Achieving new levels of recall in consent to research by combining remedial and motivational techniques.

PubMed

Festinger, David S; Dugosh, Karen L; Marlowe, Douglas B; Clements, Nicolle T

2014-04-01

Research supports the efficacy of both a remedial consent procedure (corrected feedback (CF)) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n=52) or an incentivised CF (ICF) condition (n=52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed. Quiz scores in the two conditions did not differ at the first administration (p=0.39, d=0.2); however, ICF scores were significantly higher at each subsequent administration (second: p=0.003, Cohen's d=0.6; third: p<0.0001, d=1.4; fourth: p<0.0001, d=1.6; fifth: p<0.0001, d=1.8). The ICF procedure increased consent recall from 72% to 83%, compared with the CAU condition in which recall decreased from 69% to 59%. This supports the statistical and clinical utility of a combined remedial and motivational consent procedure for enhancing recall of study information and human research protections.

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

Dibasic Esters; Final Enforceable Consent Agreement and Testing Consent Order

EPA Pesticide Factsheets

Under section 4 of the Toxic Substances Control Act (TSCA), EPA has issued a testing consent order (Order) that incorporates an enforceable consent agreement (ECA) with the Aceto Corporation, E.I. du Pont de Nemours and Company, and Solutia Inc.

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 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...

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

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.

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.

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.

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.

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...

Corrective Action Investigation Plan for Corrective Action Unit 536: Area 3 Release Site, Nevada Test Site, Nevada (Rev. 0 / June 2003), Including Record of Technical Change No. 1

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

None

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 536: Area 3 Release Site, Nevada Test Site, Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 536 consists of a single Corrective Action Site (CAS): 03-44-02, Steam Jenny Discharge. The CAU 536 site is being investigated because existing information on the nature and extent of possible contamination is insufficient to evaluate and recommend corrective action alternatives formore » CAS 03-44-02. The additional information will be obtained by conducting a corrective action investigation (CAI) prior to evaluating CAAs and selecting the appropriate corrective action for this CAS. The results of this field investigation are to be used to support a defensible evaluation of corrective action alternatives in the corrective action decision document. Record of Technical Change No. 1 is dated 3-2004.« less

Corrective Action Decision Document/Closure Report for Corrective Action Unit 383: Area E-Tunnel Sites, Nevada Test Site

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

NSTec Environmental Restoration

This Corrective Action Decision Document/Closure Report (CADD/CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 383, Area 12 E-Tunnel Sites, which is the joint responsibility of DTRA and the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO). 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 DOE, and the U.S. Department of Defense. Corrective Action Unit 383 is comprised of three Corrective Action Sites (CASs) and two adjacent areas: • CAS 12-06-06, Muckpile •more » CAS 12-25-02, Oil Spill • CAS 12-28-02, Radioactive Material • Drainage below the Muckpile • Ponds 1, 2, and 3 The purpose of this CADD/CR is to provide justification and documentation to support the recommendation for closure with no further corrective action, by placing use restrictions at the three CASs and two adjacent areas of CAU 383.« less

Corrective Action Decision Document for Corrective Action Unit 224: Decon Pad and Septic Systems Nevada Test Site, Nevada, Rev. No.: 0

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

David A. Strand

2005-05-01

This Corrective Action Decision Document has been prepared for Corrective Action Unit (CAU) 224, Decon Pad and Septic Systems, in Areas 2, 3, 5, 6, 11, and 23 of the Nevada Test Site, Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (1996). Corrective Action Unit 224 is comprised of the following corrective action sites (CASs): (1) 02-04-01, Septic Tank (Buried); (2) 03-05-01, Leachfield; (3) 05-04-01, Septic Tanks (4)/Discharge Area; (4) 06-03-01, Sewage Lagoons (3); (5) 06-05-01, Leachfield; (6) 06-17-04, Decon Pad and Wastewater Catch; (7) 06-23-01, Decon Pad Discharge Piping; (8) 11-04-01, Sewage Lagoon; and (9) 23-05-02,more » Leachfield. The purpose of this Corrective Action Decision Document is to identify and provide the rationale for the recommendation of a corrective action alternative for the nine CASs within CAU 224. Corrective action investigation activities were performed from August 10, 2004, through January 18, 2005, as set forth in the CAU 224 Corrective Action Investigation Plan.« less

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.

Corrective Action Investigation Plan for Corrective Action Unit 371: Johnnie Boy Crater and Pin Stripe Nevada Test Site, Nevada, Revision 0

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

Patrick Matthews

Corrective Action Unit (CAU) 371 is located in Areas 11 and 18 of the Nevada Test Site, which is approximately 65 miles northwest of Las Vegas, Nevada. Corrective Action Unit 371 is comprised of the two corrective action sites (CASs) listed below: • 11-23-05, Pin Stripe Contamination Area • 18-45-01, U-18j-2 Crater (Johnnie Boy) These sites are being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives. Additional information will be obtained by conducting a corrective action investigation before evaluating corrective action alternatives and selecting the appropriate correctivemore » action for each CAS. The results of the field investigation will support a defensible evaluation of viable corrective action alternatives that will be presented in the Corrective Action Decision Document. The sites will be investigated based on the data quality objectives (DQOs) developed on November 19, 2008, by representatives of the Nevada Division of Environmental Protection; U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office; Stoller-Navarro Joint Venture; and National Security Technologies, LLC. The DQO process was used to identify and define the type, amount, and quality of data needed to develop and evaluate appropriate corrective actions for CAU 371. Appendix A provides a detailed discussion of the DQO methodology and the DQOs specific to each CAS. The scope of the corrective action investigation for CAU 371 includes the following activities: • Move surface debris and/or materials, as needed, to facilitate sampling. • Conduct radiological surveys. • Measure in situ external dose rates using thermoluminescent dosimeters or other dose measurement devices. • Collect and submit environmental samples for laboratory analysis to determine internal dose rates. • Combine internal and external dose rates to determine whether total dose rates exceed final action levels (FALs). • Collect and submit environmental samples for laboratory analysis to determine whether chemical contaminants are present at concentrations exceeding FALs. • If contamination exceeds FALs, define the extent of the contamination exceeding FALs. • Investigate waste to determine whether potential source material is present. This Corrective Action Investigation Plan has been developed in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada; U.S. Department of Energy; and U.S. Department of Defense. Under the Federal Facility Agreement and Consent Order, this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Fieldwork will be conducted following approval of the plan.« less

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...

Testing Consent Order For Bisphenol A Diglycidyl Ether

EPA Pesticide Factsheets

EPA has issued a Testing Consent Order that incorporates an Enforceable Consent Agreement (ECA) pursuant to the Toxic Substances Control Act (TSCA), with the Dow Chemical Company, Shell Oil Company, and Ciba-Geigy Corporation.

Corrective Action Plan for Corrective Action Unit 271: Areas 25, 26, and 27 Septic Systems, Nevada Test Site, Nevada

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

R. B. Jackson

2003-05-01

The Areas 25, 26 and 27 Septic Systems are in the Federal Facility Agreement and Consent Order (FFACO) of 1996 as Corrective Action Unit (CAU) 271. This Corrective Action Plan (CAP) provides selected corrective action alternatives and proposes the closure methodology for CAU 271. CAU 271 is located on the Nevada Test Site (NTS) approximately 105 kilometers (65 miles) northwest of Las Vegas, Nevada, and consists of the following 15 Corrective Action Sites (CAS): CAS 25-04-1, Septic System; CAS 25-04-03, Septic System; CAS25-04-04, Septic System; CAS 25-04-08, Septic System; CAS 25-04-09, Septic System; CAS 25-04-10, Septic System; CAS 25-04-11, Septicmore » System; CAS 26-03-01, Contaminated Water Reservoir; CAS 26-04-1, Septic System; CAS 26-04-02, Septic System; CAS 26-05-01, Radioactive Leachfield; CAS-26-05-03, Septic System; CAS 26-05-04, Septic System; CAS 26-05-05, Septic System; and CAS 27-05-02, Leachfield.« less

CORRECTIVE ACTION PLAN FOR CORRECTIVE ACTION UNIT 516: SEPTIC SYSTEMS AND DISCHARGE POINTS, NEVADA TEST SITE, NEVADA

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

BECHTEL NEVADA; U.S. DEPARTMENT OF ENERGY, NATIONAL NUCLEAR SECURITY ADMINISTRATION NEVADA SITE OFFICE

2005-08-01

Corrective Action Unit (CAU) 516, Septic Systems and Discharge Points, is listed in the ''Federal Facility Agreement and Consent Order'' (FFACO) of 1996 (FFACO, 1996). CAU 516 consists of six Corrective Action Sites (CASs) located in Areas 3, 6, and 22 of the Nevada Test Site (NTS), which is located approximately 65 miles northwest of Las Vegas, Nevada (Figure 1). CAU 516 is comprised of the following six CASs: (1) 03-59-01 Building 3C-36 Septic System; (2) 03-59-02 Building 3C-45 Septic System; (3) 06-51-01 Sump and Piping; (4) 06-51-02 Clay Pipe and Debris; (5) 06-51-03 Clean-Out Box and Piping; and (6)more » 22-19-04 Vehicle Decontamination Area. Details on site history and site characterization results for CAU 516 are provided in the approved Corrective Action Investigation Plan (CAIP), (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2003), and the approved Corrective Action Decision Document (CADD) (NNSA/NSO, 2004).« less

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...

Enhancing informed consent for research and treatment.

PubMed

Dunn, L B; Jeste, D V

2001-06-01

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

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

PubMed

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

2017-06-01

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

Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods.

PubMed

Dathatri, Shubha; Gruberg, Luis; Anand, Jatin; Romeiser, Jamie; Sharma, Shephali; Finnin, Eileen; Shroyer, A Laurie W; Rosengart, Todd K

2014-05-01

Patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) often have a poor understanding of their disease and of related therapeutic risks, benefits, and alternatives. This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients' knowledge of standard consent elements. Patients undergoing first-time elective, outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process (group I) or a web-based, audiovisual presentation (group II). Preconsent and postconsent questionnaires were administered to evaluate changes in patients' self-reported understanding of standard consent elements. One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys (group I=48; group II=54). Changes in patient comprehension rates were similar between groups for risk and benefit consent elements, but group II had significantly greater improvement in the identification of treatment alternatives than group I (p=0.028). Independent of intervention, correct identification of all risks and alternatives increased significantly after consent (p<0.05); 4 of 5 queried risks were correctly identified by greater than 90% of respondents. However, misperceptions of benefits persisted after consent; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83% and 46% of respondents, respectively. Although both scripted verbal and audiovisual informed consent improved patient comprehension, important patient misperceptions regarding PCI-related outcomes and alternatives persist, independent of informed consent approach, and considerable challenges still exist in educating patients about contemplated medical procedures. Future research appears warranted to improve patient comprehension. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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...

Corrective Action Decision Document/Closure Report for Corrective Action Unit 252: Area 25 Engine Test Stand 1 Decontamination Pad, Nevada Test Site, Nevada

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

DOE /NV

This Corrective Action Decision Document/Closure Report (CADD/CR) has been prepared for Corrective Action Unit (CAU) 252: Area 25 Engine Test Stand-1 Decontamination Pad, in accordance with the Federal Facility Agreement and Consent Order (FFACO). Located at the Nevada Test Site in Nevada, CAU 252 consists of only one Corrective Action Site (25-07-04, Decontamination Pad). This CADD/CR identifies and rationalizes the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) recommendation that no corrective action is deemed necessary at CAU 252. The Corrective Action Decision Document and Closure Report have been combined into one report because the potential contaminants of concern weremore » either not detected during the corrective action investigation or were only present at naturally occurring concentrations. Based on the field results, neither corrective action or a corrective action plan is required at this site. A Notice of Completion to DOE/NV is being requested from the Nevada Division of Environmental Protection for closure of CAU 252, as well as a request that this site be moved from Appendix III to Appendix IV of the FFACO. Further, no use restrictions are required to be placed on this CAU.« less

Corrective Action Decision Document for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada: Revision 0, Including Errata Sheet

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

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

2004-04-01

This Corrective Action Decision Document identifies the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's corrective action alternative recommendation for each of the corrective action sites (CASs) within Corrective Action Unit (CAU) 204: Storage Bunkers, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. An evaluation of analytical data from the corrective action investigation, review of current and future operations at each CAS, and a detailed comparative analysis of potential corrective action alternatives were used to determine the appropriate corrective action for each CAS. There are six CASs in CAU 204, which aremore » all located between Areas 1, 2, 3, and 5 on the NTS. The No Further Action alternative was recommended for CASs 01-34-01, 02-34-01, 03-34-01, and 05-99-02; and a Closure in Place with Administrative Controls recommendation was the preferred corrective action for CASs 05-18-02 and 05-33-01. These alternatives were judged to meet all requirements for the technical components evaluated as well as applicable state and federal regulations for closure of the sites and will eliminate potential future exposure pathways to the contaminated media at CAU 204.« less

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

EPA Pesticide Factsheets

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

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

EPA Pesticide Factsheets

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

Corrective Action Investigation Plan for Corrective Action Unit 562: Waste Systems Nevada Test Site, Nevada, Revision 0

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

Alfred Wickline

2009-04-01

Corrective Action Unit 562 is located in Areas 2, 23, and 25 of the Nevada Test Site, which is approximately 65 miles northwest of Las Vegas, Nevada. Corrective Action Unit 562 is comprised of the 13 corrective action sites (CASs) listed below: • 02-26-11, Lead Shot • 02-44-02, Paint Spills and French Drain • 02-59-01, Septic System • 02-60-01, Concrete Drain • 02-60-02, French Drain • 02-60-03, Steam Cleaning Drain • 02-60-04, French Drain • 02-60-05, French Drain • 02-60-06, French Drain • 02-60-07, French Drain • 23-60-01, Mud Trap Drain and Outfall • 23-99-06, Grease Trap • 25-60-04, Buildingmore » 3123 Outfalls These sites are being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives. Additional information will be obtained by conducting a corrective action investigation before evaluating corrective action alternatives and selecting the appropriate corrective action for each CAS. The results of the field investigation will support a defensible evaluation of viable corrective action alternatives that will be presented in the Corrective Action Decision Document. The sites will be investigated based on the data quality objectives (DQOs) developed on December 11, 2008, by representatives of the Nevada Division of Environmental Protection; U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office; Stoller-Navarro Joint Venture; and National Security Technologies, LLC. The DQO process was used to identify and define the type, amount, and quality of data needed to develop and evaluate appropriate corrective actions for CAU 562. Appendix A provides a detailed discussion of the DQO methodology and the DQOs specific to each CAS. The scope of the corrective action investigation for CAU 562 includes the following activities: • Move surface debris and/or materials, as needed, to facilitate sampling. • Conduct radiological surveys. • Perform field screening. • Collect and submit environmental samples for laboratory analysis to determine the nature and extent of any contamination released by each CAS. • Collect samples of source material to determine the potential for a release. • Collect samples of potential remediation wastes. • Collect quality control samples. This Corrective Action Investigation Plan has been developed in accordance with the Federal Facility Agreement and Consent Order that was agreed to by the State of Nevada; DOE, Environmental Management; U.S. Department of Defense; and DOE, Legacy Management (FFACO, 1996; as amended February 2008). Under the Federal Facility Agreement and Consent Order, this Corrective Action Investigation Plan will be submitted to the Nevada Division of Environmental Protection for approval. Fieldwork will be conducted following approval of the plan.« less

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

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

Birney, Cathleen; Krauss, Mark J

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

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...

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

PubMed

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

2017-09-01

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

Legal aspects of deaths associated with diagnostic and therapeutic procedures.

PubMed

Puxon, M

1984-01-01

Informed voluntary consent in relation to the charge of assault and battery is examined. The full implication of informed consent is set out. The legal aspects of negligence is also examined in relation to obtaining consent and the possibility of a wrong diagnosis. Where reasonable doubt exist about the correctness of a diagnosis the position of a second opinion is discussed. Guidelines on the handling of errors in treatment and anaesthetic deaths in relation to negligence is clearly set out.

Children as donors: a national study to assess procurement of organs and tissues in pediatric intensive care units.

PubMed

Siebelink, Marion J; Albers, Marcel J I J; Roodbol, Petrie F; Van de Wiel, Harry B M

2012-12-01

A shortage of size-matched organs and tissues is the key factor limiting transplantation in children. Empirical data on procurement from pediatric donors is sparse. This study investigated donor identification, parental consent, and effectuation rates, as well as adherence to the national protocol. A national retrospective cohort study was conducted in all eight Dutch pediatric intensive care units. Records of deceased children were analyzed by an independent donation officer. Seventy-four (11%) of 683 deceased children were found to be suitable for organ donation and 132 (19%) for tissue donation. Sixty-two (84%) potential organ donors had been correctly identified; the parental consent and effectuation rate was 42%. Sixty-three (48%) potential tissue donors had been correctly identified; the parental consent and effectuation rate was 27%. Correct identification increased with age (logistic regression, organs: P = .024; tissues: P = .011). Although an overall identification rate of 84% of potential organ donors may seem acceptable, the variation observed suggests room for improvement, as does the overall low rate of identification of pediatric tissue donors. Efforts to address the shortage of organs and tissues for transplantation in children should focus on identifying potential donors and on the reasons why parents do not consent. © 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.

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

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

PubMed

Macklin, Ruth; Shepherd, Lois

2013-01-01

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

Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.

PubMed

Garrett, Sarah B; Murphy, Marie; Wiley, James; Dohan, Daniel

2017-12-01

Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.

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

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

Birney, Cathleen; Krauss, Mark J

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

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...

Testing Consent Order On 4 Nonylphenol, Branched

EPA Pesticide Factsheets

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

Enhancing Medical Decision-Making Evaluations: Introduction of Normative Data for the Capacity to Consent to Treatment Instrument.

PubMed

Gerstenecker, Adam; Niccolai, Lindsay; Marson, Daniel; Triebel, Kristen L

2016-04-01

A number of measures have been developed to assess medical decision-making capacity (MDC) in adults. However, their clinical utility is limited by a lack of available normative data. In the current study, we introduce age-independent and age-adjusted normative data for a measure of MDC: the Capacity to Consent to Treatment Instrument. The sample consisted of 308 cognitively normal, community-dwelling adults ranging in age from 19 to 86 years. For age-adjusted norms, individual raw scores were first converted to age-corrected scaled scores based on position within a cumulative frequency distribution and then grouped according to empirically supported age ranges. For age-independent norms, the same method was utilized but without age-corrections being applied or participants being grouped into age ranges. This study has the potential to enhance MDC evaluations by allowing clinicians to compare a patient's performance on the Capacity to Consent to Treatment Instrument with that of adults regardless of age as well as to same age peers. Tables containing normative corrections are supplementary material available online at http://asm.sagepub.com/supplemental. © The Author(s) 2015.

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.

Testing Consent Order on Alkyl Phthalates

EPA Pesticide Factsheets

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

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.

Testing Consent Order on Dilsodecyl Phenyl Phosphite

EPA Pesticide Factsheets

This rule announces that EPA has signed an enforceable Testing Consent Order with three manufacturers of dilsodecyl phenyl phosphite (PDDP CAS No, 25550-98-5), who have agreed to perform certain neurotoxicity tests PDDP.

Testing Consent Order for Acrylic Acid

EPA Pesticide Factsheets

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

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

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

Lynn Kidman

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

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...

Testing Consent Order for Octamethylcyclotetrasiloxane

EPA Pesticide Factsheets

This rule announces that EPA has signed an enforceable testing consent order with six manufacturers of octamethylcyclotetrasiloxane (OMCTS; CAS No. 556-67—2, who have agreed to perform certain chemical fate and environmental effects tests with OMCTS.

Testing Consent Order for Sodium Cyanide

EPA Pesticide Factsheets

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

Corrective Action Investigation Plan for Corrective Action Unit 219: Septic Systems and Injection Wells, Nevada Test Site, Nevada, Rev. No.: 0

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

David A. Strand

The Corrective Action Investigation Plan for Corrective Action Unit 219, Septic Systems and Injection Wells, has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. The purpose of the investigation is to ensure that adequate data are collected to provide sufficient and reliable information to identify, evaluate, and select technically viable corrective actions. Corrective Action Unit 219 is located in Areas 3, 16, and 23 of the Nevada Test Site, which is 65 miles northwest ofmore » Las Vegas, Nevada. Corrective Action Unit 219 is comprised of the six Corrective Action Sites (CASs) listed below: (1) 03-11-01, Steam Pipes and Asbestos Tiles; (2) 16-04-01, Septic Tanks (3); (3) 16-04-02, Distribution Box; (4) 16-04-03, Sewer Pipes; (5) 23-20-01, DNA Motor Pool Sewage and Waste System; and (6) 23-20-02, Injection Well. These sites are being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives. Additional information will be obtained by conducting a corrective action investigation prior to evaluating corrective action alternatives and selecting the appropriate corrective action for each CAS. The results of the field investigation will support a defensible evaluation of viable corrective action alternatives that will be presented in the Corrective Action Decision Document.« less

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...

Informed consent and moral integrity.

PubMed Central

Gillett, G R

1989-01-01

Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. PMID:2795625

Floodplain Assessment for the North Ancho Canyon Aggregate Area Cleanup in Technical Area 39 at Los Alamos National Laboratory

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

Hathcock, Charles Dean

This floodplain assessment was prepared in accordance with 10 Code of Federal Regulations (CFR) 1022 Compliance with Floodplain and Wetland Environmental Review Requirements, which was promulgated to implement the U.S. Department of Energy (DOE) requirements under Executive Order 11988 Floodplain Management and Executive Order 11990 Wetlands Protection. According to 10 CFR 1022, a 100-year floodplain is defined as “the lowlands adjoining inland and coastal waters and relatively flat areas and flood prone areas of offshore islands.” In this action, DOE is proposing to collect soil investigation samples and remove contaminated soil within and around selected solid waste management units (SWMUs)more » near and within the 100-year floodplain (hereafter “floodplain”) in north Ancho Canyon at Los Alamos National Laboratory (LANL). The work is being performed to comply with corrective action requirements under the 2016 Compliance Order on Consent.« less

Testing Consent Order on Mesityl Oxide

EPA Pesticide Factsheets

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

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

EPA Pesticide Factsheets

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

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

PubMed

Sanchini, Virginia; Reni, Michele; Calori, Giliola; Riva, Elisabetta; Reichlin, Massimo

2014-04-01

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

76 FR 59425 - Notice of Lodging of Consent Decree Under The Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-26

... and collection systems, to correctly establish and monitor operating parameters, and to comply with... using model test protocols, adopt new monitoring practices, correct deficiencies in recordkeeping and... Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460...

Validation, Proof-of-Concept, and Postaudit of the Groundwater Flow and Transport Model of the Project Shoal Area

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

Ahmed Hassan

2004-09-01

The groundwater flow and radionuclide transport model characterizing the Shoal underground nuclear test has been accepted by the State of Nevada Division of Environmental Protection. According to the Federal Facility Agreement and Consent Order (FFACO) between DOE and the State of Nevada, the next steps in the closure process for the site are then model validation (or postaudit), the proof-of-concept, and the long-term monitoring stage. This report addresses the development of the validation strategy for the Shoal model, needed for preparing the subsurface Corrective Action Decision Document-Corrective Action Plan and the development of the proof-of-concept tools needed during the five-yearmore » monitoring/validation period. The approach builds on a previous model, but is adapted and modified to the site-specific conditions and challenges of the Shoal site.« 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.

Testing Consent Order on Refractory Ceramic Fibers

EPA Pesticide Factsheets

This notice announces that EPA has signed signed an enforceable testing consent order under the Toxic Substances Control Act (TSCA), 15 U.S.C. section 2601 at seq., with three of the primary producers of refractory ceramic fibers (RCF).

ER Consolidated Qtrly Rpt_April thru June 2015_October 2015

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

Cochran, John

2015-10-01

This Sandia National Laboratories, New Mexico Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) fulfills all quarterly reporting requirements set forth in the Resource Conservation and Recovery Act Facility Operating Permit, and the Compliance Order on Consent. The 13 sites in the Corrective Action process are listed in Table I-1. Because the status of any Long-Term Stewardship (LTS) activity is detailed in other reports, Section I.3.0 (titled Long-Term Stewardship Work Completed) will not be presented in future ER Quarterly Reports. Section I.3.0 of this ER Quarterly Report identifies the other reports that detail LTS activities.

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

C.I. Disperse Blue; Testing Consent Order

EPA Pesticide Factsheets

This notice announces that EPA has signed an enforceable Testing Consent Order with eight companies who have agreed to perform certain health and environmental effects tests with C.I. Disperse Blue 79:1(1)8-79:1)(CAS No. 3618-72-2.

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.

1,1,2-Trichloroethane (TCE); Final Enforceable Consent Agreement and Testing Consent Order

EPA Pesticide Factsheets

EPA has issued an enforceable consent agreement (ECA) with The Dow Chemical Company; Vulcan Materials Company; Occidental Chemical Corp; Oxy Vinyls, LP; Georgia Gulf Corp; Westlake Chemical Corp; PPG, Borden Chemicals & Plastics, and Formosa Plastics.

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.

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

PubMed

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

2013-10-01

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

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...

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

Phase I Transport Model of Corrective Action Units 101 and 102: Central and Western Pahute Mesa, Nevada Test Site, Nye County, Nevada with Errata Sheet 1, 2, 3, Revision 1

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

Greg Ruskauff

2009-02-01

As prescribed in the Pahute Mesa Corrective Action Investigation Plan (CAIP) (DOE/NV, 1999) and Appendix VI of the Federal Facility Agreement and Consent Order (FFACO) (1996, as amended February 2008), the ultimate goal of transport analysis is to develop stochastic predictions of a contaminant boundary at a specified level of uncertainty. However, because of the significant uncertainty of the model results, the primary goal of this report was modified through mutual agreement between the DOE and the State of Nevada to assess the primary model components that contribute to this uncertainty and to postpone defining the contaminant boundary until additionalmore » model refinement is completed. Therefore, the role of this analysis has been to understand the behavior of radionuclide migration in the Pahute Mesa (PM) Corrective Action Unit (CAU) model and to define, both qualitatively and quantitatively, the sensitivity of such behavior to (flow) model conceptualization and (flow and transport) parameterization.« less

Corrective Action Investigation Plan for Corrective Action Unit 528: Polychlorinated Biphenyls Contamination, Nevada Test Site, Nevada, Rev. 0

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

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

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 528, Polychlorinated Biphenyls Contamination (PCBs), Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. Located in the southwestern portion of Area 25 on the NTS in Jackass Flats (adjacent to Test Cell C [TCC]), CAU 528 consists of Corrective Action Site 25-27-03, Polychlorinated Biphenyls Surface Contamination. Test Cell C was built to support the Nuclear Rocket Development Stationmore » (operational between 1959 and 1973) activities including conducting ground tests and static firings of nuclear engine reactors. Although CAU 528 was not considered as a direct potential source of PCBs and petroleum contamination, two potential sources of contamination have nevertheless been identified from an unknown source in concentrations that could potentially pose an unacceptable risk to human health and/or the environment. This CAU's close proximity to TCC prompted Shaw to collect surface soil samples, which have indicated the presence of PCBs extending throughout the area to the north, east, south, and even to the edge of the western boundary. Based on this information, more extensive field investigation activities are being planned, the results of which are to be used to support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

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.

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

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

Lynn Kidman

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

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.

Corrective action investigation plan for Corrective Action Unit 340, Pesticide Release Sites, Nevada Test Site, Nye County, Nevada

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

NONE

This Correction Action Investigation Plan (CAIP) has been developed in accordance with the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the US Department of Energy, Nevada Operations Office (DOE/NV); the State of Nevada Division of Environmental Protection (NDEP); and the US Department of Defense. As required by the FFACO (1996), this document provides or references all of the specific information for planning investigation activities associated with three Corrective Action Sites (CASs) located at the Nevada Test Site (NTS). These CASs are collectively known as Corrective Action Unit (CAU) 340, Pesticide Release Sites. According to themore » FFACO, CASs are sites that may require corrective action(s) and may include solid waste management units or individual disposal or release sites. These sites are CAS 23-21-01, Area 23 Quonset Hut 800 (Q800) Pesticide Release Ditch; CAS 23-18-03, Area 23 Skid Huts Pesticide Storage; and CAS 15-18-02, Area 15 Quonset Hut 15-11 Pesticide Storage (Q15-11). The purpose of this CAIP for CAU 340 is to direct and guide the investigation for the evaluation of the nature and extent of pesticides, herbicides, and other contaminants of potential concern (COPCs) that were stored, mixed, and/or disposed of at each of the CASs.« less

Corrective Action Investigation Plan for Corrective Action Unit 516: Septic Systems and Discharge Points, Nevada Test Site, Nevada, Rev. 0, Including Record of Technical Change No. 1

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

None

This Corrective Action Investigation Plan (CAIP) contains the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Sites Office's (NNSA/NSO's) approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 516, Septic Systems and Discharge Points, Nevada Test Site (NTS), Nevada, under the Federal Facility Agreement and Consent Order. CAU 516 consists of six Corrective Action Sites: 03-59-01, Building 3C-36 Septic System; 03-59-02, Building 3C-45 Septic System; 06-51-01, Sump Piping, 06-51-02, Clay Pipe and Debris; 06-51-03, Clean Out Box and Piping; and 22-19-04, Vehicle Decontamination Area. Located in Areasmore » 3, 6, and 22 of the NTS, CAU 516 is being investigated because disposed waste may be present without appropriate controls, and hazardous and/or radioactive constituents may be present or migrating at concentrations and locations that could potentially pose a threat to human health and the environment. Existing information and process knowledge on the expected nature and extent of contamination of CAU 516 are insufficient to select preferred corrective action alternatives; therefore, additional information will be obtained by conducting a corrective action investigation. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document. Record of Technical Change No. 1 is dated 3/2004.« less

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.

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.

Federal Register notice: Testing Consent Order for 1,1,1-Trichloroethane and Response to the Interagency Testing Committee

EPA Pesticide Factsheets

This rule announces that EPA has signed an enforceable testing consent order with five manufacturers of 1,1,1-trichloroethane (TCEA) (CAS No. 71—55—6), who have agreed to perform mutagenicity and neurotoxicity tests with TCEA.

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.

Closure Report for Corrective Action Unit 117: Area 26 Pluto Disassembly Facility, Nevada Test Site, Nevada, Revision 0

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

Mark Burmeister

This Closure Report (CR) presents information supporting the closure of Corrective Action Unit (CAU) 117: Area 26 Pluto Disassembly Facility, Nevada Test Site, Nevada. This CR complies with the requirements of the Federal Facility Agreement and Consent Order 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. Corrective Action Unit 117 comprises Corrective Action Site (CAS) 26-41-01, Pluto Disassembly Facility, located in Area 26 of the Nevada Test Site. The purpose of this CR is to provide documentation supporting the completed corrective actions and providemore » data confirming that the closure objectives for CAU 117 were met. To achieve this, the following actions were performed: • Review the current site conditions, including the concentration and extent of contamination. • Implement any corrective actions necessary to protect human health and the environment. • Properly dispose of corrective action and investigation wastes. • Document Notice of Completion and closure of CAU 117 issued by the Nevada Division of Environmental Protection. From May 2008 through February 2009, closure activities were performed as set forth in the Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 117, Area 26 Pluto Disassembly Facility, Nevada Test Site, Nevada. The purpose of the activities as defined during the data quality objectives process were: • Determine whether contaminants of concern (COCs) are present. • If COCs are present, determine their nature and extent, implement appropriate corrective actions, and properly dispose of wastes. Analytes detected during the closure activities were evaluated against final action levels to determine COCs for CAU 117. Assessment of the data generated from closure activities indicated that the final action levels were exceeded for polychlorinated biphenyls (PCBs) reported as total Aroclor and radium-226. A corrective action was implemented to remove approximately 50 cubic yards of PCB-contaminated soil, approximately 1 cubic foot of radium-226 contaminated soil (and scabbled asphalt), and a high-efficiency particulate air filter that was determined to meet the criteria of a potential source material (PSM). Electrical and lighting components (i.e., PCB-containing ballasts and capacitors) and other materials (e.g., mercury-containing thermostats and switches, lead plugs and bricks) assumed to be PSM were also removed from Building 2201, as practical, without the need for sampling. Because the COC contamination and PSMs have been removed, clean closure of CAS 26-41-01 is recommended, and no use restrictions are required to be placed on this CAU. No further action is necessary because no other contaminants of potential concern were found above preliminary action levels. The physical end state for Building 2201 is expected to be eventual demolition to slab. The DOE, National Nuclear Security Administration Nevada Site Office provides the following recommendations: • Clean closure is the recommended corrective action for CAS 26-41-01 in CAU 117. • A Notice of Completion to the DOE, National Nuclear Security Administration Nevada Site Office is requested from the Nevada Division of Environmental Protection for closure of CAU 117. • Corrective Action Unit 117 should be moved from Appendix III to Appendix IV of the Federal Facility Agreement and Consent Order.« less

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).

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...

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.

Corrective Action Investigation Plan for Corrective Action Unit 214: Bunkers and Storage Areas Nevada Test Site, Nevada: Revision 0, Including Record of Technical Change No. 1 and No. 2

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

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

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 214 under the Federal Facility Agreement and Consent Order. Located in Areas 5, 11, and 25 of the Nevada Test Site, CAU 214 consists of nine Corrective Action Sites (CASs): 05-99-01, Fallout Shelters; 11-22-03, Drum; 25-99-12, Fly Ash Storage; 25-23-01, Contaminated Materials; 25-23-19, Radioactive Material Storage; 25-99-18, Storage Area; 25-34-03, Motor Dr/Gr Assembly (Bunker); 25-34-04, Motor Dr/Gr Assembly (Bunker); and 25-34-05, Motormore » Dr/Gr Assembly (Bunker). These sites are being investigated because existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives (CAAs). The suspected contaminants and critical analyte s for CAU 214 include oil (total petroleum hydrocarbons-diesel-range organics [TPH-DRO], polychlorinated biphenyls [PCBs]), pesticides (chlordane, heptachlor, 4,4-DDT), barium, cadmium, chronium, lubricants (TPH-DRO, TPH-gasoline-range organics [GRO]), and fly ash (arsenic). The land-use zones where CAU 214 CASs are located dictate that future land uses will be limited to nonresidential (i.e., industrial) activities. The results of this field investigation will support a defensible evaluation of viable corrective action alternatives that will be presented in the corrective action decision document.« less

First Implementation of Transfusion Consent Policy in Oman: Audit of compliance from a tertiary care university hospital.

PubMed

Al-Riyami, Arwa Z; Al-Ghafri, Naif; Zia, Fehmida; Al-Huneini, Mohammed; Al-Rawas, Abdul-Hakeem; Al-Kindi, Salam; Jose, Sachin; Al-Khabori, Murtadha; Al-Sabti, Hilal; Daar, Shahina

2016-08-01

Transfusions are a common medical intervention. Discussion of the benefits, risks and alternatives with the patient is mandated by many legislations prior to planned transfusions. At the Sultan Qaboos University Hospital (SQUH), Muscat, Oman, a written transfusion consent policy was introduced in March 2014. This was the first time such a policy was implemented in Oman. This study therefore aimed to assess adherence to this policy among different specialties within SQUH. The medical records of patients who underwent elective transfusions between June and August 2014 were reviewed to assess the presence of transfusion consent forms. If present, the consent forms were examined for completeness of patient, physician and witness information. In total, the records of 446 transfused patients (299 adult and 147 paediatric patients) were assessed. Haematology patients accounted for 50% of adult patients and 71% of paediatric patients. Consent was obtained for 75% of adult and 91% of paediatric patients. The highest adherence rate was observed among adult and paediatric haematology specialists (95% and 97%, respectively). Consent forms were correctly filled out with all details provided for 51% and 52% of adult and paediatric patients, respectively. Among inadequately completed forms, the most common error was a lack of witness details (20-25%). In most cases, the pre-transfusion consent policy was successfully adhered to at SQUH. However, further work is required to ensure full compliance with the consent procedure within different specialties. Implementation of transfusion consent in other hospitals in the country is recommended.

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...

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...

Surgical correction of pectus arcuatum

PubMed Central

Ershova, Ksenia; Adamyan, Ruben

2016-01-01

Background Pectus arcuatum is a rear congenital chest wall deformity and methods of surgical correction are debatable. Methods Surgical correction of pectus arcuatum always includes one or more horizontal sternal osteotomies, resection of deformed rib cartilages and finally anterior chest wall stabilization. The study is approved by the institutional ethical committee and has obtained the informed consent from every patient. Results In this video we show our modification of pectus arcuatum correction with only partial sternal osteotomy and further stabilization by vertical parallel titanium plates. Conclusions Reported method is a feasible option for surgical correction of pectus arcuatum. PMID:29078483

Factors Affecting the Decision to Grant Consent for Organ Donation: A Survey of Adults in England.

PubMed

Webb, Gwilym; Phillips, Neil; Reddiford, Sarah; Neuberger, James

2015-07-01

Solid organ transplantation reduces both morbidity and mortality. Donation rates have increased by more than 60% in the last 6 years in the United Kingdom, largely through improved identification and management of potential donors. However, the next of kin (NoK) decline to consent in 43% of cases-the second highest rate in Europe. We aimed to define factors that influence decisions to consent for organ donation. This is an online survey of 1549 adult residents of England with results weighted to national demographics. Eighty percent would consider donating some or all of their organs. Religion, age, and ethnicity influenced this support. Concerns over body integrity, religion, and effects on the quality of care received reduce support. Only 48% recognized that NoK consent would be sought before any donation. Previous discussion and Organ Donor Register (ODR) enrollment both correlate with NoK consent: 87% would consent after discussion and ODR enrollment, 79% would consent after discussion alone, 55% would consent with ODR registration alone, and 29% would consent without either. Reported misconceptions inhibiting consent included a perceived inability to deregister from the ODR and that individuals were too old to donate. Those who did not wish to donate their own organs were more likely to overrule others' expressed wishes to donate. To ensure that organ donation occurs wherever appropriate, attention should focus primarily on determining an individual's wishes before death, ensuring that any misconceptions are corrected before a decision is made, promotion of ODR enrollment, and challenging those NoK who wish to overrule others' wishes.

Disclosure of information and informed consent: ethical and practical considerations.

PubMed

Steinberg, Avraham

2009-12-01

Disclosure of information and informed consent are relatively new concepts in the patient-physician relationship. They are based primarily on the principle of autonomy and they have many favorable practical advantages. However, the practical implementation of these requirements is fraught with difficulties, some of which can cause harm to the patient or be obstacles in fulfilling the moral obligation of beneficence. This is particularly true when disclosure of information and informed consent are done by physicians in a defensive way for fear of malpractice suits. The most ethically defensible approach is to tailor and navigate the information according to the needs and desires of each individual patient in a sensitive and empathic manner. The informed consent should be a process of mutually shared responsibility by the patient and the physician, ensuring adequate and relevant information that is well comprehended by the individual patient, and is used correctly for his or her decision making.

CLOSURE REPORT FOR CORRECTIVE ACTION UNIT165: AREA 25 AND 26 DRY WELL AND WASH DOWN AREAS, NEVADA TEST SITE, NEVADA

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

BECHTEL NEVADA

This Closure Report (CR) documents the closure activities for Corrective Action Unit (CAU) 165, Area 25 and 26 Dry Well and Washdown Areas, according to the Federal Facility Agreement and Consent Order (FFACO) of 1996. CAU 165 consists of 8 Corrective Action Sites (CASs) located in Areas 25 and 26 of the Nevada Test Site (NTS). The NTS is located approximately 105 kilometers (65 miles) northwest of Las Vegas, nevada. Site closure activities were performed according to the Nevada Division of Environmental Protection (NDEP)-approved Corrective Action Plan (CAP) for CAU 165. CAU 165 consists of the following CASs: (1) CASmore » 25-07-06, Train Decontamination Area; (2) CAS 25-07-07, Vehicle Washdown; (3) CAS 25-20-01, Lab Drain Dry Well; (4) CAS 25-47-01, Reservoir and French Drain; (5) CAS 25-51-02, Drywell; (6) CAS 25-59-01, Septic System; (7) CAS 26-07-01, Vehicle Washdown Station; and (8) CAS 26-59-01, Septic System. CAU 165, Area 25 and 26 Dry Well and Washdown Areas, consists of eight CASs located in Areas 25 and 26 of the NTS. The approved closure alternatives included No Further Action, Clean Closure, and Closure in Place with Administrative Controls.« less

Addendum to the Corrective Action Decision Document/Closure Report for Corrective Action Unit 529: Area 25 Contaminated Materials, Nevada Test Site, Nevada, Revision 1

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

Krauss, Mark J

This document constitutes an addendum to the Corrective Action Decision Document/Closure Report for Corrective Action Unit 529: Area 25 Contaminated Materials, Nevada Test Site, Nevada as described in the document Recommendations and Justifications To Remove Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order dated September 2013. The Use Restriction (UR) Removal document was approved by the Nevada Division of Environmental Protection on October 16, 2013. The approval of the UR Removal document constituted approval of each of the recommended UR removals. In conformance with the URmore » Removal document, this addendum consists of: This page that refers the reader to the UR Removal document for additional information The cover, title, and signature pages of the UR Removal document The NDEP approval letter The corresponding section of the UR Removal document This addendum provides the documentation justifying the cancellation of the UR for CAS 25-23-17, Contaminated Wash (Parcel H). This UR was established as part of FFACO corrective actions and was based on the presence of total petroleum hydrocarbon diesel-range organics contamination at concentrations greater than the NDEP action level at the time of the initial investigation.« less

The metaphysical basis of a liberal organ procurement policy.

PubMed

Hershenov, David B; Delaney, James J

2010-08-01

There remains a need to properly analyze the metaphysical assumptions underlying two organ procurement policies: presumed consent and organ sales. Our contention is that if one correctly understands the metaphysics of both the human body and material property, then it will turn out that while organ sales are illiberal, presumed consent is not. What we mean by illiberal includes violating rights of bodily integrity, property, or autonomy, as well as arguing for or against a policy in a manner that runs afoul of Rawlsian public reason.

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

PubMed

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

2017-08-01

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

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.

77 FR 52060 - Notice of Lodging of Consent Decree Pursuant to the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-28

... through best management practices, (c) capacity, management, operation and maintenance corrective action, (d) construction site inspection and enforcement, and (e) industrial facility stormwater pollution...

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

PubMed

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

2013-11-01

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

Closure Report for Corrective Action Unit 408: Bomblet Target Area Tonopah Test Range (TTR), Nevada, Revision 0

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

Mark Krauss

2010-09-01

This Closure Report (CR) presents information supporting the closure of Corrective Action Unit (CAU) 408: Bomblet Target Area (TTR), Tonopah Test Range, Nevada. This CR complies with the requirements of the Federal Facility Agreement and Consent Order 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. Corrective Action Unit 408 is located at the Tonopah Test Range, Nevada, and consists of Corrective Action Site (CAS) TA-55-002-TAB2, Bomblet Target Areas. This CAS includes the following seven target areas: • Mid Target • Flightline Bomblet Location •more » Strategic Air Command (SAC) Target Location 1 • SAC Target Location 2 • South Antelope Lake • Tomahawk Location 1 • Tomahawk Location 2 The purpose of this CR is to provide documentation supporting the completed corrective actions and data confirming that the closure objectives for the CAS within CAU 408 were met. To achieve this, the following actions were performed: • Review the current site conditions, including the concentration and extent of contamination. • Implement any corrective actions necessary to protect human health and the environment. • Properly dispose of corrective action and investigation wastes. • Document Notice of Completion and closure of CAU 408 issued by the Nevada Division of Environmental Protection. From July 2009 through August 2010, closure activities were performed as set forth in the Streamlined Approach for Environmental Restoration Plan for CAU 408: Bomblet Target Area, Tonopah Test Range (TTR), Nevada. The purposes of the activities as defined during the data quality objectives process were as follows: • Identify and remove munitions of explosive concern (MEC) associated with DOE activities. • Investigate potential disposal pit locations. • Remove depleted uranium-contaminated fragments and soil. • Determine whether contaminants of concern (COCs) are present. • If COCs are present, determine their nature and extent, implement appropriate corrective actions, and properly dispose of wastes. Analytes detected during the closure activities were evaluated against final action levels to determine COCs for CAU 408. Assessment of the data indicated COCs are not present at CAS TA-55-002-TAB2; therefore, no corrective action is necessary. No use restrictions are required to be placed on this CAU because the investigation showed no evidence of remaining soil contamination or remaining debris/waste upon completion of all investigation activities. The MEC was successfully removed and dispositioned as planned using current best available technologies. As MEC guidance and general MEC standards acknowledge that MEC response actions cannot determine with 100 percent certainty that all MEC and unexploded ordnance (UXO) are removed, the clean closure of CAU 408 will implement a best management practice of posting UXO hazard warning signs near the seven target areas. The signs will warn future land users of the potential for encountering residual UXO hazards. The DOE, National Nuclear Security Administration Nevada Site Office, provides the following recommendations: • A Notice of Completion to the DOE, National Nuclear Security Administration Nevada Site Office, is requested from the Nevada Division of Environmental Protection for closure of CAU 408. • Corrective Action Unit 408 should be moved from Appendix III to Appendix IV of the Federal Facility Agreement and Consent Order.« less

Is Decedent Race an Independent Predictor of Organ Donor Consent, or Merely a Surrogate Marker of Socioeconomic Status?

PubMed Central

DuBay, Derek A.; Redden, David; Haque, Akhlaque; Gray, Stephen; Fouad, Mona; Siminoff, Laura A.; Holt, Cheryl; Kohler, Connie; Eckhoff, Devin

2013-01-01

Background Studies have demonstrated that African American race is a strong predictor of non-donation. However, it is often and correctly argued that African American race is a crude explanatory variable that is a surrogate marker of socioeconomic status (SES), education and access to health care. We hypothesized that when controlling for these factors, African American race would cease to be a predictor of organ donation. Methods A retrospective review was performed of 1292 Alabama decedents approached for organ donation between 2006 and 2009. Multivariable logistic regression models were constructed to identify the most parsimonious model that could explain the variation in the log-odds of obtaining consent. Results Consent for donation was obtained from 49% of the decedent's families. Household income was a predictor of organ donor consent only in Caucasians. Surprisingly, household income was not statistically different between consented and non-consented African American decedents ($25,147 vs. $26,137; p=0.90). On multivariable analysis, education, urban residence and shorter distance between the decedent residence and donor hospital were significantly associated with obtaining consent for organ donation. On univariate analysis, the odds of donor consent in Caucasians compared to African Americans was 2.76 (95% CI 2.17 – 3.57). When controlling for SES and access to healthcare variables, the odds of donor consent increased to 4.36 (95% CI 2.88 – 6.61). Conclusions We interpret this result to indicate that there remains unknown but important factor(s) associated with both race and obtaining organ donor consent. Further studies are required to isolate and determine whether this factor(s) is modifiable. PMID:23018878

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.

Corrective Action Investigation Plan for Corrective Action Unit 527: Horn Silver Mine, Nevada Test Site, Nevada: Revision 1 (Including Records of Technical Change No.1, 2, 3, and 4)

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

U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office

This Corrective Action Investigation Plan contains the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 527, Horn Silver Mine, Nevada Test Site, Nevada, under the Federal Facility Agreement and Consent Order. Corrective Action Unit 527 consists of one Corrective Action Site (CAS): 26-20-01, Contaminated Waste Dump No.1. The site is located in an abandoned mine site in Area 26 (which is the most arid part of the NTS) approximately 65 miles northwest of Las Vegas. Historicalmore » documents may refer to this site as CAU 168, CWD-1, the Wingfield mine (or shaft), and the Wahmonie mine (or shaft). Historical documentation indicates that between 1959 and the 1970s, nonliquid classified material and unclassified waste was placed in the Horn Silver Mine's shaft. Some of the waste is known to be radioactive. Documentation indicates that the waste is present from 150 feet to the bottom of the mine (500 ft below ground surface). This CAU is being investigated because hazardous constituents migrating from materials and/or wastes disposed of in the Horn Silver Mine may pose a threat to human health and the environment as well as to assess the potential impacts associated with any potential releases from the waste. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

Corrective Action Investigation Plan for Corrective Action Unit 224: Decon Pad and Septic Systems Nevada Test Site, Nevada, Rev. No.: 0, with ROTC 1 and 2

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

David A. Strand

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 224: Decon Pad and Septic Systems, Nevada Test Site (NTS), Nevada. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense (DoD). The NTS is approximately 65 miles (mi) northwest of Las Vegas, Nevada (Figure 1-1). Corrective Action Unit 224 is comprised of themore » nine Corrective Action Sites (CASs) listed below: 02-04-01, Septic Tank (Buried); 03-05-01, Leachfield; 05-04-01, Septic Tanks (4)/Discharge Area; 06-03-01, Sewage Lagoons (3); 06-05-01, Leachfield; 06-17-04, Decon Pad and Wastewater Catch; 06-23-01, Decon Pad Discharge Piping; 11-04-01, Sewage Lagoon; and 23-05-02, Leachfield. Corrective Action Sites 06-05-01, 06-23-01, and 23-05-02 were identified in the 1991 Reynolds Electrical & Engineering Co., Inc. (REECo) inventory (1991). The remaining sites were identified during review of various historical documents. Additional information will be obtained by conducting a corrective action investigation (CAI) prior to evaluating and selecting a corrective action alternative for each CAS. The CAI will include field inspections, radiological and geological surveys, and sample collection. Data will also be obtained to support investigation-derived waste (IDW) disposal and potential future waste management decisions.« less

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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...

Informed consent in high-risk renal transplant recipients.

PubMed

Cocchiara, G; Lo Monte, A I; Romano, G; Romano, M; Buscemi, G

2009-06-01

Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words--informed and consent--are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.

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…

The changing face of informed surgical consent.

PubMed

Oosthuizen, J C; Burns, P; Timon, C

2012-03-01

To determine whether procedure-specific brochures improve patients' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed 'Request for Treatment' consenting process is viable on a large scale. A prospective, questionnaire-based study of 100 patients admitted for selected, elective surgical procedures. In total, 99 per cent of patients were satisfied with the information received in the out-patient department, regarding the proposed procedure. However, 38 per cent were unable to correctly state the nature of the surgery or specific procedure they were scheduled to undergo. Although the vast majority of patients were able to state the intended benefits to be gained from the procedure, only 54 per cent were able to list at least one potential complication, and 80 per cent indicated that they wished to be informed about all potential complications, even if these occurred in less than 1 per cent of cases. The introduction of procedure-specific brochures improved patients' pre-operative knowledge. Although the failings of current consenting practice are clear, the Request for Treatment consenting process would not appear to be a viable alternative because of the large number of patients unable to accurately recall the nature of the proposed surgery or potential complications, following consent counselling.

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2014 CFR

2014-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2013 CFR

2013-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2012 CFR

2012-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 80-05-7 Bisphenol A 51 FR 33047, 9/18/86 April 6, 1993 84-65-1 Anthraquinone 52 FR 21018, 6/4/87 Aug... consent orders for which the testing reimbursement period has passed. 799.18 Section 799.18 Protection of...) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS General Provisions § 799.18...

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.

Enhancing HIV Vaccine Trial Consent Preparedness Among Street Drug Users

PubMed Central

Fisher, Celia B.

2011-01-01

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

Challenges of Obtaining Informed Consent in Emergency Ward: A Qualitative Study in One Iranian Hospital

PubMed Central

Davoudi, Nayyereh; Nayeri, Nahid Dehghan; Zokaei, Mohammad Saeed; Fazeli, Nematallah

2017-01-01

Background and Objective: Regarding the fact that emergency ward has unique characteristics, whose uniqueness affects informed consent processes by creating specific challenges. Hence, it seems necessary to identify the process and challenges of informed consent in the emergency ward through a qualitative study to understand actual patients’ and health care providers’ experiences, beliefs, values, and feelings about the informed consent in the emergency ward. Through such studies, new insight can be gained on the process of informed consent and its challenges with the hope that the resulting knowledge will enable the promotion of ethical, legal as well as effective health services to the patients in the emergency ward. Method: In this qualitative study, research field was one of the emergency wards of educational and public hospitals in Iran. Field work and participant observation were carried out for 515 hours from June 2014 to March 2016. Also, conversations and semi-structured interviews based on the observations were conducted. The participants of the study were nurses and physicians working in the emergency ward, as well as patients and their attendants who were involved in the process of obtaining informed consent. Results: Three main categories were extracted from the data: a sense of frustration; reverse protection; and culture of paternalism in consent process. Conclusion: Findings of this study can be utilized in correcting the structures and processes of obtaining informed consent together with promotion of patients' ethical and legal care in emergency ward. In this way, the approaches in consent process will be changed from paternalistic approach to patient-centered care which concomitantly protects patient’s autonomy. PMID:29399235

Multimedia patient education to assist the informed consent process for knee arthroscopy.

PubMed

Cornoiu, Andrei; Beischer, Andrew D; Donnan, Leo; Graves, Stephen; de Steiger, Richard

2011-03-01

In contemporary clinical practice, the ability for orthopaedic surgeons to obtain true 'informed consent' is becoming increasingly difficult. This problem has been driven by factors including increased expectations of surgical outcome by patients and increasing complexity of surgical procedures. Surgical pamphlets and computer presentations have been advocated as ways of improving patient education, but evidence of their efficacy is limited. The aim of this study was to compare the efficacy of a computer-based multimedia (MM) presentation against standardized verbal consent and information pamphlets for patients considering knee arthroscopy surgery. A randomized, controlled prospective trial was conducted, comparing the efficacy of three methods of providing preoperative informed consent information to patients. Sixty-one patients were randomly allocated into MM, verbal consent or pamphlet groups 3-6 weeks prior to knee arthroscopy surgery. Information recall after the initial consent process was assessed by questionnaire. Retention of this information was again assessed by questionnaire at the time of surgery and 6 weeks after surgery. The MM group demonstrated a significantly greater proportion of correct responses, 98%, in the questionnaire at the time of consent, in comparison with 88% for verbal and 76% for pamphlet groups, with no difference in anxiety levels. Information was also better retained by the MM group up to 6 weeks after surgery. Patient satisfaction with information delivery was higher in the MM group. MM is an effective tool for aiding in the provision and retention of information during the informed consent process. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

Streamlined Approach for Environmental Restoration Plan for Corrective Action Unit 574: Neptune, Nevada National Security Site, Nevada

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

NSTec Environmental Restoration

2011-08-31

This Streamlined Approach for Environmental Restoration (SAFER) Plan identifies the activities required for closure of Corrective Action Unit (CAU) 574, Neptune. CAU 574 is included in the Federal Facility Agreement and Consent Order (FFACO) (1996 [as amended March 2010]) and consists of the following two Corrective Action Sites (CASs) located in Area 12 of the Nevada National Security Site: (1) CAS 12-23-10, U12c.03 Crater (Neptune); (2) CAS 12-45-01, U12e.05 Crater (Blanca). This plan provides the methodology for the field activities that will be performed to gather the necessary information for closure of the two CASs. There is sufficient information andmore » process knowledge regarding the expected nature and extent of potential contaminants to recommend closure of CAU 574 using the SAFER process. Based on historical documentation, personnel interviews, site process knowledge, site visits, photographs, field screening, analytical results, the results of the data quality objective (DQO) process (Section 3.0), and an evaluation of corrective action alternatives (Appendix B), closure in place with administrative controls is the expected closure strategy for CAU 574. Additional information will be obtained by conducting a field investigation to verify and support the expected closure strategy and provide a defensible recommendation that no further corrective action is necessary. This will be presented in a Closure Report that will be prepared and submitted to the Nevada Division of Environmental Protection (NDEP) for review and approval.« less

Phase II Transport Model of Corrective Action Unit 98: Frenchman Flat, Nevada Test Site, Nye County, Nevada, Revision 1

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

Gregg Ruskuaff

This document, the Phase II Frenchman Flat transport report, presents the results of radionuclide transport simulations that incorporate groundwater radionuclide transport model statistical and structural uncertainty, and lead to forecasts of the contaminant boundary (CB) for a set of representative models from an ensemble of possible models. This work, as described in the Federal Facility Agreement and Consent Order (FFACO) Underground Test Area (UGTA) strategy (FFACO, 1996; amended 2010), forms an essential part of the technical basis for subsequent negotiation of the compliance boundary of the Frenchman Flat corrective action unit (CAU) by Nevada Division of Environmental Protection (NDEP) andmore » National Nuclear Security Administration Nevada Site Office (NNSA/NSO). Underground nuclear testing via deep vertical shafts was conducted at the Nevada Test Site (NTS) from 1951 until 1992. The Frenchman Flat area, the subject of this report, was used for seven years, with 10 underground nuclear tests being conducted. The U.S. Department of Energy (DOE), NNSA/NSO initiated the UGTA Project to assess and evaluate the effects of underground nuclear tests on groundwater at the NTS and vicinity through the FFACO (1996, amended 2010). The processes that will be used to complete UGTA corrective actions are described in the “Corrective Action Strategy” in the FFACO Appendix VI, Revision No. 2 (February 20, 2008).« less

Closure Report for Corrective Action Unit 536: Area 3 Release Site, Nevada Test Site, Nevada

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

NSTec Environmental Restoration

Corrective Action Unit (CAU) 536 is located in Area 3 of the Nevada Test Site. CAU 536 is listed in the Federal Facility Agreement and Consent Order of 1996 as Area 3 Release Site, and comprises a single Corrective Action Site (CAS): {sm_bullet} CAS 03-44-02, Steam Jenny Discharge The Nevada Division of Environmental Protection (NDEP)-approved corrective action alternative for CAS 03-44-02 is clean closure. Closure activities included removing and disposing of total petroleum hydrocarbon (TPH)- and polyaromatic hydrocarbon (PAH)-impacted soil, soil impacted with plutonium (Pu)-239, and concrete pad debris. CAU 536 was closed in accordance with the NDEP-approved CAU 536more » Corrective Action Plan (CAP), with minor deviations as approved by NDEP. The closure activities specified in the CAP were based on the recommendations presented in the CAU 536 Corrective Action Decision Document (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, 2004). This Closure Report documents CAU 536 closure activities. During closure activities, approximately 1,000 cubic yards (yd3) of hydrocarbon waste in the form of TPH- and PAH-impacted soil and debris, approximately 8 yd3 of Pu-239-impacted soil, and approximately 100 yd3 of concrete debris were generated, managed, and disposed of appropriately. Additionally, a previously uncharacterized, buried drum was excavated, removed, and disposed of as hydrocarbon waste as a best management practice. Waste minimization techniques, such as the utilization of laboratory analysis to characterize and classify waste streams, were employed during the performance of closure« less

Patient predictors of colposcopy comprehension of consent among English- and Spanish-speaking women.

PubMed

Krankl, Julia Tatum; Shaykevich, Shimon; Lipsitz, Stuart; Lehmann, Lisa Soleymani

2011-01-01

patients with limited English proficiency may be at increased risk for diminished understanding of clinical procedures. This study sought to assess patient predictors of comprehension of colposcopy information during informed consent and to assess differences in understanding between English and Spanish speakers. between June and August 2007, English- and Spanish-speaking colposcopy patients at two Boston hospitals were surveyed to assess their understanding of the purpose, risks, benefits, alternatives, and nature of colposcopy. Patient demographic information was collected. there were 183 women who consented to participate in the study. We obtained complete data on 111 English speakers and 38 Spanish speakers. English speakers were more likely to have a higher education, greater household income, and private insurance. Subjects correctly answered an average of 7.91 ± 2.16 (72%) of 11 colposcopy survey questions. English speakers answered more questions correctly than Spanish speakers (8.50 ± 1.92 [77%] vs 6.21 ± 1.93 [56%]; p < .001). Using linear regression to adjust for confounding variables, we found that language was not significantly associated with greater understanding (p = .46). Rather, education was the most significant predictor of colposcopy knowledge (p < .001). many colposcopy patients did not understand the procedure well enough to give informed consent. The observed differences in colposcopy comprehension based on language were a proxy for differences in education. Education, not language, predicted subjects' understanding of colposcopy. These results demonstrate the need for greater attention to patients' educational background to ensure adequate understanding of clinical information. 2011 Jacobs Institute of Women's Health. Published by Elsevier Inc.

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

PubMed Central

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

2013-01-01

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

75 FR 4107 - Corrected Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

... States $655,094 and BNSF Railway Company $427,000 in past costs incurred in addressing the contamination...-wide cleanup program to address contamination of residential properties. The Department of Justice will...

76 FR 63954 - Notice of Lodging of Consent Decree Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-14

... overflows and correcting the effluent limitation violations. The City will comply with a mutually agreed... report on the status of any overflows from the Combined Sewer System (``CSS'') and their duration and...

When "altering brain function" becomes "mind control".

PubMed

Koivuniemi, Andrew; Otto, Kevin

2014-01-01

Functional neurosurgery has seen a resurgence of interest in surgical treatments for psychiatric illness. Deep brain stimulation (DBS) technology is the preferred tool in the current wave of clinical experiments because it allows clinicians to directly alter the functions of targeted brain regions, in a reversible manner, with the intent of correcting diseases of the mind, such as depression, addiction, anorexia nervosa, dementia, and obsessive compulsive disorder. These promising treatments raise a critical philosophical and humanitarian question. "Under what conditions does 'altering brain function' qualify as 'mind control'?" In order to answer this question one needs a definition of mind control. To this end, we reviewed the relevant philosophical, ethical, and neurosurgical literature in order to create a set of criteria for what constitutes mind control in the context of DBS. We also outline clinical implications of these criteria. Finally, we demonstrate the relevance of the proposed criteria by focusing especially on serendipitous treatments involving DBS, i.e., cases in which an unintended therapeutic benefit occurred. These cases highlight the importance of gaining the consent of the subject for the new therapy in order to avoid committing an act of mind control.

Corrective Action Investigation Plan for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada (December 2002, Revision No.: 0), Including Record of Technical Change No. 1

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

NNSA /NSO

The Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 204 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 204 is located on the Nevada Test Site approximately 65 miles northwest of Las Vegas, Nevada. This CAU is comprised of six Corrective Action Sites (CASs) which include: 01-34-01, Underground Instrument House Bunker; 02-34-01, Instrument Bunker; 03-34-01, Underground Bunker; 05-18-02, Chemical Explosives Storage; 05-33-01, Kay Blockhouse; 05-99-02, Explosive Storage Bunker.more » Based on site history, process knowledge, and previous field efforts, contaminants of potential concern for Corrective Action Unit 204 collectively include radionuclides, beryllium, high explosives, lead, polychlorinated biphenyls, total petroleum hydrocarbons, silver, warfarin, and zinc phosphide. The primary question for the investigation is: ''Are existing data sufficient to evaluate appropriate corrective actions?'' To address this question, resolution of two decision statements is required. Decision I is to ''Define the nature of contamination'' by identifying any contamination above preliminary action levels (PALs); Decision II is to ''Determine the extent of contamination identified above PALs. If PALs are not exceeded, the investigation is completed. If PALs are exceeded, then Decision II must be resolved. In addition, data will be obtained to support waste management decisions. Field activities will include radiological land area surveys, geophysical surveys to identify any subsurface metallic and nonmetallic debris, field screening for applicable contaminants of potential concern, collection and analysis of surface and subsurface soil samples from biased locations, and step-out sampling to define the extent of contamination, as necessary. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

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.

Streamlined Approach for Environmental Restoration (SAFER) Plan for Corrective Action Unit 117: Area 26 Pluto Disassembly Facility, Nevada Test Site, Nevada With Errata Sheets, Revision 0

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

Pat Matthews

This Streamlined Approach for Environmental Restoration (SAFER) Plan addresses the actions needed to achieve closure for Corrective Action Unit (CAU) 117, Pluto Disassembly Facility, identified in the Federal Facility Agreement and Consent Order. Corrective Action Unit 117 consists of one Corrective Action Site (CAS), CAS 26-41-01, located in Area 26 of the Nevada Test Site. This plan provides the methodology for field activities needed to gather the necessary information for closing CAS 26-41-01. There is sufficient information and process knowledge from historical documentation and investigations of similar sites regarding the expected nature and extent of potential contaminants to recommend closuremore » of CAU 117 using the SAFER process. Additional information will be obtained by conducting a field investigation before finalizing the appropriate corrective action for this CAS. The results of the field investigation will support a defensible recommendation that no further corrective action is necessary following SAFER activities. This will be presented in a Closure Report that will be prepared and submitted to the Nevada Division of Environmental Protection (NDEP) for review and approval. The site will be investigated to meet the data quality objectives (DQOs) developed on June 27, 2007, by representatives of NDEP; U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office; Stoller-Navarro Joint Venture; and National Security Technologies, LLC. The DQO process was used to identify and define the type, amount, and quality of data needed to determine and implement appropriate corrective actions for CAS 26-41-01 in CAU 117.« less

77 FR 37439 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-21

... City of Perth Amboy, New Jersey a Municipal Corporation, and the State of New Jersey, Civil Action No... inspection and engineering assessment that will result in a corrective action plan that will include...

A resolution providing for a technical correction to S. Res. 700.

THOMAS, 111th Congress

Sen. Schumer, Charles E. [D-NY

2010-12-22

Senate - 12/22/2010 Submitted in the Senate, considered, and agreed to without amendment by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

2014 Well Completion Report for Corrective Action Unit 447 Project Shoal Area Churchill County, Nevada October 2015

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

Findlay, Rick

2015-11-01

This report summarizes the drilling program conducted by the U.S. Department of Energy (DOE) Office of Legacy Management at the Project Shoal Area (Shoal) Subsurface Corrective Action Unit 447 in Churchill County, Nevada. Shoal was the location of an underground nuclear test conducted on October 26, 1963, as part of the Vela Uniform program sponsored jointly by the U.S. Department of Defense and the U.S. Atomic Energy Commission (a predecessor to DOE). The test consisted of detonating a 12-kiloton nuclear device in granitic rock at a depth of approximately 1,211 feet (ft) below ground surface (bgs) (AEC 1964). The correctivemore » action strategy for the site is focused on revising the site conceptual model and evaluating the adequacy of the monitoring well network at the site. Field activities associated with the project were conducted in accordance with the Federal Facility Agreement and Consent Order (FFACO 1996, as amended) and applicable Nevada Division of Environmental Protection (NDEP) policies and regulations.« less

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...

A booklet on participants' rights to improve consent for clinical research: a randomized trial.

PubMed

Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

2012-01-01

Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial

PubMed Central

Benatar, Jocelyne R.; Mortimer, John; Stretton, Matthew; Stewart, Ralph A. H.

2012-01-01

Objective Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). Conclusions A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials. PMID:23094034

Addendum to the Closure Report for Corrective Action Unit 357: Mud Pits and Waste Dump, Nevada Test Site, Nevada, Revision 0

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

Krauss, Mark J

This document constitutes an addendum to the Closure Report for Corrective Action Unit 357: Mud Pits and Waste Dump, Nevada Test Site, Nevada as described in the document Recommendations and Justifications To Remove Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order dated September 2013. The Use Restriction Removal document was approved by the Nevada Division of Environmental Protection on October 16, 2013. The approval of the UR Removal document constituted approval of each of the recommended UR removals. In conformance with the UR Removal document, thismore » addendum consists of: This page that refers the reader to the UR Removal document for additional information The cover, title, and signature pages of the UR Removal document The NDEP approval letter The corresponding section of the UR Removal document This addendum provides the documentation justifying the cancellation of the UR for CAS 04-26-03, Lead Bricks. This UR was established as part of FFACO corrective actions and was based on the presence of lead contamination at concentrations greater than the action level established at the time of the initial investigation.« less

Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

PubMed

Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

2015-02-07

Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p < 0.01). Patients in the intervention arm, had an average score of 69.25% (SD 14.91) correct answers as compared to 47.38% (SD 17.77) in the control arm. Satisfaction was also improved in the intervention arm (p = 0.043). There was no statistically significant difference between the control and intervention arm relating to their anxiety scores (p = 0.195). The use of a patient education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

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.

[Informed consent].

PubMed

López-Sáez, Asunción; López, de Teruel; Siso Martín, Juan

2003-11-01

Once the stage of health paternalism, exercised so many times under the pretext of the principle of benevolence, has been overcome, treatment relationships level off, they become symmetrical and balanced and in this climate of a "therapeutic alliance", both parties, the patient and the health professional, have to merge their capabilities and their limitations. The health professional can not impose general character operational methods to follow to a patient nor interventions, even though clinically correct, against a patient's will; but neither does a patient have the right to obtain treatment in accordance with his desires if these are found to be in disagreement with concrete clinical recommendations for the case dealt with according to the health professional's criteria. We can summarize what has just been stated in two basic principles: 1. The health professional is not obliged to follow the requests of a patient if he/she does not consider these clinically appropriate, but in order to follow a different treatment method, the health professional must have the consent of the patient. 2. In any case, if a patient opposes a treatment being applied to him/her, except in the few legally recognized exceptions, the health professional can try to persuade a patient to accept recommended treatment, but never can carry out treatment against the patient's will.

Corrective Action Investigation Plan for Corrective Action Unit 97: Yucca Flat/Climax Mine, Nevada National Security Site, Nevada with ROTCs 1, 2, and 3 (Revision 0, September 2000)

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

Andrews, Robert; Marutzky, Sam

2000-09-01

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) approach to collect the data necessary to evaluate Corrective Action Alternatives (CAAs) appropriate for the closure of Corrective Action Unit (CAU) 97 under the Federal Facility Agreement and Consent Order (FFACO). Corrective Action Unit 97, collectively known as the Yucca Flat/Climax Mine CAU, consists of 720 Corrective Action Sites (CASs). The Yucca Flat/Climax Mine CAU extends over several areas of the NTS and constitutes one of several areas used for underground nuclear testing in the past. The nuclear tests resulted in groundwater contamination in themore » vicinity as well as downgradient of the underground test areas. Based on site history, the Yucca Flat underground nuclear tests were conducted in alluvial, volcanic, and carbonate rocks; whereas, the Climax Mine tests were conducted in an igneous intrusion located in northern Yucca Flat. Particle-tracking simulations performed during the regional evaluation indicate that the local Climax Mine groundwater flow system merges into the much larger Yucca Flat groundwater flow systems during the 1,000-year time period of interest. Addressing these two areas jointly and simultaneously investigating them as a combined CAU has been determined the best way to proceed with corrective action investigation (CAI) activities. The purpose and scope of the CAI includes characterization activities and model development conducted in five major sequential steps designed to be consistent with FFACO Underground Test Area Project's strategy to predict the location of the contaminant boundary, develop and implement a corrective action, and close each CAU. The results of this field investigation will support a defensible evaluation of CAAs in the subsequent corrective action decision document.« less

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.

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...

CORRECTIVE ACTION DECISION DOCUMENT FOR CORRECTIVE ACTION UNIT 383: AREA 12 E-TUNNEL SITES, NEVADA TEST SITE, REV. NO. 0

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

Mark McLane

2005-03-01

This Corrective Action Decision Document (CADD) was prepared by the Defense Threat Reduction Agency (DTRA) and the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO). The recommendations and corrective actions described within this document apply to the future closure of Corrective Action Unit (CAU) 383, Area 12 E-Tunnel Sites, which is a joint DTRA and NNSA/NSO site. The CAU consists of three (3) Corrective Action Sites (CASs): CAS 12-06-06 (Muckpile); CAS 12-25-02 (Oil Spill); and CAS 12-28-02 (Radioactive Material). In addition to these CASs, E-Tunnel Ponds One, Two, and Three, and the Drainage Area above themore » ponds were included since closure of the Muckpile will impact these areas. This CADD is consistent with the requirements of the ''Federal Facility Agreement and Consent Order'' agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. The DTRA point of contact is the Nevada Operations Office, Environmental Project Manager; currently Ms. Tiffany A. Lantow. The NNSA/NSO point of contact is the Environmental Restoration, Industrial Sites Project Manager; currently Ms. Janet Appenzeller-Wing. The purpose of this CADD is to identify and provide the rationale for the selection of a recommended corrective action alternative for CAU 383. This document presents the recommended corrective action for CAU 383 (E-Tunnel Sites); however, implementation may be affected by the corrective action (to be determined) for CAU 551 (Area 12 Muckpiles) due to the close proximity of B, C, D, and F-Tunnels. The scope of this CADD consists of the following tasks: (1) Develop corrective action objectives; (2) Identify corrective action alternative screening criteria; (3) Develop corrective action alternatives; (4) Perform detailed and comparative evaluations of the corrective action alternatives in relation to the corrective action objectives and screening criteria; and (5) Recommend and justify a preferred corrective action alternative for CAU 383.« less

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

PubMed

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

2017-03-06

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

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

PubMed Central

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

2017-01-01

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

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

[Photography in plastic surgery: practices, uses and legislation].

PubMed

de Runz, A; Simon, E; Brix, M; Sorin, T; Brengard-Bresler, T; Pineau, V; Guyon, G; Claudot, F

2015-02-01

Photography in plastic surgery is omnipresent. Through its various uses, it may present both ethical and forensic risks. The objective of this study is to analyze the use of medical photography by the plastic surgeon, the perception of this use by the patient, and consequence of such use. A questionnaire about the use of medical photography was assessed to 629 plastic surgeons. A questionnaire was given to patients, about their perception of the use of photography by their surgeon. One hundred and seventy-six surgeon's questionnaires and 93 patient's questionnaires were analyzed. For 97.7% of the responding surgeons, the proportion of patients refusing to be photographed was less then 1/20. The objective of the photography was especially medicolegal for 62.5% of the surgeons, especially for following the patient progress (87.5%), partially for the formation (72.1%), partially for scientific publications (57.8%) and not at all for the personal publicity (73.1%). Surgeons often share his photographs with others surgeons (71.1%), sometimes with others medical personnel (48.8%). The security and the access to photographs were determined to be correct for 67.6% of the surgeons and perfect for 23.3%. In total, 17.2% of the surgeons obtained a written consent, 41.4% obtained an oral consent, and 38.5% did not request patient consent. It was found that 48.3% of the surgeons and 40.2% of the patients think that the right to the photographic images belong to the patient. Medical photographs expose the plastic surgeon to medico-legal risks. He must know and follow the law in order to prevent eventual legal proceedings. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

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

[Dutch Health Care Inspectorate (IGZ) abuses its inspection authority in patient files].

PubMed

van Lessen Kloeke, Koosje

2014-01-01

For its investigation regarding the transfer of data after discharge of vulnerable elderly patients from hospital to nursing homes, care homes or home care, the Dutch Health Care Inspectorate (IGZ) demands access to patients' files, without their explicit consent. Doctors who do not cooperate run the risk of penalty payments. Since it concerns a limited number of patients per practice, it would not be unreasonably onerous for the Inspectorate to allow doctors to ask their patients' consent. Other reasons mentioned by the Inspectorate, such as possible "inappropriate correction" of data and the capability of vulnerable elderly patients to give their consent seem improper grounds to breach patients' right to privacy and to demand that doctors breach professional confidentiality. The legality of the Inspectorate's actions could be addressed in a test case and should be discussed more widely in light of the Inspectorate's work plan for 2014.

Corrective Action Decision Document for Corrective Action Unit 428: Area 3 Septic Waste Systems 1 and 5, Tonopah Test Range, Nevada

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

U.S. Department of Energy, Nevada Operations Office

2000-02-08

This Corrective Action Decision Document identifies and rationalizes the US Department of Energy, Nevada Operations Office's selection of a recommended corrective action alternative (CAA) appropriate to facilitate the closure of Corrective Action Unit (CAU) 428, Septic Waste Systems 1 and 5, under the Federal Facility Agreement and Consent Order. Located in Area 3 at the Tonopah Test Range (TTR) in Nevada, CAU 428 is comprised of two Corrective Action Sites (CASs): (1) CAS 03-05-002-SW01, Septic Waste System 1 and (2) CAS 03-05-002- SW05, Septic Waste System 5. A corrective action investigation performed in 1999 detected analyte concentrations that exceeded preliminarymore » action levels; specifically, contaminants of concern (COCs) included benzo(a) pyrene in a septic tank integrity sample associated with Septic Tank 33-1A of Septic Waste System 1, and arsenic in a soil sample associated with Septic Waste System 5. During this investigation, three Corrective Action Objectives (CAOs) were identified to prevent or mitigate exposure to contents of the septic tanks and distribution box, to subsurface soil containing COCs, and the spread of COCs beyond the CAU. Based on these CAOs, a review of existing data, future use, and current operations in Area 3 of the TTR, three CAAs were developed for consideration: Alternative 1 - No Further Action; Alternative 2 - Closure in Place with Administrative Controls; and Alternative 3 - Clean Closure by Excavation and Disposal. These alternatives were evaluated based on four general corrective action standards and five remedy selection decision factors. Based on the results of the evaluation, the preferred CAA was Alternative 3. This alternative meets all applicable state and federal regulations for closure of the site and will eliminate potential future exposure pathways to the contaminated soils at the Area 3 Septic Waste Systems 1 and 5.« less

Corrective Action Decision Document for Corrective Action Unit 563: Septic Systems, Nevada Test Site, Nevada, Revision 0

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

Grant Evenson

2008-02-01

This Corrective Action Decision Document has been prepared for Corrective Action Unit (CAU) 563, Septic Systems, in accordance with the Federal Facility Agreement and Consent Order (FFACO, 1996; as amended January 2007). The corrective action sites (CASs) for CAU 563 are located in Areas 3 and 12 of the Nevada Test Site, Nevada, and are comprised of the following four sites: •03-04-02, Area 3 Subdock Septic Tank •03-59-05, Area 3 Subdock Cesspool •12-59-01, Drilling/Welding Shop Septic Tanks •12-60-01, Drilling/Welding Shop Outfalls The purpose of this Corrective Action Decision Document is to identify and provide the rationale for the recommendation of a correctivemore » action alternative (CAA) for the four CASs within CAU 563. Corrective action investigation (CAI) activities were performed from July 17 through November 19, 2007, as set forth in the CAU 563 Corrective Action Investigation Plan (NNSA/NSO, 2007). Analytes detected during the CAI were evaluated against appropriate final action levels (FALs) to identify the contaminants of concern (COCs) for each CAS. The results of the CAI identified COCs at one of the four CASs in CAU 563 and required the evaluation of CAAs. Assessment of the data generated from investigation activities conducted at CAU 563 revealed the following: •CASs 03-04-02, 03-59-05, and 12-60-01 do not contain contamination at concentrations exceeding the FALs. •CAS 12-59-01 contains arsenic and chromium contamination above FALs in surface and near-surface soils surrounding a stained location within the site. Based on the evaluation of analytical data from the CAI, review of future and current operations at CAS 12-59-01, and the detailed and comparative analysis of the potential CAAs, the following corrective actions are recommended for CAU 563.« less

Environmental Restoration Operations: Consolidated Quarterly Report January -March 2017

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

Cochran, John R.

This Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) provides the status of ongoing corrective action activities being implemented at Sandia National Laboratories, New Mexico (SNL/NM) during the January, February, and March 2017 quarterly reporting period. Table I-1 lists the Solid Waste Management Units (SWMUs) and Areas of Concern (AOCs) identified for corrective action at SNL/NM. Sections I.2.1 and I.2.2 summarize the work completed during this quarter. Section I.2.1 summarizes the quarterly activities at sites undergoing corrective action field activities. Field activities are conducted at the three groundwater AOCs (Burn Site Groundwater [BSG AOC], Technical Area [TA]-V Groundwatermore » [TAVG AOC], and Tijeras Arroyo Groundwater [TAG AOC]). Section I.2.2 summarizes quarterly activities at sites where the New Mexico Environment Department (NMED) Hazardous Waste Bureau (HWB) issued a certificate of completion and the sites are in the corrective action complete (CAC) regulatory process. Currently, SWMUs 8 and 58, 68, 149, 154, and 502 are in the CAC regulatory process. Corrective action activities are deferred at the Long Sled Track (SWMU 83), the Gun Facilities (SWMU 84), and the Short Sled Track (SWMU 240) because these three sites are active mission facilities. These three active mission sites are located in TA-III. This Sandia National Laboratories, New Mexico Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) fulfills all quarterly reporting requirements set forth in the Resource Conservation and Recovery Act Facility Operating Permit and the Compliance Order on Consent.« less

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.

Knowledge of Abortion Laws and Services Among Low-Income Women in Three United States Cities.

PubMed

Lara, Diana; Holt, Kelsey; Peña, Melanie; Grossman, Daniel

2015-12-01

Low-income women and women of color are disproportionately affected by unintended pregnancy. Lack of knowledge of abortion laws and services is one of several factors likely to hinder access to services, though little research has documented knowledge in this population. Survey with convenience sample of 1,262 women attending primary care or full-scope Ob/Gyn clinics serving low-income populations in three large cities and multivariable analyses with four knowledge outcomes. Among all participants, 53% were first-generation immigrants, 25% identified the correct gestational age limit, 41% identified state parental consent laws, 67% knew partner consent is not required, and 55% knew where to obtain abortion services. In multivariable analysis, first-generation immigrants and primarily Spanish speakers were significantly less likely than higher-generation or primarily English speakers to display correct knowledge. Design and evaluation of strategies to improve knowledge about abortion, particularly among migrant women and non-primary English speakers, is needed.

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.

HIV Testing and Treatment with Correctional Populations: People, Not Prisoners

PubMed Central

Seal, David Wyatt; Eldridge, Gloria D.; Zack, Barry; Sosman, James

2014-01-01

Institutional policies, practices, and norms can impede the delivery of ethical standard-of-care treatment for people with HIV in correctional settings. In this commentary, we focus on the fundamental issues that must be addressed to create an ethical environment in which best medical practices can be implemented when working with correctional populations. Thus, we consider ethical issues related to access to services, patient privacy, confidentiality, informed consent for testing and treatment, and issues related to the provision of services in an institutional setting in which maintenance of security is the primary mission. Medical providers must understand and navigate the dehumanization inherent in most correctional settings, competing life demands for incarcerated individuals, power dynamics within the correctional system, and the needs of family and significant others who remain in the community. PMID:20693739

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.

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

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...

Mental health screening and evaluation within prisons.

PubMed

Metzner, J L; Miller, R D; Kleinsasser, D

1994-01-01

Current national standards and/or guidelines for correctional mental health care programs emphasize the importance of various levels of mental health screening and evaluation that should be performed by qualified personnel on all inmates as part of the admission process to a prison. The authors describe the results of a study that included data from all 50 state departments of corrections regarding prison mental health screening and evaluation models. The vast majority of states appear to have adopted some variation of the most recognized guidelines and/or standards (e.g., American Psychiatric Association, National Commission on Correctional Health Care, American Public Health Association) concerning correctional health care systems. Results are also provided concerning the use of standardized psychological tests and informed consent issues.

Net Improvement of Correct Answers to Therapy Questions After PubMed Searches: Pre/Post Comparison

PubMed Central

Keepanasseril, Arun

2013-01-01

Background Clinicians search PubMed for answers to clinical questions although it is time consuming and not always successful. Objective To determine if PubMed used with its Clinical Queries feature to filter results based on study quality would improve search success (more correct answers to clinical questions related to therapy). Methods We invited 528 primary care physicians to participate, 143 (27.1%) consented, and 111 (21.0% of the total and 77.6% of those who consented) completed the study. Participants answered 14 yes/no therapy questions and were given 4 of these (2 originally answered correctly and 2 originally answered incorrectly) to search using either the PubMed main screen or PubMed Clinical Queries narrow therapy filter via a purpose-built system with identical search screens. Participants also picked 3 of the first 20 retrieved citations that best addressed each question. They were then asked to re-answer the original 14 questions. Results We found no statistically significant differences in the rates of correct or incorrect answers using the PubMed main screen or PubMed Clinical Queries. The rate of correct answers increased from 50.0% to 61.4% (95% CI 55.0%-67.8%) for the PubMed main screen searches and from 50.0% to 59.1% (95% CI 52.6%-65.6%) for Clinical Queries searches. These net absolute increases of 11.4% and 9.1%, respectively, included previously correct answers changing to incorrect at a rate of 9.5% (95% CI 5.6%-13.4%) for PubMed main screen searches and 9.1% (95% CI 5.3%-12.9%) for Clinical Queries searches, combined with increases in the rate of being correct of 20.5% (95% CI 15.2%-25.8%) for PubMed main screen searches and 17.7% (95% CI 12.7%-22.7%) for Clinical Queries searches. Conclusions PubMed can assist clinicians answering clinical questions with an approximately 10% absolute rate of improvement in correct answers. This small increase includes more correct answers partially offset by a decrease in previously correct answers. PMID:24217329

Net improvement of correct answers to therapy questions after pubmed searches: pre/post comparison.

PubMed

McKibbon, Kathleen Ann; Lokker, Cynthia; Keepanasseril, Arun; Wilczynski, Nancy L; Haynes, R Brian

2013-11-08

Clinicians search PubMed for answers to clinical questions although it is time consuming and not always successful. To determine if PubMed used with its Clinical Queries feature to filter results based on study quality would improve search success (more correct answers to clinical questions related to therapy). We invited 528 primary care physicians to participate, 143 (27.1%) consented, and 111 (21.0% of the total and 77.6% of those who consented) completed the study. Participants answered 14 yes/no therapy questions and were given 4 of these (2 originally answered correctly and 2 originally answered incorrectly) to search using either the PubMed main screen or PubMed Clinical Queries narrow therapy filter via a purpose-built system with identical search screens. Participants also picked 3 of the first 20 retrieved citations that best addressed each question. They were then asked to re-answer the original 14 questions. We found no statistically significant differences in the rates of correct or incorrect answers using the PubMed main screen or PubMed Clinical Queries. The rate of correct answers increased from 50.0% to 61.4% (95% CI 55.0%-67.8%) for the PubMed main screen searches and from 50.0% to 59.1% (95% CI 52.6%-65.6%) for Clinical Queries searches. These net absolute increases of 11.4% and 9.1%, respectively, included previously correct answers changing to incorrect at a rate of 9.5% (95% CI 5.6%-13.4%) for PubMed main screen searches and 9.1% (95% CI 5.3%-12.9%) for Clinical Queries searches, combined with increases in the rate of being correct of 20.5% (95% CI 15.2%-25.8%) for PubMed main screen searches and 17.7% (95% CI 12.7%-22.7%) for Clinical Queries searches. PubMed can assist clinicians answering clinical questions with an approximately 10% absolute rate of improvement in correct answers. This small increase includes more correct answers partially offset by a decrease in previously correct answers.

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...

(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.

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.

Comprehension of Randomization and Uncertainty in Cancer Clinical Trials Decision Making Among Rural, Appalachian Patients.

PubMed

Krieger, Janice L; Palmer-Wackerly, Angela; Dailey, Phokeng M; Krok-Schoen, Jessica L; Schoenberg, Nancy E; Paskett, Electra D

2015-12-01

Comprehension of randomization is a vital, but understudied, component of informed consent to participate in cancer randomized clinical trials (RCTs). This study examines patient comprehension of the randomization process as well as sources of ongoing uncertainty that may inhibit a patient's ability to provide informed consent to participate in RCTs. Cancer patients living in rural Appalachia who were offered an opportunity to participate in a cancer treatment RCT completed in-depth interviews and a brief survey. No systematic differences in randomization comprehension between patients who consented and those who declined participation in a cancer RCT were detected. Comprehension is conceptually distinct from uncertainty, with patients who had both high and low comprehension experiencing randomization-related uncertainty. Uncertainty about randomization was found to have cognitive and affective dimensions. Not all patients enrolling in RCTs have a sufficient understanding of the randomization process to provide informed consent. Healthcare providers need to be aware of the different types of randomization-related uncertainty. Efforts to improve informed consent to participate in RCTs should focus on having patients teach back their understanding of randomization. This practice could yield valuable information about the patient's cognitive and affective understanding of randomization as well as opportunities to correct misperceptions. Education about RCTs should reflect patient expectations of individualized care by explaining how all treatments being compared are appropriate to the specifics of a patient's disease.

Role of the treating surgeon in the consent process for elective refractive surgery.

PubMed

Schallhorn, Steven C; Hannan, Stephen J; Teenan, David; Schallhorn, Julie M

2016-01-01

To compare patient's perception of consent quality, clinical and quality-of-life outcomes after laser vision correction (LVC) and refractive lens exchange (RLE) between patients who met their treating surgeon prior to the day of surgery (PDOS) or on the day of surgery (DOS). Retrospective, comparative case series. Optical Express, Glasgow, UK. Patients treated between October 2015 and June 2016 (3972 LVC and 979 RLE patients) who attended 1-day and 1-month postoperative aftercare and answered a questionnaire were included in this study. All patients had a thorough preoperative discussion with an optometrist, watched a video consent, and were provided with written information. Patients then had a verbal discussion with their treating surgeon either PDOS or on the DOS, according to patient preference. Preoperative and 1-month postoperative visual acuity, refraction, preoperative, 1-day and 1-month postoperative questionnaire were compared between DOS and PDOS patients. Multivariate regression model was developed to find factors associated with patient's perception of consent quality. Preoperatively, 8.0% of LVC and 17.1% of RLE patients elected to meet their surgeon ahead of the surgery day. In the LVC group, 97.5% of DOS and 97.2% of PDOS patients indicated they were properly consented for surgery ( P =0.77). In the RLE group, 97.0% of DOS and 97.0% of PDOS patients stated their consent process for surgery was adequate ( P =0.98). There was no statistically significant difference between DOS and PDOS patients in most of the postoperative clinical or questionnaire outcomes. Factors predictive of patient's satisfaction with consent quality were postoperative satisfaction with vision (46.7% of explained variance), difficulties with night driving, close-up vision or outdoor/sports activities (25.4%), visual phenomena (12.2%), dry eyes (7.5%), and patient's satisfaction with surgeon's care (8.2%). Perception of quality of consent was comparable between patients that elected to meet the surgeon PDOS, and those who did not.

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.

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.

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.

Closure Report for Corrective Action Unit 151: Septic Systems and Discharge Area, Nevada Test Site, Nevada

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

NSTec Environmental Restoration

2008-04-01

Corrective Action Unit (CAU) 151 is identified in the Federal Facility Agreement and Consent Order (FFACO) as Septic Systems and Discharge Area. CAU 151 consists of the following eight Corrective Action Sites (CASs), located in Areas 2, 12, and 18 of the Nevada Test Site, approximately 65 miles northwest of Las Vegas, Nevada: (1) CAS 02-05-01, UE-2ce Pond; (2) CAS 12-03-01, Sewage Lagoons (6); (3) CAS 12-04-01, Septic Tanks; (4) CAS 12-04-02, Septic Tanks; (5) CAS 12-04-03, Septic Tank; (6) CAS 12-47-01, Wastewater Pond; (7) CAS 18-03-01, Sewage Lagoon; and (8) CAS 18-99-09, Sewer Line (Exposed). CAU 151 closure activitiesmore » were conducted according to the FFACO (FFACO, 1996; as amended February 2008) and the Corrective Action Plan for CAU 151 (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, 2007) from October 2007 to January 2008. The corrective action alternatives included no further action, clean closure, and closure in place with administrative controls. CAU 151 closure activities are summarized in Table 1. Closure activities generated liquid remediation waste, sanitary waste, hydrocarbon waste, and mixed waste. Waste generated was appropriately managed and disposed. Waste that is currently staged onsite is being appropriately managed and will be disposed under approved waste profiles in permitted landfills. Waste minimization activities included waste characterization sampling and segregation of waste streams. Some waste exceeded land disposal restriction limits and required offsite treatment prior to disposal. Other waste meeting land disposal restrictions was disposed of in appropriate onsite or offsite landfills. Waste disposition documentation is included as Appendix C.« less

Closure Report for Corrective Action Unit 516: Septic Systems and Discharge Points

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

NSTec Environmental Restoration

Corrective Action Unit (CAU) 516 is located in Areas 3, 6, and 22 of the Nevada Test Site. CAU 516 is listed in the Federal Facility Agreement and Consent Order of 1996 as Septic Systems and Discharge Points, and is comprised of six Corrective Action Sites (CASs): {sm_bullet} CAS 03-59-01, Bldg 3C-36 Septic System {sm_bullet} CAS 03-59-02, Bldg 3C-45 Septic System {sm_bullet} CAS 06-51-01, Sump and Piping {sm_bullet} CAS 06-51-02, Clay Pipe and Debris {sm_bullet} CAS 06-51-03, Clean Out Box and Piping {sm_bullet} CAS 22-19-04, Vehicle Decontamination Area The Nevada Division of Environmental Protection (NDEP)-approved corrective action alternative for CASsmore » 06-51-02 and 22-19-04 is no further action. The NDEP-approved corrective action alternative for CASs 03-59-01, 03-59-02, 06-51-01, and 06-51-03 is clean closure. Closure activities included removing and disposing of total petroleum hydrocarbon (TPH)-impacted septic tank contents, septic tanks, distribution/clean out boxes, and piping. CAU 516 was closed in accordance with the NDEP-approved CAU 516 Corrective Action Plan (CAP). The closure activities specified in the CAP were based on the recommendations presented in the CAU 516 Corrective Action Decision Document (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, 2004). This Closure Report documents CAU 516 closure activities. During closure activities, approximately 186 tons of hydrocarbon waste in the form of TPH-impacted soil and debris, as well as 89 tons of construction debris, were generated and managed and disposed of appropriately. Waste minimization techniques, such as field screening of soil samples and the utilization of laboratory analysis to characterize and classify waste streams, were employed during the performance of closure work.« less

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

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

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

This Closure Report (CR) presents information supporting a closure recommendation for Corrective Action Unit (CAU) 394: Areas 12, 18, and 29 Spill/Release Sites, Nevada Test Site, Nevada, in compliance with the requirements of the Federal Facility Agreement and Consent Order. This CAU contains six Corrective Action Sites (CASs): 12-25-04, UST 12-16-2 Waste Oil Release; 18-25-01, 18-25-02, 18-25-03, Oil Spills; 18-25-04, Spill (Diesel Fuel); and 29-44-01, Fuel Spill, located within Areas 12, 18, and 29 on the Nevada Test Site. The purpose of this CR is to provide documentation supporting recommendations of no further action or closure in place for CASsmore » within CAU 394. Throughout late 2002 and early to mid 2003, closure activities were performed as set forth in the CAU 394 Streamlined Approach for Environmental Restoration Plan. The closure activities identified the nature and extent of contaminants of potential concern at the CASs, and provided sufficient information and data to complete appropriate corrective actions for the CASs. Soil in CASs 18-25-02 and 18-25-03 containing polychlorinated biphenyls exceeding the action levels established by the Nevada Administrative Code were removed for proper disposal. The soil remaining in these CASs containing petroleum hydrocarbons exceeding the action level were closed in place with use restrictions. Corrective Action Sites 18-25-04 required no further corrective action; closure in place is required at CASs 12-25-04, 18-25-01, 18-25-02, 18-25-03, and 29-44-01; and use restrictions are required at CASs 12-25-04, 18-25-01, 18-25-02, 18-25-03 and 29-44-01. In summary, no corrective action plan is required for CAU 394.« less

Corrective Action Investigation Plan for Corrective Action Unit 555: Septic Systems Nevada Test Site, Nevada, Rev. No.: 0 with Errata

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

Pastor, Laura

2005-12-01

This Corrective Action Investigation Plan (CAIP) contains project-specific information including facility descriptions, environmental sample collection objectives, and criteria for conducting site investigation activities at Corrective Action Unit (CAU) 555: Septic Systems, Nevada Test Site (NTS), Nevada. This CAIP has been developed in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996) that was agreed to by the State of Nevada, the U.S. Department of Energy (DOE), and the U.S. Department of Defense. Corrective Action Unit 555 is located in Areas 1, 3 and 6 of the NTS, which is approximately 65 miles (mi) northwest of Las Vegas, Nevada,more » and is comprised of the five corrective action sites (CASs) shown on Figure 1-1 and listed below: (1) CAS 01-59-01, Area 1 Camp Septic System; (2) CAS 03-59-03, Core Handling Building Septic System; (3) CAS 06-20-05, Birdwell Dry Well; (4) CAS 06-59-01, Birdwell Septic System; and (5) CAS 06-59-02, National Cementers Septic System. An FFACO modification was approved on December 14, 2005, to include CAS 06-20-05, Birdwell Dry Well, as part of the scope of CAU 555. The work scope was expanded in this document to include the investigation of CAS 06-20-05. The Corrective Action Investigation (CAI) will include field inspections, radiological surveys, geophysical surveys, sampling of environmental media, analysis of samples, and assessment of investigation results, where appropriate. Data will be obtained to support corrective action alternative evaluations and waste management decisions. The CASs in CAU 555 are being investigated because hazardous and/or radioactive constituents may be present in concentrations that could potentially pose a threat to human health and the environment. Existing information on the nature and extent of potential contamination is insufficient to evaluate and recommend corrective action alternatives for the CASs. Additional information will be generated by conducting a CAI before the evaluation and selection of corrective action alternatives.« less

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.

Modelling of pore coarsening in the high burn-up structure of UO2 fuel

NASA Astrophysics Data System (ADS)

Veshchunov, M. S.; Tarasov, V. I.

2017-05-01

The model for coalescence of randomly distributed immobile pores owing to their growth and impingement, applied by the authors earlier to consideration of the porosity evolution in the high burn-up structure (HBS) at the UO2 fuel pellet periphery (rim zone), was further developed and validated. Predictions of the original model, taking into consideration only binary impingements of growing immobile pores, qualitatively correctly describe the decrease of the pore number density with the increase of the fractional porosity, however notably underestimate the coalescence rate at high burn-ups attained in the outmost region of the rim zone. In order to overcome this discrepancy, the next approximation of the model taking into consideration triple impingements of growing pores was developed. The advanced model provides a reasonable consent with experimental data, thus demonstrating the validity of the proposed pore coarsening mechanism in the HBS.

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.

Informed consent should be obtained from patients to use products (skin substitutes) and dressings containing biological material.

PubMed

Enoch, S; Shaaban, H; Dunn, K W

2005-01-01

Biological products (tissue engineered skin, allograft and xenograft, and biological dressings) are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature. This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents. The religious groups that make up about 75% of the United Kingdom population were identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products (11 biological and 6 synthetic dressings) was sent to 100 healthcare professionals working in seven specialist units in the UK. All religious leaders (100% response rate) replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals (73% response rate) surveyed knew the constituents of all the products correctly. Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients.

Corrective Action Decision Document for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada, Revision 0 with ROTC 1, 2, and Errata

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

Wickline, Alfred

2004-04-01

This Corrective Action Decision Document (CADD) has been prepared for Corrective Action Unit (CAU) 204 Storage Bunkers, Nevada Test Site (NTS), Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) that was agreed to by the State of Nevada; U.S. Department of Energy (DOE); and the U.S. Department of Defense (FFACO, 1996). The NTS is approximately 65 miles (mi) north of Las Vegas, Nevada (Figure 1-1). The Corrective Action Sites (CASs) within CAU 204 are located in Areas 1, 2, 3, and 5 of the NTS, in Nye County, Nevada (Figure 1-2). Corrective Action Unit 204 ismore » comprised of the six CASs identified in Table 1-1. As shown in Table 1-1, the FFACO describes four of these CASs as bunkers one as chemical exchange storage and one as a blockhouse. Subsequent investigations have identified four of these structures as instrumentation bunkers (CASs 01-34-01, 02-34-01, 03-34-01, 05-33-01), one as an explosives storage bunker (CAS 05-99-02), and one as both (CAS 05-18-02). The six bunkers included in CAU 204 were primarily used to monitor atmospheric testing or store munitions. The ''Corrective Action Investigation Plan (CAIP) for Corrective Action Unit 204: Storage Bunkers, Nevada Test Site, Nevada'' (NNSA/NV, 2002a) provides information relating to the history, planning, and scope of the investigation; therefore, it will not be repeated in this CADD. This CADD identifies potential corrective action alternatives and provides a rationale for the selection of a recommended corrective action alternative for each CAS within CAU 204. The evaluation of corrective action alternatives is based on process knowledge and the results of investigative activities conducted in accordance with the CAIP (NNSA/NV, 2002a) that was approved prior to the start of the Corrective Action Investigation (CAI). Record of Technical Change (ROTC) No. 1 to the CAIP (approval pending) documents changes to the preliminary action levels (PALs) agreed to by the Nevada Division of Environmental Protection (NDEP) and DOE, National Nuclear Security Administration Nevada Site Office (NNSA/NSO). This ROTC specifically discusses the radiological PALs and their application to the findings of the CAU 204 corrective action investigation.« less

Corrective Action Investigation Plan for Corrective Action Unit 140: Waste Dumps, Burn Pits, and Storage Area, Nevada Test Site, Nevada, July 2002, Rev. No. 0

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

NNSA /NV

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 140 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 140 consists of nine Corrective Action Sites (CASs): 05-08-01, Detonation Pits; 05-08-02, Debris Pits; 05-17-01, Hazardous Waste Accumulation Site (Buried); 05-19-01, Waste Disposal Site; 05-23-01, Gravel Gertie; 05-35-01, Burn Pit; 05-99-04, Burn Pit; 22-99-04, Radioactive Waste Dump; 23-17-01, Hazardous Waste Storage Area. All nine of these CASs are located withinmore » Areas 5, 22, and 23 of the Nevada Test Site (NTS) in Nevada, approximately 65 miles northwest of Las Vegas. This CAU is being investigated because disposed waste may be present without appropriate controls (i.e., use restrictions, adequate cover) and hazardous and/or radioactive constituents may be present or migrating at concentrations and locations that could potentially pose a threat to human health and the environment. The NTS has been used for various research and development projects including nuclear weapons testing. The CASs in CAU 140 were used for testing, material storage, waste storage, and waste disposal. A two-phase approach has been selected to collect information and generate data to satisfy needed resolution criteria and resolve the decision statements. Phase I will determine if contaminants of potential concern (COPCs) are present in concentrations exceeding preliminary action levels. This data will be evaluated at all CASs. Phase II will determine the extent of the contaminant(s) of concern (COCs). This data will only be evaluated for CASs with a COC identified during Phase I. Based on process knowledge, the COPCs for CAU 140 include volatile organics, semivolatile organics, petroleum hydrocarbons, explosive residues, herbicides, pesticides, polychlorinated biphenyls, metals, and radionuclides. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

Closure Report for Corrective Action Unit 261: Area 25 Test Cell A Leachfield System, Nevada Test Site, Nevada

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

T. M. Fitzmaurice

2001-04-01

The purpose of this Closure Report (CR) is to provide documentation of the completed corrective action at the Test Cell A Leachfield System and to provide data confirming the corrective action. The Test Cell A Leachfield System is identified in the Federal Facility Agreement and Consent Order (FFACO) of 1996 as Corrective Action Unit (CAU) 261. Remediation of CAU 261 is required under the FFACO (1996). CAU 261 is located in Area 25 of the Nevada Test Site (NTS) which is approximately 140 kilometers (87 miles) northwest of Las Vegas, Nevada (Figure 1). CAU 261 consists of two Corrective Actionmore » Sites (CASS): CAS 25-05-01, Leachfield; and CAS 25-05-07, Acid Waste Leach Pit (AWLP) (Figures 2 and 3). Test Cell A was operated during the 1960s and 1970s to support the Nuclear Rocket Development Station. Various operations within Building 3124 at Test Cell A resulted in liquid waste releases to the Leachfield and the AWLP. The following existing site conditions were reported in the Corrective Action Decision Document (CADD) (U.S. Department of Energy, Nevada Operations Office [DOE/NV], 1999): Soil in the leachfield was found to exceed the Nevada Division of Environmental Protection (NDEP) Action Level for petroleum hydrocarbons, the U.S. Environmental Protection Agency (EPA) preliminary remediation goals for semi volatile organic compounds, and background concentrations for strontium-90; Soil below the sewer pipe and approximately 4.5 meters (m) (15 feet [ft]) downstream of the initial outfall was found to exceed background concentrations for cesium-137 and strontium-90; Sludge in the leachfield septic tank was found to exceed the NDEP Action Level for petroleum hydrocarbons and to contain americium-241, cesium-137, uranium-234, uranium-238, potassium-40, and strontium-90; No constituents of concern (COC) were identified at the AWLP. The NDEP-approved CADD (DOWNV, 1999) recommended Corrective Action Alternative 2, ''Closure of the Septic Tank and Distribution Box, Partial Excavation, and Administrative Controls.'' The corrective action was performed following the NDEP-approved Corrective Action Plan (CAP) (DOE/NV, 2000).« less

The use of multimedia as an adjunct to the informed consent process for ankle ligament reconstruction surgery.

PubMed

Batuyong, Eldridge; Birks, Christopher; Beischer, Andrew D

2012-06-01

Obtaining "informed consent" is an integral aspect of surgery that can be fraught with difficulty. This study assessed the efficacy of a multimedia education tool in improving patients' understanding when used as an adjunct to the traditional verbal consent process regarding ankle lateral ligament reconstruction surgery. A total of 56 patients (28 males and 28 females) were recruited with a mean age of 36 years. A standardized verbal discussion regarding surgical treatment was provided to each patient. Understanding was then assessed using a knowledge questionnaire. Subsequently, each patient observed a multimedia educational program following which the knowledge questionnaire was repeated. Additional supplementary questions were then given regarding the ease of understanding and satisfaction with the 2 methods of education delivery. The patients answered 75% of the questions correctly before the multimedia module compared with 88% after it (P < .001). Patients rated the ease of understanding and the amount of information provided by the module highly (9.5 cm and 9.0 cm on a 10-cm Visual Analogue Scale scale, respectively), and 61% of patients considered that the multimedia tool performed as well as the treating surgeon. Multimedia tools used in sequence after a verbal consent resulted in improved patient understanding of pertinent information regarding ankle lateral ligament reconstruction surgery. Therapeutic Level II.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 482: Area 15 U15a/e Muckpiles and Ponds Nevada Test Site

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

NSTec Environmental Restoration

This Corrective Action Decision Document /Closure Report (CADD/CR) was prepared by the Defense Threat Reduction Agency (DTRA) for Corrective Action Unit (CAU) 482 U15a/e Muckpiles and Ponds. This CADD/CR is consistent with the requirements of the Federal Facility Agreement and Consent Order agreed to by the State of Nevada, the U.S. Department of Energy, and the U.S. Department of Defense. Corrective Action Unit 482 is comprised of three Corrective Action Sites (CASs) and one adjacent area: CAS 15-06-01, U15e Muckpile; CAS 15-06-02, U15a Muckpile; CAS 15-38-01, Area 15 U15a/e Ponds; and Drainage below the U15a Muckpile. The purpose of thismore » CADD/CR is to provide justification and documentation supporting the recommendation for closure with no further corrective action, by placing use restrictions on the three CASs and the adjacent area of CAU 482. To support this recommendation, a corrective action investigation (CAI) was performed in September 2002. The purpose of the CAI was to fulfill the following data needs as defined during the Data Quality Objective (DQO) process: (1) Determine whether contaminants of concern (COCs) are present. (2) If COCs are present, determine their nature and extent. (3) Provide sufficient information and data to determine appropriate corrective actions. The CAU 482 dataset from the CAI was evaluated based on the data quality indicator parameters. This evaluation demonstrated the quality and acceptability of the dataset for use in fulfilling the DQO data needs. Analytes detected during the CAI were evaluated against final action levels (FALs) established in this document. Tier 2 FALS were determined for the hazardous constituents of total petroleum hydrocarbons (TPH)-diesel-range organics (DRO) and the radionuclides americium (Am)-241, cesium (Cs)-137, plutonium (Pu)-238, and Pu-239. The Tier 2 FALs were calculated for the radionuclides using site-specific information. The hazardous constituents of TPH-DRO were compared to the PALs defined in the CAIP, and because none of the preliminary action levels (PALs) were exceeded, the PALs became the FALs. The radionuclide FALs were calculated using the Residual Radioactive (RESRAD) code (version 6.21). The RESRAD calculation determined the activities of all radionuclides that together would sum to an exposure dose of 25 millirem per year to a site receptor (based on their relative abundances at each CAS). Based on the field investigation, the following contaminants were determined to be present at concentrations exceeding their corresponding FALs: (1) CAS 15-06-01 - None. (2) CAS 15-06-02 - Cs-137 and Pu-239. (3) CAS 15-38-01 - Am-241, Cs-137, Pu-238, and Pu-239. (4) Drainage below CAS 15-06-02 - Cs-137 and Pu-239. Based on the data and risk evaluations, the DQO data needs presented in the Corrective Action Investigation Plan were met, and the data accurately represent the radiological and chemical risk present at CAU 482. Based on the results of the CAI data evaluation, it was determined that closure in place with use restrictions is the appropriate corrective action for CAU 482 and that use restrictions will effectively control exposure to future land users. This is based on the fact that even though the FALs were exceeded in a few samples, this remote, controlled access site poses only limited risk overall to public health and the environment. Given the relatively low levels of contamination present, it would create a greater hazard to worker safety, public health, and the environment to remove the contamination, transport it, and bury it at another location. Therefore, DTRA provides the following recommendations: (1) Close COCs in place at CAS 15-06-02, CAS 15-38-01, and the drainage below CAS 15-06-02 with use restrictions. (2) No further action for CAU 482. (3) A Notice of Completion be issued to DTRA by the Nevada Division of Environmental Protection for closure of CAU 482. (4) Move CAU 482 from Appendix III to Appendix IV of the Federal Facility Agreement and Consent Order.« less

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...

77 FR 61027 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act and Safe Drinking Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-05

... Decree resolves alleged violations of the Clean Water Act and Safe Drinking Water Act at mobile home... provide drinking water at a number of its mobile home parks and illegally discharged sewage, failed to... environmental audits at each mobile home park, implementing corrective measures, conducting regular inspections...

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.

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.

Role of the treating surgeon in the consent process for elective refractive surgery

PubMed Central

Schallhorn, Steven C; Hannan, Stephen J; Teenan, David; Schallhorn, Julie M

2016-01-01

Purpose To compare patient’s perception of consent quality, clinical and quality-of-life outcomes after laser vision correction (LVC) and refractive lens exchange (RLE) between patients who met their treating surgeon prior to the day of surgery (PDOS) or on the day of surgery (DOS). Design Retrospective, comparative case series. Setting Optical Express, Glasgow, UK. Methods Patients treated between October 2015 and June 2016 (3972 LVC and 979 RLE patients) who attended 1-day and 1-month postoperative aftercare and answered a questionnaire were included in this study. All patients had a thorough preoperative discussion with an optometrist, watched a video consent, and were provided with written information. Patients then had a verbal discussion with their treating surgeon either PDOS or on the DOS, according to patient preference. Preoperative and 1-month postoperative visual acuity, refraction, preoperative, 1-day and 1-month postoperative questionnaire were compared between DOS and PDOS patients. Multivariate regression model was developed to find factors associated with patient’s perception of consent quality. Results Preoperatively, 8.0% of LVC and 17.1% of RLE patients elected to meet their surgeon ahead of the surgery day. In the LVC group, 97.5% of DOS and 97.2% of PDOS patients indicated they were properly consented for surgery (P=0.77). In the RLE group, 97.0% of DOS and 97.0% of PDOS patients stated their consent process for surgery was adequate (P=0.98). There was no statistically significant difference between DOS and PDOS patients in most of the postoperative clinical or questionnaire outcomes. Factors predictive of patient’s satisfaction with consent quality were postoperative satisfaction with vision (46.7% of explained variance), difficulties with night driving, close-up vision or outdoor/sports activities (25.4%), visual phenomena (12.2%), dry eyes (7.5%), and patient’s satisfaction with surgeon’s care (8.2%). Conclusion Perception of quality of consent was comparable between patients that elected to meet the surgeon PDOS, and those who did not. PMID:27932862

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.

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

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

NSTec Environmental Restoration

2012-02-21

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

Communication with family after loss, in the context of transplantology.

PubMed

Skwirczyńska-Szalbierz, E; Matoszka, N; Sepioło, A; Ostrowski, M

2014-01-01

Cooperation with a patient is a joint venture, based on a division of power and authority. Its character is not hierarchical. It assumes that this power is based on knowledge and experience, which is the opposite of power based on role or position. The good doctor-patient relationship affects a range of factors, including the healing process, the possibility of understanding the causes of a disease and its treatment and in a broader perspective, trust in the health service, which can in turn have a positive influence on public attitudes to organ donation. Because consent is presumed in Poland, there is no family consent requirement for organ donation of a deceased family member. In practice, however, medical professionals usually strive to get consent from family members, and in cases of refusal, they will not harvest. The aim of our study was to answer the following questions: (1) Does the way in which care was provided for the still-alive patient, as well as the relationship between the doctor and the patient's family, influence the family's decision to agree to the harvest of the dead patient's organs? (2) Does previous experience with healthcare institutions and personnel influence their decision to agree to organ donation? Research was conducted on a group of 173 people, using a questionnaire comprising 18 questions. Obtained results show that 34% of people are satisfied with the level of medical care. The majority claim that doctors treat them without due care. Thirty-eight percent believe that doctors are capable of stopping therapy in order to get organs for transplantation. It is necessary to recognize the correlation between a correct doctor-patient relationship, gaining trust, and how reliable a doctor's opinions are. A patient's conviction that he or she is well treated may lead to regaining the belief in the straightforwardness of the doctor's opinion, and less dissatisfaction with and less criticism of medical care. Copyright © 2014 Elsevier Inc. All rights reserved.

The Maryland Division of Correction hospice program.

PubMed

Boyle, Barbara A

2002-10-01

The Maryland Division of Correction houses 24,000 inmates in 27 geographically disparate facilities. The inmate population increasingly includes a frail, elderly component, as well as many inmates with chronic or progressive diseases. The Division houses about 900 human immunodeficiency virus (HIV)-positive detainees, almost one quarter with an acquired immune deficiency syndrome (AIDS) diagnosis. A Ryan White Special Project of National Significance (SPNS) grant and the interest of a community hospice helped transform prison hospice from idea to reality. One site is operational and a second site is due to open in the future. Both facilities serve only male inmates, who comprise more than 95% of Maryland's incarcerated. "Medical parole" is still the preferred course for terminally ill inmates; a number have been sent to various local community inpatient hospices or released to the care of their families. There will always be some who cannot be medically paroled, for whom hospice is appropriate. Maryland's prison hospice program requires a prognosis of 6 months or less to live, a do-not-resuscitate (DNR) order and patient consent. At times, the latter two of these have been problematic. Maintaining the best balance between security requirements and hospice services to dying inmates takes continual communication, coordination and cooperation. Significant complications in some areas remain: visitation to dying inmates by family and fellow prisoners; meeting special dietary requirements; what role, if any, will be played by inmate volunteers. Hospice in Maryland's Division of Correction is a work in progress.

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.

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.

Closure Plan for Corrective Action Unit 109: U-2bu Subsidence Crater Nevada Test Site, Nevada

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

Shannon Parsons

1999-03-01

The U-2bu subsidence crater, Corrective Action Unit 109, will be closed in accordance with the Resource Conservation and Recovery Act, the Nevada Division of Environmental Protection operational permit, and the Federal Facilities Agreement and Consent Order. The U-2bu subsidence crater is located in Area 2 of the Nevada Test Site. It was created in 1971 by an underground nuclear test with the name Miniata. The crater has a diameter of 288 meters (944 feet) and an approximate depth of 35 meters (115 feet). The subsidence crater was used as a land disposal unit for radioactive and hazardous waste from 1973more » to 1988. Site disposal history is supported by memorandums, letters, and personnel who worked at the Nevada Test Site at the time of active disposal. Closure activities will include the excavation and disposal of impacted soil form the tip of the crater. Upon completion of excavation, verification samples will be collected to show that lead has been removed to concentrations be low regulatory action level. The area will then be backfilled and a soil flood diversion berm will be constructed, and certified by an independent professional engineer as to having followed the approved Closure Plan.« less

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.

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...

Anti-Libidinal Interventions in Sex Offenders: Medical or Correctional?

PubMed Central

Douglas, Thomas

2016-01-01

Abstract Sex offenders are sometimes offered or required to undergo pharmacological interventions intended to diminish their sex drive (anti-libidinal interventions or ALIs). In this paper, we argue that much of the debate regarding the moral permissibility of ALIs has been founded on an inaccurate assumption regarding their intended purpose—namely, that ALIs are intended solely to realise medical purposes, not correctional goals. This assumption has made it plausible to assert that ALIs may only permissibly be administered to offenders with their valid consent, in line with the approach taken to most other interventions with a medical aim. However, we argue that, contrary to this assumption, the state's intention in relation to at least some ALIs is, at least in part, to achieve correctional objectives. We evaluate two legal regimes for ALI provision—section 645 of the California Penal Code and the mental health regime in England and Wales. In each case, we identify the state's implicit purpose in imposing ALIs and argue that the Californian and English regimes both serve as counterexamples to the view that ALIs are intended solely for medical purposes. While the moral implications of our argument are not straightforward, it raises the question whether consent is required for permissible imposition of ALIs, and more generally, whether the moral permissibility of crime-preventing interventions using medical means should be assessed against the standards of medical ethics or against those of criminal justice ethics. PMID:28158492

A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

PubMed Central

Keulers, Bram J.; Scheltinga, Marc R. M.; Spauwen, Paul H. M.; van der Wilt, Gert-Jan

2010-01-01

Background Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process. Methods Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed. Results The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose. Conclusions IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process. PMID:20372902

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

Adaptive Optics Analysis of Visual Benefit with Higher-order Aberrations Correction of Human Eye - Poster Paper

NASA Astrophysics Data System (ADS)

Xue, Lixia; Dai, Yun; Rao, Xuejun; Wang, Cheng; Hu, Yiyun; Liu, Qian; Jiang, Wenhan

2008-01-01

Higher-order aberrations correction can improve visual performance of human eye to some extent. To evaluate how much visual benefit can be obtained with higher-order aberrations correction we developed an adaptive optics vision simulator (AOVS). Dynamic real time optimized modal compensation was used to implement various customized higher-order ocular aberrations correction strategies. The experimental results indicate that higher-order aberrations correction can improve visual performance of human eye comparing with only lower-order aberration correction but the improvement degree and higher-order aberration correction strategy are different from each individual. Some subjects can acquire great visual benefit when higher-order aberrations were corrected but some subjects acquire little visual benefit even though all higher-order aberrations were corrected. Therefore, relative to general lower-order aberrations correction strategy, customized higher-order aberrations correction strategy is needed to obtain optimal visual improvement for each individual. AOVS provides an effective tool for higher-order ocular aberrations optometry for customized ocular aberrations correction.

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.

Closure Report for Corrective Action Unit 356: Mud Pits and Disposal Sites, Nevada Test Site, Nevada with Errata Sheet

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

NNSA /NV

2002-11-12

This Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 356, Mud Pits and Disposal Sites, in accordance with the Federal Facility Agreement and Consent Order. This CAU is located in Areas 3 and 20 of the Nevada Test Site (NTS) approximately 65 miles northwest of Las Vegas, Nevada. Corrective Action Unit 356 consists of seven Corrective Action Sites (CASs): 03-04-01, Area 3 Change House Septic System; 03-09-01, Mud Pit Spill Over; 03-09-03, Mud Pit; 03-09-04, Mud Pit; 03-09-05, Mud Pit; 20-16-01, Landfill; and 20-22-21, Drums. This CR identifies and rationalizes the U.S. Department of Energy (DOE), Nationalmore » Nuclear Security Administration Nevada Operations Office's (NNSA/NV's) recommendation that no further corrective action and closure in place is deemed necessary for CAU 356. This recommendation is based on the results of field investigation/closure activities conducted November 20, 2001, through January 3, 2002, and March 11 to 14, 2002. These activities were conducted in accordance with the Streamlined Approach for Environmental Restoration Plan (SAFER) for CAU 356. For CASs 03-09-01, 03-09-03, 20-16-01, and 22-20-21, analytes detected in soil during the corrective action investigation were evaluated against Preliminary Action Levels (PALs) and it was determined that no Contaminants of Concern (COCs) were present. Therefore, no further action is necessary for the soil at these CASs. For CASs 03-04-01, 03-09-04, and 03-09-05, analytes detected in soil during the corrective action investigation were evaluated against PALs and identifies total petroleum hydrocarbons (TPHs) and radionuclides (i.e., americium-241 and/or plutonium 239/240) as COCs. The nature, extent, and concentration of the TPH and radionuclide COCs were bounded by sampling and shown to be relatively immobile. Therefore, closure in place is recommended for these CASs in CAU 356. Further, use restrictions are not required at this CAU beyond the NTS use restrictions identified in the SAFER Plan. In addition, the septic tank associated with CAU 356 will be closed in accordance with applicable regulations.« less

Closure Report for Corrective Action Unit 562: Waste Systems, Nevada National Security Site, Nevada

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

NSTec Environmental Restoration

2012-08-15

This Closure Report (CR) presents information supporting closure of Corrective Action Unit (CAU) 562, Waste Systems, and provides documentation supporting the completed corrective actions and confirmation that closure objectives for CAU 562 were met. This CR complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; the U.S. Department of Energy (DOE), Environmental Management; the U.S. Department of Defense; and DOE, Legacy Management (FFACO, 1996 as amended). CAU 562 consists of the following 13 Corrective Action Sites (CASs), located in Areas 2, 23, and 25 of the Nevadamore » National Security Site: · CAS 02-26-11, Lead Shot · CAS 02-44-02, Paint Spills and French Drain · CAS 02-59-01, Septic System · CAS 02-60-01, Concrete Drain · CAS 02-60-02, French Drain · CAS 02-60-03, Steam Cleaning Drain · CAS 02-60-04, French Drain · CAS 02-60-05, French Drain · CAS 02-60-06, French Drain · CAS 02-60-07, French Drain · CAS 23-60-01, Mud Trap Drain and Outfall · CAS 23-99-06, Grease Trap · CAS 25-60-04, Building 3123 Outfalls Closure activities began in October 2011 and were completed in April 2012. Activities were conducted according to the Corrective Action Plan for CAU 562 (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office [NNSA/NSO], 2011). The corrective actions included No Further Action and Clean Closure. Closure activities generated sanitary waste and hazardous waste. Some wastes exceeded land disposal limits and required offsite treatment prior to disposal. Other wastes met land disposal restrictions and were disposed in appropriate onsite or offsite landfills. NNSA/NSO requests the following: · A Notice of Completion from the Nevada Division of Environmental Protection to NNSA/NSO for closure of CAU 562 · The transfer of CAU 562 from Appendix III to Appendix IV, Closed Corrective Action Units, of the FFACO« less

Closure Report for Corrective Action Unit 544: Cellars, Mud Pits, and Oil Spills, Nevada National Security Site, Nevada, Revision 0

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

Mark Krauss and Catherine Birney

2011-05-01

This Closure Report (CR) presents information supporting the closure of Corrective Action Unit (CAU) 544: Cellars, Mud Pits, and Oil Spills, Nevada National Security Site, Nevada. This CR complies with the requirements of the Federal Facility Agreement and Consent Order 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 corrective action sites (CASs) within CAU 544 are located within Areas 2, 7, 9, 10, 12, 19, and 20 of the Nevada National Security Site. Corrective Action Unit 544 comprises the following CASs: • 02-37-08,more » Cellar & Mud Pit • 02-37-09, Cellar & Mud Pit • 07-09-01, Mud Pit • 09-09-46, U-9itsx20 PS #1A Mud Pit • 10-09-01, Mud Pit • 12-09-03, Mud Pit • 19-09-01, Mud Pits (2) • 19-09-03, Mud Pit • 19-09-04, Mud Pit • 19-25-01, Oil Spill • 19-99-06, Waste Spill • 20-09-01, Mud Pits (2) • 20-09-02, Mud Pit • 20-09-03, Mud Pit • 20-09-04, Mud Pits (2) • 20-09-06, Mud Pit • 20-09-07, Mud Pit • 20-09-10, Mud Pit • 20-25-04, Oil Spills • 20-25-05, Oil Spills The purpose of this CR is to provide documentation supporting the completed corrective actions and data confirming that the closure objectives for CASs within CAU 544 were met. To achieve this, the following actions were performed: • Review the current site conditions, including the concentration and extent of contamination. • Implement any corrective actions necessary to protect human health and the environment. • Properly dispose of corrective action and investigation wastes. • Document Notice of Completion and closure of CAU 544 issued by the Nevada Division of Environmental Protection.« 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...

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

Corrrective action decision document for the Cactus Spring Waste Trenches (Corrective Action Unit No. 426). Revision No. 1

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

NONE

The Corrective Action Decision Document (CADD) for the Cactus Spring Waste Trenches (Corrective Action Unit [CAU] No. 426) has been prepared for the US Department of Energy`s (DOE) Nevada Environmental Restoration Project. This CADD has been developed to meet the requirements of the Federal Facility Agreement and Consent Order (FFACO) of 1996, stated in Appendix VI, {open_quotes}Corrective Action Strategy{close_quotes} (FFACO, 1996). The Cactus Spring Waste Trenches Corrective Action Site (CAS) No. RG-08-001-RG-CS is included in CAU No. 426 (also referred to as the {open_quotes}trenches{close_quotes}); it has been identified as one of three potential locations for buried, radioactively contaminated materials frommore » the Double Tracks Test. The trenches are located on the east flank of the Cactus Range in the eastern portion of the Cactus Spring Ranch at the Tonopah Test Range (TTR) in Nye County, Nevada, on the northern portion of Nellis Air Force Range. The TTR is approximately 225 kilometers (km) (140 miles [mi]) northwest of Las Vegas, Nevada, by air and approximately 56 km (35 mi) southeast of Tonopah, Nevada, by road. The trenches were dug for the purpose of receiving waste generated during Operation Roller Coaster, primarily the Double Tracks Test. This test, conducted in 1963, involved the use of live animals to assess the biological hazards associated with non-nuclear detonation of plutonium-bearing devices (i.e., inhalation uptake of plutonium aerosol). The CAS consists of four trenches that received solid waste and had an overall impacted area of approximately 36 meters (m) (120 feet [ft]) long x 24 m (80 ft) wide x 3 to 4.5 m (10 to 15 ft) deep. The average depressions at the trenches are approximately 0.3 m (1 ft) below land surface.« less

Corrective Action Decision Document/Closure Report for Corrective Action 405: Area 3 Septic Systems, Tonopah Test Range, Nevada Rev. No.: 0, April 2002

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

IT Coroporation, Las Vegas, NV

2002-04-17

This Corrective Action Decision Document/Closure Report (CADD/CR) has been prepared for Corrective Action Unit (CAU) 405, Area 3 Septic Systems, in accordance with the Federal Facility Agreement and Consent Order. Located on the Tonopah Test Range (TTR) approximately 235 miles north of Las Vegas, Nevada, CAU 405 consists of three Corrective Action Sites (CASs): 03-05-002-SW03, Septic Waste System (aka: Septic Waste System [SWS] 3); 03-05-002-SW04, Septic Waste System (aka: SWS 4); 03-05-002-SW07, Septic Waste System (aka: SWS 7). The CADD and CR have been combined into one report because no further action is recommended for this CAU, and this reportmore » provides specific information necessary to support this recommendation. The CAU consists of three leachfields and associated collection systems that were installed in or near Area 3 for wastewater disposal. These systems were used until a consolidated sewer system was installed in 1990. Historically, operations within various buildin gs in and near Area 3 of the TTR generated sanitary and industrial wastewaters. There is a potential that contaminants of concern (COCs) were present in the wastewaters and were disposed of in septic tanks and leachfields. The justification for closure of this CAU without further action is based on process knowledge and the results of the investigative activities. Closure activities were performed at these CASs between January 14 and February 2, 2002, and included the removal and proper disposal of media containing regulated constituents and proper closure of septic tanks. No further action is appropriate because all necessary activities have been completed. No use restrictions are required to be imposed for these sites since the investigation showed no evidence of COCs identified in the soil for CAU 405.« less

Underground Test Area Activity Preemptive Review Guidance Nevada National Security Site, Nevada, Revision 0

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

Farnham, Irene; Rehfeldt, Kenneth

Preemptive reviews (PERs) of Underground Test Area (UGTA) Activity corrective action unit (CAU) studies are an important and long-maintained quality improvement process. The CAU-specific PER committees provide internal technical review of ongoing work throughout the CAU lifecycle. The reviews, identified in the UGTA Quality Assurance Plan (QAP) (Sections 1.3.5.1 and 3.2), assure work is comprehensive, accurate, in keeping with the state of the art, and consistent with CAU goals. PER committees review various products, including data, documents, software/codes, analyses, and models. PER committees may also review technical briefings including Federal Facility Agreement and Consent Order (FFACO)-required presentations to the Nevadamore » Division of Environmental Protection (NDEP) and presentations supporting key technical decisions (e.g., investigation plans and approaches). PER committees provide technical recommendations to support regulatory decisions that are the responsibility of the U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Field Office (NNSA/NFO) and NDEP.« less

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.

Corrective Action Investigation Plan for Corrective Action Unit 165: Areas 25 and 26 Dry Well and Washdown Areas, Nevada Test Site, Nevada (including Record of Technical Change Nos. 1, 2, and 3) (January 2002, Rev. 0)

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

U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 165 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 165 consists of eight Corrective Action Sites (CASs): CAS 25-20-01, Lab Drain Dry Well; CAS 25-51-02, Dry Well; CAS 25-59-01, Septic System; CAS 26-59-01, Septic System; CAS 25-07-06, Train Decontamination Area; CAS 25-07-07, Vehicle Washdown; CAS 26-07-01, Vehicle Washdown Station; and CAS 25-47-01, Reservoir and French Drain. All eight CASsmore » are located in the Nevada Test Site, Nevada. Six of these CASs are located in Area 25 facilities and two CASs are located in Area 26 facilities. The eight CASs at CAU 165 consist of dry wells, septic systems, decontamination pads, and a reservoir. The six CASs in Area 25 are associated with the Nuclear Rocket Development Station that operated from 1958 to 1973. The two CASs in Area 26 are associated with facilities constructed for Project Pluto, a series of nuclear reactor tests conducted between 1961 to 1964 to develop a nuclear-powered ramjet engine. Based on site history, the scope of this plan will be a two-phased approach to investigate the possible presence of hazardous and/or radioactive constituents at concentrations that could potentially pose a threat to human health and the environment. The Phase I analytical program for most CASs will include volatile organic compounds, semivolatile organic compounds, Resource Conservation and Recovery Act metals, total petroleum hydrocarbons, polychlorinated biphenyls, and radionuclides. If laboratory data obtained from the Phase I investigation indicates the presence of contaminants of concern, the process will continue with a Phase II investigation to define the extent of contamination. Based on the results of Phase I sampling, the analytical program for Phase II investigation may be reduced. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

Corrective Action Investigation Plan for Corrective Action Unit 405: Area 3 Septic Systems, Tonopah Test Range, Nevada(April 2001, Rev. 0) with Record of Technical Change No. 1

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

DOE /NV

2001-04-26

This Corrective Action Investigation Plan contains the U.S. Department of Energy, Nevada Operations Office's (DOE/NV's) approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 405, Area 3 Septic Systems, Tonopah Test Range (TTR), under the Federal Facility Agreement and Consent Order. Corrective Action Unit 405 consists of Corrective Action Sites 03-05-002-SW03, 03-05-002-SW04, and 03-05-002-SW07 (also collectively known as: Septic Waste Systems [SWSs] 3, 4, and 7). Located in Area 3 in the northwest section of the TTR, approximately 140 miles northwest of Las Vegas, this location was historically (betweenmore » 1960 and 1990) used as a research facility with the mission to perform defense-related projects, and whose operations generated sanitary and industrial wastewaters potentially contaminated with COPCs and disposed of in septic tanks and leachfields. Though Septic Waste Systems 3, 4, and 7 were origin ally constructed to receive sanitary sewage, they may have inadvertently received effluent containing potentially hazardous and radiological constituents containing acetone, benzene, ethylbenzene, 4-methyl-2-pentanone, toluene, xylenes, volatile organic compound constituents, phenols, arsenic, barium, lead, mercury, hydrocarbons of oil and grease, and uranium-234, -235, and -238. The Area 3 septic systems were documented in a DOE/NV 1996 report as being included in the septic tank abandonment program conducted by Sandia National Laboratories in 1993; however, this program was not completed and the possibility exists that some of the Area 3 septic tanks may not have been abandoned. Even though all of the SWSs addressed in this CAIP are inactive, geophysical surveys conducted in 1993 were generally inconclusive and did not provide useful data for the purposes of this investigation. The scope of this current investigation, therefore, will be to determine the existence of the identified CO PCs and excavation will be the primary investigation method employed for these leachfield systems, but this effort may be limited by existing facilities and utilities. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the subsequent corrective action decision document.« less

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.

Addendum to the Closure Report for Corrective Action Unit 165: Area 25 and 26 Dry Well and Washdown Areas, Nevada Test Site, Nevada, Revision 0

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

Krauss, Mark J

This document constitutes an addendum to the Closure Report for Corrective Action Unit 165: Area 25 and 26 Dry Well and Washdown Areas, Nevada Test Site, Nevada as described in the document Recommendations and Justifications To Remove Use Restrictions Established under the U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office Federal Facility Agreement and Consent Order dated September 2013. The Use Restriction Removal document was approved by the Nevada Division of Environmental Protection on October 16, 2013. The approval of the UR Removal document constituted approval of each of the recommended UR removals. In conformance with themore » UR Removal document, this addendum consists of: This page that refers the reader to the UR Removal document for additional information The cover, title, and signature pages of the UR Removal document The NDEP approval letter The corresponding section of the UR Removal document This addendum provides the documentation justifying the cancellation of the UR for CAS 25-20-01, Lab Drain Dry Well. This UR was established as part of FFACO corrective actions and was based on the presence of tetrachloroethene contamination at concentrations greater than the action level established at the time of the initial investigation. Although total petroleum hydrocarbon diesel-range organics contamination at concentrations greater than the NDEP action level was present at the site, no hazardous constituents of TPH-DRO exceeded the U.S. Environmental Protection Agency (EPA) Region 9 preliminary remediation goals established at the time of the initial investigation.« less

[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.

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.

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

Obesity/Overweight in Persons With Early and Chronic SCI: A Randomized, Multicenter, Controlled Lifestyle Intervention

DTIC Science & Technology

2014-10-01

A.J. Mendez, S.L. Groah, J. Kressler. Fasting plasma glucose values may significantly underestimate prevalence of dysfunctional glycemic regulation in...taken corrective actions without undertaking additional protocol changes. There have been no screening issues since protocol amendments were approved...extending approval for the project through September 9, 2015. Enclosed is the dated/stamped Informed Consent Form, approved for one additional year until

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...

Corrective Action Decision Document/Closure Report for Corrective Action Unit 371: Johnnie Boy Crater and Pin Stripe Nevada Test Site, Nevada, Revision 0

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

Patrick Matthews

This Corrective Action Decision Document/Closure Report has been prepared for Corrective Action Unit 371, Johnnie Boy Crater and Pin Stripe, located within Areas 11 and 18 at the Nevada Test Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order (FFACO). Corrective Action Unit (CAU) 371 comprises two corrective action sites (CASs): • 11-23-05, Pin Stripe Contamination Area • 18-45-01, U-18j-2 Crater (Johnnie Boy) The purpose of this Corrective Action Decision Document/Closure Report is to provide justification and documentation supporting the recommendation that no further corrective action is needed for CAU 371 based on the implementation of correctivemore » actions. The corrective action of closure in place with administrative controls was implemented at both CASs. Corrective action investigation (CAI) activities were performed from January 8, 2009, through February 16, 2010, as set forth in the Corrective Action Investigation Plan for Corrective Action Unit 371: Johnnie Boy Crater and Pin Stripe. The approach for the CAI was divided into two facets: investigation of the primary release of radionuclides and investigation of other releases (migration in washes and chemical releases). The purpose of the CAI was to fulfill data needs as defined during the data quality objective (DQO) process. The CAU 371 dataset of investigation results was evaluated based on the data quality indicator parameters. This evaluation demonstrated the dataset is acceptable for use in fulfilling the DQO data needs. Analytes detected during the CAI were evaluated against final action levels (FALs) established in this document. Radiological doses exceeding the FAL of 25 millirem per year were not found to be present in the surface soil. However, it was assumed that radionuclides are present in subsurface media within the Johnnie Boy crater and the fissure at Pin Stripe. Due to the assumption of radiological dose exceeding the FAL, corrective actions were undertaken that consist of implementing a use restriction and posting warning signs at each site. These use restrictions were recorded in the FFACO database; the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) Facility Information Management System; and the NNSA/NSO CAU/CAS files. Therefore, NNSA/NSO provides the following recommendations: • No further corrective actions are necessary for CAU 371. • A Notice of Completion to NNSA/NSO is requested from the Nevada Division of Environmental Protection for closure of CAU 371. • Corrective Action Unit 371 should be moved from Appendix III to Appendix IV of the FFACO.« less

Corrective Action Plan for Corrective Action Unit 562: Waste Systems, Nevada National Security Site, Nevada

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

NSTec Environmental Restoration

2011-04-30

This Corrective Action Plan has been prepared for Corrective Action Unit (CAU) 562, Waste Systems, in accordance with the Federal Facility Agreement and Consent Order (1996; as amended March 2010). CAU 562 consists of 13 Corrective Action Sites (CASs) located in Areas 2, 23, and 25 of the Nevada National Security Site. Site characterization activities were performed in 2009 and 2010, and the results are presented in Appendix A of the Corrective Action Decision Document for CAU 562. The scope of work required to implement the recommended closure alternatives is summarized. (1) CAS 02-26-11, Lead Shot, will be clean closedmore » by removing shot. (2) CAS 02-44-02, Paint Spills and French Drain, will be clean closed by removing paint and contaminated soil. As a best management practice (BMP), asbestos tile will be removed. (3) CAS 02-59-01, Septic System, will be clean closed by removing septic tank contents. As a BMP, the septic tank will be removed. (4) CAS 02-60-01, Concrete Drain, contains no contaminants of concern (COCs) above action levels. No further action is required; however, as a BMP, the concrete drain will be removed. (5) CAS 02-60-02, French Drain, was clean closed. Corrective actions were completed during corrective action investigation activities. As a BMP, the drain grates and drain pipe will be removed. (6) CAS 02-60-03, Steam Cleaning Drain, will be clean closed by removing contaminated soil. As a BMP, the steam cleaning sump grate and outfall pipe will be removed. (7) CAS 02-60-04, French Drain, was clean closed. Corrective actions were completed during corrective action investigation activities. (8) CAS 02-60-05, French Drain, will be clean closed by removing contaminated soil. (9) CAS 02-60-06, French Drain, contains no COCs above action levels. No further action is required. (10) CAS 02-60-07, French Drain, requires no further action. The french drain identified in historical documentation was not located during corrective action investigation activities. (11) CAS 23-60-01, Mud Trap Drain and Outfall, will be clean closed by removing sediment from the mud trap. As a BMP, the mud trap and outfall pipe will be removed. (12) CAS 23-99-06, Grease Trap, will be clean closed by removing sediment from the grease trap and backfilling the grease trap with grout. (13) CAS 25-60-04, Building 3123 Outfalls, will be clean closed by removing contaminated soil and the sludge-containing outfall pipe.« less

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.

Consultation behaviour of doctor-shopping patients and factors that reduce shopping.

PubMed

Ohira, Yoshiyuki; Ikusaka, Masatomi; Noda, Kazutaka; Tsukamoto, Tomoko; Takada, Toshihiko; Miyahara, Masahito; Funakoshi, Hiraku; Basugi, Ayako; Keira, Katsunori; Uehara, Takanori

2012-04-01

To investigate the subsequent behaviour of doctor-shopping patients (defined as those attending multiple hospitals for the same complaint) who consulted our department and factors related to cessation of doctor shopping. Patients who presented without referral to the Department of General Medicine at Chiba University Hospital in Japan (our department) completed a questionnaire at their first visit. A follow-up questionnaire was also sent to them in order to assess doctor shopping after 3 months. Then items in the questionnaires were investigated for significant differences between patients who continued or stopped doctor shopping. Logistic regression analysis was performed with items showing a significant difference between patients who stopped doctor shopping and those who continued it, in order to identify independent determinants of the cessation of shopping. A total of 978 patients who presented spontaneously to our department consented to this study, and 929 patients (95.0%) completed questionnaires correctly. Among them, 203 patients (21.9%) were identified as doctor shoppers. The follow-up survey was completed correctly by 138 patients (68.0%). Among them, 25 patients (18.1%) were found to have continued doctor shopping, which was a significantly lower rate than before (P < 0.001). Logistic regression analysis selected the following factors as independent determinants of the cessation of doctor shopping: 'confirmation of the diagnosis' (odds ratio: 8.12, 95% confidence interval: 1.46-45.26), and 'satisfaction with consultation' (odds ratio: 2.07, 95% confidence interval: 1.42-3.01). Doctor shopping decreased significantly after patients consulted our department, with 'confirmation of the diagnosis' and 'satisfaction with consultation' being identified as contributing factors. © 2010 Blackwell Publishing Ltd.

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.

Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process.

PubMed

Mexas, Fernanda; Efron, Anne; Luiz, Ronir Raggio; Cailleaux-Cezar, Michelle; Chaisson, Richard E; Conde, Marcus B

2014-02-01

for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking. To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil). Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later. A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions. The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific. The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.

Viability of cumulus cells is associated with basal AMH levels in assisted reproduction.

PubMed

Ebner, Thomas; Shebl, Omar; Holzer, Sandra; Oppelt, Peter; Petek, Erwin; Schappacher-Tilp, Gudrun; Mayer, Richard B

2014-12-01

An interesting non-invasive approach to select embryos for transfer is analyzing the health state of somatic granulosa cells surrounding the oocyte addressing their mutual dependence. This prospective study was set up to analyse whether the DNA integrity of cumulus cells correlates with preimplantation development and basal AMH levels. Therefore, 56 patients who gave written consent were enrolled. Sequential denudation of the cumulus-oocyte-complexes was performed in order to separate corona radiata from outer cumulus cells. DNA integrity of both cell types was analysed using a modified chromatin dispersion test. The percentage of viable corona radiata cells per patient showed a linear correlation to blastulation (P<0.05). These innermost cells showed significantly lower rates of strand breaks (P<0.01) as compared to outer cumulus cells. Age-corrected AMH was significantly associated with the DNA integrity of outer cumulus cells (P<0.05). For the first time it could be shown that in fact clinical embryologists deal with two different entities of cumulus cells, inner and outer ones. It seems that any protective mechanism of the female gamete follows an outward gradient, so that negative effects, e.g. apoptosis, may impair outer cumulus cells first. Age-corrected AMH reflects quality of these outer cumulus cells. AMH; Corona radiata cells; DNA fragmentation; Outer cumulus cells; SCD test. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Can stroke patients use visual analogue scales?

PubMed

Price, C I; Curless, R H; Rodgers, H

1999-07-01

Visual analogue scales (VAS) have been used for the subjective measurement of mood, pain, and health status after stroke. In this study we investigated how stroke-related impairments could alter the ability of subjects to answer accurately. Consent was obtained from 96 subjects with a clinical stroke (mean age, 72.5 years; 50 men) and 48 control subjects without cerebrovascular disease (mean age, 71.5 years; 29 men). Patients with reduced conscious level or severe dysphasia were excluded. Subjects were asked to rate the tightness that they could feel on the (unaffected) upper arm after 3 low-pressure inflations with a standard sphygmomanometer cuff, which followed a predetermined sequence (20 mm Hg, 40 mm Hg, 0 mm Hg). Immediately after each change, they rated the perceived tightness on 5 scales presented in a random order: 4-point rating scale (none, mild, moderate, severe), 0 to 10 numerical rating scale, mechanical VAS, horizontal VAS, and vertical VAS. Standard tests recorded deficits in language, cognition, and visuospatial awareness. Inability to complete scales with the correct pattern was associated with any stroke (P<0.001). There was a significant association between success using scales and milder clinical stroke subtype (P<0.01). Within the stroke group, logistic regression analysis identified significant associations (P<0.05) between impairments (cognitive and visuospatial) and inability to complete individual scales correctly. Many patients after a stroke are unable to successfully complete self-report measurement scales, including VAS.

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...

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.

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...

Mail-order pharmacy experience of veterans living with AIDS/HIV.

PubMed

Desai, Karishma Rohanraj; Chewning, Betty; Wilcox, Andrew; Safdar, Nasia

2018-02-01

The VA system is the largest single provider of healthcare in the United States and to individuals infected with HIV specifically. High quality medication management is particularly important since HIV is a chronic infectious condition which requires taking multiple medications with strict requirements for adherence to medication regimens. Veterans Administration (VA) patients are required to obtain all chronic medications using the VA mail-order pharmacy system. Drawing on Donabedian's Quality Improvement framework, this study sought to examine experiences that Veterans with HIV have with the Veterans Administration medication mail-order system, and to explore opportunities for quality improvement. A sequential, explanatory mixed-methods design was used to interview Veterans receiving care at a Midwestern Veterans Administration Hospital using a mail-order experience survey followed by in-depth interviews. All 57 Veterans, out of 72, who were successfully contacted consented to participate. Overall, Veterans evaluated the mail-order service positively and valued the accuracy (correct medication delivery). However, a notable problem emerged with respect to assuring access to HIV medications with about half (47%) indicating running out of HIV medication. Respondents identified structural issues with respect to days covered by mailed medications (90 versus current 30 days) and process issues with scheduling new refills. Veterans also indicated the information sheets were too long, complex and not helpful for their queries. Patients were open to pharmacists playing an active role during clinic visits and felt this would help manage their conditions better. Veterans generally reported that the VA Mail-order service was of high quality. However, some findings indicate there are opportunities to improve this service to be more patient-centered particularly for vulnerable HIV patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Research protections for diverted mentally ill individuals: should they be considered prisoners?

PubMed

Amory Carr, W; Amrhein, Charles; Dery, Ryna

2011-01-01

The number of diversion programs for the mentally ill has increased dramatically over the past decade. These programs serve the valuable goal of reducing the growing population of incarcerated mentally ill persons by providing supervised community treatment. Research within these programs, critical for improving outcomes for these vulnerable individuals, is complicated by the fact that participants may have legal statuses which carry significant coercive leverage. In this way their ability to freely consent to research may be limited. In this paper, the authors describe the practice of diversion and review relevant research on coercion, informed consent and decisional capacity among the mentally ill and imprisoned. Current legal protections for prisoners are then discussed in the light of a recent proposal to broaden the legal definition of "prisoner" for research purposes to include community corrections populations, thus including diverted individuals. Copyright © 2011 John Wiley & Sons, Ltd. 2011 John Wiley & Sons, Ltd.

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.

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

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

Lynn Kidman

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

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

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

Lynn Kidman

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

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.

Influence of Misalignment on High-Order Aberration Correction for Normal Human Eyes

NASA Astrophysics Data System (ADS)

Zhao, Hao-Xin; Xu, Bing; Xue, Li-Xia; Dai, Yun; Liu, Qian; Rao, Xue-Jun

2008-04-01

Although a compensation device can correct aberrations of human eyes, the effect will be degraded by its misalignment, especially for high-order aberration correction. We calculate the positioning tolerance of correction device for high-order aberrations, and within what degree the correcting effect is better than low-order aberration (defocus and astigmatism) correction. With fixed certain misalignment within the positioning tolerance, we calculate the residual wavefront rms aberration of the first-6 to first-35 terms along with the 3rd-5th terms of aberrations corrected, and the combined first-13 terms of aberrations are also studied under the same quantity of misalignment. However, the correction effect of high-order aberrations does not meliorate along with the increase of the high-order terms under some misalignment, moreover, some simple combined terms correction can achieve similar result as complex combinations. These results suggest that it is unnecessary to correct too much the terms of high-order aberrations which are difficult to accomplish in practice, and gives confidence to correct high-order aberrations out of the laboratory.

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.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 274: Septic Systems, Nevada Test Site, Nevada, Rev. No.: 0

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

Grant Evenson

2006-09-01

This Corrective Action Decision Document/Closure Report has been prepared for Corrective Action Unit 274, Septic Systems, Nevada Test Site (NTS), Nevada in accordance with the ''Federal Facility Agreement and Consent Order'' (1996). Corrective Action Unit (CAU) 274 is comprised of five corrective action sites (CASs): (1) CAS 03-02-01, WX-6 ETS Building Septic System; (2) CAS 06-02-01, Cesspool; (3) CAS 09-01-01, Spill Site; (4) CAS 09-05-01, Leaching Pit; and (5) CAS 20-05-01, Septic System. The purpose of this Corrective Action Decision Document/Closure Report is to provide justification and documentation supporting the closure of CAU 274 with no further corrective action. Tomore » achieve this, corrective action investigation (CAI) activities were performed from November 14 through December 17, 2005 as set forth in the CAU 274 Corrective Action Investigation Plan. The purpose of the CAI was to fulfill the following data needs as defined during the data quality objective (DQO) process: (1) Determine whether contaminants of concern (COCs) are present. (2) If contaminants of concern are present, determine their nature and extent. (3) Provide sufficient information and data to complete appropriate corrective actions. The CAU 274 dataset from the investigation results was evaluated based on the data quality indicator parameters. This evaluation demonstrated the quality and acceptability of the dataset for use in fulfilling the DQO data needs. Analytes detected during the CAI were evaluated against final action levels (FALs) established in this document. No analytes were detected at concentrations exceeding the FALs. No COCs have been released to the soil at CAU 274, and corrective action is not required. Therefore, the DQO data needs were met, and it was determined that no corrective action based on risk to human receptors is necessary for the site. All FALs were calculated using the industrial site worker scenario except for benzo(a)pyrene, which was calculated based on the occasional use scenario. Benzo(a)pyrene was detected above the preliminary action level at CAS 20-05-01; however, it was not identified as a COC because the concentration was below the FAL. As a best management practice and to ensure that future site workers are not exposed to this site contaminant for more than this decision-basis exposure duration, an administrative use restriction was established around the leachfield at CAS 20-05-01. In addition, the removal of the septic tanks and septic tank contents at CASs 03-02-01, 06-02-01, and 20-05-01 was performed.« less

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.

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank.

PubMed

Cervo, Silvia; Rovina, Jane; Talamini, Renato; Perin, Tiziana; Canzonieri, Vincenzo; De Paoli, Paolo; Steffan, Agostino

2013-07-30

Efforts to improve patients' understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applications, and to evaluate its effectiveness in terms of understanding and awareness, even in less educated patients. We designed a multisource informed consent procedure for patients' enrolment in a Cancer Institute Biobank (CRO-Biobank). From October 2009 to July 2011, a total of 550 cancer patients admitted to the Centro di Riferimento Oncologico IRCCS Aviano, who agreed to contribute to its biobank, were consecutively enrolled. Participants were asked to answer a self-administered questionnaire aim at exploring their understanding of biobanks and their needs for information on this topic, before and after study participation. Chi-square tests were performed on the questionnaire answers, according to gender or education. Of the 430 patients who returned the questionnaire, only 36.5% knew what a biobank was before participating in the study. Patients with less formal education were less informed by some sources (the Internet, newspapers, magazines, and our Institute). The final assessment test, taken after the multisource informed consent procedure, showed more than 95% correct answers. The information received was judged to be very or fairly understandable in almost all cases. More than 95% of patients were aware of participating in a biobank project, and gave helping cancer research (67.5%), moral obligation, and supporting cancer care as main reasons for their involvement. Our multisource informed consent information system allowed a high rate of understanding and awareness of study participation, even among less-educated participants, and could be an effective and easy-to-apply model for others to consider to contribute to a well-informed decision making process in several fields, from clinical practice to research.Further studies are needed to explore the effects on the study comprehension by each source of information, and by other sources suggested by participants in the questionnaire.

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...

Fluid Management Plan for Corrective Action Unit 447: Project Shoal Area, Subsurface, Nevada, Rev. No.: 1

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

Findlay, Rick

The U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO) initiated the Offsites Project to characterize the risk posed to human health and the environment as a result of testing at formerly used nuclear sites in Alaska, Colorado, Mississippi, Nevada, and New Mexico. The scope of this Fluid Management Plan (FMP) is to support the subsurface investigation at the Project Shoal Area (PSA) Corrective Action Unit (CAU) 447, Shoal - Subsurface, Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996). Corrective Action Unit 447 is located in the Sand Spring Range, southmore » of Highway 50, about 39 miles southeast of Fallon, Nevada. (Figure 1-1). This FMP will be used at the PSA in lieu of an individual discharge permit for each well or a general water pollution control permit for management of all fluids produced during the drilling, construction, development, testing, experimentation, and/or sampling of wells conducted by the Offsites Project. The FMP provides guidance for the management of fluids generated during investigation activities and provides the standards by which fluids may be discharged on site. Although the Nevada Division of Environmental Protection (NDEP), Bureau of Federal Facilities (BoFF) is not a signatory to this FMP, it is involved in the negotiation of the contents of this plan and approves the conditions contained within. The major elements of this FMP include: (1) establishment of a well-site operations strategy; (2) site design/layout; (3) monitoring of contamination indicators (monitoring program); (4) sump characterization (sump sampling program); (5) fluid management decision criteria and fluid disposition; and (6) reporting requirements.« less

Fluid Management Plan for Corrective Action Unit 447: Project Shoal Area, Subsurface, Nevada, Rev. No.: 1 with ROTC 1 and Errata Sheet

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

Tim Echelard

The U.S. Department of Energy (DOE), National Nuclear Security Administration Nevada Site Office (NNSA/NSO) initiated the Offsites Project to characterize the risk posed to human health and the environment as a result of testing at formerly used nuclear sites in Alaska, Colorado, Mississippi, Nevada, and New Mexico. The scope of this Fluid Management Plan (FMP) is to support the subsurface investigation at the Project Shoal Area (PSA) Corrective Action Unit (CAU) 447, Shoal-Subsurface, Nevada, in accordance with the ''Federal Facility Agreement and Consent Order'' (FFACO) (1996). Corrective Action Unit 447 is located in the Sand Spring Range, south of Highwaymore » 50, about 39 miles southeast of Fallon, Nevada. (Figure 1-1). This FMP will be used at the PSA in lieu of an individual discharge permit for each well or a general water pollution control permit for management of all fluids produced during the drilling, construction, development, testing, experimentation, and/or sampling of wells conducted by the Offsites Project. The FMP provides guidance for the management of fluids generated during investigation activities and provides the standards by which fluids may be discharged on site. Although the Nevada Division of Environmental Protection (NDEP), Bureau of Federal Facilities (BoFF) is not a signatory to this FMP, it is involved in the negotiation of the contents of this plan and approves the conditions contained within. The major elements of this FMP include: (1) establishment of a well-site operations strategy; (2) site design/layout; (3) monitoring of contamination indicators (monitoring program); (4) sump characterization (sump sampling program); (5) fluid management decision criteria and fluid disposition; and (6) reporting requirements.« less

Post-Closure Monitoring Report for Corrective Action Unit 339: Area 12 Fleet Operations Steam Cleaning Effluent Nevada Test Site, Nevada

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

K. B. Campbell

2002-09-01

The Area 12 Fleet Operations Steam Cleaning Effluent site is located in the southeastern portion of the Area 12 Camp at the Nevada Test Site. This site is identified in the Federal Facility Agreement and Consent Order (1996) as Corrective Action Site (CAS) 12-19-01 and is the only CAS assigned to Corrective Action Unit (CAU) 339. Post-closure sampling and inspection of the site were completed on March 27, 2002. Post-closure monitoring activities were scheduled biennially (every two years) in the Post-Closure Monitoring Plan provided in the Closure Report for CAU 339: Area 12 Fleet Operations Steam Cleaning Effluent, Nevada Testmore » Site (U.S. Department of Energy, Nevada Operations Office [DOEN], 1997). A baseline for the site was established by sampling in 1997. Based on the recommendations from the 1999 post-closure monitoring report (DOE/NV, 1999), samples were collected in 2000, earlier than originally proposed, because the 1999 sample results did not provide the expected decrease in total petroleum hydrocarbon (TPH) concentrations at the site. Sampling results from 2000 (DOE/NV, 2000) and 2001 (DOE/NV, 2001) revealed favorable conditions for natural degradation at the CAU 339 site, but because of differing sample methods and heterogeneity of the soil, data results from 2000 and later were not directly correlated with previous results. Post-closure monitoring activities for 2002 consisted of the following: (1) Soil sample collection from three undisturbed plots (Plots A, B, and C, Figure 2). (2) Sample analysis for TPH as oil and bio-characterization parameters (Comparative Enumeration Assay [CEA] and Standard Nutrient Panel [SNP]). (3) Site inspection to evaluate the condition of the fencing and signs. (4) Preparation and submittal of the Post-Closure Monitoring Report.« less

Hygiene-therapists could be used to screen for dental caries and periodontal disease.

PubMed

Richards, Derek

2015-12-01

A purposive sample of large NHS dental practices with a minimum of three surgeries employing at least one hygiene-therapist (HT) was taken. Asymptomatic patients attending for routine checkups who consented to the study underwent a screen by H-T for dental caries and periodontal disease (index test) followed by a screen by a general dental practitioner (reference test). Patients were recruited consecutively. H-Ts and dentists attended a compulsory training day, which covered recruitment, consenting, screening process, calibration using stock photographs and patient record form completion. Diagnostic threshold for caries was any tooth in the patient's mouth that showed evidence of frank cavitation or shadowing and opacity that would indicate dental caries into the dentine. The diagnostic threshold for periodontal disease was any pocket in the patient's mouth where the black-band of a basic periodontal examination (BPE) probe (3.5 to 5.5 mm) partially or totally disappeared (ie BPE code 3). The index test was compared with the reference test to determine true-positive, false-positive, false-negative and true-negative values. Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic odds ratios are shown in Table 1. Eighteen hundred and ninety-nine patients consented to dental screening with 996 patients being randomly allocated to see the dentist first and 903 H-T first. The time interval between the index and reference test never exceeded 21 minutes. With the exception of two practices failing to collect data on smoking and dentures there were no missing results regarding the outcome of a positive or negative screening decision. No adverse events were reported. Mean screening time was five min 25 s for H-Ts and four min 26 s for dentists. Dentists identified 668 patients with caries (Prevalence of 0.35) while H-Ts classified 548 positive and correctly identified 1,047 of the 1,231 patients with no caries. Dentists identified 1074 patients with at least one pocket exceeding 3.5 mm in depth. Of these 935 were correctly identified by the H-Ts. For the 825 screened as negative by the dentist H-Ts correctly identified 621. The results suggest that hygiene-therapists could be used to screen for dental caries and periodontal disease. This has important ramifications for service design in public-funded health systems.

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.

Concussion Knowledge in High School Football Players

PubMed Central

Cournoyer, Janie; Tripp, Brady L.

2014-01-01

Context: Participating in sports while experiencing symptoms of a concussion can be dangerous. An athlete's lack of knowledge may be one factor influencing his or her decision to report symptoms. In an effort to enhance concussion education among high school athletes, legislation in Florida has attempted to address the issue through parental consent forms. Objective: To survey high school varsity football players to determine their level of knowledge about concussions after the initiation of new concussion-education legislation. Design: Cross-sectional study. Setting: Descriptive survey administered in person during a team meeting. Patients or Other Participants: A total of 334 varsity football players from 11 high schools in Florida. Main Outcome Measure(s): Participants completed a survey and identified the symptoms and consequences of a concussion among distractors. They also indicated whether they had received education about concussions from a parent, formal education, neither, or both. Results: The most correctly identified symptoms were headache (97%), dizziness (93%), and confusion (90%), and the most correctly identified consequence was persistent headache (93%). Participants reported receiving education from their parents (54%) or from a formal source (60%). Twenty-five percent reported never receiving any education regarding concussions. No correlations were found between the method of education and the knowledge of symptoms or consequences of concussion. Conclusions: The high school football players we surveyed did not have appropriate knowledge of the symptoms and consequences of concussions. Nausea or vomiting, neck pain, grogginess, difficulty concentrating, and personality or behavioral changes were often missed by participants, and only a small proportion correctly identified brain hemorrhage, coma, and death as possible consequences of inappropriate care after a concussion. Even with parents or guardians signing a consent form indicating they discussed concussion awareness with their child, 46% of athletes suggested they had not. PMID:25162779

Concussion knowledge in high school football players.

PubMed

Cournoyer, Janie; Tripp, Brady L

2014-01-01

Participating in sports while experiencing symptoms of a concussion can be dangerous. An athlete's lack of knowledge may be one factor influencing his or her decision to report symptoms. In an effort to enhance concussion education among high school athletes, legislation in Florida has attempted to address the issue through parental consent forms. To survey high school varsity football players to determine their level of knowledge about concussions after the initiation of new concussion-education legislation. Cross-sectional study. Descriptive survey administered in person during a team meeting. A total of 334 varsity football players from 11 high schools in Florida. Participants completed a survey and identified the symptoms and consequences of a concussion among distractors. They also indicated whether they had received education about concussions from a parent, formal education, neither, or both. The most correctly identified symptoms were headache (97%), dizziness (93%), and confusion (90%), and the most correctly identified consequence was persistent headache (93%). Participants reported receiving education from their parents (54%) or from a formal source (60%). Twenty-five percent reported never receiving any education regarding concussions. No correlations were found between the method of education and the knowledge of symptoms or consequences of concussion. The high school football players we surveyed did not have appropriate knowledge of the symptoms and consequences of concussions. Nausea or vomiting, neck pain, grogginess, difficulty concentrating, and personality or behavioral changes were often missed by participants, and only a small proportion correctly identified brain hemorrhage, coma, and death as possible consequences of inappropriate care after a concussion. Even with parents or guardians signing a consent form indicating they discussed concussion awareness with their child, 46% of athletes suggested they had not.

A survey on patients' knowledge and expectations during informed consent for spinal surgery: can we improve the shared decision-making process?

PubMed

Weckbach, Sebastian; Kocak, Tugrul; Reichel, Heiko; Lattig, Friederike

2016-01-01

The informed medical consent in surgery requires to some point basic medical knowledge. The treating physicians while explaining the details and risks of the recommended procedure often imply this. We hypothesized, that patients do not have adequate medical understanding to decide about the ongoing therapy and its potential complications based on knowledge jeopardizing the patients' safety. We conducted a retrospective analysis of a prospective database using a multiple choice questionnaire with 10 basic questions about anatomy, clinical symptoms and therapies of spinal diseases in our spine clinic at a German university hospital. Included were all patients at the spine clinic who agreed to the study and to fill in the questionnaire. Furthermore the patients age, mother tongue, the past spinal surgical history, the length of duration of symptoms and the patients education were inquired. The data were analyzed descriptive. Included were 248 patients with an average age of 59 years (16-88 a). 70 % of all patients used German as their mother tongue. 30 % of the included patients already had spinal surgery and suffered on average for 13.4 years because of their spinal disorder. Overall 32.6 % of all questions were answered correctly (range 0.8-68 %). A correlation of correctly answered questions and the patients' age, duration of symptoms, mother tongue, education and past surgical history could not be described. The percentage of correctly answered questions is almost as low as the likelihood of nearness in guessing. Having this in mind the patients do not choose any treatment option based on knowledge. The physicians need to provide more basic knowledge to the patients. This would increase the amount of successful therapies, content patients and the patients safety.

Negotiation of a triparty agreement for mixed waste at Hanford

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

McGuire, H.E.; Powers, L.L.; Waite, J.L.

The US Department of Energy (DOE) is currently pursuing the activities necessary to obtain a final operating permit under the Resource Conservation and Recovery Act (RCRA) at Hanford. In addition, the Environmental Restoration Program has been established to conduct inactive site investigations and remedial actions as required under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). The anticipated cost for the inactive site cleanup is significant. This was highlighted in a DOE report, where the expected cost for Hanford cleanup is shown as approximately $27 billion. It is imperative that the RCRA closure and corrective action activities be properlymore » integrated with the CERCLA actions to ensure site cleanup is performed in a consistent and cost-effective manner. It is believed that such an objective would best be served through an integrated triparty agreement between the Washington State Department of Ecology (WSDE), the US Environmental Protection Agency (EPA), and the DOE. The WSDE wants clear enforceability in any agreement and believes such enforceability can only be obtained through a judicial consent decree. A consent decree with WSDE for RCRA compliance would have to be separate from a CERCLA Sec. 120 federal facility agreement since EPA cannot enter into a consent decree with another federal agency.« less

CORRECTIVE ACTION DECISION DOCUMENT FOR AREA 9 UXO LANDFILL, TONOPAH TEST RNGE, CAU 453, REVISION 0, MARCH 1998

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

none

1998-03-01

This Corrective Action Decision Document (CADD) has been prepared for the Area 9 Unexploded Ordnance (UXO) Landfill (Corrective Action Unit [CAU] 453) in accordance with the Federal Facility Agreement and Consent Order (FFACO) of 1996. Corrective Action Unit 453 is located at the Tonopah Test Range (TTR), Nevada, and is comprised of three individual landfill cells located northwest of Area 9. The cells are listed as one Corrective Action Site (CAS) 09-55-001-0952. The landfill cells have been designated as: � Cell A9-1 � Cell A9-2 � Cell A9-3 The purpose of this CADD is to identify and provide a rationalemore » for the selection of a recommended corrective action alternative for CAU 453. The scope of this CADD consists of the following tasks: � Develop corrective action objectives. � Identify corrective action alternative screening criteria. � Develop corrective action alternatives. � Perform detailed and comparative evaluations of the corrective action alternatives in relation to the corrective action objectives and screening criteria. � Recommend and justify a preferred corrective action alternative for the CAU. In June and July 1997, a corrective action investigation was performed that consisted of activities set forth in the Corrective Action Investigation Plan (CAIP) (DOE/NV, 1997). Subsurface investigation of the soils surrounding the cells revealed no contaminants of concern (COCs) above preliminary action levels. The cell contents were not investigated due to the potential for live UXO. Details concerning the analytical and investigation results can be found in Appendix A of this CADD. Based on the potential exposure pathways, the following corrective action objectives have been identified for CAU 453: � Prevent or mitigate human exposure to subsurface soils containing COCs, solid waste, and/or UXO. � Prevent adverse impacts to groundwater quality. Based on the review of existing data, future land use, and current operations at the TTR, the following alternatives have been developed for consideration at the Area 9 UXO Landfill CAU: � Alternative 1 - No Further Action � Alternative 2 - Closure in Place by Administrative Controls � Alternative 3 - Closure in Place by Capping � Alternative 4 - Clean Closure by Removal The corrective action alternatives were evaluated based on four general corrective action standards and five remedy selection decision factors. Based on the results of this evaluation, Alternative 2, Closure in Place by Administrative Controls, was selected as the preferred corrective action alternative. The preferred corrective action alternative was evaluated on its technical merits, focusing on performance, reliability, feasibility, and safety. The alternative was judged to meet all requirements for the technical components evaluated and to represent the most cost-effective corrective action. The alternative meets all applicable state and federal regulations for closure of the site and will reduce potential future exposure pathways to the contents of the landfill. During corrective action implementation, this alternative will present minimal potential threat to site workers. However, appropriate health and safety procedures will be developed and implemented.« less

Corrective Action Investigation Plan for Corrective Action Unit 410: Waste Disposal Trenches, Tonopah Test Range, Nevada, Revision 0 (includes ROTCs 1, 2, and 3)

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

NNSA /NV

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 410 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 410 is located on the Tonopah Test Range (TTR), which is included in the Nevada Test and Training Range (formerly the Nellis Air Force Range) approximately 140 miles northwest of Las Vegas, Nevada. This CAU is comprised of five Corrective Action Sites (CASs): TA-19-002-TAB2, Debris Mound; TA-21-003-TANL, Disposal Trench; TA-21-002-TAAL,more » Disposal Trench; 09-21-001-TA09, Disposal Trenches; 03-19-001, Waste Disposal Site. This CAU is being investigated because contaminants may be present in concentrations that could potentially pose a threat to human health and/or the environment, and waste may have been disposed of with out appropriate controls. Four out of five of these CASs are the result of weapons testing and disposal activities at the TTR, and they are grouped together for site closure based on the similarity of the sites (waste disposal sites and trenches). The fifth CAS, CAS 03-19-001, is a hydrocarbon spill related to activities in the area. This site is grouped with this CAU because of the location (TTR). Based on historical documentation and process know-ledge, vertical and lateral migration routes are possible for all CASs. Migration of contaminants may have occurred through transport by infiltration of precipitation through surface soil which serves as a driving force for downward migration of contaminants. Land-use scenarios limit future use of these CASs to industrial activities. The suspected contaminants of potential concern which have been identified are volatile organic compounds; semivolatile organic compounds; high explosives; radiological constituents including depleted uranium, beryllium, total petroleum hydrocarbons; and total Resource Conservation and Recovery Act metals. Field activities will consist of geophysical and radiological surveys, and collecting soil samples at biased locations by appropriate methods. A two-step data quality objective strategy will be followed: (1) define the nature of contamination at each CAS location by identifying any contamination above preliminary action levels (PALs); and, (2) determine the extent of contamination identified above PALs. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

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:

Parental comprehension following informed consent for pediatric cataract surgery.

PubMed

Erraguntla, Vasudha; De la Huerta, Irina; Vohra, Sunita; Abdolell, Mohamed; Levin, Alex V

2012-04-01

To investigate the effectiveness of information transfer by the pediatric cataract surgeon to the parents or guardians of children during the informed-consent process. Prospective observational case series. Parents of 31 children undergoing cataract surgery. Parents were enrolled from the clinical practice of 1 pediatric cataract surgeon. Using a checklist developed in consultation with other pediatric cataract surgeons, the surgeon discussed the nature of the disease, the course without surgical intervention, the surgical procedure, the risks and benefits, and the postoperative care. Immediately after the discussion, parents were invited to complete a questionnaire assessing information recall. Analysis of variance and the t test were used to determine associations between questionnaire scores and demographic variables. The surgeon subsequently called parents and discussed again the issues that they had not remembered correctly, as identified by the questionnaire responses. The study and data accumulation were carried out with the approval of the Research Ethics Board at The Hospital for Sick Children, Toronto, Ont. Informed consent for the research was obtained from the parents or legal guardians of the children enrolled in the study. The study adhered to the tenets of the Declaration of Helsinki. Of 31 parents, 18 (58%) overestimated their understanding of the informed-consent discussion. Parents scored well on questions about the nature of the disease and the postoperative follow-up but scored lower on questions regarding surgical risks and outcomes. Parents identified several barriers to understanding, including the large amount of information, stress, and preoccupation with the child. No association was noted between the level of understanding and demographic factors. Parents may overestimate their understanding of informed-consent discussions. Some parents may be overly optimistic about risks and outcomes. The surgeon's follow-up communication with parents that addressed aspects insufficiently understood during the initial discussion provided a way of improving comprehension. Copyright © 2012. Published by Elsevier Inc.

CORRRECTIVE ACTION DECISION DOCUMENT FOR CORRECTIVE ACTION UNIT 427: AREA 3 SEPTIC WASTE SYSTEMS 2 AND 6, TONOPAH TEST RANGE, NEVADA, REVISION 0, JUNE 1998

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

ITLV.

1998-06-01

This Corrective Action Decision Document has been prepared for the Area 3 Septic Waste Systems 2 and 6 (Corrective Action Unit 427) in accordance with the Federal Facility Agreement and Consent Order of 1996 (FFACO, 1996). Corrective Action Unit 427 is located at the Tonopah Test Range, Nevada, and is comprised of the following Corrective Action Sites, each an individual septic waste system (DOE/NV, 1996a): Septic Waste System 2 is Corrective Action Site Number 03-05-002-SW02. Septic Waste System 6 is Corrective Action Site Number 03-05-002-SW06. The purpose of this Corrective Action Decision Document is to identify and provide a rationalemore » for the selection of a recommended corrective action alternative for each Corrective Action Site. The scope of this Correction Action Decision Document consists of the following tasks: Develop corrective action objectives. Identify corrective action alternative screening criteria. Develop corrective action alternatives. Perform detailed and comparative evaluations of the corrective action alternatives in relation to the corrective action objectives and screening criteria. Recommend and justify a preferred corrective action alternative for each CAS. From November 1997 through January 1998, a corrective action investigation was performed as set forth in the Corrective Action Investigation Plan for Corrective Action Unit No. 427: Area 3 Septic Waste System Numbers 2 and 6, Tonopah Test Range, Nevada (DOE/NV, 1997b). Details can be found in Appendix A of this document. The results indicated that contamination is present in some portions of the CAU and not in others as described in Table ES-1 and shown in Figure A.2-2 of Appendix A. Based on the potential exposure pathways, the following corrective action objectives have been identified for Corrective Action Unit 427: Prevent or mitigate human exposure to subsurface soils containing TPH at concentrations greater than 100 milligrams per kilogram (NAC, 1996b). Close Septic Tank 33-5 in accordance with Nevada Administrative Code 459 (NAC, 1996c). Prevent adverse impacts to groundwater quality. Based on the review of existing data, future land use, and current operations at the Tonopah Test Range, the following alternatives were developed for consideration at the Area 3 Septic Waste Systems 2 and 6: Alternative 1 - No Further Action Alternative 2 - Closure of Septic Tank 33-5 and Administrative Controls Alternative 3 - Closure of Septic Tank 33-5, Excavation, and Disposal The corrective action alternatives were evaluated based on four general corrective action standards and five remedy selection decision factors. Based on the results of this evaluation, the preferred alternative for Corrective Action Unit 427 is Alternative 2, Closure of Septic Tank 33-5 and Administrative Controls. The preferred corrective action alternative was evaluated on technical merit, focusing on performance, reliability, feasibility, and safety. The alternative was judged to meet all requirements for the technical components evaluated. The alternative meets all applicable state and federal regulations for closure of the site and will reduce potential future exposure pathways to the contaminated soils. During corrective action implementation, this alternative will present minimal potential threat to site workers who come in contact with the waste. However, procedures will be developed and implemented to ensure worker health and safety.« less

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.

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.

Corrective Action Decision Document/Closure Report for Corrective Action Unit 372: Area 20 Cabriolet/Palanquin Unit Craters, Nevada National Security Site, Nevada, Revision 0

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

Matthews, Patrick and Sloop, Christy

2011-04-01

This Corrective Action Decision Document (CADD)/Closure Report (CR) has been prepared for Corrective Action Unit (CAU) 372, Area 20 Cabriolet/Palanquin Unit Craters, located within Areas 18 and 20 at the Nevada National Security Site, Nevada, in accordance with the Federal Facility Agreement and Consent Order (FFACO). Corrective Action Unit 372 comprises four corrective action sites (CASs): • 18-45-02, Little Feller I Surface Crater • 18-45-03, Little Feller II Surface Crater • 20-23-01, U-20k Contamination Area • 20-45-01, U-20L Crater (Cabriolet) The purpose of this CADD/CR is to provide justification and documentation supporting the recommendation that no further corrective action ismore » needed for CAU 372 based on the implementation of the corrective action of closure in place with administrative controls at all CASs. Corrective action investigation (CAI) activities were performed from November 9, 2009, through December 10, 2010, as set forth in the Corrective Action Investigation Plan for Corrective Action Unit 372: Area 20 Cabriolet/Palanquin Unit Craters. The approach for the CAI was divided into two facets: investigation of the primary release of radionuclides and investigation of other releases (migration in washes and chemical releases). The purpose of the CAI was to fulfill data needs as defined during the data quality objective (DQO) process. The CAU 372 dataset of investigation results was evaluated based on a data quality assessment. This assessment demonstrated the dataset is acceptable for use in fulfilling the DQO data needs. Investigation results were evaluated against final action levels (FALs) established in this document. A radiological dose FAL was established of 25 millirem per year based on the Remote Work Area exposure scenario (336 hours of annual exposure). Radiological doses exceeding the FAL were found to be present at all four CASs. It is assumed that radionuclide levels present within the Little Feller I and Cabriolet high contamination areas and within the craters at Palanquin and Cabriolet exceed the FAL. It is also assumed that potential source material in the form of lead bricks at Little Feller I and lead-acid batteries at Palanquin and Cabriolet exceed the FAL. Therefore, corrective actions were undertaken that consist of removing potential source material, where present, and implementing a use restriction and posting warning signs at each CAS. These use restrictions were recorded in the FFACO database; the U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) Facility Information Management System; and the NNSA/NSO CAU/CAS files. Therefore, NNSA/NSO provides the following recommendations: • No further corrective actions are necessary for CAU 372. • A Notice of Completion to NNSA/NSO is requested from the Nevada Division of Environmental Protection for closure of CAU 372. • Corrective Action Unit 372 should be moved from Appendix III to Appendix IV of the FFACO.« less

Closure plan for Corrective Action Unit 109: U-2bu subsidence crater, Nevada Test Site, Nevada

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

NONE

1999-03-01

The U-2bu subsidence crater, Corrective Action Unit 109, will be closed in accordance with the Resource Conservation and Recovery Act, the Nevada Division of Environmental Protection operational permit, and the Federal Facility Agreement and Consent Order. The U-2bu subsidence crater is located in Area 2 of the Nevada Test Site. It was created in 1971 by an underground nuclear test with the name Miniata. The crater has a diameter of 288 meters (944 feet) and an approximate depth of 35 meters (115 feet). Based on the results of the analyses reported in the site characterization report, the only constituents ofmore » concern in the U-2bu subsidence crater include leachable lead and total petroleum hydrocarbons. Closure activities will include the excavation and disposal of impacted soil from the top of the crater. Upon completion of excavation, verification samples will be collected to show that the leachable lead has been removed to concentrations below the regulatory action level. After sample results show that the lead has been removed, the excavated area will be backfilled and a soil flood diversion berm will be constructed as a best management practice. An independent registered professional engineer will certify the site was closed following the approved Closure Plan. Post-closure care is not warranted for this site because closure activities will involve removal of the Resource Conservation and Recovery Act constituents of concern.« less

Closure Report for Corrective Action Unit 104: Area 7 Yucca Flat Atmospheric Test Sites, Nevada National Security Site, Nevada

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

None

2013-06-27

This Closure Report (CR) presents information supporting closure of Corrective Action Unit (CAU) 104, Area 7 Yucca Flat Atmospheric Test Sites, and provides documentation supporting the completed corrective actions and confirmation that closure objectives for CAU 104 were met. This CR complies with the requirements of the Federal Facility Agreement and Consent Order (FFACO) that was agreed to by the State of Nevada; the U.S. Department of Energy (DOE), Environmental Management; the U.S. Department of Defense; and DOE, Legacy Management. CAU 104 consists of the following 15 Corrective Action Sites (CASs), located in Area 7 of the Nevada National Securitymore » Site: · CAS 07-23-03, Atmospheric Test Site T-7C · CAS 07-23-04, Atmospheric Test Site T7-1 · CAS 07-23-05, Atmospheric Test Site · CAS 07-23-06, Atmospheric Test Site T7-5a · CAS 07-23-07, Atmospheric Test Site - Dog (T-S) · CAS 07-23-08, Atmospheric Test Site - Baker (T-S) · CAS 07-23-09, Atmospheric Test Site - Charlie (T-S) · CAS 07-23-10, Atmospheric Test Site - Dixie · CAS 07-23-11, Atmospheric Test Site - Dixie · CAS 07-23-12, Atmospheric Test Site - Charlie (Bus) · CAS 07-23-13, Atmospheric Test Site - Baker (Buster) · CAS 07-23-14, Atmospheric Test Site - Ruth · CAS 07-23-15, Atmospheric Test Site T7-4 · CAS 07-23-16, Atmospheric Test Site B7-b · CAS 07-23-17, Atmospheric Test Site - Climax Closure activities began in October 2012 and were completed in April 2013. Activities were conducted according to the Corrective Action Decision Document/Corrective Action Plan for CAU 104. The corrective actions included No Further Action and Clean Closure. Closure activities generated sanitary waste, mixed waste, and recyclable material. Some wastes exceeded land disposal limits and required treatment prior to disposal. Other wastes met land disposal restrictions and were disposed in appropriate onsite landfills. The U.S. Department of Energy, National Nuclear Security Administration Nevada Field Office (NNSA/NFO) requests the following: · A Notice of Completion from the Nevada Division of Environmental Protection to NNSA/NFO for closure of CAU 104 · The transfer of CAU 104 from Appendix III to Appendix IV, Closed Corrective Action Units, of the FFACO« less

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...

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.

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.

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

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

NSTec Environmental Restoration

This Corrective Action Plan (CAP) has been prepared for Corrective Action Unit (CAU) 563, Septic Systems, in accordance with the Federal Facility Agreement and Consent Order. CAU 563 consists of four Corrective Action Sites (CASs) located in Areas 3 and 12 of the Nevada Test Site. CAU 563 consists of the following CASs: 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 Site characterization activities were performed in 2007, and the results are presented in Appendix A of the CAU 563 Corrective Action Decision Document.more » The scope of work required to implement the recommended closure alternatives is summarized below. CAS 03-04-02, Area 3 Subdock Septic Tank, contains no contaminants of concern (COCs) above action levels. No further action is required for this site; however, as a best management practice (BMP), all aboveground features (e.g., riser pipes and bumper posts) will be removed, the septic tank will be removed, and all open pipe ends will be sealed with grout. CAS 03-59-05, Area 3 Subdock Cesspool, contains no COCs above action levels. No further action is required for this site; however, as a BMP, all aboveground features (e.g., riser pipes and bumper posts) will be removed, the cesspool will be abandoned by filling it with sand or native soil, and all open pipe ends will be sealed with grout. CAS 12-59-01, Drilling/Welding Shop Septic Tanks, will be clean closed by excavating approximately 4 cubic yards (yd3) of arsenic- and chromium-impacted soil. In addition, as a BMP, the liquid in the South Tank will be removed, the North Tank will be removed or filled with grout and left in place, the South Tank will be filled with grout and left in place, all open pipe ends will be sealed with grout or similar material, approximately 10 yd3 of chlordane-impacted soil will be excavated, and debris within the CAS boundary will be removed. CAS 12-60-01, Drilling/Welding Shop Outfalls, contains no COCs above action levels. No further action is required for this site; however, as a BMP, three drain pipe openings will be sealed with grout.« less

A new unequal-weighted triple-frequency first order ionosphere correction algorithm and its application in COMPASS

NASA Astrophysics Data System (ADS)

Liu, WenXiang; Mou, WeiHua; Wang, FeiXue

2012-03-01

As the introduction of triple-frequency signals in GNSS, the multi-frequency ionosphere correction technology has been fast developing. References indicate that the triple-frequency second order ionosphere correction is worse than the dual-frequency first order ionosphere correction because of the larger noise amplification factor. On the assumption that the variances of three frequency pseudoranges were equal, other references presented the triple-frequency first order ionosphere correction, which proved worse or better than the dual-frequency first order correction in different situations. In practice, the PN code rate, carrier-to-noise ratio, parameters of DLL and multipath effect of each frequency are not the same, so three frequency pseudorange variances are unequal. Under this consideration, a new unequal-weighted triple-frequency first order ionosphere correction algorithm, which minimizes the variance of the pseudorange ionosphere-free combination, is proposed in this paper. It is found that conventional dual-frequency first-order correction algorithms and the equal-weighted triple-frequency first order correction algorithm are special cases of the new algorithm. A new pseudorange variance estimation method based on the three carrier combination is also introduced. Theoretical analysis shows that the new algorithm is optimal. The experiment with COMPASS G3 satellite observations demonstrates that the ionosphere-free pseudorange combination variance of the new algorithm is smaller than traditional multi-frequency correction algorithms.

[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

PubMed

Gonorazky, Sergio E

2008-01-01

The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

Range of validity for perturbative treatments of relativistic sum rules

NASA Astrophysics Data System (ADS)

Cohen, Scott M.

2003-10-01

The range of validity of perturbative calculations of relativistic sum rules is investigated by calculating the second-order relativistic corrections to the Bethe sum rule and its small momentum limit, the Thomas-Reiche-Kuhn (TRK) sum rule. For the TRK sum rule and atomic systems, the second-order correction is found to be less than 0.5% up to about Z=70. The total relativistic corrections should then be accurate at least through this range of Z, and probably beyond this range if the second-order terms are included. For Rn (Z=86), however, the second-order corrections are nearly 1%. The total corrections to the Bethe sum rule are largest at small momentum, never being significantly larger than the corresponding corrections to the TRK sum rule. The first-order corrections to the Bethe sum rule also give better than 0.5% accuracy for Z<70, and inclusion of the second-order corrections should extend this range, as well.

Solar multi-conjugate adaptive optics based on high order ground layer adaptive optics and low order high altitude correction.

PubMed

Zhang, Lanqiang; Guo, Youming; Rao, Changhui

2017-02-20

Multi-conjugate adaptive optics (MCAO) is the most promising technique currently developed to enlarge the corrected field of view of adaptive optics for astronomy. In this paper, we propose a new configuration of solar MCAO based on high order ground layer adaptive optics and low order high altitude correction, which result in a homogeneous correction effect in the whole field of view. An individual high order multiple direction Shack-Hartmann wavefront sensor is employed in the configuration to detect the ground layer turbulence for low altitude correction. Furthermore, the other low order multiple direction Shack-Hartmann wavefront sensor supplies the wavefront information caused by high layers' turbulence through atmospheric tomography for high altitude correction. Simulation results based on the system design at the 1-meter New Vacuum Solar Telescope show that the correction uniform of the new scheme is obviously improved compared to conventional solar MCAO configuration.

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...

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.

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.

The use of multimedia as an adjunct to the informed consent process for Morton's neuroma resection surgery.

PubMed

Wang, Calvin; Ammon, Peter; Beischer, Andrew D

2014-10-01

The purpose of this study was to assess if a computer-based multimedia education module (MEM) improved patients' comprehension when used as an adjunct to the standard verbal consent process for Morton's neuroma resection surgery. Nineteen patients (15 females and 4 males) considered candidates for Morton's neuroma resection surgery were prospectively recruited. A standardized verbal discussion was had with each patient regarding risks and benefits of surgery, alternative treatments, and the usual postoperative course. Patient understanding was then assessed with a questionnaire. Each patient subsequently viewed the MEM and the questionnaire was repeated. Patients also rated ease of understanding and satisfaction with both methods of patient education. Patients answered a significantly greater proportion of correct answers after viewing the MEM module (85%), compared to verbal discussion alone (61%) (P = .002). Patients rated both the ease of understanding of the module and amount of information provided by the module as a mean of 9.3 cm on a 10 cm Visual Analog Scale (VAS). The majority of patients (76%) rated the multimedia tool as having answered their questions about surgery as well or better than the treating surgeon. An interactive multimedia educational tool was a useful adjunct to the informed consent process for patients considering Morton's neuroma resection surgery. Level II, prospective cohort study. © The Author(s) 2014.

A new informed consent form model for cancer patients: preliminary results of a prospective study by the Italian Association of Medical Oncology (AIOM).

PubMed

Gori, Stefania; Greco, Maria Teresa; Catania, Chiara; Colombo, Cinzia; Apolone, Giovanni; Zagonel, Vittorina

2012-05-01

To document the preliminary validity of a new informed consent form (ICF) model in terms of face/content validity and feasibility, to collect patients' and oncologists' opinions on it, and to explore physicians' and patients' "knowledge", "opinions" about "the information exchanged". The working group for informed consent promoted by the Italian Association of Medical Oncology developed a new ICF model which was tested in ten Italian cancer centers. Patients and physicians received questionnaires on the new ICF model. Twenty-six independent oncologists were interviewed to collect their opinions. Seventy eight cancer patients were enrolled: about 90% reported having received information about diagnosis and therapy and 80% about prognosis. About 63% of oncologists had no difficulty in administering the ICF. Oncologists used "correct terms" about diagnosis in 92% of patients with localized disease and in 90% with metastasis and about therapy in respectively 75.7% and 80%. About prognosis, oncologists used "vague" and "no information-no pertinent terms" in 79% of patients with localized disease and 92.5% of patients with metastasis. The ICF seemed to have sufficient validity and feasibility. This ICF model could mean that patients require oncologists to spend more time explaining the diagnosis, prognosis and treatment, increasing patient's opportunities to participate actively in the care process. Crown Copyright © 2011. Published by Elsevier Ireland Ltd. All rights reserved.

[Evaluations for informed consent for various long-term psychiatric treatments].

PubMed

Catanesi, Roberto; Carabellese, Felice; Candelli, Chiara; La Tegola, Donatella; Taratufolo, Rosa

2010-01-01

The study was created with two distinct objectives: the first, an investigation into the quality of informed consent in patients assited by the mental health department for the Region of Puglia. The second, to look at the possibility of implementing a systematic use of tested monitoring of the daily practices of the psychiatric services. The use of the structured MacCAT-T (modified) interview was implemented. The interview was carried out on 708 patients across all areas of the mental health deparment for the Region of Puglia: 77 SPDC patients, 336 outpatients and 295 patients residing in rehabilitation centres. 31.2% of patients voluntarily hospitalised in SPDC did not know the motivations for their hospitalisation. 46.1% of patients in rehabilitation centres were also unaware of the reasons for their stay. Further problems arose in data regarding the prognosis of the disorders: 62.3% of SPDC patients, 65% of patients in rehabilitation centres and 39% of outpatients coud not describe the prognosis of their disorder. As a result of the study, the authors therefore propose: consensus monitoring through a standardised method providing targets for service improvement. The monitoring however, must be made integral in the daily activities of clinical observation. Applying the practice of consent evaluation would provide adequate support in requiring then suitable methods of legal protection, such as administrative support, which could then aid in creating correct legal continuity in treatment.

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.

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.

Implementing school malaria surveys in Kenya: towards a national surveillance system

PubMed Central

2010-01-01

Objective To design and implement surveys of malaria infection and coverage of malaria control interventions among school children in Kenya in order to contribute towards a nationwide assessment of malaria. Methods The country was stratified into distinct malaria transmission zones based on a malaria risk map and 480 schools were visited between October 2008 and March 2010. Surveys were conducted in two phases: an initial opportunistic phase whereby schools were selected for other research purposes; and a second phase whereby schools were purposively selected to provide adequate spatial representation across the country. Consent for participation was based on passive, opt-out consent rather than written, opt-in consent because of the routine, low-risk nature of the survey. All children were diagnosed for Plasmodium infection using rapid diagnostic tests, assessed for anaemia and were interviewed about mosquito net usage, recent history of illness, and socio-economic and household indicators. Children's responses were entered electronically in the school and data transmitted nightly to Nairobi using a mobile phone modem connection. RDT positive results were corrected by microscopy and all results were adjusted for clustering using random effect regression modelling. Results 49,975 children in 480 schools were sampled, at an estimated cost of US$ 1,116 per school. The overall prevalence of malaria and anaemia was 4.3% and 14.1%, respectively, and 19.0% of children reported using an insecticide-treated net (ITN). The prevalence of infection showed marked variation across the country, with prevalence being highest in Western and Nyanza provinces, and lowest in Central, North Eastern and Eastern provinces. Nationally, 2.3% of schools had reported ITN use >60%, and low reported ITN use was a particular problem in Western and Nyanza provinces. Few schools reported having malaria health education materials or ongoing malaria control activities. Conclusion School malaria surveys provide a rapid, cheap and sustainable approach to malaria surveillance which can complement household surveys, and in Kenya, show that large areas of the country do not merit any direct school-based control, but school-based interventions, coupled with strengthened community-based strategies, are warranted in western and coastal Kenya. The results also provide detailed baseline data to inform evaluation of school-based malaria control in Kenya. PMID:21034492

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

2012-03-16

... 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:

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”).

77 FR 71632 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-03

... upon written request and payment of reproduction costs. Please mail your request and payment to... or money order for $4.50 (25 cents per page reproduction cost) payable to the United States Treasury...

78 FR 23784 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-22

... upon written request and payment of reproduction costs. Please mail your request and payment to... or money order for $4.25 (25 cents per page reproduction cost) payable to the United States Treasury...

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...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-12

... agreed to hold the to-be- divested assets separate, and to maintain the economic viability, marketability... maintain the economic viability, marketability, and competitiveness of the both the Peak and Mesilla Valley...

77 FR 28388 - Myspace, LLC; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... operates a social networking Web site, www.myspace.com , that, among other features, enables a consumer who... street name and city or town; (c) email address or other online contact information, such as an instant...

76 FR 15311 - Legacy Learning Systems, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... information. In addition, comments should not include any ``[t]rade secret or any commercial or financial... respondents to determine, on a semi-annual basis, their top fifty (50) revenue-generating affiliates, and then...

77 FR 4060 - Notice of Lodging of Second Agreement and Order Regarding Modification of the Consent Decree...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... 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...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... 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.

Corrective Action Investigation Plan for Corrective Action Unit 5: Landfills, Nevada Test Site, Nevada (Rev. No.: 0) includes Record of Technical Change No. 1 (dated 9/17/2002)

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

IT Corporation, Las Vegas, NV

This Corrective Action Investigation Plan contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Office's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 5 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 5 consists of eight Corrective Action Sites (CASs): 05-15-01, Sanitary Landfill; 05-16-01, Landfill; 06-08-01, Landfill; 06-15-02, Sanitary Landfill; 06-15-03, Sanitary Landfill; 12-15-01, Sanitary Landfill; 20-15-01, Landfill; 23-15-03, Disposal Site. Located between Areas 5, 6, 12, 20, and 23 of the Nevada Test Site (NTS), CAU 5 consists of unlined landfillsmore » used in support of disposal operations between 1952 and 1992. Large volumes of solid waste were produced from the projects which used the CAU 5 landfills. Waste disposed in these landfills may be present without appropriate controls (i.e., use restrictions, adequate cover) and hazardous and/or radioactive constituents may be present at concentrations and locations that could potentially pose a threat to human health and/or the environment. During the 1992 to 1995 time frame, the NTS was used for various research and development projects including nuclear weapons testing. Instead of managing solid waste at one or two disposal sites, the practice on the NTS was to dispose of solid waste in the vicinity of the project. A review of historical documentation, process knowledge, personal interviews, and inferred activities associated with this CAU identified the following as potential contaminants of concern: volatile organic compounds, semivolatile organic compounds, polychlorinated biphenyls, pesticides, petroleum hydrocarbons (diesel- and gasoline-range organics), Resource Conservation and Recovery Act Metals, plus nickel and zinc. A two-phase approach has been selected to collect information and generate data to satisfy needed resolution criteria and resolve the decision statements. Phase I will concentrate on geophysical surveys to confirm the presence or absence of disposed waste within a CAS and verify the boundaries of disposal areas; penetrate disposal feature covers via excavation and/or drilling; perform geodetic surveys; and be used to collect both soil and environmental samples for laboratory analyses. Phase II will deal only with those CASs where a contaminant of concern has been identified. This phase will involve the collection of additional soil and/or environmental samples for laboratory analyses. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

Corrective Action Investigation Plan for Corrective Action Unit 127: Areas 25 and 26 Storage Tanks, Nevada Test Site, Nevada (Rev. No.: 0, August 2002)

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

NNSA /NV

This Corrective Action Investigation Plan (CAIP) contains the U.S. Department of Energy, National Nuclear Security Administration Nevada Operations Offices's approach to collect the data necessary to evaluate corrective action alternatives appropriate for the closure of Corrective Action Unit (CAU) 127 under the Federal Facility Agreement and Consent Order. Corrective Action Unit 127 is located on the Nevada Test Site approximately 65 miles northwest of Las Vegas, Nevada. This CAU is comprised of 12 Corrective Action Sites (CASs) located at Test Cell C; the Engine Maintenance, Assembly, and Disassembly (E-MAD) Facility; the X-Tunnel in Area 25; the Pluto Disassembly Facility; themore » Pluto Check Station; and the Port Gaston Training Facility in Area 26. These CASs include: CAS 25-01-05, Aboveground Storage Tank (AST); CAS 25-02-02, Underground Storage Tank (UST); CAS 25-23-11, Contaminated Materials; CAS 25-12-01, Boiler; CAS 25-01-06, AST; CAS 25-01-07, AST; CAS 25-02-13, UST; CAS 26- 01-01, Filter Tank (Rad) and Piping; CAS 26-01-02, Filter Tank (Rad); CAS 26-99-01, Radioactively Contaminated Filters; CAS 26-02-01, UST; CAS 26-23-01, Contaminated Liquids Spreader. Based on site history, process knowledge, and previous field efforts, contaminants of potential concern for CAU 127 include radionuclides, metals, total petroleum hydrocarbons, volatile organic compounds, asbestos, and polychlorinated biphenyls. Additionally, beryllium may be present at some locations. The sources of potential releases are varied, but releases of contaminated liquids may have occurred and may have migrated into and impacted soil below and surrounding storage vessels at some of the CASs. Also, at several CASs, asbestos-containing materials may be present on the aboveground structures and may be friable. Exposure pathways are limited to ingestion, inhalation, and dermal contact (adsorption) of soils/sediments or liquids, or inhalation of contaminants by site workers due to disturbance of contaminated materials. Future land-use scenarios limit subsequent uses of the CASs to various nonresidential (i.e., industrial) activities. Field activities will consist of radiological walkover and screening surveys, and field-screening and collecting of both tank content and soil samples, and further sample testing as appropriate. A two-step data quality objective strategy will be followed: (1) Phase I will be to collect environmental samples for laboratory analysis to confirm the presence or absence of contaminants at concentrations exceeding preliminary action levels; and (2) Phase II will be to collect additional environmental samples for laboratory analysis to determine the extent of contamination identified in Phase I. The results of this field investigation will support a defensible evaluation of corrective action alternatives in the corrective action decision document.« less

Corrective Action Plan 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)

K. B. Campbell

This Corrective Action Plan (CAP) provides selected corrective action alternatives and proposes the closure methodology for Corrective Action Unit (CAU) 262, Area 25 Septic Systems and Underground Discharge Point. CAU 262 is identified in the Federal Facility Agreement and Consent Order (FFACO) of 1996. Remediation of CAU 262 is required under the FFACO. CAU 262 is located in Area 25 of the Nevada Test Site (NTS), approximately 100 kilometers (km) (62 miles [mi]) northwest of Las Vegas, Nevada. The nine Corrective Action Sites (CASs) within CAU 262 are located in the Nuclear Rocket Development Station complex. Individual CASs are locatedmore » in the vicinity of the Reactor Maintenance, Assembly, and Disassembly (R-MAD); Engine Maintenance, Assembly, and Disassembly (E-MAD); and Test Cell C compounds. CAU 262 includes the following CASs as provided in the FFACO (1996); CAS 25-02-06, Underground Storage Tank; CAS 25-04-06, Septic Systems A and B; CAS 25-04-07, Septic System; CAS 25-05-03, Leachfield; CAS 25-05-05, Leachfield; CAS 25-05-06, Leachfield; CAS 25-05-08, Radioactive Leachfield; CAS 25-05-12, Leachfield; and CAS 25-51-01, Dry Well. Figures 2, 3, and 4 show the locations of the R-MAD, the E-MAD, and the Test Cell C CASs, respectively. The facilities within CAU 262 supported nuclear rocket reactor engine testing. Activities associated with the program were performed between 1958 and 1973. However, several other projects used the facilities after 1973. A significant quantity of radioactive and sanitary waste was produced during routine operations. Most of the radioactive waste was managed by disposal in the posted leachfields. Sanitary wastes were disposed in sanitary leachfields. Septic tanks, present at sanitary leachfields (i.e., CAS 25-02-06,2504-06 [Septic Systems A and B], 25-04-07, 25-05-05,25-05-12) allowed solids to settle out of suspension prior to entering the leachfield. Posted leachfields do not contain septic tanks. All CASs located in CAU 262 are inactive or abandoned. However, some leachfields may still receive liquids from runoff during storm events. Results from the 2000-2001 site characterization activities conducted by International Technology (IT) Corporation, Las Vegas Office are documented in the Corrective Action Investigation Report for Corrective Action Unit 262: Area 25 Septic Systems and Underground Discharge Point, Nevada Test Site, Nevada. This document is located in Appendix A of the Corrective Action Decision Document for CAU 262. Area 25 Septic Systems and Underground Discharge Point, Nevada Test Site, Nevada. (DOE/NV, 2001).« less

Closure Report for Corrective Action Unit 224: Decon Pad and Septic Systems, Nevada Test Site, Nevada

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

NSTec Environmental Restoration

Corrective Action Unit (CAU) 224 is located in Areas 02, 03, 05, 06, 11, and 23 of the Nevada Test Site, which is situated approximately 65 miles northwest of Las Vegas, Nevada. CAU 224 is listed in the Federal Facility Agreement and Consent Order (FFACO) of 1996 as Decon Pad and Septic Systems and is comprised of the following nine Corrective Action Sites (CASs): CAS 02-04-01, Septic Tank (Buried); CAS 03-05-01, Leachfield; CAS 05-04-01, Septic Tanks (4)/Discharge Area; CAS 06-03-01, Sewage Lagoons (3); CAS 06-05-01, Leachfield; CAS 06-17-04, Decon Pad and Wastewater Catch; CAS 06-23-01, Decon Pad Discharge Piping; CASmore » 11-04-01, Sewage Lagoon; and CAS 23-05-02, Leachfield. The Nevada Division of Environmental Protection (NDEP)-approved corrective action alternative for CASs 02-04-01, 03-05-01, 06-03-01, 11-04-01, and 23-05-02 is no further action. As a best management practice, the septic tanks and distribution box were removed from CASs 02-04-01 and 11-04-01 and disposed of as hydrocarbon waste. The NDEP-approved correction action alternative for CASs 05-04-01, 06-05-01, 06-17-04, and 06-23-01 is clean closure. Closure activities for these CASs included removing and disposing of radiologically and pesticide-impacted soil and debris. CAU 224 was closed in accordance with the NDEP-approved CAU 224 Corrective Action Plan (CAP). The closure activities specified in the CAP were based on the recommendations presented in the CAU 224 Corrective Action Decision Document (U.S. Department of Energy, National Nuclear Security Administration Nevada Site Office, 2005). This Closure Report documents CAU 224 closure activities. During closure activities, approximately 60 cubic yards (yd3) of mixed waste in the form of soil and debris; approximately 70 yd{sup 3} of sanitary waste in the form of soil, liquid from septic tanks, and concrete debris; approximately 10 yd{sup 3} of hazardous waste in the form of pesticide-impacted soil; approximately 0.5 yd{sup 3} of universal waste in the form of fluorescent light bulbs; and approximately 0.5 yd{sup 3} of low-level waste in the form of a radiologically impacted fire hose rack were generated, managed, and disposed of appropriately. Waste minimization techniques, such as the utilization of laboratory analysis and field screening to guide the extent of excavations, were employed during the performance of closure work.« less

Corrective Action Plan for Corrective Action Unit 428: Area 3 Septic Waste Systems 1 and 5 Tonopah Test Range, Nevada

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

D. S. Tobiason

Area 3 Septic Waste Systems 1 and 5 are located in Area 3 of the Tonopah Test Range (TTR) (Figure 1). The site is listed in the Federal Facility Agreement and Consent Order (FFACO, 1996) as Corrective Action Unit (CAU) 428 and includes Corrective Action Sites 03-05-002-SW01 (Septic Waste System 1 [SWS 1]), and 03-05-002-SW05 (Septic Waste System 5 [SWS 5]). The site history for the CAU is provided in the Corrective Action Investigation Plan (U.S. Department of Energy, Nevada Operations Office [DOE/NV], 1999). SWS 1 consists of two leachfields and associated septic tanks. SWS 1 received effluent from bothmore » sanitary and industrial sources from various buildings in Area 3 of the TTR (Figure 2). SWS 5 is comprised of one leachfield and outfall with an associated septic tank. SWS 5 received effluent from sources in Building 03-50 in Area 3 of the TTR (Figure 2). Both systems were active until 1990 when a consolidated sewer system was installed. The purpose of this Corrective Action Plan (CAP) is to provide the strategy and methodology to close the Area 3 SWS 1 and 5. The CAU will be closed following state and federal regulations and the FFACO (1996). Site characterization was done during May and June 1999. Samples of the tank contents, leachfield soil, and soil under the tanks and pipes were collected. The results of the characterization were reported in the Corrective Action Decision Document (CADD) (DOE/NV, 2000). Additional sampling was done in May 2000, the results of which are presented in this plan. Soil sample results indicated that two constituents of concern were detected above Preliminary Action Levels (PALs). Total arsenic was detected at a concentration of 68.7 milligrams per kilogram (mg/kg). The arsenic was found under the center distribution line at the proximal end of the SWS 5 Leachfield (Figure 3). Total benzo(a)pyrene was detected at a concentration of 480 micrograms per kilogram ({micro}g/kg). The benzo(a)pyrene was found in the soil under the discharge line at SWS 1 Septic Tank 33-1A (Figure 3). These concentrations are above the PALs of 3.0 mg/kg and 360 {micro}g/kg, respectively (DOE/NV, 1999) but are below the hazardous regulatory levels for these constituents. The soil will be excavated and disposed in the Nevada Test Site (NTS) Area 23 Sanitary Landfill.« less

Enhanced visual acuity and image perception following correction of highly aberrated eyes using an adaptive optics visual simulator.

PubMed

Rocha, Karolinne Maia; Vabre, Laurent; Chateau, Nicolas; Krueger, Ronald R

2010-01-01

To evaluate the changes in visual acuity and visual perception generated by correcting higher order aberrations in highly aberrated eyes using a large-stroke adaptive optics visual simulator. A crx1 Adaptive Optics Visual Simulator (Imagine Eyes) was used to correct and modify the wavefront aberrations in 12 keratoconic eyes and 8 symptomatic postoperative refractive surgery (LASIK) eyes. After measuring ocular aberrations, the device was programmed to compensate for the eye's wavefront error from the second order to the fifth order (6-mm pupil). Visual acuity was assessed through the adaptive optics system using computer-generated ETDRS opto-types and the Freiburg Visual Acuity and Contrast Test. Mean higher order aberration root-mean-square (RMS) errors in the keratoconus and symptomatic LASIK eyes were 1.88+/-0.99 microm and 1.62+/-0.79 microm (6-mm pupil), respectively. The visual simulator correction of the higher order aberrations present in the keratoconus eyes improved their visual acuity by a mean of 2 lines when compared to their best spherocylinder correction (mean decimal visual acuity with spherocylindrical correction was 0.31+/-0.18 and improved to 0.44+/-0.23 with higher order aberration correction). In the symptomatic LASIK eyes, the mean decimal visual acuity with spherocylindrical correction improved from 0.54+/-0.16 to 0.71+/-0.13 with higher order aberration correction. The visual perception of ETDRS letters was improved when correcting higher order aberrations. The adaptive optics visual simulator can effectively measure and compensate for higher order aberrations (second to fifth order), which are associated with diminished visual acuity and perception in highly aberrated eyes. The adaptive optics technology may be of clinical benefit when counseling patients with highly aberrated eyes regarding their maximum subjective potential for vision correction. Copyright 2010, SLACK Incorporated.

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.

Equivalent correction in scarf and chevron osteotomy in moderate and severe hallux valgus: a randomized controlled trial.

PubMed

Deenik, Axel; van Mameren, Henk; de Visser, Enrico; de Waal Malefijt, Maarten; Draijer, Frits; de Bie, Rob

2008-12-01

Chevron osteotomy is a widely accepted osteotomy for correction of hallux valgus.(18) Algorithms were developed to overcome the limitations of distal osteotomies. Scarf osteotomy has become popular as a versatile procedure that should be able to correct most cases of acquired hallux valgus. The purpose of this study was to evaluate whether patients with moderate or severe hallux valgus have better correction with a scarf osteotomy as compared to chevron osteotomy. After informed consent, 136 feet in 115 patients were randomized to 66 scarf and 70 chevron osteotomies. Deformities of patients were classified as mild, moderate and severe according to IMA, and both groups were compared with independent t-tests. The results were measured using radiographic HVA, IMA and DMAA measurements. There were no statistical differences in HVA, IMA and DMAA between scarf and chevron osteotomy in mild to moderate hallux valgus. In severe hallux valgus, chevron osteotomy corrected HVA better than scarf osteotomy, although this group consisted of twelve patients only. Five patients in the chevron group and seven in the scarf group developed recurrent subluxation of the metatarsophalangeal joint. In patients with moderate and severe hallux valgus, the results of chevron osteotomy were at least as effective as a scarf osteotomy. Recurrent subluxation of the first metatatarsophalangeal joint was the main cause for insufficient correction. We favor the chevron osteotomy because it is less invasive, without sacrificing correction of HVA and IMA.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... advertising and promotion of DanActive, a probiotic dairy drink, and Activia, a probiotic yogurt. According to... food or drink not covered by the foregoing that contains a probiotic, including, but not limited to...

76 FR 75883 - Facebook, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-05

... , a social networking Web site that enables a consumer who uses the site (``user'') to create an... name and name of city or town; (c) an email address or other online contact information, such as an...

78 FR 9355 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the Mount...

Federal Register 2010, 2011, 2012, 2013, 2014

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...

77 FR 58837 - CarePatrol, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-24

... participation with it, from engaging in similar acts and practices in the future. Part I.A.1 of the proposed... representations that it or its franchisees provide placement services through a network of officers, agents...

78 FR 18629 - Notice of Lodging of Proposed Partial Consent Decree Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-27

... sewer system, perform initial work over the next four years to address sewer overflows, develop a..., DC 20044- 7611. Please enclose a check or money order for $84.50 (25 cents per page reproduction cost...

40 CFR 57.403 - Written consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY... following form: As a condition of receiving a Primary Nonferrous Smelter Order (NSO) under Section 119 of... of, and obtain data from ambient air quality monitors operated by the company under the requirements...

76 FR 4201 - Kiwifruit Grown in California; Order Amending Marketing Order No. 920; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 920 [Doc. No. AO-FV-08-0174; AMS-FV-08-0085; FV08-920-3 C] Kiwifruit Grown in California; Order Amending Marketing Order No. 920; Correction AGENCY: Agricultural Marketing Service, USDA. ACTION: Correcting amendment. SUMMARY: This document...

Clinical Research Involving Minors in International and Serbian Regulations

PubMed Central

PLANOJEVIĆ, Nina; ŽIVOJINOVIĆ, Dragica

2013-01-01

Background: 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. PMID:24455493

Community perspectives on the ethical issues surrounding adolescent HIV vaccine trials in South Africa.

PubMed

Jaspan, Heather B; Soka, Nosiphiwo F; Strode, Ann E; Mathews, Catherine; Mark, Daniella; Flisher, Alan J; Wood, Robin; Bekker, Linda-Gail

2008-10-23

Adolescents globally are at high risk for HIV acquisition and are the targets of HIV prevention interventions such as HIV vaccines. In order to understand stakeholders' attitudes towards the ethical issues of adolescent involvement in HIV vaccine trials, we conducted focus group discussions with key members of a semi-urban, informal Cape Town community with high HIV prevalence in which HIV vaccine trials are taking place. Themes were identified from focus group transcripts by four researchers, and included necessity of guardian consent, age of independent consent, and confidentiality of in-trial medical results. In general, ethical adolescent HIV vaccine trials will be feasible in this community.

The value of respect in human research ethics: a conceptual analysis and a practical guide.

PubMed

Pieper, I J; Thomson, C J H

2014-01-01

In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.