sexton, Patrina; Hui, Katrina; Teitcher, Jennifer; Sugarman, Jeremy; London, Alex John; Barnes, Mark; Purpura, James; Klitzman, Robert

2015-01-01

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications--US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved.

Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

PubMed

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J

2013-12-01

Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Electronic processing of informed consents in a global pharmaceutical company environment.

PubMed

Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

2014-01-01

We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

PubMed Central

2013-01-01

Background In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Methods Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Results Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Conclusion Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects’ right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed. PMID:24267590

Interactive multimedia consent for biobanking: a randomized trial.

PubMed

Simon, Christian M; Klein, David W; Schartz, Helen A

2016-01-01

The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

Interactive multimedia consent for biobanking: A randomized trial

PubMed Central

Simon, Christian M.; Klein, David W.; Schartz, Helen A.

2015-01-01

Purpose Interactive multimedia’s potential to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence of understanding of informed consent, compared to a standard, face-to-face (F2F) biobank consent process. Methods A 2 (F2F versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the Biobank’s 9-page consent document. Results Interactivity (F(1,196)=7.56, p=0.007, partial η2=0.037) and Media (F(1,196)=4.27, p=0.04, partial η2=0.021) independently improved participants’ understanding of the Biobank consent. Interactivity (F(1,196) = 6.793, p = 0.01, partial η2=0.033), but not Media (F(1,196) = 0.455, n.s.), resulted in increased participant confidence in their understanding of the Biobank’s consent. Patients took more time to complete the multimedia (M=18.2 min.) than the F2F (M=12.6 min.) conditions. Conclusion This study demonstrated that interactivity and multimedia each can be effective at promoting individuals’ understanding and confidence in understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather separate the two constructs when studying electronic consent. PMID:25834945

Current practices and medico-legal aspects of pre-operative consent.

PubMed

Osime, O C; Okojie, O; Osadolor, F; Mohammed, S

2004-07-01

Written informed consent is a pre requisite for surgical intervention as it provides the forum for the patient to appreciate implications of the procedure and the doctor to explain details and effects of the surgery. To evaluate the practice of obtaining informed consent pre-operatively by surgeons in Benin City and proffer solutions that would enhance its practice. Cross-sectional study involving surgical patients or their relations or gurdian (in cases involving minors and unconscious patients) who were interviewed with structured ended questionnaires. Study was carried out at the University of Benin Teaching Hospital, Benin City, between 5th July and 6th September 2002. One hundred and thirty-three respondents; 53(39.2%) males and 80(60.2%) females were interviewed. Documentations regarding consent were noted in 118(88.7%) cases. Of these, 74.6% felt they had enough time to reflect on the consent obtained while 48(36.1%) respondents were meeting the individual who obtained their consent for the first time. The content of information offered patients prior to obtaining consent was found to be significantly related to the levels of education (X2= 31.44; P<0.001). Over a hundred respondents were not informed of risk of procedure. Nonetheless over 50% of respondents felt satisfied with information supplied. The quality of consent obtained from the average patient fell below expected standard. There is need for greater awareness amongst administrators of consent on the essence of improving quality of information given and mode of obtaining consent from patients.

76 FR 53898 - Proposed Administrative Settlement Agreement and Order on Consent; In Re: Ely Copper Mine...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

... inspection at the US EPA Region 1 OSRR Records and Information Center, 5 Post Office Square, Suite 100... Regional Hearing Clerk, U.S. Environmental Protection Agency, Region I, 5 Post Office Square, Suite 100... Post Office Square, Suite 100, Boston, MA 02109. In addition, a copy of the proposed settlement...

Respecting and Fulfilling the Right of Post-Primary Pupils to Consent to Participate in Trials and Evaluative Research: A Discussion Paper

ERIC Educational Resources Information Center

Maguire, Lisa K.; Byrne, Bronagh; Kehoe, Susan

2018-01-01

This paper provides an introduction to issues surrounding the participation rights of young people in research and the implications of their growing involvement in research as well as providing a discourse on the ethical implications related to consent. The unique contribution of this paper is that it considers children's rights in respect to the…

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

PubMed

Allmark, P; Mason, S

2006-08-01

To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Consent validity was found to compare favourably with similar trials examined in the Euricon study. Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.

PubMed

Dheensa, Sandi; Crawford, Gillian; Salter, Claire; Parker, Michael; Fenwick, Angela; Lucassen, Anneke

2018-01-01

Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.

Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

PubMed

Hallinan, Dara; Friedewald, Michael

2015-01-01

This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Informed consent: not just for procedures anymore.

PubMed

Feld, Andrew D

2004-06-01

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

An integrated conceptual framework for evaluating and improving 'understanding' in informed consent.

PubMed

Bossert, Sabine; Strech, Daniel

2017-10-17

The development of understandable informed consent (IC) documents has proven to be one of the most important challenges in research with humans as well as in healthcare settings. Therefore, evaluating and improving understanding has been of increasing interest for empirical research on IC. However, several conceptual and practical challenges for the development of understandable IC documents remain unresolved. In this paper, we will outline and systematize some of these challenges. On the basis of our own experiences in empirical user testing of IC documents as well as the relevant literature on understanding in IC, we propose an integrated conceptual model for the development of understandable IC documents. The proposed conceptual model integrates different methods for the participatory improvement of written information, including IC, as well as quantitative methods for measuring understanding in IC. In most IC processes, understandable written information is an important prerequisite for valid IC. To improve the quality of IC documents, a conceptual model for participatory procedures of testing, revising, and retesting can be applied. However, the model presented in this paper needs further theoretical and empirical elaboration and clarification of several conceptual and practical challenges.

Development and progress of Ireland's biobank network: Ethical, legal, and social implications (ELSI), standardized documentation, sample and data release, and international perspective.

PubMed

Mee, Blanaid; Gaffney, Eoin; Glynn, Sharon A; Donatello, Simona; Carroll, Paul; Connolly, Elizabeth; Garrigle, Sarah Mc; Boyle, Terry; Flannery, Delia; Sullivan, Francis J; McCormick, Paul; Griffin, Mairead; Muldoon, Cian; Fay, Joanna; O'Grady, Tony; Kay, Elaine; Eustace, Joe; Burke, Louise; Sheikh, Asim A; Finn, Stephen; Flavin, Richard; Giles, Francis J

2013-02-01

Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents-Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups-Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.

How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India.

PubMed

Rajaraman, Divya; Jesuraj, Nelson; Geiter, Lawrence; Bennett, Sean; Grewal, Harleen Ms; Vaz, Mario

2011-02-15

A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.

Photographic documentation, a practical guide for non professional forensic photography.

PubMed

Ozkalipci, Onder; Volpellier, Muriel

2010-01-01

Forensic photography is essential for documentation of evidence of torture. Consent of the alleged victim should be sought in all cases. The article gives information about when and how to take pictures of what as well as image authentication, audit trail, storage, faulty pictures and the kind of camera to use.

Audit cycle of documentation in laser hair removal.

PubMed

Cohen, S N; Lanigan, S W

2005-09-01

Lasercare clinics are one of the largest providers of skin laser treatment in the United Kingdom, in both private sector and National Health Service. Laser hair removal is performed by trained nurses following written protocols. Choice of laser and fluence is tailored to Fitzpatrick skin type. We audited and re-audited documentation of six criteria in patients receiving laser hair removal (signed consent, Fitzpatrick skin type, use of appropriate laser, appropriate fluence, patient satisfaction and objective assessment) across 13 clinics at different points in time. Data were obtained on 772 treatments. Overall findings revealed excellent documentation of consent, use of appropriate laser and fluence (median 100%), good documentation of skin type (median 90%) and poor documentation of patient satisfaction and objective assessment (median 67% and 53%, respectively). Comparison between baseline and repeat audit at 6-8 months (nine clinics) showed significant improvement across clinics in these latter two criteria [patient satisfaction: odds ratio (OR) 0.38, 95% confidence interval (CI) 0.15-0.78, P=0.01; objective assessment: OR 0.23, 95% CI 0.07-0.50, P=0.0003 (Mantel-Haenszel weighted odds ratios)]. We conclude that quality of documentation was generally and consistently high in multiple clinics and that re-auditing led to significant improvement in poor scores. This simple measure could easily be implemented more widely across many disciplines.

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

PubMed

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

2011-11-01

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Closure Report for the 92-Acre Area and Corrective Action Unit 111: Area 5 WMD Retired Mixed Waste Pits, Nevada National Security Site, Nevada

DOE Office of Scientific and Technical Information (OSTI.GOV)

NSTec Environmental Restoration

2012-02-21

This Closure Report (CR) presents information supporting closure of the 92-Acre Area, which includes Corrective Action Unit (CAU) 111, 'Area 5 WMD Retired Mixed Waste Pits.' This CR provides documentation supporting the completed corrective actions and confirmation that the closure objectives were met. This CR complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) (FFACO, 1996 [as amended March 2010]). Closure activities began in January 2011 and were completed in January 2012. Closure activities were conducted according to Revision 1 of the Corrective Action Decision Document/Corrective Action Plan (CADD/CAP) for the 92-Acre Area and CAU 111more » (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2010). The following closure activities were performed: (1) Construct an engineered evapotranspiration cover over the boreholes, trenches, and pits in the 92-Acre Area; (2) Install use restriction (UR) warning signs, concrete monuments, and subsidence survey monuments; and (3) Establish vegetation on the covers. UR documentation is included as Appendix C of this report. The post-closure plan is presented in detail in Revision 1 of the CADD/CAP for the 92-Acre Area and CAU 111, and the requirements are summarized in Section 5.2 of this document. When the next request for modification of Resource Conservation and Recovery Act Permit NEV HW0101 is submitted to the Nevada Division of Environmental Protection (NDEP), the requirements for post-closure monitoring of the 92-Acre Area will be included. NNSA/NSO requests the following: (1) A Notice of Completion from NDEP to NNSA/NSO for closure of CAU 111; and (2) The transfer of CAU 111 from Appendix III to Appendix IV, Closed Corrective Action Units, of the FFACO.« less

[Medical prescription and informed consent for the use of physical restraints in nursing homes in the Canary Islands (Spain)].

PubMed

Estévez-Guerra, Gabriel J; Fariña-López, Emilio; Penelo, Eva

To identify the frequency of completion of informed consent and medical prescription in the clinical records of older patients subject to physical restraint, and to analyse the association between patient characteristics and the absence of such documentation. A cross-sectional and descriptive multicentre study with direct observation and review of clinical records was conducted in nine public nursing homes, comprising 1,058 beds. 274 residents were physically restrained. Informed consent was not included in 82.5% of cases and was incomplete in a further 13.9%. There was no medical prescription in 68.3% of cases and it was incomplete in a further 12.0%. The only statistical association found was between the lack of prescription and the patients' advanced age (PR=1.03; p <0.005). Failure to produce this documentation contravenes the law. Organisational characteristics, ignorance of the legal requirements or the fact that some professionals may consider physical restraint to be a risk-free procedure may explain these results. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

18 CFR 358.7 - Transparency rule.

Code of Federal Regulations, 2010 CFR

2010-04-01

... information that was disclosed on its Internet Web site. (2) If a transmission provider discloses, in a manner... marketing function employees, the transmission provider must post notice on its Internet Web site of that..., in exchange for that voluntary consent. (d) Posting written procedures on the public Internet. A...

Rhetoric or reality: what is the legal status of the consent form in health-related research?

PubMed

Laurie, Graeme; Postan, Emily

2013-01-01

This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships-which depend crucially on trust-resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document-as the law tends to do-is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms.

Written informed consent for living liver donor evaluation: compliance with Centers for Medicare and Medicaid Services and Organ Procurement and Transplantation Network Guidelines and alibi offers.

PubMed

Thiessen, Carrie; Kim, Yunsoo A; Yoo, Peter S; Rodriguez-Davalos, Manuel; Mulligan, David; Kulkarni, Sanjay

2014-04-01

We examined written informed consent forms for living liver donor evaluations to determine whether they incorporated elements required by the Centers for Medicare and Medicaid Services (CMS) and suggested by the Organ Procurement and Transplantation Network (OPTN). We contacted each of the 41 US centers that performed at least 1 living donor liver transplant in 2011; 37 centers reported active living donor evaluation programs. Twenty-six centers shared their consent form for living donor evaluation (response rate = 70%). Each document was double-coded for consent element content. We found that 57% of the centers included the 9 mandated CMS elements. Although the OPTN guidelines are non-binding, 78% of the centers used consent forms that addressed at least two-thirds of the elements recommended by OPTN. Only 17% of the centers provided written offers of an alibi to donors who withdrew from the evaluation. On the basis of our findings, we offer suggestions that may be relevant to ongoing revisions to the OPTN living liver donor consent policy and may help centers to improve the clarity of their written consent forms. © 2014 American Association for the Study of Liver Diseases.

Participants' recall and understanding of genomic research and large-scale data sharing.

PubMed

Robinson, Jill Oliver; Slashinski, Melody J; Wang, Tao; Hilsenbeck, Susan G; McGuire, Amy L

2013-10-01

As genomic researchers are urged to openly share generated sequence data with other researchers, it is important to examine the utility of informed consent documents and processes, particularly as these relate to participants' engagement with and recall of the information presented to them, their objective or subjective understanding of the key elements of genomic research (e.g., data sharing), as well as how these factors influence or mediate the decisions they make. We conducted a randomized trial of three experimental informed consent documents (ICDs) with participants (n = 229) being recruited to genomic research studies; each document afforded varying control over breadth of release of genetic information. Recall and understanding, their impact on data sharing decisions, and comfort in decision making were assessed in a follow-up structured interview. Over 25% did not remember signing an ICD to participate in a genomic study, and the majority (54%) could not correctly identify with whom they had agreed to share their genomic data. However, participants felt that they understood enough to make an informed decision, and lack of recall did not impact final data sharing decisions or satisfaction with participation. These findings raise questions about the types of information participants need in order to provide valid informed consent, and whether subjective understanding and comfort with decision making are sufficient to satisfy the ethical principle of respect for persons.

Patient preferences toward an interactive e-consent application for research using electronic health records.

PubMed

Harle, Christopher A; Golembiewski, Elizabeth H; Rahmanian, Kiarash P; Krieger, Janice L; Hagmajer, Dorothy; Mainous, Arch G; Moseley, Ray E

2017-12-19

The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details. © The Author(s) 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

PubMed Central

Panikkar, Bindu; Smith, Natasha; Brown, Phil

2013-01-01

For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e. consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and IRB requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process. PMID:23074992

Closing the evidence gap in infectious disease: point-of-care randomization and informed consent.

PubMed

Huttner, A; Leibovici, L; Theuretzbacher, U; Huttner, B; Paul, M

2017-02-01

The informed consent document is intended to provide basic rights to patients but often fails to do so. Patients' autonomy may be diminished by virtue of their illness; evidence shows that even patients who appear to be ideal candidates for understanding and granting informed consent rarely are, particularly those with acute infections. We argue that for low-risk trials whose purpose is to evaluate nonexperimental therapies or other measures towards which the medical community is in a state of equipoise, ethics committees should play a more active role in a more standardized fashion. Patients in the clinic are continually subject to spontaneous 'pseudo-randomizations' based on local dogma and the anecdotal experience of their physicians. Stronger ethics oversight would allow point-of-care trials to structure these spontaneous randomizations, using widely available informatics tools, in combination with opt-out informed consent where deemed appropriate. Copyright © 2016. Published by Elsevier Ltd.

INDUSTRIAL WASTEWATER

EPA Science Inventory

This document contains: federal legislation, NRDC consent degree, regulations, the research program, and the different treatments used for petrochemistry, pesticides, inorganic chemicals, batteries, metal finishing, iron and steel, electric power, textiles and leather industries.

Study of Selected Petroleum Refining Residuals

EPA Pesticide Factsheets

The document describes EPA's approach to conducting the industry study required by the Environmental Defense Fund (EDF)/EPA consent decree and characterizes the study residuals and how they are managed.

ACOG Committee Opinion No. 306. Informed refusal.

PubMed

2004-12-01

Informed refusal is a fundamental component of the informed consent process. Informed consent laws have evolved to the "materiality or patient viewpoint" standard. A physician must disclose to the patient the risks, benefits, and alternatives that a reasonable person in the patient's position would want to know to make an informed decision. Throughout this process, the patient's autonomy, level of health literacy, and cultural background should be respected. The subsequent election by the patient to forgo an intervention that has been recommended by the physician constitutes informed refusal. Documentation of the informed refusal process is essential. It should include a notation that the need for the intervention, as well as risks, benefits, and alternatives to the intervention, and possible consequences of refusal, have been explained. The patient's reason for refusal also should be documented.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-C Tank Farm (C Farm) leak causes and locations for the 100 series leaking tanks (241-C-101 and 241-C-105) identified in RPP-RPT-33418, Rev. 2, Hanford C-Farm Leak Inventory Assessments Report. This document satisfies the C Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-T Tank Farm (T Farm) leak causes and locations for the 100 series leaking tanks (241-T-106 and 241-T-111) identified in RPP-RPT-55084, Rev. 0, Hanford 241-T Farm Leak Inventory Assessment Report. This document satisfies the T Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-A Tank Farm (A Farm) leak causes and locations for the 100 series leaking tanks (241-A-104 and 241-A-105) identified in RPP-ENV-37956, Hanford A and AX Farm Leak Assessment Report. This document satisfies the A Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

The right not to know HIV-test results.

PubMed

Temmerman, M; Ndinya-Achola, J; Ambani, J; Piot, P

1995-04-15

Large numbers of pregnant women in Africa have been invited to participate in studies on HIV infection. Study protocols adhere to guidelines on voluntary participation after pre-test and post-test counselling and informed consent; nevertheless, women may consent because they have been asked to do so without fully understanding the implications of being tested for HIV. Our studies in Nairobi, Kenya, show that most women tested after giving informed consent did not actively request their results, less than one third informed their partner, and violence against women because of a positive HIV-antibody test was common. It is important to have carefully designed protocols weighing the benefits against the potential harms for women participating in a study. Even after having consented to HIV testing, women should have the right not to be told their result.

Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil.

PubMed

Bueno, Mariana; Brevidelli, Maria Meimei; Cocarelli, Thaís; Santos, Gianni Mara Silva dos; Ferraz, Maria Auxiliadora; Mion, Décio

2009-01-01

It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5% concerned research with new drugs, vaccines and diagnostic tests, 48.5% consisted of undergraduate students' research projects, 68.9% of the research had no sponsorship, and 97.5% were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2%), lack of information about the protocol at the informed consent form (25.8%), as well as doubts regarding methodological and statistical issues of the protocol (77.1%). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. Among the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts about the terms used in the informed consent form as well as lack of information regarding the research at the informed consent form and methodological and statistical issues regarding the protocol.

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

PubMed Central

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

Purpose To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. Methods The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Results Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02–4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). Conclusion The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China. PMID:27701471

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

PubMed

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

Informed consent in paediatric critical care research--a South African perspective.

PubMed

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

Patients' views of the consent process for adult cardiac surgery: questionnaire survey.

PubMed

Howlader, Mohammad H; Dhanji, Al-Rehan; Uppal, Rakesh; Magee, Patrick; Wood, Alan J; Anyanwu, Ani C

2004-12-01

Consent for surgical procedures has assumed increasing importance in surgical practice in recent days especially following the public inquiry into paediatric cardiac surgery deaths at Bristol in the UK. This study examines patient perceptions and recollections following surgical consent as currently practised in a UK cardiac unit. One hundred consecutive patients who underwent cardiac surgery in a London teaching hospital from January to February 2003 were studied. Patients completed questionnaires a day before their discharge from the hospital. The majority of patients (89/100) responded that the information given at consent had been adequate or more than adequate. The time spent on the consent process was thought to be adequate by 91 patients. Eleven patients felt the consent had been insensitive. Several patients (38/100) felt use of booklets in preference to verbal explanations would be less intimidating. For most patients (94/100) the operation and postoperative course met their expectations; although 12 patients experienced untold complications, only five felt that they should have been informed of the possibility of the complication. Although most patients were informed of the risk of death during consent, at time of discharge 43 had forgotten the figure that had been quoted. Regarding the influence of media and publicity, 19 patients said that media had influenced their expectations of the consent process, 59 would have liked to see hospital league tables while 26 would have liked to know the mortality figures for their surgeon prior to giving consent. Our study shows that patients undergoing cardiac surgery are largely satisfied with our improved consent procedures in the post-Bristol era. Use of booklets may be a useful adjunct to verbal consent as currently practised.

[Quality of information in the process of informed consent for anesthesia].

PubMed

Guillén-Perales, José; Luna-Maldonado, Aurelio; Fernández-Prada, María; Guillén-Solvas, José Francisco; Bueno-Cavanillas, Aurora

2013-11-01

To assess the quality of the information that patients receive in the informed consent document signed prior to surgery. Cross-sectional study of a sample of cancer patients admitted for surgery at the University Hospital San Cecilio of Granada in 2011. After checking the inclusion criteria and obtaining their consent, demographic data were collected and procedure data, and a questionnaire «ad hoc» to assess the quality and comprehensiveness of the information provided in the informed consent. 150 patients were studied. The majority (109 over 150) said they had received sufficient information, in appropriate language, and had the opportunity to ask questions, but only 44.7% correctly answered three or more issues related to anesthesia. University education level, knowledge of the intervention, information about the anesthesia problems and appropriate language were associated. Although systematic informed consent was performed, half of the patients did not comprehend the anesthesia risks. Variables primarily related to the information received were associated with the quality of the response, but not with patient characteristics. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

Renewable Fuels Volume Standards Timeline Announced Documents

EPA Pesticide Factsheets

Consent Decrees where plaintiffs filed March 18, 2015 in alleging that EPA has violated a nondiscretionary duty under CAA to establish renewable fuel obligations applicable to the calendar year 2014 and 2015.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-U Tank Farm (U Farm) leak causes and locations for the 100 series leaking tanks (241-U-104, 241-U-110, and 241-U-112) identified in RPP-RPT-50097, Rev. 0, Hanford 241-U Farm Leak Inventory Assessment Report. This document satisfies the U-Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

Perspective: The case for research justice: inclusion of patients with limited English proficiency in clinical research.

PubMed

Glickman, Seth W; Ndubuizu, Adanma; Weinfurt, Kevin P; Hamilton, Carol D; Glickman, Lawrence T; Schulman, Kevin A; Cairns, Charles B

2011-03-01

Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

PubMed

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

2013-02-01

Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with >10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial. Copyright © 2013 Elsevier Inc. All rights reserved.

Gaining information about home visits in primary care: methodological issues from a feasibility study

PubMed Central

2014-01-01

Background Home visits are part of general practice work in Germany. Within the context of an expanding elderly population and a decreasing number of general practitioner (GPs), open questions regarding the organisation and adequacy of GPs’ care in immobile patients remain. To answer these questions, we will conduct a representative primary data collection concerning contents and organisation of GPs’ home visits in 2014. Because this study will require considerable efforts for documentation and thus substantial involvement by participating GPs, we conducted a pilot study to see whether such a study design was feasible. Methods We used a mixed methods design with two study arms in a sample of teaching GPs of the University Halle. The quantitative arm evaluates participating GPs and documentation of home visits. The qualitative arm focuses on reasons for non-participation for GPs who declined to take part in the pilot study. Results Our study confirms previously observed reasons for non-response of GPs in the particular setting of home visits including lack of time and/or interest. In contrast to previous findings, monetary incentives were not crucial for GPs participation. Several factors influenced the documentation rate of home visits and resulted in a discrepancy between the numbers of home visits documented versus those actually conducted. The most frequently reported problem was related to obtaining patient consent, especially when patients were unable to provide informed consent due to cognitive deficits. Conclusions The results of our feasibility study provide evidence for improvement of the study design and study instruments to effectively conduct a documentation-intensive study of GPs doing home visits. Improvement of instructions and questionnaire regarding time variables and assessment of the need for home visits will be carried out to increase the reliability of future data. One particularly important methodological issue yet to be resolved is how to increase the representativeness of home visit care by including the homebound patient population that is unable to provide informed consent. PMID:24884460

[Analysis of informed consent readibility in intensive care].

PubMed

Ramírez-Puerta, M R; Fernández-Fernández, R; Frías-Pareja, J C; Yuste-Ossorio, M E; Narbona-Galdó, S; Peñas-Maldonado, L

2013-11-01

To analyze the readability of informed consent documents (IC) used in an intensive care department and in the Andalusian Healthcare System (AHS). A descriptive study was carried out. The Intensive Care Unit of a tertiary Hospital, and the AHS. A review and analysis was made of the existing 14 IC models in the Intensive Care Unit and of another 14 IC models offered by the AHS, using the following readability scores: Flesch, Sentence complexity, LEGIN, Fernández-Huerta, Szigriszt and INFLESZ. Twenty-four IC (85.7%) failed to satisfy some of the indexes, while three (10.7%) did not satisfy any of them. Four documents (14.3%) satisfied all the indexes analyzed, and therefore are easy to understand. Flesch score: satisfied by one of the ICU IC (7.1%) and by three of the AHS documents (21.4%). Sentence complexity score: satisfied by 11 of the ICU IC (78.6%) and by 13 of the AHS documents (92.8%). Fernández-Huerta score: satisfied by four of the ICU IC (28.6%) and by 13 of the AHS documents (92.8%). Szigriszt score: satisfied by two of the ICU IC (14.3%) and by 11 of the AHS documents (64.3%). INFLESZ score: satisfied by two of the ICU IC (14.3%) and by 10 of the AHS documents (71.4%). The documents analyzed are generally difficult to read and understand by most people, and do not satisfy the basic purpose for which they were drafted. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

British Society of Paediatric Dentistry: a policy document on consent and the use of physical intervention in the dental care of children.

PubMed

Nunn, June; Foster, Martin; Master, Selina; Greening, Sue

2008-11-01

This policy document was prepared by J Nunn, M Foster, S Master and S Greening on behalf of the British Society of Paediatric Dentistry (BSPD). Policy documents produced by the BSPD represent a majority view, based on a consideration of currently available evidence. They are produced to provide guidance with the intention that the policy be regularly reviewed and updated to take account of changing views and developments.

The neurocognitive effects of a conducted electrical weapon compared to high intensity interval training and alcohol intoxication - implications for Miranda and consent.

PubMed

Dawes, D; Ho, J; Vincent, A S; Nystrom, P; Driver, B

2018-01-01

While the physiologic effects of conducted electrical weapons (CEW) have been the subjects of numerous studies over nearly two decades, their effects on neurocognitive functioning, both short-term and long-term, have only recently been studied. In a 2014 study involving use-of-force scenarios, including a CEW scenario, we found that there was a decline in neurocognitive performance immediately post-scenario in all groups; however this effect was transient, of questionable clinical/legal significance, not statistically different between the groups, and, returned to baseline by one hour post-scenario. Two subsequent studies by other authors have also found transient neurocognitive effects in the immediate post-exposure period; however, in one study, the effect was greater in one measure (of 5) for the CEW compared to exertion, and the authors suggested that this effect could have implications for the Miranda waiver obtained before custodial interrogation as well as consent. In our current study, we compared the neurocognitive effects of an exposure to a CEW to another exertion regimen, as well as to alcohol intoxication given the latter has significant established case law with regard to the Miranda waiver and consent. Such a comparison may offer more insight into the clinical/legal significance of any measured changes. As with the prior studies, the neurocognitive performance decrements of the CEW and exertion regimens, found only in one measure in this study (of three), were transient, and here, non-significant. Only alcohol intoxication resulted in statistically significant performance declines across all measures and these were persistent over the study period. Given that the neurocognitive changes associated with the CEW were non-significant, but were significant for alcohol intoxication, and given that current case law does not use intoxication as a per se or bright line barrier to Miranda and consent, our results do not suggest that a CEW exposure should preclude waiving of Miranda rights or obtaining consent. Copyright © 2017. Published by Elsevier Ltd.

FY08 DRMRP Clinical Trial: Strengthening Pathways to PTSD Recovery Using Systems-Level Intervention

DTIC Science & Technology

2016-05-01

consent forms and store them centrally at RTI for the required six year time period rather than storing the hard copies at their respective posts was...care. In progress. Lavelle T, et al. The cost-effectiveness of a collaborative care approach to treating depression and post -traumatic stress...effectiveness of a collaborative care approach to treating depression and post -traumatic stress disorder in military personnel. AcademyHealth

Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial

PubMed Central

2012-01-01

Background Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. Findings In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. Conclusion The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. PMID:22818109

Ethical and legal constraints to children's participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial.

PubMed

Bwakura-Dangarembizi, Mutsa; Musesengwa, Rosemary; Nathoo, Kusum J; Takaidza, Patrick; Mhute, Tawanda; Vhembo, Tichaona

2012-07-20

Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. In Zimbabwe the parental informed consent document for children participating in clinical research is modeled after Western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.

[Evaluation and improvement of the management of informed consent in the emergency department].

PubMed

del Pozo, P; García, J A; Escribano, M; Soria, V; Campillo-Soto, A; Aguayo-Albasini, J L

2009-01-01

To assess the preoperative management in our emergency surgical service and to improve the quality of the care provided to patients. In order to find the causes of non-compliance, the Ishikawa Fishbone diagram was used and eight assessment criteria were chosen. The first assessment includes 120 patients operated on from January to April 2007. Corrective measures were implemented, which consisted of meetings and conferences with doctors and nurses, insisting on the importance of the informed consent as a legal document which must be signed by patients, and the obligation of giving a copy to patients or relatives. The second assessment includes the period from July to October 2007 (n=120). We observed a high non-compliance of C1 signing of surgical consent (CRITERION 1: all patients or relatives have to sign the surgical informed consent for the operation to be performed [27.5%]) and C2 giving a copy of the surgical consent (CRITERION 2: all patients or relatives must have received a copy of the surgical informed consent for the Surgery to be performed [72.5%]) and C4 anaesthetic consent copy (CRITERION 4: all patients or relatives must have received a copy of the Anaesthesia informed consent corresponding to the operation performed [90%]). After implementing corrective measures a significant improvement was observed in the compliance of C2 and C4. In C1 there was an improvement without statistical significance. The carrying out of an improvement cycle enabled the main objective of this paper to be achieved: to improve the management of informed consent and the quality of the care and information provided to our patients.

Mariano Lake Mine: Legal Documents and Settlements

EPA Pesticide Factsheets

Mariano Lake Mine Administrative Order on Consent (AOC) with Statement of Work (SOW) and Mariano Lake Mine Site Settlement Agreement for Engineering Evaluation/Cost Analysis and Statement of Work (SOW) for the Mariano Lake Mine Site.

Addendum to the Closure Report for Corrective Action Unit 262: Area 25 Septic Systems and Underground Discharge Point, Nevada Test Site, Nevada

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lynn Kidman

2008-10-01

This document constitutes an addendum to the July 2003, Closure Report for Corrective Action Unit 262: Area 25 Septic Systems and Underground Discharge Point as described in the document Recommendations and Justifications for Modifications for Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office Federal Facility Agreement and Consent Order (UR Modification document) dated February 2008. The UR Modification document was approved by NDEP on February 26, 2008. The approval of the UR Modification document constituted approval of each of the recommended UR modifications.

Comparing Web, Group and Telehealth Formats of a Military Parenting Program

DTIC Science & Technology

2017-06-01

directed approaches. Comparative effectiveness will be tested by specifying a non - equivalence hypothesis for group -based and web-facilitated relative...Comparative effectiveness will be tested by specifying a non - equivalence hypothesis fro group based and individualized facilitated relative to self-directed...documents for review and approval. 1a. Finalize human subjects protocol and consent documents for pilot group (N=5 families), and randomized controlled

Effectiveness of Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Methods in Medicaid-Supported Prenatal Care: Trial III

ERIC Educational Resources Information Center

Windsor, Richard; Woodby, Lesa; Miller, Thomas; Hardin, Michael

2011-01-01

This two-phase evaluation documented the delivery and effectiveness of evidence-based health education methods by regular staff to pregnant smokers. During Phase 1, a total of 436 Medicaid patients were screened and 416 (95%) gave consent: 334 nonsmokers and 102 smokers. This historical Comparison (C) group was assessed to document the "normal"…

Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

PubMed Central

Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

2008-01-01

Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. PMID:19019239

Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture

PubMed Central

2014-01-01

Background The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures. Methods We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues. Results Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). Conclusions 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure’s issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met. PMID:24406055

Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

PubMed

Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad

2014-01-10

The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

Nerve injuries in orthopaedics: is there anything more we need to tell our patients?

PubMed

Ek, Eugene T; Yu, Emma P; Chan, Jason T; Love, Bruce R

2005-03-01

Perioperative nerve injuries are uncommon in most elective orthopaedic operations. However, despite the low incidence, patients tend to be most unforgiving when this complication occurs. The present study aims to determine the adequacy of the consent process, and seeks to identify deficiencies. All elective patients who experienced a perioperative nerve palsy between 1996 and 2003 were retrospectively identified. A telephone questionnaire assessed recall of the consent and risks discussed. Patients were asked what they would have liked to have been advised, and whether this would affect their decision for operation. Twenty-four of the 32 patients were contacted. From the questionnaire, 66.7% recalled discussing the risks of the operation. 66.7% would have liked to have discussed, in particular, risk of nerve palsy at time of consent. However, 83.3% of patients, knowing fully the risk of nerve injury, would still have proceeded with the operation. Of the 24 cases, only three had documentation of the risks discussed during consent. The need to adequately provide informed consent for nerve dysfunction is present. The present study demonstrates a dilemma between the provision of information and the creation of fear in the minds of recipients of surgery.

34 CFR 97.117 - Documentation of informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

34 CFR 97.117 - Documentation of informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

34 CFR 97.117 - Documentation of informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

34 CFR 97.117 - Documentation of informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects... presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the...

Informed Consent for Interventional Radiology Procedures: A Survey Detailing Current European Practice

DOE Office of Scientific and Technical Information (OSTI.GOV)

O'Dwyer, H.M.; Lyon, S.M.; Fotheringham, T.

Purpose: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. Methods: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms andmore » written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention,the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. Results: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%),non-academic (40.5%) or private (2.8%). Depending on the procedure,in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The majority of respondents were satisfied with their level of explanation regarding indications for treatment (69.3%) and the procedure (78.7%). Fifty-nine percent felt patients understood alternative treatment options. Only 37.8% of radiologists document possible complications in the patient's chart. Comments from respondents indicated that there is insufficient time for radiologists to obtain consent in all patients. Suggestions to improve current local policies included developing the role of radiology nursing staff and the use of radiology outpatient clinics. Conclusions: More than 50% of respondents are unhappy with their policies for obtaining informed consent. Interventional societies have a role to play in advocating formal consent guidelines.« less

Design-corrected variation by centre in mortality reduction in the ERSPC randomised prostate cancer screening trial.

PubMed

Hakama, Matti; Moss, Sue M; Stenman, Ulf-Hakan; Roobol, Monique J; Zappa, Marco; Carlsson, Sigrid; Randazzo, Marco; Nelen, Vera; Hugosson, Jonas

2017-06-01

Objectives To calculate design-corrected estimates of the effect of screening on prostate cancer mortality by centre in the European Randomised Study of Screening for Prostate Cancer (ERSPC). Setting The ERSPC has shown a 21% reduction in prostate cancer mortality in men invited to screening with follow-up truncated at 13 years. Centres either used pre-consent randomisation (effectiveness design) or post-consent randomisation (efficacy design). Methods In six centres (three effectiveness design, three efficacy design) with follow-up until the end of 2010, or maximum 13 years, the effect of screening was estimated as both effectiveness (mortality reduction in the target population) and efficacy (reduction in those actually screened). Results The overall crude prostate cancer mortality risk ratio in the intervention arm vs control arm for the six centres was 0.79 ranging from a 14% increase to a 38% reduction. The risk ratio was 0.85 in centres with effectiveness design and 0.73 in those with efficacy design. After correcting for design, overall efficacy was 27%, 24% in pre-consent and 29% in post-consent centres, ranging between a 12% increase and a 52% reduction. Conclusion The estimated overall effect of screening in attenders (efficacy) was a 27% reduction in prostate cancer mortality at 13 years' follow-up. The variation in efficacy between centres was greater than the range in risk ratio without correction for design. The centre-specific variation in the mortality reduction could not be accounted for by the randomisation method.

A Randomized Effectiveness Trial of a Systems-Level Approach to Stepped Care for War-Related PTSD

DTIC Science & Technology

2016-05-01

digitize consent forms and store them centrally at RTI for the required six year time period rather than storing the hard copies at their respective posts ...treating depression and post -traumatic stress disorder in military personnel. Under review. Marshall G, et al. Temporal associations among PTSD...Belsher, B, Jaycox L.H. The cost-effectiveness of a collaborative care approach to treating depression and post -traumatic stress disorder in

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon

PubMed Central

2012-01-01

Background Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Method Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Results Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Conclusions Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance. PMID:22686445

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon.

PubMed

Munung, Nchangwi Syntia; Tangwa, Godfrey B; Che, Chi Primus; Vidal, Laurent; Ouwe-Missi-Oukem-Boyer, Odile

2012-06-11

Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors' degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance.

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

A retrospective long term study of teeth restored with prefabricated carbon fiber reinforced epoxy resin posts.

PubMed

Segerström, Susanna; Astbäck, Johnny; Ekstrand, Karl D

2006-01-01

The Composipost endodontic post, made of stretched aligned carbon fibers embedded in an epoxy-resin matrix, has since the beginning of the nineties been widely used for the restoration of endodontically treated teeth. The aim of this retrospective study was to evaluate the treatment outcome of the Composipost system up to 7 years. In a study published 1998, 236 patients treated during 1992-93 by seven Swedish general dental private practitioners were studied. Five of the former seven private practitionersi consented to participate in this follow up of that study. Thus the material was reduced to 138 patients. Thirty-nine of these were excluded due to insufficient data. For the remaining 99 patients, data were collected from dental records. All patients were offered a clinical examination but only 25 accepted. Data were collected from dental records for the remaining 74 patients. The mean follow up time was 6,7 years with a range from 1 month to 10 years (median 7.6 years, SD 2.5 years), (five teeth were extracted during the previous study). The outcome was considered successful if the post and core was in situ and showed no clinical or radiographic signs of technical failures. Sixty-four teeth (65%) restored with the Composipost system were successful after a mean time of 6.7 years. Thirty-two teeth were extracted due to fractures, periapical lesions and periodontitis. Dislodgment of post was observed in three cases. In conclusion, within the limitations of this study, after a mean time of 6.7 years, the Composipost restored teeth had shorter survival times than those of previously documented cast posts.

Customising informed consent procedures for people with schizophrenia in India.

PubMed

Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

2015-10-01

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

PubMed Central

Keel, Isabelle; Immer, Franz F.; Jüni, Peter

2014-01-01

Background and Aim Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland. Methods and Analysis During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. Results Of 266 NOK approached for consent, consent was given in 137 (51.5%) cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46–6.54) and German language area (OR 0.31, 95% CI: 0.14–0.73). Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93–3.33) and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90–3.87). Conclusion Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions. PMID:25208215

Professional Disclosure Statements and Formal Plans for Supervision: Two Strategies for Minimizing the Risk of Ethical Conflicts in Post-Master's Supervision.

ERIC Educational Resources Information Center

Cobia, Debra C.; Boes, Susan R.

2000-01-01

Discusses ethical conflicts related to issues of informed consent, due process, competence, confidentiality, and dual relationships in supervision. Proposes two strategies as ways to minimize the potential for ethical conflict in post-master's supervision: the use of professional disclosure statements by supervisors and the development of formal…

Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

PubMed Central

Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

2013-01-01

Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial.

PubMed

Natale, Joanne E; Lebet, Ruth; Joseph, Jill G; Ulysse, Christine; Ascenzi, Judith; Wypij, David; Curley, Martha A Q

2017-05-01

To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child's participation in a multisite pediatric critical care clinical trial. We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent. Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P < .001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001). Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child's participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings. ClinicalTrials.gov: NCT00814099. Copyright © 2017 Elsevier Inc. All rights reserved.

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

PubMed

Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

2016-01-01

Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.

Hanford Single Shell Tank Leak Causes and Locations - 241-TX Farm

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, C. L.; Harlow, D> G.

This document identifies 241-TX Tank Farm (TX Farm) leak causes and locations for the 100 series leaking tanks (241-TX-107 and 241-TX-114) identified in RPP-RPT-50870, Rev. 0, Hanford 241-TX Farm Leak Inventory Assessment Report. This document satisfies the TX Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

Simplifying informed consent for biorepositories: stakeholder perspectives.

PubMed

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-09-01

Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

Medical Individualism or Medical Familism? A Critical Analysis of China's New Guidelines for Informed Consent: The Basic Norms of the Documentation of the Medical Record.

PubMed

Bian, Lin

2015-08-01

Modern Western medical individualism has had a significant impact on health care in China. This essay demonstrates the ways in which such Western-style individualism has been explicitly endorsed in China's 2010 directive: The Basic Norms of the Documentation of the Medical Record. The Norms require that the patient himself, rather than a member of his family, sign each informed consent form. This change in clinical practice indicates a shift toward medical individualism in Chinese healthcare legislation. Such individualism, however, is incompatible with the character of Chinese familism that is deeply rooted in the Chinese ethical tradition. It also contradicts family-based patterns of health care in China. Moreover, the requirement for individual informed consent is incompatible with numerous medical regulations promulgated in the past two decades. This essay argues that while Chinese medical legislation should learn from relevant Western ideas, it should not simply copy such practices by importing medical individualism into Chinese health care. Chinese healthcare policy is properly based on Chinese medical familist resources. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

29 CFR 4000.14 - What is the safe-harbor method for providing an issuance by electronic media?

Code of Federal Regulations, 2011 CFR

2011-07-01

... through the Internet or other electronic communication network, has affirmatively consented or confirmed... document, including whether the paper version will be provided free of charge; (v) Any hardware and...

29 CFR 4000.14 - What is the safe-harbor method for providing an issuance by electronic media?

Code of Federal Regulations, 2014 CFR

2014-07-01

... through the Internet or other electronic communication network, has affirmatively consented or confirmed... document, including whether the paper version will be provided free of charge; (v) Any hardware and...

29 CFR 4000.14 - What is the safe-harbor method for providing an issuance by electronic media?

Code of Federal Regulations, 2010 CFR

2010-07-01

... through the Internet or other electronic communication network, has affirmatively consented or confirmed... document, including whether the paper version will be provided free of charge; (v) Any hardware and...

29 CFR 4000.14 - What is the safe-harbor method for providing an issuance by electronic media?

Code of Federal Regulations, 2012 CFR

2012-07-01

... through the Internet or other electronic communication network, has affirmatively consented or confirmed... document, including whether the paper version will be provided free of charge; (v) Any hardware and...

29 CFR 4000.14 - What is the safe-harbor method for providing an issuance by electronic media?

Code of Federal Regulations, 2013 CFR

2013-07-01

... through the Internet or other electronic communication network, has affirmatively consented or confirmed... document, including whether the paper version will be provided free of charge; (v) Any hardware and...

Enhancing HIV Vaccine Trial Consent Preparedness Among Street Drug Users

PubMed Central

Fisher, Celia B.

2011-01-01

This research used open-ended and true-false questions to assess the preparedness of 96 ethnically diverse, economically and socially marginalized adult street drug users to consent to participate in HIV vaccine trials (HVT). Specific areas of consent vulnerability included misconceptions about: (1) the recuperative value and risk of vaccines in general; (2) the presence of the HIV virus within the vaccine and the possibility of contracting or transmitting HIV as a consequence of participation; (3) inclusion criteria and experimental blinds; and (4) distrust in the medical and research establishments. A brief HVT lesson administered to 30 participants was effective in correcting specific HVT knowledge misperceptions and increasing certain, but not all areas of HVT trust. Assessment of post-lesson responses to ethics-relevant questions provides information on respondents' attitudes toward AIDS safe behavior, research risks and benefits, monetary compensation, and willingness to participate. Implications for enhancing informed consent for HVT involving active drug users are discussed. PMID:20569151

National policy on testing for HIV in South Africa: an urgent need.

PubMed

Oosthuizen, H

2001-01-01

No National Policy exists in South Africa for the testing of persons who may be infected by HIV/AIDS. A Draft National Policy on Testing for HIV was published in the Government Gazette by the Minister of Health for commentary in December 1999. The policy provides for the following: circumstances under which HIV testing may be conducted; informed consent, pre-test and post-test counselling; and the interpretation of the policy. This policy will apply to persons who are able to give consent as well as to those who are legally entitled to give proxy consent to HIV testing. Testing with informed consent means that the individual has been made aware of, and understands, the implications of the test. "The vision which fueled our struggle for freedom; the deployment of energies and resources; the unity and commitment to common goals--all these are needed if we are to bring AIDS under control. Future generations will judge us on the adequacy of our response." President Nelson Mandela. DAVOS, 1996.

Recommendations and Justifications To Remove Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Birney, Cathleen; Krauss, Mark J

This document is part of an effort to reevaluate 37 FFACO and Administrative URs against the current Soils Risk-Based Corrective Action Evaluation Process. After reviewing 37 existing FFACO and Administrative URs, 3 URs addressed in this document have sufficient information to determine that these current URs may be removed, based on the RBCA criteria. This document presents recommendations on modifications to existing URs that will be consistent with the RBCA criteria.

"Teach-to-Goal" to Better Assess Informed Consent Comprehension among Incarcerated Clinical Research Participants.

PubMed

Ahalt, Cyrus; Sudore, Rebecca; Bolano, Marielle; Metzger, Lia; Darby, Anna M; Williams, Brie

2017-09-01

Correctional health research requires important safeguards to ensure that research participation is ethically conducted. In addition to having disproportionately low educational attainment and low literacy, incarcerated people suffer from health-related conditions that can affect cognition (e.g., traumatic brain injury, substance use disorders, mental illness). Yet modified informed consent processes that assess participants' comprehension of the risks and benefits of participation are not required by relevant federal guidelines. A push to assess comprehension of informed consent documents is particularly timely given an increase in demand for correctional health research in the context of criminal justice reform. We argue that comprehension assessments can identify persons who should be excluded from research and help those who will ultimately participate in studies better understand the risks and benefits of their participation. © 2017 American Medical Association. All Rights Reserved.

[Pitfalls in informed consent: a statistical analysis of malpractice law suits].

PubMed

Echigo, Junko

2014-05-01

In medical malpractice law suits, the notion of informed consent is often relevant in assessing whether negligence can be attributed to the medical practitioner who has caused injury to a patient. Furthermore, it is not rare that courts award damages for a lack of appropriate informed consent alone. In this study, two results were arrived at from a statistical analysis of medical malpractice law suits. One, unexpectedly, was that the severity of a patient's illness made no significant difference to whether damages were awarded. The other was that cases of typical medical treatment that national medical insurance does not cover were involved significantly more often than insured treatment cases. In cases where damages were awarded, the courts required more disclosure and written documents of information by medical practitioners, especially about complications and adverse effects that the patient might suffer.

Consent Processes for Mobile App Mediated Research: Systematic Review.

PubMed

Moore, Sarah; Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan

2017-08-30

Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. This review advocates the importance of participant informedness in a novel and largely unregulated research setting. ©Sarah Moore, Anne-Marie Tassé, Adrian Thorogood, Ingrid Winship, Ma'n Zawati, Megan Doerr. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 30.08.2017.

Consent Processes for Mobile App Mediated Research: Systematic Review

PubMed Central

Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan

2017-01-01

Background Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. Objective The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. Methods This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Results Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. Conclusions This review advocates the importance of participant informedness in a novel and largely unregulated research setting. PMID:28855147

Medical records and privacy: empirical effects of legislation.

PubMed

McCarthy, D B; Shatin, D; Drinkard, C R; Kleinman, J H; Gardner, J S

1999-04-01

To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study. Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan. Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs. The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents. Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members. Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.

Consent, common adverse events, and post-adverse event actions in endoscopy.

PubMed

Adler, Douglas G

2015-01-01

Endoscopy constitutes a wide range of procedures with many indications. Esophagogastroduodenoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, and enteroscopy comprise the most commonly performed procedures. These examinations all carry risk to the patient, and incumbent in this is some legal risk with regard to how the procedure is conducted, decisions made based on the intraprocedure findings, and the postprocedure results, in addition to events that occur following the procedure. This article provides an overview of consent and complications of endoscopy. Copyright © 2015 Elsevier Inc. All rights reserved.

Ensuring Cross-Cultural Equivalence in Translation of Research Consents and Clinical Documents

PubMed Central

Lee, Cheng-Chih; Li, Denise; Arai, Shoshana; Puntillo, Kathleen

2010-01-01

The aim of this article is to describe a formal process used to translate research study materials from English into traditional Chinese characters. This process may be useful for translating documents for use by both research participants and clinical patients. A modified Brislin model was used as the systematic translation process. Four bilingual translators were involved, and a Flaherty 3-point scale was used to evaluate the translated documents. The linguistic discrepancies that arise in the process of ensuring cross-cultural congruency or equivalency between the two languages are presented to promote the development of patient-accessible cross-cultural documents. PMID:18948451

22 CFR 225.115 - IRB records.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and... members voting for, against, and abstaining; the basis for requiring changes in or disapproving research...

17 CFR 240.14a-12 - Solicitation before furnishing a proxy statement.

Code of Federal Regulations, 2011 CFR

2011-04-01

... material must: (i) State the name of the author and publication, the date of prior publication, and... the case of a public or official document or statement, state whether or not the consent of the author...

Improving participant comprehension in the informed consent process.

PubMed

Cohn, Elizabeth; Larson, Elaine

2007-01-01

To critically analyze studies published within the past decade about participants' comprehension of informed consent in clinical research and to identify promising intervention strategies. Integrative review of literature. The Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and the Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched. Inclusion criteria included studies (a) published between January 1, 1996 and January 1, 2007, (b) designed as descriptive or interventional studies of comprehension of informed consent for clinical research, (c) conducted in nonpsychiatric adult populations who were either patients or volunteer participants, (d) written in English, and (e) published in peer-reviewed journals. Of the 980 studies identified, 319 abstracts were screened, 154 studies were reviewed, and 23 met the inclusion criteria. Thirteen studies (57%) were descriptive, and 10 (43%) were interventional. Interventions tested included simplified written consent documents, multimedia approaches, and the use of a trained professional (consent educator) to assist in the consent process. Collectively, no single intervention strategy was consistently associated with improved comprehension. Studies also varied in regard to the definition of comprehension and the tools used to measure it. Despite increasing regulatory scrutiny, deficiencies still exist in participant comprehension of the research in which they participate, as well as differences in how comprehension is measured and assessed. No single intervention was identified as consistently successful for improving participant comprehension, and results indicated that any successful consent process should at a minimum include various communication modes and is likely to require one-to-one interaction with someone knowledgeable about the study.

Local attitudes, moral obligation, customary obedience and other cultural practices: their influence on the process of gaining informed consent for surgery in a tertiary institution in a developing country.

PubMed

Irabor, David O; Omonzejele, Peter

2009-04-01

The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and all-knowing, and this is buttressed by the cultural practice of customary obedience to those 'above you': either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-SX Tank Farm (SX Farm) leak causes and locations for the 100 series leaking tanks (241-SX-107, 241-SX-108, 241-SX-109, 241-SX-111, 241-SX-112, 241-SX-113, 241-SX-114, and 241-SX-115) identified in RPP-ENV-39658, Rev. 0, Hanford SX-Farm Leak Assessments Report. This document satisfies the SX Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

[Informed consent consultation as a part of patient safety in pediatric traumatology].

PubMed

Kraus, R; Heberer, J

2013-10-01

In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

Informed consent in human experimentation before the Nuremberg code.

PubMed

Vollmann, J; Winau, R

1996-12-07

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

Legal aspects of the management of chronic pain.

PubMed

Mendelson, G; Mendelson, D

1991-11-04

To review the legal provisions which control the prescription of opioid analgesics in Australia, and to summarise the areas in which practitioners who treat patients with chronic pain may expect to become involved with the legal system. The relevant legislation was reviewed, and a selective review was undertaken of literature dealing with the legal aspects of pain and suffering which may form a basis for personal injury claims. Case law which deals with issues of consent to treatment was also examined. Statutory requirements which control the prescription of opioids were summarised. Leading cases on patient consent were discussed to clarify for the practitioner the principles which the Courts use in the assessment of the validity of the consent given by patients for treatment. The assessment of the pain patient involved in litigation was briefly discussed. The prescription and administration of opioid analgesics must be in accordance with the legislative provisions. Treatment options must be discussed and explained to patients so that valid consent can be obtained. Patients' questions must be answered in full, and documentation in the clinical record is required.

Measuring the impacts of seclusion on psychiatry inpatients and the effectiveness of a pilot single-session post-seclusion counselling intervention.

PubMed

Whitecross, Fiona; Seeary, Amy; Lee, Stuart

2013-12-01

Despite the accumulation of evidence demonstrating patients' accounts of trauma associated with seclusion, the use of evidence-based post-seclusion debriefing is not apparent in the published work. This study aimed to identify the impacts seclusion has on an individual using the Impact of Events - Revised (IES-R), a standardized and widely used measure of trauma symptoms, and measure the effectiveness of a post-seclusion counselling intervention in mitigating the experience of seclusion-related trauma and reducing time spent in seclusion. The study design involved a comparison of the seclusion-related trauma and time in seclusion that was experienced by consenting patients managed on the two inpatient wards of Alfred Psychiatry. To investigate the efficacy of post-seclusion counselling to reduce event-related trauma as well as the use of seclusion, a brief single-session intervention was piloted comparing outcomes for patients treated on a ward implementing semistructured post-seclusion counselling and patients treated on a ward continuing with post-seclusion support as usual. A total of 31 patients consented to participate, with approximately 47% reporting trauma symptoms consistent with 'probable post-traumatic stress disorder' (IES-R total score, >33), although there was no difference in trauma experience between groups. Significantly fewer hours were spent in seclusion for patients treated on the ward piloting the post-seclusion counselling intervention. Findings, therefore, highlight not only the potential for significant trauma stemming from a seclusion event, but also the capacity for the implementation of such interventions as post-seclusion counselling to raise awareness of the need to minimize time spent in seclusion for patients. © 2013 Australian College of Mental Health Nurses Inc.

Retrospective access to data: the ENGAGE consent experience

PubMed Central

Tassé, Anne Marie; Budin-Ljøsne, Isabelle; Knoppers, Bartha Maria; Harris, Jennifer R

2010-01-01

The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance. This is even more so for retrospective access to data for secondary uses, wherein the original consent did not foresee such use. The first part of this paper provides a brief historical overview of the ethical and legal frameworks governing consent issues in biobanking generally, before turning to the secondary use of retrospective data in epidemiological biobanks. Such use raises particularly complex issues when (1) the original consent provided is restricted; (2) the minor research subject reaches legal age; (3) the research subject dies; or (4) samples and data were obtained during medical care. Our analysis demonstrates the inconclusive, and even contradictory, nature of guidelines and confirms the current lack of compatible regulations. The second part of this paper uses the European Network for Genetic and Genomic Epidemiology (ENGAGE Consortium) as a case study to illustrate the challenges of research using previously collected data sets in Europe. Our study of 52 ENGAGE consent forms and information documents shows that a broad range of mechanisms were developed to enable secondary use of the data that are part of the ENGAGE Consortium. PMID:20332813

Retrospective access to data: the ENGAGE consent experience.

PubMed

Tassé, Anne Marie; Budin-Ljøsne, Isabelle; Knoppers, Bartha Maria; Harris, Jennifer R

2010-07-01

The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance. This is even more so for retrospective access to data for secondary uses, wherein the original consent did not foresee such use. The first part of this paper provides a brief historical overview of the ethical and legal frameworks governing consent issues in biobanking generally, before turning to the secondary use of retrospective data in epidemiological biobanks. Such use raises particularly complex issues when (1) the original consent provided is restricted; (2) the minor research subject reaches legal age; (3) the research subject dies; or (4) samples and data were obtained during medical care. Our analysis demonstrates the inconclusive, and even contradictory, nature of guidelines and confirms the current lack of compatible regulations. The second part of this paper uses the European Network for Genetic and Genomic Epidemiology (ENGAGE Consortium) as a case study to illustrate the challenges of research using previously collected data sets in Europe. Our study of 52 ENGAGE consent forms and information documents shows that a broad range of mechanisms were developed to enable secondary use of the data that are part of the ENGAGE Consortium.

Refining the Enrolment Process in Emergency Medicine Research.

PubMed

Sahan, Kate M; Channon, Keith M; Choudhury, Robin P; Kharbanda, Rajesh K; Lee, Regent; Sheehan, Mark

2016-04-01

Research in the emergency setting involving patients with acute clinical conditions is needed if there are to be advances in diagnosis and treatment. But research in these areas poses ethical and practical challenges. One of these is the general inability to obtain informed consent due to the patient's lack of mental capacity and insufficient time to contact legal representatives. Regulatory frameworks which allow this research to proceed with a consent 'waiver', provided patients lack mental capacity, miss important ethical subtleties. One of these is the varying nature of mental capacity among emergency medicine patients. Not only is their capacity variable and often unclear, but some patients are also likely to be able to engage with the researcher and the context to varying degrees. In this paper we describe the key elements of a novel enrolment process for emergency medicine research that refines the consent waiver and fully engages with the ethical rationale for consent and, in this context, its waiver. The process is verbal but independently documented during the 'emergent' stages of the research. It provides appropriate engagement with the patient, is context-sensitive and better addresses ethical subtleties. In line with regulation, full written consent for on-going participation in the research is obtained once the emergency is passed.

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.

PubMed

Verástegui, Emma L

2006-12-13

A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade. The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico

PubMed Central

Verástegui, Emma L

2006-01-01

Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients. PMID:17166274

When Spiders Bite: The Use, Misuse, and Unintended Consequences of ``Silent Information''

NASA Astrophysics Data System (ADS)

Keenan, Thomas P.

Spiders are the workhorses of the Internet, silently (and almost invisibly) traversing the online world, 24 hours a day, looking for information that may be of interest to someone. It is being archived, organized, and sold, usually without the knowledge or consent of the subject of the information. Serious consequences are starting to appear, such as the withdrawal of three candidates from the October 2008 Canadian Federal election because of previous online indiscretions. While these were intentional if mis-guided postings, information made available without our consent can have equally devastating effects. Advances in artificial intelligence, as well as the increasing tendency to post more and more information, such as videos, will make the gathering, aggregation, and republishing of this “silent information” an increasingly important issue that must be addressed from the technical, social, ethical and legal perspectives, and sooner rather than later.

Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.

PubMed

Hall, Eric William; Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S

2017-03-06

Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant. Video-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts. Clinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N). ©Eric William Hall, Travis H Sanchez, Aryeh D Stein, Rob Stephenson, Maria Zlotorzynska, Robert Craig Sineath, Patrick S Sullivan. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.03.2017.

Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial

PubMed Central

Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S

2017-01-01

Background Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. Objective The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). Methods From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Results Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant. Conclusions Video-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts. Trail Registration Clinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N). PMID:28264794

Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context?

PubMed

Mendyk, Anne-Marie; Labreuche, Julien; Henon, Hilde; Girot, Marie; Cordonnier, Charlotte; Duhamel, Alain; Leys, Didier; Bordet, Régis

2015-04-24

The provision of informed consent is a prerequisite for inclusion of a patient in a clinical research project. In some countries, the legislation on clinical research authorizes a third person to provide informed consent if the patient is unable to do so directly (i.e. surrogate consent). This is the case during acute stroke, when the symptoms may prevent the patient from providing informed consent and thus require a third party to be approached. Identification of factors associated with the medical team's decision to resort to surrogate consent may (i) help the care team during the inclusion process and (ii) enable the patient's family circle to be better informed (and thus feel less guilty) about providing surrogate consent. Patients included in the BIOSTROKE cohort (initially dedicated to the analysis of factors influencing stroke severity) were divided into two groups: those having provided informed consent directly and those for whom a third party (such as a family member) had provided surrogate consent. We compared the groups in terms of the initial clinical characteristics (age, gender, type of stroke, severity on the National Institutes of Health Stroke Scale (NIHSS), pre-stroke cognitive status according to the Informant Questionnaire on Cognitive Decline in the Elderly, and the stroke's aetiology) and the functional and cognitive impairments (according to the NIHSS, the modified Rankin score (mRS) and the Mini Mental State Examination) on post-stroke days 8 and 90. Three hundred and ninety five patients were included (mean ± SD age: 67 ± 15 years; 53% males). Surrogate consent had been obtained in 228 cases, and 167 patients had provided consent themselves. The patients included with surrogate consent were likely to be older and more aphasic, with a pre-existing cognitive disorder and more severe stroke (relative to the patients having provided consent). In terms of recovery, the patients included with surrogate consent had a worse functional prognosis (day 90 mRS ≥3: 57.6%, compared with 16.8% in patients having provided consent themselves; p < 0.0001) and a worse cognitive prognosis (day 90 MMS < 24: 15.4% and 4.8%, respectively; p < 0.002). The mortality rate was significantly higher in the surrogate consent group. We found that in addition to age, aphasia and stroke severity, pre-stroke cognitive status is a factor that should prompt the care team to consider requesting surrogate consent for participation in a clinical study. Given that the unfavourable outcome in patients with surrogate consent is often due to their initial clinical state (rather than inclusion in a trial per se), the issue of the family's feelings of guilt (and how to avoid these feelings) should be further addressed.

Negotiating boundaries: Accessing donor gametes in India.

PubMed

Widge, A; Cleland, J

2011-01-01

This paper documents how couples and providers access donor materials for conception in the Indian context and perceptions about using them. The objective is to facilitate understanding of critical issues and relevant concerns. A postal survey was conducted with a sample of 6000 gynaecologists and in-depth interviews were -conducted with 39 gynaecologists in four cities. Donor gametes are relatively more acceptable than a few years ago, especially if confidentiality can be -maintained, though lack of availability of donor materials is sometimes an impediment to infertility treatment. Donor sperms are usually accessed from in-house or commercial sperm banks, pathology laboratories, IVF centres, -professional donors, relatives or friends. There is scepticism about screening procedures of sperm banks. Donor eggs are usually accessed from voluntary donors, friends, relatives, egg sharing programmes, donation from other patients, advertising and commercial donors. There are several concerns regarding informed consent for using donated gametes, using -relatives and friends gametes, the unregulated use of gametes and embryos, record keeping and documentation, -unethical and corrupt practices and commercialisation. These issues need to be addressed by patients, providers and regulatory authorities by providing -information, counselling, ensuring informed consent, addressing exploitation and commercialisation, ensuring -monitoring, proper documentation and transparency.

Negotiating boundaries: Accessing donor gametes in India

PubMed Central

Widge, A.; Cleland, J.

2011-01-01

Background: This paper documents how couples and providers access donor materials for conception in the Indian context and perceptions about using them. The objective is to facilitate understanding of critical issues and relevant concerns. Methods: A postal survey was conducted with a sample of 6000 gynaecologists and in-depth interviews were conducted with 39 gynaecologists in four cities. Results: Donor gametes are relatively more acceptable than a few years ago, especially if confidentiality can be maintained, though lack of availability of donor materials is sometimes an impediment to infertility treatment. Donor sperms are usually accessed from in-house or commercial sperm banks, pathology laboratories, IVF centres, professional donors, relatives or friends. There is scepticism about screening procedures of sperm banks. Donor eggs are usually accessed from voluntary donors, friends, relatives, egg sharing programmes, donation from other patients, advertising and commercial donors. There are several concerns regarding informed consent for using donated gametes, using relatives and friends gametes, the unregulated use of gametes and embryos, record keeping and documentation, unethical and corrupt practices and commercialisation. Conclusion: These issues need to be addressed by patients, providers and regulatory authorities by providing information, counselling, ensuring informed consent, addressing exploitation and commercialisation, ensuring monitoring, proper documentation and transparency. PMID:24753849

[Level of information of students at the University of Regensburg concerning organ donation and transplantation--informed or not informed consent in organ donation?].

PubMed

Banas, B; Bleyer, B; Eckert, M; Gruber, H; Pfirstinger, J; Schaller, O; Dietl, B

2013-04-01

As a result of the actual amendment of the German transplantation law, every citizen will be regularly asked by health insurance companies about his attitude towards post-mortem organ donation--without the obligation to decide. The aim is to increase the willingness of donations as well as the availability of organs. Therefore, we investigated the level of information of students at the University of Regensburg and their agreement to organ transplantation regarding an informed consent. Using an interdisciplinary developed questionnaire (Medicine, Theology, Educational Science) the level of information concerning process and possibilities of organ donation, the possession of an organ donor card, as well as the active or passive consent to donate organs was investigated. Out of 1225 respondents 31.5% had an organ donor card, 49.1% wanted to donate organs, 32.1% were unsure. 98% generally favoured organ donation. However, serious information deficits about brain death were identified: 37.4% did not know that brain death is a prerequisite for a post-mortem organ donation, 18% thought brain death is reversible, 52.7% were not aware of the necessity of intensive medical care. Furthermore, providing information about other potential donor organs including lungs, pancreas, small intestine, and tissue is required. Health insurance companies and responsible authorities need to close the identified gaps in knowledge in order to achieve "informed" consent with organ donation, which might increase the availability and number of donor organs. © Georg Thieme Verlag KG Stuttgart · New York.

A resolution to authorize testimony, documents and legal representation.

THOMAS, 112th Congress

Sen. Reid, Harry [D-NV

2011-05-05

Senate - 05/05/2011 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

25 CFR 162.571 - What are the consent requirements for an amendment to a WSR lease?

Code of Federal Regulations, 2014 CFR

2014-04-01

... AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Amendments § 162.571 What are... review. (d) Unless specifically authorized in the lease, a written power of attorney, or a court document...

25 CFR 162.571 - What are the consent requirements for an amendment to a WSR lease?

Code of Federal Regulations, 2013 CFR

2013-04-01

... AND WATER LEASES AND PERMITS Wind and Solar Resource Leases Wsr Lease Amendments § 162.571 What are... review. (d) Unless specifically authorized in the lease, a written power of attorney, or a court document...

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

PubMed

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Longitudinal informed consent competency in stable community patients with schizophrenia: A one-week training and one-year follow-up study.

PubMed

Wang, Xueqin; Yu, Xin; Appelbaum, Paul S; Tang, Hongyu; Yao, Guizhong; Si, Tianmei; Ma, Yating; Li, Tao; Yu, Ling; Shi, Chuan; Ma, Yibin; Li, Lingli

2016-01-01

This study explores the efficacy of a one-week informed consent information training process for improving competence to provide consent in stable community patients with schizophrenia over a one-year follow-up period. A one-week training session designed to enhance competence to provide informed consent for research was conducted. The training was guided by a research protocol that provided detailed explanations of each major conceptual unit. Participants were followed for one year, and comprised 50 stable community outpatients with schizophrenia who were randomly assigned to either an intervention group (IG, n=33) or a control group (CG, n=17) that did not receive any training. The Chinese Mandarin MacArthur Competence Assessment Tool-Clinical Research (MacCAT-CR) was used to assess competence for informed consent pre-training (baseline), post-training (one week later), and at the end of one year. A repeated measures analysis comparing the IG and CG at pre-training, post-training and the one-year follow-up revealed significant improvements in the Understanding and Appreciation subscale following the one-week training. However, by the end of one year, scores returned to baseline levels, with the exception of the Appreciation subscale, which was below baseline. There were significant main effects across time on the Appreciation and Reasoning subscales, indicating considerable changes over time. The CG showed no significant changes from pre-training to one week later or at one-year follow-up for all subscales. The capacities of understanding and appreciation can be improved in stable community patients with schizophrenia after one week of training; however, this training effect is not sustained one year later. The results suggest that more intensive or periodic trainings may be needed to maintain long-term competence levels in patients with schizophrenia, particularly with regard to their capacity to appreciate the nature and consequences of study participation. Copyright © 2015 Elsevier B.V. All rights reserved.

Research ethics board approval for an international thromboprophylaxis trial.

PubMed

Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

2012-06-01

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

PubMed Central

Slosky, Laura E.; Burke, Natasha L.; Siminoff, Laura A.

2014-01-01

Background. In stressful situations, decision making processes related to informed consent may be compromised. Given the profound levels of distress that surrogates of children in pediatric intensive care units (PICU) experience, it is important to understand what factors may be influencing the decision making process beyond the informed consent. The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT). Method. Participants were 76 children under sedation in a PICU and their surrogate decision makers. Measures included the Post Decision Clinician Survey, observer checklist, and post-decision interview. Results. Age of the pediatric patient was related to participation decisions in the RCT such that older children were more likely to be enrolled. Mentioning the sponsoring institution was associated with declining to participate in the RCT. Type of health care provider and overt recommendations to participate were not related to enrollment. Conclusion. Decisions to participate in research by surrogates of children in the PICU appear to relate to child demographics and subtleties in communication; however, no modifiable characteristics were related to increased participation, indicating that the informed consent process may not be compromised in this population. PMID:25161672

Recommendations and Justifications for Modifications To Downgrade Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order, Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Birney, Cathleen; Krauss, Mark J

This document is part of an effort to reevaluate 37 FFACO and Administrative URs against the current Soils Risk-Based Corrective Action Evaluation Process. After reviewing 37 existing FFACO and Administrative URs, 11 URs addressed in this document have sufficient information to determine that these current URs may be downgraded to Administrative URs based on the RBCA criteria. This document presents recommendations on modifications to existing URs that will be consistent with the RBCA criteria.

Stakeholder perceptions of Environmental Management Plans as an environmental protection tool for major developments in the UK

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bennett, Sophie; Kemp, Simon; Hudson, Malcolm D., E-mail: mdh@soton.ac.uk

Insufficient implementation and the lack of legislative requirements for follow-up measures following the approval of projects are consistently highlighted as major shortcomings of Environmental Impact Assessment (EIA). Although adopted over 15 years ago by the World Bank, Environmental Management Plans (EMPs) were only semi-formalised in the UK in 2008 and arguably provide a continuous link or ‘bridge’ between the EIA process pre-consent and an Environmental Management System (EMS) post-consent. Drawing on twenty-one semi-structured interviews with stakeholders and thematic analysis of their responses, and a broad-scale practitioner survey, this study aimed to assess the effectiveness of EMPs as an environmental protectionmore » tool across the project lifecycle for major developments. The findings revealed a mixed picture of EMP effectiveness in practice, with EMPs only partially fulfilling a bridging role between EIA and EMS. There is no ‘gold standard’ terminology for EMPs, all having slightly different uses, thus presenting different focuses to different stakeholders and further enhancing variation in practice. For many stakeholders, the effectiveness was simply not known, due to the lack of communication and follow-up that still exists. EMP–EMS linkages were shown to be effective from the developer's perspective when a single organisation has involvement across all project phases, though weaknesses occur when multiple parties are involved. Among other stakeholders, knowledge varied significantly; whilst some were in agreement that the linkages worked, many were unaware of the connections and thought of them as two quite separate tools. Stakeholders advocated for the need to make EMPs a legal requirement; for improved communication between stakeholders during EMP implementation and increased documentation of project outcomes; and for EMPs to be consistently written by environmental professionals. Furthermore, weak links in the current process may be improved by providing detailed guidance for organisations on the potential for EMP–EMS linkages, with the additional aim of encouraging stakeholders to broaden their current specialist knowledge on environmental protection tools. - Highlights: • We assessed the effectiveness of Environmental Management Plans (EMPs) for major developments, focusing on delivery of mitigation and monitoring. • EIA and Environmental Management Systems (EMS) post-consent are weakly linked. • The use of EMPs varies significantly in practise, partly due to the range of terminology used. • Linkages are hampered by poor communication and follow-up • More detailed guidance on how EMPs can successfully link with EMS is required.« less

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the United States Department of Health and Human Services' Office for Human Research Protections... documentation may include: (1) Copies of the human subjects research protocol, advertisements, recruitment... human subjects research protocol, advertisements, recruitment material, and informed consent forms by...

16 CFR 1028.115 - IRB records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false IRB records. 1028.115 Section 1028.115 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL PROTECTION OF HUMAN SUBJECTS § 1028.115 IRB... evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports...

32 CFR 219.115 - IRB records.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 2 2012-07-01 2012-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

32 CFR 219.115 - IRB records.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 2 2013-07-01 2013-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

32 CFR 219.115 - IRB records.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

32 CFR 219.115 - IRB records.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 2 2010-07-01 2010-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

32 CFR 219.115 - IRB records.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 2 2011-07-01 2011-07-01 false IRB records. 219.115 Section 219.115 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS... consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2...

Contents and readability of currently used surgical/procedure informed consent forms in Nigerian tertiary health institutions.

PubMed

Ezeome, E R; Chuke, P I; Ezeome, I V

2011-01-01

Surgical informed consent forms should have evidence that their use will enhance a shared decision-making which is the fundamental objective of informed consent in clinical practice. In the absence of any guideline in Nigeria on the content and language of informed consent forms, we sort to examine the surgical and procedure consent forms used by Federal tertiary health institutions in Nigeria, to know whether they fulfill the basic elements of informed consent. The surgical and procedure informed consent forms of 33 tertiary health institutions in Nigeria were assessed for their readability and contents. Adequacy of their content was evaluated based on provision for 28 content items identified as necessary information to be provided in a good consent form. The potential of the forms to be comprehended were assessed with Flesch readability formula. The contents of majority of the forms were scant. None of the forms made provision for documentation of the patient's permission for blood transfusion, tissue disposal, awareness of the risks of not undergoing the prescribed treatment, and the risk of anesthesia. Risk disclosures were only mentioned in specific terms in 11.4% of the forms. Less than 10% of the forms made provisions for an interpreter, signature of anesthetists, alternative to the procedure to be mentioned, and answering of the patient's questions. The Flesch reading ease scores of the forms ranged from 34.1 (Difficult) to 67.5 (Standard), with a mean score of 55.2 (Fairly difficult level). Field evaluation of the forms show that they shall be partly understood by 13- to 15-year-old patients with basic education but are best understood by literate adult patients. The content of majority of the informed consent forms used in Nigerian tertiary health institutions are poor and their readability scores are not better than those used in developed parts of the world. Health Institutions in Nigeria should revise their informed consent forms to improve their contents and do a usability trial on the sample forms before deployment in order to ensure that they are comprehensible for their patient population.

Automated Detection of Privacy Sensitive Conditions in C-CDAs: Security Labeling Services at the Department of Veterans Affairs

PubMed Central

Bouhaddou, Omar; Davis, Mike; Donahue, Margaret; Mallia, Anthony; Griffin, Stephania; Teal, Jennifer; Nebeker, Jonathan

2016-01-01

Care coordination across healthcare organizations depends upon health information exchange. Various policies and laws govern permissible exchange, particularly when the information includes privacy sensitive conditions. The Department of Veterans Affairs (VA) privacy policy has required either blanket consent or manual sensitivity review prior to exchanging any health information. The VA experience has been an expensive, administratively demanding burden on staffand Veterans alike, particularly for patients without privacy sensitive conditions. Until recently, automatic sensitivity determination has not been feasible. This paper proposes a policy-driven algorithmic approach (Security Labeling Service or SLS) to health information exchange that automatically detects the presence or absence of specific privacy sensitive conditions and then, to only require a Veteran signed consent for release when actually present. The SLS was applied successfully to a sample of real patient Consolidated-Clinical Document Architecture(C-CDA) documents. The SLS identified standard terminology codes by both parsing structured entries and analyzing textual information using Natural Language Processing (NLP). PMID:28269828

Automated Detection of Privacy Sensitive Conditions in C-CDAs: Security Labeling Services at the Department of Veterans Affairs.

PubMed

Bouhaddou, Omar; Davis, Mike; Donahue, Margaret; Mallia, Anthony; Griffin, Stephania; Teal, Jennifer; Nebeker, Jonathan

2016-01-01

Care coordination across healthcare organizations depends upon health information exchange. Various policies and laws govern permissible exchange, particularly when the information includes privacy sensitive conditions. The Department of Veterans Affairs (VA) privacy policy has required either blanket consent or manual sensitivity review prior to exchanging any health information. The VA experience has been an expensive, administratively demanding burden on staffand Veterans alike, particularly for patients without privacy sensitive conditions. Until recently, automatic sensitivity determination has not been feasible. This paper proposes a policy-driven algorithmic approach (Security Labeling Service or SLS) to health information exchange that automatically detects the presence or absence of specific privacy sensitive conditions and then, to only require a Veteran signed consent for release when actually present. The SLS was applied successfully to a sample of real patient Consolidated-Clinical Document Architecture(C-CDA) documents. The SLS identified standard terminology codes by both parsing structured entries and analyzing textual information using Natural Language Processing (NLP).

Breech presentation: an audit project as means of pursuing clinical excellence.

PubMed

Siassakos, D; Anderson, H; Panter, K

2005-10-01

Clinical audit is an effective quality improvement process to evaluate important clinical issues. Breech presentation is such an issue due to its contribution to the rising caesarean section (CS) rate. We set out to assess the management of breech presentation using, as standards, the delivery suite protocol and national guidelines. Our first audit revealed a low success rate of external cephalic version (ECV) and deficient documentation of written consent for ECV, other aspects of care being satisfactory. The results were presented to a multidisciplinary meeting and disseminated to relevant stakeholders. A re-audit was then performed. It confirmed significant improvement in the documentation of consent for ECV. It also revealed a good detection rate of breech, optimal offer rate of ECV and good neonatal outcome. However, uptake of ECV as well as the success rate could both be improved so as to reduce the CS rate for breech presentation. We discuss options for improving the uptake and success rate for ECV.

Testing an alternate informed consent process.

PubMed

Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

2009-01-01

One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

Wisconsin statutes regarding HIV testing in primary care: frequent questions and answers.

PubMed

Vergeront, J M; Reiser, W J; Druckenmiller, J K; Krchnavek, K A; Davis, J P

1998-12-01

The authors review Wisconsin statutes related to human immunodeficiency virus (HIV) testing in primary care, including the areas of written informed consent, documentation of consent, testing without consent, testing of minors, disclosure of test results without the consent of the test subject, reporting requirements, discrimination, access by insurance companies and third-party payors to HIV test results, and civil liabilities and criminal penalties associated with violation of HIV-related state statutes. During the course of the HIV epidemic in Wisconsin, many individuals (service providers, legislators, consumers and advocates) supported the enactment of HIV-related legislation. Today, Wisconsin has some of the nation's most comprehensive HIV legislation. These laws have set a legal framework that balances the rights of individuals with protection of public's health. The relatively low seroprevalence of HIV infection in Wisconsin can be attributed, in part, to the state's HIV-related legislation. While Wisconsin HIV legislation is broadly focused, much of it is concerned with HIV testing. This article examines common questions as they pertain to HIV testing in primary care and to the following areas addressed by state statutes: counseling and referral for health and support services [Wisconsin statute s. 252 14(3)] informed consent for testing or disclosure [Wisconsin statute s. 252.15(2)] written consent to disclose [Wisconsin statute s. 252.15(3) & (4)] testing without consent of the test subject [Wisconsin statute s. 252.15(2)] confidentiality of an HIV test [Wisconsin statute s. 252.15(5)] reporting of positive test results [Wisconsin statute s. 252.15(7)] discrimination [Wisconsin statute s. 252.14(2)] civil and criminal liabilities [Wisconsin statute s. 252.14(4); 252.15(8) & (9)].

Ethics in clinical research: the Indian perspective.

PubMed

Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

Practice and documentation of palliative sedation: a quality improvement initiative

PubMed Central

McKinnon, M.; Azevedo, C.; Bush, S.H.; Lawlor, P.; Pereira, J.

2014-01-01

Background Palliative sedation (ps), the continuous use of sedating doses of medication to intentionally reduce consciousness and relieve refractory symptoms at end of life, is ethically acceptable if administered according to standards of best practice. Procedural guidelines outlining the appropriate use of ps and the need for rigorous documentation have been developed. As a quality improvement strategy, we audited the practice and documentation of ps on our palliative care unit (pcu). Methods A pharmacy database search of admissions in 2008 identified, for a subsequent chart review, patients who had received either a continuous infusion of midazolam (≥10 mg/24 h), regular parenteral dosing of methotrimeprazine (≥75 mg daily), or regular phenobarbital. Documentation of the decision-making process, consent, and medication use was collected using a data extraction form based on current international ps standards. Results Interpretation and comparison of data were difficult because of an apparent lack of a consistent operational definition of ps. Patient records had no specific documentation in relation to ps initiation, to clearly identified refractory symptoms, and to informed consent in 60 (64.5%), 43 (46.2%), and 38 (40.9%) charts respectively. Variation in the medications used was marked: 54 patients (58%) were started on a single agent and 39 (42%), on multiple agents. The 40 patients (43%) started on midazolam alone received a mean daily dose of 21.4 mg (standard deviation: 24.6 mg). Conclusions The lack of documentation and standardized practice of ps on our pcu has resulted in a quality improvement program to address those gaps. They also highlight the importance of conducting research and developing clinical guidelines in this area. PMID:24764700

A resolution to authorize production of documents to the Department of Defense Inspector General.

THOMAS, 111th Congress

Sen. Reid, Harry [D-NV

2009-01-08

Senate - 01/08/2009 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize testimony, documents, and representation in United States v. Allen.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2013-11-18

Senate - 11/18/2013 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

17 CFR 140.24 - Control and accountability procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the risk of compromise and reduce storage costs. (2) Top Secret documents, except for the controlled...) Records shall be maintained to show the number and distribution of reproduced copies to all Top Secret... the consent of the originator. (3) Unless restricted by the originating agency, Secret and...

A Guide to Adolescent Health Care EPSDT.

ERIC Educational Resources Information Center

Health Care Financing Administration (DHEW), Washington, DC.

This document provides guidelines for individuals giving health care to adolescents through the Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Program. Chapter One briefly indicates needs of adolescents and outlines legal aspects of health care for adolescents such as age of majority, informed consent, confidentiality, disclosure of…

46 CFR 67.142 - Penalties.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Documentation; Mortgagee Consent; Validation § 67.142 Penalties. (a) An owner or operator of a vessel with a... fact during the application process for or application process to renew a fishery endorsement of the... information or knowingly conceals a material fact during the application process for or application process to...

46 CFR 67.142 - Penalties.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Documentation; Mortgagee Consent; Validation § 67.142 Penalties. (a) An owner or operator of a vessel with a... fact during the application process for or application process to renew a fishery endorsement of the... information or knowingly conceals a material fact during the application process for or application process to...

46 CFR 67.142 - Penalties.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Documentation; Mortgagee Consent; Validation § 67.142 Penalties. (a) An owner or operator of a vessel with a... fact during the application process for or application process to renew a fishery endorsement of the... information or knowingly conceals a material fact during the application process for or application process to...

46 CFR 67.142 - Penalties.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Documentation; Mortgagee Consent; Validation § 67.142 Penalties. (a) An owner or operator of a vessel with a... fact during the application process for or application process to renew a fishery endorsement of the... information or knowingly conceals a material fact during the application process for or application process to...

46 CFR 67.142 - Penalties.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Documentation; Mortgagee Consent; Validation § 67.142 Penalties. (a) An owner or operator of a vessel with a... fact during the application process for or application process to renew a fishery endorsement of the... information or knowingly conceals a material fact during the application process for or application process to...

Postal consent for upper gastrointestinal endoscopy.

PubMed

Shepherd, H A; Bowman, D; Hancock, B; Anglin, J; Hewett, D

2000-01-01

Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought". To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy. Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire. 275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92. 2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable". A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-BY Tank Farm (BY Farm) and 241-TY Tank Farm (TY Farm) leak causes and locations for the 100 series leaking tanks (241-BY-103, 241-TY-103, 241-TY-104, 241-TY-105, and 241-TY-106) identified in RPP-RPT-43704, Hanford BY Farm Leak Assessments Report, and in RPP-RPT-42296, Hanford TY Farm Leak Assessments Report. This document satisfies the BY and TY Farm portion of the target (T04) in Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

PubMed Central

Molyneux, Sassy; Njue, Maureen; Boga, Mwanamvua; Akello, Lilian; Olupot-Olupot, Peter; Engoru, Charles; Kiguli, Sarah; Maitland, Kathryn

2013-01-01

Objective To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future. Methods A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya. Findings Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal. Conclusion While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach. PMID:23408950

To share or not to share: a randomized trial of consent for data sharing in genome research.

PubMed

McGuire, Amy L; Oliver, Jill M; Slashinski, Melody J; Graves, Jennifer L; Wang, Tao; Kelly, P Adam; Fisher, William; Lau, Ching C; Goss, John; Okcu, Mehmet; Treadwell-Deering, Diane; Goldman, Alica M; Noebels, Jeffrey L; Hilsenbeck, Susan G

2011-11-01

Despite growing concerns toward maintaining participants' privacy, individual investigators collecting tissue and other biological specimens for genomic analysis are encouraged to obtain informed consent for broad data sharing. Our purpose was to assess the effect on research enrollment and data sharing decisions of three different consent types (traditional, binary, or tiered) with varying levels of control and choices regarding data sharing. A single-blinded, randomized controlled trial was conducted with 323 eligible adult participants being recruited into one of six genome studies at Baylor College of Medicine in Houston, Texas, between January 2008 and August 2009. Participants were randomly assigned to one of three experimental consent documents (traditional, n = 110; binary, n = 103; and tiered, n = 110). Debriefing in follow-up visits provided participants a detailed review of all consent types and the chance to change data sharing choices or decline genome study participation. Before debriefing, 83.9% of participants chose public data release. After debriefing, 53.1% chose public data release, 33.1% chose restricted (controlled access database) release, and 13.7% opted out of data sharing. Only one participant declined genome study participation due to data sharing concerns. Our findings indicate that most participants are willing to publicly release their genomic data; however, a significant portion prefers restricted release. These results suggest discordance between existing data sharing policies and participants' judgments and desires.

Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines.

PubMed

Symonds, R P; Lord, K; Mitchell, A J; Raghavan, D

2012-09-25

Throughout the world there are problems recruiting ethnic minority patients into cancer clinical trials. A major barrier to trial entry may be distrust of research and the medical system. This may be compounded by the regulatory framework governing research with an emphasis on written consent, closed questions and consent documentation, as well as fiscal issues. The Leicester UK experience is that trial accrual is better if British South Asian patients are approached by a senior doctor rather than someone of perceived lesser hierarchical status and a greater partnership between the hospital and General Practitioner may increase trial participation of this particular ethnic minority. In Los Angeles, USA, trial recruitment was improved by a greater utilisation of Hispanic staff and a Spanish language-based education programme. Involvement of community leaders is essential. While adhering to national, legal and ethnical standards, information sheets and consent, it helps if forms can be tailored towards the local ethnic minority population. Written translations are often of limited value in the recruitment of patients with no or limited knowledge of English. In some cultural settings, tape-recorded verbal consent (following approval presentations) may be an acceptable substitute for written consent, and appropriate legislative changes should be considered to facilitate this option. Approaches should be tailored to specific minority populations, taking consideration of their unique characteristics and with input from their community leadership.

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study.

PubMed

Wilhelm, Marcel; Rief, Winfried; Doering, Bettina K

2018-05-21

Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects. Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation. Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen's d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects. Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

The requirement for prior consent to participate on survey response rates: a population-based survey in Grampian

PubMed Central

Angus, Val C; Entwistle, Vikki A; Emslie, Margaret J; Walker, Kim A; Andrew, Jane E

2003-01-01

Background A survey was carried out in the Grampian region of Scotland with a random sample of 10,000 adults registered with a General Practitioner in Grampian. The study complied with new legislation requiring a two-stage approach to identify and recruit participants, and examined the implications of this for response rates, non-response bias and speed of response. Methods A two-stage survey was carried out consistent with new confidentiality guidelines. Individuals were contacted by post and asked by the Director of Public Health to consent to receive a postal or electronic questionnaire about communicating their views to the NHS. Those who consented were then sent questionnaires. Response rates at both stages were measured. Results 25% of people returned signed consent forms and were invited to complete questionnaires. Respondents at the consent stage were more likely to be female (odds ratio (OR) response rate of women compared to men = 1.5, 95% CI 1.4, 1.7), less likely to live in deprived postal areas (OR = 0.59, 95% CI 0.45, 0.78) and more likely to be older (OR for people born in 1930–39 compared to people born in 1970–79 = 2.82, 95% CI 2.36, 3.37). 80% of people who were invited to complete questionnaires returned them. Response rates were higher among older age groups. The overall response rate to the survey was 20%, relative to the original number approached for consent (1951/10000). Conclusion The requirement of a separate, prior consent stage may significantly reduce overall survey response rates and necessitate the use of substantially larger initial samples for population surveys. It may also exacerbate non-response bias with respect to demographic variables. PMID:14622444

A resolution to authorize document production in United States v. Douglas D. Hampton (D.D.C.).

THOMAS, 112th Congress

Sen. Reid, Harry [D-NV

2011-04-07

Senate - 04/07/2011 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize testimony, document production, and legal representation in United States v. Richard F. "Dickie" Scruggs.

THOMAS, 112th Congress

Sen. Reid, Harry [D-NV

2012-03-21

Senate - 03/21/2012 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize testimony, documents, and representation in State of Florida v. Lawrence, Denny, & Scarbrough.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2013-10-01

Senate - 10/01/2013 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize testimony, documents, and representation in City of Lafayette v. Bryan Benoit.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2014-05-20

Senate - 05/20/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize document production and testimony by, and representation of, the Select Committee on Intelligence.

THOMAS, 111th Congress

Sen. Reid, Harry [D-NV

2010-07-28

Senate - 07/28/2010 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

40 CFR 263.20 - The manifest system.

Code of Federal Regulations, 2010 CFR

2010-07-01

... person if he knows the shipment does not conform to the EPA Acknowledgment of Consent; and unless, in... without a tracking document that includes all information required by 40 CFR 262.84. (3) Compliance Date... designated facility on either the manifest or the shipping paper; and (4) The person delivering the hazardous...

17 CFR 270.0-4 - Incorporation by reference.

Code of Federal Regulations, 2011 CFR

2011-04-01

... company or any other person. If a certificate of an independent public accountant or accountants is... with such requirements unless the written consent of the accountant or accountants to such... entered under any of those Sections, or (4) If it is a document that has been filed in paper with respect...

17 CFR 270.0-4 - Incorporation by reference.

Code of Federal Regulations, 2014 CFR

2014-04-01

... company or any other person. If a certificate of an independent public accountant or accountants is... with such requirements unless the written consent of the accountant or accountants to such... entered under any of those Sections, or (4) If it is a document that has been filed in paper with respect...

17 CFR 270.0-4 - Incorporation by reference.

Code of Federal Regulations, 2012 CFR

2012-04-01

... company or any other person. If a certificate of an independent public accountant or accountants is... with such requirements unless the written consent of the accountant or accountants to such... entered under any of those Sections, or (4) If it is a document that has been filed in paper with respect...

17 CFR 270.0-4 - Incorporation by reference.

Code of Federal Regulations, 2010 CFR

2010-04-01

... company or any other person. If a certificate of an independent public accountant or accountants is... with such requirements unless the written consent of the accountant or accountants to such... entered under any of those Sections, or (4) If it is a document that has been filed in paper with respect...

17 CFR 270.0-4 - Incorporation by reference.

Code of Federal Regulations, 2013 CFR

2013-04-01

... company or any other person. If a certificate of an independent public accountant or accountants is... with such requirements unless the written consent of the accountant or accountants to such... entered under any of those Sections, or (4) If it is a document that has been filed in paper with respect...

75 FR 76988 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-10

... Enrollment, Chain and Ownership System (PECOS) Security Consent Form; Use: The primary function of the... for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3... the primary document used by CMS in developing the national Medicaid budget estimates that are...

A resolution to authorize testimony, documents, and representations in United States v. Renzi, et al.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2013-04-24

Senate - 04/24/2013 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize testimony in writing, documents, and representation in Whitnum v. Town of Greenwich, et al.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2013-04-25

Senate - 04/25/2013 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution to authorize testimony and document production in Richard Bowen v. Department of the Navy (MSPB).

THOMAS, 111th Congress

Sen. Reid, Harry [D-NV

2009-04-03

Senate - 04/03/2009 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

45 CFR 690.115 - IRB records.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 45 Public Welfare 3 2014-10-01 2014-10-01 false IRB records. 690.115 Section 690.115 Public... SUBJECTS § 690.115 IRB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain... reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents...

45 CFR 690.115 - IRB records.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 45 Public Welfare 3 2012-10-01 2012-10-01 false IRB records. 690.115 Section 690.115 Public... SUBJECTS § 690.115 IRB records. (a) An institution, or when appropriate an IRB, shall prepare and maintain... reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents...

A resolution to authorize testimony, document production, and representation in State of North Dakota v. Beatrice Quill.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2014-07-23

Senate - 07/23/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Corrective Action Decision Document/Closure Report for Corrective Action Unit 570: Area 9 Yucca Flat Atmospheric Test Sites, Nevada National Security Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Matthews, Patrick

2013-11-01

This Corrective Action Decision Document/Closure Report presents information supporting the closure of Corrective Action Unit (CAU) 570: Area 9 Yucca Flat Atmospheric Test Sites, Nevada National Security Site, Nevada. This complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE), Environmental Management; U.S. Department of Defense; and DOE, Legacy Management. The purpose of the CADD/CR is to provide justification and documentation supporting the recommendation that no further corrective action is needed.

Intra-articular glucocorticoid injections in patients with juvenile idiopathic arthritis in a Singapore hospital.

PubMed

Leow, Olivia Min Yi; Lim, Lee Kean; Ooi, Pei Ling; Shek, Lynette Pei Chi; Ang, Elizabeth You Ning; Son, Mary Beth

2014-05-01

This study aimed to evaluate the efficacy and safety of intra-articular glucocorticoid (IAG) injections in our institution in children with juvenile idiopathic arthritis (JIA). This is a retrospective assessment of IAG injections performed by the Department of Paediatrics, National University Hospital, Singapore, from October 2009 to October 2011. A total of 26 procedures were evaluated for efficacy, considering parameters such as clinical response, changes in systemic medication, length of time between repeat injections, safety, consent-taking, pre- and post-procedural advice, compliance with aseptic technique, and post-procedural complications. A total of 26 IAG injections of triamcinolone hexacetonide were administered over 17 occasions (i.e. patient encounters) to ten patients with JIA during the study period. After the injections, clinical scoring by a paediatric rheumatologist showed overall improvement by an average of 2.62 points out of 15. Besides six patient encounters that had an increase in systemic medication on the day of the injection, five required an increase within six months post injection, two required no adjustments, and one resulted in a decrease in medications. In all, 21 injections did not require subsequent injections. The mean interval between repeat injections was 7.8 months. Cutaneous side effects were noted in three anatomically difficult joints. Medical documentation with regard to patient progress was found to be lacking. As per the recommendations of the American College of Rheumatology, we safely used IAG injections as the first-line therapy in our group of patients with oligoarticular JIA, and/or as an adjunct to systemic therapy in our patients with JIA.

Intra-articular glucocorticoid injections in patients with juvenile idiopathic arthritis in a Singapore hospital

PubMed Central

Leow, Olivia Min Yi; Lim, Lee Kean; Ooi, Pei Ling; Shek, Lynette Pei Chi; Ang, Elizabeth You Ning; Son, Mary Beth

2014-01-01

INTRODUCTION This study aimed to evaluate the efficacy and safety of intra-articular glucocorticoid (IAG) injections in our institution in children with juvenile idiopathic arthritis (JIA). METHODS This is a retrospective assessment of IAG injections performed by the Department of Paediatrics, National University Hospital, Singapore, from October 2009 to October 2011. A total of 26 procedures were evaluated for efficacy, considering parameters such as clinical response, changes in systemic medication, length of time between repeat injections, safety, consent-taking, pre- and post-procedural advice, compliance with aseptic technique, and post-procedural complications. RESULTS A total of 26 IAG injections of triamcinolone hexacetonide were administered over 17 occasions (i.e. patient encounters) to ten patients with JIA during the study period. After the injections, clinical scoring by a paediatric rheumatologist showed overall improvement by an average of 2.62 points out of 15. Besides six patient encounters that had an increase in systemic medication on the day of the injection, five required an increase within six months post injection, two required no adjustments, and one resulted in a decrease in medications. In all, 21 injections did not require subsequent injections. The mean interval between repeat injections was 7.8 months. Cutaneous side effects were noted in three anatomically difficult joints. Medical documentation with regard to patient progress was found to be lacking. CONCLUSION As per the recommendations of the American College of Rheumatology, we safely used IAG injections as the first-line therapy in our group of patients with oligoarticular JIA, and/or as an adjunct to systemic therapy in our patients with JIA. PMID:24862747

The Psychosocial and Independent Living Donor Advocate Evaluation and Post-surgery Care of Living Donors.

PubMed

Rudow, Dianne LaPointe; Swartz, Kathleen; Phillips, Chelsea; Hollenberger, Jennifer; Smith, Taylor; Steel, Jennifer L

2015-09-01

Solid organ transplantation as a treatment for end stage organ failure has been an accepted treatment option for decades. Despite advances in medicine and technology, and increased awareness of organ donation and transplantation, the gap between supply and demand continues to widen. Living donation has been an option that has increased the number of transplants despite the continued shortage of deceased organs. In the early 2000s live donor transplantation reached an all-time high in the United States. As a result, a consensus meeting was convened in 2000 to increase the oversight of living donor transplantation. Both the Centers for Medicare and Medicaid Services and the United Network for Organ Sharing developed regulations that transplant programs performing live donor transplantation. These regulations and guidelines involve the education, evaluation, informed consent process and living donor follow-up care. Two areas in which had significant changes included the psychosocial and the independent living donor advocate (ILDA) evaluation. The purpose of this paper was to outline the current regulations and guidelines associated with the psychosocial and ILDA evaluation as well as provide further recommendations for the administration of a high quality evaluation of living donors. The goals and timing of the evaluation and education of donors; qualifications of the health care providers performing the evaluation; components of the evaluation; education provided to donors; documentation of the evaluation; participation in the selection committee meeting; post-decline and post-donation care of donors is described. Caveats including the paired donor exchange programs and non-directed and directed donation are also considered.

The impact of an oral hygiene education module on patient practices and nursing documentation.

PubMed

Coke, Lola; Otten, Karine; Staffileno, Beth; Minarich, Laura; Nowiszewski, Candice

2015-02-01

Oral hygiene is inconsistent among patients with cancer and is a national patient care issue. To promote comfort and nutritional status, oral hygiene for patients with cancer is important. The purpose of this study was to develop an evidence-based oral hygiene educational module (EM) for nursing and patient care technician (PCT) staff to promote consistent oral hygiene patient education; evaluate patient understanding of oral hygiene practices post-EM; and determine staff documentation frequency of oral hygiene care. Pre- and post-EM data were collected using a developed oral hygiene assessment tool; nursing documentation data were collected by chart review. Post-EM data were collected eight weeks post-EM. Data were analyzed using frequencies and the Mann-Whitney U test. Twenty-two patient documentation pairs were collected. Compared to pre-EM, admission teaching, patient education, and patient oral hygiene practices improved post-EM. Post-EM oral hygiene documentation and PCT teaching increased.

A resolution designating June 27, 2012, as "National Post-Traumatic Stress Disorder Awareness Day".

THOMAS, 112th Congress

Sen. Conrad, Kent [D-ND

2012-05-10

Senate - 05/24/2012 Resolution agreed to in Senate without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution designating June 27, 2011, as "National Post-Traumatic Stress Disorder Awareness Day".

THOMAS, 112th Congress

Sen. Conrad, Kent [D-ND

2011-05-26

Senate - 06/21/2011 Resolution agreed to in Senate with an amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

46 CFR 109.563 - Posting of documents.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Posting of documents. 109.563 Section 109.563 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS Miscellaneous § 109.563 Posting of documents. The master or person in charge shall ensure that the following are...

46 CFR 109.563 - Posting of documents.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Posting of documents. 109.563 Section 109.563 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS Miscellaneous § 109.563 Posting of documents. The master or person in charge shall ensure that the following are...

46 CFR 109.563 - Posting of documents.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 4 2011-10-01 2011-10-01 false Posting of documents. 109.563 Section 109.563 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS Miscellaneous § 109.563 Posting of documents. The master or person in charge shall ensure that the following are...

46 CFR 109.563 - Posting of documents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Posting of documents. 109.563 Section 109.563 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS Miscellaneous § 109.563 Posting of documents. The master or person in charge shall ensure that the following are...

46 CFR 109.563 - Posting of documents.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 4 2013-10-01 2013-10-01 false Posting of documents. 109.563 Section 109.563 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) A-MOBILE OFFSHORE DRILLING UNITS OPERATIONS Miscellaneous § 109.563 Posting of documents. The master or person in charge shall ensure that the following are...

Perpetuating Myths, Fables, and Fairy Tales: A Half Century of Electronic Fetal Monitoring

PubMed Central

Sartwelle, Thomas P.; Johnston, James C.; Arda, Berna

2015-01-01

Electronic fetal monitoring (EFM) entered clinical medical practice at the same time bioethics became reality. Bioethics changed the medical ethics landscape by replacing the traditional Hippocratic benign paternalism with patient autonomy, informed consent, beneficence, and nonmaleficence. But EFM use represents the polar opposite of bioethics' revered principles—it has been documented for half a century to be completely ineffectual, used without informed consent, and harmful to mothers and newborns alike. Despite EFM's ethical misuse, there has been no outcry from the bioethical world. Why? This article answers that question, discussing EFM's history and the reasons it was issued an ethics pass. And it explores the reason that even today mothers are still treated with blatant medical paternalism, deprived of autonomy and informed consent, and subjected to real medical risks under the guise that EFM is an essential safety device when in fact it is used almost solely to protect physicians and hospitals from cerebral palsy lawsuits. PMID:28824967

77 FR 13633 - Notice of Lodging Proposed Consent Decree

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-07

... wetlands in southeastern Massachusetts and to restore and perform compensatory mitigation at three existing... Protection Agency, 5 Post Office Square, Suite 100, Boston, Massachusetts 02109-3912. In addition, the... with the United States District Court for the District of Massachusetts in United States v. Charles...

77 FR 69505 - Notice of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-19

... application forms, parental consent forms, and pre and post parent/student surveys. Surveys are designed to... programs are designed to engage underrepresented rising 5th-8th grade students in a one-on-one virtual... mentoring opportunities in science, technology, engineering, and math (STEM) disciplines for female students...

[Legal aspects of post-mortem radiology in the Netherlands].

PubMed

Venderink, W; Dute, J C J

2016-01-01

In the Netherlands, the application of post-mortem radiology (virtual autopsy) is on the rise. Contrary to conventional autopsy, with post-mortem radiology the body remains intact. There is uncertainty concerning the legal admissibility of post-mortem radiology, since the Dutch Corpse Disposal Act does not contain any specific regulations for this technique. Autopsy and post-mortem radiology differ significantly from a technical aspect, but these differences do not have far-reaching legal consequences from a legal perspective. Even though the body remains intact during post-mortem radiology, the bodily integrity of a deceased person is breached if it would be applied without previously obtained consent. This permission can only be obtained after the relatives are fully informed about the proposed activity. In this respect, it is not relevant which technique is used, be it post-mortem radiology or autopsy. Therefore, the other legal conditions for post-mortem radiology are essentially identical to those for autopsy.

Informed consent: do information pamphlets improve post-operative risk-recall in patients undergoing total thyroidectomy: prospective randomized control study.

PubMed

Alsaffar, Hussain; Wilson, Lindsay; Kamdar, Dev P; Sultanov, Faizullo; Enepekides, Danny; Higgins, Kevin M

2016-02-13

Informed consent consists of basic five elements: voluntarism, capacity, disclosure, understanding, and ultimate decision-making. Physician disclosure, patient understanding, and information retention are all essential in the doctor-patient relationship. This is inclusive of helping patients make and manage their decisions and expectations better and also to deal with any consequences and/or complications that arise. This study investigates whether giving patients procedure-specific handouts pre-operatively as part of the established informed consent process significantly improves overall risk-recall following surgery. These handouts outline the anticipated peri-operative risks and complications associated with total thyroidectomy, as well as the corrective measures to address complications. In addition, the influence of potential confounders affecting risk-recall, such as anxiety and pre-existing memory disturbance, are also examined. Consecutive adult (≥18 years old) patients undergoing total thyroidectomy at a single academic tertiary care referral centre are included. Participants are randomly assigned into either the experimental group (with pamphlets) or the control group by a computerized randomization system (Clinstat). All participants filled out a Hospital Anxiety and Depression Scale (HADS) and they are tested by the physician for short-term memory loss using the Memory Impairment Screen (MIS) exam. All patients are evaluated at one week post-operatively. The written recall questionnaire test is also administered during this clinical encounter. Forty-nine patients are included--25 of them receive verbal consent only, while another 24 patients received both verbal consent and patient education information pamphlets. The overall average of correct answers for each group was 83% and 80% in the control and intervention groups, respectively, with no statistically significant differences. There are also no statistically significant differences between the two groups, in both interview duration, in time between interviews, and in recall tests. No correlation is also apparent between the pre-op HADS score and the recall questionnaire overall score. A pre-operative thyroid surgical information pamphlet alone might not be sufficient to enhance patient test scores and optimally educate the patient on their expected care pathway in thyroid surgery. Supplementation with alternative means of patient education perhaps using emerging technologies needs to be further investigated.

Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

75 FR 78252 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-15

... Review Boards--OMB Control Number 0910-0130--Extension When reviewing clinical research studies regulated... participating in clinical research. In the Federal Register of August 17, 2010 (75 FR 50766), FDA published a 60... IRB will use in performing its functions; the research protocols, informed consent documents, progress...

17 CFR 230.472 - Filing of amendments; number of copies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... exhibits and all other papers and documents filed as part of the amendment, and eight additional copies of... include the consent of the certifying accountant to the use of his certificate in connection with the... Commission three complete, unmarked copies of every amendment, including exhibits and all other papers and...

17 CFR 230.472 - Filing of amendments; number of copies.

Code of Federal Regulations, 2014 CFR

2014-04-01

... exhibits and all other papers and documents filed as part of the amendment, and eight additional copies of... include the consent of the certifying accountant to the use of his certificate in connection with the... Commission three complete, unmarked copies of every amendment, including exhibits and all other papers and...

17 CFR 230.472 - Filing of amendments; number of copies.

Code of Federal Regulations, 2011 CFR

2011-04-01

... exhibits and all other papers and documents filed as part of the amendment, and eight additional copies of... include the consent of the certifying accountant to the use of his certificate in connection with the... Commission three complete, unmarked copies of every amendment, including exhibits and all other papers and...

17 CFR 230.472 - Filing of amendments; number of copies.

Code of Federal Regulations, 2013 CFR

2013-04-01

... exhibits and all other papers and documents filed as part of the amendment, and eight additional copies of... include the consent of the certifying accountant to the use of his certificate in connection with the... Commission three complete, unmarked copies of every amendment, including exhibits and all other papers and...

17 CFR 230.472 - Filing of amendments; number of copies.

Code of Federal Regulations, 2012 CFR

2012-04-01

... exhibits and all other papers and documents filed as part of the amendment, and eight additional copies of... include the consent of the certifying accountant to the use of his certificate in connection with the... Commission three complete, unmarked copies of every amendment, including exhibits and all other papers and...

Identifying Values: The Front-End of Systemic School Restructuring.

ERIC Educational Resources Information Center

Lee, In-Sook

The comprehensive categories of values, and the values in each category, to be articulated and consented to by stakeholders in school restructuring are explored through a qualitative case-study approach. A public elementary school that had approximately 530 students and that was undergoing restructuring was selected. Site visits, document reviews,…

A resolution to authorize written testimony, document production, and representation in Montana Fish, Wildlife and Parks Foundation, Inc. v. United States.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2014-04-10

Senate - 04/10/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

76 FR 9579 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... Enrollment, Chain and Ownership System (PECOS) Security Consent Form; Use: The primary function of the... proposed information collection for the proper performance of the Agency's function; (2) the accuracy of.... Form CMS-37 is the primary document used by CMS in developing the national Medicaid budget estimates...

Marriage and Family Therapy and Traditional Counselor Education Programs.

ERIC Educational Resources Information Center

Beamish, Patricia; Navin, Sally

This document presents a review of the literature on salient ethical issues in marriage and family counseling. Issues addressed in the paper include: (1) defining the client and the welfare and rights of individuals versus those of the family system; (2) issues of informed consent and manipulative therapeutic interventions; (3) issues related to…

49 CFR 1503.409 - Service of documents.

Code of Federal Regulations, 2010 CFR

2010-10-01

... consented to in writing by the person served, except that such service is not effective if the party making... electronic mail or facsimile transmission, the party making service must file with the Enforcement Docket... in accordance with this part. The service will be considered valid as of the date and the time that...

A resolution authorizing the Committee on Rules and Administration to prepare a revised edition of the Standing Rules of the Senate as a Senate document.

THOMAS, 113th Congress

Sen. Schumer, Charles E. [D-NY

2013-11-04

Senate - 11/04/2013 Submitted in the Senate, considered, and agreed to without amendment by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Legal Issues for Adolescents with Chronic Illnesses and Disabilities and Their Families. CYDLINE Reviews.

ERIC Educational Resources Information Center

Minnesota Univ., Minneapolis. National Center for Youth with Disabilities.

This collection of annotated bibliographies focuses on a broad spectrum of legal issues, and is drawn from a national database of current programs and literature regarding adolescents with chronic illnesses and other disabilities. Bibliographic materials listed include documents and articles concerning the following: consent and confidentiality…

A simplified protocol for banking bone from surgical donors requiring a 90-day quarantine and an HIV-1 antibody test.

PubMed

La Prairie, A J; Gross, M

1991-02-01

The banking of femoral heads from patients who undergo total hip arthroplasty provides a valuable resource for orthopedic surgery. Quality assurance of the banked bone used in clinical procedures requires documented policies for screening, procuring, storing and distributing. Potential donors are screened at the time of donation for malignant disease, possible communicable disease, sepsis and high-risk life-styles. After negative culture results are confirmed and appropriate documentation has been completed, the bone is frozen at -70 degrees C. A quarantine period of 90 days follows. The donor is followed up 90 days or more postoperatively. At that time written consent is obtained for donation of the recovered tissue to the bone bank and for serology testing for human immunodeficiency virus (HIV-1) antibody, hepatitis B surface antigen (HBsAG), hepatitis B core antibody (HBcAb) and syphilis, and the donor is rescreened for contraindications. This protocol meets or exceeds all existing standards. The combination of obtaining consent and serology testing at 90 days streamlines the logistics of banking bone from surgical donors.

The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent

PubMed Central

Brim, Remy L; Miller, Franklin G

2013-01-01

There has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents. PMID:23239742

Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

PubMed

Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

2009-10-01

Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

How US institutional review boards decide when researchers need to translate studies

PubMed Central

Klitzman, Robert

2013-01-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees’ (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. PMID:23475805

How US institutional review boards decide when researchers need to translate studies.

PubMed

Klitzman, Robert

2014-03-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.

Informed consent for clinical trials: a comparative study of standard versus simplified forms.

PubMed

Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

1998-05-06

A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (P<.0001). However, the degree to which the participants understood the forms was essentially the same for the LSU form (58%; 95% CI = 48.6%-67.0%) and the SWOG form (56%; 95% CI = 43.8%-66.8%). These findings raise serious questions regarding the adequacy of the design of written informed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

Auditing of clinical research ethics in a children's and women's academic hospital.

PubMed

Bortolussi, Robert; Nicholson, Diann

2002-06-01

Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits. The research audit is a valuable tool in improving research ethics performance but requires considerable resources.

RCRA Summary Document for the David Witherspoon 1630 Site, Knoxville, Tennessee

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pfeffer, J.

2008-06-10

The 48-acre David Witherspoon, Inc. (DWI) 1630 Site operated as an unregulated industrial landfill and scrap yard. The Tennessee Division of Superfund (TDSF) closed the landfill in 1974. During the period of operation, the site received solid and liquid wastes from salvage and industrial operations. The site consists of five separate tracts of land including a small portion located across the Norfolk Southern Railroad track. The landfill occupies approximately 5 acres of the site, and roughly 20 acres of the 48 acres contains surface and buried debris associated with the DWI dismantling business operation. Beginning in 1968, the state ofmore » Tennessee licensed DWI to receive scrap metal at the DWI 1630 Site, contaminated with natural uranium and enriched uranium (235U) not exceeding 0.1 percent by weight (TDSF 1990). The U.S. Department of Energy (DOE) has agreed to undertake remedial actions at the DWI 1630 Site as specified under a Consent Order with the Tennessee Department of Environment and Conservation (TDEC) (Consent Order No. 90-3443, April 4, 1991), and as further delineated by a Memorandum of Understanding (MOU) between DOE and the State of Tennessee (MOU Regarding Implementation of Consent Orders, October 6, 1994). The soil and debris removal at the DWI 1630 Site is being performed by Bechtel Jacobs Company LLC (BJC) on behalf of the DOE. Remediation consists of removing contaminated soil and debris from the DWI 1630 site except for the landfill area and repairing the landfill cap. The DWI 1630 remediation waste that is being disposed at the Environmental Management Waste Management Facility (EMWMF) as defined as waste lot (WL) 146.1 and consists primarily of soils and soil like material, incidental debris and secondary waste generated from the excavation of debris and soil from the DWI 1630 site. The WL 146.1 includes soil, soil like material (e.g., shredded or chipped vegetation, ash), discrete debris items (e.g., equipment, drums, large scrap metal, cylinders, and cable) and populations of debris type items (e.g., piles of bricks, small scrap metal, roofing material, scaffolding, and shelving) that are located throughout the DWI 1630 site. The project also generates an additional small volume of secondary waste [e.g., personal protective equipment (PPE), and miscellaneous construction waste] that is bagged and included in bulk soil shipments to the EMWMF. The Waste Acceptance Criteria (WAC) for the EMWMF does not allow for material that does not meet the Resource Conservation and Recovery Act (RCRA) Land Disposal Restrictions (LDRs). The waste being excavated in certain areas of the DWI 1630 site contained soil that did not meet RCRA LDR criteria; therefore this waste had to be segregated for treatment or alternate disposal offsite. This document identifies the approach taken by the DWI 1630 project to further characterize the areas identified during the Phase II Remedial Investigation (RI) as potentially containing RCRA-characteristic waste. This document also describes the methodology used to determine excavation limits for areas determined to be RCRA waste, post excavation sampling, and the treatment and disposal of this material.« less

Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries.

PubMed

Kabakama, Severin; Gallagher, Katherine E; Howard, Natasha; Mounier-Jack, Sandra; Burchett, Helen E D; Griffiths, Ulla K; Feletto, Marta; LaMontagne, D Scott; Watson-Jones, Deborah

2016-08-19

Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90-70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social mobilisation, consent, and acceptability lessons were consistent across world regions and HPV vaccination projects/programmes. These can be used to guide HPV vaccination communication strategies without additional formative research.

A resolution designating the month of June 2013 as "National Post-Traumatic Stress Disorder Awareness Month".

THOMAS, 113th Congress

Sen. Heitkamp, Heidi [D-ND

2013-06-12

Senate - 06/12/2013 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

A resolution designating the month of June 2014 as "National Post-Traumatic Stress Disorder Awareness Month".

THOMAS, 113th Congress

Sen. Heitkamp, Heidi [D-ND

2014-06-23

Senate - 06/23/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

77 FR 32703 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-01

... organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Post-Trade Transparency for Agency Pass...

An empirical assessment of the short-term impacts of a reading of Deborah Zoe Laufer's drama Informed Consent on attitudes and intentions to participate in genetic research.

PubMed

Rothwell, Erin; Botkin, Jeffrey R; Cheek-O'Donnell, Sydney; Wong, Bob; Case, Gretchen A; Johnson, Erin; Matheson, Trent; Wilson, Alena; Robinson, Nicole R; Rawlings, Jared; Horejsi, Brooke; Lopez, Ana Maria; Byington, Carrie L

2018-01-01

This study assessed the short-term impact of the play "Informed Consent" by Deborah Zoe Laufer (a fictionalized look at the controversy over specimens collected from the Havasupai Tribe for diabetes research in 1989) on perceptions of trust, willingness to donate biospecimens, and attitudes toward harm and privacy among the medical and undergraduate students, faculty, and the public in the Intermountain West. Surveys were administered before and after a staged reading of the play by professional actors. Survey items included the short form Trust in Medical Researchers, and single-item questions about group identity, ethics of genetic testing in children, and willingness to donate biospecimens. In addition, respondents were given the option to answer open-ended questions through e-mail. Out of the 481 who attended the play, 421 completed both the pre and post surveys, and 166 participants completed open-ended questions online approximately 1 week after the play. Across all participants, there were significant declines for trust in medical researchers and for the survey item "is it ethical for investigators to test children for adult onset diseases" (p < .001 for both) following the play. There was a significant increase in agreement to improve group identity protections (p < .001) and there were no differences on willingness to donate biospecimens to research (p = .777). Qualitative data provided extensive contextual data supporting these perspectives. This is one of the first studies to document short-term impacts of a theatrical performance on both attitudes and behavioral intentions toward research ethics and clinical research participation. Future research should continue to explore the impact of theatrical performances among public and investigators on the ethical issues and complexities in clinical research.

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

PubMed Central

2013-01-01

Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons. PMID:23879694

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.

PubMed

Nishimura, Adam; Carey, Jantey; Erwin, Patricia J; Tilburt, Jon C; Murad, M Hassan; McCormick, Jennifer B

2013-07-23

Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.

PubMed

Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F

2014-07-08

Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.

PubMed

Fisher, Celia B; Arbeit, Miriam R; Dumont, Melissa S; Macapagal, Kathryn; Mustanski, Brian

2016-02-01

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational, and voluntary self-consent. Sixty sexually active SGMY (ages 14-17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not "out" to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills every day, logistics, and post-trial access to PrEP. Results demonstrate youth's ability to self-consent to age- and population-appropriate procedures, and underscore the value of empirical studies for informing institutional review board (IRB) protections of SGMY research participants. © The Author(s) 2016.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers through Evidence-based Ethics

PubMed Central

Fisher, Celia B.; Arbeit, Miriam R.; Dumont, Melissa S.; Macapagal, Kathryn; Mustanski, Brian

2016-01-01

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational and voluntary self-consent. Sixty sexually active SGMY (ages 14–17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not “out” to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills everyday, logistics, and post-trial access to PrEP. Results demonstrate youth’s ability to self-consent to age- and population- appropriate procedures, and underscore the value of empirical studies for informing IRB protections of SGMY research participants. PMID:26956988

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

PubMed

Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

2015-10-01

The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers both to the health professional's obligation of information disclosure to the patient and to the quality of the patient's understanding and decision making. In other words, it does not refer to the single moment of the agreement, but to the whole complex process of gaining information, deciding and consenting. Several factors may restrict informed consent, including the patient's competence, provision of limited information, ineffective communication between patients and professionals, the hospital environment itself and privacy problems.According to the World Health Organization (WHO), people are increasingly urged to make choices for themselves or for their family members in regards to health care use. However, at the same time, inadequate or problematic health literacy skills have been reported in approximately half of the adult population in eight European countries. "Health literacy is linked to literacy and entails people's knowledge, motivation and competences to access, understand, appraise and apply health information in order to make judgments and take decisions in everyday life concerning health care, disease prevention and health promotion to maintain or improve quality of life during the life course". There are many instruments measuring either health literacy in general or some dimensions of health literacy (e.g. numeracy), health literacy related to specific issues (e.g. nutrition, diabetes) or health literacy of specific populations (e.g. adolescents). The diversity of existing instruments, which includes diversity in terms of scoring and ranges, makes the comparison of the results of different studies difficult. Index thresholds and ranges for different levels of health literacy for most tools were set based either on that of other well established health literacy instruments used in the same study, or on experts' assessments of the required health literacy scores. Adequate health literacy could be considered as the capacity of successfully completing most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions designed to reduce the effects of limited health literacy in general. Some of the outcomes of the included studies were comprehension and behavioral intent, outcomes which could be strongly related to the informed consent process. Without making any distinction of the studies referring to the informed consent process, they conclude that several health literacy interventions, for example, adding video to narrative, could improve an individual's comprehension. Schenker et al. conducted a systematic review on the interventions to improve patient comprehension of medical and surgical procedures, including articles published until 2008. One of their conclusions was that, in most studies, while particular attention is needed for interventions provided to patients with limited literacy, the literacy of the patients was not addressed or assessed.Since then, many articles on health literacy and informed consent have been published. According to a recent review on best practices and new models of health literacy for informed consent, which includes papers published from 2004 to 2014, over half of the collected articles were published since 2010. This review, which is limited to literature within the US and its territories, and does not focus on the evaluation of the recommended practices in the literature, concludes that different tactics for simplifying written documents and clarifying verbal exchanges, and the use of multimedia formats and computerized exchanges might ameliorate constraints to health literate communications required for informed consent.Studies have evaluated the effectiveness of health literacy interventions which aim to improve the informed consent process. Improvement of the informed consent process may refer not only to the patients' comprehension but also, for example, to the recall of the information provided, to their intention to ask for clarifications, or to their satisfaction with the procedure. Interventions described and tested in the literature focus on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, p<0.005), the authors concluded that simplifying written material increases appeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)

Women's, midwives' and obstetricians' experiences of a structured process to document refusal of recommended maternity care.

PubMed

Jenkinson, Bec; Kruske, Sue; Stapleton, Helen; Beckmann, Michael; Reynolds, Maree; Kildea, Sue

2016-12-01

Ethical and professional guidance for midwives and obstetricians emphasises informed consent and respect for patient autonomy; the right to refuse care is well established. However, the existing literature is largely silent on the appropriate clinical responses when pregnant women refuse recommended care, and accounts of disrespectful interactions and conflict are numerous. Policies and processes to support women and maternity care providers are rare and unstudied. To document the perspectives of women, midwives and obstetricians following the introduction of a structured process (Maternity Care Plan; MCP) to document refusal of recommended maternity care in a large tertiary maternity unit. A qualitative, interpretive study involved thematic analysis of in-depth semi-structured interviews with women (n=9), midwives (n=12) and obstetricians (n=9). Four major themes were identified including: 'Reassuring and supporting clinicians'; 'Keeping the door open'; 'Varied awareness, criteria and use of the MCP process' and 'No guarantees'. Clinicians felt protected and reassured by the structured documentation and communication process and valued keeping women engaged in hospital care. This, in turn, protected women's access to maternity care. However, the process could not guarantee favourable responses from other clinicians subsequently involved in the woman's care. Ongoing discussions of risk, perceived by women and some midwives to be pressure to consent to recommended care, were still evident. These limitations may have been attributable to the absence of agreed criteria for initiating the MCP process and fragmented care. Varying awareness and use of the process also diminished women's access to it. Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

Deliberative Assessment of Surrogate Consent in Dementia Research

PubMed Central

Kim, Scott Y. H.; Uhlmann, Rebecca A.; Appelbaum, Paul S.; Knopman, David S.; Kim, H. Myra; Damschroder, Laura; Beattie, Elizabeth; Struble, Laura; De Vries, Raymond

2009-01-01

Background Research involving incapacitated persons with dementia involves complex scientific, legal, and ethical issues, making traditional surveys of layperson views regarding the ethics of such research challenging. We therefore assessed the impact of democratic deliberation (DD)—involving balanced, detailed education and peer deliberation—on the views of those responsible for persons with dementia. Methods 178 community-recruited caregivers or primary decision-makers for persons with dementia were randomly assigned to either an all-day DD session group or a control group. Educational materials used for the DD session were vetted for balance and accuracy by an interdisciplinary advisory panel. We assessed the acceptability of family surrogate consent for dementia research (‘surrogate-based research’ or SBR) from a societal policy perspective as well as from the more personal perspectives of deciding for a loved one or for oneself (surrogate and self perspectives), assessed at baseline, immediately post-DD session, and a month after DD date, for 4 research scenarios of varying risk-benefit profiles. Results At baseline, a majority in both DD and control groups supported a policy of family consent for dementia research for all research scenarios. The support for a policy of family consent for SBR increased for the DD group, but not for the control group; the change in the DD group was maintained one month later. In the DD group, there were transient changes in attitudes from surrogate or self perspectives; in the control group, there were no changes from baseline in attitude toward surrogate consent from any perspective. Conclusions Intensive, balanced, and accurate education along with peer deliberation provided by democratic deliberation leads to a sustained increase in support for a societal policy of family consent for dementia research among those responsible for dementia patients. PMID:20188635

Deliberative assessment of surrogate consent in dementia research.

PubMed

Kim, Scott Y H; Uhlmann, Rebecca A; Appelbaum, Paul S; Knopman, David S; Kim, H Myra; Damschroder, Laura; Beattie, Elizabeth; Struble, Laura; De Vries, Raymond

2010-07-01

Research involving incapacitated persons with dementia entails complex scientific, legal, and ethical issues, making traditional surveys of layperson views on the ethics of such research challenging. We therefore assessed the impact of democratic deliberation (DD), involving balanced, detailed education and peer deliberation, on the views of those responsible for persons with dementia. One hundred and seventy-eight community-recruited caregivers or primary decision-makers for persons with dementia were randomly assigned to either an all-day DD session group or a control group. Educational materials used for the DD session were vetted for balance and accuracy by an interdisciplinary advisory panel. We assessed the acceptability of family-surrogate consent for dementia research ("surrogate-based research") from a societal policy perspective as well as from the more personal perspectives of deciding for a loved one or for oneself (surrogate and self-perspectives), assessed at baseline, immediately post-DD session, and 1 month after DD date, for four research scenarios of varying risk-benefit profiles. At baseline, a majority in both the DD and control groups supported a policy of family consent for dementia research in all research scenarios. The support for a policy of family consent for surrogate-based research increased in the DD group, but not in the control group. The change in the DD group was maintained 1 month later. In the DD group, there were transient changes in attitudes from surrogate or self-perspectives. In the control group, there were no changes from baseline in attitude toward surrogate consent from any perspective. Intensive, balanced, and accurate education, along with peer deliberation provided by democratic deliberation, led to a sustained increase in support for a societal policy of family consent in dementia research among those responsible for dementia patients. Copyright 2010 The Alzheimer

Clinical Research Nurse | Center for Cancer Research

Cancer.gov

We are looking for a Research Nurse to join our women’s malignancies clinical team to help us manage the care of patients participating in clinical trials. Duties include, but are not limited to, collection and reporting of clinical data; reporting adverse events; filing amendments and regulatory documents; consenting, screening and collecting samples from patients and

42 CFR 110.60 - Documentation a requester who is determined to be eligible must submit for the Secretary to make...

Code of Federal Regulations, 2012 CFR

2012-10-01

... covered injury or its health complications must submit an itemized statement from each healthcare provider... each healthcare provider (e.g., a treating neurologist for neurological issues and a treating... payers for, such services or items. Consent for the Program to communicate directly with the healthcare...

42 CFR 110.60 - Documentation a requester who is determined to be eligible must submit for the Secretary to make...

Code of Federal Regulations, 2011 CFR

2011-10-01

... covered injury or its health complications must submit an itemized statement from each healthcare provider... each healthcare provider (e.g., a treating neurologist for neurological issues and a treating... payers for, such services or items. Consent for the Program to communicate directly with the healthcare...

42 CFR 110.60 - Documentation a requester who is determined to be eligible must submit for the Secretary to make...

Code of Federal Regulations, 2013 CFR

2013-10-01

... covered injury or its health complications must submit an itemized statement from each healthcare provider... each healthcare provider (e.g., a treating neurologist for neurological issues and a treating... payers for, such services or items. Consent for the Program to communicate directly with the healthcare...

42 CFR 110.60 - Documentation a requester who is determined to be eligible must submit for the Secretary to make...

Code of Federal Regulations, 2014 CFR

2014-10-01

... covered injury or its health complications must submit an itemized statement from each healthcare provider... each healthcare provider (e.g., a treating neurologist for neurological issues and a treating... payers for, such services or items. Consent for the Program to communicate directly with the healthcare...

A resolution to authorize document production and representation in Care One Management LLC, et al. v. United Healthcare Workers East, SEIU 1199, et al.

THOMAS, 113th Congress

Sen. Reid, Harry [D-NV

2014-03-13

Senate - 03/13/2014 Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

Minors' capacity to refuse treatment: a reply to Gilmore and Herring.

PubMed

Cave, Emma; Wallbank, Julie

2012-01-01

Re R and Re W allow a parent to consent to treatment a competent minor refuses, but the cases have not been tested post-Human Rights Act 1998. Gilmore and Herring offer a means by which they might be distinguished or sidelined. They interpret Gillick to say that in order to consent a minor need only have a full understanding of the particular treatment. They argue that the minors in Re R and Re W were refusing all treatment which requires a separate assessment of capacity-an assessment which was not made. We fear that this distinction would not be workable in clinical practice and argue that their interpretation of Gillick is flawed. From a clinician's point of view, competence cannot always be judged in relation to a specific treatment, but instead must relate to the decision. We show that a decision can incorporate more than one treatment, and more than one decision might be made about one treatment. A minor's understanding of a specific treatment is not always sufficient to demonstrate competence to make a decision. The result is that whilst there might be situations when a parent and a minor both have the power to consent to a particular treatment, they will not share concurrent powers in relation to the same decision. Consequently, a challenge to Re R and Re W, if forthcoming, would need to take a different form. We emphasise the necessity to minimise the dichotomy between legal consent and how consent works in medical practice.

Improving the Quality of Oral and Maxillofacial Surgical Notes in an Indian Public Sector Hospital in Accordance with the Royal College of Surgeons Guidelines: A Completed Audit Loop Study.

PubMed

Krishnan, B; Prasad, G Arun; Madhan, B

2016-09-01

Proper and adequate documentation in operation notes is a basic tool of clinical practice with medical and legal implications. An audit was done to ascertain if oral and maxillofacial surgery operative notes in an Indian public sector hospital adhered to the guidelines published by the Royal College of Surgeons England. Fifty randomly selected operative notes were evaluated against the guidelines by RCS England with regards to the essential generic components of an operation note. Additional criteria relevant to oral and Maxillofacial Surgery were also evaluated. Changes were introduced in the form of Oral and Maxillofacial Surgery specific consent forms, diagram sheets and a computerized operation note proforma containing all essential and additional criteria along with prefilled template of operative findings. Re-audit of 50 randomly selected operation notes was performed after a 6 month period. In the 1st audit cycle, excellent documentation ranging from 94 to 100 % was seen in 9 essential criteria. Unsatisfactory documentation was observed in criteria like assistant name, date of surgery. Most consent forms contained abbreviations and some did not provide all details. Additional criteria specific to Oral and Maxillofacial Surgery scored poorly. In the 2nd Audit for loop completion, excellent documentation was seen in almost all essential and additional criteria. Mean percentage of data point inclusion improved from 84.6 to 98.4 % (0.001< P value <0.005). The use of abbreviations was seen in only 6 notes. Regular audits are now considered a mandatory quality improvement process that seeks to improve patient care and outcomes. To the best of our knowledge, this is the first completed audit on operation notes documentation in Oral and Maxillofacial Surgery from India. The introduction of a computerized operation note proforma showed excellent improvement in operation note documentation. Surgeons can follow the RCS guidelines to ensure standardization of operation notes.

An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting

PubMed Central

Madathil, Kapil Chalil; Koikkara, Reshmi; Obeid, Jihad; Greenstein, Joel S.; Sanderson, Iain C.; Fryar, Katrina; Moskowitz, Jay; Gramopadhye, Anand K.

2013-01-01

Purpose Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system – an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. Methods This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. Results The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. Discussion The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences. PMID:23757370

28 CFR 549.80 - Authority to conduct autopsies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... this section, the Warden may order an autopsy or post-mortem operation, including removal of tissue for... person (e.g., coroner, or next-of-kin, or the decedent's consent in the case of tissue removed for...-of-kin that they may telegraph the institution collect with their response. Where permission is not...

28 CFR 549.80 - Authority to conduct autopsies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... this section, the Warden may order an autopsy or post-mortem operation, including removal of tissue for... person (e.g., coroner, or next-of-kin, or the decedent's consent in the case of tissue removed for...-of-kin that they may telegraph the institution collect with their response. Where permission is not...

10 CFR 600.161 - Termination.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Nonprofit Organizations Post-Award Requirements § 600.161 Termination. (a) Awards may be terminated in whole or in part only if paragraph (a) (1), (2) or (3) of this section apply. (1) By DOE, if a recipient materially fails to comply with the terms and conditions of an award. (2) By DOE with the consent of the...

10 CFR 600.161 - Termination.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Nonprofit Organizations Post-Award Requirements § 600.161 Termination. (a) Awards may be terminated in whole or in part only if paragraph (a) (1), (2) or (3) of this section apply. (1) By DOE, if a recipient materially fails to comply with the terms and conditions of an award. (2) By DOE with the consent of the...

10 CFR 600.161 - Termination.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Nonprofit Organizations Post-Award Requirements § 600.161 Termination. (a) Awards may be terminated in whole or in part only if paragraph (a) (1), (2) or (3) of this section apply. (1) By DOE, if a recipient materially fails to comply with the terms and conditions of an award. (2) By DOE with the consent of the...

75 FR 75650 - Temporary Rule Regarding Principal Trades With Certain Advisory Clients

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-06

....m. and 3 p.m. All comments received will be posted without change; we do not edit personal... became subject to the Advisers Act with respect to those accounts, and the client relationship became... section 206(3)'s transaction-by-transaction written disclosure and consent requirements without the...

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

PubMed

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D'Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-04-05

International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

[Terms of informed consent for users of dental clinics in Brazil: legal and ethical issues].

PubMed

Sales-Peres, Sílvia Helena de Carvalho; Sales-Peres, Arsênio; Eleutério, Adriana Silveira de Lima; de Oliveira, José Luiz Góes; Gigliotti, Mariana Pracucio

2011-01-01

The consent of patient before the beginning of any procedure has to be a respected condition, without any exception. It is necessary the patients to be aware of their health status, their specific needs, the intention of each treatment, the alternatives plans (including no treatment), to know their prognostic, risks, consequences, limitations, and to be aware of their responsibilities and those of your dentist, resulting in the success of the treatment. The Informed Consent (TCLE) aims to fortify and to clarify the position of the patient, being established the rights and duties of both parts - patient and professional. The integral knowledge of the treatment will minimize the anxiety of the patient and treatment complications, and promote greater quality of dental services and improve the satisfaction of both dentist and patient. However, there are few articles in Brazil about this, but there are some ethics problems involving dental clinics regarding this document of information for the patient. Therefore, the aim of this work is to carry through a critical revision on the subject demonstrating the importance of the TCLE in the Brazilian dental clinics.

Hanford Single-Shell Tank Leak Causes and Locations - 241-BY and 241-TY Farm

DOE Office of Scientific and Technical Information (OSTI.GOV)

Girardot, Crystal L.; Harlow, Donald G.

This document identifies 241-BY Tank Farm (BY Farm) and 241-TY Tank Farm (TY Farm) lead causes and locations for the 100 series leaking tanks (241-BY-103, 241-TY-103, 241-TY-104, 241-TY-105 and 241-TY-106) identified in RPP-RPT-43704, Hanford BY Farm Leak Assessments Report, and in RPP-RPT-42296, Hanford TY Farm Leak Assessments Report. This document satisfies the BY and TY Farm portion of the target (T04) in the Hanford Federal Facility Agreement and Consent Order milestone M-045-91F.

Financial "risk-sharing" or refund programs in assisted reproduction: an Ethics Committee opinion.

PubMed

2016-10-01

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6). Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 477: Area 12 N-Tunnel Muckpile, Nevada Test Site

DOE Office of Scientific and Technical Information (OSTI.GOV)

NSTec Environmental Restoration

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 477, N-Tunnel Muckpile. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Corrective Action Unit 477 is comprised of one Corrective Action Site (CAS): • 12-06-03, Muckpile The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure with no further action, by placing use restrictions on CAUmore » 477.« less

75 FR 5036 - Proposed Posting, Posting and Deposting of Stockyards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-01

...The Grain Inspection, Packers and Stockyards Administration published a document in the Federal Register on July 6, 2004, concerning the proposed posting, posting and deposting of stockyards. The document shows the facility number for Shamrock Livestock Commission, Shamrock, Texas is the same as the facility number assigned to Texas Cattle Exchange, Inc., Eastland, Texas (TX-346).

78 FR 16412 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Consent Decree Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-15

....regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know your identity or...: Throughout this document whenever ``we,'' ``us,'' or ``our'' is used, we mean EPA. This supplementary... Title V of the Clean Air Act (CAA). EPA is also approving 326 IAC 2-7-10.5(k), which requires public...

Impact of Institutional Review Board Practice Variation on Observational Health Services Research

PubMed Central

Green, Lee A; Lowery, Julie C; Kowalski, Christine P; Wyszewianski, Leon

2006-01-01

Objective To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. Data Source and Setting Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. Design Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. Data Collection and Abstraction Methods Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. Principal Findings Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites.Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document.Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. Conclusions Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects. PMID:16430608

Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.

PubMed

Satalkar, Priya; Elger, Bernice Simone; Shaw, David

2016-04-01

Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles. We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.

ACOG Committee Opinion No. 646: Ethical Considerations for Including Women as Research Participants.

PubMed

2015-11-01

Inclusion of women in research studies is necessary for valid inferences about health and disease in women. The generalization of results from trials conducted in men may yield erroneous conclusions that fail to account for the biologic differences between men and women. Although significant changes in research design and practice have led to an increase in the proportion of women included in research trials, knowledge gaps remain because of a continued lack of inclusion of women, especially those who are pregnant, in premarketing research trials. This document provides a historical overview of issues surrounding women as participants in research trials, followed by an ethical framework and discussion of the issues of informed consent, contraception requirements, intimate partner consent, and the appropriate inclusion of pregnant women in research studies.

The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent.

PubMed

Egekeze, Nkemakolam; Dubin, Jonathan; Williams, Karen; Bernhardt, Mark

2016-10-05

Integral to an orthopaedic surgeon-patient informed consent discussion is the assessment of patient comprehension of their medical care. However, little is known about how to optimize patient comprehension of an informed consent discussion. The purpose of our study was to evaluate three time-controlled informed consent discussion methods to determine which optimized patient comprehension immediately after the discussion. Sixty-seven consecutive patients with knee osteoarthritis who were considered medically appropriate for a knee corticosteroid injection were enrolled in our trial. Participants were randomized and were allocated into one of three groups in a parallel fashion and 1:1:1 ratio. Our three groups varied by sensory input and included verbal (hearing), verbal and video (hearing and sight), and verbal and model (hearing, sight, and touch). Each participant listened to a 10-minute scripted lecture given by a researcher; this lecture was based on content from the American Academy of Orthopaedic Surgeons patient education web site OrthoInfo. Patient comprehension was assessed after the lecture using a validated questionnaire called the Nkem test. Our primary outcome evaluated patient comprehension utilizing a pairwise comparison of mean comprehension scores between the groups. The primary outcome was analyzed using a one-way analysis of variance with the least significant difference calculated post hoc and a 95% confidence interval (95% CI). The health-care staff, study participants, and outcome assessor were each blinded to group assignments. The mean comprehension scores were 84% (95% CI, 79% to 88%) for the verbal and model group, 74% (95% CI, 63% to 80%) for the verbal and video group, and 71% (95% CI, 61% to 80%) for the verbal group. The omnibus analysis of variance was significant and showed a difference among the groups (p = 0.019). The pairwise comparison of the groups using the least significant difference calculated post hoc showed that the verbal and model group outperformed the verbal group (p = 0.01) and the verbal and video group (p = 0.023). Multisensory patient education incorporating OrthoInfo and an anatomic model optimized patient comprehension immediately after a time-controlled informed consent discussion. This finding could play an important role in improving surgeon-patient communication in the field of orthopaedic surgery. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Improving decision making about clinical trial participation – a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial

PubMed Central

Juraskova, I; Butow, P; Bonner, C; Bell, M L; Smith, A B; Seccombe, M; Boyle, F; Reaby, L; Cuzick, J; Forbes, J F

2014-01-01

Background: Decision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial. Methods: The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up). Results: Data from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS–DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up. Conclusions: This was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation. PMID:24892447

Does Writing about Past Childhood Abuse Reduce Psychological and Physical Symptoms?

ERIC Educational Resources Information Center

Antal, Holly M.; Range, Lillian M.

2009-01-01

To see if writing about former abuse reduced depression, somatic, and sleep complaints, 664 undergraduates were screened for past physical or sexual abuse. Of those abused, 88 consenting students were randomly assigned to no-writing control or writing (20 minutes on 4 different days) about abuse or trivial topics. All completed pre-, post-, and…

Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya.

PubMed

Okello, George; Jones, Caroline; Bonareri, Maureen; Ndegwa, Sarah N; McHaro, Carlos; Kengo, Juddy; Kinyua, Kevin; Dubeck, Margaret M; Halliday, Katherine E; Jukes, Matthew C H; Molyneux, Sassy; Brooker, Simon J

2013-05-16

There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors' experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. National Institute of Health NCT00878007.

Balancing Benefits and Risks of Immortal Data: Participants' Views of Open Consent in the Personal Genome Project.

PubMed

Zarate, Oscar A; Brody, Julia Green; Brown, Phil; Ramirez-Andreotta, Mónica D; Perovich, Laura; Matz, Jacob

2016-01-01

An individual's health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become "immortalized" in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched to each other. Reidentification (re-ID), the process of associating an individual's name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants. The ethical challenges of online data sharing are heightened as so-called big data becomes an increasingly important research tool and driver of new research structures. Big data is shifting research to include large numbers of researchers and institutions as well as large numbers of participants providing diverse types of data, so the participants' consent relationship is no longer with a person or even a research institution. In addition, consent is further transformed because big data analysis often begins with descriptive inquiry and generation of a hypothesis, and the research questions cannot be clearly defined at the outset and may be unforeseeable over the long term. In this article, we consider how expanded data sharing poses new challenges, illustrated by genomics and the transition to new models of consent. We draw on the experiences of participants in an open data platform-the Personal Genome Project-to allow study participants to contribute their voices to inform ethical consent practices and protocol reviews for big-data research. © 2015 The Hastings Center.

Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya

PubMed Central

2013-01-01

Background There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Methods Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors’ experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Results Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. Conclusions A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. Trial registration National Institute of Health NCT00878007 PMID:23680181

Mandating audio-video recording of informed consent: are we right in enforcing this?

PubMed

Agrawal, A R; Joshi, R P; Shah, V

2014-07-01

Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of '...never do harm to anyone' and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner. Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision.

Judicial and legislative viewpoints on physician misestimation of patient dysutilities: a problem for decision analysts.

PubMed

Mazur, D J

1990-01-01

Appellate courts, state legislatures, and ethicists have recently (post-1972) been interested-through the evolving court doctrine of informed consent-in patient-physician joint decision making. Yet these professional groups' approaches differ markedly from that of decision analysis, failing to include an explicit role for patients' rational processing of information in informed consent. In addition, these groups charge that decision analysts are misestimating patient dysutilities. This paper examines three issues: 1) in what sense(s), if any, is decision-analytic work in individualized medical decision making misestimating patient dysutilities, 2) if this misestimation is real, whether it is an example of the normative-descriptive tensions that exist in medical decision making, and 3) in what ways do the relationships between decision-analytic and judicial decision making change when informed consent is viewed in terms of contract law as opposed to tort law. This paper argues that a key link dividing these professional groups is the differing weights given to the "value of information" by decision-analytic vs. non-decision-analytic frameworks.

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

PubMed Central

Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial. PMID:21098066

Education of medical biochemists in Bosnia and Herzegovina.

PubMed

Winterhalter-Jadrić, Mira; Causević, Adlija; Jadrić, Radivoj; Corić, Jozo; Hasić, Sabaheta; Kiseljaković, Emina

2011-01-01

In this paper we would like to briefly introduce readers to the situation in the field of laboratory medicine in Bosnia and Herzegovina, with a focus on training in the field of medical biochemistry. As in some of neighboring countries, term Medical biochemist is the usual name for the Clinical biochemist or Clinical chemist in Bosnia and Herzegovina. Despite the difficult period through which the profession had passed in the last two decades, laboratory work, particularly clinical biochemistry, has managed to retain the necessary quality and keep pace with the developed world. In post war period, Society of Medical Biochemists of Bosnia and Herzegovina held regular meetings each year as a part of "life long learning" process, where both scientific and vocational lecturers presented their work. A single law on the state level would provide us with more defined and precise answers, such as: who can get a specialization, how long should last the training for medical biochemistry specialists (duration in years). This law should be in consent with the program described in EC4 or other documents given by the EFCC (European Federation of Clinical Chemistry and Laboratory Medicine) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine).

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

PubMed Central

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire. Results The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Conclusions Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings. PMID:25133065

Qualitative study of knowledge and attitudes to biobanking among lay persons in Nigeria.

PubMed

Igbe, Michael A; Adebamowo, Clement A

2012-10-16

Interest in biobanking for collection of specimens for non-communicable diseases research has grown in recent times. This paper explores the perspectives of Nigerians on donation of specimen for the biobanking research. We conducted 16 Focus Group Discussions (FGD) with individuals from different ethnic, age and socio-economic groups in Kano (North), Enugu (Southeast), Oyo States (Southwest) and Abuja, the Federal Capital Territory (Central) of Nigeria. We used topic guides and prompt statements to explore the knowledge and understanding of interviewees to general issues about biobanking of biospecimens, their use and specifically about role of biobanking in non-communicable diseases research. A total of 123 individuals participated in 16 focus group discussions in 2011. Our participants had limited knowledge of the concept of biobanking but accepted it once they were educated about it and saw it as a worthwhile venture. Half of our study participants supported use of broad consent, a quarter supported restricted consent while the remaining quarter were in favour of tiered consent. Most discussants support shipment of their samples to other countries for further research, but they prefer those collaborations to be done only with competent, ethical researchers and they would like to receive feedback about such projects. The majority preferred health care as a benefit from participation, particularly for any unexpected condition that may be discovered during the course of the research instead of financial compensation. Participants emphasized the need to ensure that donated samples were not used for research that contradicts their religious beliefs. Our study demonstrates that our participants accepted biobanking once they understand it but there were different attitudes to elements of biobanking such as type of consent. Our study highlights the need to carefully document population attitudes to elements of modern scientific research and the consenting process.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 478: Area 12 T-Tunnel Ponds, Nevada Test Site

DOE Office of Scientific and Technical Information (OSTI.GOV)

NSTec Environmental Restoration

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 478, Area 12 T-Tunnel Ponds. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 478 is comprised of one corrective action site (CAS): • 12-23-01, Ponds (5) RAD Area The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure in place with usemore » restrictions for CAU 478.« less

Corrective Action Decision Document/Closure Report for Corrective Action Unit 559: T Tunnel Compressor/Blower Pad, Nevada Test Site

DOE Office of Scientific and Technical Information (OSTI.GOV)

NSTec Environmental Restoration

This Corrective Action Decision Document (CADD)/Closure Report (CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 559, T-Tunnel Compressor/Blower Pad. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order (FFACO) agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Corrective Action Unit 559 is comprised of one Corrective Action Site (CAS): • 12-25-13, Oil Stained Soil and Concrete The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation for closure in place with use restrictionsmore » for CAU 559.« less

Nutritional Needs in Hot Environments-Applications for Military Personnel in Field Operations

DTIC Science & Technology

1993-04-01

other official documentation. Human subjects who participated in studies described in those chapters gave their free and informed voluntary consent...Hopkins University School of Hygiene and Public Health, Baltimore, Maryland JOEL A. GRINKER, Program in Human Nutrition, School of Public Health...of Food Science and Human Nutrition, Colorado State University, Fort Collins GILBERT LEVEILLE, Nabisco Brands Incorporated, East Hanover, New Jersey

75 FR 57300 - Notice of Application From Uranium One USA, Inc., for Consent to an Indirect Change of Control...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... under 10 CFR 2.315(c), must be filed in accordance with the NRC E-Filing rule (72 FR 49139, August 28, 2007). The E-Filing rule requires participants to submit and serve all adjudicatory documents over the.... To comply with the procedural requirements of E-Filing, at least ten (10) days prior to the filing...

76 FR 70766 - Notice of Application From FMRI for Consent to an Indirect Change of Control for Source Material...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-15

... Submissions (E-Filing) All documents filed in NRC adjudicatory proceedings, including a request for hearing, a... entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC E-Filing rule (72 FR 49139, August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory...

29 CFR 102.114 - Filing and service of papers by parties; form of papers; manner and proof of filing or service...

Code of Federal Regulations, 2011 CFR

2011-07-01

..., including facsimile transmission, is permitted only with the consent of the party being served. Unless... telephone, followed by service of a copy in a manner designed to insure receipt by them by the close of the... objections by facsimile transmission pursuant to this section, receipt of the transmitted document by the...

29 CFR 102.114 - Filing and service of papers by parties; form of papers; manner and proof of filing or service...

Code of Federal Regulations, 2010 CFR

2010-07-01

..., including facsimile transmission, is permitted only with the consent of the party being served. Unless... telephone, followed by service of a copy in a manner designed to insure receipt by them by the close of the... objections by facsimile transmission pursuant to this section, receipt of the transmitted document by the...

Tank waste remediation system nuclear criticality safety program management review

DOE Office of Scientific and Technical Information (OSTI.GOV)

BRADY RAAP, M.C.

1999-06-24

This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999.

The retrospective documentation of legal cases with bile duct injury that were submitted for consideration to İstanbul Forensic Medicine Institute by the courts between 2008–2012

PubMed Central

Karakaya, M. Arif; Koç, Okay; Ekiz, Feza; Ağaçhan, A. Feran

2014-01-01

Objective: The aim was to evaluate the parameters that were considered by Forensic Medicine in bile duct injury as well as the issues that the physicians were found to be faulty. Material and Methods: The following parameters were investigated in 21 files that were referred to Istanbul Forensic Medicine Institute with request of expert opinion between 2008–2012; expert decisions, patient’s age, gender, written patient consent, diagnosis, type of first surgery, surgical complications, timing of complication diagnosis within the scope of complication management, patient’s referral timing, troubleshooting procedures and mortality rate. Results: Physicians were found to be faulty in all files. The reason for physician fault was failure to show the necessary professional care and attention in one (4.7%) file, late recognition of injury and late transfer of the patient in 20 (95.3%) files. Written consent had not been obtained in any of the files. Thirteen patients were female (61.9%) and 8 (30.1%) were male, with a mean age of 43.3 years. Nineteen patients had cholelithiasis (90.4%), and two patients (9.5%) had a mass in the head of the pancreas. Cholecystectomy was performed laparoscopically in 15 patients (78.9%), and with open surgery in 4 patients (21.1%). The Whipple procedure was performed in two patients. The diagnosis was made during the operation in one patient (4.7%), and in the post-operative period in 20 patients (95.3%). The time to diagnosis after surgery was between 3–6 days. All of the patients had been referred to third level health care facilities. The timing of transfer was 1 day in the patient who was diagnosed during the operation, and ranged between 4–10 days in those who were diagnosed postoperatively. Reasons for late referral were delays related to pending test results in 12 patients, vague signs in 3 patients, and following-up patients with the thought that the biliary fistula will heal by itself in 5 patients. Mortality was not observed in any of the examined files. Conclusion: The issues where physicians were most frequently found to be faulty were failure to obtain written patient consent, late recognition of injury and late transfer of the patient. PMID:25931931

'Screening audit' as a quality assurance tool in good clinical practice compliant research environments.

PubMed

Park, Sinyoung; Nam, Chung Mo; Park, Sejung; Noh, Yang Hee; Ahn, Cho Rong; Yu, Wan Sun; Kim, Bo Kyung; Kim, Seung Min; Kim, Jin Seok; Rha, Sun Young

2018-04-25

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital's Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. RESULTS: Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as "critical," "major," "minor," and "not a finding" (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors' decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being "major" or "critical" (p = 0.002, < 0.0001, < 0.0001, respectively). Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants' personal information were associated with higher audit grade (p < 0.0001, p = 0.0001, p < 0.0001, p = 0.003). We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in "non-responding" and "critical" studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits.

An audit of parents'/guardians' wishes recorded after coronial autopsies in cases of sudden unexpected death in infancy: issues raised and future directions.

PubMed

Cohen, M C; Blakey, S; Donn, T; McGovern, S; Parry, L

2009-07-01

In the U.K., cases of sudden unexpected death in infancy are under the jurisdiction of the Coroner and consent for a post-mortem is not required. Prior to the Human Tissue Act 2006 (HTA) there was also no requirement to request retention of tissue (blocks and slides). The HTA stipulates that parental/ guardian consent is mandatory to retain or dispose of all tissues after the Coroners' purposes have been fulfilled. In 2007, in order to avoid confusion with the consent needed for hospital post-mortems, a new form was introduced by Sheffield Children's Hospital NHS Foundation Trust (SCH) called Record of parents'/guardians'wishes regarding samples taken at a Coroner's post mortem. This version specifically asks if blocks and slides may be retained as part of the medical record, or are to be disposed of, and for parental agreement (or not) for the frozen tissue, blocks and slides to be used for education, audit, quality control and medical research. One hundred and nineteen Coroners' postmortems covering the years 2006-2007 were reviewed. All parents/guardians (P/G) were contacted and the outcomes of P/G wishes recorded by SCH staff, Coroners' Officers (CO) and Police Family Liaison Officers (PFLO) were analysed and compared (44% from CO were outstanding at the time of audit). Any delay in recording P/G wishes by these three groups was also compared. In 2006, parental agreement to the use of blocks and slides for education, audit, quality control and medical research was 94%, 77% and 75% for SCH, CO and PFLO, respectively. In 2007 it was 84%, 37% and 100% for the same groups. Permission for the retention of frozen tissue given to SCH, CO and PFLO was 90%, 62% and 100% in 2006 and 90%, 44% and 100% in 2007, respectively. Cases where parents did not wish for the retention or use of tissue (including blocks and slides) were 3%, 15% and 0% in 2006 for SCH, CO and PFLO respectively, and 0% for all groups in 2007. Training of staff in all aspects of post-mortem and bereavement care is essential for ascertaining parental wishes. Families should be provided with the knowledge that allows them to make informed choices. The analysis of the results of the audit supports this view.

Partnering with patients to realize the benefits of social media.

PubMed

Colbert, James A; Lehmann, Lisa Soleymani

2015-03-01

Despite widespread concern about the potential risks of the use of social media, we are optimistic that social networks and blogs have the potential to enhance the practice of medicine by allowing clinicians to share ideas and information within the health care community, with patients, and with the general public. In particular, we believe that there can be value in posting information related to a patient encounter on social media, but only if care has been taken to consider the consequences of such a post from the patient's perspective. Thus, having a discussion with a patient and obtaining verbal consent before posting even deidentified patient information should become standard practice for all physicians who use social media. Copyright © 2015 Elsevier Inc. All rights reserved.

Continuing oversight through site monitoring: experiences of an institutional ethics committee in an Indian tertiary-care hospital.

PubMed

Shetty, Yashashri C; Marathe, Padmaja; Kamat, Sandhya; Thatte, Urmila

2012-01-01

WHO-TDR and the Indian Council of Medical Research recommend site visits by institutional ethics committees (IECs) for continued oversight, to ensure the ethical conduct of research. Our IEC conducted seven site visits in 2008-2009 using a standardised format to monitor adherence to protocol and the informed consent process. The study identified issues related to informed consent (6/7), deviation from protocol (5/7), reporting of study progress to the IEC (3/7), recruiting additional participants without IEC approval (2/7), reporting of serious adverse events (1/7), investigator's lack of awareness of protocol and the informed consent document (2/7) and other findings. Investigators were informed about the findings and were asked to submit an explanation. The IEC issued warnings about not repeating such lapses in the future (5/7), restricted enrollment of new participants (2/7), recommended continued good clinical practice training to the study team (4/7), advised the recruitment of additional study coordinators (2/7), and requested the submission of adverse event reports (2/7) or sponsors' audit reports (2/7). Our study showed that the ethical conduct of studies can be ensured by conducting routine site monitoring.

Ethically sustainable governance in the biobanking of eggs and embryos for research.

PubMed

Stroud, Karla; O'Doherty, Kieran C

2015-12-01

Biobanking of human tissues is associated with a range of ethical, legal, and social (ELS) challenges. These include difficulties in operationalising informed consent protocols, protecting donors' privacy, managing the return of incidental findings, conceptualising ownership of tissues, and benefit sharing. Though largely unresolved, these challenges are well documented and debated in academic literature. One common response to the ELS challenges of biobanks is a call for strong and independent governance of biobanks. Theorists who argue along these lines suggest that since fully informed consent to a single research project is often not feasible, research participants should be given the additional protection of being allowed to consent to the governance framework of the biobank. Such governance therefore needs to be transparent and ethically sustainable. In this paper we review the governance challenges of establishing and maintaining human tissue biobanks. We then discuss how the creation of a biobank for eggs and embryos, in particular, may introduce additional or unique challenges beyond those presented by the biobanking of other human tissues. Following previous work on biobank governance, we argue that ethically sustainable governance needs to be participatory, adaptive, and trustworthy.

Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

PubMed

Fadare, Joseph O; Porteri, Corinna

2010-03-01

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

VET in Schools Students: Characteristics and Post-School Employment and Training Experiences. Support Document

ERIC Educational Resources Information Center

Misko, Josie; Korbel, Patrick; Blomberg, Davinia

2017-01-01

This document was produced by the author based on their research for the report, "VET in Schools Students: Characteristics and Post-School Employment and Training Experiences," and is an added resource for further information. This support document presents the variables used and the findings of the supplementary analysis in the linked…

Engaging research participants to inform the ethical conduct of mobile imaging, pervasive sensing, and location tracking research.

PubMed

Nebeker, Camille; Lagare, Tiffany; Takemoto, Michelle; Lewars, Brittany; Crist, Katie; Bloss, Cinnamon S; Kerr, Jacqueline

2016-12-01

Researchers utilize mobile imaging, pervasive sensing, social media, and location tracking (MISST) technologies to observe and intervene with participants in their natural environment. The use of MISST methods and tools introduces unique ethical issues due to the type and quantity of data, and produces raising new challenges around informed consent, risk assessment, and data management. Since MISST methods are relatively new in behavioral research, there is little documented evidence to guide institutional review board (IRB) risk assessment and inform appropriate risk management strategies. This study was conducted to contribute the participant perspectives when considering ethical and responsible practices. Participants (n = 82) enrolled in an observational study where they wore several MISST devices for 1 week completed an exit survey. Survey items focused on the following: 1-device comfort, 2-informed consent, 3-privacy protections, and 4-bystander engagement. The informed consent process reflected participant actual experience. Device comfort and privacy were raised as concerns to both the participants and bystanders. While the majority of the participants reported a positive experience, it is important to note that the participants were volunteers who were not mandated to wear tracking devices and that persons who are mandated may not have a similar response. Findings support strategies proposed in the Kelly et al. (2013) ethical framework, which emphasizes procedures to improve informed consent, protect privacy, manage data, and respect bystander rights when using a wearable camera.

Practical Communication Guidance to Improve Phase I Informed Consent Conversations and Decision-Making in Pediatric Oncology

PubMed Central

Johnson, Liza-Marie; Leek, Angela C.; Drotar, Dennis; Noll, Robert B.; Rheingold, Susan R.; Kodish, Eric D.; Baker, Justin N.

2015-01-01

Background It can be difficult to explain pediatric Phase I oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. Methods Suggestions for improving the informed consent process were first solicited from Phase I study clinicians via questionnaire. Eight parents who had enrolled their child on a Phase I pediatric oncology trial were recruited for an advisory group designed to assess the clinicians’ suggestions and make additional recommendations for improving informed consent for pediatric Phase I trials. Results A Phase I Communication Model was designed to incorporate the suggestions of clinicians and families. It focuses on education of parents/families about Phase I trials at specific time points during a child’s illness, but specifically at the point of relapse. We also present an informative Phase I fact sheet that can be distributed to families. Conclusions Families who will be offered information about a Phase I clinical trial can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be further enhanced when oncologists address key themes, beginning at diagnosis and continuing through important decision points during the child’s illness. This model should be prospectively evaluated. PMID:25873253

Revised Tijeras Arroyo Groundwater Current Conceptual Model and Corrective Measures Evaluation Report - February 2018.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Copland, John R.

The U.S. Department of Energy (DOE) and the management and operating (M&O) contractor for Sandia National Laboratories beginning on May 1, 2017, National Technology & Engineering Solutions of Sandia, LLC (NTESS), hereinafter collectively referred to as DOE/NTESS, prepared this Revised Tijeras Arroyo Groundwater Current Conceptual Model (CCM) and Corrective Measures Evaluation (CME) Report , referred to as the Revised CCM/CME Report, to meet requirements under the Sandia National Laboratories-New Mexico (SNL/NM) Compliance Order on Consent (Consent Order). The Consent Order became effective on April 29, 2004. The Consent Order identifies the Tijeras Arroyo Groundwater (TAG) Area of Concern (AOC) asmore » an area of groundwater contamination requiring further characterization and corrective action. In November 2004, New Mexico Environment Department (NMED) approved the July 2004 CME Work Plan. In April 2005, DOE and the SNL M&O contractor at the time, Sandia Corporation (Sandia), hereinafter collectively referred to as DOE/Sandia, submitted a CME Report, but NMED did not finalize review of that document. In December 2016, DOE/Sandia submitted a combined and updated CCM/CME Report. NMED issued a disapproval letter in May 2017 that included comments on the December 2016 CCM/CME Report. In August 2017, NMED and DOE/NTESS staff held a meeting to discuss and clarify outstanding issues. This Revised CCM/CME Report addresses (1) the issues presented in the NMED May 2017 disapproval letter and (2) findings from the August 2017 meeting.« less

Physician perspectives on legal processes for resolving end-of-life disputes.

PubMed

Chidwick, Paula; Sibbald, Robert

2011-01-01

In order to understand how to effectively approach end-of-life disputes, this study surveyed physicians' attitudes towards one process for resolving end-of-life disputes, namely, the Consent and Capacity Board of Ontario. In this case, the process involved examining interpretation of best interests between substitute decision-makers and medical teams. Physicians who made "Form G" applications to the Consent and Capacity Board of Ontario that resulted in a decision posted on the open-access database, Canadian Legal Information Institute (CanLii), were identified and surveyed. This purposive sample led to 13 invitations to participate and 12 interviews (92% response rate). Interviews were conducted using a prescribed interview guide. No barriers to the Consent and Capacity Board process were reported. Applications were made when physicians reached an impasse with the family and further treatment was perceived to be "unethical." The most significant challenge reported was the delay when appeals were launched. Appeals extended the process for an indefinite period of time making it so lengthy it negated any perceived benefits of the process. Benefits included that a neutral third party, namely the Consent and Capacity Board, was able to assess best interests. Also, when decisions were timely, further harm to the patient was minimized. Physicians reported this particular approach, namely the Consent and Capacity Board has a mechanism that is worthwhile, patient centred, process oriented, orderly and efficient for resolving end-of-life disputes and, in particular, determining best interests. However, unless the appeal process can be adjusted to respond to the ICU context there is a risk of not serving the best interest of patients. Physicians would recommend framing end-of-life treatment plans in the positive instead of negative, for example, propose palliative care and no escalation of treatment as opposed to withdrawal.

Acquirement and Interpretation of Public Documentation of Cultural Heritage - WeChat & Post-disaster Rebuilding of Shangri-La Ancient City

NASA Astrophysics Data System (ADS)

Huo, X. W.; Zhang, G.; Shang, J.; Qi, X. J.; Li, G. L.; Huang, Z. Y.

2015-09-01

The essay introduces the methodology and reflection upon the acquirement and interpretation of public documentation supporting the post-disaster reconstruction of the Shangri-La historic town after struck by fire in 2014. The proposed acquirement platform is developed on the basis of WeChat, a popular mobile communication App on smart phones in China. Historic photos and related documents of the burnt historic area are then accumulated to be analytically interpreted to inform post-disaster reconstruction planning.

Impact of an educational video as a consent tool on knowledge about cure research among patients and caregivers at HIV clinics in South Africa.

PubMed

Hendricks, Melany; Nair, Gonasagrie; Staunton, Ciara; Pather, Michael; Garrett, Nigel; Baadjies, Dianno; Kidd, Martin; Moodley, Keymanthri

2018-04-01

Despite increasing access to antiretroviral therapy in low- and middle-income countries, only 54% of eligible individuals were receiving treatment in Africa by 2015. Recent developments in HIV cure research have been encouraging. However, the complex science and procedures of cure research render the informed consent process challenging. This study evaluates the impact of a video tool on educating participants about HIV cure. A questionnaire assessing the content of the video was administered to adults recruited from two clinics in South Africa. Patients and their care partners, who provided voluntary informed consent, were included in the study. The questionnaire was administered in each participant's home language before, immediately after and at 3 months after viewing the video, in an uncontrolled quasi-experimental 'one group pre-test-post-test' design. Scoring was carried out according to a predetermined scoring grid, with a maximum score of 22. A total of 88 participants, median age 32.0 years and 86% female, were enrolled and completed the pre- and post-video questionnaires. Twenty-nine (33%) completed the follow-up questionnaire 3 months later to assess retention of knowledge. Sixty-three (72%) participants had a known HIV-positive status. A significant increase (10.1 vs 15.1, P =0.001) in knowledge about HIV and HIV cure immediately after viewing the video was noted. No statistically significant difference in knowledge between HIV-positive and -negative patients was noted at baseline. After 3 months, a decrease in performance participation (14 vs 13.5, P =0.19) was noted. However, knowledge scores achieved after 3 months remained significantly higher than scores at baseline (13.5 vs 9.5, P <0.01). This research showed that a video intervention improved participants' knowledge related to HIV, HIV cure research and ethics, and the improvement was sustained over 3 months. Video intervention may be a useful tool to add to the consent process when dealing with complex medical research questions.

Saudi Arabia: Background and U.S. Relations

DTIC Science & Technology

2012-11-27

unclear whether the kingdom’s gender guardianship system, which requires women to document the consent of a male relative for most public actions, will...they see as discrimination at home and unwarranted Saudi intervention on the side of the Sunni government to suppress mostly Shia unrest in...while many Saudis welcomed the king’s announcement concerning the participation of women in the next session of the advisory Shura Council and in the

Mission Connect Mild TBI Translational Research Consortium

DTIC Science & Technology

2010-08-31

symptoms are known to be associated with the study drug, atorvastatin , and they are listed in the Informed Consent document. In this second year of the...confirm that atorvastatin (see note below) given during the acute phase of MTBI has no adverse effects in patients with MTBI NOTE: Due to an...FDA hold on all human studies involving erythropoietin, the neuroprotective agent for this phase II clinical trial was changed to atorvastatin

An e-consent-based shared EHR system architecture for integrated healthcare networks.

PubMed

Bergmann, Joachim; Bott, Oliver J; Pretschner, Dietrich P; Haux, Reinhold

2007-01-01

Virtual integration of distributed patient data promises advantages over a consolidated health record, but raises questions mainly about practicability and authorization concepts. Our work aims on specification and development of a virtual shared health record architecture using a patient-centred integration and authorization model. A literature survey summarizes considerations of current architectural approaches. Complemented by a methodical analysis in two regional settings, a formal architecture model was specified and implemented. Results presented in this paper are a survey of architectural approaches for shared health records and an architecture model for a virtual shared EHR, which combines a patient-centred integration policy with provider-oriented document management. An electronic consent system assures, that access to the shared record remains under control of the patient. A corresponding system prototype has been developed and is currently being introduced and evaluated in a regional setting. The proposed architecture is capable of partly replacing message-based communications. Operating highly available provider repositories for the virtual shared EHR requires advanced technology and probably means additional costs for care providers. Acceptance of the proposed architecture depends on transparently embedding document validation and digital signature into the work processes. The paradigm shift from paper-based messaging to a "pull model" needs further evaluation.

Donor Outcomes in Living Donor Liver Transplantation-Analysis of 275 Donors From a Single Centre in India.

PubMed

Narasimhan, Gomathy; Safwan, Mohamed; Kota, Venugopal; Reddy, Mettu S; Bharathan, Anand; Dabora, Abderrhaim; Kaliamoorthy, Ilankumaran; Kanagavelu, Rathnavel G; Srinivasan, Vijaya; Rela, Mohamed

2016-06-01

Live donor liver transplantation is the predominant form of liver transplantation in India and in most Asian countries. Donor outcome reports are an important source of information to be shared with prospective donors at the time of informed consent. This is the first donor outcome series from India. Analysis of donor characteristics and morbidity of 275 live donors from a single large volume center is documented. Two hundred seventy-five patients donated from November 2009 to October 2014, 144 were women and 131 were men, 180 donated to adults and 95 donated to children. Right lobe donors were majority at 62.2% followed by left lateral segment 28%. Two thirds of the live donors did not have any morbidity; 114 complications were encountered in 85 patients. The complications were graded as per Clavien 5 tier grading and major morbidity (grade III b, grade IV grade V) was 4.36%. Postoperative biliary complication was seen in 3 donors. This large single-center study is the first donor outcome report from India, and the results are comparable to other published donor series. Documentation and regular audit of donor outcomes is important to help improve the safety of donor hepatectomy and to provide a database for informed consent of prospective donors.

Addendum to the Closure Report for Corrective Action Unit 357: Mud Pits and Waste Dump, Nevada Test Site, Nevada, Revision 0

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krauss, Mark J

This document constitutes an addendum to the Closure Report for Corrective Action Unit 357: Mud Pits and Waste Dump, Nevada Test Site, Nevada as described in the document Recommendations and Justifications To Remove Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order dated September 2013. The Use Restriction Removal document was approved by the Nevada Division of Environmental Protection on October 16, 2013. The approval of the UR Removal document constituted approval of each of the recommended UR removals. In conformance with the UR Removal document, thismore » addendum consists of: This page that refers the reader to the UR Removal document for additional information The cover, title, and signature pages of the UR Removal document The NDEP approval letter The corresponding section of the UR Removal document This addendum provides the documentation justifying the cancellation of the UR for CAS 04-26-03, Lead Bricks. This UR was established as part of FFACO corrective actions and was based on the presence of lead contamination at concentrations greater than the action level established at the time of the initial investigation.« less

23 CFR Appendix A to Part 1327 - Abridged Listing of the American Association of Motor Vehicle Administrators Violations Exchange...

Code of Federal Regulations, 2013 CFR

2013-04-01

... with BAC at or over_ (detail field required) A12Refused to submit to test for alcohol—Implied Consent..., and Instruction Permit) D35Failure to comply with financial responsibility law D38Failure to post..., penalties and/or costs related to the original violation D72Inability to control vehicle D74Operating a...

23 CFR Appendix A to Part 1327 - Abridged Listing of the American Association of Motor Vehicle Administrators Violations Exchange...

Code of Federal Regulations, 2010 CFR

2010-04-01

... with BAC at or over_ (detail field required) A12Refused to submit to test for alcohol—Implied Consent..., and Instruction Permit) D35Failure to comply with financial responsibility law D38Failure to post..., penalties and/or costs related to the original violation D72Inability to control vehicle D74Operating a...

23 CFR Appendix A to Part 1327 - Abridged Listing of the American Association of Motor Vehicle Administrators Violations Exchange...

Code of Federal Regulations, 2014 CFR

2014-04-01

... with BAC at or over _ (detail field required) A12Refused to submit to test for alcohol—Implied Consent..., and Instruction Permit) D35Failure to comply with financial responsibility law D38Failure to post..., penalties and/or costs related to the original violation D72Inability to control vehicle D74Operating a...

23 CFR Appendix A to Part 1327 - Abridged Listing of the American Association of Motor Vehicle Administrators Violations Exchange...

Code of Federal Regulations, 2011 CFR

2011-04-01

... with BAC at or over_ (detail field required) A12Refused to submit to test for alcohol—Implied Consent..., and Instruction Permit) D35Failure to comply with financial responsibility law D38Failure to post..., penalties and/or costs related to the original violation D72Inability to control vehicle D74Operating a...

23 CFR Appendix A to Part 1327 - Abridged Listing of the American Association of Motor Vehicle Administrators Violations Exchange...

Code of Federal Regulations, 2012 CFR

2012-04-01

... with BAC at or over_ (detail field required) A12Refused to submit to test for alcohol—Implied Consent..., and Instruction Permit) D35Failure to comply with financial responsibility law D38Failure to post..., penalties and/or costs related to the original violation D72Inability to control vehicle D74Operating a...

To designate the facility of the United States Postal Service located at 2105 East Cook Street in Springfield, Illinois, as the "Colonel John H. Wilson, Jr. Post Office Building".

THOMAS, 111th Congress

Rep. Hare, Phil [D-IL-17

2009-01-14

House - 02/11/2009 Ordered to be Reported by Unanimous Consent. (All Actions) Notes: For further action, see S.234, which became Public Law 111-7 on 3/9/2009. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Stress Effects on Transfer from Virtual Environment Flight Training to Stressful Flight Environments

DTIC Science & Technology

2009-06-01

research participants from Experiment 1 ....................................................150 Figure 6.2 Informed consent HRV analysis...INTENTIONALLY LEFT BLANK 1 I. INTRODUCTION Anxiety never disappears in a human being in an airplane — it merely remains dormant when there is no...two counterproductive results: (1) high levels of anxiety that inhibit both training and post-training performance, and (2) stress that interferes

Speech Understanding in Noise in the Bison Command, Control, Communications and Intelligence (C3I) Mobile Command Post (MCP)

DTIC Science & Technology

2010-12-01

messages étaient présentés au moyen des haut-parleurs en présence de bruit dans le véhicule. Même si des notes relativement faibles ont été obtenues...Research Ethics Committee. Each subject read the protocol and provided informed consent before participating. The terms and conditions of remuneration

Addendum to the Corrective Action Decision Document/Closure Report for Corrective Action Unit 529: Area 25 Contaminated Materials, Nevada Test Site, Nevada, Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Krauss, Mark J

This document constitutes an addendum to the Corrective Action Decision Document/Closure Report for Corrective Action Unit 529: Area 25 Contaminated Materials, Nevada Test Site, Nevada as described in the document Recommendations and Justifications To Remove Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order dated September 2013. The Use Restriction (UR) Removal document was approved by the Nevada Division of Environmental Protection on October 16, 2013. The approval of the UR Removal document constituted approval of each of the recommended UR removals. In conformance with the URmore » Removal document, this addendum consists of: This page that refers the reader to the UR Removal document for additional information The cover, title, and signature pages of the UR Removal document The NDEP approval letter The corresponding section of the UR Removal document This addendum provides the documentation justifying the cancellation of the UR for CAS 25-23-17, Contaminated Wash (Parcel H). This UR was established as part of FFACO corrective actions and was based on the presence of total petroleum hydrocarbon diesel-range organics contamination at concentrations greater than the NDEP action level at the time of the initial investigation.« less

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

PubMed Central

Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

2009-01-01

Abstract Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of – and responsibility for – group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test. PMID:19876544

Improving the Quality of Voluntary Medical Male Circumcision through Use of the Continuous Quality Improvement Approach: A Pilot in 30 PEPFAR-Supported Sites in Uganda

PubMed Central

Opio, Alex; Calnan, Jacqueline; Njeuhmeli, Emmanuel

2015-01-01

Background Uganda adopted voluntary medical male circumcision (VMMC) (also called Safe Male Circumcision in Uganda), as part of its HIV prevention strategy in 2010. Since then, the Ministry of Health (MOH) has implemented VMMC mostly with support from the United States President’s Emergency Plan for AIDS Relief (PEPFAR) through its partners. In 2012, two PEPFAR-led external quality assessments evaluated compliance of service delivery sites with minimum quality standards. Quality gaps were identified, including lack of standardized forms or registers, lack of documentation of client consent, poor preparedness for emergencies and use of untrained service providers. In response, PEPFAR, through a USAID-supported technical assistance project, provided support in quality improvement to the MOH and implementing partners to improve quality and safety in VMMC services and build capacity of MOH staff to continuously improve VMMC service quality. Methods and Findings Sites were supported to identify barriers in achieving national standards, identify possible solutions to overcome the barriers and carry out improvement plans to test these changes, while collecting performance data to objectively measure whether they had bridged gaps. A 53-indicator quality assessment tool was used by teams as a management tool to measure progress; teams also measured client-level indicators through self-assessment of client records. At baseline (February-March 2013), less than 20 percent of sites scored in the “good” range (>80%) for supplies and equipment, patient counseling and surgical procedure; by November 2013, the proportion of sites scoring “good” rose to 67 percent, 93 percent and 90 percent, respectively. Significant improvement was noted in post-operative follow-up at 48 hours, sexually transmitted infection assessment, informed consent and use of local anesthesia but not rate of adverse events. Conclusion Public sector providers can be engaged to address the quality of VMMC using a continuous quality improvement approach. PMID:26207986

Professional Stress and Burnout in U.S. Military Medical Personnel Deployed to Afghanistan.

PubMed

Adler, Amy B; Adrian, Amanda L; Hemphill, Marla; Scaro, Nicole H; Sipos, Maurice L; Thomas, Jeffrey L

2017-03-01

Studies of medical staff members have consistently documented high levels of burnout compared to those in other professions. Although there are studies of burnout in military medical staff, there are gaps in understanding the experience of medical staff while they are deployed and few occupationally-related factors associated with decreased burnout have been identified in this population. To assess work-related variables accounting for burnout over and above rank, post-traumatic stress disorder (PTSD) symptoms, and professional stressors in the deployed environment. U.S. military medical staff members were surveyed in Afghanistan. The survey assessed burnout (emotional exhaustion and depersonalization), PTSD symptoms, perception of professional stressors, self-care behaviors, taking care of team members (team care), general leadership, and health-promoting leadership. Participants provided informed consent under a protocol approved by the institutional review board at Walter Reed Army Institute of Research, and coordinated through the Washington Headquarters Service and the Joint Casualty Care Research Team located in Afghanistan. A total of 344 individuals provided their consent (83.3%) and completed the survey. Correlations found significant positive relationships between perception of professional stressors and levels of burnout. Significant negative correlations were found between burnout and self-care, team care, general leadership, and health-promoting leadership. Regression analyses found self-care and team care accounted for less burnout even after controlling for rank, PTSD symptoms, and professional stressors. Health-promoting leadership accounted for less burnout even after controlling for these same covariates and general leadership as well. Although a cross-sectional survey, results provide three specific directions for reducing burnout in deployed medical staff. By emphasizing self-care, team care, and health-promoting leadership, policy makers, researchers, and leaders can address factors that influence burnout in this, and other occupational contexts. In addition, the constructs of team care and leadership offer novel contributions to the study of burnout in medical personnel. Reprint & Copyright © of 2017 Association Military Surgeons of the U.S.

The Consequences of Vagueness in Consent to Organ Donation.

PubMed

Shaw, David M

2017-07-01

In this article I argue that vagueness concerning consent to post-mortem organ donation causes considerable harm in several ways. First, the information provided to most people registering as organ donors is very vague in terms of what is actually involved in donation. Second, the vagueness regarding consent to donation increases the distress of families of patients who are potential organ donors, both during and following the discussion about donation. Third, vagueness also increases the chances that the patient's intention to donate will not be fulfilled due to the family's distress. Fourth, the consequent reduction in the number of donated organs leads to avoidable deaths and increased suffering among potential recipients, and distresses them and their families. There are three strategies which could be used to reduce the harmful effects of this vagueness. First, recategorizing the reasons (commonly referred to as 'overrules' under the current system) given by families who refuse donation from registered donors would bring greater clarity to donation discussions. Second, people who wish to donate their organs should be encouraged to discuss their wishes in detail with their families, and to consider recording their wishes in other ways. Finally, the consent system for organ donation could be made more detailed, ensuring both that more information is provided to potential donors and that they have more flexibility in how their intentions are indicated; this last strategy, however, could have the disadvantage of discouraging some potential donors from registering. © 2016 John Wiley & Sons Ltd.

A dialectical perspective on informed consent to treatment: an examination of radiologists' dilemmas and negotiations.

PubMed

Olufowote, James Olumide

2011-06-01

Informed consent to treatment (ICT), designed to honor patient autonomy, has been an important subject of inquiry in many disciplines. To foreground the dynamic and dilemmatic tendencies of ICT practice implied by previous inquiries, I advanced relational dialectics theory into the realm of physicians' experiences with ICT. On performing a dialectical analysis of transcripts from focus group discussions with radiologists, I found them experiencing four primary tensions: (a) between simple and complex ICT; (b) between radiologist and patient control; (c) between standardized and idiosyncratic practice (involving struggles between documentation and conversational process, and between vague and detailed language use); and (d) between withholding and disclosing alternatives. Moreover, I drew on concepts from relational dialectics theory to capture the various ways radiologists negotiate these dialectics. I conclude with practical applications for physician and patient training and interprofessional coordination.

Biobanks for non-clinical purposes and the new law on forensic biobanks: does the Italian context protect the rights of minors?

PubMed

Tozzo, Pamela; Pegoraro, Renzo; Caenazzo, Luciana

2010-12-01

Biobanks are an important resource for medical research. Genetic research on biological material from minors can yield valuable information that can improve our understanding of genetic-environmental interactions and the genesis and development of early onset genetic disorders. The major ethical concerns relating to biobanks concern consent, privacy, confidentiality, commercialisation, and the right to know or not to know. However, research on paediatric data raises specific governance and ethical questions with regard to consent and privacy. We have considered the Italian normative context focusing on what is mentioned in each document on the ethical and legal requirements that guarantee the rights of minors. We found out that there is no systematic reflection on the ethical and policy issues arising from the participation of minors in biobank research. Moreover, we have focused on the same aspects for the new Italian Law on the National Forensic Biobank.

Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research

PubMed Central

Abdelghany, Osama; Johnston, Susan; Rarus, Rachel; Austin-Szwak, Jennifer; Kirkwood, Craig

2017-01-01

Pharmacists' specialized training and knowledge qualify them to lead and engage in research pertaining to optimal medication use. Performing research promotes pharmacy professionalism and fosters interdisciplinary collaboration. To conduct research appropriately, one must have thorough knowledge of when institutional review board (IRB) approval is required and how to successfully navigate IRB processes. The overarching mission of the IRB overseeing research at an organization per federal guidelines is to protect the rights and welfare of human subjects participating in research. This article discusses the following general pharmacy practice–based considerations relating to IRB processes: strategies for developing research projects, key distinctions between quality improvement and research, practical considerations for submitting IRB applications and documentation, different categories of IRB submission, informed consent and conditions for waivers or alterations of consent, and principal investigator obligations for approved research. Pharmacists should also account for organization-specific IRB processes when designing, submitting, and implementing research projects. PMID:28321137

Pre- to Post-Immigration Alcohol Use Trajectories among Recent Latino Immigrants

PubMed Central

Sanchez, Mariana; De La Rosa, Mario; Blackson, Timothy C.; Sastre, Francisco; Rojas, Patria; Li, Tan; Dillon, Frank

2014-01-01

The escalation of alcohol use among some Latino immigrant groups as their time in the United States increases has been well-documented. Yet, little is known about the alcohol use behaviors of Latino immigrants prior to immigration. This prospective longitudinal study examines pre- to post-immigration alcohol use trajectories among a cohort of recent Latino immigrants. Retrospective pre-immigration data were collected at baseline from a sample of 455 Cuban, South American and Central American Latinos ages 18–34 who immigrated to the U.S. less than one year prior. Two follow-up assessments (12 months apart) reported on their post-immigration alcohol use in the past 90 days. We hypothesized (a) overall declines in pre- to post-immigration alcohol among recent Latino immigrants and (b) gender/documentation specific effects, with higher rates of alcohol use among males and undocumented participants compared to their female and documented counterparts. Growth curve analyses revealed males had higher levels of pre-immigration alcohol use with steeper declines in post-immigration alcohol use compared to females. Declines in alcohol use frequency were observed for documented, but not undocumented males. No changes in pre- to post-immigration alcohol use were found for documented or undocumented females. This study contributes to the limited knowledge of pre- to post-immigration alcohol use patterns among Latinos in the United States. Future research is needed to identify social determinants associated with the alcohol use trajectories of recent Latino immigrants, as it may inform prediction, prevention, and treatment of problem-drinking behaviors among the largest and fastest growing ethnic minority in the United States. PMID:25243834

Orthodontic informed consent considering information load and serial position effect.

PubMed

Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

2015-03-01

Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of "chunking." There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation. There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of "chunking" over traditional informed consent methods in terms of patient improvement in overall comprehension, treatment recall, and treatment comprehension. The treatment domain is the most affected. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Welsh Government proposals: organ and tissue donation reforms.

PubMed

McHale, Jean V

In November 2011, the Welsh Government published a consultation document setting out proposals for legislation on organ and tissue donation. The scheme would introduce a notable change in the law from a consent-based 'opt-in' scheme for transplantation to an 'opt-out' one. This article explores the scope of the current law concerning organ transplantation. It considers the proposals for reform and some of the challenges which might arise in implementing the legislation.

77 FR 1091 - Post Office Closing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-09

...This document informs the public that an appeal of the closing of the Alvord, Iowa post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioners, and others to take appropriate action.

77 FR 2099 - Post Office Closing

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-13

...This document informs the public that an appeal of the closing of the Hope, Minnesota post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioners, and others to take appropriate action.

'Take Ten' improving the surgical post-take ward round: a quality improvement project.

PubMed

Banfield, Danielle Alice; Adamson, Carly; Tomsett, Amy; Povey, James; Fordham, Tony; Richards, Sarah Kathryn

2018-01-01

The surgical post-take ward round is a complex multidisciplinary interaction in which new surgical patients are reviewed and management plans formulated. Its fast-paced nature can lead to poor communication and inaccurate or incomplete documentation with potential detriment to patient safety. Junior team members often do not fully understand the diagnosis and management plan. The aims of this project were to improve both communication and documentation on the surgical post-take ward round, influencing patient safety. The ward round was deconstructed to identify individual roles and determine where intervention would have the most impact. Ten important points were identified that should be documented in the management of an acute surgical patient; observations, examination, impression, investigations, antibiotics, intravenous fluids, VTE assessment, nutrition status, estimated length of stay and ceiling of treatment. A 'Take Ten' checklist was devised with these items to be used as a 'time out' after each patient with the whole team for discussion, clarification and clear documentation. Four plan do study act cycles were completed over a period of a year. A retrospective review of post-take documentation preintervention and postintervention was performed, and the percentage of points that were accurately documented was calculated. For further clarification, 2 weekends were compared-one where the checklist was used and one where it was not. Results showed documentation postintervention varied between categories but there was improvement in documentation of VTE assessment, fluids, observations and investigations. On direct comparison of weekends the checklist showed improved documentation in all categories except length of stay. Junior team members found the checklist improved understanding of diagnosis and management plan, and encouraged a more effective ward round. The 'Take Ten' checklist has been well received. Three years on from its inception, the checklist has become an integral part of the post-take ward round, thanks to the multidisciplinary engagement in the project.

Leveraging Observations of Security Force Assistance in Afghanistan for Global Operations

DTIC Science & Technology

2013-01-01

commercial use only. Unauthorized posting of RAND electronic documents to a non-RAND website is prohibited. RAND electronic documents are protected under...copyright law. Permission is required from RAND to reproduce, or reuse in another form, any of our research documents for commercial use . For...contained herein are protected by law. This representation of RAND intellectual property is provided for noncommercial use only. Unauthorized posting of

Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals.

PubMed

Lawton, Julia; Snowdon, Claire; Morrow, Susan; Norman, Jane E; Denison, Fiona C; Hallowell, Nina

2016-04-11

Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur. To address these potential difficulties, we undertook a qualitative evaluation of the internal pilot of a trial (Got-it) involving women who had a retained placenta (RP). We explored the experiences and views of women and staff about the information and consent pathway used within the pilot, in order to provide recommendations for use in future peripartum trials involving recruitment in emergency situations. In-depth interviews were undertaken with staff (n = 27) and participating women (n = 22). Interviews were analysed thematically. The accounts of women and staff were compared to identify differences and similarities in their views about recruitment and consent procedures. Women and staff regarded recruitment as having been straightforward and facilitated by the use of simplified (verbal and written) summaries of trial information. Both parties, however, conveyed discordant views about whether fully informed consent had been obtained. These differences in perspectives appeared to arise from the different factors and considerations impinging on women and staff at the time of recruitment. While staff placed emphasis on promoting understanding in the emergency situation of RP by imparting information in clear and succinct ways, women highlighted the experiential realities of their pre- and post-birthing situations, and how these had led to quick decisions being made without full engagement with the potential risks of trial participation. To facilitate informed consent, women suggested that trial information should be given during the antenatal period, and, in doing so, articulated a rights-based discourse. Staff, however, voiced opposition to this approach by emphasising a duty of care to all pregnant women, and raising concerns about causing undue distress to the majority of individuals who would not subsequently develop a RP. By drawing upon the perspectives of women and staff involved in the same trial we have shown that they may operate within different experiential and ethical paradigms. In doing so, we argue for the potential benefits of drawing upon multiple perspectives when developing information and consent pathways used in future (peripartum) trials. ISCRTN 88609453 .

[Prevention of the post-surgical insatisfactions and possible medico-legal complications].

PubMed

Flageul, G; Pessis, R

2017-10-01

The purpose of this work is to better understand the reasons for post-surgical instability and what makes up the bed of medico-legal complications. Beyond technical competence, it is essential to observe a very high degree of rigor in listening to the real motivations in order to give the most accurate possible surgical indications and in particular to know to detect and never to operate certain patients who, whatever we do, will always be dissatisfied. The quality of information is one of the essential elements of prevention: information is part of the care and there is no therapeutic success without a successful relationship between a caregiver and a carereceiver. Before the surgery, it is essential to pre-establish written proof of the proper delivery of the information by signing a receipt and an informed consent document. However, the information does not stop at the time of the operative gesture and it is necessary to be able to provide complete and timely information about any post-surgical complications. Furthermore, aesthetic medicine is well understood and rigorously implemented, contributes to the prevention of surgical and medico-legal complications, reducing the heaviness of certain surgical gestures. The question of e-reputation should in no way be neglected. From this point of view, prevention consists in controlling as much as possible the Internet environment. Indeed, where, in the past, in the presence of a dissatisfied patient awaited us, the fear of word-of-mouth or trial is added to the risk of harm E-reputation whose implications can be very damaging. At a time when the intensive use of the Internet allows anyone to get out of anonymity, we must also control these tools at the risk of sacrificing our expertise at the coronation of amateurs. Copyright © 2017. Published by Elsevier Masson SAS.

The Root Cause of Post-traumatic and Developmental Stress Disorder, Phase 2

DTIC Science & Technology

2013-10-01

have tested and validated. Project 2 will investigate post -mortem anatomy in subjects with major depression and/or PTSD. Both molecular and...Award Number: W81XWH-11-2-0166 TITLE: The Root Cause of Post -traumatic and Developmental Stress Disorder, Phase II PRINCIPAL INVESTIGATOR: Keith...construed as an official Department of the Army position, policy or decision unless so designated by other documentation. REPORT DOCUMENTATION PAGE

Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

PubMed

Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

2017-04-01

Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

NASA combined file postings statistics based on NASA Thesaurus, January 1968 - January 1991

NASA Technical Reports Server (NTRS)

1991-01-01

The NASA Combined File Postings Statistics is published semiannually (January and July). This alphabetical listing of postable subject terms contained in the NASA Thesaurus is used to display the number of postings (documents) indexed by each subject term from 1968 to data. The postings totals per term are separated by announcement or other media into STAR, IAA, NLN, and OTHER columnar entries covering the NASA document collection (1968 to date). Over 595,000 book postings for NALNET Books held by NASA Libraries are included under the NLN column. CSTAR postings as well as some previously unreported series are listed under the 'other' column. The distribution of 18,748,083 postings among the 17,304 Thesaurus terms is tabulated on the last page of Combined File Postings Statistics.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

As part of the Hanford Federal Facility Agreement and Consent Order negotiations (Ecology et al. 1994), the US Department of Energy, Richland Operations Office, the US Environmental Protection Agency, and the Washington State Department of Ecology agreed that liquid effluent discharges to the ground on the Hanford Site which affect groundwater or have the potential to affect ground would be subject to permitting under the structure of Chapter 173-216 (or 173-218 where applicable) of the Washington Administrative Code, the State Waste Discharge Permit Program. As a result of this decision, the Washington State Department of Ecology and the US Departmentmore » of Energy, Richland Operations Office entered into Consent Order No. DE 91NM-177, (Ecology and DOE-RL 1991). The Consent Order No. DE 91NM-177 requires a series of permitting activities for liquid effluent discharges. This document presents the State Waste Discharge Permit (SWDP) application for the 200-E Chemical Drain Field. Waste water from the 272-E Building enters the process sewer line directly through a floor drain, while waste water from the 2703-E Building is collected in two floor drains, (north and south) that act as sumps and are discharged periodically. The 272-E and 2703-E Buildings constitute the only discharges to the process sewer line and the 200-E Chemical Drain Field.« less

Using Option Grids: steps toward shared decision-making for neonatal circumcision.

PubMed

Fay, Mary; Grande, Stuart W; Donnelly, Kyla; Elwyn, Glyn

2016-02-01

To assess the impact, acceptability and feasibility of a short encounter tool designed to enhance the process of shared decision-making and parental engagement. We analyzed video-recordings of clinical encounters, half undertaken before and half after a brief intervention that trained four clinicians how to use Option Grids, using an observer-based measure of shared decision-making. We also analyzed semi-structured interviews conducted with the clinicians four weeks after their exposure to the intervention. Observer OPTION(5) scores were higher at post-intervention, with a mean of 33.9 (SD=23.5) compared to a mean of 16.1 (SD=7.1) for pre-intervention, a significant difference of 17.8 (95% CI: 2.4, 33.2). Prior to using the intervention, clinicians used a consent document to frame circumcision as a default practice. Encounters with the Option Grid conferred agency to both parents and clinicians, and facilitated shared decision-making. Clinician reported recognizing the tool's positive effect on their communication process. Tools such as Option Grids have the potential to make it easier for clinicians to achieve shared decision-making. Encounter tools have the potential to change practice. More research is needed to test their feasibility in routine practice. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Improving Army Basic Research: Report of an Expert Panel on the Future of Army Laboratories

DTIC Science & Technology

2012-01-01

commercial use only. Unauthorized posting of RAND electronic documents to a non-RAND website is prohibited. RAND electronic documents are protected under...complete. Copies may not be duplicated for commercial purposes. Unauthorized posting of RAND documents to a non-RAND website is prohibited. RAND...Inspired senior scientists and technologists with vision will be essential in research as well as in the design , development, evaluation, and

Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries.

PubMed

de Vries, Jantina; Munung, Syntia Nchangwi; Matimba, Alice; McCurdy, Sheryl; Ouwe Missi Oukem-Boyer, Odile; Staunton, Ciara; Yakubu, Aminu; Tindana, Paulina

2017-02-02

The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when. In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers.

Engaging a state: Facebook comments on a large population biobank.

PubMed

Platt, Tevah; Platt, Jodyn; Thiel, Daniel; Kardia, Sharon L R

2017-07-01

Scholarship on newborn screening, dried bloodspot retention, and large population biobanking call consistently for improved public engagement. Communication with participants likely occurs only in the context of collection, consent, or notification, if at all. We ran an 11-week advertising campaign to inform Michigan Facebook users unlikely to know that their or their children's dried bloodspots (DBSs) were stored in a state biobank. We investigated the pattern and content of comments posted during the campaign, focusing on users' questions, attitudes and concerns, and the role the moderator played in addressing them. We used Facebook data to quantitatively assess engagement and employed conventional content analysis to investigate themes, attitudes, and social dynamics among user and moderator comments. Five ad sets elicited comments during campaign weeks 4-8, reaching ∼800,000 Facebook users ($6000). Gravitating around broad, underlying ethical, legal, and social issues, 180 posts from 129 unique users related to newborn screening or biobanking. Thirty six conveyed negative attitudes and 33 conveyed positive attitudes; 53 posed questions. The most prevalent themes identified were consent, privacy, bloodspot use, identifiability, inclusion criteria, research benefits, (mis)trust, genetics, DBS destruction, awareness, and the role of government. The moderator's 81 posts were responsive-answering questions, correcting or clarifying information, or providing information about opting out. Facebook ad campaigns can improve engagement by pushing out relevant content and creating dynamic, responsive, visible forums for discussion. Reduced control over messaging may be worth the trade-off for creating accessible, transparent, people-centered engagement on public health issues that are sensitive and complex.

Factors predictive of increased influenza and pneumococcal vaccination coverage in long-term care facilities: the CMS-CDC standing orders program Project.

PubMed

Bardenheier, Barbara H; Shefer, Abigail; McKibben, Linda; Roberts, Henry; Rhew, David; Bratzler, Dale

2005-01-01

Between 1999 and 2002, a multistate demonstration project was conducted in long-term care facilities (LTCFs) to encourage implementation of standing orders programs (SOP) as evidence-based vaccine delivery strategies to increase influenza and pneumococcal vaccination coverage in LTCFs. Examine predictors of increase in influenza and pneumococcal vaccination coverage in LTCFs. Intervention study. Self-administered surveys of LTCFs merged with data from OSCAR (On-line Survey Certification and Reporting System) and immunization coverage was abstracted from residents' medical charts in LTCFs. Twenty LTCFs were sampled from 9 intervention and 5 control states in the 2000 to 2001 influenza season for baseline and during the 2001 to 2002 influenza season for postintervention. Each state's quality improvement organization (QIO) promoted the use of standing orders for immunizations as well as other strategies to increase immunization coverage among LTCF residents. Multivariate analysis included Poisson regression to determine independent predictors of at least a 10 percentage-point increase in facility influenza and pneumococcal vaccination coverage. Forty-two (20%) and 59 (28%) of the facilities had at least a 10 percentage-point increase in influenza and pneumococcal immunizations, respectively. In the multivariate analysis, predictors associated with increase in influenza vaccination coverage included adoption of requirement in written immunization protocol to document refusals, less-demanding consent requirements, lower baseline influenza coverage, and small facility size. Factors associated with increase in pneumococcal vaccination coverage included adoption of recording pneumococcal immunizations in a consistent place, affiliation with a multifacility chain, and provision of resource materials. To improve the health of LTCF residents, strategies should be considered that increase immunization coverage, including written protocol for immunizations and documentation of refusals, documenting vaccination status in a consistent place in medical records, and minimal consent requirements for vaccinations.

Assessing the Effect of Simulated Physical Objects and Elements in Virtual Environments on Social Influence

DTIC Science & Technology

2006-07-01

include impression formation, decision making, paranormal beliefs, bargaining and negotiating, communication, and group problem-solving. No specific...take part in this study, your involvement will last for about an hour. WHAT WILL HAPPEN DURING THIS STUDY? If you agree to participate in this study...of what will happen during the study if you decide to participate. You are not waiving any legal rights by signing this Informed Consent Document. Your

Chinese-English Rocketry Dictionary. Volume 1

DTIC Science & Technology

1977-10-01

ftb9UJi22by 7602nd Air Intelligence Group C v&-O ,) , dctober 1977 AP S0~ 4, 48 ~ DIMIIBUTION STATEMENT A. Approved for public releaM, Distribution...Unlimited Reproduction of all or ary part of this document without the written consent of 7602nd Air Intelligence Group is strictly prohibited __ 1-: n__...Staff for Intelligence, United Statts Air Force, the 7602nd Air Intelligence Group reactivated it it, April 1977 to complete the series, making use of

Clinical photography in dermatology: ethical and medico-legal considerations in the age of digital and smartphone technology.

PubMed

Kunde, Lauren; McMeniman, Erin; Parker, Malcolm

2013-08-01

Clinical photography has long been an important aspect in the management of dermatological pathology and has many applications in contemporary dermatology practice. With the continuous evolution of digital and smartphone technology, clinicians must maintain ethical and medico-legal standards. This article reviews how dermatology trainees are utilising this technology in their clinical practice and what procedures they follow when taking photos of patients. We review the ethical and legal considerations of clinical photography in dermatology and present a hypothetical medico-legal scenario. Dermatology registrars were surveyed on their use of personal smartphones and digital equipment for photographing patients in their clinical practice. Numerous medico-legal providers were approached to provide medico-legal advice about a hypothetical scenario. We found that the use of these technologies is prevalent among dermatology registrars and all respondents reported regular use. Clinicians should routinely obtain and document adequate patient consent in relation to clinical photography, utilise strict privacy settings on smartphones and other digital devices and ensure that the images are stored on these devices for minimal periods. Express consent documentation in the clinical file puts the clinician in a more defensible position if a complaint is made to the medical board or privacy commissioner. © 2013 The Authors. Australasian Journal of Dermatology © 2013 The Australasian College of Dermatologists.

How anonymous is ‘anonymous’? Some suggestions towards a coherent universal coding system for genetic samples

PubMed Central

Schmidt, Harald; Callier, Shawneequa

2012-01-01

So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible. PMID:22345546

How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system for genetic samples.

PubMed

Schmidt, Harald; Callier, Shawneequa

2012-05-01

So-called 'anonymous' tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in 'consent or anonymise' policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as 'anonymised', 'anonymous' or 'non-identifiable' be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible.

77 FR 41190 - Revised Document Posted: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH-190] Revised Document Posted: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012, Correction AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the...

Ethics and law in research with human biological samples: a new approach.

PubMed

Petrini, Carlo

2014-01-01

During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.

CASP - An intervention by community volunteers to reduce suicidal behaviour among refugees.

PubMed

Vijayakumar, Lakshmi; Mohanraj, Rani; Kumar, Shuba; Jeyaseelan, Visalakshi; Sriram, Savitha; Shanmugam, Madhumathi

2017-11-01

Refugees are at risk of psychiatric morbidity because of forced migration, traumatic events and resettlement in unfamiliar environments. Many live in low- and middle-income countries (LAMIC) under stressful conditions contributing to increased suicide risk. This study assessed the feasibility of regular contact and use of safety planning cards (CASP) by community volunteers (CVs) in reducing suicidal behaviour among Sri Lankan refugees residing in camps in Tamil Nadu, South India. A household survey was carried out on consenting adults in two refugee camps - one intervention and one control - randomly selected using lottery method. The primary outcome was reduction in suicidal behaviour. Experience of trauma during war and migration, depression, post-traumatic stress and alcohol use were documented. Individuals scoring >16 on Centre for Epidemiological Studies Depression (CESD) or >30 on Post-traumatic Stress Disorder (PTSD) or with active/passive suicidal ideation or a history of previous suicidal attempts were considered as high risk. CVs were trained to deliver CASP intervention to high-risk individuals. Change from baseline to follow-up was computed for intervention and control groups, and the difference between changes in suicide rates was compared using proportion test. In total, 639 refugees from intervention and 664 from control camps participated. Of the 288 high-risk refugees in intervention camp, 139 completed the intervention. In the control camp, 187 were categorised as high risk. Prevalence of suicide attempts was 6.1%. Following intervention, differences between sites in changes in combined suicide (attempted suicides and suicides) rates per 100,000 per year were 519 (95% confidence interval (CI): 136-902; p < .01). CASP, an intervention involving contact by CVs and use of safety planning cards, is feasible to implement and can reduce suicidal behaviour among refugees. Its replication in more settings will enhance validity.

Examining Accuracy of Self-Assessment of In-Training Examination Performance in a Context of Guided Self-Assessment.

PubMed

Babenko, Oksana; Campbell-Scherer, Denise; Schipper, Shirley; Chmelicek, John; Barber, Tanya; Duerksen, Kimberley; Ross, Shelley

2017-06-01

In our family medicine residency program, we have established a culture of guided self-assessment through a systematic approach of direct observation of residents and documentation of formative feedback. We have observed that our residents have become more accurate in self-assessing their clinical performance. The objective of this study was to examine whether this improved accuracy extended to residents' self-assessment of their medical knowledge and clinical reasoning on the In-Training Examination (ITE). In November each year, residents in their first (PGY1) and second (PGY2) years of residency take the ITE (240 multiple-choice questions). Immediately before and right after taking the ITE, residents complete a questionnaire, self-assessing their knowledge and predicting their performances, overall and in eight high-level domains. Consented data from residents who took the ITE in 2009-2015 (n=380, 60% participation rate) were used in the Generalized Estimating Equations analyses. PGY2 residents outperformed PGY1 residents; Canadian medical graduates consistently outperformed international medical graduates; urban and rural residents performed similarly overall. Residents' pre-post self-assessments were in line with residents' actual performance on the overall examination and in the domains of Adult Medicine and Care of Surgical Patients. The underperforming residents in this study accurately predicted both pre- and post-ITE that they would perform poorly. Our findings suggest that the ITE operates well in our program. There was a tendency among residents in this study to appropriately adjust their self-assessment of their overall performance after completing the ITE. Irrespective of the residency year, resident self-assessment was less accurate on individual domains.

A Pilot Intervention to Increase Women’s Coping Skills in Family Reintegration After Deployment in Combat Areas

DTIC Science & Technology

2016-01-01

phase of this study (Authors, 2014), and the impact of deployment on these variables. Specifically, we hypothesized women’s post -deployment...reintegration experience is challenging for all soldiers, the goal of this study was to document the post -deployment family reintegration experiences of women... posted , what their roles were, and how the family functioned in their absence (Waldman, 2009). The purpose of this study was to document the

The right to an heir in the era of assisted reproduction.

PubMed

Benshushan, A; Schenker, J G

1998-05-01

The latest remarkable technological advances in assisted reproduction, which enable cryopreservation of spermatozoa, embryos and ovarian tissue, raise difficult and debatable legal, social, ethical and moral issues concerning the right to posthumous reproduction. Furthermore, reports on the attitudes of the general public and of centres licensed for infertility treatment in the United Kingdom found that the majority of women and centres support the idea of posthumous reproduction. In this paper we review the data published on this issue, and after considering the various aspects, we conclude that each case should be discussed and authorized by a multidisciplinary committee that includes physicians, clergy, psychiatrists, psychologists, sociologists and other appropriate parties. In our opinion, the main principles that should guide this committee would allow posthumous reproduction in the context of marriage when a prior consent exists. For unmarried persons, post-mortem donation of gametes should be done only anonymously, if they are in agreement with existing laws concerning infertility treatments in every country and after appropriate consent and proper counselling. Moreover, any case which involves consanguinity or a possibility of incest should be forbidden, both for ethical and genetic reasons. In a case of pre-existing siblings, they should be consulted and their informed consent should be granted in advance so as to avoid legal problems in the inheritance of property.

12 CFR 611.1216 - Public availability of documents related to the termination.

Code of Federal Regulations, 2010 CFR

2010-01-01

... termination. 611.1216 Section 611.1216 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Termination of System Institution Status § 611.1216 Public availability of documents related to the termination. (a) We may post on our Web site, or require you to post on your Web site: (1) Results...

76 FR 16250 - Planning Resource Adequacy Assessment Reliability Standard

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

..., to utilize a ``one day in ten years'' loss of load criterion, and to document and post load and...'' loss of load criterion, and to document and post load and resource capability in each area or..., based on ``one day in ten years'' loss of load expectation principles, for the analysis, assessment and...