Development and Pilot Testing of a Video-Assisted Informed Consent Process

PubMed Central

Sonne, Susan C.; Andrews, Jeannette O.; Gentilin, Stephanie M.; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-01-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n=61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. PMID:23747986

Development and pilot testing of a video-assisted informed consent process.

PubMed

Sonne, Susan C; Andrews, Jeannette O; Gentilin, Stephanie M; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-09-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock-informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n = 61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, the comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

49 CFR 1503.423 - Consent orders.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Assessment of Civil Penalties by TSA § 1503.423 Consent orders. (a) Issuance. At any time before the issuance..., may agree to dispose of the case by the issuance of a consent order by TSA. (b) Contents. A consent...

Federal Register notice: Testing Consent Orders on Aniline and Seven Substituted Anilines

EPA Pesticide Factsheets

EPA has signed ECAs with manufacturers (including importers) to perform health and environmental effects tests on aniline and with manufacturers to perform health and/or environmental effects tests on seven substituted anilines they manufacture.

29 CFR 6.43 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Consent findings and order. 6.43 Section 6.43 Labor Office... Interest Proceedings § 6.43 Consent findings and order. (a) At any time prior to the receipt of evidence or... Administrative Law Judge, the parties may enter into consent findings and an order disposing of the proceeding in...

29 CFR 6.32 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Consent findings and order. 6.32 Section 6.32 Labor Office... Consent findings and order. (a) At any time prior to the receipt of evidence or, at the discretion of the... enter into consent findings and an order disposing of the proceeding in whole or in part. (b) Any...

Consent Agreement and Consent Order

EPA Pesticide Factsheets

Contains legal consent agreement and consent order for the assessment of a civil penality pursuant to Section 14(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), BioLab Inc., Conyers, GA, September 14, 1998.

Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.

PubMed

D'Cruz, L

2010-07-24

Consent is an integral part of delivering the care patients want. In order to consent to treatment, patients must have the legal capacity to give valid consent. If this three stage test is satisfied, the patient can elect to have any treatment they wish even if it is not in their best interest. Before a patient is able to consent to treatment they must have adequate knowledge about the risks, benefits and alternatives to the treatment. The amount of information provided to the patient by the dentist is determined to some degree by the legal system prevailing. The patient must voluntarily agree to treatment without being coerced by the dentist or other parties and if things change during treatment the patient needs to be advised. Written consent is very useful in the defence of cases but simply signing the consent form does not mean that the patient knows or understands the treatment to which they have agreed.

29 CFR 6.18 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Consent findings and order. 6.18 Section 6.18 Labor Office... Contracts Subject to the Service Contract Act) § 6.18 Consent findings and order. (a) At any time prior to... of the decision of the Administrative Law Judge, the parties may enter into consent findings and an...

Sunset dates of chemicals subject to final TSCA section 4: test requirements and related section 12(b) actions

EPA Pesticide Factsheets

This table lists all chemical substances and mixtures that are and/or have been the subject of final TSCA Section 4 test rules and/or TSCA Section 4 enforceable consent agreements/orders (ECAs) issued under the TSCA Existing Chemicals Testing Program.

75 FR 29782 - Notice of Proposed Consent Decree and Proposed Order on Consent Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... DEPARTMENT OF JUSTICE Notice of Proposed Consent Decree and Proposed Order on Consent Under the Clean Water Act Notice is hereby given that, on May 18, 2010, a proposed Consent Decree in United States... 301(a) and 504(a) of the Clean Water Act, 33 U.S.C. 1311(a) & 1364(a), in connection with un-permitted...

77 FR 64519 - Magnesium Elektron; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... FEDERAL TRADE COMMISSION [File No. 091 0094] Magnesium Elektron; Analysis of Agreement Containing Consent Orders To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement. SUMMARY: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair...

75 FR 10798 - Richard J. Stanton; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... Order to Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement. SUMMARY: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair... -- embodied in the consent agreement -- that would settle these allegations. DATES: Comments must be received...

Paul Oil Company, Inc. Consent Agreements and Proposed Final Orders

EPA Pesticide Factsheets

Proposed settlements, recorded in two Consent Agreements and Final Orders (“Proposed Consent Agreements”), between EPA and Paul Oil Company, Inc., to resolve two civil administrative penalty proceedings.

Community pharmacists' experience with pharmacogenetic testing.

PubMed

Moaddeb, Jivan; Mills, Rachel; Haga, Susanne B

2015-01-01

Appendix 1 Statements of knowledge of correct medication use Appendix 2 Statements of self-efficacy of correct medication use Appendix 3 Statements of skills of correct medication use To characterize the experiences and feasibility of offering pharmacogenetic (PGx) testing in a community pharmacy setting. Pharmacists were invited to complete a survey about PGx testing for each patient who was offered testing. If the patient consented, pharmacists were also asked to complete a follow-up survey about the process of returning PGx testing results to patients and follow-up with the prescribing provider. Community pharmacies in North Carolina from August through November 2014. Pharmacists at five community pharmacies. Patient consent for testing, time to introduce PGx testing initially and communicate results, interpretation of test results, and recommended medication changes. Of the 69 patients offered testing, 56 (81%) consented. Pre-test counseling typically lasted 1-5 minutes (81%), and most patients (55%) did not have any questions about the testing. Most pharmacists reported test results to patients by phone (84%), with discussions taking less than 1 minute (48%) or 1-5 minutes (52%). Most pharmacists believed the patients understood their results either very well (54%) or somewhat well (41%). Pharmacists correctly interpreted 47 of the 53 test results (89%). All of the incorrect interpretations were for patients with test results indicating a dosing or drug change (6/19; 32%). Pharmacists reported contacting the ordering physician for four patients to discuss results indicating a dosage or drug change. The provision of PGx services in a community pharmacy setting appears feasible, requiring little additional time from the pharmacist, and many patients seem interested in PGx testing. Additional training may be necessary to improve test result interpretation, as well as for communication with both patients and ordering physicians.

75 FR 53968 - Reverb Communications, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-02

... final the agreement's proposed order. This matter involves the public relations, marketing, and sales... Consent Order To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement... or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public...

Sunset Dates of Chemicals Subject to Final TSCA Section 4 and Related 12(b) Actions

EPA Pesticide Factsheets

This Table lists, in ascending chemical Abstract Service (CAS) Registry number order, all chemical substances and mixtures that are and/or have been the subject of final TSCA Section 4 test rules and/or TSCA Section 4 enforceable consent agreements/orders.

75 FR 28616 - Agilent Technologies, Inc.; Analysis of the Agreement Containing Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-21

... equipment used to test cell phones and communications equipment, machines that determine the contents of... employ various analytical techniques to test samples of many types, are used by academic researchers... require the sensitivity provided by ICP-MS, and because many customers perform tests pursuant to...

Security Paving Company, Inc.: Consent Agreement and Proposed Final Order

EPA Pesticide Factsheets

Consent Agreement and Proposed Final Order (“Proposed Consent Agreement”), between the U.S. Environmental Protection Agency, Region 9 (“EPA”), and Security Paving Company (“Respondent”) to resolve a civil administrative penalty proceeding.

41 CFR 60-30.13 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... EXECUTIVE ORDER 11246 Prehearing Procedures § 60-30.13 Consent findings and order. (a) General. At any time..., the parties may jointly move to defer the receipt of any evidence for a reasonable time to permit... result in a just disposition of the issues involved. (b) Content. Any agreement containing consent...

41 CFR 60-30.13 - Consent findings and order.

Code of Federal Regulations, 2011 CFR

2011-07-01

... result in a just disposition of the issues involved. (b) Content. Any agreement containing consent... EXECUTIVE ORDER 11246 Prehearing Procedures § 60-30.13 Consent findings and order. (a) General. At any time after the issuance of a complaint and prior to or during the reception of evidence in any proceeding...

77 FR 25235 - Significant New Use Rules on Certain Chemical Substances

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

... action may also affect certain entities through pre-existing import certification and export notification..., including provisions for developing test data. B. What is the agency's authority for taking this action...) consent orders). Tests recommended by EPA to provide sufficient information to evaluate the chemical...

Feasibility of an Assessment Tool for Children's Competence to Consent to Predictive Genetic Testing: a Pilot Study.

PubMed

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Christiaans, Imke; Grisso, Thomas; van Goudoever, Johannes B; Lindauer, Ramón J L

2015-12-01

Knowledge on children's capacities to consent to medical treatment is limited. Also, age limits for asking children's consent vary considerably between countries. Decision-making on predictive genetic testing (PGT) is especially complicated, considering the ongoing ethical debate. In order to examine just age limits for alleged competence to consent in children, we evaluated feasibility of a standardized assessment tool, and investigated cutoff ages for children's competence to consent to PGT. We performed a pilot study, including 17 pediatric outpatients between 6 and 18 years at risk for an autosomal dominantly inherited cardiac disease, eligible for predictive genetic testing. The reference standard for competence was established by experts trained in the relevant criteria for competent decision-making. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) served as index test. Data analysis included raw agreement between competence classifications, difference in mean ages between children judged competent and judged incompetent, and estimation of cutoff ages for judgments of competence. Twelve (71 %) children were considered competent by the reference standard, and 16 (94 %) by the MacCAT-T, with an overall agreement of 76 %. The expert judgments disagreed in most cases, while the MacCAT-T judgments agreed in 65 %. Mean age of children judged incompetent was 9.3 years and of children judged competent 12.1 years (p = .035). With 90 % sensitivity, children younger than 10.0 years were judged incompetent, with 90 % specificity children older than 11.8 years were judged competent. Feasibility of the MacCAT-T in children is confirmed. Initial findings on age cutoffs are indicative for children between the age of 12 and 18 to be judged competent for involvement in the informed consent process. Future research on appropriate age-limits for children's alleged competence to consent is needed.

38 CFR 1.492 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 1.492 Section 1.492 Pensions... Disclosures and Use § 1.492 Order not applicable to records disclosed without consent to researchers, auditors...

42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 2.62 Section 2.62 Public Health PUBLIC HEALTH SERVICE... without consent to researchers, auditors and evaluators. A court order under these regulations may not...

38 CFR 1.492 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 1.492 Section 1.492 Pensions... Disclosures and Use § 1.492 Order not applicable to records disclosed without consent to researchers, auditors...

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.

77 FR 48858 - Significant New Use Rules on Certain Chemical Substances

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... affect certain entities through pre-existing import certification and export notification rules under... developing test data. B. What is the agency's authority for taking this action? Section 5(a)(2) of TSCA (15 U....e., SNURs without TSCA section 5(e) consent orders). Tests recommended by EPA to provide sufficient...

75 FR 57169 - Significant New Use Rules on Certain Chemical Substances

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

... action may also affect certain entities through pre-existing import certification and export notification... provisions for developing test data. B. What is the Agency's Authority for Taking this Action? Section 5(a)(2...., SNURs without TSCA section 5(e) consent orders). Toxicity concerns. Tests recommended by EPA to provide...

76 FR 25353 - Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... FEDERAL TRADE COMMISSION [File No. 111 0051] Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed consent... Pharmaceuticals PLC (``Hikma'') that is designed to remedy the anticompetitive effects of Hikma's acquisition of...

29 CFR 1955.20 - Consent findings and orders.

Code of Federal Regulations, 2011 CFR

2011-07-01

... will result in a just disposition of the issues. (2) Any agreement containing consent findings and a... § 1955.20 Consent findings and orders. (a)(1) At any time during the proceeding a reasonable opportunity... and the duration thereof shall be in the discretion of the administrative law judge, after...

Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 489: WWII UXO Sites, Tonopah Test Range, Nevada; May 2005

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

Bechtel Nevada; U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office

2005-05-01

This Streamlined Approach for Environmental Restoration Plan provides the details for the closure of Corrective Action Unit (CAU) 489: WWII UXO Sites, Tonopah Test Range. CAU 489 is located at the Tonopah Test Range and is currently listed in Appendix III of the Federal Facility Agreement and Consent Order of 1996.

49 CFR 383.72 - Implied consent to alcohol testing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Implied consent to alcohol testing. 383.72 Section 383.72 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER... consent to alcohol testing. Any person who holds a CDL is considered to have consented to such testing as...

75 FR 42752 - Nestle' HealthCare Nutrition, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-22

... FEDERAL TRADE COMMISSION [File No. 092 3087] Nestle' HealthCare Nutrition, Inc.; Analysis of... containing a consent order from Nestle; HealthCare Nutrition, Inc. (``respondent''). The proposed consent... Drug Administration (FDA) pursuant to the Nutrition Labeling and Education Act of 1990 (NLEA). Under...

77 FR 35391 - Franklin Budget Car Sales, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... FEDERAL TRADE COMMISSION [File No. 102 3094] Franklin Budget Car Sales, Inc.; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed Consent Agreement... from Franklin's Budget Car Sales, Inc., also doing business as Franklin Toyota/Scion (``Franklin Toyota...

78 FR 3425 - Filiquarian Publishing, LLC; Choice Level, LLC; and Joshua Linsk; Analysis of Proposed Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-16

... FEDERAL TRADE COMMISSION [File No. 112 3195] Filiquarian Publishing, LLC; Choice Level, LLC; and Joshua Linsk; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal Trade Commission... approval, an agreement containing a consent order from Filiquarian Publishing, LLC; Choice Level, LLC; and...

29 CFR 1955.20 - Consent findings and orders.

Code of Federal Regulations, 2010 CFR

2010-07-01

... § 1955.20 Consent findings and orders. (a)(1) At any time during the proceeding a reasonable opportunity... will result in a just disposition of the issues. (2) Any agreement containing consent findings and a...) On or before the expiration of the time granted for negotiations, the parties or their counsel may...

77 FR 58838 - ABCSP, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-24

... FEDERAL TRADE COMMISSION [File No. 112 3168] ABCSP, Inc.; Analysis of Proposed Consent Order to... or before October 17, 2012. ADDRESSES: Interested parties may file a comment online or on paper, by.... Write ``AABCSP, Inc.,-- consent, FTC File No. 112 3168'' on your comment, and file your comment online...

77 FR 52322 - McClellan Air Force Base Superfund Site Proposed Notice of Administrative Order on Consent

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-29

... ENVIRONMENTAL PROTECTION AGENCY [FRL-9723-5] McClellan Air Force Base Superfund Site Proposed Notice of Administrative Order on Consent AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... consent concerning portions of the McClellan Air Force Base Superfund Site (``Site'') in McClellan...

19 CFR 210.76 - Modification or rescission of exclusion orders, cease and desist orders, and consent orders.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 19 Customs Duties 3 2010-04-01 2010-04-01 false Modification or rescission of exclusion orders, cease and desist orders, and consent orders. 210.76 Section 210.76 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR PRACTICES IN IMPORT TRADE ADJUDICATION AND ENFORCEMENT...

County of Hawaii Department of Public Works: Consent Agreement and Final Order (2005)

EPA Pesticide Factsheets

Consent Agreement and Final Order for The County of Hawaii Department of Public Works, Hilo, Hawaii, including proposed order of compliance, closure of large capacity cesspools. Docket no. UIC-AO-2005-0013

40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Required test FR citation Di(heptyl, nonyl, undecyl) phthalate (D711P) as a mixture of the following six substances: (1) diheptyl phthalate (branched and linear isomers), CAS No. 68515-44-6 Environmental effects. January 9, 1989. (2) dinonyl phthalate (branched and linear isomers), CAS No. 68515-45-7 ......do Do. (3...

40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Required test FR citation Di(heptyl, nonyl, undecyl) phthalate (D711P) as a mixture of the following six substances: (1) diheptyl phthalate (branched and linear isomers), CAS No. 68515-44-6 Environmental effects. January 9, 1989. (2) dinonyl phthalate (branched and linear isomers), CAS No. 68515-45-7 ......do Do. (3...

40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Required test FR citation Di(heptyl, nonyl, undecyl) phthalate (D711P) as a mixture of the following six substances: (1) diheptyl phthalate (branched and linear isomers), CAS No. 68515-44-6 Environmental effects. January 9, 1989. (2) dinonyl phthalate (branched and linear isomers), CAS No. 68515-45-7 ......do Do. (3...

40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Required test FR citation Di(heptyl, nonyl, undecyl) phthalate (D711P) as a mixture of the following six substances: (1) diheptyl phthalate (branched and linear isomers), CAS No. 68515-44-6 Environmental effects. January 9, 1989. (2) dinonyl phthalate (branched and linear isomers), CAS No. 68515-45-7 ......do Do. (3...

Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing

PubMed Central

Cohn, Elizabeth Gross; Jia, Haomiao; Smith, Winifred Chapman; Erwin, Katherine; Larson, Elaine L.

2013-01-01

Purpose/Objectives To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC). Design A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality. Setting A major urban teaching hospital in the northeastern region of the United States. Sample 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters. Methods For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. Main Research Variables The essential elements of information and communication for informed consent. Findings The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting. Conclusions The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. Implications for Nursing The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it. PMID:21708532

Patient Education and Informed Consent for Preimplantation Genetic Diagnosis: Health Literacy for Genetics and Assisted Reproductive Technology

PubMed Central

McGowan, Michelle L.; Burant, Chris; Moran, Rocio; Farrell, Ruth

2013-01-01

Introduction Innovative applications of genetic testing have emerged within the field of assisted reproductive technology through preimplantation genetic diagnosis (PGD). As in all forms of genetic testing, adequate genetic counseling and informed consent are critical. Despite the growing recognition of the role of informed consent in genetic testing, there is little data available about how this process occurs in the setting of PGD. Methods A cross sectional study of IVF clinics offering PGD in the U.S. was conducted to assess patient education and informed consent practices. Descriptive data were collected with a self-administered survey instrument. Results More than half of the clinics offering PGD required genetic counseling prior to PGD (56%). Genetic counseling was typically performed by certified genetic counselors (84 %). Less than half (37%) of the clinics required a separate informed consent process for genetic testing of embryonic cells. At a majority of those clinics requiring a separate informed consent for genetic testing (54%), informed consent for PGD and genetic testing took place as a single event before beginning IVF procedures. Conclusions The results suggest that patient education and informed consent practices for PGD have yet to be standardized. These findings warrant the establishment of professional guidelines for patient education and informed consent specific to embryonic genetic testing. PMID:19652605

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

40 CFR 721.5185 - Morpholine, 4-(1-oxo-2-propenyl)-.

Code of Federal Regulations, 2010 CFR

2010-07-01

...), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(5)(xv), (a)(6)(v), (b) (concentration set at 0. 1 percent), and (c). The following material has been tested in accordance with the American Society for Testing Materials (ASTM) F739 method and found by EPA to satisfy the consent order's...

2015 Clean Air Act Vehicle and Engine Enforcement Case Resolutions

EPA Pesticide Factsheets

2015 Enforcement case resolutions such as expedited settlement agreements, administrative settlement agreements, administrative penalty orders, consent agreements and final orders, and consent decrees are listed by respondent name below.

2016 Clean Air Act Vehicle and Engine Enforcement Case Resolutions

EPA Pesticide Factsheets

2016 Enforcement case resolutions such as expedited settlement agreements, administrative settlement agreements, administrative penalty orders, consent agreements and final orders, and consent decrees are listed by respondent name below.

2018 Clean Air Act Vehicle and Engine Enforcement Case Resolutions

EPA Pesticide Factsheets

2018 Enforcement case resolutions such as expedited settlement agreements, administrative settlement agreements, administrative penalty orders, consent agreements and final orders, and consent decrees are listed by respondent name below.

2017 Clean Air Act Vehicle and Engine Enforcement Case Resolutions

EPA Pesticide Factsheets

2017 Enforcement case resolutions such as expedited settlement agreements, administrative settlement agreements, administrative penalty orders, consent agreements and final orders, and consent decrees are listed by respondent name below.

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

22 CFR 128.11 - Consent agreements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Consent agreements. 128.11 Section 128.11... § 128.11 Consent agreements. (a) The Directorate of Defense Trade Controls and the respondent may, by agreement, submit to the Administrative Law Judge a proposal for the issuance of a consent order. The...

22 CFR 128.11 - Consent agreements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Consent agreements. 128.11 Section 128.11... § 128.11 Consent agreements. (a) The Directorate of Defense Trade Controls and the respondent may, by agreement, submit to the Administrative Law Judge a proposal for the issuance of a consent order. The...

22 CFR 128.11 - Consent agreements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Consent agreements. 128.11 Section 128.11... § 128.11 Consent agreements. (a) The Directorate of Defense Trade Controls and the respondent may, by agreement, submit to the Administrative Law Judge a proposal for the issuance of a consent order. The...

40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Polytetrafluoroethylene, DCN No. 63040000018B ......do Do. Fluorotelomer-based composite substance: (1) For Paper containing three of the following chemical substances as specified in the ECA: (i) Perfluoroalkylethyl...) Perfluoroalkyl acrylate copolymer, ACC 158022 ......do Do. (iii) Perfluoroalkyl methacrylate polymer, EPA...

No Understanding, No Consent: The Case Against Alternative Medicine.

PubMed

Shahvisi, Arianne

2016-02-01

The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession. © 2016 John Wiley & Sons Ltd.

29 CFR 1921.8 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... WORKERS' COMPENSATION ACT Prehearing Procedures § 1921.8 Consent findings and order. (a) General. At any... disposing of a proceeding shall also provide: (1) That the order shall have the same force and effect as an...

Tijeras Arroyo Groundwater Current Conceptual Model and Corrective Measures Evaluation Report - December 2016.

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

Copland, John R.

This Tijeras Arroyo Groundwater Current Conceptual Model and Corrective Measures Evaluation Report (CCM/CME Report) has been prepared by the U.S. Department of Energy (DOE) and Sandia Corporation (Sandia) to meet requirements under the Sandia National Laboratories-New Mexico (SNL/NM) Compliance Order on Consent (the Consent Order). The Consent Order, entered into by the New Mexico Environment Department (NMED), DOE, and Sandia, became effective on April 29, 2004. The Consent Order identified the Tijeras Arroyo Groundwater (TAG) Area of Concern (AOC) as an area of groundwater contamination requiring further characterization and corrective action. This report presents an updated Conceptual Site Model (CSM)more » of the TAG AOC that describes the contaminant release sites, the geological and hydrogeological setting, and the distribution and migration of contaminants in the subsurface. The dataset used for this report includes the analytical results from groundwater samples collected through December 2015.« less

EPA Administrative Order on Consent (AOC) with ERP Compliant Coke, LLC

EPA Pesticide Factsheets

This Administrative Order on Consent with ERP Compliant Coke was effective August 2016. The Walter Coke facility located in North Birmingham was purchased by ERP Compliant Coke, LLC in February 2016 out of bankruptcy proceedings.

Shell Martinez Refinery, Martinez, CA: Consent Agreement and Final Order

EPA Pesticide Factsheets

Final executed Consent Agreement and Final Order (CA/FO) negotiated between EPA Region 9, and Shell Oil Products US relating to violations discovered during routine compliance evaluation inspections at the Shell Martinez Refinery in Martinez, California.

Do gifts increase consent to home-based HIV testing? A difference-in-differences study in rural KwaZulu-Natal, South Africa

PubMed Central

McGovern, Mark E; Herbst, Kobus; Tanser, Frank; Mutevedzi, Tinofa; Canning, David; Gareta, Dickman; Pillay, Deenan; Bärnighausen, Till

2016-01-01

Abstract Background: Despite the importance of HIV testing for controlling the HIV epidemic, testing rates remain low. Efforts to scale up testing coverage and frequency in hard-to-reach and at-risk populations commonly focus on home-based HIV testing. This study evaluates the effect of a gift (a US$5 food voucher for families) on consent rates for home-based HIV testing. Methods: We use data on 18 478 individuals (6 418 men and 12 060 women) who were successfully contacted to participate in the 2009 and 2010 population-based HIV surveillance carried out by the Wellcome Trust's Africa Health Research Institute in rural KwaZulu-Natal, South Africa. Of 18 478 potential participants contacted in both years, 35% (6 518) consented to test in 2009, and 41% (7 533) consented to test in 2010. Our quasi-experimental difference-in-differences approach controls for unobserved confounding in estimating the causal effect of the intervention on HIV-testing consent rates. Results: Allocation of the gift to a family in 2010 increased the probability of family members consenting to test in the same year by 25 percentage points [95% confidence interval (CI) 21–30 percentage points; P < 0.001]. The intervention effect persisted, slightly attenuated, in the year following the intervention (2011). Conclusions: In HIV hyperendemic settings, a gift can be highly effective at increasing consent rates for home-based HIV testing. Given the importance of HIV testing for treatment uptake and individual health, as well as for HIV treatment-as-prevention strategies and for monitoring the population impact of the HIV response, gifts should be considered as a supportive intervention for HIV-testing initiatives where consent rates have been low. PMID:27940483

Consent Agreement and Final Order: U.S. Army, Hawaii, Kilauea Military Camp and Pohakuloa Training Area

EPA Pesticide Factsheets

Consent Agreement and (Proposed) Final Order containing Stipulations and Findings, and Settlement Terms relating to U.S. Army, Hawaii, Kilauea Military Camp and Pohakuloa Training Area Docket No. UIC-09-2016-0001.

Anaconda Copper Mine, Yerington, NV; Proposed Settlement Agreement and Order on Consent

EPA Pesticide Factsheets

This notice announces the availability for review and comment of an administrative Settlement Agreement and Order on Consent under CERCLA between the EPA and Atlantic Richfield Company regarding the Anaconda Copper Mine Site in Yerington, Nevada.

Taylor Farms Retail Inc., Salinas, CA; Consent Agreement and Final Order

EPA Pesticide Factsheets

Consent Agreement and Final Order (Proposed CA/FO), between the U.S. Environmental Protection Agency, Region IX (EPA or Complainant), and Taylor Farms Retail Inc. (Respondent), 150 Main Street Salinas, CA 93901. Docket Number CWA-09-2018-0010

Access to special care dentistry, part 3. Consent and capacity.

PubMed

Dougall, A; Fiske, J

2008-07-26

This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

Should consent be required for organ procurement?

PubMed

Zambrano, Alexander

2018-06-08

Must we obtain a patient's consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient's prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement. © 2018 John Wiley & Sons Ltd.

78 FR 77106 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

...: Headquarters Air Force, Deputy Under Secretary of the Air Force (Space). ACTION: Publicize Consent Order... Force (Space), as the Compliance Officer under the Federal Trade Commission (FTC) Decision and Order... Under Secretary of the Air Force (Space). This position is now held by Dr. Troy Meink. [[Page 77107...

Improving the Proficiency of Research Consent Administrators.

PubMed

Larson, Elaine L; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D; Cohn, Elizabeth G

2015-08-01

To describe the development and testing of a module to improve consent administrators' skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Development and psychometric testing of video module including community vignettes. Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre- and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t-test 95% confidence interval of difference: -0.18 to -0.88; two-tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0-35), but years of experience was not significantly associated with either pre- or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. © 2015 Wiley Periodicals, Inc.

Consent Agreement and [Proposed] Final Order: N.F. Kawakami Store Ltd.

EPA Pesticide Factsheets

Consent Agreement and [Proposed] Final Order between the EPA Region 9, and N.F. Kawakami Store Ltd. to resolve a civil administrative proceeding under Sections 1423(c)(3)(B) of the Safe Drinking Water Act. Docket No. UIC-09-2018-0003.

A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy.

PubMed

Friedlander, Joel A; Loeben, Greg S; Finnegan, Patricia K; Puma, Anita E; Zhang, Xuemei; de Zoeten, Edwin F; Piccoli, David A; Mamula, Petar

2011-04-01

To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.

49 CFR 383.72 - Implied consent to alcohol testing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 5 2011-10-01 2011-10-01 false Implied consent to alcohol testing. 383.72 Section 383.72 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER... consent to alcohol testing. Any person who holds a CLP or CDL or is required to hold a CLP or CDL is...

Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

PubMed

Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

2014-09-01

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

Law & Order, CSI, and NCIS: The Association Between Exposure to Crime Drama Franchises, Rape Myth Acceptance, and Sexual Consent Negotiation Among College Students.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Lei, Ming; Ren, Chunbo; Ran, Weina

2015-01-01

Previous research has identified that exposure to the crime drama genre lowers rape myth acceptance and increases sexual assault prevention behaviors such as bystander intervention. However, recent content analyses have revealed marked differences in the portrayal of sexual violence within the top three crime drama franchises. Using a survey of 313 college freshmen, this study explores the influence of exposure to the three most popular crime drama franchises: Law & Order, CSI, and NCIS. Findings indicate that exposure to the Law & Order franchise is associated with decreased rape myth acceptance and increased intentions to adhere to expressions of sexual consent and refuse unwanted sexual activity; whereas exposure to the CSI franchise is associated with decreased intentions to seek consent and decreased intentions to adhere to expressions of sexual consent. Exposure to the NCIS franchise was associated with decreased intentions to refuse unwanted sexual activity. These results indicate that exposure to the specific content of each crime drama franchise may have differential results on sexual consent negotiation behaviors.

32 CFR 634.8 - Implied consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent... their consent to evidential tests for alcohol or other drug content of their blood, breath, or urine...

Do gifts increase consent to home-based HIV testing? A difference-in-differences study in rural KwaZulu-Natal, South Africa.

PubMed

McGovern, Mark E; Herbst, Kobus; Tanser, Frank; Mutevedzi, Tinofa; Canning, David; Gareta, Dickman; Pillay, Deenan; Bärnighausen, Till

2016-12-01

Despite the importance of HIV testing for controlling the HIV epidemic, testing rates remain low. Efforts to scale up testing coverage and frequency in hard-to-reach and at-risk populations commonly focus on home-based HIV testing. This study evaluates the effect of a gift (a US$5 food voucher for families) on consent rates for home-based HIV testing. We use data on 18 478 individuals (6 418 men and 12 060 women) who were successfully contacted to participate in the 2009 and 2010 population-based HIV surveillance carried out by the Wellcome Trust's Africa Health Research Institute in rural KwaZulu-Natal, South Africa. Of 18 478 potential participants contacted in both years, 35% (6 518) consented to test in 2009, and 41% (7 533) consented to test in 2010. Our quasi-experimental difference-in-differences approach controls for unobserved confounding in estimating the causal effect of the intervention on HIV-testing consent rates. Allocation of the gift to a family in 2010 increased the probability of family members consenting to test in the same year by 25 percentage points [95% confidence interval (CI) 21-30 percentage points; P  < 0.001]. The intervention effect persisted, slightly attenuated, in the year following the intervention (2011). In HIV hyperendemic settings, a gift can be highly effective at increasing consent rates for home-based HIV testing. Given the importance of HIV testing for treatment uptake and individual health, as well as for HIV treatment-as-prevention strategies and for monitoring the population impact of the HIV response, gifts should be considered as a supportive intervention for HIV-testing initiatives where consent rates have been low. © The Author 2016. Published by Oxford University Press on behalf of the International Epidemiological Association

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)].

29 CFR 502.40 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Consent findings and order. 502.40 Section 502.40 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF THE...

29 CFR 501.40 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Consent findings and order. 501.40 Section 501.40 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF THE...

Royal Wine Corporation d/b/a/ Royal Kedem (Herzog Wine Cellars), Oxnard, CA; Consent Agreement and Final Order

EPA Pesticide Factsheets

Consent Agreement and Final Order (Proposed CA/FO), between the U.S. Environmental Protection Agency, Region 9 (EPA or Complainant), and Royal Wine Corporation, d/b/a Royal Kedem (Herzog Wine Cellars or Respondent). Docket Number CWA-09-2018-0004.

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

PubMed

Bradbury, Angela R; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K; Churpek, Jane; Daly, Mary B; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L; Domchek, Susan M

2015-06-01

Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

Improving the Proficiency of Research Consent Administrators

PubMed Central

Larson, Elaine L.; Lally, Rachel; Foe, Gabriella; Joaquin, Gabriela; Meyer, Dodi D.; Cohn, Elizabeth G.

2015-01-01

Abstract Objective: To describe the development and testing of a module to improve consent administrators’ skills when obtaining research consent from culturally and linguistically diverse and low literacy populations. Design: Development and psychometric testing of video module including community vignettes. Methods: Following initial content, face, and construct validity testing by experts, a field trial was conducted with pre‐ and postknowledge tests and satisfaction surveys completed by 112 consent administrators. Results: Mean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t‐test 95% confidence interval of difference: –0.18 to –0.88; two‐tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0–35), but years of experience was not significantly associated with either pre‐ or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made. Conclusion: Although pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training. PMID:25676061

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

77 FR 26438 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-04

...EPA is taking direct final action to approve State Implementation Plan (SIP) revisions submitted by the Maryland Department of the Environment (MDE) pertaining to the GenOn Chalk Point Generating Station (Chalk Point). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SOX), and nitrogen oxides (NOX) from Chalk Point. These revisions also remove the 1978 and 1979 Consent Orders for the Chalk Point generating station from the Maryland SIP as those Consent Orders have been superseded by the 2011 Consent Decree. EPA is approving these SIP revisions because the reductions of PM, SOX, and NOX are beneficial for reducing ambient levels of the PM, sulfur dioxide (SO2), nitrogen dioxide (NO2) and ozone. They also reduce visible emissions from Chalk Point. This action is being taken under the Clean Air Act (CAA).

Written Informed-Consent Statutes and HIV Testing

PubMed Central

Ehrenkranz, Peter D.; Pagán, José A.; Begier, Elizabeth M.; Linas, Benjamin; Madison, Kristin; Armstrong, Katrina

2009-01-01

Background Almost 1 million Americans are infected with HIV, yet it is estimated that as many as 250,000 of them do not know their serostatus. This study examined whether people residing in states with statutes requiring written informed consent prior to HIV testing were less likely to report a recent HIV test. Methods The study is based on survey data from the 2004 Behavioral Risk Factor Surveillance System. Logistic regression was used to assess the association between residence in a state with a pre-test written informed-consent requirement and individual self-report of recent HIV testing. The regression analyses controlled for potential state- and individual-level confounders. Results Almost 17% of respondents reported that they had been tested for HIV in the prior 12 months. Ten states had statutes requiring written informed consent prior to routine HIV testing; nine of those were analyzed in this study. After adjusting for other state- and individual-level factors, people who resided in these nine states were less likely to report a recent history of HIV testing (OR=0.85; 95% CI=0.80, 0.90). The average marginal effect was −0.02 (p<0.001, 95%CI= −0.03, −0.01); thus, written informed-consent statutes are associated with a 12% reduction in HIV testing from the baseline testing level of 17%. The association between a consent requirement and lack of testing was greatest among respondents who denied HIV risk factors, were non-Hispanic whites, or who had higher levels of education. Conclusions This study’s findings suggest that the removal of written informed-consent requirements might promote the non–risk-based routine-testing approach that the CDC advocates in its new testing guidelines. PMID:19423271

78 FR 65313 - Actavis, Inc. a corporation, and Warner Chilott PLC; Analysis of Agreement Containing Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... FEDERAL TRADE COMMISSION [File No. 131 0152] Actavis, Inc. a corporation, and Warner Chilott PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment AGENCY: Federal Trade Commission... (``Consent Agreement'') from Actavis, Inc. (``Actavis'') and Warner Chilcott plc (``Warner Chilcott'') that...

40 CFR 721.10237 - Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts.

Code of Federal Regulations, 2014 CFR

2014-07-01

... ratios are as specified in the TSCA section 5(e) consent order. (B) Upon start-up of manufacture of the PMN at any new facility, conduct the American Society for Testing and Materials International (ASTM..., demonstrating that formaldehyde emissions are less than or equal to 0.04 ppm. (C) Development and implementation...

40 CFR 721.10237 - Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts.

Code of Federal Regulations, 2013 CFR

2013-07-01

... ratios are as specified in the TSCA section 5(e) consent order. (B) Upon start-up of manufacture of the PMN at any new facility, conduct the American Society for Testing and Materials International (ASTM..., demonstrating that formaldehyde emissions are less than or equal to 0.04 ppm. (C) Development and implementation...

78 FR 5207 - Certain Led Photographic Lighting Devices and Components Thereof; Commission's Final...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-24

...Notice is hereby given that the U.S. International Trade Commission has found a violation of section 337 in this investigation and has issued a general exclusion order prohibiting importation of infringing LED photographic lighting devices and components thereof. The Commission has also determined to terminate certain respondents on the basis of a consent order stipulation, and has issued a consent order.

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.

Healthcare professionals' and patients' perspectives on consent to clinical genetic testing: moving towards a more relational approach.

PubMed

Samuel, Gabrielle Natalie; Dheensa, Sandi; Farsides, Bobbie; Fenwick, Angela; Lucassen, Anneke

2017-08-08

This paper proposes a refocusing of consent for clinical genetic testing, moving away from an emphasis on autonomy and information provision, towards an emphasis on the virtues of healthcare professionals seeking consent, and the relationships they construct with their patients. We draw on focus groups with UK healthcare professionals working in the field of clinical genetics, as well as in-depth interviews with patients who have sought genetic testing in the UK's National Health Service (data collected 2013-2015). We explore two aspects of consent: first, how healthcare professionals consider the act of 'consenting' patients; and second how these professional accounts, along with the accounts of patients, deepen our understanding of the consent process. Our findings suggest that while healthcare professionals working in genetic medicine put much effort into ensuring patients' understanding about their impending genetic test, they acknowledge, and we show, that patients can still leave genetic consultations relatively uninformed. Moreover, we show how placing emphasis on the informational aspect of genetic testing is not always reflective of, or valuable to, patients' decision-making. Rather, decision-making is socially contextualised - also based on factors outside of information provision. A more collaborative on-going consent process, grounded in virtue ethics and values of honesty, openness and trustworthiness, is proposed.

78 FR 40140 - Proposed CERCLA Administrative Settlement Agreement and Order on Consent for the Mercury Refining...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-03

... and Order on Consent for the Mercury Refining Superfund Site, Towns of Guilderland and Colonie, Albany...'') pertaining to the Mercury Refining Superfund Site (``Site'') located in the Towns of Guilderland and Colonie...-1866. Comments should be sent to the individual identified below and should reference the Mercury...

77 FR 52021 - Proposed CERCLA Administrative Settlement Agreement and Order on Consent for the Mercury Refining...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... and Order on Consent for the Mercury Refining Superfund Site, Towns of Guilderland and Colonie, Albany... Management of Michigan, Inc. (hereafter ``Settling Parties'') pertaining to the Mercury Refining Superfund... Superfund Mercury Refining Superfund Site Special Account, which combined total $79,028.49. Each Settling...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

75 FR 37806 - Twitter, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... FEDERAL TRADE COMMISSION [File No. 092 3093] Twitter, Inc.; Analysis of Proposed Consent Order to... in paper form. Comments should refer to``Twitter, Inc., File No. 092 3093'' to facilitate the... weblink: ( http://public.commentworks.com/ftc/twitter ) and following the instructions on the web-based...

77 FR 66595 - U.S. Air Force Broadcast of Consent Order, and Determination of Interest Level for a United...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

...: Headquarters Air Force, Deputy Under Secretary of the Air Force (Space). ACTION: Publicize Consent Order, and... solicitation issuance. The Deputy Under Secretary of the Air Force (Space), as the Compliance Officer under the...) ULA afford all space vehicle manufacturers [[Page 66596

77 FR 25953 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the 1980...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... Promulgation of Air Quality Implementation Plans; Maryland; Removal of the 1980 Consent Order for the Maryland Slag Company AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA... issued to the Maryland Slag Company (now known as MultServ). The 1980 Consent Order is no longer required...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

29 CFR 1905.24 - Consent findings and rules or orders.

Code of Federal Regulations, 2010 CFR

2010-07-01

... findings and rules or orders. (a) General. At any time before the reception of evidence in any hearing, or... result in a just disposition of the issues involved. (b) Contents. Any agreement containing consent... accordance with the agreement. (c) Submission. On or before the expiration of the time granted for...

30 CFR 44.27 - Consent findings and rules or orders.

Code of Federal Regulations, 2010 CFR

2010-07-01

... STANDARDS Hearings § 44.27 Consent findings and rules or orders. (a) General. At any time after a request..., representations of the parties, and probability of an agreement which will result in a just disposition of the... time granted for negotiations, the parties or their counsel may: (1) Submit the proposed agreement to...

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...

29 CFR 801.66 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 3 2010-07-01 2010-07-01 false Consent findings and order. 801.66 Section 801.66 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR OTHER LAWS APPLICATION... Administrative Law Judge; and (4) A waiver of any right to challenge or contest the validity of the findings and...

29 CFR 500.232 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Administrative Law Judge; and (4) A waiver of any right to challenge or contest the validity of the findings and... 29 Labor 3 2010-07-01 2010-07-01 false Consent findings and order. 500.232 Section 500.232 Labor Regulations Relating to Labor (Continued) WAGE AND HOUR DIVISION, DEPARTMENT OF LABOR REGULATIONS MIGRANT AND...

77 FR 1491 - Sigma Corporation; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-10

... FEDERAL TRADE COMMISSION [File No. 101 0080] Sigma Corporation; Analysis of Proposed Consent Order... instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Sigma.... Write ``Sigma, File No. 101 0080'' on your comment. Your comment--including your name and your state...

Information and consent in internet paternity testing: focus on minors' protection in Italy.

PubMed

Caenazzo, Luciana; Tozzo, Pamela; Benciolini, Paolo; Rodriguez, Daniele

2008-12-01

Paternity testing in Italy is usually performed by private laboratories and universities having direct contacts with the applicants. Recently, the number of paternity tests offered through laboratory websites has increased in Italy and Europe. The execution of genetic tests, including paternity testing based on DNA analysis, represents a complex act, which contains three main steps. Paternity analyses carried out by laboratories via Internet are performed on samples collected by the applicants and then mailed back to the laboratories without any patient-physician relationship. Information is given to the subjects through the laboratory's website or mailed with the test order form. The execution of "household" DNA analysis without technical precautions may provide an incorrect response with severe consequences on the individual who has undergone testing, on the family involved, and on society in general. The problems connected with this kind of analysis are not technical, but ethical and deontological. In this work, we will discuss the problems related to information and consent by way of outlining the relevant Italian laws and codes of medical ethics. The Italian Privacy's Guarantor is assessing the ethical and legal implications, but regulations are not yet in place. We believe that adequate information related to this practice cannot be given via Internet, and, consequently, the validity of the consent expressed during this kind of procedure can be uncertain. Further, we will analyze issues regarding the importance of minors' protection when a paternity test is performed via Internet. In our opinion, the complexity of the situations and expectations linked to paternity investigations require a special sensitivity in dealing with each case, based on a patient-physician relationship in the decision-making process especially referring to the defense of the minors' well-being.

Testing an online, dynamic consent portal for large population biobank research.

PubMed

Thiel, Daniel B; Platt, Jodyn; Platt, Tevah; King, Susan B; Fisher, Nicole; Shelton, Robert; Kardia, Sharon L R

2015-01-01

Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research. Working with Private Access Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health. Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online. Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge. © 2014 S. Karger AG, Basel.

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.

40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

Code of Federal Regulations, 2010 CFR

2010-07-01

...-64-1 Acetone Health effects January 23, 1995. 71-55-6 1,1,1-Trichloroethane Health effects August 23, 1989. 78-83-1 Isobutyl alcohol Health effects January 23, 1995. 79-10-7 Acrylic Acid Health effects... Health effects September 23, 1991. Chemical fate September 23, 1991. 106-91-2 Glycidyl methacrylate...

40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

Code of Federal Regulations, 2011 CFR

2011-07-01

...-64-1 Acetone Health effects January 23, 1995. 71-55-6 1,1,1-Trichloroethane Health effects August 23, 1989. 78-83-1 Isobutyl alcohol Health effects January 23, 1995. 79-10-7 Acrylic Acid Health effects... Health effects September 23, 1991. Chemical fate September 23, 1991. 106-91-2 Glycidyl methacrylate...

40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... March 4, 1992. 84-74-2 Di-n-butyl phthalate Environmental effects January 9, 1989. 84-75-3 Di-n-hexyl phthalate Environmental effects January 9, 1989. Chemical fate January 9, 1989. 100-40-3 4-Vinylcyclohexene...-ethylhexyl phthalate Chemical fate January 9, 1989. 119-06-2 Ditridecyl phthalate Chemical fate January 9...

40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... March 4, 1992. 84-74-2 Di-n-butyl phthalate Environmental effects January 9, 1989. 84-75-3 Di-n-hexyl phthalate Environmental effects January 9, 1989. Chemical fate January 9, 1989. 100-40-3 4-Vinylcyclohexene...-ethylhexyl phthalate Chemical fate January 9, 1989. 119-06-2 Ditridecyl phthalate Chemical fate January 9...

40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Environmental Releases Report November 18, 1994. 112-35-6 Triethylene glycol monomethyl ether Health effects... Health effects November 23, 1993. 994-05-8 Tertiary-amyl methyl ether Health effects March 21, 1995. 1634-04-4 Methyl tert-butyl ether Health effects March 31, 1988. 2461-18-9 Lauryl glycidyl ether 1 Health...

77 FR 73655 - Epic Marketplace, Inc., and Epic Media Group, LLC; Analysis of Proposed Consent Order To Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-11

... prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to...; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed... period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the...

77 FR 25901 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the 1980...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... Promulgation of Air Quality Implementation Plans; Maryland; Removal of the 1980 Consent Order for the Maryland... Consent Order is no longer required to satisfy any applicable Federal regulations and the Clean Air Act... Science, Air Protection Division, Mailcode 3AP00, U.S. Environmental Protection Agency, Region III, 1650...

30 CFR 44.27 - Consent findings and rules or orders.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., representations of the parties, and probability of an agreement which will result in a just disposition of the... STANDARDS Hearings § 44.27 Consent findings and rules or orders. (a) General. At any time after a request for hearing is filed in accordance with § 44.14, a reasonable opportunity may be afforded to permit...

42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 2.62 Section 2.62 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT...

42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 2.62 Section 2.62 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT...

42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 2.62 Section 2.62 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT...

42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Order not applicable to records disclosed without consent to researchers, auditors and evaluators. 2.62 Section 2.62 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT...

77 FR 50508 - Brain-Pad, Inc; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-21

... FEDERAL TRADE COMMISSION [File No. 122 3073] Brain-Pad, Inc; Analysis of Proposed Consent Order To... instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Brain-Pad... September 17, 2012. Write ``Brain-Pad, File No. 122 3073'' on your comment. Your comment--including your...

75 FR 65380 - In the Matter of Certain Lighting Products; Notice of Commission Decision Not To Review an...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-22

...Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's initial determination (Order No. 7) granting a joint motion to terminate the sole respondent in the above-captioned investigation on the basis of a settlement agreement and a proposed consent order. The Commission has issued the subject consent order. The investigation is terminated.

Approaches to informed consent for hypothesis-testing and hypothesis-generating clinical genomics research.

PubMed

Facio, Flavia M; Sapp, Julie C; Linn, Amy; Biesecker, Leslie G

2012-10-10

Massively-parallel sequencing (MPS) technologies create challenges for informed consent of research participants given the enormous scale of the data and the wide range of potential results. We propose that the consent process in these studies be based on whether they use MPS to test a hypothesis or to generate hypotheses. To demonstrate the differences in these approaches to informed consent, we describe the consent processes for two MPS studies. The purpose of our hypothesis-testing study is to elucidate the etiology of rare phenotypes using MPS. The purpose of our hypothesis-generating study is to test the feasibility of using MPS to generate clinical hypotheses, and to approach the return of results as an experimental manipulation. Issues to consider in both designs include: volume and nature of the potential results, primary versus secondary results, return of individual results, duty to warn, length of interaction, target population, and privacy and confidentiality. The categorization of MPS studies as hypothesis-testing versus hypothesis-generating can help to clarify the issue of so-called incidental or secondary results for the consent process, and aid the communication of the research goals to study participants.

Direct-to-Consumer Genetic Testing: Helping Patients Make Informed Choices
.

PubMed

Mahon, Suzanne M

2018-02-01

Using direct-to-consumer genetic testing (DTCGT), individuals can order a genetic test, collect and submit a saliva sample, and obtain results about their genetic risk for a variety of traits and health conditions without involving a healthcare provider. Potential benefits of DTCGT include personal control over genetic information and health management decisions, whereas potential risks include misinterpretation of results, psychosocial distress, and lack of informed consent. Oncology nurses can provide education, support, and advocacy to enable patients to truly understand the positives and negatives associated with DTCGT.
.

Educating anesthesia residents to obtain and document informed consent for epidural labor analgesia: does simulation play a role?

PubMed

Antoniou, A; Marmai, K; Qasem, F; Cherry, R; Jones, P M; Singh, S

2018-05-01

Informed consent is required before placing an epidural. At our hospital, teaching of residents about this is done informally at the bedside. This study aimed to assess the ability of anesthesia residents to acquire and retain knowledge required when seeking informed consent for epidural labor analgesia. It assessed how well this knowledge was translated to clinical ability, by assessing the verbal consent process during an interaction with a standardized patient. Twenty anesthesia residents were randomized to a 'didactic group' or a 'simulation group'. Each resident was presented with a written scenario and asked to document the informed consent process, as they normally would do (pre-test). The didactic group then had a presentation about informed consent, while the simulation group members interviewed a simulated patient, the scenarios focusing on different aspects of consent. All residents then read a scenario and documented their informed consent process (post-test). Six weeks later all residents interviewed a standardized patient in labor and documented the consent from this interaction (six-week test). There was no significant difference in the baseline performance of the two groups. Both groups showed significant improvement in their written consent documentation at the immediate time point, the improvement in the didactic group being greater. The didactic group performed better at both the immediate time point and the six-week time point. In this small study, a didactic teaching method proved better than simulation-based teaching in helping residents to gain knowledge needed to obtain informed consent for epidural labor analgesia. Copyright © 2017 Elsevier Ltd. All rights reserved.

The impact of parental consent on the HIV testing of minors.

PubMed

Meehan, T M; Hansen, H; Klein, W C

1997-08-01

This investigation assessed change in use of human immunodeficiency virus (HIV) testing by minors after removal of the parental consent requirement in Connecticut. HIV counseling and testing records for 13- to 17-year-olds who accessed publicly funded testing sites were analyzed. The number of visits increased by 44% from the 12-month period before the statutory change (n = 656) to the 12-month period thereafter (n = 965). The number of HIV tests increased twofold. Visits and tests of high-risk minors tripled. Minors should have the right to consent to HIV testing.

The impact of parental consent on the HIV testing of minors.

PubMed Central

Meehan, T M; Hansen, H; Klein, W C

1997-01-01

OBJECTIVES: This investigation assessed change in use of human immunodeficiency virus (HIV) testing by minors after removal of the parental consent requirement in Connecticut. METHODS: HIV counseling and testing records for 13- to 17-year-olds who accessed publicly funded testing sites were analyzed. RESULTS: The number of visits increased by 44% from the 12-month period before the statutory change (n = 656) to the 12-month period thereafter (n = 965). The number of HIV tests increased twofold. Visits and tests of high-risk minors tripled. CONCLUSIONS: Minors should have the right to consent to HIV testing. PMID:9279271

Securing recruitment and obtaining informed consent in minority ethnic groups in the UK.

PubMed

Lloyd, Cathy E; Johnson, Mark R D; Mughal, Shanaz; Sturt, Jackie A; Collins, Gary S; Roy, Tapash; Bibi, Rukhsana; Barnett, Anthony H

2008-03-30

Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1) our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2) the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation rates.

76 FR 71564 - ScanScout, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-18

... deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment... FEDERAL TRADE COMMISSION [File No. 102 3185] ScanScout, Inc.; Analysis of Proposed Consent Order... Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec. 2.34 the Commission Rules of Practice, 16...

77 FR 35389 - EPN, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the... FEDERAL TRADE COMMISSION [File No. 112 3143] EPN, Inc.; Analysis of Proposed Consent Order to Aid.... 721, 15 U.S.C. 46(f), and Sec. 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby...

76 FR 81929 - San Fernando Valley Area 2; Notice of Proposed Administrative Order on Consent Re: 4057 and 4059...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-29

... the Trust on ability to pay grounds. Under the Agreement, the Trust will pay $1500 (one thousand five... notice of a proposed administrative order on consent (Agreement)with the Spirito Family Trust and Alice C...: EPA will receive written comments relating to the settlement until January 30, 2012. EPA will consider...

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

Gaining informed consent for blood transfusion.

PubMed

Whitmore, Emma; Gerrard, Rebecca; Coffey, Kairen

Transfusion of blood and blood products is a common procedure that has significant benefits but is also associated with serious risks. Patients needing blood transfusion require full information on these benefits and risks in order to make informed consent. This article, the first in a five-part series, discusses the process of gaining consent and resources available to support patients and health professionals in this.

The Court versus Consent Decrees? Schools, "Horne v. Flores" and Judicial Strategies of Institutional Reform Litigation

ERIC Educational Resources Information Center

Chilton, Bradley; Chwialkowski, Paul

2014-01-01

Is the U.S. Supreme Court inviting litigants to take aim at unraveling injunctions in institutional reform litigation--especially consent decrees in the schools? In "Horne v. Flores" (2009), the court remanded a 17-year-old school reform case to a federal judge with orders to look beyond consent decrees on financing, reducing class…

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.

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2013 CFR

2013-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2011 CFR

2011-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2014 CFR

2014-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2010 CFR

2010-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

40 CFR 721.6479 - Tetrahydroheteropolycycle (generic).

Code of Federal Regulations, 2012 CFR

2012-07-01

... listed in the TSCA section 5(e) consent order for this substance. The NCEL is 1.0 ug/m3 as an 8-hour time.... Requirements as specified in § 721.63 (a)(1)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii) (if no data on cartridge service life testing has been reviewed and approved by EPA), (a)(5)(xii) (if data on cartridge service...

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.

Consent-based access to core EHR information. Collaborative approaches in Norway.

PubMed

Heimly, Vigdis; Berntsen, Kirsti E

2009-01-01

Lack of access to updated drug information is a challenge for healthcare providers in Norway. Drug charts are updated in separate EHR systems but exchange of drug information between them is lacking. In order to provide ready access to updated medication information, a project for consent-based access to a core EHR has been established. End users have developed requirements for additions to the medication modules in the EHR systems in cooperation with vendors, researchers and standardization workers. The modules are then implemented by the vendors, tested in the usability lab, and finally tested by the national testing and approval service before implementation. An ethnographic study, with focus on future users and their interaction with other actors regarding medicines and medication, has included semi-/unstructured interviews with the involved organizational units. The core EHR uses the EHR kept by the patient's regular GP as the main source of information. A server-based solution has been chosen in order to keep the core EHR accessible outside the GP's regular work hours. The core EHR is being tested, and the EHR-vendors are implementing additions to their systems in order to facilitate communication with the core EHR. All major EHR-system vendors in Norway participate in the project. The core EHR provides a generic basis that may be used as a pilot for a national patient summary. Examples of a wider use of the core EHR can be: shared individual plans to support continuity of care, summary of the patient's contacts with health providers in different organizations, and core EHR information such as important diagnoses, allergies and contact information. Extensive electronic cooperation and communication requires that all partners adjust their documentation practices to fit with other actors' needs. The implementation effects on future work practices will be followed by researchers.

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.

40 CFR Appendix A to Subpart E of... - Schedule for Developing Consent Agreements and Test Rules

Code of Federal Regulations, 2010 CFR

2010-07-01

... calculated from the date EPA receives the ITC report recommending a chemical for testing. Week Consent... Advance Notice of Proposed Rulemaking (ANPR) where the testing recommendations of the ITC raise unusually...

The extent of surgical patients' understanding.

PubMed

Pugliese, Omar Talhouk; Solari, Juan Lombardi; Ferreres, Alberto R

2014-07-01

The notion that consent to surgery must be informed implies not only that information should be provided by the surgeon but also that the information should be understood by the patient in order to give a foundation to his or her decision to accept or refuse treatment and thus, achieve autonomy for the patient. Nonetheless, this seems to be an idyllic situation, since most patients do not fully understand the facts offered and thus the process of surgical informed consent, as well as the patient's autonomy, may be jeopardized. Informed consent does not always mean rational consent.

Ethical considerations in genomic testing for hematologic disorders.

PubMed

Marron, Jonathan M; Joffe, Steven

2017-07-27

As our technological capacities improve, genomic testing is increasingly integrating into patient care. The field of clinical hematology is no exception. Genomic testing carries great promise, but several ethical issues must be considered whenever such testing is performed. This review addresses these ethical considerations, including issues surrounding informed consent and the uncertainty of the results of genomic testing; the challenge of incidental findings; and possible inequities in access to and benefit from such testing. Genomic testing is likely to transform the practice of both benign and malignant hematology, but clinicians must carefully consider these core ethical issues in order to make the most of this exciting and evolving technology. © 2017 by The American Society of Hematology.

The Least Bad Option: Unilateral Extubation after Declaration of Death by Neurological Criteria.

PubMed

Bliss, Sally E; Macauley, Robert C

2015-01-01

Typically, the determination of death by neurological criteria follows a very specific protocol. An apnea test is performed with further confirmation as necessary, and then mechanical ventilation is withdrawn with the consent of the family after they have had an opportunity to "say goodbye," and at such a time to permit organ retrieval (with authorization of the patient or consent of the next of kin). Such a process maximizes transparency and ensures generalizability. In exceptional circumstances, however, it may be necessary to deviate from this protocol in order to spare family members unnecessary suffering and to reduce moral distress felt by clinical staff. It may also be appropriate, we argue, to refrain from even inquiring about organ donation when the next-of-kin is not only certain to refuse, but lacks the decision-making capacity to potentially consent. The case described in this article calls into question generally reliable assumptions about determination of death by neurological criteria, where the best the clinical team could do for the patient and his family was "the least bad option." Copyright 2015 The Journal of Clinical Ethics. All rights reserved.

Informed consent for blood tests in people with a learning disability.

PubMed

Goldsmith, Lesley; Woodward, Val; Jackson, Leigh; Skirton, Heather

2013-09-01

This article is a report of a study of informed consent in people with a learning disability. The aims of the study were to explore the information needs of people with mild-to-moderate learning disabilities with respect to consent for blood tests and to identify ways of facilitating informed consent. The recent political agenda for social change in the UK has emphasized the right of people with a learning disability to have more autonomy and make their own decisions. As in other countries, there has also been a shift towards shared decision-making in healthcare practice. Qualitative study using an ethnographic approach. An ethnographic approach was used for this qualitative study. Phase 1 involved observation of six participants with a learning disability having a routine blood test in general practice, followed by semi-structured interviews with 14 participants with a learning disability in Phase 2. Data were collected between February 2009-February 2010. The data showed that consent procedures were often inadequate and provision of information to patients prior to a blood test was variable. People with a learning disability expressed clearly their information requirements when having a routine blood test; this included not wanting any information in some cases. Healthcare practitioners and people with a learning disability need to be familiar with current consent law in their own country to facilitate valid consent in the healthcare context. This study demonstrated the value of qualitative research in exploring the knowledge and attitudes of people with learning disability. © 2012 Blackwell Publishing Ltd.

32 CFR 634.8 - Implied consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... to blood, breath, or urine tests. Persons who drive on the installation shall be deemed to have given their consent to evidential tests for alcohol or other drug content of their blood, breath, or urine...

Implementing Routine HIV Testing: The Role of State Law

PubMed Central

Wolf, Leslie E.; Donoghoe, Alexis; Lane, Tim

2007-01-01

In September 2006, the Centers for Disease Control and Prevention (CDC) recommended routine HIV testing for all Americans aged 13–64, which would eliminate requirements for written consent and pretest counseling as previously required. However, this approach may conflict with state requirements concerning pretest counseling and informed consent for HIV testing. Our survey of state HIV testing laws demonstrates that the majority of states have HIV testing requirements that are inconsistent with the CDC's recommendations. Moreover, states that have recently amended their laws have not eased the requirements for pretest counseling and informed consent. The reasons for the persistence of these legal requirements must be understood to effect policy changes to increase HIV testing. PMID:17925853

78 FR 27258 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... of the proposed Consent Decree upon written request and payment of reproduction costs. Please mail... 20044- 7611. Please enclose a check or money order for $9.75 (25 cents per page reproduction cost...

78 FR 70321 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... of the consent decree upon written request and payment of reproduction costs. Please mail your.... Please enclose a check or money order for $25.50 (25 cents per page reproduction cost) payable to the...

78 FR 55756 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

... of the consent decree upon written request and payment of reproduction costs. Please mail your.... Please enclose a check or money order for $27.50 (25 cents per page reproduction cost) payable to the...

78 FR 41953 - Notice of Lodging of Proposed Consent Decree under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-12

... a paper copy of the consent decree upon written request and payment of reproduction costs. Please... 20044-7611. Please enclose a check or money order for $13.00 (25 cents per page reproduction cost...

77 FR 61640 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-10

... consent decree upon written request and payment of reproduction costs. Please mail your request and... enclose a check or money order for $9.50 (25 cents per page reproduction cost) payable to the United...

Child consent and the law: an insight and discussion into the law relating to consent and competence.

PubMed

Parekh, S A

2007-01-01

The law governing consent for children is not very clear. A child can consent to treatment but usually in practice is unable to refuse it. Even if both the child and parents refuse treatment, courts are reluctant to accept this, particularly if it is in the best interest of the child. In order to consent to treatment, a child must be competent enough to do so, and this competence is judged usually by a doctor. Children can even consent to contraceptives and abortion if 'competent' to do so. This concept perfectly lacks moral, ethical and emotional competence, and judgement of competence is carried out usually purely scientifically by pure science-orientated objective professionals like doctors. A broad discussion about the issues of children refusing treatment is conducted from the legal, ethical and philosophical point of view. Life-saving treatment and various other cases are also discussed. There is no right answer to the question. A more holistic approach is needed, and not only doctors but also sociologists, care specialists and even clergymen should be asked to judge competence in a multidisciplinary environment, particularly for contraceptives and abortion. This multidisciplinary working can be extended to other areas in medical law as well particularly in light of changes in medicine. Experience in life should be valued in a decision-making environment for judging competence. The law in relation to child consent is unclear and requires changes in order to clarify what is perceived as the child's best interest.

A Pilot Study of Simple Interventions to Improve Informed Consent in Clinical Research: Feasibility, Approach, and Results

PubMed Central

Kass, Nancy; Taylor, Holly; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2014-01-01

Background Informed consent is intended to ensure that individuals understand the purpose, risks, and benefits of research studies, and then can decide, voluntarily, whether to enroll. However, research suggests that consent procedures do not always lead to adequate participant understanding and may be longer and more complex than necessary. Studies also suggest some consent interventions, including enhanced consent forms and extended discussions with patients, increase understanding, yet methodologic challenges have been raised in studying consent in actual trial settings. This study aimed to examine the feasibility of testing two consent interventions in actual studies and also to measure effectiveness of interventions in improving understanding of trials. Methods Participants enrolling in any of eight ongoing clinical trials (“collaborating studies”) were, for the purposes of this study, sequentially assigned to one of three study arms involving different informed consent procedures (one control and two intervention). Control participants received standard consent form and processes. Participants in the 1st intervention arm received a bulleted fact-sheet providing simple summaries of all study components in addition to the standard consent form. Participants in the 2nd intervention arm received the bulleted fact-sheet and standard consent materials and then also engaged with a member of the collaborating study staff in a feedback Q&A session. Following consent procedures, we administered closed and open ended questions to assess patient understanding and we assessed literacy level. Descriptive statistics, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of patient understanding. Results 144 participants enrolled. Using regression analysis participants receiving the 2nd intervention, which included a standard consent form, bulleted fact sheet and structured question and answer session with a study staff member, had open-ended question scores that were 7.6 percentage points higher (p=.02) than participants who received the control arm (standard consent only), although unadjusted comparisons did not reach statistical significance. Eleven clinical trial investigators agreed to participate and 8 trials provided sufficient data to be included, thereby demonstrating feasibility of consent research in actual settings. Conclusions Our study supports the hypothesis that patients receiving both bulleted fact sheets and a question and answer session have higher understanding compared to patients receiving standard consent form and procedures alone. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples for effectiveness. PMID:25475879

78 FR 24778 - Notice of Lodging of Proposed Consent Decree Under the Resource Conservation and Recovery Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail... 20044-7611. Please enclose a check or money order for $5.25 (25 cents per page reproduction cost...

78 FR 42547 - Notice of Lodging of Proposed Consent Decree under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... . We will provide a paper copy of the Consent Decree upon written request and payment of reproduction..., Washington, DC 20044-7611. Please enclose a check or money order for $12.25 (25 cents per page reproduction...

77 FR 71449 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-30

... provide a paper copy of the consent decree upon written request and payment of reproduction costs. Please... 20044-7611. Please enclose a check or money order for $4.25 (25 cents per page reproduction cost...

77 FR 70811 - Notice of Lodging of Proposed Consent Decree Under the Formerly Utilized Sites Remedial Action...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-27

... Consent Decree upon written request and payment of reproduction costs. Please mail your request and... enclose a check or money order for $6.00 (25 cents per page reproduction cost) payable to the United...

16 CFR 1118.20 - Procedures for consent order agreements.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1118.20 Section 1118.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INVESTIGATIONS, INSPECTIONS AND INQUIRIES UNDER THE CONSUMER PRODUCT SAFETY ACT... Commission's regulations relating to substantial product hazards (16 CFR part 1115). For all other consent...

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

Dotson, Patrick Wells

Sandia National Laboratories is a multi-purpose engineering and science laboratory owned by the U.S. Department of Energy (DOE)/National Nuclear Security Administration and managed and operated by Sandia Corporation (Sandia), a wholly-owned subsidiary of Lockheed Martin Corporation. This Solid Waste Management Unit (SWMU) Assessment Report (SAR) for the Sandia National Laboratories, New Mexico (SNL/NM), Coyote Test Field, Building 9960 Surface Discharge, has been prepared in accordance with Section V of the Compliance Order on Consent (the Consent Order) between the New Mexico Environment Department (NMED), DOE, and Sandia (NMED April 2004). The DOE and Sandia formally notified the NMED of thismore » newly identified or suspected SWMU or Area of Concern (AOC) by letter dated December 9, 2014. This SAR is being submitted in accordance with the NMED Hazardous Waste Bureau (HWB) letter dated February 16, 2015 letter (Kieling February 2015). This SAR presents the available information for the Building 9960 Surface Discharge, including location, designation of type and function, a general description, the operational dates, waste characteristics, and a summary of existing analytical wastewater and soil data« less

Testing with feedback improves recall of information in informed consent: A proof of concept study.

PubMed

Roberts, Katherine J; Revenson, Tracey A; Urken, Mark L; Fleszar, Sara; Cipollina, Rebecca; Rowe, Meghan E; Reis, Laura L Dos; Lepore, Stephen J

2016-08-01

This study investigates whether applying educational testing approaches to an informed consent video for a medical procedure can lead to greater recall of the information presented. Undergraduate students (n=120) were randomly assigned to watch a 20-min video on informed consent under one of three conditions: 1) tested using multiple-choice knowledge questions and provided with feedback on their answers after each 5-min segment; 2) tested with multiple choice knowledge questions but not provided feedback after each segment; or 3) watched the video without knowledge testing. Participants who were tested and provided feedback had significantly greater information recall compared to those who were tested but not provided feedback and to those not tested. The effect of condition was stronger for moderately difficult questions versus easy questions. Inserting knowledge tests and providing feedback about the responses at timed intervals in videos can be effective in improving recall of information. Providing informed consent information through a video not only standardizes the material, but using testing with feedback inserted within the video has the potential to increase recall and retention of this material. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A Medical Area Network of Virtual Technology (MANVT)

DTIC Science & Technology

2011-10-01

translational research projects be captured, undergo quality control and are stored/managed in such a way that they can be mined to test and generate new...translational research is that access to detailed clinical data typically requires proper informed consent and IRB approval; however, in order to design ...attributes of interest at an early stage of the process. 12B2 overcomes these challenges by enabling researchers to design and execute queries

78 FR 63494 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act and the Emergency Planning...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail... 20044-7611. Please enclose a check or money order for $7.50 (25 cents per page reproduction cost...

78 FR 35315 - Notice of Lodging of Proposed Third Amendment to Consent Decree Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

... to 2006 Consent Decree upon written request and payment of reproduction costs. Please mail your.... Please enclose a check or money order for $3.50 (25 cents per page reproduction cost) payable to the...

When Can the Child Speak for Herself? The Limits of Parental Consent in Data Protection Law for Health Research.

PubMed

Taylor, Mark J; Dove, Edward S; Laurie, Graeme; Townend, David

2017-11-13

Draft regulatory guidance suggests that if the processing of a child's personal data begins with the consent of a parent, then there is a need to find and defend an enduring consent through the child's growing capacity and on to their maturity. We consider the implications for health research of the UK Information Commissioner's Office's (ICO) suggestion that the relevant test for maturity is the Gillick test, originally developed in the context of medical treatment. Noting the significance of the welfare principle to this test, we examine the implications for the responsibilities of a parent to act as proxy for their child. We argue, contrary to draft ICO guidance, that a data controller might legitimately continue to rely upon parental consent as a legal basis for processing after a child is old enough to provide her own consent. Nevertheless, we conclude that data controllers should develop strategies to seek fresh consent from children as soon as practicable after the data controller has reason to believe they are mature enough to consent independently. Techniques for effective communication, recommended to address challenges associated with Big Data analytics, might have a role here in addressing the dynamic relationship between data subject and processing. Ultimately, we suggest that fair and lawful processing of a child's data will be dependent upon data controllers taking seriously the truism that consent is ongoing, rather than a one-time event: the core associated responsibility is to continue to communicate with a data subject regarding the processing of personal data. © The Author 2017. Published by Oxford University Press.

Routine screening: informed consent, stigma and the waning of HIV exceptionalism.

PubMed

Wynia, Matthew K

2006-01-01

The Centers for Disease Control and Prevention (CDC) recently recommended that HIV screening should become routine for all adults in the United States. Implicit in the CDC proposal is the notion that pre-test counseling would be more limited than at present, and that written informed consent to screening would no longer be required. If widely implemented, routine testing would mark a tremendous shift in the US HIV screening strategy. There are a number of considerations used to determine what screening tests should be routine, and HIV fits the bill in almost every regard. Yet the stigma associated with HIV infection remains, making the CDC's recommendation highly controversial. Will minimizing requirements for pre-test counseling and special written informed consent lead to unexpected or unwanted HIV testing, or do these stringent counseling and consent requirements needlessly scare people away? Will widespread and routine testing be associated with declining stigmatization, or will it drive some patients away from seeking desperately needed health care? These are high stakes questions, and we're about to find out the answers.

HIV and the epidemiologist.

PubMed

Gillett, G

1989-11-18

The need for reliable epidemiological data on HIV seropositivity rates in a general population appears to conflict with the ethical requirement that consent be obtained from persons whose blood is screened for HIV antibodies. Gillet contends that informed consent is not necessary for epidemiological screening since there is no reason to link blood samples and test results with identifiable individuals. He argues that it is ethical to test blood drawn from hospital patients who have given a very general and "non-informative sort of consent" that their blood can be used anonymously for research. Even this degree of consent may be unnecessary since it would be impossible to trace an HIV positive anonymous blood sample to its source. Gillet also argues that this method of obtaining samples relieves epidemiologists of the obligation to notify individuals whose blood tests positive for HIV.

A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

PubMed

Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

2015-01-01

In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

76 FR 9610 - Notice of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... pollution control technology; undertake periodic equipment testing; and to submit required reports. The... DEPARTMENT OF JUSTICE Notice of Proposed Consent Decree Under the Clean Air Act Notice is hereby... the Eastern District of California. The Consent Decree in this Clean Air Act enforcement action...

CLOSURE REPORT FOR CORRECTIVE ACTION UNIT 204: STORAGE BUNKERS, NEVADA TEST SITE, NEVADA

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

NONE

Corrective Action Unit (CAU) 330 consists of four Corrective Action Sites (CASs) located in Areas 6, 22, and 23 of the Nevada Test Site (NTS). The unit is listed in the Federal Facility Agreement and Consent Order (FFACO, 1996) as CAU 330: Areas 6, 22, and 23 Tanks and Spill Sites. CAU 330 consists of the following CASs: CAS 06-02-04, Underground Storage Tank (UST) and Piping CAS 22-99-06, Fuel Spill CAS 23-01-02, Large Aboveground Storage Tank (AST) Farm CAS 23-25-05, Asphalt Oil Spill/Tar Release

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk.

PubMed

Iltis, Ana

2006-08-01

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.

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.

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

PubMed

Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2015-02-01

Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

Mapping public policy on genetics.

PubMed

Weisfeld, N E

2002-06-01

The mapping of the human genome and related advances in genetics are stimulating the development of public policies on genetics. Certain notions that currently prevail in public policy development overall--including the importance of protecting privacy of information, an interest in cost-effectiveness, and the power of the anecdote--will help determine the future of public policy on genetics. Information areas affected include discrimination by insurers and employers, confidentiality, genetic databanks, genetic testing in law enforcement, and court-ordered genetic testing in civil cases. Service issues address clinical standards, insurance benefits, allocation of resources, and screening of populations at risk. Supply issues encompass funding of research and clinical positions. Likely government actions include, among others: (1) Requiring individual consent for the disclosure of personal information, except when such consent would impose inordinate costs; (2) licensing genetic databases; (3) allowing courts to use personal information in cases where a refusal to use such information would offend the public; (4) mandating health insurers to pay for cost-effective genetic services; (5) funding pharmaceutical research to develop tailored products to prevent or treat diseases; and (6) funding training programs.

HIV pre-test practices: an online survey examining perceptions of informed consent and pre-test information delivery in health care settings across the WHO European Region.

PubMed

Bell, Stephen; Casabona, Jordi; Tsereteli, Nino; Raben, Dorthe; de Wit, John

2017-05-01

The objective of this study was to gather health professionals' perceptions about gaining informed consent and delivering HIV pre-test information. An online self-report survey was completed by 338 respondents involved in HIV testing in 55 countries in the WHO European Region. Nearly two thirds (61.5%) of respondents thought that HIV testing guidelines used in their country of work included recommendations about pre-test information; 83% thought they included recommendations regarding obtaining informed consent. One third (34%) of respondents thought that written informed consent was required; respondents from Eastern Europe and Central Asia were more likely to perceive this as required. Respondents from Western Europe thought pre-test information about the following aspects was significantly less likely to be addressed than respondents in other regions: the right to decline a test; services available after a positive test; laws/regulations impacting someone being tested and receiving a positive test result; potential risks for a client taking an HIV test; the possible need for partner notification after a positive test result. Results offer insight into perceived HIV pre-test practices in all but two national settings across the WHO European Region, and can be used in the development and evaluation of future HIV testing guidelines in the WHO European Region. Findings highlight that practices of obtaining written informed consent depart from current guidelines in some HIV testing settings. Furthermore, findings underscore that it is uncommon for pre-test information to address legal and social risks and harms that people testing HIV-positive may incur. This differs from the most recent global WHO guidelines emphasising the importance of such information, and raises important questions regarding the implications and appropriateness of the currently dominant focus of recommendations on streamlining the HIV testing process.

Assessing chronic stroke survivors with aphasia sheds light on prevalence of spatial neglect

PubMed Central

Hreha, Kimberly; Mulry, Claire; Gross, Melissa; Jedziniak, Tarah; Gramas, Natanya; Ohevshalom, Leora; Sheridan, Alisha; Szabo, Gretchen; Davison, Christina; Barrett, A. M.

2016-01-01

Background Stroke is a chronic disease. Standardized assessment is essential in order to determine areas for treatment. Individuals with aphasia are often excluded from research, because it is believed that their language impairments may impact their ability to provide informed consent. Thus, right spatial neglect could be under-diagnosed. Objective This study was developed to (1) determine the frequency of spatial neglect in chronic left-brain stroke survivors with aphasia, (2) determine the clinical utility of an aphasia-friendly consent form, and (3) determine any differences between neglect and no-neglect groups regarding activities of daily living (ADL) performance and community independence. Methods Forty-six people were consented at community center. Three were screen failures secondary to the exclusion criteria. A novel, aphasia-friendly consent form was developed to facilitate participation of individuals with aphasia. This enabled 93% or 40 out of the 43 recruited participants to be included in this study. The Behavioral Inattention Test-conventional and the Catherine Bergego Scale via Kessler Foundation Neglect Assessment Process (CBS via KF-NAP) were utilized to determine neglect. The Life Space Questionnaire was used to determine community mobility and independence. The Barthel Index (BI) was used for objective clarification of performance in ADL. Results Successful use of the consent form resulted in determination that five out of 40 (12.5%) met criteria for spatial neglect; (on the CBS via KF-NAP). The neglect group had lower scores on the Life Space, suggesting less community mobility and independence, however, it was not statistically significant (p = 0.16). Differences in BI scores were also not significant (p = .013) but the neglect group did have reduced independence. Conclusions This study demonstrates the need to administer functional neglect assessments in left-brain stroke and to include individuals with aphasia in research. PMID:27322860

Assessing chronic stroke survivors with aphasia sheds light on prevalence of spatial neglect.

PubMed

Hreha, Kimberly; Mulry, Claire; Gross, Melissa; Jedziniak, Tarah; Gramas, Natanya; Ohevshalom, Leora; Sheridan, Alisha; Szabo, Gretchen; Davison, Christina; Barrett, A M

2017-03-01

Stroke is a chronic disease. Standardized assessment is essential in order to determine areas for treatment. Individuals with aphasia are often excluded from research, because it is believed that their language impairments may impact their ability to provide informed consent. Thus, right spatial neglect could be under-diagnosed. This study was developed to (1) determine the frequency of spatial neglect in chronic left-brain stroke survivors with aphasia, (2) determine the clinical utility of an aphasia-friendly consent form, and (3) determine any differences between neglect and no-neglect groups regarding activities of daily living (ADL) performance and community independence. Forty-six people were consented at community center. Three were screen failures secondary to the exclusion criteria. A novel, aphasia-friendly consent form was developed to facilitate participation of individuals with aphasia. This enabled 93% or 40 out of the 43 recruited participants to be included in this study. The Behavioral Inattention Test-conventional and the Catherine Bergego Scale via Kessler Foundation Neglect Assessment Process (CBS via KF-NAP) were utilized to determine neglect. The Life Space Questionnaire was used to determine community mobility and independence. The Barthel Index (BI) was used for objective clarification of performance in ADL. Successful use of the consent form resulted in determination that five out of 40 (12.5%) met criteria for spatial neglect; (on the CBS via KF-NAP). The neglect group had lower scores on the Life Space, suggesting less community mobility and independence, however, it was not statistically significant (p = 0.16). Differences in BI scores were also not significant (p = .013) but the neglect group did have reduced independence. This study demonstrates the need to administer functional neglect assessments in left-brain stroke and to include individuals with aphasia in research.

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.

Balancing the quality of consent.

PubMed Central

Hansson, M O

1998-01-01

The rule that one must obtain informed consent is well established in medical ethics and an intrinsic part of clinical practice and of research in biomedicine. However, there is a tendency that the rule today is being applied too rigidly and with too little sensitivity to the values that are at stake in connection with different kinds of research protocols. It is here argued that the quality of consent needs to be balanced against variables such as degree of confidentiality and importance of values at stake, in order to be ethically acceptable. Appropriate information and consent procedures should be adjusted accordingly. Three levels are suggested, ranging from extensively informed consent with both written and oral information, through informed refusal with only a limited amount of information given to, at the other end of the scale, just making relevant information available. PMID:9650113

77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-04

...EPA proposes to approve State Implementation Plan (SIP) revisions submitted by the Maryland Department of the Environment (MDE). These revisions approve specific provisions of a 2011 Consent Decree between MDE and GenOn to reduce particulate matter (PM), sulfur oxides (SOX), and nitrogen oxides (NOX) from the GenOn Chalk Point generating station (Chalk Point). These revisions also remove the 1978 and 1979 Consent Orders for the Chalk Point generating station from the Maryland SIP as those Consent Orders have been superseded by the 2011 Consent Decree. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

77 FR 517 - Notice of Lodging of Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-05

... given that on December 29, 2011, a proposed consent decree in United States, et al. v. Essroc Cement... statutory and regulatory requirements of the Clean Air Act (the ``Act'') at Essroc cement plants: the... X at five cement kilns. The proposed consent decree also requires testing a selective catalytic...

Disclosure of HIV status on informed consent forms presents an ethical dilemma for protection of human subjects.

PubMed

Gray, Ronald H; Sewankambo, Nelson K; Wawer, Maria J; Serwadda, David; Kiwanuka, Noah; Lutalo, Tom

2006-02-01

The privacy of copies of consent forms provided to research participants cannot be guaranteed. Therefore, consent forms that disclose a subject's HIV status may result in breach of confidentiality and cause social harms. Under the ethical principle of beneficence defined in the Belmont Report, we recommend that disclosure of HIV status be through voluntary counseling and testing; however, whenever possible, copies of consent form should not specify HIV status.

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

Is consent in medicine a concept only of modern times?

PubMed Central

Dalla-Vorgia, P; Lascaratos, J; Skiadas, P; Garanis-Papadatos, T

2001-01-01

Although the issue of consent in medical practice has grown immensely in recent years, and it is generally believed that historical cases are unknown, our research amongst original ancient Greek and Byzantine historical sources reveals that it is a very old subject which ancient philosophers and physicians have addressed. Plato, in ancient Greece, connected consent with the quality of a free person and even before him, Hippocrates had advocated seeking the patient's cooperation in order to combat the disease. In Alexander the Great's era and later on in Byzantine times, not only was the consent of the patient necessary but physicians were asking for even more safeguards before undertaking a difficult operation. Our study has shown that from ancient times physicians have at least on occasion been driven to seek the consent of their patient either because of respect for the patient's autonomy or from fear of the consequences of their failure. Key Words: Consent • history of medicine • medical ethics PMID:11233382

Adoption of workplaces and reach of employees for a multi-faceted intervention targeting low back pain among nurses' aides.

PubMed

Rasmussen, Charlotte Diana Nørregaard; Larsen, Anne Konring; Holtermann, Andreas; Søgaard, Karen; Jørgensen, Marie Birk

2014-05-01

Workplace adoption and reach of health promotion are important, but generally poorly reported. The aim of this study is therefore to evaluate the adoption of workplaces (organizational level) and reach of employees (individual level) of a multi-faceted workplace health promotion and work environment intervention targeting low back pain among nurses' aides in elderly care. Percentage of adopters was calculated among eligible workplaces and differences between adopters and non-adopters were evaluated through workplace registrations and manager questionnaires from all eligible workplaces. From the adopted workplaces reach was calculated among eligible employees as the percentage who responded on a questionnaire. Responders were compared with non-responders using data from company registrations. Among responders, comparisons based on questionnaire data were performed between those consenting to participate in the intervention (consenters) and those not consenting to participate in the intervention (non-consenters). Comparisons were done using Student's t-test for the continuous variables, Fisher's exact test for dichotomous variables and the Pearson's chi(2) for categorical variables. Moreover odds ratios for non-responding and non-consenting were investigated with binary logistic regression analyses. The project was adopted by 44% of the offered workplaces. The main differences between adopters and non-adopters were that workplaces adopting the intervention had a more stable organization as well as a management with positive beliefs of the intervention's potential benefits. Of eligible employees, 71% responded on the questionnaire and 57% consented to participate. Non-responders and non-consenters did not differ from the responders and consenters on demographic factors and health. However, more non-responders and non-consenters were low skilled, worked less than 30 hours pr. week, and worked evening and nightshift compared to responders and consenters, respectively. Consenters had more musculoskeletal pain and reduced self-rated health, as well as higher physical exertion during work compared to non-consenters. Our recruitment effort yielded a population of consenters that was representative of the target population of nurses' aides with respect to demographic factors, and health. Moreover more consenters had problems like pain and high physical exertion during work, which fitted the scope of the intervention. The study is registered as ISRCTN78113519.

Consent process for US-based family reference DNA samples.

PubMed

Katsanis, Sara H; Snyder, Lindsey; Arnholt, Kelly; Mundorff, Amy Z

2018-01-01

DNA collection from family members of the missing is a tenet for missing persons' and mass fatality investigations. Procedures for consenting family members are disparate, depending on the context supporting the reason for sample collection. While guidelines and best practices have been developed for handling mass fatalities and for identification of the missing, these guidelines do not address standard consent practices for living family members of potential victims. We examined the relevant U.S. laws, international guidelines and best practices, sampled consent forms currently used for DNA collection of family members, and drafted model language for a consent form to communicate the required and recommended information. We modeled the consent form on biobank consenting practices and tested the consent language among students and the general population for constructive feedback and readability. We also asked respondents to consider the options for DNA collection and either hypothetically agree or disagree. The model language presented here highlights information important to relay in consent processes and can serve as a foundation for future consent practices in mass fatalities and missing persons' investigations. Copyright © 2017 Elsevier B.V. All rights reserved.

77 FR 51801 - Cooperativa de Farmacias Puertorriquenas; Analysis of Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

... FEDERAL TRADE COMMISSION [File No. 101 0079] Cooperativa de Farmacias Puertorriquenas; Analysis of... prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to... of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent...

77 FR 47844 - Renown Health; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-10

... FEDERAL TRADE COMMISSION [File No. 111 0101] Renown Health; Analysis of Agreement Containing... or deceptive acts or practices or unfair methods of competition. The attached Analysis To Aid Public... of thirty (30) days. The following Analysis To Aid Public Comment describes the terms of the consent...

78 FR 300 - IDEXX Laboratories, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

... FEDERAL TRADE COMMISSION [File No. 101 0023] IDEXX Laboratories, Inc.; Analysis of Proposed... or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public.... The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the...

Capacity, consent, and mental health legislation: time for a new standard?

PubMed

O'Brien, Anthony J

2010-01-01

Recent international reforms in mental health legislation have introduced a capacity test as a criterion for civil commitment. There are proposals that a common test of incapacity should apply in both mental and physical health under a single legislative framework for all cases in which the normally accepted standard of informed consent for treatment is not met. Capacity is a complex concept, but can be reliably assessed in clinical practice. Nurses need to be involved in the policy debate about capacity and consent in mental health care.

19 CFR 210.75 - Proceedings to enforce exclusion orders, cease and desist orders, consent orders, and other...

Code of Federal Regulations, 2010 CFR

2010-04-01

... STATES INTERNATIONAL TRADE COMMISSION INVESTIGATIONS OF UNFAIR PRACTICES IN IMPORT TRADE ADJUDICATION AND... the unfair practices that were originally the basis for issuing such order; (ii) Bring civil actions...

The new genetics and informed consent: differentiating choice to preserve autonomy.

PubMed

Bunnik, Eline M; de Jong, Antina; Nijsingh, Niels; de Wert, Guido M W R

2013-07-01

The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre-test information and achieving autonomous decision-making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized by the International Association of Bioethics, these challenges were presented for three different areas in which these so-called 'new genetics' technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set-up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set-up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct-to-consumer applications of the new genetics. © 2013 John Wiley & Sons Ltd.

(Why) should we require consent to participation in research?

PubMed Central

Wertheimer, Alan

2014-01-01

It is widely accepted that informed consent is a requirement of ethical biomedical research. It is less clear why this is so. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. This article argues that the consent requirement cannot be defended by appeal to any simple principle, such as not treating people merely as a means, bodily integrity, and autonomy. As an argumentative strategy the article asks whether it would be legitimate for the state to require people to participate in research. I argue that while it would be legitimate and potentially justifiable to coerce people to participate in research as a matter of first-order moral principles, there are good reasons to adopt a general prohibition on coercive participation as a matter of second-order morality. PMID:25937932

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.

Planned Parenthood League of Massachusetts v. Attorney General.

PubMed

1997-03-18

The Supreme Judicial Court of Massachusetts sustained a state statute which required pregnant unmarried minors to obtain the consent of both parents or a judge of the Superior Court in order to have an abortion. The court held that the state's interest in protecting the welfare of its minors and ensuring informed consent justified restrictions on a minor's constitutional right to choose an abortion. The court held unconstitutional, however, the law's requirement that the minor obtain the consent of both parents as an undue burden on the minor's due process rights.

Effects of depression and social support on comprehension and recall of informed consent information among Parkinson disease patients and their caregivers.

PubMed

Teng, Ellen J; Petersen, Nancy J; Hartman, Christine; Matthiesen, Ellen; Kallen, Michael; Cook, Karon F; Ford, Marvella E

2012-01-01

Relatively little attention has focused on the impact of psychiatric conditions on human subjects' comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process. Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers (t-tests, Fisher's exact tests, and ANCOVAs). T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present (p = 0.02). Having a support person present during the informed consent process helps depressed PD patients better retain information in the short-term, but effects diminish over the long-term. Implications for interventions will be discussed.

EFFECTS OF DEPRESSION AND SOCIAL SUPPORT ON COMPREHENSION AND RECALL OF INFORMED CONSENT INFORMATION AMONG PARKINSON DISEASE PATIENTS AND THEIR CAREGIVERS*

PubMed Central

TENG, ELLEN J.; PETERSEN, NANCY J.; HARTMAN, CHRISTINE; MATTHIESEN, ELLEN; KALLEN, MICHAEL; COOK, KARON F.; FORD, MARVELLA E.

2014-01-01

Objective Relatively little attention has focused on the impact of psychiatric conditions on human subjects’ comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process. Method Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers (t-tests, Fisher's exact test, and ANCOVAs). Results T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present (p = 0.02). Conclusions Having a support person present during the informed consent process helps depressed PD patients better retain information in the short term, but effects diminish over the long term. Implications for interventions will be discussed. PMID:22641931

Underground Test Area (UGTA) Closure Report for Corrective Action Unit 98: Frenchman Flat Nevada National Security Site, Nevada, Revision 1 ROTC-1

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

Farnham, Irene

This Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 98, Frenchman Flat, Nevada National Security Site (NNSS), Nevada. The Frenchman Flat CAU was the site of 10 underground nuclear tests, some of which have impacted groundwater near the tests. This work was performed as part of the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) Underground Test Area (UGTA) Activity in accordance with the Federal Facility Agreement and Consent Order (FFACO). This CR describes the selected corrective action to be implemented during closure to protect human health and the environment from the impactedmore » groundwater« less

The Association between End-of-Life Care and the Time Interval between Provision of a Do-Not-Resuscitate Consent and Death in Cancer Patients in Korea.

PubMed

Baek, Sun Kyung; Chang, Hye Jung; Byun, Ja Min; Han, Jae Joon; Heo, Dae Seog

2017-04-01

We explored the relationship between the use of each medical intervention and the length of time between do-not-resuscitate (DNR) consent and death in Korea. A total of 295 terminal cancer patients participated in this retrospective study. Invasive interventions (e.g., cardiopulmonary resuscitation, intubation, and hemodialysis), less invasive interventions (e.g., transfusion, antibiotic use, inotropic use, and laboratory tests), and the time interval between the DNR order and death were evaluated. The subjects were divided into three groups based on the amount of time between DNR consent and death (G1, time interval ≤ 1 day; G2, time interval > 1 day to ≤ 3 days; and G3, time interval > 3 days). In general, there were fewer transfusions and laboratory tests near death. Invasive interventions tended to be implemented only in the G1 group. There was also less inotrope use and fewer laboratory tests in the G3 group than G1 and G2. Moreover, the G3 group received fewer less invasive interventions than those in G1 (odds ratio [OR], 0.16; 95% confidence interval [CI], 0.03 to 0.84; 3 days before death, and OR, 0.16; 95% CI, 0.04 to 0.59; the day before death). The frequency of less invasive interventions both 1 and 3 days before death was significantly lower for the G3 group than the G1 (p ≤ 0.001) and G2 group compared to G1 (p=0.001). Earlier attainment of DNR permission was associated with reduced use of medical intervention. Thus, physicians should discuss death with terminal cancer patients at the earliest practical time to prevent unnecessary and uncomfortable procedures and reduce health care costs.

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

PubMed

Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

2016-06-01

The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States.

PubMed

Garrison, Nanibaa' A; Sathe, Nila A; Antommaria, Armand H Matheny; Holm, Ingrid A; Sanderson, Saskia C; Smith, Maureen E; McPheeters, Melissa L; Clayton, Ellen W

2016-07-01

In 2011, an Advanced Notice of Proposed Rulemaking proposed that de-identified human data and specimens be included in biobanks only if patients provide consent. The National Institutes of Health Genomic Data Sharing policy went into effect in 2015, requiring broad consent from almost all research participants. We conducted a systematic literature review of attitudes toward biobanking, broad consent, and data sharing. Bibliographic databases included MEDLINE, Web of Science, EthxWeb, and GenETHX. Study screening was conducted using DistillerSR. The final 48 studies included surveys (n = 23), focus groups (n = 8), mixed methods (n = 14), interviews (n = 1), and consent form analyses (n = 2). Study quality was characterized as good (n = 19), fair (n = 27), and poor (n = 2). Although many participants objected, broad consent was often preferred over tiered or study-specific consent, particularly when broad consent was the only option, samples were de-identified, logistics of biobanks were communicated, and privacy was addressed. Willingness for data to be shared was high, but it was lower among individuals from under-represented minorities, individuals with privacy and confidentiality concerns, and when pharmaceutical companies had access to data. Additional research is needed to understand factors affecting willingness to give broad consent for biobank research and data sharing in order to address concerns to enhance acceptability.Genet Med 18 7, 663-671.

The adequacy of informed consent forms in genetic research in Oman: a pilot study.

PubMed

Al-Riyami, Asya; Jaju, Deepali; Jaju, Sanjay; Silverman, Henry J

2011-08-01

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman. The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review. Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms. Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. © 2011 Blackwell Publishing Ltd.

32 CFR 634.37 - Voluntary breath and bodily fluid testing based on implied consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Traffic Supervision § 634.37 Voluntary breath and bodily fluid testing based on implied consent... the person was driving under the influence of alcohol or drugs. (3) A request was made to the person...

32 CFR 634.37 - Voluntary breath and bodily fluid testing based on implied consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) DEPARTMENT OF THE ARMY (CONTINUED) LAW ENFORCEMENT AND CRIMINAL INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Traffic Supervision § 634.37 Voluntary breath and bodily fluid testing based on implied consent... the person was driving under the influence of alcohol or drugs. (3) A request was made to the person...

78 FR 55076 - Ganley Ford West, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-09

... FEDERAL TRADE COMMISSION [File No. 122 3269] Ganley Ford West, Inc.; Analysis of Proposed Consent... for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Ganley Ford, File No. 122... receive it on or before October 3, 2013. Write ``Ganley Ford, File No. 122 3269'' on your comment. Your...

75 FR 51460 - Novartis AG; Analysis of Proposed Agreement Containing Consent Orders to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-20

... of a controlling interest in Alcon, Inc. (``Alcon'') from Nestle, S.A. The proposed Consent Agreement..., Novartis proposes to acquire all of the outstanding shares of Alcon held by Nestle in a transaction valued... pharmaceuticals headquartered in Basel, Switzerland. Nestle is the world's largest food company, and is...

78 FR 24201 - Graco, Inc.; Analysis of Agreement Containing Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-24

.... (``GlasCraft''). The Commission Complaint (``Complaint'') alleges that, at the time of the acquisitions... supply of fast-set equipment might later be interrupted as a result of litigation. To reduce that barrier... be restored. IV. The Consent Agreement Since the acquisitions were completed some time ago, it is not...

76 FR 11277 - In the Matter of Collaborative System Products and Components Thereof (II); Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-01

... (``ID'') (Order No. 20) issued by the presiding administrative law judge (``ALJ'') on January 24, 2011 granting a consent motion to terminate the above-captioned investigation in its entirety based upon a... consent motion to terminate the instant investigation on the ground that the parties have reached a...

Informed consent to medical treatment--the Israeli experience.

PubMed

Weil, Z

1998-01-01

The ideological foundation of the doctrine of "informed consent" is rooted in the concept of personal freedom and freedom of choice. The concept of individual autonomy is represented by the "reasonable patient" standard which requires the disclosure of all information which a reasonable person in the position of the patient would need in order to make a rational decision regarding a proposed medical treatment. This attitude, however, conflicts with the traditional paternalism which is reflected in the "reasonable physician" standard, that is that a doctor must disclose that medical information which a rational doctor would relate to a patient in order to receive his consent. The enactment of the Patients' Rights Law in Israel in 1996 was an essential turning point in Israeli medical law. Section 13 of the new law explicitly establishes the requirement of informed consent and the details which a doctor must relate to a patient in order to reach the said agreement. Nevertheless, the law does not state the standard according to which it should be assessed whether the disclosure was proper. In a recent decision (C.A. 434/94 Shai Berman et al. v. Mor--the Institute for Medical Information, Ltd.) the Israeli Supreme Court took a step forward and determined that the duty to inform a patient will be judged by recognised criteria of negligence as they apply to the merits of each case.

Preconceptional genetic carrier testing and the commercial offer directly-to-consumers

PubMed Central

Borry, Pascal; Henneman, Lidewij; Lakeman, Phillis; ten Kate, Leo P.; Cornel, Martina C.; Howard, Heidi C.

2011-01-01

Recently, a number of commercial companies are offering preconceptional carrier tests directly-to-consumers. This offer raises a number of concerns and issues above and beyond those encountered with preconceptional tests offered within the traditional health care setting. In order to bring some of these issues to light and to initiate dialogue on this topic, this article discusses the following issues: the current offer of preconceptional carrier tests (until the end of 2010) through online commercial companies; the implications for the informed consent procedure and the need for good information; the need for medical supervision and follow-up; and the appropriate use of existing resources. The article concludes with some reflections about the potential sustainability of the offer of preconceptional carrier tests directly-to-consumers. PMID:21362685

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.

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.

The Associations Between the Religious Background, Social Supports, and Do-Not-Resuscitate Orders in Taiwan

PubMed Central

Lin, Kuan-Han; Chen, Yih-Sharng; Chou, Nai-Kuan; Huang, Sheng-Jean; Wu, Chau-Chung; Chen, Yen-Yuan

2016-01-01

Abstract Prior studies have demonstrated important implications related to religiosity and a do-not-resuscitate (DNR) decision. However, the association between patients’ religious background and DNR decisions is vague. In particular, the association between the religious background of Buddhism/Daoism and DNR decisions has never been examined. The objective of this study was to examine the association between patients’ religious background and their DNR decisions, with a particular focus on Buddhism/Daoism. The medical records of the patients who were admitted to the 3 surgical intensive care units (SICU) in a university-affiliated medical center located at Northern Taiwan from June 1, 2011 to December 31, 2013 were retrospectively collected. We compared the clinical/demographic variables of DNR patients with those of non-DNR patients using the Student t test or χ2 test depending on the scale of the variables. We used multivariate logistic regression analysis to examine the association between the religious backgrounds and DNR decisions. A sample of 1909 patients was collected: 122 patients had a DNR order; and 1787 patients did not have a DNR order. Old age (P = 0.02), unemployment (P = 0.02), admission diagnosis of “nonoperative, cardiac failure/insufficiency” (P = 0.03), and severe acute illness at SICU admission (P < 0.01) were significantly associated with signing of DNR orders. Patients’ religious background of Buddhism/Daoism (P = 0.04), married marital status (P = 0.02), and admission diagnosis of “postoperative, major surgery” (P = 0.02) were less likely to have a DNR order written during their SICU stay. Furthermore, patients with poor social support, as indicated by marital and working status, were more likely to consent to a DNR order during SICU stay. This study showed that the religious background of Buddhism/Daoism was significantly associated with a lower likelihood of consenting to a DNR, and poor social support was significantly associated with a higher likelihood of having a DNR order written during SICU stay. PMID:26817913

The Associations Between the Religious Background, Social Supports, and Do-Not-Resuscitate Orders in Taiwan: An Observational Study.

PubMed

Lin, Kuan-Han; Chen, Yih-Sharng; Chou, Nai-Kuan; Huang, Sheng-Jean; Wu, Chau-Chung; Chen, Yen-Yuan

2016-01-01

Prior studies have demonstrated important implications related to religiosity and a do-not-resuscitate (DNR) decision. However, the association between patients' religious background and DNR decisions is vague. In particular, the association between the religious background of Buddhism/Daoism and DNR decisions has never been examined. The objective of this study was to examine the association between patients' religious background and their DNR decisions, with a particular focus on Buddhism/Daoism.The medical records of the patients who were admitted to the 3 surgical intensive care units (SICU) in a university-affiliated medical center located at Northern Taiwan from June 1, 2011 to December 31, 2013 were retrospectively collected. We compared the clinical/demographic variables of DNR patients with those of non-DNR patients using the Student t test or χ test depending on the scale of the variables. We used multivariate logistic regression analysis to examine the association between the religious backgrounds and DNR decisions.A sample of 1909 patients was collected: 122 patients had a DNR order; and 1787 patients did not have a DNR order. Old age (P = 0.02), unemployment (P = 0.02), admission diagnosis of "nonoperative, cardiac failure/insufficiency" (P = 0.03), and severe acute illness at SICU admission (P < 0.01) were significantly associated with signing of DNR orders. Patients' religious background of Buddhism/Daoism (P = 0.04), married marital status (P = 0.02), and admission diagnosis of "postoperative, major surgery" (P = 0.02) were less likely to have a DNR order written during their SICU stay. Furthermore, patients with poor social support, as indicated by marital and working status, were more likely to consent to a DNR order during SICU stay.This study showed that the religious background of Buddhism/Daoism was significantly associated with a lower likelihood of consenting to a DNR, and poor social support was significantly associated with a higher likelihood of having a DNR order written during SICU stay.

Adoption of workplaces and reach of employees for a multi-faceted intervention targeting low back pain among nurses’ aides

PubMed Central

2014-01-01

Background Workplace adoption and reach of health promotion are important, but generally poorly reported. The aim of this study is therefore to evaluate the adoption of workplaces (organizational level) and reach of employees (individual level) of a multi-faceted workplace health promotion and work environment intervention targeting low back pain among nurses’ aides in elderly care. Methods Percentage of adopters was calculated among eligible workplaces and differences between adopters and non-adopters were evaluated through workplace registrations and manager questionnaires from all eligible workplaces. From the adopted workplaces reach was calculated among eligible employees as the percentage who responded on a questionnaire. Responders were compared with non-responders using data from company registrations. Among responders, comparisons based on questionnaire data were performed between those consenting to participate in the intervention (consenters) and those not consenting to participate in the intervention (non-consenters). Comparisons were done using Student's t-test for the continuous variables, Fisher's exact test for dichotomous variables and the Pearson’s chi2 for categorical variables. Moreover odds ratios for non-responding and non-consenting were investigated with binary logistic regression analyses. Results The project was adopted by 44% of the offered workplaces. The main differences between adopters and non-adopters were that workplaces adopting the intervention had a more stable organization as well as a management with positive beliefs of the intervention’s potential benefits. Of eligible employees, 71% responded on the questionnaire and 57% consented to participate. Non-responders and non-consenters did not differ from the responders and consenters on demographic factors and health. However, more non-responders and non-consenters were low skilled, worked less than 30 hours pr. week, and worked evening and nightshift compared to responders and consenters, respectively. Consenters had more musculoskeletal pain and reduced self-rated health, as well as higher physical exertion during work compared to non-consenters. Conclusions Our recruitment effort yielded a population of consenters that was representative of the target population of nurses’ aides with respect to demographic factors, and health. Moreover more consenters had problems like pain and high physical exertion during work, which fitted the scope of the intervention. Trial registration The study is registered as ISRCTN78113519. PMID:24885476

South Africa: Durban's ante-natal clinic environment and its impact on a woman's choice to test for HIV during pregnancy.

PubMed

Groves, Allison K; Eyakuze, Cynthia

2010-10-01

Informed consent, counselling and confidentiality are key tenets of a human rights approach to HIV testing. In this article, based on an oral poster presentation at AIDS 2010, Allison K. Groves and Cynthia Eyakuze discuss the results of a study on HIV testing of women in ante-natal clinics in Durban, South Africa and how communication about testing may undermine the practice of obtaining informed consent.

Ethical, Legal and Social Issues in Japan on the Determination of Blood Relationship via DNA Testing.

PubMed

Toya, Waki

2017-01-01

DNA paternity testing has recently become more widely available in Japan. The aim of this paper is to examine the issues surrounding (1) the implementing agency, whether the testing is conducted in a commercial direct-to-consumer (DTC) setting or a judicial non-DTC setting, and (2) the implementation conditions and more specifically the legal capacity of the proband (test subject). Literature research in Japanese and English was conducted. Some countries prohibit commercial DNA testing without the consent of the proband or her or his legally authorized representative. But as in some cases, the results of DTC paternity testing have proven to be unreliable. I propose a complete prohibition of DTC DNA paternity testing in Japan. In many cases of paternity testing, the proband is a minor. This has led to debate about whether proxy consent is sufficient for paternity testing or whether additional safeguards (such as a court order) are required. In cases where commercial DNA testing has been conducted and the test results are produced in court as evidence, the court must judge whether or not to admit these results as evidence. Another important issue is whether or not paternity testing should be legally mandated in certain cases. If we come to the conclusion that DNA test results are the only way to conclusively establish a parent-child relationship, then our society may prioritize even more genetic relatedness over other conceptions of a parent-child relationship. This prioritization could adversely affect families created through assisted reproductive technology (ART), especially in situations where children are not aware of their biological parentage. This paper argues for a complete prohibition of DTC DNA paternity testing in Japan, and highlights that broader ethical and legal deliberation on such genetic services is required.

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.

Informed consent and nudging.

PubMed

Simkulet, William

2018-06-19

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure. © 2018 John Wiley & Sons Ltd.

Facilitating enrollment in a Cancer Registry through modified consent procedures: a pilot study.

PubMed

Mazanec, Susan; Daly, Barbara; Meropol, Neal J; Step, Mary

2012-12-01

Research registries are increasingly important in medical research and are essential to the mission of cancer centers. However, designing enrollment and data collection procedures that are consistent with ethical norms and regulatory requirements yet are efficient and cost effective is a major challenge. Current standard consent forms can be a barrier to enrollment because of their length, multiple components, and technical language. We pilot tested an IRB-approved registry booklet and simplified one-page, tiered consent form, allowing for choice of extent of participation. The booklet was mailed to patients with breast cancer as part of their routine information packet prior to the first clinic appointment. A research nurse met with 27 patients at initial treatment to review the booklet, answer questions, obtain informed consent, and collect quality of life data. The consent rate was 78% with 21 patients enrolling in the study. Twelve of the 21 patients (57%) did not read the booklet prior to the visit. The 9 patients (43%) who had read the booklet prior to arrival found it easy to understand. The multi-stage, simplified consent process and data collection were acceptable to these patients and readily integrated into clinical operations. An easy-to-read registry booklet may be an effective guide for discussion, but in-person consent procedures and further testing of the approach are required.

Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

PubMed

Gitanjali, B; Raveendran, R; Pandian, D G; Sujindra, S

2003-01-01

Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. A simulated clinical trial in two tertiary health care facilities on in-patients. An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. The percentages of those consenting after full disclosure 29/102 (30%) and after partial disclosure 15/50 (30%) were the same. There was a significant (p=0.043) gender difference with a lesser percentage of females (30%) consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

Testing Consent Agreement for N-methylpyrrolidone

EPA Pesticide Factsheets

EPA has signed an Enforceable Consent Agreement (ECA) pursuant to the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., with Arco Chemical Company, BASF Corporation, and International Specialty Products Company.

Informed consent to opioid agonist maintenance treatment: recommended ethical guidelines.

PubMed

Carter, Adrian; Hall, Wayne

2008-02-01

Some bioethicists have questioned whether opioid addicted individuals are able to provide free and informed consent to opioid agonist maintenance treatment. Conflicting motives for providing such treatment (e.g. improving the personal health of addicts and protecting public health and order) can also influence what individuals are required to consent to, and how that consent is obtained. We discuss both issues and attempt to specify the conditions for obtaining informed consent to agonist maintenance treatment for opioid addiction. We briefly review the neuroscientific literature on the effects of addiction on the autonomy and decision-making capacity of opioid dependent individuals, and ascertain how informed consent to the treatment of opioid addiction should be obtained. We also provide an ethical analysis of the competing social and medical forces that influence the consent process and make some recommendations on how to ensure that individuals enter maintenance treatment that is provided in an effective and ethical way. Our analysis shows that whilst the autonomy of opioid dependent individuals is impaired by their addiction, they do retain the ability to consent to treatment provided they are not in acute withdrawal or intoxication. These symptoms should have abated, either by supervised withdrawal or stabilisation on agonist maintenance, before they are asked to consent to a detailed treatment contract. Once stabilised, individuals should be provided with detailed information about the risks and benefits of all treatments, and restrictions and regulations under which they are provided. Informed consent is an important part of the treatment process that should be obtained in ways that increase the autonomy and decision-making capacity in opioid addicts.

Comprehensibility of patient consent forms for radiation therapy of cervical cancer.

PubMed

MacDougall, Deborah Skinner; Connor, Ulla M; Johnstone, Peter A S

2012-06-01

The construct of Health Literacy (HL) deals with patients' capacity to understand their health-related instructions, consent forms, and other documents. A significant challenge of providing healthcare to patients with low HL is the complex nature of the disease process, and of requisite treatments. In radiation oncology specifically, the delivery of ionizing radiation is difficult enough to describe; describing radiation toxicity in terms of the underlying physics and biology is daunting. A multimodal analysis of a small sample of patient consent forms was undertaken in order to address this issue more closely, and identify the extent to which such literature contributes to the challenges faced by patients with low HL. Members of national cooperative group panels dealing with gynecologic cancer were asked to submit copies of consent forms provided to patients with stage II cervical cancer. Four such forms were submitted and reviewed by a single person with expertise in linguistics using standard tools. Three of the four consents scored within the lower portion of the "adequate" range. One consent was not suitable. Consent readability ranged from grades 12.18 to 16.13; this means that they required at least a high school education to interpret, and in two cases required post-graduate coursework. There is significant room for improvement in consent form design and structure. When considering cultural and socioeconomic appropriateness of patient consent forms, input of staff with expertise in linguistics should be sought. Copyright © 2012 Elsevier Inc. All rights reserved.

A survey of doctors at a UK teaching hospital to assess understanding of recent changes to consent law.

PubMed

O'Brien, J W; Natarajan, M; Shaikh, I

2017-06-01

The UK Supreme Court recently ruled that when consenting patients for treatments or procedures, clinicians must also discuss any associated material risks. We surveyed medical staff at a large UK teaching hospital in order to ascertain knowledge of consent law and current understanding of this change. Email survey sent to medical staff in all specialities at Norfolk and Norwich University Hospital in February 2016. 245 responses (141 Consultants and 104 junior doctors, response rate 32%). 82% consent patients for procedures at least monthly and 23% daily. 31% were not familiar with the concept of material risk. 35% were familiar with the recent change in consent law, 41% were not. 18% were "very uncertain" and 64% "a little uncertain" that their consenting process meets current legal requirements. >92% think that landmark cases and changes in law should be discussed through professional bodies and circulated better locally. The majority were not familiar with the concept of material risk and recent legal changes. A majority were not confident that their practice meets current requirements, suggesting that recent changes in consent law may not be widely understood at this hospital. We suggest more guidance and education may be necessary than is currently available. Increased understanding of recent changes to consent law will reduce the risk taken by NHS trusts and offer patients a service compliant with Supreme Court guidance.

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.

Laboratory Information Systems in Molecular Diagnostics: Why Molecular Diagnostics Data are Different.

PubMed

Lee, Roy E; Henricks, Walter H; Sirintrapun, Sahussapont J

2016-03-01

Molecular diagnostic testing presents new challenges to information management that are yet to be sufficiently addressed by currently available information systems for the molecular laboratory. These challenges relate to unique aspects of molecular genetic testing: molecular test ordering, informed consent issues, diverse specimen types that encompass the full breadth of specimens handled by traditional anatomic and clinical pathology information systems, data structures and data elements specific to molecular testing, varied testing workflows and protocols, diverse instrument outputs, unique needs and requirements of molecular test reporting, and nuances related to the dissemination of molecular pathology test reports. By satisfactorily addressing these needs in molecular test data management, a laboratory information system designed for the unique needs of molecular diagnostics presents a compelling reason to migrate away from the current paper and spreadsheet information management that many molecular laboratories currently use. This paper reviews the issues and challenges of information management in the molecular diagnostics laboratory.

An easy test but a hard decision: ethical issues concerning non-invasive prenatal testing for autosomal recessive disorders

PubMed Central

Skirton, Heather; Goldsmith, Lesley; Chitty, Lyn S

2015-01-01

Prenatal testing based on cell-free fetal DNA in maternal serum is now possible for specific monogenic conditions, and studies have shown that the use of non-invasive testing is supported by prospective parents and health professionals. However, some ethical issues have been raised concerning informed consent and paternal rights. The objective of this study was to explore ethical aspects of the use of non-invasive prenatal diagnostic testing for autosomal recessive disorders. We used a qualitative cross-sectional design, based on Thematic Analysis, and recruited 27 individuals of reproductive age who were carriers of one of four conditions: thalassaemia, sickle cell disease, cystic fibrosis or spinal muscular atrophy. Data were collected via focus groups or interviews. Participants were aware of the potential for such tests to be viewed as routine and suggested that obtaining written consent and allowing time for consideration is needed to facilitate autonomous choice and informed consent. All participants felt that mothers should be able to request such tests, but fathers who declined carrier testing should be made aware that fetal test results may reveal their status. We suggest that a written record of consent for non-invasive prenatal diagnosis should be used as a standard to help reinforce the serious nature of the test results. Where the father's carrier status could be revealed through fetal testing, he should be made aware of this before the results are available. Health professionals should discuss with the pregnant woman the best way to manage unsought information about the father's carrier status to minimise family disruption. PMID:25351779

Professional self-concept and professional values of senior students of the nursing department.

PubMed

Çöplü, Mehtap; Tekinsoy Kartın, Pınar

2018-01-01

This study was carried out in order to determine professional self-concept and professional values in the students, who were studying in the final year of the nursing department in schools providing undergraduate education in the Inner Anatolia Region. This cross-sectional study was conducted on a total of 619 senior students of nursing departments in the Inner Anatolia Region. Data were collected using a Student Information Form, Professional Self-Concept Scale for the Student Nurses, and The Nurses' Professional Values Scale. Descriptive statistics, the Shapiro-Wilk test, the t-test, analysis of variance, and the Bonferroni tests were used for data analysis. Ethical Considerations: A written consent was obtained from Ethics Board of Erciyes University Faculty of Medicine and from nursing schools participating in the study. Prior to data collection, students were informed about the purpose of the study and gave written and verbal consents. Participation in the study was on voluntary basis. In the study, students' total and sub-dimension scores from the Professional Self-Concept Scale for the Student Nurses and total scores from the Nurses' Professional Values Scale were moderately high. It was detected that women received higher scores than men from the sub-dimension of professional attributes; the students who had positive perception of the nursing image and voluntarily selected their department received high scores from professional satisfaction, professional competence, and professional attributes sub-dimensions of the Professional Self-Concept Scale for the Student Nurses ( p < 0.001). In order to improve students' perceptions of professional self-concept and professional values, it is thought that students' awareness should be increased on these topics.

Lessons Learned from the Frenchman Flat Flow and Transport Modeling External Peer Review

NASA Astrophysics Data System (ADS)

Becker, N. M.; Crowe, B. M.; Ruskauff, G.; Kwicklis, E. M.; Wilborn, B.

2011-12-01

The objective of the U.S. Department of Energy's Underground Test Area Program program is to forecast, using computer modeling, the contaminant boundary of radionuclide transport in groundwater at the Nevada National Security Site that exceeds the Safe Drinking Water Act after 1000 yrs. This objective is defined within the Federal Facilities Agreement and Consent Order between the Department of Energy, Department of Defense and State of Nevada Division of Environmental Protection . At one of the Corrective Action Units, Frenchman Flat, a Phase I flow and transport model underwent peer review in 1999 to determine if the model approach, assumptions and results adequate to be used as a decision tool as a basis to negotiate a compliance boundary with Nevada Division of Environmental Protection. The external peer review decision was that the model was not fully tested under a full suite of possible conceptual models, including boundary conditions, flow mechanisms, other transport processes, hydrological framework models, sensitivity and uncertainty analysis, etc. The program went back to collect more data, expand modeling to consider other alternatives that were not adequately tested, and conduct sensitivity and uncertainty analysis. A second external peer review was held in August 2010. Their conclusion that the new Frenchman Flat flow and transport modeling analysis were adequate as a decision tool and that the model was ready to advance to the next step in the Federal Facilities Agreement and Consent Order strategy. We will discuss the processes to changing the modeling that occurred between the first and second peer reviews, and then present the second peer review general comments. Finally, we present the lessons learned from the total model acceptance process required for federal regulatory compliance.

Implied consent refusal impact

DOT National Transportation Integrated Search

1991-09-01

This report examines the extent to which persons suspected of DWI refuse to take a chemical test as required by law, describes implied consent laws in 50 States, analyzes the relation of law features to refusal rate, and analyzes the characteristics ...

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.

Mediating Justice: Women's Perceptions of Fairness in the Civil Protection Order Process.

PubMed

Hefner, M Kristen; Baboolal, Aneesa A; Fleury-Steiner, Ruth E; Miller, Susan L

2018-05-01

Mediation use has grown rapidly in the past few decades as an efficacious method of civil dispute resolution. However, early research suggests that civil mediation may cause further harm to victims of intimate partner abuse because, based on the inherent power dynamics of abusive relationships, they are not able to effectively advocate on their own behalf. In addition, organizational efficiency concerns have led to the development of consent processes for civil protection orders (POs). However, research has yet to examine the extent to which victims of intimate partner violence who take part in these consent processes perceive the process and associated outcomes as fair. Using qualitative data ( N = 19 interviews) collected from women who sought civil POs through Family Court in Delaware, this research finds that the consent process and women's interactions with mediators reproduce power inequalities that are inherent in cases of intimate partner abuse, which shape their perceptions of fairness in the PO process and outcomes. Victims being silenced and disempowered throughout the consent process results in cumulative effects-similar tactics used by batterers-which continue to leave victims vulnerable. In addition, the power asymmetry victims experience in abusive relationships is replicated by the legal institution and court structure in terms of not having access to attorneys, not receiving guidance and advocacy, and, at times, experiencing insensitive treatment. Thus, this study provides insight into the inequalities present within the PO consent process that can create further harm to victims.

75 FR 46940 - Nufarm Limited; Analysis of Agreement Containing Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... competition in the markets for three phenoxy herbicide products: MCPA, MCPP-p, and 2,4DB. On March 5, 2008... the sale of the phenoxy herbicides: MCPA, MCPP-P, and 2,4DB. The Consent Agreement has been placed on... monopoly positions in the United States markets for two phenoxy herbicide markets (MCPA and MCPP-p) and...

Use of a modified informed consent process among vulnerable patients: a descriptive study.

PubMed

Sudore, Rebecca L; Landefeld, C Seth; Williams, Brie A; Barnes, Deborah E; Lindquist, Karla; Schillinger, Dean

2006-08-01

Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding. To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information. Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal). Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives. Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36). Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension. Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.

Testing for HIV without permission.

PubMed

Gillon, R

1987-03-28

A proposal has been made by R. Doll ("A proposal for doing prevalence studies of AIDS," British Medical Journal 1987 Feb 14; 294(6569): 244) to carry out anonymous screening for AIDS on blood samples taken in hospitals for other purposes. Gillon analyzes ethical objections to the proposal: (1) the testing--which constitutes nontherapeutic research--would be done without the patient's consent; and (2) patients could not be told whether they have HIV antibodies even if they wished to know. He denies that a patient who lets blood be taken for testing is giving implied consent for the use of that blood for purposes other than the patient's benefit. Included with his article is an inset "outline proposal for obtaining implied consent to prevalence studies for HIV antibody." It calls for leaflets to be given to patients explaining the research goal, the implications for the patient, and the fact that permission for such testing will be assumed unless explicitly withheld.

Negligence in securing informed consent and medical malpractice.

PubMed

Perry, C

1988-01-01

The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

Use of altered informed consent in pragmatic clinical research.

PubMed

McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

2015-10-01

There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

Readability of informed consent forms in clinical trials conducted in a skin research center

PubMed Central

Samadi, Aniseh; Asghari, Fariba

2016-01-01

Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

Trends and Determinants of Familial Consent for Corneal Donation in Chinese.

PubMed

Lee, Allie; Ni, Michael Y; Luk, Amanda C K; Lau, Jessie K P; Lam, Karen S Y; Li, Tom K; Wong, Catherine S M; Wong, Victoria W Y

2017-03-01

Corneal transplantation is the treatment of choice for many corneal diseases. At present, there is a global shortage of corneal transplant tissues, and failure to obtain consent from families of potential donors is a major limiting factor in tissue procurement. All family members of potential donors after cardiac death approached by the local eye bank staff members from January 2008 to December 2014 in Hong Kong were included. Reasons for consent or refusal and sociodemographic details of the deceased and the family members approached were reviewed. Trends in consent rates from 2008 to 2014 were examined. Multivariable logistic regression was performed to examine determinants of donation among cases from 2013 to 2014. A total of 1740 cases were identified. The overall consent rate was 36.8%, and the consent rate did not change significantly over the 7-year study period (P = 0.24). The most common reason for consent by family members was "the wish to help others" (86.0%), and the most common reason for refusal was "traditional Chinese culture to keep the body intact after death" (42.7%). From the multivariable analysis in the subset of cases from 2013 to 2014 (n = 628), family members were more likely to consent when the deceased was female (adjusted odds ratio 1.45, P = 0.03), with a do-not-resuscitate order (adjusted odds ratio 2.27, P < 0.001). The consent rate for eye donation did not change significantly from 2008 to 2014. Our findings suggest that health education and promotion campaigns need to address cultural barriers to organ donation.

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...

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

PubMed

Sugarman, J; McCrory, D C; Hubal, R C

1998-04-01

To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

76 FR 45617 - Notice of Lodging of the Consent Decree Under the Resource Conservation and Recovery Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... underground storage tank (UST) facilities; failure to perform annual tests of automatic line leak detectors... detectors for piping on the UST systems. CHEVRON also agrees under the Consent Decree to install dispenser...

The acceptability of conducting data linkage research without obtaining consent: lay people's views and justifications.

PubMed

Xafis, Vicki

2015-11-17

A key ethical issue arising in data linkage research relates to consent requirements. Patients' consent preferences in the context of health research have been explored but their consent preferences regarding data linkage specifically have been under-explored. In addition, the views on data linkage are often those of patient groups. As a result, little is known about lay people's views and their preferences about consent requirements in the context of data linkage. This study explores lay people's views and justifications regarding the acceptability of conducting data linkage research without obtaining consent. A qualitative study explored lay people's views regarding consent requirements in data linkage via four hypothetical data linkage scenarios of increasing complexity. Prior to considering the scenarios, participants were provided with information regarding best practice data linkage processes via discussion and a diagrammatic representation of the process. Lay people were able to understand the intricate processes involved in data linkage and the key protections afforded within a short amount of time. They were supportive of data linkage research and, on the whole, believed it should be conducted without consent provided a data linkage organization de-identifies the data used so that researchers do not handle identifiable data. Many thought that de-identified data holds a different status to identifiable data and should be used without specific consent in research that aims to benefit society. In weighing up conflicting values and interests, participants shifted consent preferences before arriving at their final consent preference for each scenario and provided justifications for their choices. They considered the protection of people's information, societal benefits, and the nature and constraints of research and recognized that these need to be balanced. With some exposure to the features of data linkage, lay people have the capacity to understand the processes sufficiently in order to consider ethical issues associated with consent preferences. Shifts in views reveal the complexity of such decisions. While privacy protection remained an important consideration for most participants, adequate protection measures adopted in best practice data linkage were viewed by most as protection enough for data linkage to proceed without specific individual consent.

Preservation of the capacity to appoint a proxy decision maker: implications for dementia research.

PubMed

Kim, Scott Y H; Karlawish, Jason H; Kim, H Myra; Wall, Ian F; Bozoki, Andrea C; Appelbaum, Paul S

2011-02-01

Research involving persons with impaired decision-making capacity (such as persons with Alzheimer disease [AD]) remains ethically challenging, especially when the research involves significant risk. If individuals incapable of consenting to research studies were able to appoint a research proxy, it would allow for an appointed surrogate (rather than a de facto surrogate) to represent the subject. To assess the extent to which persons with AD retain their capacity to appoint a research proxy. Interview study. Academic research. One hundred eighty-eight persons with AD were interviewed for their capacity to appoint a proxy for research and to provide consent to 2 hypothetical research scenarios, a lower-risk randomized clinical trial testing a new drug (drug RCT) and a higher-risk randomized clinical trial testing neurosurgical cell implants using a sham control condition (neurosurgical RCT). Categorical capacity status for each subject was determined by independent videotaped reviews of capacity interviews by 5 experienced psychiatrists. Categorical capacity determinations for the capacity to appoint a research proxy, capacity to consent to a drug RCT, and capacity to consent to a neurosurgical RCT. Data showed that 37.7% (40 of 106) of those deemed incapable of consenting to the drug RCT and 54.8% (86 of 157) of those deemed incapable of consenting to the neurosurgical RCT were found capable of appointing a research proxy. Only 7 of 186 (3.8%) were deemed capable of consenting to the neurosurgical RCT by all 5 psychiatrists. A substantial proportion of persons with AD who were thought incapable of consenting to lower-risk or higher-risk studies have preserved capacity for appointing a research proxy. Because few persons are found to be unequivocally capable of providing independent consent to higher-risk AD research, providing for an appointed surrogate even after the onset of AD, which might best be done in the early stages of the illness, may help address key ethical challenges to AD research.

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

Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

PubMed

De Vries, Raymond Gene; Tomlinson, Tom; Kim, Hyungjin Myra; Krenz, Chris; Haggerty, Diana; Ryan, Kerry A; Kim, Scott Y H

2016-01-01

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

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

Nuclear Rocket Test Facility Decommissioning Including Controlled Explosive Demolition of a Neutron-Activated Shield Wall

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

Michael Kruzic

2007-09-01

Located in Area 25 of the Nevada Test Site, the Test Cell A Facility was used in the 1960s for the testing of nuclear rocket engines, as part of the Nuclear Rocket Development Program. The facility was decontaminated and decommissioned (D&D) in 2005 using the Streamlined Approach For Environmental Restoration (SAFER) process, under the Federal Facilities Agreement and Consent Order (FFACO). Utilities and process piping were verified void of contents, hazardous materials were removed, concrete with removable contamination decontaminated, large sections mechanically demolished, and the remaining five-foot, five-inch thick radiologically-activated reinforced concrete shield wall demolished using open-air controlled explosive demolitionmore » (CED). CED of the shield wall was closely monitored and resulted in no radiological exposure or atmospheric release.« less

49 CFR 40.27 - May an employer require an employee to sign a consent or release in connection with the DOT drug...

Code of Federal Regulations, 2010 CFR

2010-10-01

... TESTING PROGRAMS Employer Responsibilities § 40.27 May an employer require an employee to sign a consent or release in connection with the DOT drug and alcohol testing program? No, as an employer, you must... 49 Transportation 1 2010-10-01 2010-10-01 false May an employer require an employee to sign a...

Content Analysis of Informed Consent for Whole Genome Sequencing Offered by Direct-to-Consumer Genetic Testing Companies.

PubMed

Niemiec, Emilia; Borry, Pascal; Pinxten, Wim; Howard, Heidi Carmen

2016-12-01

Whole exome sequencing (WES) and whole genome sequencing (WGS) have become increasingly available in the research and clinical settings and are now also being offered by direct-to-consumer (DTC) genetic testing (GT) companies. This offer can be perceived as amplifying the already identified concerns regarding adequacy of informed consent (IC) for both WES/WGS and the DTC GT context. We performed a qualitative content analysis of Websites of four companies offering WES/WGS DTC regarding the following elements of IC: pre-test counseling, benefits and risks, and incidental findings (IFs). The analysis revealed concerns, including the potential lack of pre-test counseling in three of the companies studied, missing relevant information in the risks and benefits sections, and potentially misleading information for consumers. Regarding IFs, only one company, which provides opportunistic screening, provides basic information about their management. In conclusion, some of the information (and related practices) present on the companies' Web pages salient to the consent process are not adequate in reference to recommendations for IC for WGS or WES in the clinical context. Requisite resources should be allocated to ensure that commercial companies are offering high-throughput sequencing under responsible conditions, including an adequate consent process. © 2016 WILEY PERIODICALS, INC.

Headline violence and silenced pleasure: contested framings of consensual sex, power and rape in Delhi, India 2011-2014.

PubMed

Edmunds, Emme; Gupta, Ankit

2016-05-01

Though coercion and rape have cast a persistent shadow over prospects of sexual health and consent in contemporary India, other narratives, agency and tools are quietly emerging to transform collective claims of power and bodily dignity. In these narratives from collectives, NGOs, on social media and among friends, dialogues about consent and pleasure feature prominently. This paper analyses statements in the news made by highly visible political and public figures regarding the subject of rape in the context of themes emerging from ethnography and semi-structured interviews with middle class people in Delhi. Using the device of social frameworks, contested framings of rape and consent are examined in order to interrogate essentialist gender norms, compare putative "causes" of rape, and highlight local efforts promoting sexual consent, health and well-being. Copyright © 2016 Elsevier Inc. All rights reserved.

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

PubMed Central

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials. PMID:26990899

[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.

Are there limits to respect for autonomy in bioethics?

PubMed

de Roubaix, Malcolm

2008-06-01

I discuss the significance of respect for personal autonomy in bioethics with reference to its practical expression: rational informed patient choice. The question is whether, given the apparent practical limitations to this notion, bioethical autonomy should be seen as an absolute. After a historical review of informed consent and its development, I discuss the requirements for informed consent. Some inherent tensions are evaluated, as is the applicability of the notion that in order to be legitimate, autonomy should do some ethical work. Limits to the notion of informed consent are explored with reference to six examples: the right of women to reproductive autonomy; the autonomy of legally minor Jehovah's Witnesses; autonomy in cosmetic surgery; inappropriate treatment; autonomy and human medical research, and euthanasia and other end-of-life options. The discussion is within a South African framework with reference to other jurisdictions and decisions where appropriate. I conclude that whilst some unusual instances of limitation of bioethical informed consent might be ethically justifiable, the arguments presented point to the opposite: the unfounded limitation of informed consent.

Reflecting on Earlier Experiences with Unsolicited Findings: Points to Consider for Next-Generation Sequencing and Informed Consent in Diagnostics

PubMed Central

Rigter, Tessel; Henneman, Lidewij; Kristoffersson, Ulf; Hall, Alison; Yntema, Helger G; Borry, Pascal; Tönnies, Holger; Waisfisz, Quinten; Elting, Mariet W; Dondorp, Wybo J; Cornel, Martina C

2013-01-01

High-throughput nucleotide sequencing (often referred to as next-generation sequencing; NGS) is increasingly being chosen as a diagnostic tool for cases of expected but unresolved genetic origin. When exploring a higher number of genetic variants, there is a higher chance of detecting unsolicited findings. The consequential increased need for decisions on disclosure of these unsolicited findings poses a challenge for the informed consent procedure. This article discusses the ethical and practical dilemmas encountered when contemplating informed consent for NGS in diagnostics from a multidisciplinary point of view. By exploring recent similar experiences with unsolicited findings in other settings, an attempt is made to describe what can be learned so far for implementing NGS in standard genetic diagnostics. The article concludes with a set of points to consider in order to guide decision-making on the extent of return of results in relation to the mode of informed consent. We hereby aim to provide a sound basis for developing guidelines for optimizing the informed consent procedure. PMID:23784691

Research participation by people with intellectual disability and mental health issues: an examination of the processes of consent.

PubMed

Taua, Chris; Neville, Christine; Hepworth, Julie

2014-12-01

Balancing the demands of research and ethics is always challenging, and even more so when recruiting vulnerable groups. Within the context of current legislation and international human rights declarations, it is strongly advocated that research can and must be undertaken with all recipients of health-care services. Research in the field of intellectual disability presents particular challenges in regards to consenting processes. This paper is a reflective overview and analysis of the complex processes undertaken, and events that occurred in gaining informed consent from people with intellectual disability to participate in a study exploring their experiences of being an inpatient in mental health hospitals within Aotearoa/New Zealand. A framework based on capacity, information, and voluntariness is presented, with excerpts from the field provided to explore consenting processes. The practical implications of the processes utilized are then discussed in order to stimulate debate regarding clearer and enhanced methods of gaining informed consent from people with intellectual disability. © 2014 Australian College of Mental Health Nurses Inc.

Free will and psychiatric assessments of criminal responsibility: a parallel with informed consent.

PubMed

Meynen, Gerben

2010-11-01

In some criminal cases a forensic psychiatrist is asked to make an assessment of the state of mind of the defendant at the time of the legally relevant act. A considerable number of people seem to hold that the basis for this assessment is that free will is required for legal responsibility, and that mental disorders can compromise free will. In fact, because of the alleged relationship between the forensic assessment and free will, researchers in forensic psychiatry also consider the complicated metaphysical discussions on free will relevant to the assessment. At the same time, there is concern about the lack of advancement with respect to clarifying the nature of the forensic assessment. In this paper I argue that, even if free will is considered relevant, there may be no need for forensic researchers to engage into metaphysical discussions on free will in order to make significant progress. I will do so, drawing a parallel between the assessment of criminal responsibility on the one hand, and the medical practice of obtaining informed consent on the other. I argue that also with respect to informed consent, free will is considered relevant, or even crucial. This is the parallel. Yet, researchers on informed consent have not entered into metaphysical debates on free will. Meanwhile, research on informed consent has made significant progress. Based on the parallel with respect to free will, and the differences with respect to research, I conclude that researchers on forensic assessment may not have to engage into metaphysical discussions on free will in order to advance our understanding of this psychiatric practice.

Free will and psychiatric assessments of criminal responsibility: a parallel with informed consent

PubMed Central

2010-01-01

In some criminal cases a forensic psychiatrist is asked to make an assessment of the state of mind of the defendant at the time of the legally relevant act. A considerable number of people seem to hold that the basis for this assessment is that free will is required for legal responsibility, and that mental disorders can compromise free will. In fact, because of the alleged relationship between the forensic assessment and free will, researchers in forensic psychiatry also consider the complicated metaphysical discussions on free will relevant to the assessment. At the same time, there is concern about the lack of advancement with respect to clarifying the nature of the forensic assessment. In this paper I argue that, even if free will is considered relevant, there may be no need for forensic researchers to engage into metaphysical discussions on free will in order to make significant progress. I will do so, drawing a parallel between the assessment of criminal responsibility on the one hand, and the medical practice of obtaining informed consent on the other. I argue that also with respect to informed consent, free will is considered relevant, or even crucial. This is the parallel. Yet, researchers on informed consent have not entered into metaphysical debates on free will. Meanwhile, research on informed consent has made significant progress. Based on the parallel with respect to free will, and the differences with respect to research, I conclude that researchers on forensic assessment may not have to engage into metaphysical discussions on free will in order to advance our understanding of this psychiatric practice. PMID:20424919

14 CFR 16.109 - Orders terminating eligibility for grants, cease and desist orders, and other compliance orders.

Code of Federal Regulations, 2010 CFR

2010-01-01

... opportunity for a hearing if, in the Director's determination, the agency proposes to issue an order terminating eligibility for grants pursuant to 49 U.S.C. 47106(e) and 47111(d), an order suspending the... proposed consent order under § 16.243(e). (d) If the respondent fails to request a hearing or to file an...

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

Analysis of the status of informed consent in medical research involving human subjects in public hospitals in Shanghai.

PubMed

Jianping, Wang; Li, Lan; Xue, Di; Tang, Zhongjin; Jia, Xieyang; Wu, Rong; Xi, Yiqun; Wang, Tong; Zhou, Ping

2010-07-01

The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed by questionnaires. The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors.

[Schizophrenia and informed consent to research].

PubMed

Fovet, T; Amad, A; Thomas, P; Jardri, R

2015-10-01

Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

Efficacy of an Educational Intervention to Increase Consent for HIV Testing in Rural Appalachia

PubMed Central

Basta, Tania B.; Stambaugh, Teena; Fisher, Celia B.

2016-01-01

This study sought to assess barriers and enhance readiness to consent to home and Planned Parenthood HIV testing among 60 out-patients from a mental health and substance abuse clinic in rural Appalachia. Testing barriers included not knowing where to get tested, lack of confidentiality, and loss of partners if one tested sero-positive. The intervention yielded lowered HIV stigma, increase in HIV knowledge, and agreement to take the HIV home test. These results are encouraging because they suggest that a brief educational intervention is a critical pathway to the success of the National Institutes on Drug Abuse’s Seek, Test, Treat, and Retain initiative in poor rural counties. PMID:27789935

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.

The influence of process and patient factors on the recall of consent information in mentally competent patients undergoing surgery for neck of femur fractures.

PubMed

Khan, S K; Karuppaiah, K; Bajwa, A S

2012-07-01

Informed consent is an ethical and legal prerequisite for major surgical procedures. Recent literature has identified 'poor consent' as a major cause of litigation in trauma cases. We aimed to investigate the patient and process factors that influence consent information recall in mentally competent patients (abbreviated mental test score [AMTS] ≥6) presenting with neck of femur (NOF) fractures. A prospective study was conducted at a tertiary unit. Fifty NOF patients (cases) and fifty total hip replacement (THR) patients (controls) were assessed for process factors (adequacy and validity of consent) as well as patient factors (comprehension and retention) using consent forms and structured interview proformas. The two groups were matched for ASA (American Society of Anesthesiologists) grade and AMTS. The consent forms were adequate in both groups but scored poorly for validity in the NOF group. Only 26% of NOF patients remembered correctly what surgery they had while only 48% recalled the risks and benefits of the procedure. These results were significantly poorer than in THR patients (p = 0.0001). This study confirms that NOF patients are poor at remembering the information conveyed to them at the time of consent when compared with THR patients despite being intellectually and physiologically matched. We suggest using preprinted consent forms (process factors), information sheets and visual aids (patient factors) to improve retention and recall.

77 FR 20848 - Notice of Lodging of Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

... labeled marine diesel engines in their respective operations. The Consent Decree requires Settling...-ignition engine manufacturer, and National Steel and Shipbuilding Company, a marine vessel manufacturer... Selective Catalytic Reduction emissions control technology at a marine engine test stand operated at...

Evaluation of the King-Devick Test to Assess Eye Movements and the Performance of Rapid Number Naming in Concussed and Non-Concussed Service Members

DTIC Science & Technology

2016-07-01

individuals who report a history of concussion on their baseline questionnaires vary from the pre-combatives baseline K-D Test assessment of individuals who...given the informed consent and HIPAA documents • Any volunteers that agrees to the consent process will be given a pre-combatives questionnaire and K-D...test before training begins • Volunteers who suffer a concussive event during training will be given a post-incident questionnaire (which includes

Interpretation of Do Not Attempt Resuscitation Orders for Children Requiring Anesthesia and Surgery.

PubMed

Fallat, Mary E; Hardy, Courtney

2018-05-01

This clinical report addresses the topic of pre-existing do not attempt resuscitation or limited resuscitation orders for children and adolescents undergoing anesthesia and surgery. Pertinent considerations for the clinician include the rights of children, decision-making by parents or legally approved representatives, the process of informed consent, and the roles of surgeon and anesthesiologist. A process of re-evaluation of the do not attempt resuscitation orders, called "required reconsideration," should be incorporated into the process of informed consent for surgery and anesthesia, distinguishing between goal-directed and procedure-directed approaches. The child's individual needs are best served by allowing the parent or legally approved representative and involved clinicians to consider whether full resuscitation, limitations based on procedures, or limitations based on goals is most appropriate. Copyright © 2018 by the American Academy of Pediatrics.

"Would you test your children without their consent?" and other sticky dilemmas in the field of cancer genetic testing.

PubMed

Brierley, Karina L; Bonadies, Danielle C; Moyer, Anne; Matloff, Ellen T

2014-09-01

Cancer genetic testing is surrounded by myriad ethical, legal, and psychosocial implications which are being revisited as testing expands into an everyday practice and into more complicated areas like whole exome and direct-to-consumer testing. We chose to survey cancer genetic counselors and physicians from a wide range of non-genetics specialties to determine what they would do if faced with the complex decisions associated with cancer genetic testing, how their views compare, and how they align with current guidelines and data. Genetic counselors were significantly more likely than non-genetics physicians to bill their insurance for testing (94.9 vs. 86.8 %; p = 0.001) and purchase life insurance before testing (86.6 vs. 68.6 %; p = 0.000) and were less likely to use an alias (3.2 vs. 13.2 %; p = 0.000) or order testing on their own DNA (15.3 vs. 24.2 %; p = 0.004). They were also less likely to test their minor children (0.9 vs. 33.1 %; p = 0.000) or test their children without their knowledge and consent/assent (1.4 vs.11.5 %; p = 0.000). The results of our study indicate that there is wide variation regarding what clinicians predict they would do in the areas of ethical, legal and psychosocial issues in cancer genetic testing. Cancer genetic counselors' choices are more aligned with professional guidelines, likely due to their experience in the field and awareness of current guidelines. These data are a starting point for a broader discussion of who should offer cancer genetic counseling and testing to patients, particularly as the complexity of the available testing options and associated issues increase with whole exome sequencing.

Closure Report for Corrective Action Unit 563: Septic Systems, Nevada Test Site, Nevada

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

NSTec Environmental Restoration

2010-02-28

Corrective Action Unit (CAU) 563 is identified in the Federal Facility Agreement and Consent Order (FFACO) as “Septic Systems” and consists of the following four Corrective Action Sites (CASs), located in Areas 3 and 12 of the Nevada Test Site: · CAS 03-04-02, Area 3 Subdock Septic Tank · CAS 03-59-05, Area 3 Subdock Cesspool · CAS 12-59-01, Drilling/Welding Shop Septic Tanks · CAS 12-60-01, Drilling/Welding Shop Outfalls Closure activities were conducted from September to November 2009 in accordance with the FFACO (1996, as amended February 2008) and the Corrective Action Plan for CAU 563. The corrective action alternatives includedmore » No Further Action and Clean Closure.« less

40 CFR 24.02 - Issuance of initial orders; definition of final orders and orders on consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION AGENCY GENERAL RULES GOVERNING ISSUANCE OF AND ADMINISTRATIVE HEARINGS ON INTERIM STATUS... following a final decision by the Regional Administrator, or after thirty days from issuance if no hearing... in these procedures to the Regional Administrator shall be understood to be to the Assistant...

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.

Rethinking HIV exceptionalism: the ethics of opt-out HIV testing in sub-Saharan Africa

PubMed Central

2010-01-01

Abstract Opt-out testing for the human immunodeficiency virus (HIV) incorporates testing as a routine part of health care for all patients unless they refuse. The ethics of this approach to testing in sub-Saharan Africa is a source of controversy. Opt-out HIV testing is expected to improve survival by increasing case detection and thus linking more HIV-infected people to earlier treatment, provided there is effective patient follow-up and programme sustainability. At the population level, these benefits will likely outweigh the potential negative consequences of individuals experiencing HIV-related stigma. These justifications appeal to consequentialist moral theories that the acceptability of an action depends upon its outcomes. On the other hand, liberal moral theories state that the autonomy of individuals should always be protected unless restricting autonomy is necessary to protect the welfare of others. Opt-out consent may restrict autonomy and it is unclear whether it would benefit people other than those being tested. Yet, the doctrine of libertarian paternalism proposes that it is justifiable and desirable to use unobtrusive mechanisms to help individuals make choices to maximize their own welfare. Central to this idea are the premises featured by supporters of opt-out consent that individuals will not always make the best choices for their own welfare but they may be influenced to do so in ways that will not compromise their freedom of choice. Also important is the premise that all policies inevitably exert some such influence: opt-in consent encourages test refusal just as opt-out consent encourages acceptance. Based on these premises, opt-out testing may be an effective and ethically acceptable policy response to Africa’s HIV epidemic. PMID:20865076

Rethinking HIV exceptionalism: the ethics of opt-out HIV testing in sub-Saharan Africa.

PubMed

April, Michael D

2010-09-01

Opt-out testing for the human immunodeficiency virus (HIV) incorporates testing as a routine part of health care for all patients unless they refuse. The ethics of this approach to testing in sub-Saharan Africa is a source of controversy. Opt-out HIV testing is expected to improve survival by increasing case detection and thus linking more HIV-infected people to earlier treatment, provided there is effective patient follow-up and programme sustainability. At the population level, these benefits will likely outweigh the potential negative consequences of individuals experiencing HIV-related stigma. These justifications appeal to consequentialist moral theories that the acceptability of an action depends upon its outcomes. On the other hand, liberal moral theories state that the autonomy of individuals should always be protected unless restricting autonomy is necessary to protect the welfare of others. Opt-out consent may restrict autonomy and it is unclear whether it would benefit people other than those being tested. Yet, the doctrine of libertarian paternalism proposes that it is justifiable and desirable to use unobtrusive mechanisms to help individuals make choices to maximize their own welfare. Central to this idea are the premises featured by supporters of opt-out consent that individuals will not always make the best choices for their own welfare but they may be influenced to do so in ways that will not compromise their freedom of choice. Also important is the premise that all policies inevitably exert some such influence: opt-in consent encourages test refusal just as opt-out consent encourages acceptance. Based on these premises, opt-out testing may be an effective and ethically acceptable policy response to Africa's HIV epidemic.

Capacity to consent to research among patients with bipolar disorder.

PubMed

Misra, Sahana; Ganzini, Linda

2004-06-01

Experts have debated the influence of mental illness on decision-making capacity. This paper reviews concepts of decision-making capacity and existing research on the influence of mental illness on capacity to consent to research. We propose how bipolar disorder, especially mania, may have an effect on consent capacity. The current conceptualization of capacity utilizes legal standards of 'choice', 'understanding', 'appreciation' and 'rational reasoning', as well as voluntarism, or the assurance that the patient is free to agree or to decline to participate in research. Studies of patients with schizophrenia suggest impaired cognition influences 'understanding' and is more important than severity of psychosis in affecting decision-making abilities. There are no studies of sources and extent of impairment to consent to research among manic patients. Mania may influence a patient's understanding of the research protocol, but also alter the patient's views, values and level of insight, thus impairing decision-making abilities at the 'appreciation' standard even when the patient understands the relevant information. Mania may impact freedom to decide, yet paradoxically, manic patients may be less influenced by others and less vulnerable to coercion, undue influence and undue incentives compared to patients without mental illness. We suggest that in patients with mood disorders, the legal standard of appreciation be thoroughly probed during the consent procedure. Studies of the effect of mania and depression on consent capacity and voluntarism are needed in order to develop processes that increase safeguards in the informed consent process.

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

Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

2014-01-01

Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

A computer-based education intervention to enhance surrogates' informed consent for genomics research.

PubMed

Shelton, Ann K; Freeman, Bradley D; Fish, Anne F; Bachman, Jean A; Richardson, Lloyd I

2015-03-01

Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research. To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research. A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent. Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004). Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. ©2015 American Association of Critical-Care Nurses.

A qualitative study to assess school nurses' views on vaccinating 12-13 year old school girls against human papillomavirus without parental consent.

PubMed

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-07-21

In the UK, parental consent for the routine vaccination of 12-13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given, and in the UK, this includes conducting, and acting upon, an assessment of the maturity and competence of an adolescent minor. To facilitate this, policies, training and support structures for health providers should be implemented.

A qualitative study to assess school nurses' views on vaccinating 12–13 year old school girls against human papillomavirus without parental consent

PubMed Central

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-01-01

Background In the UK, parental consent for the routine vaccination of 12–13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. Methods HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix™). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. Results School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Conclusion Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given, and in the UK, this includes conducting, and acting upon, an assessment of the maturity and competence of an adolescent minor. To facilitate this, policies, training and support structures for health providers should be implemented. PMID:19622145

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.

Can the critically ill consent to participation in commercial television programmes? An Australian prehospital and emergency medicine perspective.

PubMed

Mackenney, Jonathan N

2015-08-01

The fly-on-the-wall medical documentary is a popular television phenomenon. When patients can give appropriate consent to filming, the final product can be both educational for the public and rewarding for its subjects. However, in the dynamic world of emergency and prehospital medicine, consenting critically ill patients before filming is a significant challenge. The main barriers to gaining valid consent in the field and in the ED are limited time to inform the patient and the diminished capacity of the sick patient. Although there is an argument that involvement in a commercial film might be beneficial to several parties, including the patient, these benefits do not amount to therapeutic necessity if prior consent is not obtainable. Despite this, we still see acutely incapacitated patients featured in some television programmes. In these cases, the conventional process of consent might be being sidestepped in order to obtain permission for broadcast retrospectively. This alternative process fails to recognise that incapacitated patients require protection from an invasion of privacy that occurs when a crew is filming their resuscitations. This harm has already occurred by the time consent is sought. Ultimate responsibility for defending the patients' interests during their medical treatment rests with the medical practitioner. We argue that filming a patient without prior consent in both the prehospital and emergency environment is ethically unsound: it threatens trust in the healthcare relationship and might compromise the patient's dignity and privacy. Robust guidelines should be developed for all healthcare professionals who engage with commercial film crews. © 2015 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Does parental consent for birth control affect underage pregnancy rates? The case of Texas.

PubMed

Girma, Sourafel; Paton, David

2013-12-01

Previous work based on conjectural responses of minors predicted that the 2003 Texas requirement for parental consent for state-funded birth control to minors would lead to a large increase in underage pregnancies. We use state- and county-level data to test this prediction. The latter allow us to compare the impact of parental consent in counties with and without state-funded family planning clinics. We control for characteristics systematically correlated with the presence of state-funded clinics by combining difference-in-difference estimation with propensity score-weighted regressions. The evidence suggests that the parental consent mandate led to a large decrease in attendance at family planning clinics among teens but did not lead to an increase in underage pregnancies.

From nationwide standardized testing to school-based alternative embedded assessment in Israel: Students' performance in the matriculation 2000 project

NASA Astrophysics Data System (ADS)

Dori, Yehudit J.

2003-01-01

Matriculation 2000 was a 5-year project aimed at moving from the nationwide traditional examination system in Israel to a school-based alternative embedded assessment. Encompassing 22 high schools from various communities in the country, the Project aimed at fostering deep understanding, higher-order thinking skills, and students' engagement in learning through alternative teaching and embedded assessment methods. This article describes research conducted during the fifth year of the Project at 2 experimental and 2 control schools. The research objective was to investigate students' learning outcomes in chemistry and biology in the Matriculation 2000 Project. The assumption was that alternative embedded assessment has some effect on students' performance. The experimental students scored significantly higher than their control group peers on low-level assignments and more so on assignments that required higher-order thinking skills. The findings indicate that given adequate support and teachers' consent and collaboration, schools can transfer from nationwide or statewide standardized testing to school-based alter-native embedded assessment.

[The meaning of autonomy in Chinese culture: obtaining informed consent for operation].

PubMed

Lin, Mei-Ling; Wu, Jo Yung-Wei; Huang, Mei-Chih

2008-10-01

The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.

Hypothetical contractarianism and the disclosure requirement problem in informed consent.

PubMed

Cust, Kenneth F T

1991-01-01

Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse.

Consent for participating in clinical trials - Is it really informed?

PubMed

Alexa-Stratulat, Teodora; Neagu, Marius; Neagu, Anca-Iulia; Alexa, Ioana Dana; Ioan, Beatrice Gabriela

2018-06-22

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected. © 2018 John Wiley & Sons Ltd.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

49 CFR 209.209 - Hearing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Hearing. 209.209 Section 209.209 Transportation... TRANSPORTATION RAILROAD SAFETY ENFORCEMENT PROCEDURES Compliance Orders § 209.209 Hearing. (a) When a respondent... and the respondent fail to agree upon an acceptable consent order, the hearing officer designated by...

49 CFR 209.209 - Hearing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Hearing. 209.209 Section 209.209 Transportation... TRANSPORTATION RAILROAD SAFETY ENFORCEMENT PROCEDURES Compliance Orders § 209.209 Hearing. (a) When a respondent... and the respondent fail to agree upon an acceptable consent order, the hearing officer designated by...

Cultural aspects related to informed consent in health research: A systematic review.

PubMed

Halkoaho, Arja; Pietilä, Anna-Maija; Ebbesen, Mette; Karki, Suyen; Kangasniemi, Mari

2016-09-01

In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. Our findings indicate that cultural perspectives relating to the informed consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. The researchers' awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research. © The Author(s) 2015.

[Informed Treatment Consent and Refusal in Advanced Endonasal Surgery: The Ethical Dilemma of Olfaction Sacrifice in Surgery for Chronic Rhinosinusitis with Polyposis].

PubMed

Subtil, João; Araújo, João Pedro; Saraiva, José; Santos, Alberto; Vera-Cruz, Paulo; Paço, João; Pais, Diogo

2015-01-01

Olfaction is frequently affected in chronic rhino-sinusitis with polyposis and has been recognised to have important impact on quality of life. Surgical resolution on cases of maximal medical therapy failure is an option to relieve symptoms, with debates as to how extensive surgery should be. A more radical approach will achieve better disease control with less relapse, but can also compromise olfaction. This decision about a more radical surgical approach should be shared with the patient. Thorough informed consent regarding disease control and hyposmia should be taken. Literature review and consultation with a board of experts. We propose some elements to be included in the informed consent discussion, in order to broadly address the surgical limitations regarding anosmia as a frequent complaint, as well as the different options and their associated consequences. Radical surgery decision making should be shared with the patient and the informed consent should be as thorough as possible regarding disease control and hyposmia resolution.

Consenting to counter-normative sexual acts: differential effects of consent on anger and disgust as a function of transgressor or consenter.

PubMed

Russell, Pascale Sophie; Piazza, Jared

2015-01-01

Anger and disgust may have distinct roles in sexual morality; here, we tested hypotheses regarding the distinct foci, appraisals, and motivations of anger and disgust within the context of sexual offenses. We conducted four experiments in which we manipulated whether mutual consent (Studies 1-3) or desire (Study 4) was present or absent within a counter-normative sexual act. We found that anger is focused on the injustice of non-consensual sexual acts, and the transgressor of the injustice (Studies 1 and 3). Furthermore, the sexual nature of the act was not critical for the elicitation of anger--as anger also responded to unjust acts of violence (Study 3). By contrast, we hypothesised and found that disgust is focused on whether or not a person voluntarily engaged in, desired or consented to a counter-normative sexual act (Studies 2-4). Appraisals of abnormality and degradation were the primary appraisals of disgust, and the sexual nature of the act was a critical elicitor of disgust (Study 3). A final study ruled out victimisation as the mechanism of the effect of consent on disgust and indicated that the consenter's sexual desire was the mechanism (Study 4). Our results reveal that anger and disgust have differential roles in consent-related sexual offenses due to the distinct appraisals and foci of these emotions.

Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing

PubMed Central

Sénécal, Karine; Thys, Kristof; Vears, Danya F; Van Assche, Kristof; Knoppers, Bartha M; Borry, Pascal

2016-01-01

The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as ‘young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of ‘minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle. PMID:27302841

Legal approaches regarding health-care decisions involving minors: implications for next-generation sequencing.

PubMed

Sénécal, Karine; Thys, Kristof; Vears, Danya F; Van Assche, Kristof; Knoppers, Bartha M; Borry, Pascal

2016-11-01

The development of next-generation sequencing (NGS) technologies are revolutionizing medical practice, facilitating more accurate, sophisticated and cost-effective genetic testing. NGS is already being implemented in the clinic assisting diagnosis and management of disorders with a strong heritable component. Although considerable attention has been paid to issues regarding return of incidental or secondary findings, matters of consent are less well explored. This is particularly important for the use of NGS in minors. Recent guidelines addressing genomic testing and screening of children and adolescents have suggested that as 'young children' lack decision-making capacity, decisions about testing must be conducted by a surrogate, namely their parents. This prompts consideration of the age at which minors can provide lawful consent to health-care interventions, and consequently NGS performed for diagnostic purposes. Here, we describe the existing legal approaches regarding the rights of minors to consent to health-care interventions, including how laws in the 28 Member States of the European Union and in Canada consider competent minors, and then apply this to the context of NGS. There is considerable variation in the rights afforded to minors across countries. Many legal systems determine that minors would be allowed, or may even be required, to make decisions about interventions such as NGS. However, minors are often considered as one single homogeneous population who always require parental consent, rather than recognizing there are different categories of 'minors' and that capacity to consent or to be involved in discussions and decision-making process is a spectrum rather than a hurdle.

Forcible Rape: An Analysis of Legal Issues.

ERIC Educational Resources Information Center

National Inst. of Law Enforcement and Criminal Justice (Dept. of Justice/LEAA), Washington, DC.

Traditionally, rape has been defined as "carnal knowledge of a woman by force and against her will." The test of force has been crucial, and consent deduced. Victims were assumed to be consenting parties unless criminal circumstances could be proved. Victims were oftened questioned about past sexual behavior. Current reform efforts have attempted…

Confidentiality, Informed Consent, and Ethical Considerations in Reviewing the Client's Psychotherapy Records

ERIC Educational Resources Information Center

Blunt, David R.

2006-01-01

Ethical dilemmas that break the confidentiality of the client eventually test the psychologist's boundaries such that not taking action may place the patient in a position where they suffer, hurt themselves, or others. The effectiveness in obtaining a valid informed consent might depend upon the therapists training, experience, and sound judgment…

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.

The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial.

PubMed

Winter, Matthew; Kam, Jonathan; Nalavenkata, Sunny; Hardy, Ellen; Handmer, Marcus; Ainsworth, Hannah; Lee, Wai Gin; Louie-Johnsun, Mark

2016-11-01

To determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. In this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015). Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. In all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. This study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Ethical and legal implications of whole genome and whole exome sequencing in African populations.

PubMed

Wright, Galen E B; Koornhof, Pieter G J; Adeyemo, Adebowale A; Tiffin, Nicki

2013-05-28

Rapid advances in high throughput genomic technologies and next generation sequencing are making medical genomic research more readily accessible and affordable, including the sequencing of patient and control whole genomes and exomes in order to elucidate genetic factors underlying disease. Over the next five years, the Human Heredity and Health in Africa (H3Africa) Initiative, funded by the Wellcome Trust (United Kingdom) and the National Institutes of Health (United States of America), will contribute greatly towards sequencing of numerous African samples for biomedical research. Funding agencies and journals often require submission of genomic data from research participants to databases that allow open or controlled data access for all investigators. Access to such genotype-phenotype and pedigree data, however, needs careful control in order to prevent identification of individuals or families. This is particularly the case in Africa, where many researchers and their patients are inexperienced in the ethical issues accompanying whole genome and exome research; and where an historical unidirectional flow of samples and data out of Africa has created a sense of exploitation and distrust. In the current study, we analysed the implications of the anticipated surge of next generation sequencing data in Africa and the subsequent data sharing concepts on the protection of privacy of research subjects. We performed a retrospective analysis of the informed consent process for the continent and the rest-of-the-world and examined relevant legislation, both current and proposed. We investigated the following issues: (i) informed consent, including guidelines for performing culturally-sensitive next generation sequencing research in Africa and availability of suitable informed consent documents; (ii) data security and subject privacy whilst practicing data sharing; (iii) conveying the implications of such concepts to research participants in resource limited settings. We conclude that, in order to meet the unique requirements of performing next generation sequencing-related research in African populations, novel approaches to the informed consent process are required. This will help to avoid infringement of privacy of individual subjects as well as to ensure that informed consent adheres to acceptable data protection levels with regard to use and transfer of such information.

Ethical and legal implications of whole genome and whole exome sequencing in African populations

PubMed Central

2013-01-01

Background Rapid advances in high throughput genomic technologies and next generation sequencing are making medical genomic research more readily accessible and affordable, including the sequencing of patient and control whole genomes and exomes in order to elucidate genetic factors underlying disease. Over the next five years, the Human Heredity and Health in Africa (H3Africa) Initiative, funded by the Wellcome Trust (United Kingdom) and the National Institutes of Health (United States of America), will contribute greatly towards sequencing of numerous African samples for biomedical research. Discussion Funding agencies and journals often require submission of genomic data from research participants to databases that allow open or controlled data access for all investigators. Access to such genotype-phenotype and pedigree data, however, needs careful control in order to prevent identification of individuals or families. This is particularly the case in Africa, where many researchers and their patients are inexperienced in the ethical issues accompanying whole genome and exome research; and where an historical unidirectional flow of samples and data out of Africa has created a sense of exploitation and distrust. In the current study, we analysed the implications of the anticipated surge of next generation sequencing data in Africa and the subsequent data sharing concepts on the protection of privacy of research subjects. We performed a retrospective analysis of the informed consent process for the continent and the rest-of-the-world and examined relevant legislation, both current and proposed. We investigated the following issues: (i) informed consent, including guidelines for performing culturally-sensitive next generation sequencing research in Africa and availability of suitable informed consent documents; (ii) data security and subject privacy whilst practicing data sharing; (iii) conveying the implications of such concepts to research participants in resource limited settings. Summary We conclude that, in order to meet the unique requirements of performing next generation sequencing-related research in African populations, novel approaches to the informed consent process are required. This will help to avoid infringement of privacy of individual subjects as well as to ensure that informed consent adheres to acceptable data protection levels with regard to use and transfer of such information. PMID:23714101

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial.

PubMed

Siu, Jennifer M; Rotenberg, Brian W; Franklin, Jason H; Sowerby, Leigh J

2016-06-01

To determine patient recall of specific risks associated with endoscopic sinus surgery and whether an adjunct multimedia education module is an effective patient tool in enhancing the standard informed consent process. Prospective, randomized, controlled trial. Fifty consecutive adult patients scheduled for endoscopic sinus surgery at a rhinology clinic of a tertiary care hospital were recruited for this study. Informed consent was studied by comparing the number of risks recalled when patients had a verbal discussion in conjunction with a 6-minute interactive module or the verbal discussion alone. Early recall was measured immediately following the informed consent process, and delayed recall was measured 3 to 4 weeks after patient preference details were also collected. Early risk recall in the multimedia group was significantly higher than the control group (P = .0036); however, there was no difference between the groups in delayed risk recall. Seventy-six percent of participants expressed interest in viewing the multimedia module if available online between the preoperative and procedural day. Sixty-eight percent of patients preferred having the multimedia module as an adjunct to the informed consent process as opposed to the multimedia consent process alone. There is an early improvement in overall risk recall in patients who complete an interactive multimedia module, with a clear patient preference for this method. Here we emphasize the well-known challenges of patient education and demonstrate the effectiveness of integrating technology into clinical practice in order to enhance the informed consent process. 1b Laryngoscope, 126:1273-1278, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

75 FR 57080 - In the Matter of Aerotest Operations, Inc. (Aerotest Radiography and Research Reactor); Order...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-17

..., consented to the indirect transfer of control of the above facility from its current owner, Autoliv to X-Ray Industries, Inc. (X- Ray), (together, the applicants), pursuant to 10 CFR 50.80. By its terms, the Order of...

User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic.

PubMed

Ramos, S Raquel

2017-11-01

Health information exchange is the electronic accessibility and transferability of patient medical records across various healthcare settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multistep, multiframework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step 1 was a cross-sectional, descriptive, qualitative study that used user-centric design interviews to create the user interface. This informed Step 2. Step 2 consisted of a one group posttest to examine perceptions of usefulness, ease of use, preference, and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share health information. Comprehension is key factor in the ability to make informed decisions.

NEUROPSYCHOLOGICAL PERFORMANCE WITHIN-PERSON VARIABILITY IS ASSOCIATED WITH REDUCED TREATMENT CONSENT CAPACITY

PubMed Central

Gurrera, Ronald J.; Karel, Michele J.; Azar, Armin R.; Moye, Jennifer

2013-01-01

OBJECTIVES The capacity of older adults to make health care decisions is often impaired in dementia and has been linked to performance on specific neuropsychological tasks. Within-person across-test neuropsychological performance variability has been shown to predict future dementia. This study examined the relationship of within-person across-test neuropsychological performance variability to a current construct of treatment decision (consent) capacity. DESIGN Participants completed a neuropsychological test battery and a standardized capacity assessment. Standard scores were used to compute mean neuropsychological performance and within-person across-test variability. SETTING Assessments were performed in the participant’s preferred location (e.g., outpatient clinic office, senior center, or home). PARTICIPANTS Participants were recruited from the community with fliers and advertisements, and consisted of men (N=79) and women (N=80) with (N=83) or without (N=76) significant cognitive impairment. MEASUREMENTS Participants completed the MacArthur Competence Assessment Tool - Treatment (MacCAT-T) and 11 neuropsychological tests commonly used in the cognitive assessment of older individuals. RESULTS Neuropsychological performance and within-person variability were independently associated with continuous and dichotomous measures of capacity, and within-person neuropsychological variability was significantly associated with within-person decisional ability variability. Prevalence of incapacity was greater than expected in participants with and without significant cognitive impairment when decisional abilities were considered separately. CONCLUSIONS These findings are consistent with an emerging construct of consent capacity in which discrete decisional abilities are differentially associated with cognitive processes, and indicate that the sensitivity and accuracy of consent capacity assessments can be improved by evaluating decisional abilities separately. PMID:23831178

Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

PubMed Central

Vučemilo, Luka; Borovečki, Ana

2015-01-01

Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

Settlement of Clean Water Act Violations

EPA Pesticide Factsheets

Fully executed copy of the Administrative Order for Compliance on Consent (AOCC) between EPA and Fluid Recovery Services, Inc., Hart Resource Technologies, Inc., and Pennsylvania Brine Treatment, Inc.

Assessing capacity to consent to treatment with cholinesterase inhibitors in dementia using a specific and standardized version of the MacArthur Competence Assessment Tool (MacCAT-T).

PubMed

Mueller, Tanja; Haberstroh, Julia; Knebel, Maren; Oswald, Frank; Kaspar, Roman; Kemper, Christoph J; Halder-Sinn, Petra; Schroeder, Johannes; Pantel, Johannes

2017-02-01

The use of assessment tools has been shown to improve the inter-rater reliability of capacity assessments. However, instrument-based capacity assessments of people with dementia face challenges. In dementia research, measuring capacity with instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) mostly employ hypothetical treatment vignettes that can overwhelm the abstraction capabilities of people with dementia and are thus not always suitable for this target group. The primary aim of this study was to provide a standardized real informed consent paradigm that enables the dementia-specific properties of capacity to consent to treatment in people with dementia to be identified in a real informed consent process that is both externally valid and ethically justifiable. The sample consisted of 53 people with mild to moderate dementia and a group of 133 people without cognitive impairment. Rather than using a hypothetical treatment vignette, we used a standardized version of the MacCAT-T to assess capacity to consent to treatment with cholinesterase inhibitors in people with dementia. Inter-rater reliability, item statistics, and psychometric properties were also investigated. Intraclass correlations (ICCs) (0.951-0.990) indicated high inter-rater reliability of the standardized real informed consent paradigm. In the dementia group, performance on different items of the MacCAT-T varied. Most people with dementia were able to express a treatment choice, and were aware of the need to take a tablet. Further information on the course of the disorder and the benefits and risks of the treatment were less understood, as was comparative reasoning regarding treatment alternatives. The standardized real informed consent paradigm enabled us to detect dementia-specific characteristics of patients' capacity to consent to treatment with cholinesterase inhibitors. In order to determine suitable enhanced consent procedures for this treatment, we recommend the consideration of MacCAT-T results on an item level. People with dementia seem to understand only basic information. Our data indicate that one useful strategy to enhance capacity to consent is to reduce attention and memory demands as far as possible.

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.

Different Diagnosis, Shared Vulnerabilities: The Value of Cross Disorder Validation of Capacity to Consent.

PubMed

Rosen, Allyson; Weitlauf, Julie C

2015-01-01

A screening measure of capacity to consent can provide an efficient method of determining the appropriateness of including individuals from vulnerable patient populations in research, particularly in circumstances in which no caregiver is available to provide surrogate consent. Seaman et al. (2015) cross-validate a measure of capacity to consent to research developed by Jeste et al. (2007). They provide data on controls, caregivers, and patients with mild cognitive impairment and dementia. The study demonstrates the importance of validating measures across disorders with different domains of incapacity, as well as the need for timely and appropriate follow-up with potential participants who yield positive screens. Ultimately clinical measures need to adapt to the dimensional diagnostic approaches put forward in DSM 5. Integrative models of constructs, such as capacity to consent, will make this process more efficient by avoiding the need to test measures in each disorder. Until then, cross-validation studies, such as the work by Seaman et al. (2015) are critical.

76 FR 15313 - Chitika, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... network advertiser that engages in online behavioral advertising, the practice of tracking consumers... activity. Chitika offers an online behavioral advertising service in which it acts as an intermediary... order to serve advertising targeted to the individual consumer's interests. When a consumer visits a Web...

New Chemicals Exposure Limits section 5(e) Order Boilerplate insert under the Toxic Substances Control Act (TSCA) New Chemicals Program

EPA Pesticide Factsheets

The New Chemicals Exposure Limits (NCELs) section 5(e) Consent Order insert presents the standard NCELs provisions. The actual NCEL concentration is an empty blank to be completed depending on the toxicity of the specific chemical involved.

29 CFR 1608.8 - Adherence to court order.

Code of Federal Regulations, 2011 CFR

2011-07-01

... United States District Court or other court of competent jurisdiction, whether entered by consent or after contested litigation, in a case brought to enforce a Federal, State, or local equal employment... taken pursuant to the direction of a Court Order cannot give rise to liability under title VII. ...

29 CFR 1608.8 - Adherence to court order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... United States District Court or other court of competent jurisdiction, whether entered by consent or after contested litigation, in a case brought to enforce a Federal, State, or local equal employment... taken pursuant to the direction of a Court Order cannot give rise to liability under title VII. ...

78 FR 13673 - HTC America, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... modifying various pre-installed applications and components in order to differentiate its products from.... As the customized applications and components are pre-installed on the device, consumers do not... together, failed to provide reasonable and appropriate security in the design and customization of software...

[The Evans case and the right not to be forced to reproduce].

PubMed

Alkorta Idiakez, Itziar

2006-01-01

The article analyses the ruling of the European Court of Human Rights, Evans v. United Kingdom, of March 7, 2006 (application no. 6339/05) from the perspective of the nature and the effects of a consent together with the conservation and disposal of cryopreserved embryos. Several prevailing normative models are studied in order to look at the disposal of embryos and to test its legal consistency. As a conclusion and basing it on the Evans case, there is a proposition to distinguish between the acts of disposal of spare embryos from IVF programs and the deposit of embryos as a way to prevent lack of fertility.

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.

Associations between Mode of HIV Testing and Consent, Confidentiality, and Referral: A Comparative Analysis in Four African Countries

PubMed Central

Obermeyer, Carla Makhlouf; Neuman, Melissa; Desclaux, Alice; Wanyenze, Rhoda; Ky-Zerbo, Odette; Cherutich, Peter; Namakhoma, Ireen; Hardon, Anita

2012-01-01

Background Recommendations about scaling up HIV testing and counseling highlight the need to provide key services and to protect clients' rights, but it is unclear to what extent different modes of testing differ in this respect. This paper examines whether practices regarding consent, confidentiality, and referral vary depending on whether testing is provided through voluntary counseling and testing (VCT) or provider-initiated testing. Methods and Findings The MATCH (Multi-Country African Testing and Counseling for HIV) study was carried out in Burkina Faso, Kenya, Malawi, and Uganda. Surveys were conducted at selected facilities. We defined eight outcome measures related to pre- and post-test counseling, consent, confidentiality, satisfactory interactions with providers, and (for HIV-positive respondents) referral for care. These were compared across three types of facilities: integrated facilities, where testing is provided along with medical care; stand-alone VCT facilities; and prevention of mother-to-child transmission (PMTCT) facilities, where testing is part of PMTCT services. Tests of bivariate associations and modified Poisson regression were used to assess significance and estimate the unadjusted and adjusted associations between modes of testing and outcome measures. In total, 2,116 respondents tested in 2007 or later reported on their testing experience. High percentages of clients across countries and modes of testing reported receiving recommended services and being satisfied. In the unadjusted analyses, integrated testers were less likely to meet with a counselor before testing (83% compared with 95% of VCT testers; p<0.001), but those who had a pre-test meeting were more likely to have completed consent procedures (89% compared with 83% among VCT testers; p<0.001) and pre-test counseling (78% compared with 73% among VCT testers; p = 0.015). Both integrated and PMTCT testers were more likely to receive complete post-test counseling than were VCT testers (59% among both PMTCT and integrated testers compared with 36% among VCT testers; p<0.001). Adjusted analyses by country show few significant differences by mode of testing: only lower satisfaction among integrated testers in Burkina Faso and Uganda, and lower frequency of referral among PMTCT testers in Malawi. Adjusted analyses of pooled data across countries show a higher likelihood of pre-test meeting for those testing at VCT facilities (adjusted prevalence ratio: 1.22, 95% CI: 1.07–1.38) and higher satisfaction for stand-alone VCT facilities (adjusted prevalence ratio: 1.15; 95% CI: 1.06–1.25), compared to integrated testing, but no other associations were statistically significant. Conclusions Overall, in this study most respondents reported favorable outcomes for consent, confidentiality, and referral. Provider-initiated ways of delivering testing and counseling do not appear to be associated with less favorable outcomes for clients than traditional, client-initiated VCT, suggesting that testing can be scaled up through multiple modes without detriment to clients' rights. Please see later in the article for the Editors' Summary PMID:23109914

Associations between mode of HIV testing and consent, confidentiality, and referral: a comparative analysis in four African countries.

PubMed

Obermeyer, Carla Makhlouf; Neuman, Melissa; Desclaux, Alice; Wanyenze, Rhoda; Ky-Zerbo, Odette; Cherutich, Peter; Namakhoma, Ireen; Hardon, Anita

2012-01-01

Recommendations about scaling up HIV testing and counseling highlight the need to provide key services and to protect clients' rights, but it is unclear to what extent different modes of testing differ in this respect. This paper examines whether practices regarding consent, confidentiality, and referral vary depending on whether testing is provided through voluntary counseling and testing (VCT) or provider-initiated testing. The MATCH (Multi-Country African Testing and Counseling for HIV) study was carried out in Burkina Faso, Kenya, Malawi, and Uganda. Surveys were conducted at selected facilities. We defined eight outcome measures related to pre- and post-test counseling, consent, confidentiality, satisfactory interactions with providers, and (for HIV-positive respondents) referral for care. These were compared across three types of facilities: integrated facilities, where testing is provided along with medical care; stand-alone VCT facilities; and prevention of mother-to-child transmission (PMTCT) facilities, where testing is part of PMTCT services. Tests of bivariate associations and modified Poisson regression were used to assess significance and estimate the unadjusted and adjusted associations between modes of testing and outcome measures. In total, 2,116 respondents tested in 2007 or later reported on their testing experience. High percentages of clients across countries and modes of testing reported receiving recommended services and being satisfied. In the unadjusted analyses, integrated testers were less likely to meet with a counselor before testing (83% compared with 95% of VCT testers; p<0.001), but those who had a pre-test meeting were more likely to have completed consent procedures (89% compared with 83% among VCT testers; p<0.001) and pre-test counseling (78% compared with 73% among VCT testers; p = 0.015). Both integrated and PMTCT testers were more likely to receive complete post-test counseling than were VCT testers (59% among both PMTCT and integrated testers compared with 36% among VCT testers; p<0.001). Adjusted analyses by country show few significant differences by mode of testing: only lower satisfaction among integrated testers in Burkina Faso and Uganda, and lower frequency of referral among PMTCT testers in Malawi. Adjusted analyses of pooled data across countries show a higher likelihood of pre-test meeting for those testing at VCT facilities (adjusted prevalence ratio: 1.22, 95% CI: 1.07-1.38) and higher satisfaction for stand-alone VCT facilities (adjusted prevalence ratio: 1.15; 95% CI: 1.06-1.25), compared to integrated testing, but no other associations were statistically significant. Overall, in this study most respondents reported favorable outcomes for consent, confidentiality, and referral. Provider-initiated ways of delivering testing and counseling do not appear to be associated with less favorable outcomes for clients than traditional, client-initiated VCT, suggesting that testing can be scaled up through multiple modes without detriment to clients' rights. Please see later in the article for the Editors' Summary.

Readability of Invasive Procedure Consent Forms.

PubMed

Eltorai, Adam E M; Naqvi, Syed S; Ghanian, Soha; Eberson, Craig P; Weiss, Arnold-Peter C; Born, Christopher T; Daniels, Alan H

2015-12-01

Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch-Kincaid Grade Level, Fog Scale, SMOG Index, Coleman-Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. © 2015 Wiley Periodicals, Inc.

Readability of Invasive Procedure Consent Forms

PubMed Central

Eltorai, Adam E. M.; Naqvi, Syed S.; Ghanian, Soha; Eberson, Craig P.; Weiss, Arnold‐Peter C.; Born, Christopher T.

2015-01-01

Abstract Background Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. Materials and methods To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch–Kincaid Grade Level, Fog Scale, SMOG Index, Coleman–Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Results Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Conclusion Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. PMID:26678039

Prévention de la transmission mère-enfant du VIH/sida au Bénin: le consentement des femmes au dépistage est-il libre et éclairé ?

PubMed Central

Kêdoté, N.M.; Brousselle, A.; Champagne, F.; Laudy, D.

2016-01-01

Résumé Introduction Dans les politiques internationales et nationales sur le VIH/sida, le consentement libre et éclairé est reconnu comme une composante essentielle des programmes de dépistage. Le consentement libre et éclairé implique pour les femmes enceintes d’obtenir des informations sur le programme de prévention de la transmission du VIH de la mère à l’enfant (PTME), de les comprendre et de faire un choix autonome après avoir évalué les risques et avantages. Cependant, aucune évaluation du programme de PTME ne s’est intéressée au consentement. L’objectif de cet article est d’explorer le caractère libre et éclairé du consentement des femmes enceintes quant au dépistage et à leurs motivations à faire le test. Méthode Nous avons utilisé des données récoltées dans le cadre d’une analyse d’implantation du programme de PTME au Bénin. Cette analyse s’appuie sur un devis d’étude de cas multiples incluant six maternités choisies parmi les 56 sites fonctionnels. Spécifiquement pour l’analyse du consentement, nous avons associé les données provenant d’une enquête à celles d’une recherche qualitative. Résultats Hormis trois cas de dépistage à l’insu, le caractère volontaire du consentement au test est respecté sur les sites de PTME. Vingt-neuf cas de refus ont été identifiés. Les raisons les plus souvent évoquées par les femmes enceintes sont la peur du résultat positif et de ses conséquences sur la vie familiale dans 55,2 % des cas et l’attente de l’accord ou du désaccord du mari dans 27,6 % des cas. Si globalement le consentement a été volontaire sur tous les sites, son caractère éclairé est moins probant. PMID:27840660

Ethical issues raised by genetic testing with oligonucleotide microarrays.

PubMed

Grody, Wayne W

2003-02-01

Because genes and alterations within them determine the identity, characteristics, and inheritance of every individual, the application of genetic science to humans has long been surrounded by apprehension, controversy, and real or perceived potential for abuse. Crude eugenics practices of the past now find a theoretical rebirth and transformation through the use of modern molecular genetic technologies for mutation detection, predictive and prenatal diagnosis, and, ultimately, gene replacement. The advent of oligonucleotide microarray analysis, in which hundreds or thousands of genes and mutations can be tested in parallel, offers tremendous promise for more accurate, sensitive, and efficient genetic testing. At the same time, however, this powerful technology dramatically increases the number and scope of ethical concerns accompanying each individual test request. This article considers the evolution and implications of these concerns, from the initial ordering of a microarray test by the physician to such issues as informed consent, privacy, confidentiality, clinical utility, discrimination, stigmatization, ethnic and population impact, and reimbursement.

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

Live donor transplantation--the incompetent donor: comparative law.

PubMed

Wolfman, Samuel; Shaked, Tali

2008-12-01

Informed consent of the patient to medical treatment is an essential prerequisite for any invasive medical procedure. However in emergency cases, when the patient is unable to sign a consent form due to unconsciousness or to psychotic state, than the primary medical consideration shall take place. In such a case, in order to save life or even prevent a major medical hazard to the patient, doctors are allowed, in certain cases and in accordance with well accepted medical practice, to perform invasive procedures, major surgery or risky pharmacological treatment, without the explicit consent of the patient. All the above refers to the cases when avoidance of such non-consented treatment may harm severely the health and wellbeing of the patient and there is no doubt that such treatment is for the ultimate benefit of the patient. The question, however, shall arise when such a medical procedure is not necessarily for the benefit of the patient, but rather for the benefit of somebody else. Such is the case in the transplantation area and the question of living donor-donee relationship. This paper shall analyze the legal situation in cases of non competent donors whose consent cannot be considered legal consent given in full understanding and out of free will. It will also compare three legal systems, the Israeli, the American and the traditional Jewish law, with regard to the different approaches to this human problem, where the autonomy of the donor may be sacrificed for the purpose of saving life of another person.

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.

Informed consent: is it a myth?

PubMed

Herz, D A; Looman, J E; Lewis, S K

1992-03-01

The issue of informed consent at it relates to neurosurgical professional malpractice liability and litigation has been of concern for 20 years or more. The problem persists, and the subject has been addressed by providing patient education with full disclosure regarding neurosurgical procedures. In the process of imparting informed consent, the authors studied the effectiveness of specific neurosurgical health care teaching. One hundred six persons undergoing anterior cervical fusion or lumbar laminectomy were instructed by a neurosurgeon and clinical nurse specialist with a master's degree in neurosurgery. Written testing was performed in each case immediately after a formal teaching session before surgery. Questions were simple and covered only four general topics: 1) diagnosis and surgical techniques; 2) operative risks; 3) postoperative care; and 4) goals and benefits relating to surgery. The mean score on testing immediate retention of information revealed a 43.5% overall performance rate. When patients were tested approximately 6 weeks later, the score dropped to 38.4%. This was statistically significant (chi 2, P less than 0.05). The authors encourage the concept of patient education. The data in the current study, however, suggest that the reasonable and prudent neurosurgeon making a concerted effort at patient education, with the assistance of a professional educator, cannot necessarily expect accurate patient or family recall or comprehension. Fulfillment of the doctrine of informed consent by neurosurgeons may very well be mythical.

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.

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.

Regulation of Genetic Tests

MedlinePlus

... Informed Consent for Genomics Research Intellectual Property Online Bioethics Resources Privacy in Genomics Regulation of Genetic Tests ... Research Intellectual Property Issues in Genetics Archive Online Bioethics Resources Privacy in Genomics Regulation of Genetic Tests ...

Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.

PubMed

Andrews, Joseph E; Moore, J Brian; Weinberg, Richard B; Sissine, Mysha; Gesell, Sabina; Halladay, Jacquie; Rosamond, Wayne; Bushnell, Cheryl; Jones, Sara; Means, Paula; King, Nancy M P; Omoyeni, Diana; Duncan, Pamela W

2018-05-02

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

SH Bell Site Boundary Map

EPA Pesticide Factsheets

S.H. Bell is subject to other ongoing obligations set forth in the December 5, 2016, “Stipulated Settlement and Final Consent Order,” including continued operation and maintenance of the monitors.

Administrative Order - Cherokee Oil

EPA Pesticide Factsheets

Contains legal consent agreement for Cherokee Oil Resources under CERCLA section 122(g) (4), Charlotte, Mecklenburg County, North Carolina, August 4, 1997 Region ID: 04 DocID: 28332, DocDate: 08-04-1997

In re Visbeck.

PubMed

1986-02-04

The Superior Court of New Jersey ordered the appointment of a guardian to consent to implantation of a feeding tube for a 90-year-old patient who had suffered a severely disabling stroke, though her son had not agreed to the proposed procedure. The court reasoned that a patient who becomes incompetent does not lose the right to accept or refuse medical treatment; instead, a substitute or surrogate decision maker exercises the patient's right of consent. Without the surgical implantation of a feeding tube in the patient's stomach, she would have suffered death from dehydration and starvation.

Return of results in translational iPS cell research: considerations for donor informed consent

PubMed Central

2013-01-01

Efforts have emerged internationally to recruit donors with specific disease indications and to derive induced pluripotent cell lines. These disease-specific induced pluripotent stem cell lines have the potential to accelerate translational goals such as drug discovery and testing. One consideration for donor recruitment and informed consent is the possibility that research will result in findings that are clinically relevant to the cell donor. Management protocols for such findings should be developed a priori and disclosed during the informed consent process. The California Institute for Regenerative Medicine has developed recommendations for informing donors in sponsored research. These recommendations include obtaining consent to recontact tissue donors for a range of scientific, medical and ethical considerations. This article reviews the basis for these recommendations and suggests conditions that may be appropriate when reporting findings to donors. PMID:23336317

A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial.

PubMed

Rubright, Jonathan; Sankar, Pamela; Casarett, David J; Gur, Ruben; Xie, Sharon X; Karlawish, Jason

2010-12-01

Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent. Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid. Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level. Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison with cognitively normal older adult norms. AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on the measures of appreciation or reasoning. A consent process that addresses the deficits in memory and attention of a patient with AD can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. ClinicalTrials.Gov#NCT00105612, http://clinicaltrials.gov/show/NCT00105612.

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.

A memory and organizational aid improves AD research consent capacity: Results of a randomized, controlled trial

PubMed Central

Rubright, Jonathan; Sankar, Pamela; Casarett, David J; Gur, Ruben; Xie, Sharon X; Karlawish, Jason

2010-01-01

Objectives AD patients' early and progressive cognitive impairments hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, we tested whether a memory and organizational aid improves AD patient performance on measures of capacity and competency to give informed consent. Design, Setting, and Participants AD patients randomly assigned to standard consent, or standard plus a memory and organizational aid. Intervention Memory and organizational aid summarized at a 6th grade reading level the content of information mandated under the Common Rule's informed consent disclosure requirements. Measurements Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison to cognitively normal older adult norms. Results AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on measures of appreciation or reasoning. Conclusions A consent process that addresses an AD patients' deficits in memory and attention can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. PMID:20808101

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.

PubMed

Allen, Ashleigh A; Chen, Donna T; Bonnie, Richard J; Ko, Tomohiro M; Suratt, Colleen E; Lee, Joshua D; Friedmann, Peter D; Gordon, Michael; McDonald, Ryan; Murphy, Sean M; Boney, Tamara Y; Nunes, Edward V; O'Brien, Charles P

2017-10-01

Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit. Copyright © 2017. Published by Elsevier Inc.

Legal and ethical aspects of deliberate G-induced loss of consciousness experiments.

PubMed

Euretig, J G

1991-07-01

Informed consent is both a legal and accepted ethical prerequisite to nontherapeutic human experimentation. The informed consent obtained from the subject in G-LOC experimentation is in the same form as the risk disclosures used in high-G acceleration experiments. However, in high acceleration protocols G-LOC is a potential risk while in G-LOC experiments it is the result. The case law embodies three modern evidentiary standards (the "professional," "material fact," and "possible risks" tests) employed by common law courts when deciding whether the risk disclosures are sufficient to elicit the informed consent of the subject. Each standard is applied against the disclosures in the G-LOC protocol to determine if the elements of the requirement are met. The risk disclosures are wanting in specific identification under the three tests. The deficiency is the failure to inform the subject that G-LOC may result in a pathologic state of unconsciousness about which little is known. Without complete disclosure of this lacking state of medical knowledge, it is questionable whether informed consent can be given. If subjected to judicial scrutiny, the disclosures stated in the G-LOC protocol used in government sponsored research will probably be found deficient.

Pharmacogenetic testing, informed consent and the problem of secondary information.

PubMed

Netzer, Christian; Biller-Andorno, Nikola

2004-08-01

Numerous benefits for patients have been predicted if prescribing decisions were routinely accompanied by pharmacogenetic testing. So far, little attention has been paid to the possibility that the routine application of this new technology could result in considerable harm to patients. This article emphasises that pharmacogenetic testing shares both the opportunities and the pitfalls with 'conventional' disease-genetic testing. It demonstrates that performing pharmacogenetic tests as well as interpreting the results are extraordinarily complex issues requiring a high level of expertise. It further argues that pharmacogenetic testing can have a huge impact on clinical decisions and may influence the therapeutic strategy as well as the clinical monitoring of a patient. This view challenges the predominant paradigm that pharmacogenetic testing will predict patients' responses to medicines, but that it will not provide any other significant disease-specific predictive information about the patient or family members. The article also questions published proposals to reduce the consent procedure for pharmacogenetic testing to a simple statement that the physician wishes to test a sample of the patient's DNA to see if a drug will be safe or whether it will work, and presents an alternative model that is better suited to protect patient's interests and to obtain meaningful informed consent. The paper concludes by outlining conditions for the application of pharmacogenetic testing in clinical practice in a way that can make full use of its potential benefits while minimising possible harm to patients and their families.

Conflict of interest issues in informed consent for research on human subjects: a South Asian perspective.

PubMed

Jafarey, Aamir M

2002-07-01

Health research for progress in the control and conquest of disease afflicting man is unquestionable. Concerns arise when motives other than the advancement of scientific knowledge and benefit for individuals and society are the driving force behind clinical trials. These conflicts of interests become even more pronounced when dealing with populations rendered vulnerable by virtue of poverty and ignorance. South Asia with its teeming millions represents one such region. This essay examines the reasons that make this population vulnerable to exploitation. Informed consent in the process of research is an area where such conflicts are prone to arise. In order to ensure that conflicting interests of researchers and funding agencies are kept in check, the processes of informed consent and ethical review of research need to be strengthened. Suggestions are put forward to modify the consent process to match the needs of South Asia and to strengthen the ethical review process for safeguarding the rights of the study subjects. But perhaps the most important safeguard against exploitation is the virtuous researcher himself with noble intentions.

Quality, not just quantity: Lessons learned from HIV testing in Salvador, Brazil

PubMed Central

MacCarthy, Sarah; Rasanathan, Jennifer J. K.; Dourado, Ines; Gruskin, Sofia

2015-01-01

Studies have demonstrated that an early HIV diagnosis is a critical first step toward continued engagement in care. We examined HIV testing experiences in Salvador, Brazil, to understand how a focus on quality services can inform service provision more generally in the post–2015 global health agenda. Seventeen semi-structured interviews were conducted with HIV-positive pregnant women in Salvador, a large urban centre of northeast Brazil. Interviews were transcribed, translated, and coded for analysis. Deductive codes confirmed factors identified in the literature review. Inductive codes highlighted new factors emerging from the initial coding. ‘Quality’ was defined according to global and national guidelines as HIV testing with informed and voluntary consent, counselling, and confidentiality (3Cs). No pregnant woman experienced all elements of the 3Cs. Three women did not experience any informed and voluntary consent, counselling, or confidentiality. Few women provided consent overall and none received pre-test counselling. Post-test counselling and confidentiality of services were more consistently provided. This study suggests that testing in Salvador—the third-largest city in the country—is not of the quality called for by global and national guidelines, despite the fact that HIV testing is being routinely provided for HIV-positive pregnant women in Brazil. Going forward, additional clarity around the 3Cs is necessary to improve how the quality, not just the quantity, of HIV services is measured. PMID:24881693

77 FR 65550 - Compete, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

... Public Reference Room, Room 130-H, 600 Pennsylvania Avenue NW., Washington, DC 20580, either in person or... interested persons. Comments received during this period will become part of the public record. After thirty... proposed order. Compete develops software for tracking consumers as they shop, browse and interact with...

17 CFR 155.4 - Trading standards for introducing brokers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the extent possible, that each order received from a customer or from an option customer which is... of the customer or option customer before any order in any future or in any commodity option in the... consent of the account owner, if the affiliated person has gained knowledge of the customer's or option...

77 FR 66841 - The Sherwin-Williams Company; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... include any sensitive personal information, like anyone's Social Security number, date of birth, driver's... make final the agreement's proposed order. This matter involves Sherwin-Williams's marketing and sale... and practices in the future. Part I addresses the marketing of zero VOC paints. It prohibits Sherwin...

78 FR 46950 - Ecobaby Organics, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

... any sensitive personal information, like anyone's Social Security number, date of birth, driver's... or make final the agreement's proposed order. This matter involves respondent's marketing and sale of... respondent from engaging in similar acts and practices in the future. Part I addresses the marketing of VOC...

76 FR 2908 - Nonprofit Management LLC and Jeremy Ryan Claeys; Analysis of Proposed Consent Order To Aid Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... involves the advertising, marketing, and sale of environmental certifications. From approximately February... proposed order bars respondents, in connection with the labeling, advertising, marketing, promotion...://www.testedgreen.com , as well as mass e-mails linking to their Web site. The marketing claimed that...

76 FR 18762 - Google, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

... final the agreement's proposed order. On February 9, 2010, Google launched a social networking service... street name and city or town; (c) email address or other online contact information, such as a user... networking service (``Google Buzz'') it used personal information previously collected for other purposes...

17 CFR 155.3 - Trading standards for futures commission merchants.

Code of Federal Regulations, 2014 CFR

2014-04-01

... controls to: (1) Insure, to the extent possible, that each order received from a customer which is... affiliated person has gained knowledge of the customer's order prior to the transmission to the floor of the... reason of their relationship to such other person, except with such other person's prior consent and in...

17 CFR 155.3 - Trading standards for futures commission merchants.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Insure, to the extent possible, that each order received from a customer which is executable at or near... gained knowledge of the customer's order prior to the transmission to the floor of the appropriate... reason of their relationship to such other person, except with such other person's prior consent and in...

75 FR 28654 - In the Matter of Certain Restraining Systems for Transport, Components Thereof, and Methods of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-21

... Not To Review an Initial Determination Granting Respondent's Second Amended Motion To Terminate the... administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 6) granting respondent's second amended motion to terminate the investigation in its entirety based on a consent order stipulation and to...

Informed Consent and Cognitive Dysfunction After Noncardiac Surgery in the Elderly.

PubMed

Hogan, Kirk J; Bratzke, Lisa C; Hogan, Kendra L

2018-02-01

Cognitive dysfunction 3 months after noncardiac surgery in the elderly satisfies informed consent thresholds of foreseeability in 10%-15% of patients, and materiality with new deficits observed in memory and executive function in patients with normal test performance beforehand. At present, the only safety step to avoid cognitive dysfunction after surgery is to forego surgery, thereby precluding the benefits of surgery with removal of pain and inflammation, and resumption of normal nutrition, physical activity, and sleep. To assure that consent for surgery is properly informed, risks of both cognitive dysfunction and alternative management strategies must be discussed with patients by the surgery team before a procedure is scheduled.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

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.

Why is it hard to make progress in assessing children's decision-making competence?

PubMed

Hein, Irma M; Troost, Pieter W; Broersma, Alice; de Vries, Martine C; Daams, Joost G; Lindauer, Ramón J L

2015-01-10

For decades, the discussion on children's competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children's interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children's competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children's competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children's medical decision-making competence. Understanding children's competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child's decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children's competency, in which the most prominent question concerns the lack of a clear operationalization of children's competence to consent. Empirical data are needed to substantiate the discussion. The empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

Red Hill

EPA Pesticide Factsheets

Information about the Red Hill Bulk Fuel Storage Facility in Hawaii Administrative Order on Consent (AOC), an enforceable agreement of the Hawaii Department of Health, the Environmental Protection Agency, and the U.S. Navy -- Defense Logistics Agency.

Johnny M Administrative Order on Consent

EPA Pesticide Factsheets

This Settlement Agreement provides for the performance of a removal action and the reimbursement of certain response costs incurred by the United States at or in connection with the Johnny M Mine Area.

S.H. Bell Section 114 Information Request

EPA Pesticide Factsheets

S.H. Bell is subject to other ongoing obligations set forth in the December 5, 2016, “Stipulated Settlement and Final Consent Order,” including continued operation and maintenance of the monitors.

The impact of presumed consent legislation on cadaveric organ donation: a cross-country study.

PubMed

Abadie, Alberto; Gay, Sebastien

2006-07-01

In the U.S., Great Britain and in many other countries, the gap between the demand and the supply of human organs for transplantation is on the rise, despite the efforts of governments and health agencies to promote donor registration. In some countries of continental Europe, however, cadaveric organ procurement is based on the principle of presumed consent. Under presumed consent legislation, a deceased individual is classified as a potential donor in absence of explicit opposition to donation before death. This article analyzes the impact of presumed consent laws on donation rates. For this purpose, we construct a dataset on organ donation rates and potential factors affecting organ donation for 22 countries over a 10-year period. We find that while differences in other determinants of organ donation explain much of the variation in donation rates, after controlling for those determinants presumed consent legislation has a positive and sizeable effect on organ donation rates. We use the panel structure of our dataset to test and reject the hypothesis that unmeasured determinants of organ donation rates confound our empirical results.

Family tree and ancestry inference: is there a need for a 'generational' consent?

PubMed

Wallace, Susan E; Gourna, Elli G; Nikolova, Viktoriya; Sheehan, Nuala A

2015-12-09

Genealogical research and ancestry testing are popular recreational activities but little is known about the impact of the use of these services on clients' biological and social families. Ancestry databases are being enriched with self-reported data and data from deoxyribonucleic acid (DNA) analyses, but also are being linked to other direct-to-consumer genetic testing and research databases. As both family history data and DNA can provide information on more than just the individual, we asked whether companies, as a part of the consent process, were informing clients, and through them clients' relatives, of the potential implications of the use and linkage of their personal data. We used content analysis to analyse publically-available consent and informational materials provided to potential clients of ancestry and direct-to-consumer genetic testing companies to determine what consent is required, what risks associated with participation were highlighted, and whether the consent or notification of third parties was suggested or required. We identified four categories of companies providing: 1) services based only on self-reported data, such as personal or family history; 2) services based only on DNA provided by the client; 3) services using both; and 4) services using both that also have a research component. The amount of information provided on the potential issues varied significantly across the categories of companies. 'Traditional' ancestry companies showed the greatest awareness of the implications for family members, while companies only asking for DNA focused solely on the client. While in some cases companies included text recommending clients inform their relatives, showing they recognised the issues, often it was located within lengthy terms and conditions or privacy statements that may not be read by potential clients. We recommend that companies should make it clearer that clients should inform third parties about their plans to participate, that third parties' data will be provided to companies, and that that data will be linked to other databases, thus raising privacy and issues on use of data. We also suggest investigating whether a 'generational consent' should be created that would include more than just the individual in decisions about participating in genetic investigations.

Taiwan Policy Act of 2013

THOMAS, 113th Congress

Rep. Ros-Lehtinen, Ileana [R-FL-27

2013-01-25

House - 08/01/2013 Ordered to be Reported in the Nature of a Substitute (Amended) by Unanimous Consent. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand.

PubMed

Taylor, H E; Bramley, D E P

2012-11-01

The provision of written information is a component of the informed consent process for research participants. We conducted a readability analysis to test the hypothesis that the language used in patient information and consent forms in anaesthesia research in Australia and New Zealand does not meet the readability standards or expectations of the Good Clinical Practice Guidelines, the National Health and Medical Research Council in Australia and the Health Research Council of New Zealand. We calculated readability scores for 40 patient information and consent forms using the Simple Measure of Gobbledygook and Flesch-Kincaid formulas. The mean grade level of patient information and consent forms when using the Simple Measure of Gobbledygook and Flesch-Kincaid readability formulas was 12.9 (standard deviation of 0.8, 95% confidence interval 12.6 to 13.1) and 11.9 (standard deviation 1.1, 95% confidence interval 11.6 to 12.3), respectively. This exceeds the average literacy and comprehension of the general population in Australia and New Zealand. Complex language decreases readability and negatively impacts on the informed consent process. Care should be exercised when providing written information to research participants to ensure language and readability is appropriate for the audience.

Effects of financial incentives on the intention to consent to organ donation: a questionnaire survey.

PubMed

Mayrhofer-Reinhartshuber, D; Fitzgerald, A; Benetka, G; Fitzgerald, R

2006-11-01

Shortage of donor organs is a serious problem for transplantation medicine. One controversial suggestion to increase the number of organ donors is financial incentives for consent. The aim of this study was to test whether different forms and amounts of financial incentives were apt to increase the consent to organ donation. Data were collected via questionnaires in urban and rural regions of Austria and randomly assigned to settings with three different amounts of financial incentives. The questionnaire was designed by using the theory of planned behaviour of Ajzen. Parents 69 mothers and 35 fathers; ages 25 to 65 years were evaluated for intention to consent to organ donation, perceived social norm, and positive/ negative aspects of organ donation without and with various financial incentives. The intention to consent to organ donation dropped highly significantly (Z = -7.556 P = .000) from the basic condition (M = 1.13; confidence interval [CIs] 0.78 to 1.51) to the condition with financial incentives (M = -1.58; CI, 1.96 to -1.15). No influence of the amount of financial incentive was observed. Highly significant differences were measured between both conditions for the social norm (Z = -5.638; P < .000) and the attitude toward organ donation (Z = -1.962; P < .05; Z = -2.104; P < .035). Financial incentives led to decreased consents and elicited strong rejections and negative reactions of the participants. Taking money for consent to organ donation seems to be a strict taboo for most people in Austrian society.

77 FR 66843 - The PPG Architectural Finishes, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... does not include any sensitive personal information, like anyone's Social Security number, date of... the agreement or make final the agreement's proposed order. This matter involves PPG's marketing and... prevent PPG from engaging in similar acts and practices in the future. Part I addresses the marketing of...

78 FR 73895 - In the Matter of FMRI, Inc., Muskogee, Oklahoma Facility

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-09

... Licensee of good cause. VI. In accordance with 10 CFR 2.202, FMRI must, and any other person adversely... this Order within 20 days of its publication in the Federal Register. Where good cause is shown... of good cause for the extension. The answer may consent to this Order. If the answer includes a...

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.

"I understood…but some parts were confusing and hard to grasp": Patients' perception of informed consent forms and clinical trials in Eldoret, Kenya.

PubMed

Naanyu, Violet; Some, Fatma F; Siika, Abraham M

2014-01-01

A signed informed consent (IC) form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants' experiences and thoughts. All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider's advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants' opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

Should informed consent be based on rational beliefs?

PubMed Central

Savulescu, J; Momeyer, R W

1997-01-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences. PMID:9358347

Should informed consent be based on rational beliefs?

PubMed

Savulescu, J; Momeyer, R W

1997-10-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences.

Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique.

PubMed

Lin, Yen-Ko; Chen, Chao-Wen; Lee, Wei-Che; Lin, Tsung-Ying; Kuo, Liang-Chi; Lin, Chia-Ju; Shi, Leiyu; Tien, Yin-Chun; Cheng, Yuan-Chia

2017-11-29

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients' knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department (ED) were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts' opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

"Genetic exceptionalism" in medicine: clarifying the differences between genetic and nongenetic tests.

PubMed

Green, Michael J; Botkin, Jeffrey R

2003-04-01

Predictive genetic tests are now available for assessing susceptibility to a variety of conditions, including breast and colon cancer, hemochromatosis, and Alzheimer and Huntington disease. Much controversy surrounds the application of these tests, stemming from their similarities to and differences from other tests commonly used in asymptomatic persons. Some have argued that genetic tests are unique and therefore justify special consideration with regard to informed consent and privacy. This paper examines the arguments for such "genetic exceptionalism" and concludes that no clear, significant distinctions between genetic and nongenetic tests justify a different approach to testing by clinicians. Nevertheless, with many genetic tests, the results may cause stigmatization, family discord, and psychological distress. Regardless of whether a test is genetic, when this combination of characteristics is present and when health care providers are not specifically trained to interpret results, testing should be performed with particular caution and the highest standards of informed consent and privacy protection should be applied.

Huntington's disease predictive testing: the case for an assessment approach to requests from adolescents.

PubMed Central

Binedell, J; Soldan, J R; Scourfield, J; Harper, P S

1996-01-01

Adolescents who are actively requesting Huntington's predictive testing of their own accord pose a dilemma to those providing testing. In the absence of empirical evidence as regards the impact of genetic testing on minors, current policy and guidelines, based on the ethical principles of non-maleficence and respect for individual autonomy and confidentiality, generally exclude the testing of minors. It is argued that adherence to an age based exclusion criterion in Huntington's disease predictive testing protocols is out of step with trends in UK case law concerning minors' consent to medical treatment. Furthermore, contributions from developmental psychology and research into adolescents' decision making competence suggest that adolescents can make informed choices about their health and personal lives. Criteria for developing an assessment approach to such requests are put forward and the implications of a case by case evaluation of competence to consent in terms of clinicians' tolerance for uncertainty are discussed. PMID:8950670

Red Hill Administrative Order on Consent

EPA Pesticide Factsheets

Orderequiring the Navy and DLA to take actions, subject to DOH and EPA approval, to address fuel releases and implement infrastructure improvements to protect human health and the environment Red Hill Bulk Fuel Storage Facility in Hawaii.

Affirming the importance of the Taiwan Relations Act.

THOMAS, 113th Congress

Rep. Royce, Edward R. [R-CA-39

2014-02-28

House - 03/25/2014 Ordered to be Reported in the Nature of a Substitute (Amended) by Unanimous Consent. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Immediate Establishment of Syrian War Crimes Tribunal Resolution

THOMAS, 113th Congress

Rep. Smith, Christopher H. [R-NJ-4

2013-09-09

House - 04/30/2014 Ordered to be Reported in the Nature of a Substitute (Amended) by Unanimous Consent. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

Western Hemisphere Drug Policy Commission Act of 2014

THOMAS, 113th Congress

Rep. Engel, Eliot L. [D-NY-16

2014-05-09

House - 06/26/2014 Ordered to be Reported in the Nature of a Substitute (Amended) by Unanimous Consent. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

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.

2017-17: JGJJG LLC

EPA Pesticide Factsheets

The United States Environmental Protection Agency (“EPA”) is providing notice of a proposed Consent Agreement and Final Order (“CA/FO”) for violations of Section 1423(b) of the Safe Drinking Water Act (“SDWA or Act”).

Emergency research without consent under Polish law.

PubMed

Rózyńska, Joanna; Czarkowski, Marek

2007-09-01

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.

Informed Consent for Radiation in Interventional Radiology Procedures.

PubMed

Zener, Rebecca; Johnson, Peter; Wiseman, Daniele; Pandey, Sachin; Mujoomdar, Amol

2018-02-01

To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P < .05). A total of 81% of patients wanted to be informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses. Copyright © 2017. Published by Elsevier Inc.

Neurocognitive Models of Medical Decision-Making Capacity in Traumatic Brain Injury Across Injury Severity.

PubMed

Triebel, Kristen L; Novack, Thomas A; Kennedy, Richard; Martin, Roy C; Dreer, Laura E; Raman, Rema; Marson, Daniel C

2016-01-01

To identify neurocognitive predictors of medical decision-making capacity (MDC) in participants with mild and moderate/severe traumatic brain injury (TBI). Academic medical center. Sixty adult controls and 104 adults with TBI (49 mild, 55 moderate/severe) evaluated within 6 weeks of injury. Prospective cross-sectional study. Participants completed the Capacity to Consent to Treatment Instrument to assess MDC and a neuropsychological test battery. We used factor analysis to reduce the battery test measures into 4 cognitive composite scores (verbal memory, verbal fluency, academic skills, and processing speed/executive function). We identified cognitive predictors of the 3 most clinically relevant Capacity to Consent to Treatment Instrument consent standards (appreciation, reasoning, and understanding). In controls, academic skills (word reading, arithmetic) and verbal memory predicted understanding; verbal fluency predicted reasoning; and no predictors emerged for appreciation. In the mild TBI group, verbal memory predicted understanding and reasoning, whereas academic skills predicted appreciation. In the moderate/severe TBI group, verbal memory and academic skills predicted understanding; academic skills predicted reasoning; and academic skills and verbal fluency predicted appreciation. Verbal memory was a predictor of MDC in controls and persons with mild and moderate/severe TBI. In clinical practice, impaired verbal memory could serve as a "red flag" for diminished consent capacity in persons with recent TBI.

Saudi views on consenting for research on medical records and leftover tissue samples

PubMed Central

2010-01-01

Background Consenting for retrospective medical records-based research (MR) and leftover tissue-based research (TR) continues to be controversial. Our objective was to survey Saudis attending outpatient clinics at a tertiary care hospital on their personal preference and perceptions of norm and current practice in relation to consenting for MR and TR. Methods We surveyed 528 Saudis attending clinics at a tertiary care hospital in Saudi Arabia to explore their preferences and perceptions of norm and current practice. The respondents selected one of 7 options from each of 6 questionnaires. Results Respondents' mean (SD) age was 33 (11) years, 42% were males, 56% were patients, 84% had ≥ secondary school education, and 10% had previously volunteered for research. Respectively, 40% and 49% perceived that the norm is to conduct MR and TR without consent and 38% and 37% with general or proposal-specific consent; the rest objected to such research. There was significant difference in the distribution of choices according to health status (patients vs. companions) for MR (adjusted Kruskal-Wallis test P = 0.03) but not to age group, gender, education level, or previous participation in research (unadjusted P = 0.02 - 0.59). The distributions of perceptions of current practice and norm were similar (unadjusted Marginal Homogeneity test P = 0.44 for MR and P = 0.89 for TR), whereas the distributions of preferences and perceptions of norm were different (adjusted P = 0.09 for MR and P = 0.02 for TR). The distributions of perceptions of norm, preferences, and perceptions of current practice for MR were significantly different from those of TR (adjusted P < 0.009 for all). Conclusions We conclude that: 1) there is a considerable diversity among Saudi views regarding consenting for retrospective research which may be related to health status, 2) the distribution of perceptions of norm was similar to the distribution of perceptions of current practice but different from that of preferences, and 3) MR and TR are perceived differently in regard to consenting. PMID:20955580

Urine testing for drugs of abuse: a survey of suburban parent-adolescent dyads.

PubMed

Schwartz, Richard H; Silber, Tomas J; Heyman, Richard B; Sheridan, Michael J; Estabrook, Dawn M

2003-02-01

The American Academy of Pediatrics is opposed to involuntary diagnostic testing for drugs of abuse. To gather data about attitudes of parents and their teenagers about involuntary drug testing on parental request. Adolescents and their accompanying parents separately answered a printed survey in the offices of their private pediatrician. The survey posed 2 hypothetical questions about urine testing: (1) Do parents have the right to ask a teenager's physician to order a urine test for drugs of abuse without the teenager's knowledge-if the teenager has falling school grades, an uncooperative attitude, and major untruthfulness? (2) In such a case, should the teenager's physician obtain a urine test for drugs on parental request only, without the teenager's consent? A total of 393 paired evaluable surveys were collected: 77.6% from Virginia and 22.4% from Ohio. There were no significant differences in answers between the 2 study sites. Of the students, 85.8% had either an A or a B grade point average. Current marijuana use was unusually low in our teenaged respondents. Of the parents surveyed, 81.7% would want a physician to be able to perform a urine test for drugs of abuse for a problematic teenager without the young person's consent. The answers to the 2 questions about urine drug tests had poor kappa coefficients of agreement between teenagers and parents (0.04 and 0.09, respectively). Reanalysis, using the variables of age, grade point average, and frequency of marijuana smoking, showed little difference in agreement scores. In the 2 suburban pediatric practices surveyed, parental opinions and expectations were at variance with the American Academy of Pediatrics policy statement on nonconsensual urine drug testing in the presence of clinical problems. Pediatricians need to be conscious of this clinical-ethical dilemma, become familiar with the American Academy of Pediatrics policy on drug testing, and develop their own position and expertise in this area. The dyad method (parent-teenager survey) is novel and improved the methodology of our study. We surveyed middle-class suburban adolescents while previous studies of adolescents surveyed inner-city populations.

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.

PubMed

Addissie, Adamu; Davey, Gail; Newport, Melanie J; Addissie, Thomas; MacGregor, Hayley; Feleke, Yeweyenhareg; Farsides, Bobbie

2014-05-02

Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting

PubMed Central

2014-01-01

Background Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. PMID:24885049

Finance issue brief: genetic testing.

PubMed

Herstek, J

1999-06-25

States have enacted genetic testing laws to address the contentious privacy, consent, research, discrimination, insurance and employment issues surrounding genetic information. These genetic testing laws attempt to strike a balance between the concerns of the consumer, research, insurance and business communities.

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.

78 FR 58305 - Honeywell International, Inc.; Analysis of Agreement Containing Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

..., formulas, patterns, devices, manufacturing processes, or customer names. If you want the Commission to give... barcode scanners, barcode printers, RFID systems and voice recognition systems. III. Scan Engines The...

76 FR 24481 - Notice of Two Proposed Agreements, a CERCLA Agreement and Order on Consent for Removal Action by...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

... Prospective Purchaser Agreement Related to Gasoline Service Stations' Underground Storage Tanks Currently...) gasoline service stations currently owned or leased by Caribbean Petroleum Corporation (``CPC'') and...

Consent Agreement and Final Order Issued to Clark Construction Group, LLC

EPA Pesticide Factsheets

EPA Mid-Atlantic Region and Clark Construction Group, LLC has reached an agreement to settle Clean Water Act violations at The Wharf at Southwest Waterfront construction site in the amount of $19,000.

75 FR 79377 - NBTY, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... NBTY Products contained a significant amount of DHA (docosahexaenoic acid, a polyunsaturated Omega-3...) Disney Princess Gummies; (3) Disney Pixar Cars Gummies; (4) Disney Winnie the Pooh Gummies; (5) Disney...

32 CFR 228.11 - Restrictions on the taking of photographs.

Code of Federal Regulations, 2012 CFR

2012-07-01

... photographs. In order to protect the security of the Agency's facilities, photographs may be taken on protected property only with the consent of the NSA Director of Security or his designee. The taking of...

32 CFR 228.11 - Restrictions on the taking of photographs.

Code of Federal Regulations, 2010 CFR

2010-07-01

... photographs. In order to protect the security of the Agency's facilities, photographs may be taken on protected property only with the consent of the NSA Director of Security or his designee. The taking of...

32 CFR 228.11 - Restrictions on the taking of photographs.

Code of Federal Regulations, 2011 CFR

2011-07-01

... photographs. In order to protect the security of the Agency's facilities, photographs may be taken on protected property only with the consent of the NSA Director of Security or his designee. The taking of...

32 CFR 228.11 - Restrictions on the taking of photographs.

Code of Federal Regulations, 2013 CFR

2013-07-01

... photographs. In order to protect the security of the Agency's facilities, photographs may be taken on protected property only with the consent of the NSA Director of Security or his designee. The taking of...

Gibbon Packing, LLC proposed Consent Agreement Final Order

EPA Pesticide Factsheets

The EPA is providing notice of a proposed Administrative Penalty Assessment against Gibbon Packing, LLC, for alleged violations at the facility located in 218 East Highway 30, P.O. Box 730, Gibbon, NE 68840 (“facility”).

76 FR 26729 - Ceridian Corporation; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-09

... result of these failures, hackers executed an SQL injection attack on the Powerpay Web site and Web application. Through this attack, the hackers found personal information stored in Powerpay on Ceridian's...

78 FR 17720 - Notice of Lodging of Revised Second Agreement and Order Regarding Modification of the Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

... publically owned treatment works owned and operated by the City of Baton Rouge and the Parish of East Baton... December 31, 2018 and the City/Parish would implement additional work including installation of a... 20044-7611. Please enclose a check or money order for $7.00 (25 cents per page reproduction cost...

Patient-Centered Imaging: Shared Decision Making for Cardiac Imaging Procedures with Exposure to Ionizing Radiation

PubMed Central

Einstein, Andrew J.; Berman, Daniel S.; Min, James K.; Hendel, Robert C.; Gerber, Thomas C.; Carr, J. Jeffrey; Cerqueira, Manuel D.; Cullom, S. James; DeKemp, Robert; Dickert, Neal; Dorbala, Sharmila; Garcia, Ernest V.; Gibbons, Raymond J.; Halliburton, Sandra S.; Hausleiter, Jörg; Heller, Gary V.; Jerome, Scott; Lesser, John R.; Fazel, Reza; Raff, Gilbert L.; Tilkemeier, Peter; Williams, Kim A.; Shaw, Leslee J.

2014-01-01

Objective To identify key components of a radiation accountability framework fostering patient-centered imaging and shared decision-making in cardiac imaging. Background An NIH-NHLBI/NCI-sponsored symposium was held in November 2012 to address these issues. Methods Symposium participants, working in three tracks, identified key components of a framework to target critical radiation safety issues for the patient, the laboratory, and the larger population of patients with known or suspected cardiovascular disease. Results Use of ionizing radiation during an imaging procedure should be disclosed to all patients by the ordering provider at the time of ordering, and reinforced by the performing provider team. An imaging protocol with effective dose ≤3mSv is considered very low risk, not warranting extensive discussion or written consent. However, a protocol effective dose <20mSv was proposed as a level requiring particular attention in terms of shared decision-making and either formal discussion or written informed consent. Laboratory reporting of radiation dosimetry is a critical component of creating a quality laboratory fostering a patient-centered environment with transparent procedural methodology. Efforts should be directed to avoiding testing involving radiation, in patients with inappropriate indications. Standardized reporting and diagnostic reference levels for computed tomography and nuclear cardiology are important for the goal of public reporting of laboratory radiation dose levels in conjunction with diagnostic performance. Conclusions The development of cardiac imaging technologies revolutionized cardiology practice by allowing routine, noninvasive assessment of myocardial perfusion and anatomy. It is now incumbent upon the imaging community to create an accountability framework to safely drive appropriate imaging utilization. PMID:24530677

Analysis of the concept of informed consent concerning the use of genetic material according to the European Convention on Bioethics and in other solutionsm - Propositions for broad consent for future genetic research from the point of view of the activity of the Biobank.

PubMed

Patryn, Rafał; Sak, Jarosław

2017-09-21

The aim of the article is a critical presentation of the typology of consents included in the European Convention on Bioethics and in other formal solutions concerning the gathering of genetic material in institutions called Biobanks. Existing types of Acts of Consent are inaccurate in their scope and possess insufficient information regarding the gathering of genetic material (application, usage, processing) and their final (future and diverse) use. Lack of precise legal regulations on the broad future use of genetic material may result in various formal problems relating both to research participants as well as those commissioning the research. Ultimately, it may lead to various complications with the appropriate legal interpretation of consent and possible claims on behalf of the donors. The presented proposition of consent with a terminal premise is to be applied eventually to legal and formal aspects of the collecting of genetic material. It is a possible solution which would clarify the issue of informed consent, and may be implemented in the regulations of the Convention as well as constitute a self-contained legislative solution to this matter. For example, Polish law in its current form, without the ratification of the Bioethical Convention, allows the collecting of material for genetic testing for determination of the risk of genetic defects in common genetic material from people who are planning to have a child.

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.

Correlation Between Insight and Capacity to Consent to Research in Subjects With Bipolar Disorder Type I and Schizophrenia.

PubMed

López-Jaramillo, Carlos; Tobler, Chantal Aristizábal; Gómez, Constanza Ovalle; Triana, Jaime Escobar

2016-01-01

Schizophrenia and bipolar disorder type I (BD-I) can affect patient autonomy and capacity to consent to participate in research. Other variables associated with the autonomy of patients must be explored in order to improve the quality of the currently available tools. To evaluate the relationship between insight and the capacity to consent to participate in research in patients with BD-I and schizophrenia. A cross-sectional and longitudinal study was conducted with 120 subjects (40 subjects with schizophrenia, 40 with BD-I, and 40 healthy controls). The tools used were the Scale Assessment Insight-Expanded (SAI-E) and the MacArthur Competence Assessment Tool-Treatment (MacCAT-CR), which was first adapted culturally, and its validity and reliability assessed. The results obtained on each scale were compared and the association between them were evaluated. There is a direct correlation between the capacity to consent to research, measured using the MacCAT-CR tool, and the degree of insight, measured using the SAI-E scale, with an effect size of 1.3 for BD-I and 2.03 for schizophrenia. The results suggest that there is a correlation between the degree of insight and the capacity to consent to research in subjects with schizophrenia and BD-I. Insight should therefore be included as a relevant variable to assess the capacity to consent, and future studies should include it when researching on or designing new tools which aim at a greater respect of patient autonomy. Copyright © 2016 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Improving validity of informed consent for biomedical research in Zambia using a laboratory exposure intervention.

PubMed

Zulu, Joseph Mumba; Lisulo, Mpala Mwanza; Besa, Ellen; Kaonga, Patrick; Chisenga, Caroline C; Chomba, Mumba; Simuyandi, Michelo; Banda, Rosemary; Kelly, Paul

2014-01-01

Complex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent. Data were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views. Factors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention. Selecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.

A feasibility study for a clinical decision support system prompting HIV testing.

PubMed

Chadwick, D R; Hall, C; Rae, C; Rayment, Ml; Branch, M; Littlewood, J; Sullivan, A

2017-07-01

Levels of undiagnosed HIV infection and late presentation remain high globally despite attempts to increase testing. The objective of this study was to evaluate a risk-based prototype application to prompt HIV testing when patients undergo routine blood tests. Two computer physician order entry (CPOE) systems were modified using the application to prompt health care workers (HCWs) to add an HIV test when other tests selected suggested that the patient was at higher risk of HIV infection. The application was applied for a 3-month period in two areas, in a large London hospital and in general practices in Teesside/North Yorkshire. At the end of the evaluation period, HCWs were interviewed to assess the usability and acceptability of the prompt. Numbers of HIV tests ordered in the general practice areas were also compared before and after the prompt's introduction. The system was found to be both useable and generally acceptable to hospital doctors, general practitioners and nurse practitioners, with little evidence of prompt/alert fatigue. The issue of the prompt appearing late in the patient consultation did lead to some difficulties, particularly around discussion of the test and consent. In the general practices, around 1 in 10 prompts were accepted and there was a 6% increase in testing rates over the 3-month study period (P = 0.169). Using a CPOE-based clinical decision support application to prompt HIV testing appears both feasible and acceptable to HCWs. Refining the application to provide more accurate risk stratification is likely to make it more effective. © 2016 British HIV Association.

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 33 2012-07-01 2012-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 33 2013-07-01 2013-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 32 2014-07-01 2014-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

Closure Report for Corrective Action Unit 415: Project 57 No. 1 Plutonium Dispersion (NTTR) Nevada Test and Training Range, Nevada, Revision 0 with ROTC-1

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

Cabble, Kevin J.; Boehlecke, Robert F.

This Closure Report (CR) presents information supporting the closure of Corrective Action Unit (CAU) 415: Project 57 No. 1 Plutonium Dispersion, which is located on Range 4808A of the Nevada Test and Training Range (NTTR). This CR 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. CAU 415 comprises one corrective action site (CAS): NAFR-23-02, Pu Contaminated Soil. The purpose of this CR is to provide justification and documentation supporting the recommendationmore » that no further corrective action is needed for CAU 415 based on the implementation of the corrective action of Closure in Place.« less

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2014 CFR

2014-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2013 CFR

2013-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2012 CFR

2012-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2011 CFR

2011-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

76 FR 39105 - Beiersdorf, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

... size. Part II covers any representation that a drug, dietary supplement, or cosmetic causes weight or..., about the health benefits of any drug, dietary supplement, or cosmetic, unless the representation is non...

77 FR 54576 - Proposed RCRA Prospective Purchaser Agreement, Order on Consent and Covenant Not To Sue for a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-05

... contaminated soils; planting of trees and other native vegetation; installing walkways; installing new... N. Chevrolet Avenue, Flint, Michigan (Site). The EPA identification number for the Site is MID 005...

77 FR 31611 - Proposed CERCLA Section 122(g)(4) Administrative Agreement and Order on Consent for the Mercury...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-29

... and Recycle Technologies, Inc., American Lamp Recycling, LLC, Lighting Resources, LLC, Western Finger Lakes Solid Waste Management Authority, H-B Instrument Company, Inc. and H.J. Heinz Company (hereinafter...

12 CFR 509.203 - Answer, consequences of failure to answer, and consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the party lacks sufficient information to admit or deny each allegation of fact. A statement of lack... allowed may request that the Office exercise its discretion to vacate such a default Order. A default...

Camp Minden Fact Sheet April 2014

EPA Pesticide Factsheets

Two groups of PRPs which include GD/ATK and Hercules Inc. signed Administrative Orders on Consent with the EPA that will remove and dispose approximately 3.7 million pounds of explosive material at the Explo Systems, Inc Camp Minden, Louisiana site.

Building and evaluating an ontology-based tool for reasoning about consent permission

PubMed Central

Grando, Adela; Schwab, Richard

2013-01-01

Given the lack of mechanisms for specifying, sharing and checking the compliance of consent permissions, we focus on building and testing novel approaches to address this gap. In our previous work, we introduced a “permission ontology” to capture in a precise, machine-interpretable form informed consent permissions in research studies. Here we explain how we built and evaluated a framework for specifying subject’s permissions and checking researcher’s resource request in compliance with those permissions. The framework is proposed as an extension of an existing policy engine based on the eXtensible Access Control Markup Language (XACML), incorporating ontology-based reasoning. The framework is evaluated in the context of the UCSD Moores Cancer Center biorepository, modeling permissions from an informed consent and a HIPAA form. The resulting permission ontology and mechanisms to check subject’s permission are implementation and institution independent, and therefore offer the potential to be reusable in other biorepositories and data warehouses. PMID:24551354

Competence to consent to treatment: a guide for the psychiatrist.

PubMed

Draper, R J; Dawson, D

1990-05-01

During the last decade there has been increasing pressure to legislate legal rights for psychiatric patients especially in relation to consent to treatment. The attempt to subject the irrationality of psychotic illness to the due process of rational laws has caused problems. Revision of the Ontario Mental Health Act (MHA) has already led to situations in which patients are being incarcerated without treatment because of review board decisions regarding dangerousness and competence. The test in the revised MHA is whether the patient is competent to give or withhold consent for treatment. Existing guidelines for determination of competence to consent to treatment rely upon observer judgement and are open to challenge on grounds of subjectivity. The medical directors of the ten Ontario provincial psychiatric hospitals have therefore developed a guide and schema to operationalize the MHA definitions, a novel feature of which is the examination of competence in such a way as to elicit and capture the patient's own responses upon which an objective determination is made.

Clinical research involving minors in international and serbian regulations.

PubMed

Planojević, Nina; Zivojinović, Dragica

2013-07-01

Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

Pastoral power and gynaecological examinations: a Foucauldian critique of clinician accounts of patient-centred consent.

PubMed

Cook, Catherine; Brunton, Margaret

2015-05-01

Invasive non-sedated clinical procedures such as gynaecological examinations are normalised; however, there is limited research highlighting the relational and technical skills required for clinicians to ensure patients' continued consent. A considerable body of research emphasises that women dislike examinations, leading to their non-compliance or a delayed follow up for gynaecological and sexual health problems. However, medical research focuses on 'problem' women; the role of clinicians receives limited appraisal. This article draws on interviews with sexual health clinicians in New Zealand, from metropolitan and provincial locations. The gynaecological care of women in New Zealand attained international notoriety with the 1988 publication of Judge Cartwright's inquiry into ethical shortcomings in cervical cancer research at the National Women's Hospital. Judge Cartwright's recommendations included patient-centred care in order to ensure informed consent had been received for clinical procedures and research participation. This article's critical analysis is that, although clinicians' language draws on humanistic notions of patient-centredness, Foucault's notion of secularised pastoral power enables a more nuanced appreciation of the ethical work undertaken by clinicians when carrying out speculum examinations. The analysis highlights both the web of power relations present during examination practices and the strategies clinicians use to negotiate women's continued consent; which is significant because consent is usually conceptualised as an event, rather than an unfolding, unstable process. © 2015 The Authors. Sociology of Health & Illness © 2015 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2013 CFR

2013-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2012 CFR

2012-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2014 CFR

2014-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

77 FR 15803 - Notice of Lodging of Stipulated Order Regarding Modification of Consent Decree in United States v...

Federal Register 2010, 2011, 2012, 2013, 2014

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... Decree in United States v. Kentucky Utilities Company Under the Clean Air Act Under 28 CFR 50.7, notice... Decree (``Stipulated Order'') between Kentucky Utilities Company (``Kentucky Utilities'') and the United... provisions of the Clean Air Act, 42 U.S.C. 7401, et seq., in connection with its operation of the E.W. Brown...

Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023.

THOMAS, 113th Congress

Rep. Ryan, Paul [R-WI-1

2013-03-15

Senate - 10/16/2013 Ordered held at desk by unanimous consent. Pursuant to the order of 10/16/2013. (All Actions) Notes: Provisions of this budget resolution were included in H.J.RES.59. Tracker: This bill has the status Resolving DifferencesHere are the steps for Status of Legislation:

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

Notice of Proposed Administrative Penalty Assessment for JGJJG LLC. Farmingdale, NY

EPA Pesticide Factsheets

The United States Environmental Protection Agency (“EPA”) is providing notice of a proposed Consent Agreement and Final Order (“CA/FO”) for violations of Section 1423(b) of the Safe Drinking Water Act (“SDWA or Act”).

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Calling for an end to attacks on Syrian civilians and expanded humanitarian access.

THOMAS, 113th Congress

Rep. Royce, Edward R. [R-CA-39

2014-03-14

House - 04/30/2014 Ordered to be Reported in the Nature of a Substitute (Amended) by Unanimous Consent. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

77 FR 62238 - Alan B. Miller and Universal Health Services; Analysis of Agreement Containing Consent Orders To...

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77 FR 4060 - Notice of Lodging of Second Agreement and Order Regarding Modification of the Consent Decree...

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... improve its sewage collection system including addressing Unauthorized Discharges such as sanitary sewer... used in the sewage collection system. The Department of Justice will receive for a period of thirty (30...

78 FR 20642 - Notice of Proposed CERCLA Agreement and Order on Consent for Removal Action by Bona Fide...

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... Fernando Valley Area 2 Superfund Site, Glendale Chromium Operable Unit, 264 W. Spazier Ave., Burbank... Site, Glendale Chromium Operable Unit, located at 264 W. Spazier Ave., Burbank, California. Under the...

Intensive Care Unit Physician's Attitudes on Do Not Resuscitate Order in Palestine.

PubMed

Abdallah, Fatima S; Radaeda, Mahdy S; Gaghama, Maram K; Salameh, Basma

2016-01-01

There is some ambiguity concerning the do-not-resuscitate (DNR) orders in the Arabic world. DNR is an order written by a doctor, approved by the patient or patient surrogate, which instructs health care providers to not do CPR when cardiac or respiratory arrest occurs. Therefore, this research study investigated the attitudes of Intensive Care Unit physicians and nurses on DNR order in Palestine. A total of 123 males and females from four different hospitals voluntarily participated in this study by signing a consent form; which was approved by the Ethical Committee at Birzeit University and the Ministry of Health. A non-experimental, quantitative, descriptive, and co-relational method was used, the data collection was done by a three page form consisting of the consent form, demographical data, and 24 item-based questionnaire based on a 5-point-Likert scale from strongly agree (score 1) to strongly disagree (score 5). The Statistical Package for Social Sciences (SPSS) software program version 17.0 was used to analyze the data. Finding showed no significant relationship between culture and opinion regarding the DNR order, but religion did. There was statistical significance difference between the physicians' and nurses' religious beliefs, but there was no correlation. Moreover, a total of 79 (64.3%) physicians and nurses agreed with legalizing the DNR order in Palestine. There was a positive attitude towards the legalization of the DNR order in Palestine, and culture and religion did not have any affect towards their attitudes regarding the legalization in Palestine.

Assessment and instruction to promote higher order thinking in nursing students.

PubMed

Kantar, Lina D

2014-05-01

The dearth of data on the role of assessment in higher education formed the two purposes of this study: first, to explore assessment strategies commonly used in nursing education by analyzing the curriculum documents of three baccalaureate nursing programs in Lebanon against Bloom's Taxonomy of learning, and second to unravel issues of instruction and assessment by categorizing data into teacher- and learner-centered strategies. Content analysis research technique applied to analyze the curriculum documents of three baccalaureate nursing programs in Beirut, Lebanon. After obtaining IRB approval and consent to access the curriculum documents of the programs, data were analyzed using the content analysis research technique. Data on assessments and instruction were categorized into student-centered and teacher-centered. Data revealed deficiency in employing learner-centered strategies in the assessment and instruction of the three programs. There was evidence that educators of the programs focus on teaching content and examining retention, thus supporting prior notions on teaching to the test and accusations in earnest on adherence to the traditional and behavioral curriculum perspectives. Such curricula leave little room for the development of higher order thinking in learners. Although assessments are believed to be indicators of program and teaching effectiveness, there is relatively alarming information on the incompatibility between current assessment practices and demands of the workplace. There is an urgent need for transforming educators' beliefs, knowledge, and skills on testing, since teaching to pass a test could impede knowledge transfer and deter the development of learners' higher order thinking skills. © 2013.

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.

Design and preliminary recruitment results of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP).

PubMed

Turner, E L; Metcalfe, C; Donovan, J L; Noble, S; Sterne, J A C; Lane, J A; Avery, K N; Down, L; Walsh, E; Davis, M; Ben-Shlomo, Y; Oliver, S E; Evans, S; Brindle, P; Williams, N J; Hughes, L J; Hill, E M; Davies, C; Ng, S Y; Neal, D E; Hamdy, F C; Martin, R M

2014-06-10

Screening for prostate cancer continues to generate controversy because of concerns about over-diagnosis and unnecessary treatment. We describe the rationale, design and recruitment of the Cluster randomised triAl of PSA testing for Prostate cancer (CAP) trial, a UK-wide cluster randomised controlled trial investigating the effectiveness and cost-effectiveness of prostate-specific antigen (PSA) testing. Seven hundred and eighty-five general practitioner (GP) practices in England and Wales were randomised to a population-based PSA testing or standard care and then approached for consent to participate. In the intervention arm, men aged 50-69 years were invited to undergo PSA testing, and those diagnosed with localised prostate cancer were invited into a treatment trial. Control arm practices undertook standard UK management. All men were flagged with the Health and Social Care Information Centre for deaths and cancer registrations. The primary outcome is prostate cancer mortality at a median 10-year-follow-up. Among randomised practices, 271 (68%) in the intervention arm (198,114 men) and 302 (78%) in the control arm (221,929 men) consented to participate, meeting pre-specified power requirements. There was little evidence of differences between trial arms in measured baseline characteristics of the consenting GP practices (or men within those practices). The CAP trial successfully met its recruitment targets and will make an important contribution to international understanding of PSA-based prostate cancer screening.

Adult Spinal Deformity Patients Recall Fewer Than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period.

PubMed

Saigal, Rajiv; Clark, Aaron J; Scheer, Justin K; Smith, Justin S; Bess, Shay; Mummaneni, Praveen V; McCarthy, Ian M; Hart, Robert A; Kebaish, Khaled M; Klineberg, Eric O; Deviren, Vedat; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher P

2015-07-15

Recall of the informed consent process in patients undergoing adult spinal deformity surgery and their family members was investigated prospectively. To quantify the percentage recall of the most common complications discussed during the informed consent process in adult spinal deformity surgery, assess for differences between patients and family members, and correlate with mental status. Given high rates of complications in adult spinal deformity surgery, it is critical to shared decision making that patients are adequately informed about risks and are able to recall preoperative discussion of possible complications to mitigate medical legal risk. Patients undergoing adult spinal deformity surgery underwent an augmented informed consent process involving both verbal and video explanations. Recall of the 11 most common complications was scored. Mental status was assessed with the mini-mental status examination-brief version. Patients subjectively scored the informed consent process and video. After surgery, the recall test and mini-mental status examination-brief version were readministered at 5 additional time points: hospital discharge, 6 to 8 weeks, 3 months, 6 months, and 1 year postoperatively. Family members were assessed at the first 3 time points for comparison. Fifty-six patients enrolled. Despite ranking the consent process as important (median overall score: 10/10; video score: 9/10), median patient recall was only 45% immediately after discussion and video re-enforcement and subsequently declined to 18% at 6 to 8 weeks and 1 year postoperatively. Median family recall trended higher at 55% immediately and 36% at 6 to 8 weeks postoperatively. The perception of the severity of complications significantly differs between patient and surgeon. Mental status scores showed a transient, significant decrease from preoperation to discharge but were significantly higher at 1 year. Despite being well-informed in an optimized informed consent process, patients cannot recall most surgical risks discussed and recall declines over time. Significant progress remains to improve informed consent retention. 3.

Pulmonary tuberculosis in outpatients in Sabah, Malaysia: advanced disease but low incidence of HIV co-infection.

PubMed

William, Timothy; Parameswaran, Uma; Lee, Wai Khew; Yeo, Tsin Wen; Anstey, Nicholas M; Ralph, Anna P

2015-01-31

Tuberculosis (TB) is generally well controlled in Malaysia, but remains an important problem in the nation's eastern states. In order to better understand factors contributing to high TB rates in the eastern state of Sabah, our aims were to describe characteristics of patients with TB at a large outpatient clinic, and determine the prevalence of HIV co-infection. Additionally, we sought to test sensitivity and specificity of the locally-available point-of-care HIV test kits. We enrolled consenting adults with smear-positive pulmonary TB for a 2-year period at Luyang Clinic, Kota Kinabalu, Malaysia. Participants were questioned about ethnicity, smoking, prior TB, disease duration, symptoms and comorbidities. Chest radiographs were scored using a previously devised tool. HIV was tested after counselling using 2 point-of-care tests for each patient: the test routinely in use at the TB clinic (either Advanced Quality™ Rapid Anti-HIV 1&2, FACTS anti-HIV 1/2 RAPID or HIV (1 + 2) Antibody Colloidal Gold), and a comparator test (Abbott Determine™ HIV-1/2, Inverness Medical). Positive tests were confirmed by enzyme immunoassay (EIA), particle agglutination and line immunoassay. 176 participants were enrolled; 59 (33.5%) were non-Malaysians and 104 (59.1%) were male. Smoking rates were high (81/104 males, 77.9%), most had cavitary disease (51/145, 64.8%), and 81/176 (46.0%) had haemoptysis. The median period of symptoms prior to treatment onset was 8 weeks. Diabetes was present in 12. People with diabetes or other comorbidities had less severe TB, suggesting different healthcare seeking behaviours in this group. All participants consented to HIV testing: three (1.7%) were positive according to Determine™ and EIA, but one of these tested negative on the point-of-care test available at the clinic (Advanced Quality™ Rapid Anti-HIV 1&2). The low number of positive tests and changes in locally-available test type meant that accurate estimates of sensitivity and specificity were not possible. Patients had advanced disease at diagnosis, long diagnostic delays, low HIV co-infection rates, high smoking rates among males, and migrants may be over-represented. These findings provide important insights to guide local TB control efforts. Caution is required in using some point-of-care HIV tests, and ongoing quality control measures are of major importance.

Child and adolescent musculoskeletal pain (CAM-Pain) feasibility study: testing a method of identifying, recruiting and collecting data from children and adolescents who consult about a musculoskeletal condition in UK general practice.

PubMed

Michaleff, Zoe A; Campbell, Paul; Hay, Alastair D; Warburton, Louise; Dunn, Kate M

2018-06-14

Test a method of identifying, recruiting and collecting data from children and adolescents who consult their general practitioner about a musculoskeletal condition. Prospective cohort feasibility study. 13 general practices in West Midlands of England. Patients aged 8-19 years who consult their general practice about a musculoskeletal condition. Patients were identified via a relevant musculoskeletal Read code entered at the point of consultation. Feasibility was assessed in terms of study processes (recruitment rates), data collection procedures (duration, response variability), resource utilisation (mail-outs) and ethical considerations (acceptability). From October 2016 to February 2017, an eligible musculoskeletal Read code was entered on 343 occasions, 202 patients were excluded (declined, n=153; screened not suitable, n=49) at the point of consultation. The remaining 141 patients were mailed an invitation to participate (41.1%); 46 patients responded to the invitation (response rate: 32.6%), of which 27 patients consented (consent rate: 19.1%). Participants mean age was 13.7 years (SD 2.7) and current pain intensity was 2.8 (SD 2.7). All participants completed the 6-week follow-up questionnaire. All participants found the interview questions to be acceptable and would consider participating in a similar study in the future. The majority of general practitioners/nurse practitioners, and all of the research nurses reported to be adequately informed about the study and found the study processes acceptable. The expected number of participants were identified and invited, but consent rate was low (<20%) indicating that this method is not feasible (eg, for use in a large prospective study). Recruiting children and adolescents with musculoskeletal conditions in a primary care setting currently presents a challenge for researchers. Further work is needed to identify alternative ways to conduct studies in this population in order to address the current knowledge gap in this field. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Medical decision-making capacity in cognitively impaired Parkinson's disease patients without dementia.

PubMed

Martin, Roy C; Okonkwo, Ozioma C; Hill, Joni; Griffith, H Randall; Triebel, Kristen; Bartolucci, Alfred; Nicholas, Anthony P; Watts, Ray L; Stover, Natividad; Harrell, Lindy E; Clark, David; Marson, Daniel C

2008-10-15

Little is currently known about the higher order functional skills of patients with Parkinson disease and cognitive impairment. Medical decision-making capacity (MDC) was assessed in patients with Parkinson's disease (PD) with cognitive impairment and dementia. Participants were 16 patients with PD and cognitive impairment without dementia (PD-CIND), 16 patients with PD dementia (PDD), and 22 healthy older adults. All participants were administered the Capacity to Consent to Treatment Instrument (CCTI), a standardized capacity instrument assessing MDC under five different consent standards. Parametric and nonparametric statistical analyses were utilized to examine capacity performance on the consent standards. In addition, capacity outcomes (capable, marginally capable, or incapable outcomes) on the standards were identified for the two patient groups. Relative to controls, PD-CIND patients demonstrated significant impairment on the understanding treatment consent standard, clinically the most stringent CCTI standard. Relative to controls and PD-CIND patients, PDD patients were impaired on the three clinical standards of understanding, reasoning, and appreciation. The findings suggest that impairment in decisional capacity is already present in cognitively impaired patients with PD without dementia and increases as these patients develop dementia. Clinicians and researchers should carefully assess decisional capacity in all patients with PD with cognitive impairment. (c) 2008 Movement Disorder Society.

Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda.

PubMed

Ssali, Agnes; Poland, Fiona; Seeley, Janet

2015-12-03

Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team. Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis. Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects. Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers' perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

Physicians’ Perspectives on the Uncertainties and Implications of Chromosomal Microarray Testing of Children and Families

PubMed Central

Reiff, Marian; Ross, Kathryn; Mulchandani, Surabhi; Propert, Kathleen Joy; Pyeritz, Reed E.; Spinner, Nancy B.; Bernhardt, Barbara A.

2012-01-01

Chromosomal microarray analysis (CMA) has improved the diagnostic rate of genomic disorders in pediatric populations, but can produce uncertain and unexpected findings. This paper explores clinicians’ perspectives and identifies challenges in effectively interpreting results and communicating with families about CMA. Responses to an online survey were obtained from 40 clinicians who had ordered CMA. Content included practice characteristics and perceptions, and queries about a hypothetical case involving uncertain and incidental findings. Data were analyzed using non-parametric statistical tests. Clinicians’ comfort levels differed significantly for explaining uncertain, abnormal, and normal CMA results, with lowest levels for uncertain results. Despite clinical guidelines recommending informed consent, many clinicians did not consider it pertinent to discuss the potential for CMA to reveal information concerning biological parentage or predisposition to late-onset disease, in a hypothetical case. Many non-genetics professionals ordering CMA did not feel equipped to interpret the results for patients, and articulated needs for education and access to genetics professionals. This exploratory study highlights key challenges in the practice of genomic medicine, and identifies needs for education, disseminated practice guidelines, and access to genetics professionals, especially when dealing with uncertain or unexpected findings. PMID:22989118

Cabin Fee Act of 2014

THOMAS, 113th Congress

Rep. Hastings, Doc [R-WA-4

2014-06-17

House - 06/19/2014 Ordered to be Reported by Unanimous Consent. (All Actions) Notes: For further action, see H.R.3979, which became Public Law 113-291 on 12/19/2014. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

75 FR 80051 - The Dannon Company, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

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2010-12-21

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78 FR 9355 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the Mount...

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2013-02-08

... of the Environment (MDE) for the purpose of removing Mount Saint Mary's College 1979 Consent Order....regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know your identity or...