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.

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.

22 CFR 221.32 - Change in agreements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Change in agreements. 221.32 Section 221.32 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ISRAEL LOAN GUARANTEE STANDARD TERMS AND CONDITIONS Covenants § 221.32 Change in agreements. No Noteholder will consent to any change or waiver of any provision...

22 CFR 221.32 - Change in agreements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Change in agreements. 221.32 Section 221.32 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ISRAEL LOAN GUARANTEE STANDARD TERMS AND CONDITIONS Covenants § 221.32 Change in agreements. No Noteholder will consent to any change or waiver of any provision...

22 CFR 221.32 - Change in agreements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Change in agreements. 221.32 Section 221.32 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ISRAEL LOAN GUARANTEE STANDARD TERMS AND CONDITIONS Covenants § 221.32 Change in agreements. No Noteholder will consent to any change or waiver of any provision...

22 CFR 221.32 - Change in agreements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Change in agreements. 221.32 Section 221.32 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ISRAEL LOAN GUARANTEE STANDARD TERMS AND CONDITIONS Covenants § 221.32 Change in agreements. No Noteholder will consent to any change or waiver of any provision...

22 CFR 221.32 - Change in agreements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Change in agreements. 221.32 Section 221.32 Foreign Relations AGENCY FOR INTERNATIONAL DEVELOPMENT ISRAEL LOAN GUARANTEE STANDARD TERMS AND CONDITIONS Covenants § 221.32 Change in agreements. No Noteholder will consent to any change or waiver of any provision...

77 FR 31008 - Enforceable Consent Agreement Development for Two Cyclic Siloxanes; Solicitation of Interested...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

... EPA. EPA has evaluated the proposal and believes that proceeding with the negotiation of a consent... in participating in the negotiations to notify EPA and announces a public meeting to initiate negotiations. DATES: The meeting to initiate ECA negotiations for D4 and D5 environmental monitoring will be...

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...

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...

78 FR 63566 - Proposed Collection; Comment Request for Form 8838

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... concerning Form 8838, Consent To Extend the Time To Assess Tax Under Section 367-Gain Recognition Agreement... . SUPPLEMENTARY INFORMATION: Title: Consent To Extend the Time To Assess Tax Under Section 367- Gain Recognition... the transferor makes a gain recognition agreement. This agreement allows the transferor to defer the...

26 CFR 1.467-8 - Automatic consent to change to constant rental accrual for certain rental agreements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... accrual for certain rental agreements. 1.467-8 Section 1.467-8 Internal Revenue INTERNAL REVENUE SERVICE... Taken § 1.467-8 Automatic consent to change to constant rental accrual for certain rental agreements. (a... rental accrual method, as described in § 1.467-3, for all of its section 467 rental agreements described...

Testing Consent Agreement for N-methylpyrrolidone

EPA Pesticide Factsheets

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

13 CFR 120.536 - Servicing and liquidation actions that require the prior written consent of SBA.

Code of Federal Regulations, 2010 CFR

2010-01-01

... that require the prior written consent of SBA. (a) Actions by Lenders and CDCs. Except as otherwise provided in a Supplemental Guarantee Agreement with a Lender or an Agreement with a CDC, SBA must give its prior written consent before a Lender or CDC takes any of the following actions: (1) Increases the...

13 CFR 120.536 - Servicing and liquidation actions that require the prior written consent of SBA.

Code of Federal Regulations, 2012 CFR

2012-01-01

... that require the prior written consent of SBA. (a) Actions by Lenders and CDCs. Except as otherwise provided in a Supplemental Guarantee Agreement with a Lender or an Agreement with a CDC, SBA must give its prior written consent before a Lender or CDC takes any of the following actions: (1) Increases the...

13 CFR 120.536 - Servicing and liquidation actions that require the prior written consent of SBA.

Code of Federal Regulations, 2014 CFR

2014-01-01

... that require the prior written consent of SBA. (a) Actions by Lenders and CDCs. Except as otherwise provided in a Supplemental Guarantee Agreement with a Lender or an Agreement with a CDC, SBA must give its prior written consent before a Lender or CDC takes any of the following actions: (1) Increases the...

13 CFR 120.536 - Servicing and liquidation actions that require the prior written consent of SBA.

Code of Federal Regulations, 2013 CFR

2013-01-01

... that require the prior written consent of SBA. (a) Actions by Lenders and CDCs. Except as otherwise provided in a Supplemental Guarantee Agreement with a Lender or an Agreement with a CDC, SBA must give its prior written consent before a Lender or CDC takes any of the following actions: (1) Increases the...

13 CFR 120.536 - Servicing and liquidation actions that require the prior written consent of SBA.

Code of Federal Regulations, 2011 CFR

2011-01-01

... that require the prior written consent of SBA. (a) Actions by Lenders and CDCs. Except as otherwise provided in a Supplemental Guarantee Agreement with a Lender or an Agreement with a CDC, SBA must give its prior written consent before a Lender or CDC takes any of the following actions: (1) Increases the...

Proponent-Indigenous agreements and the implementation of the right to free, prior, and informed consent in Canada

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

Papillon, Martin, E-mail: martin.papillon@umontreal.ca; Rodon, Thierry, E-mail: thierry.rodon@pol.ulaval.ca

Indigenous peoples have gained considerable agency in shaping decisions regarding resource development on their traditional lands. This growing agency is reflected in the emergence of the right to free, prior, and informed consent (FPIC) when Indigenous rights may be adversely affected by major resource development projects. While many governments remain non-committal toward FPIC, corporate actors are more proactive at engaging with Indigenous peoples in seeking their consent to resource extraction projects through negotiated Impact and Benefit Agreements. Focusing on the Canadian context, this article discusses the roots and implications of a proponent-driven model for seeking Indigenous consent to natural resourcemore » extraction on their traditional lands. Building on two case studies, the paper argues that negotiated consent through IBAs offers a truncated version of FPIC from the perspective of the communities involved. The deliberative ethic at the core of FPIC is often undermined in the negotiation process associated with proponent-led IBAs. - Highlights: • FPIC is becoming a norm for resource extraction projects on Indigenous lands. • Proponent-led IBAs have become the main instrument to establish FPIC in Canada. • Case studies show elite-driven IBA negotiations do not always create the conditions for FPIC. • We need to pay attention to community deliberations as an inherent aspect of FPIC.« less

77 FR 47381 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-08

...., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on.... EPA or the Department of Justice may withdraw or withhold consent to the proposed settlement agreement... Justice determines that consent to the settlement agreement should be withdrawn, the terms of the...

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

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.

Gender differences in heterosexual college students' conceptualizations and indicators of sexual consent: implications for contemporary sexual assault prevention education.

PubMed

Jozkowski, Kristen N; Peterson, Zoë D; Sanders, Stephanie A; Dennis, Barbara; Reece, Michael

2014-01-01

Because sexual assault is often defined in terms of nonconsent, many prevention efforts focus on promoting the clear communication of consent as a mechanism to reduce assault. Yet little research has specifically examined how sexual consent is being conceptualized by heterosexual college students. In this study, 185 Midwestern U.S. college students provided responses to open-ended questions addressing how they define, communicate, and interpret sexual consent and nonconsent. The study aimed to assess how college students define and communicate consent, with particular attention to gender differences in consent. Results indicated no gender differences in defining consent. However, there were significant differences in how men and women indicated their own consent and nonconsent, with women reporting more verbal strategies than men and men reporting more nonverbal strategies than women, and in how they interpreted their partner's consent and nonconsent, with men relying more on nonverbal indicators of consent than women. Such gender differences may help to explain some misunderstandings or misinterpretations of consent or agreement to engage in sexual activity, which could partially contribute to the occurrence of acquaintance rape; thus, a better understanding of consent has important implications for developing sexual assault prevention initiatives.

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

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.

Using Working Agreements in Participatory Action Research: Working through Moral Problems with Malaysian Students

ERIC Educational Resources Information Center

Balakrishnan, Vishalache; Cornforth, Sue

2013-01-01

In this paper we propose that taking time before the work begins to develop agreements about how to work together in participatory action research enables researchers to directly address several ethical issues that can be problematic in this type of research: gaining fully informed consent; in-group confidentiality; cultural misconceptions; and…

Pilot evaluation of parental and professional views regarding consent in neonatal medicine by telephone interviews and questionnaires

PubMed Central

2017-01-01

Objective The objectives of the study were to determine (1) parental and professional views regarding the type of consent required for common neonatal interventions and (2) whether there has been a change in professional understanding regarding the requirements of consent since the last UK survey in 2003. Design Cohort study of (1) parents of babies admitted to a single-centre tertiary neonatal unit and (2) healthcare professionals. Methods The views of 8 parents of former neonatal patients and 69 neonatal professionals were sought using online and telephone survey methodology regarding 20 neonatal interventions and whether implied consent, explicit verbal consent or explicit written consent should be obtained. Results Agreement, defined as both parental and professional consensus on the type of consent required, was present in 12/20 of the interventions. Comparison between professional views in 2003 demonstrated a change regarding type of consent for 50% of interventions with a shift towards obtaining explicit written consent certain treatments. Conclusions The study indicates areas of consensus that exist between parents and professionals regarding consent for common neonatal interventions and a change in professional views regarding consent since the last UK survey in 2003. These data might help inform the development of national guidance for how professionals should obtain consent in neonatology. PMID:29637148

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.

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.

Consent Agreement with the US Department of Interior (DOI), Bureau of Indian Affairs (BIA) and Bureau of Indian Education (BIE)

EPA Pesticide Factsheets

Consent Agreement between EPA and the Department of Interior (DOI), Bureau of Indian Affairs and Bureau of Indian Education (BIE) for violations of RCRA, CAA, TSCA, AHERA, and SDWA. These violations involve schools and public water systems.

76 FR 45793 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

...., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on... in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed... Department of Justice determines that consent to this settlement agreement should be withdrawn, the terms of...

76 FR 58507 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-21

... through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or... intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent... Act. Unless EPA or the Department of Justice determines that consent to this settlement agreement...

77 FR 19013 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-29

...., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on... the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the... EPA or the Department of Justice determines that consent to the settlement agreement should be...

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...

29 CFR 1905.24 - Consent findings and rules or orders.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

30 CFR 44.27 - Consent findings and rules or orders.

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-15

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

78 FR 18979 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

... Constitution Ave. NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal... litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed... Department of Justice determines that consent to this settlement agreement should be withdrawn, the terms of...

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...

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.

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...

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...

5 CFR 2634.804 - Evidence of compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... positions requiring the advice and consent of the Senate, evidence of any action taken to comply with the...) For ethics agreements of incumbents in positions which required the advice and consent of the Senate..., nor an incumbent in, an advice-and-consent position, must also promptly send evidence of any action...

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 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...

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...

22 CFR 33.5 - Guaranty agreements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Guaranty agreements. 33.5 Section 33.5 Foreign... UNDER SECTION 7 § 33.5 Guaranty agreements. (a) Period in effect. Agreements are effective for a Fiscal... September 30. (b) Guaranty agreement transfer. A guaranty agreement may, with the Secretary's prior consent...

22 CFR 33.5 - Guaranty agreements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Guaranty agreements. 33.5 Section 33.5 Foreign... UNDER SECTION 7 § 33.5 Guaranty agreements. (a) Period in effect. Agreements are effective for a Fiscal... September 30. (b) Guaranty agreement transfer. A guaranty agreement may, with the Secretary's prior consent...

22 CFR 33.5 - Guaranty agreements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Guaranty agreements. 33.5 Section 33.5 Foreign... UNDER SECTION 7 § 33.5 Guaranty agreements. (a) Period in effect. Agreements are effective for a Fiscal... September 30. (b) Guaranty agreement transfer. A guaranty agreement may, with the Secretary's prior consent...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

29 CFR 102.62 - Election agreements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 29 Labor 2 2013-07-01 2013-07-01 false Election agreements. 102.62 Section 102.62 Labor... Act § 102.62 Election agreements. (a) Consent election agreements with final regional director... of the regional director, enter into an agreement providing for the waiver of a hearing and for an...

12 CFR 1805.302 - Restrictions on use of assistance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Restrictions on use of assistance. 1805.302 Section 1805.302 Banks and Banking COMMUNITY DEVELOPMENT FINANCIAL INSTITUTIONS FUND, DEPARTMENT OF THE... Assistance Agreement. (b) An Awardee may not distribute assistance to an Affiliate without the Fund's consent...

78 FR 68863 - Notice of Lodging of Proposed Stipulation, Consent Decree and Settlement Agreement Under the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... in Rootstown, Ohio, formerly operating under Delphi's Packard Electric/Electronic Architecture... payment to: Consent Decree Library, U.S. DOJ--ENRD, P.O. Box 7611, Washington, DC 20044-7611. Please...

29 CFR 70.42 - Consent to Pay Fees.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Consent to Pay Fees. 70.42 Section 70.42 Labor Office of the....42 Consent to Pay Fees. (a) The filing of a request under this subpart will be deemed to constitute an agreement by the requester to pay all applicable fees charged under this part up to and including...

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...

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...

75 FR 57272 - The Dun & Bradstreet Corporation; Analysis of Agreement Containing Consent Order to Aid Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-20

..., demographic, and other information that allow their customers to market to teachers, administrators, schools... turning to the other company. By contrast, MCH lacked a K-12 database comparable to MDR or QED's..., including the time and cost to develop a database with market coverage and accuracy comparable to MDR or QED...

78 FR 41090 - Exemption From Certain Prohibited Transaction Restrictions

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... fees and expenses. JJ. ``Eligible Yield Supplement Agreement'' means any yield supplement agreement... provision described in subsections III.JJ.(1)-(3) without the consent of the Trustee; (5) It is entered into...

1995 Report on Hanford site land disposal restrictions for mixed waste

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

Black, D.G.

This report was submitted to meet the requirements of Hanford Federal Facility Agreement and Consent Order Milestone M-26-01E. This milestone requires the preparation of an annual report that covers characterization, treatment, storage, minimization, and other aspects of land disposal restricted mixed waste at the Hanford Site. The U.S. Department of Energy, its predecessors, and contractors at the Hanford Site were involved in the production and purification of nuclear defense materials from the early 1940s to the late 1980s. These production activities have generated large quantities of liquid and solid radioactive mixed waste. This waste is subject to regulation under authoritymore » of both the Resource Conservation and Recovery Act of 1976 and Atomic Energy Act of 1954. This report covers mixed waste only. The Washington State Department of Ecology, U.S. Environmental Protection Agency, and U.S. Department of Energy have entered into an agreement, the Hanford Federal Facility Agreement and Consent Order (commonly referred to as the Tri-Party Agreement) to bring the Hanford Site operations into compliance with dangerous waste regulations. The Tri-Party Agreement required development of the original land disposal restrictions (LDRs) plan and its annual updates to comply with LDR requirements for radioactive mixed waste. This report is the fifth update of the plan first issued in 1990. Tri-Party Agreement negotiations completed in 1993 and approved in January 1994 changed and added many new milestones. Most of the changes were related to the Tank Waste Remediation System and these changes are incorporated into this report.« less

Broad Consent For Research With Biological Samples: Workshop Conclusions

PubMed Central

Grady, Christine; Eckstein, Lisa; Berkman, Ben; Brock, Dan; Cook-Deegan, Robert; Fullerton, Stephanie M.; Greely, Hank; Hansson, Mats G.; Hull, Sara; Kim, Scott; Lo, Bernie; Pentz, Rebecca; Rodriguez, Laura; Weil, Carol; Wilfond, Benjamin S.; Wendler, David

2016-01-01

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The NIH Clinical Center’s Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. The manuscript describes areas of agreement as well as areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic. PMID:26305750

The UIC ICBG (University of Illinois at Chicago International Cooperative Biodiversity Group) Memorandum of Agreement: a model of benefit-sharing arrangement in natural products drug discovery and development.

PubMed

Soejarto, D D; Gyllenhaal, C; Fong, H H S; Xuan, L T; Hiep, N T; Hung, N V; Bich, T Q; Southavong, B; Sydara, K; Pezzuto, J M

2004-02-01

The Convention on Biodiversity mandates a new approach to the discovery of natural product drugs, one that incorporates concepts of national ownership of genetic resources, intellectual property rights in traditional knowledge, and sharing of economic benefits with countries that are the source of new natural products. The International Cooperative Biodiversity Group (ICBG) program was established to support experimentation in implementation of the Convention through development and execution of international agreements for bioprospecting. The agreement of one such ICBG program, between the University of Illinois at Chicago and institutions in Vietnam and Laos, is presented here. The core elements contained in the single, five-way Memorandum of Agreement are the arrangements for intellectual property rights, treatment of informed consent, and plans for benefit-sharing (including the sharing of short- and long-term royalty benefits, capacity building, and community reciprocity). Program participants were able to develop a practical and flexible agreement that satisfies the wishes of all institutions that are parties to it.

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

Protection of children's rights to self-determination in research.

PubMed

Sterling, Cheryl M; Walco, Gary A

2003-01-01

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made (i.e., oneself as opposed to one's child). Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as its pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented.

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.

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...

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...

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...

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

PubMed Central

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

2008-01-01

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

76 FR 17416 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

.... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed.... Unless EPA or the Department of Justice determines, based on any comment submitted, that consent should...

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...

77 FR 47095 - Notice of Proposed Settlement Agreement Under the Park System Resource Protection Act

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-07

... of Interior, National Park Service has reached a settlement with University of Miami, on behalf of... the Settlement Agreement between the United States and University of Miami and the R/V F.G. Walton... of the Settlement Agreement may also be obtained by mail from the Consent Decree Library, P.O. Box...

Consent and refusal in dementia research: conceptual and practical considerations.

PubMed

Cohen-Mansfield, J

2003-01-01

This article discusses types of consent refusals, rates of refusal, factors that affect consent, and methods to increase rates of consent in elderly research participants and in those with dementia in particular. Refusals can be categorized according to several types: complete refusal, refusal that is time-contingent, partial refusal, and contingent agreement. Rates of consent vary greatly across studies of persons with dementia. This variation can also be affected by different methodologies of calculating rates, in addition to differences in content of studies, populations, and procedures. To warrant consent, a study must first be scientifically sound, with a high likelihood of advancing knowledge, and must provide maximal protection to participants. Consent rates are affected by the following factors: levels of anticipated risks and benefits of the study, relationships among the different caregivers involved in the care of the potential subject, the ability of the researcher to properly identify and locate the person who needs to provide consent, characteristics and attitudes of the person providing consent, and the method of obtaining consent, including timing, location, method of presentation, and type of consent requested. An understanding of these issues can assist the researcher in tailoring research procedures so as to maximize rates of consent. It also raises ethical issues that warrant further discussion concerning the process of obtaining consent from and for persons with dementia.

26 CFR 1.481-4 - Adjustments taken into account with consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... effecting a change in method of accounting, including the taxable year or years in which the amount of the... Commissioner's consent to a change in method of accounting. (b) An agreement to the terms and conditions of a change in method of accounting under § 1.446-1(e)(3), including the taxable year or years prescribed by...

33 CFR 155.4045 - Required agreements or contracts with the salvage and marine firefighting resource providers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... resource providers in your plan that have been arranged by contract or other approved means. (b) You must obtain written consent from the resource provider stating that they agree to be listed in your plan. This.... The response plan must identify the location of this written consent, which must be: (1) On board the...

33 CFR 155.4045 - Required agreements or contracts with the salvage and marine firefighting resource providers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... resource providers in your plan that have been arranged by contract or other approved means. (b) You must obtain written consent from the resource provider stating that they agree to be listed in your plan. This.... The response plan must identify the location of this written consent, which must be: (1) On board the...

33 CFR 155.4045 - Required agreements or contracts with the salvage and marine firefighting resource providers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... resource providers in your plan that have been arranged by contract or other approved means. (b) You must obtain written consent from the resource provider stating that they agree to be listed in your plan. This.... The response plan must identify the location of this written consent, which must be: (1) On board the...

33 CFR 155.4045 - Required agreements or contracts with the salvage and marine firefighting resource providers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... resource providers in your plan that have been arranged by contract or other approved means. (b) You must obtain written consent from the resource provider stating that they agree to be listed in your plan. This.... The response plan must identify the location of this written consent, which must be: (1) On board the...

33 CFR 155.4045 - Required agreements or contracts with the salvage and marine firefighting resource providers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... resource providers in your plan that have been arranged by contract or other approved means. (b) You must obtain written consent from the resource provider stating that they agree to be listed in your plan. This.... The response plan must identify the location of this written consent, which must be: (1) On board the...

78 FR 37814 - Tesoro Corporation and Tesoro Logistics Operations LLC; Analysis of Proposed Agreement Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-24

... FEDERAL TRADE COMMISSION [File No. 131 0052] Tesoro Corporation and Tesoro Logistics Operations... Orders (``Consent Agreement'') with Tesoro Corporation and Tesoro Logistics Operations LLC (``Respondents... Metropolitan Statistical Area (``Boise MSA''). The Acquisition would reduce the competitive options [[Page...

76 FR 68189 - Healthcare Technology Holdings, Inc.; Analysis of Proposed Agreement Containing Consent Orders To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-03

... FEDERAL TRADE COMMISSION [File No. 111 0097] Healthcare Technology Holdings, Inc.; Analysis of... Public Comment I. Introduction The Federal Trade Commission (``Commission'') has accepted from Healthcare Technology Holdings, Inc. (``Healthcare Technology''), subject to final approval, an Agreement Containing...

Administrative Settlement Agreement and Order on Consent for Removal Action - CERCLA Docket No. 04-2010-3756

EPA Pesticide Factsheets

Contains legal agreement for the Huntsville Gas Company site under CERCLA Sections 104, 106(a), 107, and 122, Huntsville, Madison County, Alabama, November 24, 2009 Region ID: 04 DocID: 10685283, DocDate: 11-24-2009

[Dentistry and healthcare legislation 3: informed consent].

PubMed

Brands, W G; van der Ven, J M; Eijkman, M A J

2013-06-01

The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

43 CFR 3280.5 - May BLM require the modification of lease requirements in connection with the creation and...

Code of Federal Regulations, 2012 CFR

2012-10-01

... requirements in connection with the creation and operation of a unit agreement? 3280.5 Section 3280.5 Public... with the creation and operation of a unit agreement? (a) BLM may, with the consent of the lessees... connection with the creation and operation of any such unit agreement as BLM may consider necessary or...

43 CFR 3280.5 - May BLM require the modification of lease requirements in connection with the creation and...

Code of Federal Regulations, 2013 CFR

2013-10-01

... requirements in connection with the creation and operation of a unit agreement? 3280.5 Section 3280.5 Public... with the creation and operation of a unit agreement? (a) BLM may, with the consent of the lessees... connection with the creation and operation of any such unit agreement as BLM may consider necessary or...

43 CFR 3280.5 - May BLM require the modification of lease requirements in connection with the creation and...

Code of Federal Regulations, 2011 CFR

2011-10-01

... requirements in connection with the creation and operation of a unit agreement? 3280.5 Section 3280.5 Public... with the creation and operation of a unit agreement? (a) BLM may, with the consent of the lessees... connection with the creation and operation of any such unit agreement as BLM may consider necessary or...

43 CFR 3280.5 - May BLM require the modification of lease requirements in connection with the creation and...

Code of Federal Regulations, 2014 CFR

2014-10-01

... requirements in connection with the creation and operation of a unit agreement? 3280.5 Section 3280.5 Public... with the creation and operation of a unit agreement? (a) BLM may, with the consent of the lessees... connection with the creation and operation of any such unit agreement as BLM may consider necessary or...

Administrative Settlement Agreement and Order on Consent for Removal Action - Kentucky Wood Preserving Superfund Site. Docket No. 04-2009-3762

EPA Pesticide Factsheets

Contains legal agreement for the Kentucky Wood Preserving Superfund site under CERCLA Sections 104, 106(a), 107 and 122, Winchester, Kentucky, February 9, 2009 Region ID: 04 DocID: 10452978, DocDate: 02-09-2009

Administrative Settlement Agreement and Order on Consent for Removal Action, CERCLA Docket No. 04-2009-3979, Forshaw Chemicals, Inc.

EPA Pesticide Factsheets

Contains legal agreement for the Forshaw Chemicals site under CERCLA Sections 104, 106(a), 107 and 122, Charlotte, Mecklenburg County, North Carolina, August 11, 2009 Region ID: 04 DocID: 10539125, DocDate: 08-11-2009

Administrative Settlement Agreement and Order on Consent for Remedial Investigation/Feasibility Study - Holtra Chem/Honeywell Inc. Superfund Site. CERCLA-04-2009-3980

EPA Pesticide Factsheets

Contains legal agreement for the LCP-Holtrachem Superfund site under CERCLA Sections 104, 107, and 122, Riegelwood, Columbus County, North Carolina , September 15, 2009 Region ID: 04 DocID: 10453068, DocDate: 09-15-2009

40 CFR 144.63 - Financial assurance for plugging and abandonment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regional Administrator consents to termination of the policy by the owner or operator as specified in... the trust agreement to the Regional Administrator. An owner or operator of a Class I well injecting hazardous waste must submit the originally signed duplicate of the trust agreement to the Regional...

ADMINISTRATIVE SETTLEMENT AGREEMENT AND ORDER ON CONSENT FOR REMEDIAL INVESTIGATION/FEASIBILITY STUDY, B.F. GOODRICH. CERCLA DOCKET NO. 04-2010-3761.

EPA Pesticide Factsheets

legal agreement about the B. F. Goodrich Superfund Site Calvert City, Marshall County, Kentucky between EPA and Goodrich Corporation, PolyOne Corporation, and Westlake Vinyls, Inc. Region ID: 04 DocID: 10453129, DocDate: 12-09-2009

75 FR 71441 - Universal Health Services, Inc. and Psychiatric Solutions, Inc.; Analysis of Agreement Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-23

... FEDERAL TRADE COMMISSION [File No. 101 0142] Universal Health Services, Inc. and Psychiatric Solutions, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment AGENCY: Federal Trade... Health Services, Inc. (collectively, ``UHS'') and Psychiatric Solutions, Inc. (``PSI''). The purpose of...

25 CFR 163.41 - Postgraduation recruitment, continuing education and training programs.

Code of Federal Regulations, 2010 CFR

2010-04-01

... proper channels for internships within Bureau of Indian Affairs forestry programs and, with the consent... channels and pursuant to an interagency agreement, for an internship within the Bureau of Indian Affairs... Corporation may apply, through proper channels and pursuant to a cooperative agreement, for an internship...

7 CFR 1488.18 - Covenant against contingent fees.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AGRICULTURAL COMMODITIES Financing of Export Sales of Agricultural Commodities From Private Stocks Under CCC..., CCC shall have the right, without limitation on any other rights it may have, to annul the financing agreement without liability to CCC. Should the financing agreement be annulled, CCC will promptly consent to...

7 CFR 1488.18 - Covenant against contingent fees.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AGRICULTURAL COMMODITIES Financing of Export Sales of Agricultural Commodities From Private Stocks Under CCC..., CCC shall have the right, without limitation on any other rights it may have, to annul the financing agreement without liability to CCC. Should the financing agreement be annulled, CCC will promptly consent to...

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.

Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues

PubMed Central

Harper, Barbara; Stone, Dave; O’Neill, Catherine; Berger, Patricia; Harris, Stuart; Donatuto, Jamie

2011-01-01

Background: When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers. Objectives: In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health–related or natural-resource–related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements. Discussion: Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control. Conclusions: Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource–related IPR considerations. PMID:21890450

Conducting research with tribal communities: sovereignty, ethics, and data-sharing issues.

PubMed

Harding, Anna; Harper, Barbara; Stone, Dave; O'Neill, Catherine; Berger, Patricia; Harris, Stuart; Donatuto, Jamie

2012-01-01

When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers. In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health-related or natural-resource-related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements. Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control. Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource-related IPR considerations.

76 FR 25688 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal... the Department of Justice may withdraw or withhold consent to the proposed settlement agreement if the..., inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice...

75 FR 37438 - Minnesota Rural Health Cooperative; Analysis of the Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-29

... benefit consumers; and (2) the price agreements are reasonably necessary to realize those efficiencies... behavior, none of the programs creates enforceable obligations for physicians to improve their clinical... engage in them on its own without any involvement from the other clinics. Finally, the challenged conduct...

76 FR 28226 - Southwest Health Alliances, Inc., Doing Business as BSA Provider Network; Analysis of Agreement...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-16

... BSA Provider Network; Analysis of Agreement Containing Consent Order To Aid Public Comment AGENCY... unfair methods of competition. The attached Analysis To Aid Public Comment describes both the allegations... placed on the public record for a period of thirty (30) days. The following Analysis To Aid Public...

75 FR 48686 - Tops Markets LLC; Analysis of Agreement Containing Consent Orders to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... FEDERAL TRADE COMMISSION [File No. 101 0074] Tops Markets LLC; Analysis of Agreement Containing... electronically or in paper form. Comments should refer to``Tops-Penn Traffic, File No. 101 0074'' to facilitate... identifiable health information. In addition, comments should not include any ``[t]rade secret or any...

1999 Report on Hanford Site land disposal restriction for mixed waste

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

BLACK, D.G.

This report was submitted to meet the requirements of Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-26-011. This milestone requires the preparation of an annual report that covers characterization, treatment, storage, minimization, and other aspects of managing land-disposal-restricted mixed waste at the Hanford Facility.

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.

Annual Progress Report on the Development of Waste Tank Leak Monitoring and Detection and Mitigation Activities in Support of M-45-08

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

DEFIGH PRICE, C.

2000-09-25

Milestone M-45-09E of the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement or TPA) [TPA 1996] requires submittal of an annual progress report on the development of waste tank leak detection, monitoring, and mitigation (LDMM) activities associated with the retrieval of waste from single-shell tanks (SSTs). This report details progress for fiscal year 2000, building on the current LDMM strategy and including discussion of technologies, applications, cost, schedule, and technical data. The report also includes discussion of demonstrations conducted and recommendations for additional testing. Tri-Party Agreement Milestones M-45-08A and M-45-08B required design and demonstration of LDMM systems for initialmore » retrieval of SST waste. These specific milestones have recently been deleted as part of the M-45-00A change package. Future LDMM development work has been incorporated into specific technology demonstration milestones and SST waste retrieval milestones in the M-45-03 and M-45-05 milestone series.« less

75 FR 54873 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-09

...., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on... parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or... the Act. Unless EPA or the Department of Justice determines that consent to this settlement agreement...

75 FR 8947 - M. Catherine Higgins; Analysis of the Agreement Containing Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-26

... FEDERAL TRADE COMMISSION [File No. 051 0252] M. Catherine Higgins; Analysis of the Agreement... prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to... public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes...

77 FR 33218 - Graco, Inc.; Analysis of Proposed Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-05

... FEDERAL TRADE COMMISSION [Docket No. 9350] Graco, Inc.; Analysis of Proposed Agreement Containing... or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public... Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to...

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...

76 FR 56455 - DaVita, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-13

... agreement package can be obtained from the FTC Home Page (for September 2, 2011), on the World Wide Web, at... to ongoing dialysis treatments. The relevant geographic markets for the provision of dialysis... case in many of the geographic markets identified in the Commission's complaint. Each of the geographic...

Language Policy and the Manufacturing of Consent for Foreign Intervention in Colombia (La política lingüística y la fabricación del consentimiento para la intervención extranjera en Colombia)

ERIC Educational Resources Information Center

Valencia, Marlon

2013-01-01

The present paper provides a critical analysis of Colombia's National Program of Bilingualism focusing on the ideologies behind it, how it facilitates the manufacturing of Colombian citizens' consent for foreign intervention through free trade agreements, and the progressive dismantling of public education. The program is analyzed with a critical…

Surrogacy commissioning fathers and HIV.

PubMed

Jordaan, Donrich W

2013-10-11

Surrogacy is not regulated by a single legal instrument only, nor is confirmation of a surrogacy agreement by the High Court an unqualified green light for the surrogacy process to proceed. In the context of the HIV status of the commissioning father, whose gametes are to be used for the conception of the child in pursuance of a surrogacy agreement, the intended in vitro fertilisation of the surrogate mother may only take place on condition that the commissioning father, and his semen, have been tested for HIV; that he has consented to his HIV status being made available to the surrogate mother, and if he is HIV-positive, that sperm washing will be used to minimise the risk of infection and that the surrogate mother has been informed of his HIV status, and given her informed consent. 

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

PubMed

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

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

Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes

PubMed Central

Chin, William Wei Lim; Wieschowski, Susanne; Prokein, Jana; Illig, Thomas

2016-01-01

Modern approaches for research with human biospecimens employ a variety of substantially different types of ethics approval and informed consent. In most cases, standard ethics reporting such as “consent and approval was obtained” is no longer meaningful. A structured analysis of 120 biospecimen studies recently published in top journals revealed that more than 85% reported on consent and approval, but in more than 90% of cases, this reporting was insufficient and thus potentially misleading. Editorial policies, reporting guidelines, and material transfer agreements should include recommendations for meaningful ethics reporting in biospecimen research. Meaningful ethics reporting is possible without higher word counts and could support public trust as well as networked research. PMID:27483445

47 CFR 1.248 - Prehearing conferences; hearing conferences.

Code of Federal Regulations, 2010 CFR

2010-10-01

... leading to a consent agreement. (d) This paragraph applies to broadcast proceedings only. (1) At the...) In hearings involving applications for new, improved and changed facilities and in comparative...

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

Administrative Settlement Agreement and Order on Consent for Removal Action, in the Matter of: Forshaw Chemicals Site, Charlotte, Mecklenburg County, North Carolina, Forshaw Chemicals, Inc. Respondent, CERCLA DOCKET NO. 04-2009-3979

EPA Pesticide Factsheets

Contains legal agreement for the Forshaw Chemicals site under CERCLA Sections 104, 106(a), 107 and 122, Charlotte, Mecklenburg County, North Carolina, August 17, 2009 Region ID: 04 DocID: 10427285, DocDate: 08-17-2009

[Current legal framework conditions for running and utilization of biobanks. Part 2: data protection and informed consent].

PubMed

Haier, J

2013-10-01

Informed consent of donors of biomaterials represents an essential pillar of legal conformity of business organizations even for biobanks. For the assessment of self-determination of donors and freedom of research for users of biobanks there is a general consensus on the necessity for a social and individual agreement for the participation of donors in research projects. However, demands are often made for which the legal implementation is at least contentious and can be considered as excessive and biased. In part 2 of this review series the current legal foundation of data protection and informed consent is summarized on the basis of normative and ethical principles. With respect to appropriation of data and biosamples it can be deduced that by conformation to corresponding framework conditions the informed consent of donors in particular can be constructed independent of the project.

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.

Groundwater impact assessment for the 216-U-17 Crib, 200 West Area

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

Reidel, S.P.; Johnson, V.G.; Kline, N.W.

1993-06-01

As required by the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement milestone M-17-00A), this report assesses the impact to groundwater from discharge of process condensate to the ground at the 216-U-17 Crib. The assessment considers impacts associated with moisture movement through soil beneath the crib and the potential transport of contaminants to the groundwater.

Tank waste remediation system nuclear criticality safety program management review

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

BRADY RAAP, M.C.

1999-06-24

This document provides the results of an internal management review of the Tank Waste Remediation System (TWRS) criticality safety program, performed in advance of the DOE/RL assessment for closure of the TWRS Nuclear Criticality Safety Issue, March 1994. Resolution of the safety issue was identified as Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-40-12, due September 1999.

Consistency of physicians' legal standard and personal judgments of competency in patients with Alzheimer's disease.

PubMed

Marson, D C; Earnst, K S; Jamil, F; Bartolucci, A; Harrell, L E

2000-08-01

To investigate the consistency of physician judgments of treatment consent capacity (competency) for patients with Alzheimer's disease (AD) when specific legal standards (LS) for competency are used, and to identify the LS most clinically relevant to experienced physicians. Control and AD patient participants were videotaped being administered a measure of capacity to consent to medical treatment. Study physicians viewed videotapes of these assessments individually and made competency judgments for each participant under different LS followed by their own personal judgment of competency. A university medical center. Participants were 10 older controls and 21 patients with AD (10 with mild and 11 with moderate AD). Five physicians with experience assessing the competency of AD patients were recruited from the geriatric psychiatry, geriatric medicine, and neurology services of a university medical center. The 31 participants were videotaped performing on a measure of treatment consent capacity (Capacity to Consent to Treatment Instrument) (CCTI). The CCTI consists of two clinical vignettes (A-neoplasm and B-cardiac) that test competency under five LS. Vignette A and B assessments were videotaped separately for each participant (total videotapes for sample = 62). Each study physician viewed each videotaped vignette individually, made judgments under each of the LS (competent or incompetent), and then made his/her own personal competency judgment. Physicians were blinded to participant diagnosis. Within participant group, consistency of physician judgments was evaluated across LS and personal judgments using percentage agreement and kappa. Agreement between personal and LS judgments for the AD group was evaluated for each physician using logistic regression. As expected, physicians as a group generally demonstrated very high percentage agreement in their LS and personal competency judgments for the control group. For the AD group, mean percentage judgment agreement among physicians ranged from a high of 84% (LS1) (evidencing a treatment choice) to a low of 67% (LS3) (appreciating consequences of treatment choice). Mean percentage agreement for personal competency judgments was 76%. For the AD sample, kappa analyses for physicians as a group demonstrated significant agreement not attributable to chance for LS5 (understanding treatment situation/choices) (k = 0.57, P = .001), LS4 (providing rational reasons for treatment choice) (k = 0.39, P = .04), and also for personal judgments (k = 0.48, P = .009). Analysis of LS judgment agreement within physician indicated that physicians applied the LS as discrete standards. Within-physician and for the AD sample, personal competency judgments were associated significantly with judgments on LS5 (P = .001), LS4 (P = .004), and LS3 (P < .04). Experienced physicians demonstrated significant agreement assessing competency in AD patients when judgments were based upon specific legal standards. Personal competency judgments of physicians showed a substantially higher level of agreement than found in a previous study, where specific LS were not used. These results suggest that consistency of physician competency judgments can be enhanced if they are guided by knowledge of specific LS. Physicians' personal competency judgments were most closely associated with comprehension and reasoning LS, the most conservative and clinically appropriate standards for deciding competency.

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”).

76 FR 17671 - Notice of Proposed Consent Decree Under the Clean Air Act

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

... Acquisition Corporation's bulk gasoline terminal in Saipan, Northern Marianas Islands. The violations include... Building, P.O. Box 500377, Saipan, MP 96950. During the public comment period, the proposed agreements may...

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...

Enforcement Action Protects Shoreline

EPA Pesticide Factsheets

Two sections of “living shoreline” along the Lafayette River in Norfolk, Virginia, constructed under an EPA consent agreement with the city, are part of a broader effort to stabilize the banks of a community vulnerable to sea level rise.

76 FR 3886 - Proposed Administrative Settlement Agreement Under Section 122(h) of the Comprehensive...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-21

... Industries, Inc., Bayer CropScience Inc., Colonial Heights Packaging, Inc., Continental Holdings, Inc., Croda... received and may modify or withdraw its consent to the settlement if comments received disclose facts or...

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”).

Coercion, incarceration, and chemical castration: an argument from autonomy.

PubMed

Douglas, Thomas; Bonte, Pieter; Focquaert, Farah; Devolder, Katrien; Sterckx, Sigrid

2013-10-01

In several jurisdictions, sex offenders may be offered chemical castration as an alternative to further incarceration. In some, agreement to chemical castration may be made a formal condition of parole or release. In others, refusal to undergo chemical castration can increase the likelihood of further incarceration though no formal link is made between the two. Offering chemical castration as an alternative to further incarceration is often said to be partially coercive, thus rendering the offender's consent invalid. The dominant response to this objection has been to argue that any coercion present in such cases is compatible with valid consent. In this article, we take a different tack, arguing that, even if consent would not be valid, offering chemical castration will often be supported by the very considerations that underpin concerns about consent: considerations of autonomy. This is because offering chemical castration will often increase the offender's autonomy, both at the time the offer is made and in the future.

Randomization to Standard and Concise Informed Consent Forms: Development of Evidence-Based Consent Practices

PubMed Central

Enama, Mary E.; Hu, Zonghui; Gordon, Ingelise; Costner, Pamela; Ledgerwood, Julie E.; Grady, Christine

2012-01-01

Background Consent to participate in research is an important component of the conduct of ethical clinical trials. Current consent practices are largely policy-driven. This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects randomized to concise or to standard informed consent forms as one approach to developing evidence-based consent practices. Methods Participants (N=111) who enrolled into two Phase I investigational influenza vaccine protocols (VRC 306 and VRC 307) at the NIH Clinical Center were randomized to one of two IRB-approved consents; either a standard or concise form. Concise consents had an average of 63% fewer words. All other aspects of the consent process were the same. Questionnaires about the study and the consent process were completed at enrollment and at the last visit in both studies. Results Subjects using concise consent forms scored as well as those using standard length consents in measures of comprehension (7 versus 7, p=0.79 and 20 versus 21, p=0.13), however, the trend was for the concise consent group to report feeling better informed. Both groups thought the length and detail of the consent form was appropriate. Conclusions Randomization of study subjects to different length IRB-approved consents forms as one method for developing evidence-based consent practices, resulted in no differences in study comprehension or satisfaction with the consent form. A concise consent form may be used ethically in the context of a consent process conducted by well-trained staff with opportunities for discussion and education throughout the study. PMID:22542645

Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

PubMed

Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

2014-12-01

Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

Description of a Mobile-based Electronic Informed Consent System Development.

PubMed

Hwang, Min-A; Kwak, In Ja

2015-01-01

Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

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

PubMed

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

2010-12-01

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

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

PubMed Central

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

2010-01-01

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

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...

A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

PubMed

Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

2015-01-01

To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

Assessment of mental capacity to consent to treatment in anorexia nervosa: A comparison of clinical judgment and MacCAT-T and consequences for clinical practice.

PubMed

Elzakkers, Isis F F M; Danner, Unna N; Grisso, Thomas; Hoek, Hans W; van Elburg, Annemarie A

Informed consent requires adequate mental capacity to consent to treatment. Mental capacity (MC) to consent to treatment refers to the ability to make medical decisions. MC is assessed in a general psychiatric interview, but this clinical assessment is known to overestimate mental capacity in patients and the inter rater reliability is low. The MacArthur Competence Assessment Tool for Treatment (MacCAT-T) has emerged as the gold standard to assess mental capacity to consent to treatment. The MacCAT-T is a semi-structured interview designed to aid clinicians in this assessment and has shown good inter rater reliability in patients with schizophrenia and other mental disorders, but has hardly been studied in patients with anorexia nervosa. Patients with anorexia nervosa (AN) regularly avoid treatment, even when severely ill and discussion includes assessing MC to consent to treatment. The aim of this study is to compare clinical judgment and the MacCAT-T in evaluating MC in patients with AN which in turn may influence use of the MacCAT-T in daily practice. In a sample of 70 consecutively referred severely ill patients with AN with a mean BMI of 15.5 kg/m 2 and a mean duration of illness of 8.6 years, clinical assessment of MC by experienced psychiatrists and the outcome of the MacCAT-T interview were compared. Agreement (κ-value) was calculated. Agreement between clinical assessment and outcome of the MacCAT-T was questionable (κ 0.23). Unlike in other psychiatric populations, clinicians judged a high proportion of patients with AN as having diminished MC. The MacCAT-T can be useful in assessing MC in AN when used in addition to clinical judgment to aid clinicians in complex cases. Why clinicians judge a relatively high proportion of patients with AN as having diminished MC, in contrast to lower proportions in other psychiatric disorders, is an area in need of further research. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

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 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 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...

CWA-05-2018-0001 Public Notice and Proposed Consent Agreement and Final Orde

EPA Pesticide Factsheets

Central Fuel Company (Respondent) discharges pollutants to tributaries of the Tuscarawas River. Alleged violations were identified during an inspection of the Central Fuel Company'scoal processing plant in New Philadelphia, Ohio, in May of 2016.

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...

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

PubMed

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

2013-04-01

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

Efficient Method of Achieving Agreements between Individuals and Organizations about RFID Privacy

NASA Astrophysics Data System (ADS)

Cha, Shi-Cho

This work presents novel technical and legal approaches that address privacy concerns for personal data in RFID systems. In recent years, to minimize the conflict between convenience and the privacy risk of RFID systems, organizations have been requested to disclose their policies regarding RFID activities, obtain customer consent, and adopt appropriate mechanisms to enforce these policies. However, current research on RFID typically focuses on enforcement mechanisms to protect personal data stored in RFID tags and prevent organizations from tracking user activity through information emitted by specific RFID tags. A missing piece is how organizations can obtain customers' consent efficiently and flexibly. This study recommends that organizations obtain licenses automatically or semi-automatically before collecting personal data via RFID technologies rather than deal with written consents. Such digitalized and standard licenses can be checked automatically to ensure that collection and use of personal data is based on user consent. While individuals can easily control who has licenses and license content, the proposed framework provides an efficient and flexible way to overcome the deficiencies in current privacy protection technologies for RFID systems.

77 FR 13324 - Fresenius Medical Care AG & Co. KGaA; Analysis of Agreement Containing Consent Orders To Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

... site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and... services. The Parties Headquartered in Bad Homburg, Germany, Fresenius is the largest provider of...

Settlement with the Department of the Interior (DOI) to Resolve Violations at Schools in Indian Country

EPA Pesticide Factsheets

Consent Agreement with the DOI, BIA and Bureau of Indian Education (BIE) on alleged violations at schools and public water systems owned, operated or the responsibility of DOI. Violations occurred under the CAA, CWA, SDWA, TSCA, ADHERA.

77 FR 35978 - Johnson & Johnson and Synthes, Inc.; Analysis of Agreement Containing Consent Orders to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... the most common fractures in the human body. Distal radius fractures generally occur as a result of an... comprehensive and broad-based manufacturer of products related to all aspects of human health care. In 2011, J&J...

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

PubMed

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

2014-09-01

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

Interpreting the Clinical Significance of Capacity Scores for Informed Consent in Alzheimer Disease Clinical Trials

PubMed Central

Karlawish, Jason; Kim, Scott Y. H.; Knopman, David; van Dyck, Christopher H.; James, Bryan D.; Bioethics, M.; Marson, Daniel

2014-01-01

Objective Among Alzheimer disease (AD) patients enrolled in a clinical trial, the authors assessed the ability of a standardized capacity assessment procedure to identify persons who are capable of giving their own informed consent. Design Cross-sectional interview. Setting Thirteen sites participating in a randomized and placebo controlled study of simvastatin for the treatment of mild to moderate AD. Participants Persons with mild to moderate AD and their study partners enrolled in the simvastatin clinical trial. Measurements Interviews to assess decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR). Results Judges blinded to the subject’s clinical status had a high rate of agreement on patients capable of giving their own informed consent (κ = 0.73). The understanding subscale had the best receiver operator characteristic and an analysis of positive and negative predictive values over a range of hypothetical prevalences of incapacity to consent demonstrated the value of a range of understanding cut-points. Conclusion Among mild to moderate AD patients, enrolled in an actual clinical trial, these results suggest evidence based guidelines for using the MacCAT-CR understanding subscale to help guide judgments about whether a patient has the capacity to consent. PMID:18556397

Informed consent comprehension in African research settings.

PubMed

Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

2014-06-01

Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure. © 2014 John Wiley & Sons Ltd.

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.

76 FR 64945 - Teva Pharmaceutical Industries Ltd. and Cephalon, Inc.; Analysis of Agreement Containing Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-19

... Pharmaceutical, Inc. (``Par'') all of Teva's rights and assets relating to its generic transmucosal fentanyl citrate lozenges (``fentanyl citrate'') and generic extended release cyclobenzaprine hydrochloride..., by lessening competition in the U.S. markets for fentanyl citrate, cyclobenzaprine hydrochloride, and...

Consent Decree for RD/RA for OU-4 - Weyerhaeuser Co. Plymouth Treating Plant. Civil Action Number 4:08-CV-179-D

EPA Pesticide Factsheets

Contains legal agreement for the Domtar Paper Company LLC (formerly Weyerhaeuser Company) site under CERCLA Sections 106 and 107, Martin County, North Carolina, January 7, 2009 DocID: 10452888, DocDate: 01-07-2009

40 CFR 790.68 - Modification of consent agreements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... negotiations and invite parties who wish to participate in or monitor these negotiations to contact the Agency...) and describing the nature of the modifications. (iii) Where, in EPA's judgment, the requested... lack of laboratory availability, lack of availability of suitable test substance (e.g., 14-C labelled...

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

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

PubMed Central

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

2013-01-01

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

40 CFR 264.143 - Financial assurance for closure.

Code of Federal Regulations, 2011 CFR

2011-07-01

... effect until the Regional Administrator consents to termination of the policy by the owner or operator as... policy by sending notice by certified mail to the owner or operator and the Regional Administrator... paragraph and submitting an originally signed duplicate of the trust agreement to the Regional Administrator...

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

EPA Pesticide Factsheets

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

76 FR 45801 - Perrigo Company and Paddock Laboratories, Inc.; Analysis of Agreement Containing Consent Orders...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

...), 600 Pennsylvania Avenue, NW., Washington, DC 20580. FOR FURTHER INFORMATION CONTACT: Christine Palumbo... individuals' home contact information from comments before placing them on the Commission Web site. Because... shampoo is a prescription shampoo used to treat seborrheic dermatitis, an inflammatory condition that...

78 FR 45194 - General Electric Company; Analysis of Proposed Agreement Containing Consent Order To Aid Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... industries throughout the globe. GE's aviation segment, among other things, designs and manufactures jet... anticompetitive effects of the proposed transaction. The design and production of an aircraft engine, along with... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes...

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

EPA Pesticide Factsheets

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

75 FR 56472 - Amendments to Enforceable Consent Agreement Procedural Rules

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... process that EPA is changing include when and how to initiate negotiations and inserting a firm deadline at which negotiations will terminate. EPA is also deleting, modifying, or consolidating several... Committee (ITC) provisions in a separate section, to make it clearer that there is one ECA negotiation...

45 CFR 601.9 - Access by historical researchers and former Presidential appointees.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) NATIONAL SCIENCE FOUNDATION CLASSIFICATION AND DECLASSIFICATION OF NATIONAL SECURITY INFORMATION § 601.9... access to classified information may be granted only as is essential to the accomplishment of lawful and... execute written agreements to safeguard the information and written consent to the Foundation's review of...

45 CFR 601.9 - Access by historical researchers and former Presidential appointees.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) NATIONAL SCIENCE FOUNDATION CLASSIFICATION AND DECLASSIFICATION OF NATIONAL SECURITY INFORMATION § 601.9... access to classified information may be granted only as is essential to the accomplishment of lawful and... execute written agreements to safeguard the information and written consent to the Foundation's review of...

45 CFR 601.9 - Access by historical researchers and former Presidential appointees.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) NATIONAL SCIENCE FOUNDATION CLASSIFICATION AND DECLASSIFICATION OF NATIONAL SECURITY INFORMATION § 601.9... access to classified information may be granted only as is essential to the accomplishment of lawful and... execute written agreements to safeguard the information and written consent to the Foundation's review of...

45 CFR 601.9 - Access by historical researchers and former Presidential appointees.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) NATIONAL SCIENCE FOUNDATION CLASSIFICATION AND DECLASSIFICATION OF NATIONAL SECURITY INFORMATION § 601.9... access to classified information may be granted only as is essential to the accomplishment of lawful and... execute written agreements to safeguard the information and written consent to the Foundation's review of...

45 CFR 601.9 - Access by historical researchers and former Presidential appointees.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) NATIONAL SCIENCE FOUNDATION CLASSIFICATION AND DECLASSIFICATION OF NATIONAL SECURITY INFORMATION § 601.9... access to classified information may be granted only as is essential to the accomplishment of lawful and... execute written agreements to safeguard the information and written consent to the Foundation's review of...

26 CFR 301.6324A-1 - Election of and agreement to special lien for estate tax deferred under section 6166 or 6166A.

Code of Federal Regulations, 2010 CFR

2010-04-01

... they consent to the creation of the lien. (Property so designated need not be property included in the... special powers of appointment, beneficiaries of a gift over in default of exercise of any such power, co...

75 FR 1785 - Agrium Inc. and CF Industries Holding, Inc.; Analysis of the Agreement Containing Consent Orders...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-13

... number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, comments should not include any ``[t... fertilizers: nitrogen, phosphate, and potash, as well as control release fertilizers and micronutrients...

Consent Agreement and Final Order Against Xutapa Properties, LLC for Safe Drinking Water Act Violations

EPA Pesticide Factsheets

Under Section 1423 (c) of the Safe Drinking Water Act, 42 U.S.C. § 300h-2, the EPA is assessing a civil penalty to Xutapa Properties, LLC for maintaining seven injection wells with the potential to contaminate groundwater resources.

75 FR 5796 - Danaher Corporation and MDS, Inc.; Analysis of Agreement Containing Consent Orders to Aid Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-04

..., Ontario, MDS is a life sciences company that operates three core businesses, MDS Analytical Technologies... life sciences company that manufactures and sells scientific research equipment that it distributes... devices and associated reagent products, to Life Technologies Corp. (``Life Technologies'') within 10 days...

Informed Consent Agreements: Standards of Care for Digital Social Work Practices

ERIC Educational Resources Information Center

Mattison, Marian

2018-01-01

The inclusion of remote digital practices (e-mail, texting, blogging, social media) to deliver social work services raises unique ethical and legal challenges for client and practitioner. Competent care necessitates providing clients with information that would materially affect clients' decisions whether to assume the risks, benefits, and…

76 FR 44924 - Cardinal Health, Inc.; Analysis of Agreement Containing Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-27

... in these cities. These nuclear pharmacies produced, distributed, and sold single photon emission... market''). The Commission's complaint alleges that Cardinal and Biotech were the only two providers of... Commission's complaint alleges that Cardinal and Biotech were the only two providers of low energy...

78 FR 53457 - Phoebe Putney Health System, Inc., et al.; Analysis of Proposed Agreement Containing Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... all management control of Palmyra to Phoebe Putney under a long-term lease arrangement (the... for additional information or documentary material (within the meaning of 16 CFR 803.20), Phoebe... submitting such additional information or documentary material. This provision will prevent smaller, non...

Proposed Consent Agreement and Final Order (CAFO), Docket No.:CWA-04-2018-5501(b)

EPA Pesticide Factsheets

The EPA proposed CAFO assesses an administrative penalty of $3,346 for unauthorized discharges of dredged and/or fill material into waters of the United States in violation of Section 301 of the Clean Water Act, 33 U.S.C. Section 1311.

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2013 CFR

2013-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2012 CFR

2012-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2014 CFR

2014-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

7 CFR 1488.18 - Covenant against contingent fees.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Financing of Export Sales of Agricultural Commodities From Private Stocks Under CCC Export Credit Sales... exporter for the purpose of securing business. For breach or violation of this warranty, CCC shall have the... liability to CCC. Should the financing agreement be annulled, CCC will promptly consent to the reduction or...

7 CFR 1488.18 - Covenant against contingent fees.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Financing of Export Sales of Agricultural Commodities From Private Stocks Under CCC Export Credit Sales... exporter for the purpose of securing business. For breach or violation of this warranty, CCC shall have the... liability to CCC. Should the financing agreement be annulled, CCC will promptly consent to the reduction or...

7 CFR 1488.18 - Covenant against contingent fees.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Financing of Export Sales of Agricultural Commodities From Private Stocks Under CCC Export Credit Sales... exporter for the purpose of securing business. For breach or violation of this warranty, CCC shall have the... liability to CCC. Should the financing agreement be annulled, CCC will promptly consent to the reduction or...

A novel metadata management model to capture consent for record linkage in longitudinal research studies.

PubMed

McMahon, Christiana; Denaxas, Spiros

2017-11-06

Informed consent is an important feature of longitudinal research studies as it enables the linking of the baseline participant information with administrative data. The lack of standardized models to capture consent elements can lead to substantial challenges. A structured approach to capturing consent-related metadata can address these. a) Explore the state-of-the-art for recording consent; b) Identify key elements of consent required for record linkage; and c) Create and evaluate a novel metadata management model to capture consent-related metadata. The main methodological components of our work were: a) a systematic literature review and qualitative analysis of consent forms; b) the development and evaluation of a novel metadata model. We qualitatively analyzed 61 manuscripts and 30 consent forms. We extracted data elements related to obtaining consent for linkage. We created a novel metadata management model for consent and evaluated it by comparison with the existing standards and by iteratively applying it to case studies. The developed model can facilitate the standardized recording of consent for linkage in longitudinal research studies and enable the linkage of external participant data. Furthermore, it can provide a structured way of recording consent-related metadata and facilitate the harmonization and streamlining of processes.

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.

Alcohol and Sexual Consent Scale: Development and Validation

ERIC Educational Resources Information Center

Ward, Rose Marie; Matthews, Molly R.; Weiner, Judith; Hogan, Kathryn M.; Popson, Halle C.

2012-01-01

Objective: To establish a short measure of attitudes toward sexual consent in the context of alcohol consumption. Methods: Using a multistage and systematic measurement development process, the investigators developed the Alcohol and Sexual Consent Scale using a sample of college students. Results: The resulting 12-item scale, the Alcohol and…

Beyond informed consent.

PubMed Central

Bhutta, Zulfiqar A.

2004-01-01

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

Negative ethical behaviors in Saudi hospitals: How prevalent are they perceived to be? – Statement agreement study

PubMed Central

Fayez, R.; Nawwab, A.; Al-Jahdali, H.; Baharoon, S.; Binsalih, S.; Al Sayyari, A.

2013-01-01

BACKGROUND: There is limited information about the prevalence of unethical behavior and how is perceived among health care providers. The aim of this study is to assess such behavior and how is perceived. MATERIALS AND METHODS: This is a cross-sectional study among three groups of professionals. Total participants were 370 and included medical staff, medical residents, and nurses in five medical specialties in four tertiary hospitals in Saudi Arabia (two Ministry of Health Hospitals and two military Hospitals). Participants were asked to rate their agreement with occurrence of 15 “negative” unethical behavior scenarios in their workplace. The scenarios covered areas of “respect for persons”, “interprofessional relationships”, and “empathy with patients”. RESULTS: Majority of respondents agreed that “unethical” behavior occurred in their workplace, including confidentiality being compromised (36.3%), informed consent not taken properly (60.2%), and bad news not well-delivered (62.2%). Other significant area agreement included doctors lacking empathy (47.8%), patient autonomy not fully respected (42.5%), discrimination (41.2%), and being pressurized to write inaccurate reports (31.2%). Respondents in medicine had the lowest rate of agreement and those in psychiatry had the highest (mean of 49.8% and 82.3%, respectively). Respondents with length of employment of less than 6 years had significantly higher agreement that unethical behavior occurs compared to those with length of employment of more than 6 years. Males were more likely than females to agree that unethical behavior occurs. The biggest difference was seen in the behavior of “informed consent not properly taken” with a gender margin of 18.7% (P = 0.001). CONCLUSION: There is high prevalence of behavior that is considered unethical as perceived by various health care workers at Saudi hospitals. PMID:24251232

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

PubMed Central

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

2013-01-01

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

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

PubMed Central

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

2016-01-01

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

76 FR 56452 - Proposed Administrative Settlement Agreement and Order on Consent for Removal Action for 6472...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-13

... contaminated soils on Site above applicable Michigan Act 451, Part 201 Direct Contact Criteria for residential sites (``Part 201''); if field screening indicates that soil contamination exceeds Part 201 requirements... sidewall and floor confirmation soil samples in accordance with the State of Michigan Sampling Strategies...

76 FR 71027 - Proposed Settlement Agreements, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

.... Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word... intervenors to the respective actions at issue. EPA or the Department of Justice may withdraw or withhold... the Act. Unless EPA or the Department of Justice determines that consent to these settlements...

77 FR 14523 - Western Digital Corporation; Analysis of Agreement Containing Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-12

... of Viviti Technologies Ltd., formerly known as Hitachi Global Storage Technologies Ltd. (``HGST''), a... negotiate the purchase price of desktop HDDs at a global level. The desktop HDD market is highly... Digital'') proposed acquisition of Viviti Technologies Ltd., formerly known as Hitachi Global Storage...

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

Code of Federal Regulations, 2010 CFR

2010-07-01

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

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

Code of Federal Regulations, 2011 CFR

2011-07-01

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

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

Code of Federal Regulations, 2012 CFR

2012-07-01

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

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

Code of Federal Regulations, 2013 CFR

2013-07-01

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

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

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 32 2014-07-01 2014-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-21

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

A resolution expressing support for the Ukrainian people in light of President Yanukovych's decision not to sign an Association Agreement with the European Union.

THOMAS, 113th Congress

Sen. Murphy, Christopher [D-CT

2013-12-12

Senate - 01/07/2014 Resolution agreed to in Senate without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

76 FR 78259 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

... online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY... online at https://ftcpublic.commentworks.com/ftc/valeantsanoficonsent , by following the instructions on... calling (202) 326-2222. You can file a comment online or on paper. For the Commission to consider your...

A resolution supporting full implementation of the Comprehensive Peace Agreement and other efforts to promote peace and stability in Sudan, and for other purposes.

THOMAS, 111th Congress

Sen. Feingold, Russell D. [D-WI

2010-02-01

Senate - 03/04/2010 Resolution agreed to in Senate without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

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...

77 FR 58129 - Clean Water Act Class II: Proposed Administrative Settlement, Penalty Assessment and Opportunity...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... Wireless PCS, LLC AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has entered into a Consent Agreement with New Cingular Wireless PCS, LLC to resolve violations of the Clean Water... Wireless (AWS) for potential EPCRA Section 311 and 312 reporting violations, CWA violations related to...

76 FR 20372 - Notice of Lodging of Consent Decree and Settlement Agreement Regarding Natural Resource Damage...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-12

..., Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR... resolves claims for natural resource damages and assessment costs of the United States Department of the..., Environment and Natural Resources Division, and either e-mailed to [email protected] or mailed to...

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...

Consent Agreement and Final Order for AMVAC Chemical Corporation

EPA Pesticide Factsheets

EPA has reason to believe that the pesticide Fluensulfone 480EC (a/k/a Nimitz) is misbranded as defined in section 2(q)(1)(F) of FIFRA, 7 U.S.C. § 136(q)(1)(F) and section 2(q)(1)(G) of FIFRA, 7 U.S.C. § 136(q)(1)(G).

75 FR 42749 - Fidelity National Financial, Inc.; Analysis of the Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-22

... FEDERAL TRADE COMMISSION [File No. 091 0032] Fidelity National Financial, Inc.; Analysis of the... prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to... comments electronically or in paper form. Comments should refer to ``Fidelity National Financial, File No...

16 CFR 1605.13 - Procedures for Consent Order Agreements.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1605.13 Section 1605.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT... including any rights to seek judicial review or otherwise challenge or contest the validity of the....), the Flammable Fabrics Act (15 U.S.C. 1191 et seq.), and the Consumer Product Safety Act (15 U.S.C...

78 FR 45536 - Solera Holdings, Inc.; Analysis of Proposed Agreement Containing Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-29

... anticompetitive effects of its consummated acquisition of Actual Systems of America, Inc. (``Actual Systems... Hollander, Inc. (``Hollander''), and Actual Systems both provide YMS to the automotive recycling industry... which to analyze the competitive effects of the acquisition is YMS. The relevant [[Page 45538...

31 CFR 215.11 - Miscellaneous provisions.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., STATE, CITY AND COUNTY INCOME OR EMPLOYMENT TAXES BY FEDERAL AGENCIES Withholding Agreement § 215.11..., or (b) To consent to the application of any provision of law of the State, city or county which has... withheld taxes to a State, city or county that do not conform to the usual fiscal practices of agencies, or...

31 CFR 215.11 - Miscellaneous provisions.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., STATE, CITY AND COUNTY INCOME OR EMPLOYMENT TAXES BY FEDERAL AGENCIES Withholding Agreement § 215.11..., or (b) To consent to the application of any provision of law of the State, city or county which has... withheld taxes to a State, city or county that do not conform to the usual fiscal practices of agencies, or...

75 FR 4552 - Clean Water Act Class II: Proposed Administrative Settlement, Penalty Assessment, and Opportunity...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

... CONTACT: Michael Calhoun, Special Litigation and Projects Division (2248-A), U.S. Environmental Protection...-9001; e-mail: calhoun[email protected] . SUPPLEMENTARY INFORMATION: I. Background In July 2005, Hydro... supplemental audit reports in 2006 and 2007. EPA and Hydro have signed an administrative Consent Agreement...

Protocol Information Office (PIO) | Division of Cancer Prevention

Cancer.gov

PIO Instructions and Tools Find instructions, forms, and templates for the management of all types of Division of Cancer Prevention clinical trials.Read more about PIO Instructions and Tools Clinical Trials Reference Materials Model clinical agreements, human subject protection and informed consent models, gender and minority inclusion information, and monitoring policy and

77 FR 71593 - Robert Bosch GmbH; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-03

... state identification number or foreign country equivalent, passport number, financial account number, or... for licensing certain patents which may be used in the implementation of two industry standards... elimination of the direct competition between Robinair and Bosch would allow the combined entity to exercise...

Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

PubMed

Mamotte, Nicole; Wassenaar, Douglas

2017-09-01

Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

77 FR 70440 - Hertz Global Holdings, Inc.; Analysis of Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-26

... state identification number or foreign country equivalent, passport number, financial account number, or... information. In addition, do not include any ``[t]rade secret or any commercial or financial information which... convenience, autonomy, or cost efficiency of renting a car, and, as a practical matter, customers are unlikely...

78 FR 44521 - Environmental Impact Statement; Proposed Cattle Fever Tick Control Barrier in South Texas

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... result from installing game fencing as a barrier to keep animals that carry cattle fever ticks and..., we determined that game fencing could help prevent the spread of cattle fever ticks to U.S. cattle... toward installation of game fencing, with landowner consent and cost-share agreement, on privately owned...

2 CFR 180.220 - Are any procurement contracts included as covered transactions?

Code of Federal Regulations, 2010 CFR

2010-01-01

... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Are any procurement contracts included as... contracts awarded directly by a Federal agency; but (2) Do include some procurement contracts awarded by non... expected to equal or exceed $25,000. (2) The contract requires the consent of an official of a Federal...

28 CFR 50.23 - Policy against entering into final settlement agreements or consent decree that are subject to...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Attorney, unless authority to approve the settlement itself lies with a more senior Department official, in which case the more senior official will have such approval authority. (c) Regardless of whether... principles set forth in this section are intended to provide guidance to attorneys for the Government and are...

76 FR 78258 - Valeant Pharmaceuticals International, Inc.; Analysis of Agreement Containing Consent Order to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

....S.C. Sec. 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. 45, in the market for tretinoin... rights to two pharmaceutical products, Refissa, a branded tretinoin emollient cream, and a generic tretinoin emollient cream, to Spear Pharmaceuticals (``Spear''), the company that owns both products. II...

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

Girardot, Crystal L.; Harlow, Donald G.

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

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

Girardot, Crystal L.; Harlow, Donald G.

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

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

Girardot, Crystal L.; Harlow, Donald G.

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

77 FR 42733 - Novartis AG; Analysis of Agreement Containing Consent Orders to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... to relieve pain from injections and surgery. Lidocaine-prilocaine is available in both 30 gram tubes and packages containing five 5 gram tubes (``5-5 tubes''). The 5-5 tubes are used only in hospitals, while the 30 gram tubes are prescribed directly to patients for home use. Fougera, Hi-Tech...

75 FR 10795 - PepsiCo, Inc.; Analysis of Agreement Containing Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-09

... acquisitions of two of its bottlers and the subsequent exclusive license from Dr Pepper Snapple Group, Inc. (``DPSG''), to bottle, distribute and sell the Dr Pepper, Crush, and Schweppes carbonated soft drink... Mug Root Beer. III. Licensor Dr Pepper Snapple Group, Inc. DPSG is a corporation organized, existing...

77 FR 66867 - Corning Incorporated; Analysis of Proposed Agreement Containing Consent Order To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis To... Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Corning Becton, File No... public record for a period of thirty (30) days. The following Analysis To Aid Public Comment describes...

75 FR 7428 - Amendments to Enforceable Consent Agreement Procedural Rules

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-19

..., EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of... of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is... significantly faster than a rule can be promulgated. E. When Does EPA Use Test Rules? EPA typically uses test...

75 FR 56538 - Air Products and Chemicals, Inc.; Analysis of Proposed Agreement Containing Consent Orders to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... certain regional markets in the United States for the manufacture and sale of bulk liquid oxygen and bulk... the United States that produce liquid atmospheric gases, including liquid oxygen and liquid nitrogen.... For most of these applications, there is no viable substitute for the use of oxygen or nitrogen...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-30

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

77 FR 60119 - Proposed Consent Agreements: DesignerWare, LLC, Timothy Kelly and Ronald P. Koller, Aspen Way...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... Rental Agent: the capacity to track the physical location of rented computers via WiFi hotspot locations. The information derived from WiFi hotspot contacts can frequently pinpoint a computer's location to a... a list of publicly available WiFi hotspots with the street addresses for the particular hotspots...

76 FR 26768 - In the Matter of Certain Adjustable-Height Beds and Components Thereof; Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-09

...) issued by the presiding administrative law judge (``ALJ'') granting a joint motion to terminate the above... Granting a Joint Motion To Terminate the Investigation Based on a Settlement Agreement and Consent Order... 31, 2011, Invacare and the respondents filed a joint motion to terminate the investigation based on a...

77 FR 26760 - Kinder Morgan, Inc.; Analysis of Proposed Agreement Containing Consent Orders To Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... to as natural gas liquids or NGLs. Interstate pipelines have a limit on how much NGLs natural gas can... gas processing plant to remove those liquids before it can be transported on interstate pipelines... Gas Transmission, and Trailblazer pipelines, as well as associated processing and storage capacity. On...

77 FR 50717 - Notice of Lodging of Proposed Consent Decree and Settlement Agreement Under the Comprehensive...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... the Comprehensive Environmental Response, Compensation, and Liability Act and Federal Water Pollution... Federal Water Pollution Control Act (``Clean Water Act''), 33 U.S.C. 1321(f), related to the release or... resource damages under CERCLA and the Clean Water Act at the former EPT manufacturing facility in Joplin...

7 CFR 3015.205 - General provisions for grants and cooperative agreements with institutions of higher education...

Code of Federal Regulations, 2013 CFR

2013-01-01

... informed consent shall include any exculpatory language through which the subject is made to waiver, or to... or similar action has been duly adopted or passed as an official act of its governing body... General, through any authorized representative, access to and the right to examine all records, books...

7 CFR 3015.205 - General provisions for grants and cooperative agreements with institutions of higher education...

Code of Federal Regulations, 2012 CFR

2012-01-01

... informed consent shall include any exculpatory language through which the subject is made to waiver, or to... or similar action has been duly adopted or passed as an official act of its governing body... General, through any authorized representative, access to and the right to examine all records, books...

Legal interfaces in telemedicine technology.

PubMed

Lott, C M

1996-05-01

Telemedicine, an emerging technology which seeks to use advanced telecommunications equipment to enhance medical care, is progressing rapidly in the Department of Defense health care delivery system. This paper recommends that a cautious, preventive law approach be simultaneously initiated to ensure that the technology does not abridge patients' rights to confidentiality or security of medical records, and that agreement on practice parameters be developed. Seven interfaces, in the areas of informed consent, physician liability, non-physician liability, costs, practice parameters, physician-patient relationships, and ergonomics, are discussed in the context of telemedicine. The author recommends that telemedicine pioneers include the legal community's early input in the application of telemedicine technology to help avoid needless litigation.

An ethical framework for sharing patient data without consent.

PubMed

Navarro, Robert

2008-01-01

There is no consensus on how to share patient records privately. Data privacy concepts are surveyed and a framework is presented for the safe sharing of sensitive data. It is argued that tailoring the data sharing to the privacy breach risks of each project holds out the best compromise for keeping the trust of the public and providing for the best quality data where detailed patient consent is not possible. To improve the protection of data by reducing privacy breaches and thus enable appropriate patient data sharing without consent. Any harm arising from data sharing must come from the data being identified, either fully or partially. The first step is an agreement on an acceptable privacy breach risk. Next, proceed to measure that risk for the proposed data when held by a given recipient. Finally, select from a menu of mitigation strategies (people, process and technical) to achieve acceptable risk. The framework is tested against the current UK approach administered by the Patient Information Advisory Group. The hard problem of non-consented data sharing should be divided into the easier (though non-trivial) ones of data and recipient breach risk measurement. Directed research in these two areas will help move the data sharing problem into the 'solved' pile.

The Capacity to Consent to Research among Older Adults

ERIC Educational Resources Information Center

Lee, Minhong

2010-01-01

The aim of this study was to develop and validate an assessment tool for research consent competence in older participants. A four-item instrument was developed to assess the capacity of the older adults to consent to research. Data were obtained from 203 nursing home residents from two facilities and 201 community-dwelling older adults in a…

The role of environmental accidental risk assessment in the process of granting development consent.

PubMed

Kontic, Branko; Gerbec, Marko

2009-11-01

Environmental impact assessment (EIA) is a procedure that must be followed for certain types of development before they are granted development consent. The procedure requires the developer to compile an environmental impact report (EIR) describing the likely significant effects of the project on the environment. A regulatory requirement in Slovenia is that an accidental risk assessment for a new installation should be a part of an EIR. The article shows how risk assessment (RA) related to accidental release of methylene diphenyl diisocyanate (MDI) or a polyvalent alcohol mixture from a new planned unit of a chemical factory in the Alpine region of Slovenia was performed in the framework of an EIA for the purpose of obtaining a construction permit. Two accidental scenarios were considered: (a) a spill of 20 m(3) of MDI or polyvalent alcohol mixture into the river Soca (the river runs close to the chemical factory) and (b) a fire in the warehouse storing the raw material, where emission of toxic gases HCN, NO(x), and CO is expected during combustion of MDI. One of the most important results of this case is the agreement among the developer, the competent authority, and a consultant in the field of EIA and RA to positively conclude the licensing process despite the absence of formal (regulatory) limit values for risk. It has been approved that transparent, reasonably uncertain, and semi-quantitative environmental risk assessment is an inevitable component of an EIA, and an essential factor in informed, licensing-related decision making.

A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

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

PubMed

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

2016-06-01

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

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

Girardot, Crystal L.; Harlow, Donald G.

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

77 FR 37674 - Koninklijke Ahold N.V./Safeway, Inc.; Analysis of Agreement Containing Consent Orders To Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-22

...: Giant Carlisle, Giant Landover, Stop & Shop New York Metro, and Stop & Shop New England. Peapod, a grocery delivery service, also is included within Ahold USA. Safeway is one of the largest food-and-drug... products and services provides a ``one-stop shopping'' experience for consumers by enabling them to shop in...

75 FR 61141 - In the Matter of The Coca-Cola Company; Analysis of Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-04

... subsequent exclusive license from Dr Pepper Snapple Group, Inc. (``DPSG''), to bottle, distribute, and sell the Dr Pepper, Diet Dr Pepper, and Canada Dry carbonated soft drink brands of DPSG in certain... from the sale of all products were about $31 billion. III. Licensor Dr Pepper Snapple Group, Inc. DPSG...

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

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

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

2005-05-01

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

76 FR 37152 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

... with the United States District Court for the Eastern District of Wisconsin. In this action, the United... agreement in this matter. On May 12, 2004, the United States District Court for the Eastern District of... remedy for the remainder of the Site, i.e., the Lower River, Middle River, and Inner Harbor portions of...

75 FR 7266 - Roaring Fork Valley Physicians I.P.A.; Analysis of the Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-18

... FEDERAL TRADE COMMISSION [File No. 061 0172] Roaring Fork Valley Physicians I.P.A.; Analysis of... attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms... Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to...

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...

Screening the use of informed consent forms prior to procedures involving operative dentistry: ethical aspects

PubMed Central

Graziele Rodrigues, Livia; De Souza, João Batista; De Torres, Erica Miranda; Ferreira Silva, Rhonan

2017-01-01

Background. The present study aimed to screen the knowledge and attitudes of dentists toward the use of informed consent forms prior to procedures involving operative dentistry. Methods. A research tool containing questions (questionnaire) regarding the use of informed consent forms was developed. The questionnaire consisted of seven questions structured to screen the current practice in operative dentistry towards the use of informed consent forms. Results. The questionnaires were distributed among 731 dentists, of which 179 returned them with answers. Sixty-seven dentists reported not using informed consent forms. The main reasons for not using informed consent forms were: having a complete dental record signed by the patient (67.2%) and having a good relation with patients (43.6%). The dentists who reported using informed consent forms revealed that they obtained them from other dentists and made their own modifications (35.9%). Few dentists revealed contacting lawyers (1.7%) and experts in legal dentistry (0.9%) for the development of their informed consent forms. Conclusion. A high number of dentists working in the field of operative dentistry behave according to the ethical standards in the clinical practice, becoming unprotected against ethical and legal actions. PMID:28413600

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

PubMed

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

2017-12-01

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

Continuing review of ethics in clinical trials: a surveillance study in Iran

PubMed Central

Mohamadi, Amin; Asghari, Fariba; Rashidian, Arash

2014-01-01

In recent years, notable measures have been taken to protect the rights of participants in biomedical research in Iran. The present study examines possible trends in adherence to ethical codes regarding informed consent after the development of the National Code of Ethics in Biomedical Research (NCEBR) and establishment of research ethics committees. In this retrospective study, 126 dissertations from Tehran University of Medical Sciences were evaluated for adherence to ethical codes. These dissertations were all in clinical trial design and had been presented in the years 1999 and 2009, that is, precisely before and after the development of the NCEBR. A checklist was developed to evaluate the ethical issues associated with informed consent. A single investigator retrieved and evaluated the consent forms from the dissertations. Borderline cases were discussed with other investigators to reach a consensus decision. Based on the checklist, the Standardized Ethical Score (SES) was calculated for each consent form. The mean SES and the rate of consent form attachment were compared between the two years. In total, 70 dissertations had reported obtaining informed consent from study participants, whereas consent forms were attached in only 22 dissertations (17.50%). The percentage of dissertations with the consent form attached increased over time from 12.2% in 1999 to 20.8% in 2009 (P > 0.05), but the majority still did not include a consent form. Moreover, the mean SES of consent forms was significantly higher in 1999 (0.746) than in 2009 (0.428), highlighting the need for more training of researchers and improved surveillance by the ethics committees. A great amount of effort is still needed to make the consent process more ethical, especially for dissertations as a less visible part of academic research. As for students, more systematic training focused on research ethics should be implemented prior to thesis submission. PMID:26587202

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.

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

PubMed

Grunberg, F

1990-06-01

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

Autonomy, privacy and informed consent 3: elderly care perspective.

PubMed

Scott, P A; Välimäki, M; Leino-Kilpi, H; Dassen, T; Gasull, M; Lemonidou, C; Arndt, M

Despite the growing interest in clinical healthcare ethics, there is a dearth of empirical studies investigating the ethical elements of day-to-day clinical practice from the perspective of either patients or staff. This article, the third in a four-part series, reports the results of a Scottish Study that formed part of a multi-site comparative study funded by the European Commission. It explores patient autonomy, privacy and informed consent in the care of elderly people in long-stay care facilities (i.e. nursing homes and continuing care units). A convenience sample of 101 elderly residents and their nurses (n = 160) participated in the study. Data were collected by means of a self-completion questionnaire for staff and a structured interview schedule for elderly residents. Results indicate marked differences between staff's and residents' responses on three of the four dimensions explored: information-giving, and opportunity to participate in decision-making about care and consent. There was much closer agreement between staff's and residents' responses regarding protection of patient privacy. From the results of this study there is indication of a clear need for further empirical studies exploring issues of patient autonomy, privacy and informed consent in the day-to-day nursing care of older people. Findings to date suggest there is still a significant need to educate staff concerning ethical awareness and sensitivity to the dignity and rights of patients.

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.

[Episodic breathlessness: translation and consenting of the international definition using the Delphi method].

PubMed

Simon, S T; Weingärtner, V; Voltz, R; Bausewein, C

2014-10-01

Similar to pain, refractory breathlessness can occur episodically. Episodic Breathlessness is a distressing symptom in patients with advanced life-limiting disease. The lack of a universal definition impedes symptom understanding in clinical practice and effective management, respectively. The aim of the study was to formally consent a German translation of the English definition and terminology of episodic breathlessness. A web-based Delphi survey was conducted with German breathlessness experts (breathlessness working group of Germany's National Guideline (S3) for Palliative Care). Drafts of German-language definitions und terminology were assessed using structured questionnaires by binary rating or rankings, respectively. Optional comments were analysed by content analysis. Consensus was defined by ≥ 70% agreement among participants. In two resulting Delphi-rounds 8/16 (50%) und 11/16 (69%) experts, 30-59 years of age, 50%/55% female, participated. After the second round, consensus was reached for the symptom's description "Atemnotattacke" (73%) and a German-language definition (90%). The terms "vorhersehbar" vs. "unvorhersehbar" were directly consented for the categorization (88%). The formally consented German definition and terminology of episodic breathlessness enable clearer symptom understanding and provide a precise basis for education and research on the symptom and its management also in Germany. Effective management options are warranted to improve quality of life of suffering patients and their relatives. © Georg Thieme Verlag KG Stuttgart · New York.

"I didn't have anything to decide, I wanted to help my kids" - An interview-based study of consent procedures for sampling human biological material for genetic research in rural Pakistan.

PubMed

Kongsholm, Nana Cecilie Halmsted; Lassen, Jesper; Sandøe, Peter

2018-05-03

Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values underlying informed consent. Over a two-week period in April 2014 we conducted semi-structured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors' accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. We argue that while building and maintaining trusting relationships in research is important - not least in developing countries - strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out.

75 FR 35033 - U-Haul International, Inc. and AMERCO; Analysis of Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... comments electronically or in paper form. Comments should refer to``U-Haul AMERCO, File No. 081 0157'' to... paper form, must be clearly labeled ``Confidential,'' and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c...). Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please...

Optical Processing.

DTIC Science & Technology

1986-06-01

Further improvements are clearly necessary. 2.2.2 Future Work It would appear that transverse cross-talk is a serious problem in thermally based bistable... manufacturing purposes except under an agreement or with the consent in writing of Ferranti pic and then only on the condition that this notice is...applications which might: (a) appear to benefit from the advantages offered by optical processing (such as large parallelism and dense global inter

Active choice but not too active: Public perspectives on biobank consent models

PubMed Central

Simon, Christian M.; L’Heureux, Jamie; Murray, Jeffrey C.; Winokur, Patricia; Weiner, George; Newbury, Elizabeth; Shinkunas, Laura; Zimmerman, Bridget

2013-01-01

Purpose Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. Methods The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. Results Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. Conclusion Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result. PMID:21555942

Improving the Proficiency of Research Consent Administrators.

PubMed

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

2015-08-01

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

Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research. PMID:22347696

Consent process for US-based family reference DNA samples.

PubMed

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

2018-01-01

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

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

MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

PubMed

Gysels, Marjolein; Evans, Catherine J; Lewis, Penney; Speck, Peter; Benalia, Hamid; Preston, Nancy J; Grande, Gunn E; Short, Vicky; Owen-Jones, Eleanor; Todd, Chris J; Higginson, Irene J

2013-12-01

There is little guidance on the particular ethical concerns that research raises with a palliative care population. To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

A burn center paradigm to fulfill deferred consent public disclosure and community consultation requirements for emergency care research.

PubMed

Blackford, Martha G; Falletta, Lynn; Andrews, David A; Reed, Michael D

2012-09-01

To fulfill Food and Drug Administration and Department of Health and Human Services emergency care research informed consent requirements, our burn center planned and executed a deferred consent strategy gaining Institutional Review Board (IRB) approval to proceed with the clinical study. These federal regulations dictate public disclosure and community consultation unique to acute care research. Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study. Published accounts of deferred consent strategies focus on acute care resuscitation practices. We adapted those strategies to design and conduct a comprehensive public notification/community consultation plan to satisfy deferred consent requirements for burn center research. To implement a robust media campaign we engaged the hospital's public relations department, distributed media materials, recruited hospital staff for speaking engagements, enlisted community volunteers, and developed initiatives to inform "hard-to-reach" populations. The hospital's IRB determined we fulfilled our obligation to notify the defined community. Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

Development and testing of a tool for assessing and resolving medication-related problems in older adults in an ambulatory care setting: the individualized medication assessment and planning (iMAP) tool.

PubMed

Crisp, Ginny D; Burkhart, Jena Ivey; Esserman, Denise A; Weinberger, Morris; Roth, Mary T

2011-12-01

Medication is one of the most important interventions for improving the health of older adults, yet it has great potential for causing harm. Clinical pharmacists are well positioned to engage in medication assessment and planning. The Individualized Medication Assessment and Planning (iMAP) tool was developed to aid clinical pharmacists in documenting medication-related problems (MRPs) and associated recommendations. The purpose of our study was to assess the reliability and usability of the iMAP tool in classifying MRPs and associated recommendations in older adults in the ambulatory care setting. Three cases, representative of older adults seen in an outpatient setting, were developed. Pilot testing was conducted and a "gold standard" key developed. Eight eligible pharmacists consented to participate in the study. They were instructed to read each case, make an assessment of MRPs, formulate a plan, and document the information using the iMAP tool. Inter-rater reliability was assessed for each case, comparing the pharmacists' identified MRPs and recommendations to the gold standard. Consistency of categorization across reviewers was assessed using the κ statistic or percent agreement. The mean κ across the 8 pharmacists in classifying MRPs compared with the gold standard was 0.74 (range, 0.54-1.00) for case 1 and 0.68 (range, 0.36-1.00) for case 2, indicating substantial agreement. For case 3, percent agreement was 63% (range, 40%-100%). The mean κ across the 8 pharmacists when classifying recommendations compared with the gold standard was 0.87 (range, 0.58-1.00) for case 1 and 0.88 (range, 0.75-1.00) for case 2, indicating almost perfect agreement. For case 3, percent agreement was 68% (range, 40%-100%). Clinical pharmacists found the iMAP tool easy to use. The iMAP tool provides a reliable and standardized approach for clinical pharmacists to use in the ambulatory care setting to classify MRPs and associated recommendations. Future studies will explore the predictive validity of the tool on clinical outcomes such as health care utilization. Copyright © 2011 Elsevier HS Journals, Inc. All rights reserved.

Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk.

PubMed

Rogers, C G; Tyson, J E; Kennedy, K A; Broyles, R S; Hickman, J F

1998-04-01

The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted.

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

PubMed

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

2013-11-25

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

The structures and the role of an international agency for the control of satellites

NASA Technical Reports Server (NTRS)

Dupuy, R. J.

1984-01-01

Legal questions involved in the liability of a proposed agency which would control internationally owned satellites for monitoring worldwide compliance with arms control agreements are discussed. Difficulties in acquiring the signed consent of all the relevant nations, and guaranteeing satisfactory compliance with the terms of such an agreement are noted. Additional problems to be solved comprise the construction of the ground based facilities and the satellites, the funding for the venture, and the reconciliation of the functions of the proposed agency with the sovereignty of individual states. The agency would gather, treat, and format data for signatories of arms control agreements and provide technical assistance in crisis conditions. It is concluded that the existence and functioning of the agency would reduce the amount of classified information and would consequently reduce the level of international tensions.

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

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

PubMed Central

Yoshizawa, Go; Sasongko, Teguh H.; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases. PMID:28775738

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

PubMed

Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.

Seeking worldwide professional consensus on the principles of end-of-life care for the critically ill. The Consensus for Worldwide End-of-Life Practice for Patients in Intensive Care Units (WELPICUS) study.

PubMed

Sprung, Charles L; Truog, Robert D; Curtis, J Randall; Joynt, Gavin M; Baras, Mario; Michalsen, Andrej; Briegel, Josef; Kesecioglu, Jozef; Efferen, Linda; De Robertis, Edoardo; Bulpa, Pierre; Metnitz, Philipp; Patil, Namrata; Hawryluck, Laura; Manthous, Constantine; Moreno, Rui; Leonard, Sara; Hill, Nicholas S; Wennberg, Elisabet; McDermid, Robert C; Mikstacki, Adam; Mularski, Richard A; Hartog, Christiane S; Avidan, Alexander

2014-10-15

Great differences in end-of-life practices in treating the critically ill around the world warrant agreement regarding the major ethical principles. This analysis determines the extent of worldwide consensus for end-of-life practices, delineates where there is and is not consensus, and analyzes reasons for lack of consensus. Critical care societies worldwide were invited to participate. Country coordinators were identified and draft statements were developed for major end-of-life issues and translated into six languages. Multidisciplinary responses using a web-based survey assessed agreement or disagreement with definitions and statements linked to anonymous demographic information. Consensus was prospectively defined as >80% agreement. Definitions and statements not obtaining consensus were revised based on comments of respondents, and then translated and redistributed. Of the initial 1,283 responses from 32 countries, consensus was found for 66 (81%) of the 81 definitions and statements; 26 (32%) had >90% agreement. With 83 additional responses to the original questionnaire (1,366 total) and 604 responses to the revised statements, consensus could be obtained for another 11 of the 15 statements. Consensus was obtained for informed consent, withholding and withdrawing life-sustaining treatment, legal requirements, intensive care unit therapies, cardiopulmonary resuscitation, shared decision making, medical and nursing consensus, brain death, and palliative care. Consensus was obtained for 77 of 81 (95%) statements. Worldwide consensus could be developed for the majority of definitions and statements about end-of-life practices. Statements achieving consensus provide standards of practice for end-of-life care; statements without consensus identify important areas for future research.

Validity of a measure to assess healthy eating and physical activity policies and practices in Australian childcare services.

PubMed

Dodds, Pennie; Wyse, Rebecca; Jones, Jannah; Wolfenden, Luke; Lecathelinais, Christophe; Williams, Amanda; Yoong, Sze Lin; Finch, Meghan; Nathan, Nicole; Gillham, Karen; Wiggers, John

2014-06-09

Childcare services represent a valuable obesity prevention opportunity, providing access to a large portion of children at a vital point in their development. Few rigorously validated measures exist to measure healthy eating and physical activity policies and practices in this setting, and no such measures exist that are specific to the childcare setting in Australia. This was a cross sectional study, comparing two measures (pen and paper survey and observation) of healthy eating and physical activity policies and practices in childcare services. Research assistants attended consenting childcare services (n = 42) across the Hunter region of New South Wales, Australia and observed practices for one day. Nominated Supervisors and Room Leaders of the service also completed a pen and paper survey during the day of observation. Kappa statistics and proportion agreement were calculated for a total of 43 items relating to healthy eating and physical activity policies and practices. Agreement ranged from 38%-100%. Fifty one percent of items showed agreement of greater than or equal to 80%. Items assessing the frequency with which staff joined in active play with children reported the lowest percent agreement, while items assessing availability of beverages such as juice, milk and cordial, as well as the provision of foods such as popcorn, pretzels and sweet biscuits, reported the highest percent agreement. Kappa scores ranged from -0.06 (poor agreement) to 1 (perfect agreement). Of the 43 items assessed, 27 were found to have moderate or greater agreement. The study found that Nominated Supervisors and Room Leaders were able to accurately report on a number of healthy eating and physical activity policies and practices. Items assessing healthy eating practices tended to have higher kappa scores than those assessing physical activity related policies or practices. The tool represents a useful instrument for public health researchers and policy makers working in this setting.

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

Retreat from Nuremberg: can we prevent unethical medical research?

PubMed

Horner, J S

1999-09-01

The prosecution of doctors guilty of appalling human rights abuses at Nuremberg was achieved on the mistaken premise that the research community already had a code of conduct which, if applied, would have made such abuses impossible. In fact, not only was there no such code but when the 'Nuremberg Code' was published after the trial it continued to be ignored by many doctors for some thirty years afterwards. Indeed its central principle of informed consent has itself been eroded by subsequent international agreements on the ethics of medical research. This review shows that the mechanisms for approval of medical research which have now been promulgated in England and Wales, in practice, are applied on a very variable basis. Research in vulnerable groups unable to give fully informed consent such as children, prisoners and the incompetent elderly require the application of more rigorous standards of ethical control than those currently in operation. The use of vulnerable populations in the developing world and the application of international standards to them is also considered. A number of suggestions for improvements in current procedures in all these areas are put forward. The proposals for the United Kingdom would meet the requirements of the European Convention on bioethical research and the recent government consultation paper on medical treatment and research in incompetent adults.

24 CFR 5.230 - Consent by assistance applicants and participants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Consent by assistance applicants and participants. 5.230 Section 5.230 Housing and Urban Development Office of the Secretary, Department of Housing and Urban Development GENERAL HUD PROGRAM REQUIREMENTS; WAIVERS Disclosure and...

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

PubMed

Putniņa, Aivita

2013-12-01

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

A Model Designed to Enhance Informed Consent: Experiences From the HIV Prevention Trials Network

PubMed Central

Woodsong, Cynthia; Karim, Quarraisha Abdool

2005-01-01

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment. PMID:15727968

Improving the Proficiency of Research Consent Administrators

PubMed Central

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

2015-01-01

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

Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form

PubMed Central

Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B.; Lee-Kim, Youngna; Shah, Mona D.

2018-01-01

Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to <5 min per admission, and improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to <1 min per admission, decreased consenting numbers and increased work efficiency by >90%. PMID:29333497

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

PubMed

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

2011-04-01

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

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

PubMed

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

2003-01-01

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

Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form.

PubMed

Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B; Lee-Kim, Youngna; Shah, Mona D

2018-01-01

Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to <5 min per admission, and improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to <1 min per admission, decreased consenting numbers and increased work efficiency by >90%.

Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

NASA Astrophysics Data System (ADS)

Klein, Eran; Ojemann, Jeffrey

2016-08-01

Objective. Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices.

PubMed

Klein, Eran; Ojemann, Jeffrey

2016-08-01

Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

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

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

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

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

Assessment of Habitual Diners Nutrient Intake in a Military-Operated Garrison Dining Facility Fort Devens 1

DTIC Science & Technology

1988-11-01

Human Subjects participated in these studies after giving their free and informed voluntary consent. Investigators adhered to AR 70-25 and USAMRDC...diet and nutrition, abstinence from tobacco products, smoking cessation, avoidance of substance abuse, and stress management. A renewed interest in...a Volunteer Agreement in accordance with the approved Human Use protocol. Demographic questionnaires (Appendix C) which included information about

75 FR 70921 - Simon Property Group, Inc.; Analysis of Proposed Agreement Containing Consent Orders To Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-19

... site, at http:[sol][sol]www.ftc.gov[sol]os[sol]publiccomments.shtm. Because comments will be made.../simonproperty . If this Notice appears at http:[sol][sol]www.regulations.gov[sol]search[sol]index.jsp, you may... regulations.gov forwards to it. You may also visit the FTC Web site at http:[sol][sol]www.ftc.gov[sol] to read...

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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.

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

PubMed Central

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

USign--a security enhanced electronic consent model.

PubMed

Li, Yanyan; Xie, Mengjun; Bian, Jiang

2014-01-01

Electronic consent becomes increasingly popular in the healthcare sector given the many benefits it provides. However, security concerns, e.g., how to verify the identity of a person who is remotely accessing the electronic consent system in a secure and user-friendly manner, also arise along with the popularity of electronic consent. Unfortunately, existing electronic consent systems do not pay sufficient attention to those issues. They mainly rely on conventional password based authentication to verify the identity of an electronic consent user, which is far from being sufficient given that identity theft threat is real and significant in reality. In this paper, we present a security enhanced electronic consent model called USign. USign enhances the identity protection and authentication for electronic consent systems by leveraging handwritten signatures everyone is familiar with and mobile computing technologies that are becoming ubiquitous. We developed a prototype of USign and conducted preliminary evaluation on accuracy and usability of signature verification. Our experimental results show the feasibility of the proposed model.

Why female sex workers participate in HIV research: the illusion of voluntariness.

PubMed

Reed, Elizabeth; Fisher, Celia B; Blankenship, Kim M; West, Brooke S; Khoshnood, Kaveh

2017-07-01

The purpose of this study was to examine factors influencing the motivation for and perceived voluntariness of participation in non-intervention HIV research among female sex workers (FSW) in India. FSW (n = 30) who participated in non-intervention HIV studies in the previous three years were recruited from a local community-based organization. Semi-structured qualitative interviews focused on women's personal and economic motivations for participation and their perceptions of the informed consent process. Interviews were audio-recorded, translated, transcribed, and reviewed for common themes. Content analysis indicated that while many women reported willing participation, reports of obligatory participation were also a common theme. Obligations included money-related pressures and coercion by other FSW, social pressures, not wanting to disappoint the researchers, and perceiving that they had a contractual agreement to complete participation as a result of signing the consent form. Findings suggest a need for additional efforts during and following informed consent to prevent obligatory participation in HIV research studies among FSW. Findings emphasize the importance of integrating ongoing participant feedback into research ethics practices to identify issues not well addressed via standard ethics protocols when conducting HIV research among vulnerable populations.

Recovery of transplantable organs after cardiac or circulatory death: Transforming the paradigm for the ethics of organ donation

PubMed Central

Verheijde, Joseph L; Rady, Mohamed Y; McGregor, Joan

2007-01-01

Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination. PMID:17519030

Facing negative reactions to sexuality education through a Multicultural Human Rights framework.

PubMed

Paiva, Vera; Silva, Valeria N

2015-11-01

Sexuality education, its protocols and planning are contingent on an ever-changing political environment that characterizes the field of sexuality in most countries. In Brazil, human rights perspectives shaped the country's response to the AIDS epidemic, and indirectly influenced the public acceptability of sexuality education in schools. Since 2011, however, as multiple fundamentalist movements emerged in the region, leading to recurrent waves of backlashes in all matters related to sexuality, both health and educational policies have begun to crawl backwards. This article explores human rights-based approaches to health, focusing on a multicultural rights-based framework and on productive approaches to broadening the dialogue about sustained consent to sexuality education. Multicultural human rights (MHR) approaches are dialogical in two domains: the communication process that guarantees consent and community agreements and the constructionist psychosocial-educational methodologies. In its continuous process of consent, the MHR approach allowed for distinct values translation and diffused the resistance to sexuality education in the participant schools/cities, successfully sustaining notions of equality and protection of the right to a comprehensive sexuality education that does not break group solidarity and guarantees acceptability of differences. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-06-01

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

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.

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Gillies, Katie; Entwistle, Vikki; Treweek, Shaun P; Fraser, Cynthia; Williamson, Paula R; Campbell, Marion K

2015-10-27

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

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

PubMed Central

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

2017-01-01

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

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries.

PubMed

Mystakidou, Kyriaki; Panagiotou, Irene; Katsaragakis, Stelios; Tsilika, Eleni; Parpa, Efi

2009-09-01

Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms 'HIV/AIDS', 'informed consent', 'clinical trials', 'developing world'. Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.

Developing a new model for patient recruitment in mental health services: a cohort study using Electronic Health Records

PubMed Central

Callard, Felicity; Broadbent, Matthew; Denis, Mike; Hotopf, Matthew; Soncul, Murat; Wykes, Til; Lovestone, Simon; Stewart, Robert

2014-01-01

Objectives To develop a new model for patient recruitment that harnessed the full potential of Electronic Health Records (EHRs). Gaining access to potential participants’ health records to assess their eligibility for studies and allow an approach about participation (‘consent for contact’) is ethically, legally and technically challenging, given that medical data are usually restricted to the patient's clinical team. The research objective was to design a model for identification and recruitment to overcome some of these challenges as well as reduce the burdensome (and/or time consuming) gatekeeper role of clinicians in determining who is appropriate or not to participate in clinical research. Setting Large secondary mental health services context, UK. Participants 2106 patients approached for ‘consent for contact’. All patients in different services within the mental health trust are gradually and systematically being approached by a member of the clinical care team using the ‘consent for contact’ model. There are no exclusion criteria. Primary and secondary outcome measures Provision of ‘consent for contact’. Results A new model (the South London and Maudsley NHS Trust Consent for Contact model (SLaM C4C)) for gaining patients’ consent to contact them about research possibilities, which is built around a de-identified EHR database. The model allows researchers to contact potential participants directly. Of 2106 patients approached by 25 October 2013, nearly 3 of every 4 gave consent for contact (1560 patients; 74.1%). Conclusions The SLaM C4C model offers an effective way of expediting recruitment into health research through using EHRs. It reduces the gatekeeper function of clinicians; gives patients greater autonomy in decisions to participate in research; and accelerates the development of a culture of active research participation. More research is needed to assess how many of those giving consent for contact subsequently consent to participate in particular research studies. PMID:25468503

Pilot-scale treatability test plan for the 200-BP-5 operable unit

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

Not Available

This document presents the treatability test plan for pilot-scale pump and treat testing at the 200-BP-5 Operable Unit. This treatability test plan has been prepared in response to an agreement between the U.S. Department of Energy (DOE), the U.S. Environmental Protection Agency (EPA), and the State of Washington Department of Ecology (Ecology), as documented in Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement, Ecology et al. 1989a) Change Control Form M-13-93-03 (Ecology et al. 1994) and a recent 200 NPL Agreement Change Control Form (Appendix A). The agreement also requires that, following completion of the activities described in thismore » test plan, a 200-BP-5 Operable Unit Interim Remedial Measure (IRM) Proposed Plan be developed for use in preparing an Interim Action Record of Decision (ROD). The IRM Proposed Plan will be supported by the results of this treatability test plan, as well as by other 200-BP-5 Operable Unit activities (e.g., development of a qualitative risk assessment). Once issued, the Interim Action ROD will specify the interim action(s) for groundwater contamination at the 200-BP-5 Operable Unit. The treatability test approach is to conduct a pilot-scale pump and treat test for each of the two contaminant plumes associated with the 200-BP-5 Operable Unit. Primary contaminants of concern are {sup 99}Tc and {sup 60}Co for underwater affected by past discharges to the 216-BY Cribs, and {sup 90}Sr, {sup 239/240}Pu, and Cs for groundwater affected by past discharges to the 216-B-5 Reverse Well. The purpose of the pilot-scale treatability testing presented in this testplan is to provide the data basis for preparing an IRM Proposed Plan. To achieve this objective, treatability testing must: Assess the performance of groundwater pumping with respect to the ability to extract a significant amount of the primary contaminant mass present in the two contaminant plumes.« less

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

PubMed Central

2013-01-01

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

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

PubMed

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

2017-11-29

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

The Minor's Right to Consent to Medical Treatment: A Corollary of the Constitutional Right of Privacy

ERIC Educational Resources Information Center

Raitt, G. Emmett, Jr.

1975-01-01

Argues that the existing rules governing a physician's liability for treating a child without parental consent merit reconsideration because the minor possesses a fundamental constitutional right, stemming from the right of privacy, to consent to medical care. Proposes guidelines for the development of a legislative program implementing these…

How to address the ethics of reproductive travel to developing countries: a comparison of national self-sufficiency and regulated market approaches.

PubMed

Crozier, G K D; Martin, Dominique

2012-04-01

One of the areas of concern raised by cross-border reproductive travel regards the treatment of women who are solicited to provide their ova or surrogacy services to foreign consumers. This is particularly troublesome in the context of developing countries where endemic poverty and low standards for both medical care and informed consent may place these women at risk of exploitation and harm. We explore two contrasting proposals for policy development regarding the industry, both of which seek to promote ethical outcomes and social justice: While one proposal advocates efforts to minimize cross-border demand for female reproductive resources through the pursuit of national self-sufficiency, the other defends cross-border trade as a means for meeting the needs of vulnerable groups. Despite the conflicting objectives of the proposed strategies, the paper identifies common values and points of agreement between the two, including the importance of regulations to safeguard those providing ova or surrogacy services. © 2012 Blackwell Publishing Ltd.

A pilot study of clinical agreement in cardiovascular preparticipation examinations: how good is the standard of care?

PubMed

O'Connor, Francis G; Johnson, Jeremy D; Chapin, Mark; Oriscello, Ralph G; Taylor, Dean C

2005-05-01

To evaluate the interobserver agreement between physicians regarding a abnormal cardiovascular assessment on athletic preparticipation examinations. Cross-sectional clinical survey. Outpatient Clinic, United States Military Academy, West Point, NY. We randomly selected 101 out of 539 cadet-athletes presenting for a preparticipation examination. Two primary care sports medicine fellows and a cardiologist examined the cadets. After obtaining informed consent from all participants, all 3 physicians separately evaluated all 101 cadets. The physicians recorded their clinical findings and whether they thought further cardiovascular evaluation (echocardiography) was indicated. Rate of referral for further cardiovascular evaluation, clinical agreement between sports medicine fellows, and clinical agreement between sports medicine fellows and the cardiologist. Each fellow referred 6 of the 101 evaluated cadets (5.9%). The cardiologist referred none. Although each fellow referred 6 cadets, only 1 cadet was referred by both. The kappa statistic for clinical agreement between fellows is 0.114 (95% CI, -0.182 to 0.411). There was no clinical agreement between the fellows and the cardiologist. This pilot study reveals a low level of agreement between physicians regarding which athletes with an abnormal examination deserved further testing. It challenges the standard of care and questions whether there is a need for improved technologies or improved training in cardiovascular clinical assessment.

USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS

PubMed Central

Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles; Moses, Agnes; Nkhoma, Jacqueline; Tenthani, Lyson; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.

2009-01-01

Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research. PMID:19385837

Making a difference: incorporating theories of autonomy into models of informed consent.

PubMed

Delany, C

2008-09-01

Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

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

Girardot, Crystal L.; Harlow, Donald G.

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

Improving informed consent: Stakeholder views.

PubMed

Anderson, Emily E; Newman, Susan B; Matthews, Alicia K

2017-01-01

Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders-research participants and those responsible for obtaining informed consent-to inform potential development of a multimedia informed consent "app." This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

PubMed

Mendelson, Scott J; Courtney, D Mark; Gordon, Elisa J; Thomas, Leena F; Holl, Jane L; Prabhakaran, Shyam

2018-03-01

No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays. © 2018 American Heart Association, Inc.

Customising informed consent procedures for people with schizophrenia in India.

PubMed

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

2015-10-01

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

Nebraska files suit to block disposal site

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

Not Available

Just when the Central Interstate Low-Level Radioactive Waste Compact thought things might be starting to go its way, the state of Nebraska, following instructions from Gov. Ben Nelson, has filed a new lawsuit to block development of an LLW disposal site within its borders. The suit maintains that the recently reconfigured proposed site (in which an area of wetlands was excluded) has not received [open quotes]community consent,[close quotes] as required by state law; says that site developer, US Ecology, has not obtained county consent; and asks that the court permanently prevent development of any LLW site in Nebraska until communitymore » consent is demonstrated.« less

Modified informed consent in a viral seroprevalence study in the Caribbean.

PubMed

Cox, Cheryl; Macpherson, CNL

1996-07-01

An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented with conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communites in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

PubMed Central

de Laat, Sonya; Schwartz, Lisa

2016-01-01

Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines. PMID:27625066

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

PubMed

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

2011-02-15

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

Improving informed consent: Stakeholder views

PubMed Central

Anderson, Emily E.; Newman, Susan B.; Matthews, Alicia K.

2017-01-01

Purpose Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders—research participants and those responsible for obtaining informed consent—to inform potential development of a multimedia informed consent “app.” Methods This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. Results We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Conclusions Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms. PMID:28949896

Ethical challenges in developing an educational video to empower potential participants during consent processes in HIV cure research in South Africa.

PubMed

Staunton, Ciara; de Roubaix, Malcolm; Baatjies, Dianno; Black, Gill; Hendricks, Melany; Rossouw, Theresa; Moodley, Keymanthri

2018-04-01

Obtaining consent for HIV research is complex, particularly in low- and middle-income countries. Low levels of education, complexity of science and research processes, confusion about basic elements of research, and socio-economic conditions that make access to medical care difficult have collectively led to concerns about the adequacy of the consent process. Given the exponential growth of HIV prevention and treatment research in South Africa, HIV researchers are increasingly facing challenges obtaining authentic informed consent from potential participants. It is anticipated that HIV cure research, despite being in its infancy in South Africa, will introduce a new discourse into a population that is often struggling to understand the differences between 'cure', 'preventive and therapeutic vaccines' and other elements of the research process. Coupled with this, South Africa has a complex history of 'illegitimate' or 'false cures' for HIV. It is therefore logical to anticipate that HIV cure research may face significant challenges during consent processes. HIV prevention research in South Africa has demonstrated the importance of early community engagement in educating potential research participants and promoting community acceptance of research. Consequently, in an attempt to extrapolate from this experience of engaging with communities early regarding cure research, a 15-minute educational video entitled ' I have a dream: a world without HIV ' was developed to educate and ultimately empower potential research participants to make informed choices during consent processes in future HIV cure clinical trials. To aid others in the development of educational interventions, this paper discusses the challenges faced in developing this educational video.

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

PubMed

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

2017-11-13

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

THE ETHICS OF OCCUPATIONAL HEALTH AND SAFETY IN TURKEY: RESPONSIBILITY AND CONSENT TO RISK.

PubMed

Artvinli, Fatih

2016-06-01

Work-related diseases, injuries, risks and deaths are the issues that have been recently gaining importance especially in developing countries. The ethical dimensions of occupational health and safety have remained as relatively understudied areas. Concepts such as responsibility, consent, autonomy, paternalism, choice, and certain values or justifications that are used in medical ethics and bioethics are also applicable to occupational health and safety. This article examines the ethical issues of responsibility and consent to occupational risk. It will first define the concepts of consent and risk, and then different views on responsibility and consent to risk will be discussed. The article will also examine the responsibility of the society and government regarding these concepts.

Ethics of human testing.

PubMed

Salter, D C

1990-08-01

What should one do, and why? Anyone asking such questions--and everyone does so hundreds of time each day--is concerned with ethics. Product development and testing raise many ethical questions. Particularly since the rise of 'green consumerism', these are of increasing concern to people outside the cosmetics industry, and so should be of interest to those inside it. The major problem seems to be that of reaching agreement on moral and ethical issues. Overcoming this problem involves investigating what is meant by 'ethics', and how decisions depend not on facts but on 'facts-as-perceived'. These in turn depend on many factors, with one's philosophy being the most fundamental. The range of philosophical options is reviewed and it is proposed that wider discussion is the only just way to achieve agreement. Yet some things are not negotiable. There are certain key moral concepts in terms of which discussion must take place for it to be relevant. In ethics of human testing, 'respect for others', that is, avoiding exploitation, is the principal one. Some synthesis of the key moral concepts like that of Immanuel Kant is therefore recommended as the soundest and most widely acceptable basis for the necessary discussion. Defining the responsible use of human subjects covers a range of issues, moral, historical, legal and professional. For example, there may be ethical difficulties in deliberate damage induction as in SPF and irritancy testing. But above all, to avoid exploitation, there is a moral and also a legal requirement that subjects are truly volunteers. This is the basis of the concept of 'informed consent', required but not generally explained in current professional codes of practice. It is unjustified to exploit those who may be under duress, such as 'in-house volunteers' and those with low incomes. Hence in conclusion, criteria for obtaining valid informed consent are briefly reviewed. By considering issues such as these, we can help ensure that cosmetic scientists are true professionals, that is, those who recognise and are concerned with the ethical basis of their work.

[Ethical opinion survey on the periodical health examination among workers: privacy protection and informed consent on the information of the heath examination among workers in small and medium-sized enterprises].

PubMed

Takahashi, Norito; Fujino, Akihiro

2006-03-01

We investigated the ethical opinions concerning the information on legal regular health examinations with a questionnaire for 757 workers in enterprises that contracted a part-time occupational physician as there were no full-time occupational health professionals. Thirty to 50% of the workers answered that the information on their health examination was known to their superiors and their colleagues. Also, 20 to 40% of the workers answered that the information was made known to other people without obtaining their agreement. This tendency among the group of sick workers was stronger than in the group of healthy workers. On the other hand, the workers who suspected that the information on their health examination might be made available to other people exceeded the majority. In these enterprises, there seemed to be ethical problems from the point of the protection of privacy. It was also shown that the consideration of ethics concerning the protection of the privacy of the information on worker's health examinations was not high. However, it was suggested that the ethical opinion concerning worker's informed consent was high, as there were 85% or more workers who answered that agreement of the workers themselves was necessary for disclosing the information on their medical examination.

48 CFR 244.201-1 - Consent requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

....201-1 Consent requirements. In all solicitations and contracts involving the development or delivery of any information technology, whether acquired as a service or as a supply, consider the need for a...

The right to an heir in the era of assisted reproduction.

PubMed

Benshushan, A; Schenker, J G

1998-05-01

The latest remarkable technological advances in assisted reproduction, which enable cryopreservation of spermatozoa, embryos and ovarian tissue, raise difficult and debatable legal, social, ethical and moral issues concerning the right to posthumous reproduction. Furthermore, reports on the attitudes of the general public and of centres licensed for infertility treatment in the United Kingdom found that the majority of women and centres support the idea of posthumous reproduction. In this paper we review the data published on this issue, and after considering the various aspects, we conclude that each case should be discussed and authorized by a multidisciplinary committee that includes physicians, clergy, psychiatrists, psychologists, sociologists and other appropriate parties. In our opinion, the main principles that should guide this committee would allow posthumous reproduction in the context of marriage when a prior consent exists. For unmarried persons, post-mortem donation of gametes should be done only anonymously, if they are in agreement with existing laws concerning infertility treatments in every country and after appropriate consent and proper counselling. Moreover, any case which involves consanguinity or a possibility of incest should be forbidden, both for ethical and genetic reasons. In a case of pre-existing siblings, they should be consulted and their informed consent should be granted in advance so as to avoid legal problems in the inheritance of property.

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

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

PubMed Central

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

2012-01-01

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

Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

NASA Technical Reports Server (NTRS)

Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

2015-01-01

Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP-funded studies. The development of the Remote Consent process, the laws allowing transmission of consent via electronic means, total metrics to date, and remaining challenges (e.g., response issues, use of International Partner data, biospecimens/genetic data) for the research use of LSAH/LSDA data will be described.

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

PubMed Central

2013-01-01

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

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

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

Michael Kruzic

2007-09-01

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

Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

PubMed

Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

2017-04-01

Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

[Current legal framework conditions for running and utilization of biobanks: Part 3: ownership and rights of use].

PubMed

Haier, J

2014-10-01

The organizing institution of a biobank can be of public or private law in nature and the form can be freely selected. Biomaterials must be legally valued as objects whereby inalienable personality rights are still valid even if ownership is transferred. The treating physician does not automatically acquire a comprehensive right of ownership or utilization for the materials taken during the treatment. The biobank acquires tangible property and user rights on the samples by a legal agreement between the donor and the biobank. Reutilization clauses in submission contracts should not be used due to the danger of a formularization development and surprise clauses. During the processing of biomaterials within the biobank substantially new characteristics can appear which have an effect on ownership and commercialization rights. The donor does not have a utilization right in the sense of a patent or copyright. If there are changes in the legal form and the use by third parties, the declaration of consent by the donor remains fully effective. There are special risks for the donor if the biobank transfers these biomaterials. This must be clarified before finalizing the agreement on sample transference and utilization in the sense of an informed decision.

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

PubMed Central

Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

2015-01-01

Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions. PMID:26384724

Assessing usefulness and researcher satisfaction with consent form templates.

PubMed

Larson, Elaine L; Teller, Alan; Aguirre, Alejandra N; Jackson, Jhia; Meyer, Dodi

2017-08-01

We aimed to improve the research consenting process by developing and evaluating simplified consent forms. Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates. At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them ( p <0.001). Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 1 2013-04-01 2013-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 1 2014-04-01 2014-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

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

PubMed Central

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

2017-01-01

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

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2016-10-01

the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed

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.

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation

PubMed Central

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Objective To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. Setting We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants’ comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. Participants The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. Outcome measure The primary outcome measure was reliability and validity of the questionnaire. Results Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73–0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. Conclusions We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. PMID:24961716

Digitised audio questionnaire for assessment of informed consent comprehension in a low-literacy African research population: development and psychometric evaluation.

PubMed

Afolabi, Muhammed O; Bojang, Kalifa; D'Alessandro, Umberto; Ota, Martin O C; Imoukhuede, Egeruan B; Ravinetto, Raffaella; Larson, Heidi J; McGrath, Nuala; Chandramohan, Daniel

2014-06-24

To develop and psychometrically evaluate an audio digitised tool for assessment of comprehension of informed consent among low-literacy Gambian research participants. We conducted this study in the Gambia where a high illiteracy rate and absence of standardised writing formats of local languages pose major challenges for research participants to comprehend consent information. We developed a 34-item questionnaire to assess participants' comprehension of key elements of informed consent. The questionnaire was face validated and content validated by experienced researchers. To bypass the challenge of a lack of standardised writing formats, we audiorecorded the questionnaire in three major Gambian languages: Mandinka, Wolof and Fula. The questionnaire was further developed into an audio computer-assisted interview format. The digitised questionnaire was administered to 250 participants enrolled in two clinical trials in the urban and rural areas of the Gambia. One week after first administration, the questionnaire was readministered to half of the participants who were randomly selected. Participants were eligible if enrolled in the parent trials and could speak any of the three major Gambian languages. The primary outcome measure was reliability and validity of the questionnaire. Item reduction by factor analysis showed that 21 of the question items have strong factor loadings. These were retained along with five other items which were fundamental components of informed consent. The 26-item questionnaire has high internal consistency with a Cronbach's α of 0.73-0.79 and an intraclass correlation coefficient of 0.94 (95% CI 0.923 to 0.954). Hypotheses testing also showed that the questionnaire has a positive correlation with a similar questionnaire and discriminates between participants with and without education. We have developed a reliable and valid measure of comprehension of informed consent information for the Gambian context, which might be easily adapted to similar settings. This is a major step towards engendering comprehension of informed consent information among low-literacy participants. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

PubMed

Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

2017-02-01

Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.

Parental views on informed consent for expanded newborn screening.

PubMed

Moody, Louise; Choudhry, Kubra

2013-09-01

An increasing array of rare inherited conditions can be detected as part of the universal newborn screening programme. The introduction and evaluation of these service developments require consideration of the ethical issues involved and appropriate mechanisms for informing parents and gaining consent if required. Exploration of parental views is needed to inform the debate and specifically consider whether more flexible protocols are needed to fit with the public perception of new developments in this context. This study has been undertaken to explore perceptions and attitudes of parents and future parents to an expanded newborn screening programme in the United Kingdom and the necessary information provision and consent processes. A mixed methods study involving focus groups (n = 29) and a web-survey (n = 142) undertaken with parents and future parents. Parents want guaranteed information provision with clear decision-making powers and an awareness of the choices available to them. The difference between existing screening provision and expanded screening was not considered to be significant enough by participants to warrant formal written, informed consent for expanded screening. It is argued that the ethical review processes need to be more flexible towards the provision of information and consent processes for service developments in newborn screening. © 2011 John Wiley & Sons Ltd.

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

PubMed

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

2011-11-01

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

Environmental cleanup: The challenge at the Hanford Site, Washington, USA

NASA Astrophysics Data System (ADS)

Gray, Robert H.; Becker, C. Dale

1993-07-01

Numerous challenges face those involved with developing a coordinated and consistent approach to cleaning up the US Department of Energy’s (DOE) Hanford Site in southeastern Washington. These challenges are much greater than those encountered when the site was selected and the world’s first nuclear complex was developed almost 50 years ago. This article reviews Hanford’s history, operations, waste storage/disposal activities, environmental monitoring, and today’s approach to characterize and clean up Hanford under a Federal Facility Agreement and Consent Order, signed by DOE, the Environmental Protection Agency, and the Washington Sate Department of Ecology. Although cleanup of defense-related waste at Hanford holds many positive benefits, negative features include high costs to the US taxpayer, numerous uncertainties concerning the technologies to be employed and the risks involved, and the high probability that special interest groups and activists at large will never be completely satisfied. Issues concerning future use of the site, whether to protect and preserve its natural features or open it to public exploitation, remain to be resolved.

Strengthening Data Confidentiality and Integrity Protection in the Context of a Multi-Centric Information System Dedicated to Autism Spectrum Disorder.

PubMed

Ben Said, Mohamed; Robel, Laurence; Golse, Bernard; Jais, Jean Philippe

2017-01-01

Autism spectrum disorders (ASD) are complex neuro-developmental disorders affecting children in early age. Diagnosis relies on multidisciplinary investigations, in psychiatry, neurology, genetics, electrophysiology, neuro-imagery, audiology, and ophthalmology. To support clinicians, researchers, and public health decision makers, we developed an information system dedicated to ASD, called TEDIS. It was designed to manage systematic, exhaustive and continuous multi-centric patient data collection via secured internet connections. TEDIS will be deployed in nine ASD expert assessment centers in Ile-DeFrance district. We present security policy and infrastructure developed in context of TEDIS to protect patient privacy and clinical information. TEDIS security policy was organized around governance, ethical and organisational chart-agreement, patients consents, controlled user access, patients' privacy protection, constrained patients' data access. Security infrastructure was enriched by further technical solutions to reinforce ASD patients' privacy protection. Solutions were tested on local secured intranet environment and showed fluid functionality with consistent, transparent and safe encrypting-decrypting results.

A resolution expressing the sense of the Senate that effective sharing of passenger information from inbound international flight manifests is a crucial component of our national security and that the Department of Homeland Security must maintain the information sharing standards required under the 2007 Passenger Name Record Agreement between the United States and the European Union.

THOMAS, 112th Congress

Sen. Lieberman, Joseph I. [ID-CT

2011-05-09

Senate - 05/18/2011 Resolution agreed to in Senate without amendment and an amended preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

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

Girardot, Crystal L.; Harlow, Donald G.

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

Tank characterization report for single-shell tank 241-U-110. Revision 1

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

Brown, T.M.; Jensen, L.

1993-09-01

Tank 241-U-110 (U-110) is a Hanford Site waste tank that was ;most recently sampled in November and December 1989. Analysis of the samples obtained from tank U-110 was conducted to support the characterization of the contents of this tank and to support Hanford Federal Facility Agreement and Consent Order milestone M-10-00 (Ecology, et al. 1992). Because of incomplete recovery of the waste during sampling, there may be bias in the results of this characterization report.

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study.

PubMed

Parker, Melissa J; de Laat, Sonya; Schwartz, Lisa

2016-09-13

Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Qualitative research study involving individual interviews and grounded theory methodology. SDMs for children enrolled into the SQUEEZE pilot trial. Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Sub-orbital commercial human spaceflight and informed consent.

PubMed

Carminati, Maria-Vittoria; Griffith, Doug; Campbell, Mark R

2011-02-01

Commercial spaceflight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. Technical informed consent of spaceflight participants is required by the commercial spaceflight operator for regulatory purposes. Additionally, though not required by regulation, the aerospace medicine professional involved in the medical screening of both spaceflight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various federal and state regulations regarding informed consent for sub-orbital commercial spaceflight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

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

Children, biobanks and the scope of parental consent

PubMed Central

Hens, Kristien; Cassiman, Jean-Jacques; Nys, Herman; Dierickx, Kris

2011-01-01

The use of stored tissue samples from children for genetic research raises specific ethical questions that are not all analogous to those raised when adult participants are concerned. These include issues with regard to consent, as it is typically a parent who consents to the use of samples from children. In this paper, we discuss the scope of parental consent. This scope has a temporal dimension and one related to the content of consent. It is not questioned that the temporal scope of parental consent is limited and that young adults have the right to decide on the fate of their samples when they reach the age of maturity. With regard to the content of consent, the question remains whether parents are allowed to give full broad consent to any possible future research on the samples of their children. We argue that they should not be allowed to do so, based on two premises. First, it is generally acknowledged that children have a right to express their own values and that they should be given the opportunity to develop their own autonomy as they grow older. Second, research and science are not completely value-free and some types of research may be more sensitive than other types. Children should be given the opportunity to express their values also in this respect. PMID:21386873

Gene co-ops and the biotrade: translating genetic resource rights into sustainable development.

PubMed

Reid, W V

1996-04-01

The 1992 Convention on Biological Diversity marks a basic change in the international status of genetic resources. Prior to the Convention, these resources were considered to be the "heritage of mankind.' Although the intent of this open access regime was to ensure the widespread availability of genetic resources for agriculture and industry, commercial use of the resources provided no additional economic incentive for conservation by source countries. The Biodiversity Convention corrects this policy failure by establishing that states have sovereign rights over their genetic resources, thereby enabling market incentives to complement various multilateral mechanisms that might directly fund biodiversity conservation. A number of obstacles face countries that are translating this broad right to regulate access into specific policies, laws, and regulations designed to meet conservation and development objectives. A review of these obstacles and of trends in technological development suggest that nations and developing country institutions should take a set of actions to develop access legislation and Material Transfer Agreements, establish biodiversity "cooperatives' and intermediary institutions to facilitate information exchange, develop minimum standards for access legislation, and require that prior informed consent of local communities be obtained by all biodiversity collectors.

Informed consent in the context of pharmacogenomic research: ethical considerations.

PubMed

Howard, H C; Joly, Y; Avard, D; Laplante, N; Phillips, M; Tardif, J C

2011-06-01

Although the scientific research surrounding pharmacogenomics (PGx) has been relatively plentiful, the ethical research concerning this discipline has developed rather conservatively. Following investigation of the ethical, legal and social issues (ELSI) of PGx research, as well as consulting with key stakeholders, we identified six outstanding ethical issues raised by the informed consent process in PGx research: (1) scope of consent; (2) consent to 'add-on' studies; (3) protection of personal information; (4) commercialization; (5) data sharing; and (6) potential risks stemming from population-based research. In discussing these six areas as well as offering specific considerations, this article offers a solid base from which future practical guidelines for informed consent in PGx research can be constructed. As such, this effort works toward filling the ELSI gap and provides ethical support to the numerous PGx projects undertaken by researchers every year.

Legal protection of informed consent of minors.

PubMed

Osuna, Eduardo

2010-06-01

One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

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

PubMed

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

2017-05-01

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

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

PubMed

Irabor, David O; Omonzejele, Peter

2009-04-01

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

Questionnaire on Brain Death and Organ Procurement.

PubMed

Hammad, Saleh; Alnammourah, Manal; Almahmoud, Farah; Fawzi, Mais; Breizat, Abdel-Hadi

2017-02-01

The subject of organs for transplant after brain death raises many concerns, including definition and timing of death, how to permit human organ transplant, and the idea of paying for organs. Many ethical concerns are raised regarding regulations and procedures for organ transplant in developing countries. These include where and how to obtain organs and the concept of justice in organ distribution. We administered 2682 questionnaires to 628 men and 2054 women over 24 months (range, 18 to 70 years old). We included people from universities, colleges, and the general public and asked questions on the circumstances of death, the conditions of conversations around organ donation, and reasons for acceptance or refusal of donation. The identical questionnaire, consisting of 8 questions, was administered twice: before and after a teaching session on brain death and organ procurement. The study was approved by our Ethical Review Committee and in accordance with the ethical guidelines of the 1975 Helsinki Declaration. Written informed consent was obtained from all participants. We found that 72.1% understood brain death in the prequestionnaire and 88% understood brain death in the postquestionnaire, with 63.8% versus 68% accepting the concept of brain death, 50.6% versus 58.3% thinking that their religion is against brain death, 11.3% versus 11.3% carrying a donor card, 50.7% versus 58.9% wanting to carry a donor card, 46.4% versus 56.4% agreeing to give consent for organ donation if a relative was diagnosed with brain death, 28.3% versus 50% aware of the laws and regulations concerning brain death and organ donation and transplant in Jordan, and 35.4% versus 40% in agreement with the Presumed Consent Law, respectively. In Jordan, along with legal requirements concerning brain death and organ donation and transplant, there is a lack of acceptance of organ donation after brain death, necessitating further work and activities to achieve self-sufficiency from donated organs.

Saudi mothers' preferences about breaking bad news concerning newborns: a structured verbal questionnaire

PubMed Central

2011-01-01

Background Breaking bad news (BBN) to parents whose newborn has a major disease is an ethical dilemma. In Saudi Arabia, BBN about newborns is performed according to the parental preferences that have been reported from non-Arabic/non-Islamic countries. Saudi mothers' preferences about BBN have not yet been studied. Therefore, we aimed to elicit the preferences of Saudi mothers about BBN concerning newborns. Methods We selected a convenience sample of 402 Saudi mothers, aged 18-50 years, who had no previous experience with BBN. We selected them via a simple number-randomization scheme from the premises of a level III Saudi hospital between October of 2009 and January of 2011. We used a hypothetical situation (BBN about trisomy 21) to elicit their preferences about BBN concerning newborns via a structured verbal questionnaire composed of 12 multiple-choice questions. We expressed their preferences as percentages (95% confidence interval), and we used the Kendall's W test (W) to assess the degree of agreement in preferences. Results The Saudi mothers preferred that BBN be conducted with both parents together (64% [60-69]), albeit with weak levels of agreement (W = 0.29). They showed moderate agreement in their preferences that BBN should be conducted early (79% [75-83], W = 0.48), in detail (81% [77-85], W = 0.52), in person (88% [85-91], W = 0.58), and in a quiet setting (86% [83-90], W = 0.53). With extremely weak agreement, they preferred to have a known person present for support during BBN (56% [51-61], W = 0.01), to have close bodily contact with their babies (66% [61-70], W = 0.10), and to have no another patients present (64% [59-68], W = 0.08). They showed moderate levels of agreement in their desires to detail, in advance, their preferences about process of BBN by giving a reversible, written informed consent that could be utilized for guidance, if needed (80% [76-84], W = 0.36). Conclusions In our experience, Saudi mothers' preferences about BBN concerning newborns are varied, suggesting that a "one-size-fits-all" approach is inappropriate. A reversible, written informed consent detailing their preferences about BBN that would be kept in their medical records and utilized for guidance, if needed, may be the best solution, given this level of diversity. These findings merit further study. PMID:21861876

Current practice and recommendations in UK epilepsy monitoring units. Report of a national survey and workshop.

PubMed

Hamandi, Khalid; Beniczky, Sandor; Diehl, Beate; Kandler, Rosalind H; Pressler, Ronit M; Sen, Arjune; Solomon, Juliet; Walker, Matthew C; Bagary, Manny

2017-08-01

Inpatient video-EEG monitoring (VEM) is an important investigation in patients with seizures or blackouts, and in the pre-surgical workup of patients with epilepsy. There has been an expansion in the number of Epilepsy Monitoring Units (EMU) in the UK offering VEM with a necessary increase in attention on quality and safety. Previous surveys have shown variation across centres on issues including consent and patient monitoring. In an effort to bring together healthcare professionals in the UK managing patients on EMU, we conducted an online survey of current VEM practice and held a one-day workshop convened under the auspices of the British Chapter of the ILAE. The survey and workshop aimed to cover all aspects of VEM, including pre-admission, consent procedures, patient safety, drug reduction and reinstatement, seizure management, staffing levels, ictal testing and good data recording practice. This paper reports on the findings of the survey, the workshop presentations and workshop discussions. 32 centres took part in the survey and there were representatives from 22 centres at the workshop. There was variation in protocols, procedures and consent processes between units, and levels of observation of monitored patients. Nevertheless, the workshop discussion found broad areas of agreement on points. A survey and workshop of UK epilepsy monitoring units found that some variability in practice is inevitable due to different local arrangements and patient groups under investigation. However, there were areas of clear consensus particularly in relation to consent and patient safety that can be applied to most units and form a basis for setting minimum standards. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Consenting to invasive contraceptives: an ethical analysis of adolescent decision-making authority for long-acting reversible contraception.

PubMed

Behmer Hansen, Rosemary Talbot; Arora, Kavita Shah

2018-06-14

Since USA constitutional precedent established in 1976, adolescents have increasingly been afforded the right to access contraception without first obtaining parental consent or authorisation. There is general agreement this ethically permissible. However, long-acting reversible contraception (LARC) methods have only recently been prescribed to the adolescent population. They are currently the most effective forms of contraception available and have high compliance and satisfaction rates. Yet unlike other contraceptives, LARCs are associated with special procedural risks because they must be inserted and removed by trained healthcare providers. It is unclear whether the unique invasive nature of LARC changes the traditional ethical calculus of permitting adolescent decision-making in the realm of contraception. To answer this question, we review the risk-benefit profile of adolescent LARC use. Traditional justifications for permitting adolescent contraception decision-making authority are then considered in the context of LARCs. Finally, analogous reasoning is used to evaluate potential differences between permitting adolescents to consent for LARC procedures versus for emergency and pregnancy termination procedures. Ultimately, we argue that the invasive nature of LARCs does not override adolescents' unique and compelling need for safe and effective forms of contraception. In fact, LARCs may oftentimes be in the best interest of adolescent patients who wish to prevent unintended pregnancy. We advocate for the specific enumeration of adolescents' ability to consent to both LARC insertion and removal procedures within state policies. Given the provider-dependent nature of LARCs and the stigma regarding adolescent sexuality, special political and procedural safeguards to protect adolescent autonomy are warranted. © 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.

Consent for third molar tooth extractions in Australia and New Zealand: a review of current practice.

PubMed

Badenoch-Jones, E K; Lynham, A J; Loessner, D

2016-06-01

Informed consent is the legal requirement to educate a patient about a proposed medical treatment or procedure so that he or she can make informed decisions. The purpose of the study was to examine the current practice for obtaining informed consent for third molar tooth extractions (wisdom teeth) by oral and maxillofacial surgeons in Australia and New Zealand. An online survey was sent to 180 consultant oral and maxillofacial surgeons in Australia and New Zealand. Surgeons were asked to answer (yes/no) whether they routinely warned of a specific risk of third molar tooth extraction in their written consent. Seventy-one replies were received (39%). The only risks that surgeons agreed should be routinely included in written consent were a general warning of infection (not alveolar osteitis), inferior alveolar nerve damage (temporary and permanent) and lingual nerve damage (temporary and permanent). There is significant variability among Australian and New Zealand oral and maxillofacial surgeons regarding risk disclosure for third molar tooth extractions. We aim to improve consistency in consent for third molar extractions by developing an evidence-based consent form. © 2016 Australian Dental Association.

Public preferences on written informed consent for low‐risk pragmatic clinical trials in Spain

PubMed Central

Carcas, Antonio J.; Carné, Xavier; Wendler, David

2017-01-01

Aims Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low‐risk pRCTs. The present study was designed to assess whether this view is specific to the US. Methods The study took the form of a cross‐sectional, probability‐based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low‐risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. Results A total of 2008 adults sampled from a probability‐based online panel responded to the web‐based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7–37.1%) than the alternative of verbal consent (12.7–14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. Conclusions The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low‐risk pRCTs. PMID:28419518

Development of a consent resource for genomic data sharing in the clinical setting.

PubMed

Riggs, Erin Rooney; Azzariti, Danielle R; Niehaus, Annie; Goehringer, Scott R; Ramos, Erin M; Rodriguez, Laura Lyman; Knoppers, Bartha; Rehm, Heidi L; Martin, Christa Lese

2018-06-13

Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing. To determine whether the consent form and video accurately conveyed key data sharing concepts, we surveyed 5,162 members of the general public. We measured comprehension at baseline, after reading the form and watching the video. Additionally, we assessed participants' attitudes toward genomic data sharing. Participants' performance on comprehension questions significantly improved over baseline after reading the form and continued to improve after watching the video. Results suggest reading the form alone provided participants with important knowledge regarding broad data sharing, and watching the video allowed for broader comprehension. These materials are now available at http://www.clinicalgenome.org/share . These resources will provide patients a straightforward way to share their genetic and health information, and improve the scientific community's access to data generated through routine healthcare.

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

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

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

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

Compliance program data management system for The Idaho National Engineering Laboratory/Environmental Protection Agency

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

Hertzler, C.L.; Poloski, J.P.; Bates, R.A.

1988-01-01

The Compliance Program Data Management System (DMS) developed at the Idaho National Engineering Laboratory (INEL) validates and maintains the integrity of data collected to support the Consent Order and Compliance Agreement (COCA) between the INEL and the Environmental Protection Agency (EPA). The system uses dBase III Plus programs and dBase III Plus in an interactive mode to enter, store, validate, manage, and retrieve analytical information provided on EPA Contract Laboratory Program (CLP) forms and CLP forms modified to accommodate 40 CFR 264 Appendix IX constituent analyses. Data analysis and presentation is performed utilizing SAS, a statistical analysis software program. Archivingmore » of data and results is performed at appropriate stages of data management. The DMS is useful for sampling and analysis programs where adherence to EPA CLP protocol, along with maintenance and retrieval of waste site investigation sampling results is desired or requested. 3 refs.« less

Legal regulation of surrogate motherhood in Israel.

PubMed

Frenkel, D A

2001-01-01

The Israeli Law on surrogate motherhood demands a preconception agreement to include payments to be made to the surrogate mother. Surrogacy arrangements with family members are forbidden. Commercial surrogacy is allowed and encouraged. The Law causes many problems. Validity of consent given by surrogate mothers is doubtful. Possible future psychological harm are ignored. There is a danger of "commodification" of children. Abusing women of low socio-economic status as breeding machines may be another outcome. No clear responsibility is imposed on the "intended parents" for an impaired child. The law ignores possibility of divorce or death of the "intended parents" before the child's birth. Splitting motherhood is another social problem that has to be dealt with. So far the sperm of the husband from the "intended parents" has to be used, but further steps may follow. It is not certain that a policy of "positive eugenics" will not develop.

TWRS Retrieval and Storage Mission and Immobilized Low Activity Waste (ILAW) Disposal Plan

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

BURBANK, D.A.

This project plan has a twofold purpose. First, it provides a waste stream project plan specific to the River Protection Project (RPP) (formerly the Tank Waste Remediation System [TWRS] Project) Immobilized Low-Activity Waste (LAW) Disposal Subproject for the Washington State Department of Ecology (Ecology) that meets the requirements of Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-90-01 (Ecology et al. 1994) and is consistent with the project plan content guidelines found in Section 11.5 of the Tri-Party Agreement action plan (Ecology et al. 1998). Second, it provides an upper tier document that can be used as themore » basis for future subproject line-item construction management plans. The planning elements for the construction management plans are derived from applicable U.S. Department of Energy (DOE) planning guidance documents (DOE Orders 4700.1 [DOE 1992] and 430.1 [DOE 1995a]). The format and content of this project plan are designed to accommodate the requirements mentioned by the Tri-Party Agreement and the DOE orders. A cross-check matrix is provided in Appendix A to explain where in the plan project planning elements required by Section 11.5 of the Tri-Party Agreement are addressed.« less

Clinical genomics, big data, and electronic medical records: reconciling patient rights with research when privacy and science collide.

PubMed

Kulynych, Jennifer; Greely, Henry T

2017-04-01

Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data 'de-identified', removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic 'personalized medicine' now confront the problem of governing the secondary use of clinical genomic data as privacy risks escalate. We argue that regulators should no longer permit HIPAA-covered entities to treat dense genomic data as de-identified health information. Even with this step, the Privacy Rule would still permit disclosure of clinical genomic data for research, without consent, under a data use agreement, so we also urge that providers give patients specific notice before disclosing clinical genomic data for research, permitting (where possible) some degree of choice and control. To aid providers who offer clinical gene sequencing, we suggest both general approaches and specific actions to reconcile patients' rights and interests with genomic research.

Clinical genomics, big data, and electronic medical records: reconciling patient rights with research when privacy and science collide

PubMed Central

Greely, Henry T.

2017-01-01

Abstract Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data ‘de-identified’, removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic ‘personalized medicine’ now confront the problem of governing the secondary use of clinical genomic data as privacy risks escalate. We argue that regulators should no longer permit HIPAA-covered entities to treat dense genomic data as de-identified health information. Even with this step, the Privacy Rule would still permit disclosure of clinical genomic data for research, without consent, under a data use agreement, so we also urge that providers give patients specific notice before disclosing clinical genomic data for research, permitting (where possible) some degree of choice and control. To aid providers who offer clinical gene sequencing, we suggest both general approaches and specific actions to reconcile patients’ rights and interests with genomic research. PMID:28852559

Informed consent and the law--an English legal perspective.

PubMed

Hassan, Majid

2008-01-01

'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

Chemically dependent physicians and informed consent disclosure.

PubMed

Ackerman, T F

1996-01-01

Developments in law, professional guidelines, and public attitudes support informed consent disclosure by physicians who have been treated for chemical dependency. This view is built on the apparent materiality of the risk of relapse to informed treatment decisions by patients. Several considerations undercut this position. The probability is remote that a patient will be injured by a recovering physician who suffers an undetected relapse while being properly monitored. Monitoring by impaired physicians programs provides a more sensitive and specific mechanism for detecting relapsed physicians. Moreover, compromise of the privacy and employment rights of recovering physicians by consent disclosure is not justified if programs provide rigorous monitoring that protects the welfare of patients. Finally, required consent disclosure will reduce referrals of chemically dependent physicians to impaired physicians programs, thereby increasing the danger to patients. Limiting demands for required consent disclosure necessitates effective operation of impaired physicians programs.

Pharmaceutical information systems and possible implementations of informed consent -- developing an heuristic.

PubMed

Ploug, Thomas; Holm, Søren

2012-11-16

Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system.The danger of routinisation of consent is identified.The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent.

Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India.

PubMed

Yousuf, R M; Fauzi, A R M; How, S H; Rasool, A G; Rehana, K

2007-06-01

Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries. The objective of this descriptive study was to evaluate the perceptions and practices among attending medical professionals in matters relating to informed consent in selected hospitals. A questionnaire-based cross sectional survey among doctors in the two tertiary care hospitals, one in Malaysia and the other in Kashmir, was performed. Awareness on informed consent was universal with "reasonable physician standard" as the most popular choice. As compared to doctors in Malaysia, doctors from Kashmir showed a tendency to reservedly disclose medical information (p-value equals 0.051) and withhold it, if it was deemed potentially harmful (p-value is less than 0.001) or requested so by relatives (p-value is less than 0.023). They also withheld some information from female patients (p-value is less than 0.001). When consent was refused despite needing lifesaving intervention, the majority of both respondents (73 percent versus 80 percent) considered intervention without consent to be justified. Respondents from Malaysia felt that parents could refuse treatment on their children's behalf on the basis of their beliefs (p-value is less than 0.001). Despite a very high awareness of informed consent, the model chosen reflected age-old medical paternalism. Doctors' opinions are accorded a larger role in clinical decision-making in Kashmir. The results emphasise the need for doctors to change their attitude and acknowledge the patient's autonomy, which is the basis of modern medical ethics, and yet still be aware of the cultural and religious views of the local population.

Legal briefing: informed consent in the clinical context.

PubMed

Pope, Thaddeus Mason; Hexum, Melinda

2014-01-01

This issue's "Legal Briefing" column covers recent legal developments involving informed consent.1 We covered this topic in previous articles in The Journal of Clinical Ethics.2 But an updated discussion is warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. We categorize recent legal developments into the following 13 categories: (1) Medical Malpractice Liability, (2) Medical Malpractice Liability in Wisconsin, (3) Medical Malpractice Liability in Novel Situations, (4) Enforcement by Criminal Prosecutors, (5) Enforcement by State Medical Boards, (6) Enforcement through Anti-Discrimination Laws, (7) Statutorily Mandated Disclosures Related to End-of-Life Counseling, (8) Statutorily Mandated Disclosures Related to Aid in Dying, (9) Statutorily Mandated Disclosures Related to Abortion, (10) Statutorily Mandated Disclosures Related to Telemedicine, (11) Statutorily Mandated Disclosures Related to Other Interventions, (12) Statutorily Mandated Gag and Censorship Laws, (13) Informed Consent in the Research Context. Copyright 2014 The Journal of Clinical Ethics. All rights reserved.

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

PubMed

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D'Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-04-05

International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

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

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

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

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

1998 report on Hanford Site land disposal restrictions for mixed waste

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

Black, D.G.

1998-04-10

This report was submitted to meet the requirements of Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement) Milestone M-26-01H. This milestone requires the preparation of an annual report that covers characterization, treatment, storage, minimization, and other aspects of managing land-disposal-restricted mixed waste at the Hanford Facility. The US Department of Energy, its predecessors, and contractors on the Hanford Facility were involved in the production and purification of nuclear defense materials from the early 1940s to the late 1980s. These production activities have generated large quantities of liquid and solid mixed waste. This waste is regulated under authority of bothmore » the Resource Conservation and Recovery Act of l976 and the Atomic Energy Act of 1954. This report covers only mixed waste. The Washington State Department of Ecology, US Environmental Protection Agency, and US Department of Energy have entered into the Tri-Party Agreement to bring the Hanford Facility operations into compliance with dangerous waste regulations. The Tri-Party Agreement required development of the original land disposal restrictions (LDR) plan and its annual updates to comply with LDR requirements for mixed waste. This report is the eighth update of the plan first issued in 1990. The Tri-Party Agreement requires and the baseline plan and annual update reports provide the following information: (1) Waste Characterization Information -- Provides information about characterizing each LDR mixed waste stream. The sampling and analysis methods and protocols, past characterization results, and, where available, a schedule for providing the characterization information are discussed. (2) Storage Data -- Identifies and describes the mixed waste on the Hanford Facility. Storage data include the Resource Conservation and Recovery Act of 1976 dangerous waste codes, generator process knowledge needed to identify the waste and to make LDR determinations, quantities stored, generation rates, location and method of storage, an assessment of storage-unit compliance status, storage capacity, and the bases and assumptions used in making the estimates.« less

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

PubMed Central

Vučemilo, Luka; Borovečki, Ana

2015-01-01

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

HANFORD SITE CENTRAL PLATEAU CLEANUP COMPLETION STRATEGY

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

BERGMAN TB

2011-01-14

Cleanup of the Hanford Site is a complex and challenging undertaking. The U.S. Department of Energy (DOE) has developed a comprehensive vision for completing Hanford's cleanup mission including transition to post-cleanup activities. This vision includes 3 principle components of cleanup: the {approx}200 square miles ofland adjacent to the Columbia River, known as the River Corridor; the 75 square miles of land in the center of the Hanford Site, where the majority of the reprocessing and waste management activities have occurred, known as the Central Plateau; and the stored reprocessing wastes in the Central Plateau, the Tank Wastes. Cleanup of themore » River Corridor is well underway and is progressing towards completion of most cleanup actions by 2015. Tank waste cleanup is progressing on a longer schedule due to the complexity of the mission, with construction of the largest nuclear construction project in the United States, the Waste Treatment Plant, over 50% complete. With the progress on the River Corridor and Tank Waste, it is time to place increased emphasis on moving forward with cleanup of the Central Plateau. Cleanup of the Hanford Site has been proceeding under a framework defmed in the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement). In early 2009, the DOE, the State of Washington Department of Ecology, and the U.S. Environmental Protection Agency signed an Agreement in Principle in which the parties recognized the need to develop a more comprehensive strategy for cleanup of the Central Plateau. DOE agreed to develop a Central Plateau Cleanup Completion Strategy as a starting point for discussions. This DOE Strategy was the basis for negotiations between the Parties, discussions with the State of Oregon, the Hanford Advisory Board, and other Stakeholder groups (including open public meetings), and consultation with the Tribal Nations. The change packages to incorporate the Central Plateau Cleanup Completion Strategy were signed by the Parties on October 26,2010, and are now in the process of being implemented.« less

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.

PubMed

Wilman, E; Megone, C; Oliver, S; Duley, L; Gyte, G; Wright, J M

2015-11-04

Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials? A systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature. Between them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent. Despite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.

Ethics in international health research: a perspective from the developing world.

PubMed Central

Bhutta, Zulfiqar Ahmed

2002-01-01

Health research plays a pivotal role in addressing inequities in health and human development, but to achieve these objectives the research must be based on sound scientific and ethical principles. Although it is accepted that ethics play a central role in health research in developing countries, much of the recent debate has focused on controversies surrounding internationally sponsored research and has taken place largely without adequate participation of the developing countries. The relationship between ethical guidelines and regulations, and indigenously sponsored and public health research has not been adequately explored. For example, while the fundamental principles of ethical health research, such as community participation, informed consent, and shared benefits and burdens, remain sacrosanct other issues, such as standards of care and prior agreements, merit greater public debate within developing countries. In particular, the relationship of existing ethical guidelines to epidemiological and public health research merits further exploration. In order to support health research in developing countries that is both relevant and meaningful, the focus must be on developing health research that promotes equity and on developing local capacity in bioethics. Only through such proactive measures can we address the emerging ethical dilemmas and challenges that globalization and the genomics revolution will bring in their wake. PMID:11953789

Sub-orbital commercial Human space flight and informed consent in the United States

NASA Astrophysics Data System (ADS)

Carminati, Maria-Vittoria « Giugi »; Griffith, Doug; Campbell, Mark R.

2013-12-01

Commercial space flight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. In the United States, technical informed consent of space flight participants is required by the commercial space flight operator for regulatory purposes. Additionally, though not required by U.S. regulation, the aerospace medicine professional involved in the medical screening of both space flight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various US federal and state regulations regarding informed consent for sub-orbital commercial space flight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

Evaluation of image quality of digital photo documentation of female genital injuries following sexual assault.

PubMed

Ernst, E J; Speck, Patricia M; Fitzpatrick, Joyce J

2011-12-01

With the patient's consent, physical injuries sustained in a sexual assault are evaluated and treated by the sexual assault nurse examiner (SANE) and documented on preprinted traumagrams and with photographs. Digital imaging is now available to the SANE for documentation of sexual assault injuries, but studies of the image quality of forensic digital imaging of female genital injuries after sexual assault were not found in the literature. The Photo Documentation Image Quality Scoring System (PDIQSS) was developed to rate the image quality of digital photo documentation of female genital injuries after sexual assault. Three expert observers performed evaluations on 30 separate images at two points in time. An image quality score, the sum of eight integral technical and anatomical attributes on the PDIQSS, was obtained for each image. Individual image quality ratings, defined by rating image quality for each of the data, were also determined. The results demonstrated a high level of image quality and agreement when measured in all dimensions. For the SANE in clinical practice, the results of this study indicate that a high degree of agreement exists between expert observers when using the PDIQSS to rate image quality of individual digital photographs of female genital injuries after sexual assault. © 2011 International Association of Forensic Nurses.

MEDICAL PRIVACY REGULATION: Questions Remain About Implementing the New Consent Requirement

DTIC Science & Technology

2001-04-01

1996 called for the development of comprehensive privacy standards that would establish rights for patients with respect to their medical records and...Project MGMA Medical Group Management Association Contents Page 1 GAO-01-584 Patient Consent April 6, 2001 The Honorable James M. Jeffords Chairman...of 1996 called for the development of comprehensive privacy standards that would establish rights for patients with respect to their medical records

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.

Medicaid Consent to Sterilization forms: historical, practical, ethical, and advocacy considerations.

PubMed

Block-Abraham, Dana; Arora, Kavita S; Tate, Danielle; Gee, Rebekah E

2015-06-01

The US government developed a Medicaid Consent to Sterilization form in the mid-1970s to protect vulnerable populations from coerced sterilization. US health care practices have evolved significantly since that time. The form, however, has not changed, and may be preventing access to desired services for the same vulnerable populations it was originally created to protect. This paper discusses the relevant historical, practical use, ethical, and advocacy considerations of the Medicaid sterilization consent form and proposes changes to make the form more pertinent to today's medical environment.

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

PubMed Central

2012-01-01

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

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

PubMed

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

2012-07-20

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

Survey of risks and benefits communication strategies by research nurses.

PubMed

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

2017-01-01

An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking "accept" on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process.

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

PubMed

Rosen, Allyson; Weitlauf, Julie C

2015-01-01

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

[Acute scrotal pain in childhood: legal pitfalls].

PubMed

Bader, Pia; Hugemann, Christoph; Frohneberg, Detlef

2017-12-01

Acute scrotal pain in childhood is an emergency.Sudden scrotal pain may be caused by a variety of diseases. Therefore, it is important to carefully consider the specific medical history and possible differential diagnoses in each case for fast and decisive action (e. g. in case of testicular torsion). As minors lack the capacity for consent, it is absolutely necessary to obtain consent from their legal guardian. However, obtaining consent in the available time frame can cause organisational challenges in an acute emergency, which may lead to situations in the daily routine where a therapeutic decision needs to be taken (including surgery) without legal security based on consent by the guardian. In some cases, the child's consent also needs to be taken into account, depending on its age and development.For the physician and surgeon in charge, the legal evaluation of the case at hand and therewith the obtainment of legal security are of great significance. © Georg Thieme Verlag KG Stuttgart · New York.

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning.

PubMed

Klein, Eran

2016-10-01

Implantable brain-computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified-short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains-risks pertaining to identity, agency, and stigma-are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.

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

PubMed

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

2003-02-01

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

In new territory: consent and the extended duties dental nurse.

PubMed

Elsden, Jacqui

2015-02-01

With the introduction of direct access to treatment from dental care professionals (DCPs) in 2013, dental nurses are being trained to support the wider dental team in a number of additional skills. The name for this expanded team role is Extended Duties Dental Nurse (EDDN). These new duties take the EDDN into new territories, one of which includes the issue of consent. This article explains the background to direct access and the extra responsibilities for EDDNs in terms of consent and indemnity. It explores the new knowledge required to gain valid consent and presents a scenario for consideration. The article concludes that it is important for EDDNs to develop their professional approach, taking early advice from the referring dentist and/or professional indemnity adviser if faced with an unfamiliar scenario.

Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic

PubMed Central

2012-01-01

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. PMID:23157854

Consent to medical research of vulnerable subjects from the French point of view: the example of consent in research in the case of Alzheimer disease.

PubMed

Duguet, Anne-Marie; Boyer-Beviere, Bénédicte

2011-12-01

The consent to research is the expression of autonomy. Some groups are vulnerable and cannot give free consent because their conditions limit their decision making or because they are unable to consent themselves (minor, incompetent adults). International standards and recommendations for medical research protect vulnerable subjects (article 17 of the Helsinki declaration, guidelines 9 and 13 of the CIOMS, article 17 of the Oviedo Convention). French Law protects mostly three categories of vulnerable people: minors, adults with a legal representative, and the people living in sanitary and social establishments. Specific protection is given as well to pregnant women, detainees and persons with psychiatric disorders in involuntary commitment. From the example of research with Alzheimer patients the authors show the original provisions of French legislation to involve in medical research incompetent patients with or without legal protection. Clinical research on Alzheimer's disease poses challenges as never before to research ethics. In fact, the development of the disease progressively reduces the patient's ability to make choices: the latter is no longer capable, but is not totally incapacitated. Several solutions are offered for a "proxy" consent or authorisation.

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

PubMed Central

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire. Results The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Conclusions Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings. PMID:25133065

Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN60695184 (date of registration: 13 May 2009), ISRCTN80061723 (date of registration: 8 March 2010), ISRCTN69423238 (date of registration: 18 November 2010).

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.

Corrective Action Decision Document for Corrective Action Unit 340: Pesticide Release sites, Nevada Test Site, Nevada

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

DOE /NV

This Corrective Action Decision Document has been prepared for Corrective Action Unit 340, the NTS Pesticide Release Sites, in accordance with the Federal Facility Agreement and Consent Order of 1996 (FFACO, 1996). Corrective Action Unit 340 is located at the Nevada Test Site, Nevada, and is comprised of the following Corrective Action Sites: 23-21-01, Area 23 Quonset Hut 800 Pesticide Release Ditch; 23-18-03, Area 23 Skid Huts Pesticide Storage; and 15-18-02, Area 15 Quonset Hut 15-11 Pesticide Storage. The purpose of this Corrective Action Decision Document is to identify and provide a rationale for the selection of a recommended correctivemore » action alternative for each Corrective Action Site. The scope of this Corrective 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; and Recommend and justify a preferred corrective action alternative for each Corrective Action Site.« less

The Ethics of Stem Cell-Based Aesthetic Surgery: Attitudes and Perceptions of the Plastic Surgery Community.

PubMed

Nayar, Harry S; Caplan, Arthur L; Eaves, Felmont F; Rubin, J Peter

2014-08-01

The emerging field of stem cell-based aesthetics has raised ethical concerns related to advertising campaigns and standards for safety and efficacy. The authors sought to characterize the attitudes of plastic surgeons regarding the ethics of stem cell-based aesthetics. A cross-sectional electronic survey was distributed to 4592 members of the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons. Statements addressed ethical concerns about informed consent, conflicts of interest, advertising, regulation, and stem cell tourism. An agreement score (AS) from 0 to 100 was calculated for each statement. Majority agreement was designated as ≥60 and majority disagreement as ≤40. A total of 770 questionnaires were received (16.7%). The majority of respondents indicated that knowledge regarding the risks and benefits of stem cell procedures is insufficient to obtain valid informed consent (AS, 29) and that direct-to-consumer advertising for these technologies is inappropriate and unethical (AS, 23). Most respondents reported that patients should be actively warned against traveling abroad to receive aesthetic cell therapies (AS, 86) and that registries and evaluations of these clinics should be made publicly available (AS, 71). Even more respondents noted that financial conflicts of interest should be disclosed to patients (AS, 96) and that professional societies should participate in establishing regulatory standards (AS, 93). The plastic surgeons surveyed in this study support a well-regulated, evidence-based approach to aesthetic procedures involving stem cells. © 2014 The American Society for Aesthetic Plastic Surgery, Inc.

[Presumptive organ donations for transplants agreement of the Ethics Committee of the University of Chile Medical School].

PubMed

Roa, A; Rosselot, E

1995-04-01

The ethics committee of the Faculty of Medicine, University of Chile was consulted about the ethical aspects of presumptive organ donation for transplantation. After analyzing the problem, the committee concluded that every human being has the right to make use of his organs freely, voluntarily and according to his own discernment. The society has no right to make obligatory this donation, even after death. The foundations of this agreement were laid in a series of reasons. In fact, the corpse is not a juridical but a ethical asset and deserves respect for whom it was. It cannot be commercialized and is the only non-religious object susceptible of profanation. It is also object of popular affective and religious manifestations. Beliefs and affects must be respected. Organ donation is an act of charity and cannot be compulsory. The organ donation consent must be explicit, voluntary and solemn.

Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

PubMed

Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

2013-01-30

Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.

[Provision of information to patients. Legal and humanitarian requirements].

PubMed

Schara, J; Brandt, L

2008-09-01

Any treatment to which the patient has not expressly consented constitutes an assault according to our legal system. The patient's agreement is therefore necessary for every elective treatment. Patients cannot give meaningful consent until they have received detailed information on their illness, its presumed course, the treatment options and the risks they are exposed to both with and without treatment. This requires provision of information to allow self-determination. The requirement for the patient alone to make decisions arises from the personal rights in our [German] Constitution. If the information provided has been inadequate the doctor is liable for all negative-including life-changing-consequences, regardless of whether or not the risk that has been realised is one that is expressly required to be explained. The Federal Court of Justice requires the doctor to address each patient's personality and their fate when providing information (BGH, NHW 1983, 328, 329). It is not permissible for the duty to provide information to be delegated to a third party unless strict obligations are fulfilled (BGH 7.11.2006 VI ZR 206/05).

[Provision of information to patients - legal and humanitarian requirements].

PubMed

Schara, J; Brandt, L

2008-02-01

Any treatment to which the patient has not expressly consented constitutes an assault according to our legal system. The patient's agreement is therefore necessary for every elective treatment. Patients cannot give meaningful consent until they have received detailed information on their illness, its presumed course, the treatment options and the risks they are exposed to both with and without treatment. This requires provision of information to allow self-determination. The requirement for the patient alone to make decisions arises from the personal rights in our [German] Constitution. If the information provided has been inadequate the doctor is liable for all negative-including life-changing-consequences, regardless of whether or not the risk that has been realised is one that is expressly required to be explained. The Federal Court of Justice requires the doctor to address each patient's personality and their fate when providing information (BGH, NHW 1983, 328, 329). It is not permissible for the duty to provide information to be delegated to a third party unless strict obligations are fulfilled (BGH 7.11.2006 VI ZR 206/05).

Navigating the legal and ethical foundations of informed consent and confidentiality in integrated primary care.

PubMed

Hudgins, Cathy; Rose, Sandra; Fifield, Peter Y; Arnault, Steve

2013-03-01

This article describes findings from ongoing research and analysis of current literature in addition to discussions with leaders in the field, communications with lawyers and administrators of advocacy and government agencies pertaining to integrated primary care (IPC). Standards of care are established based on a myriad of factors, including professional codes of ethics, case law, state and federal laws, professional standards, existing best practices, current professional guidelines, administrative rules and regulations, and licensing board regulations. Regulations may differ for behavioral health and medical providers, posing challenges in IPC settings. This article provides a review of these regulations, particularly 42CFR Part 2, a federal law governing confidentiality for substance abuse programs, Health Insurance Portability and Accountability Act (HIPAA), and state laws relevant to patient care in IPC settings. On the basis of findings from the study, the authors make recommendations related to patient care practices concerning informed consent and release of information procedures, treatment and warm hand-off protocols, documentation and electronic record keeping, agreements with other providers, and billing. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

"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.

[Incapacitated persons - participation rights and the legal concept of the capacity to consent].

PubMed

Damm, Reinhard

2016-09-01

Legal problems related to the capacity to consent and decision-making have recently become increasingly important. This concerns the prerequisites and limitations of legal participation as a basis of social participation. Among the relevant social spheres and fields of action, this particulary concerns medicine and health care as well as disability and care. At the normative level, with a view to those concerned, this leads to fundamental questions resulting from the tension between self-determination and care as basic legal and ethical standards. At the empirical level, there are debates between the law and the sciences with regard to the relevant knowledge base for the assessment of (in)capacity to consent. The traditional controversies about the relevant legal criteria determining the existence or absence of capacity to consent are intensified by some recent legal developments, two of which must be highlighted. One of these is the postulate, increasingly emphasized by courts and legislator, of an at least communicative involvement of persons incapable to give consent in the decision-making process. The other is the fundamental discussion of medical ethics on concepts of assisted self-determination and supported decision-making, the consequences of which will also be of relevance at the legal level. Insofar, the development of guardianship law and the legal requirements of the UN Disability Rights Convention are of particular importance.

REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT'S RIGHTS: CURRENT SITUATION IN AZERBAIJAN.

PubMed

Rustamova, F A; Mammadov, V G; Munir, K M

Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles underlie the national health care law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in the national law, create conditions for the implementation of the patient's rights. The basic law governing the doctor-patient relationship, Law on Protection of Health of Population in Azerbaijan, reflects the basic patients' rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the country's different medical institutions. Due to the absence of any legally approved standards for informed consent forms, public and private health care institutions individually develop such forms, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The research made it possible to make conclusions about the necessary measures to improve and unify the informed consent form. The authors also analyzed the main provisions of the medical law of Azerbaijan and identified the main trends of its further development.

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.

78 FR 5837 - Notice of Lodging Proposed Consent Decree

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. Porter... complaint filed by the United States against Wesley Porter, Wes Porter Development Company, LLC, Temple and... Division, P.O. Box 7611, Washington, DC 20044, and refer to United States v. Porter, DJ 90-5-1-1-18341. The...

Informed consent for innovative surgery: A survey of patients and surgeons

PubMed Central

Lee Char, Susan J.; Hills, Nancy K.; Lo, Bernard; Kirkwood, Kimberly S.

2012-01-01

Background Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials, without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice, without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure. Methods 85 attending surgeons and 383 adult postoperative patients completed surveys. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetical partial hepatectomy. Results Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, around 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon’s first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the procedure’s novel nature, potentially unknown risks and benefits, and whether it would be the surgeon’s first time performing the procedure. Conclusions To promote informed decision making and autonomy among patients considering innovative surgery, surgeons should disclose the procedure’s novel nature, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients. PMID:23218878

"It's all about trust": reflections of researchers on the complexity and controversy surrounding biobanking in South Africa.

PubMed

Moodley, Keymanthri; Singh, Shenuka

2016-10-10

Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. In-depth qualitative interviews were conducted with a purposive sample of 21 researchers - 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40-60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements (MTAs) were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa.

Engineering practice variation through provider agreement: a cluster-randomized feasibility trial.

PubMed

McCarren, Madeline; Twedt, Elaine L; Mansuri, Faizmohamed M; Nelson, Philip R; Peek, Brian T

2014-01-01

Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers) to "favor" a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design. Agreeable providers were randomized to "favor" either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate. All four institutional review boards waived documentation of patient consent. Providers (n=18) followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients). In the "favor hydrochlorothiazide" group, there was 99% adherence to that strategy. In the "favor chlorthalidone" group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25-50 mg/day) and 100% for chlorthalidone (12.5-25.0 mg/day). Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy. Providers prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change in non-research clinicians. Waiver of patient consent can broaden the representation of patients, providers, and settings.

Patient consent to publication and data sharing in industry and NIH-funded clinical trials.

PubMed

Spence, O'Mareen; Onwuchekwa Uba, Richie; Shin, Seongbin; Doshi, Peter

2018-05-03

Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. Therefore, non-publication trials-and, more recently, lack of data sharing-are widely considered to violate the trust of trial participants. Existing practices regarding patient consent to publication and data sharing have not been evaluated. Analyzing informed consent forms (ICFs), we studied what trial participants were told regarding investigators' intention to contribute to medical knowledge, publish trial results, and share de-identified trial data. We obtained 98 ICFs of industry-funded pre-marketing trials for all (17) antibiotics approved by the European Medicines Agency and 46 ICFs of publicly funded trials from the National Heart, Lung and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository. Three authors independently reviewed ICFs to identify and extract what was stated or implied regarding: (1) publication of results; (2) sharing de-identified data; (3) data ownership; (4) confidentiality of identifiable data; and (5) whether the trial will produce knowledge that offers public benefit. Consensus was obtained from the two reviewers with the greatest overall agreement on all five measures. Disagreements were resolved through discussion among all authors. Four (3%) trials indicated a commitment to publish trial results; 140 (97%) did not commit to publishing trial results; six (4%) indicated a commitment to share de-identified data with third party researchers. Commitments to share were more common in publicly funded trials than industry-funded trials (7% vs 3%). A total of 103 (72%) ICFs indicated the trials will or may produce knowledge that offers public benefits, while 131 (91%) ICFs left unstated who "owned" trial data; of those with statements, the sponsor always claimed ownership. Patient confidentiality was guaranteed in 137 (95%) trials. Our results suggest that consent forms rarely disclose investigators' intentions regarding the sharing of de-identified data or publication of trial results.

Interobserver Variation in Response Evaluation Criteria in Solid Tumors 1.1.

PubMed

Karmakar, Arunabha; Kumtakar, Apeksha; Sehgal, Himanshu; Kumar, Savith; Kalyanpur, Arjun

2018-06-19

Response Evaluation Criteria in Solid Tumors (RECIST 1.1) is the gold standard for imaging response evaluation in cancer trials. We sought to evaluate consistency of applying RECIST 1.1 between 2 conventionally trained radiologists, designated as A and B; identify reasons for variation; and reconcile these differences for future studies. The study was approved as an institutional quality check exercise. Since no identifiable patient data was collected or used, a waiver of informed consent was granted. Imaging case report forms of a concluded multicentric breast cancer trial were retrospectively reviewed. Cohen's kappa was used to rate interobserver agreement in Response Evaluation Data (target response, nontarget response, new lesions, overall response). Significant variations were reassessed by a senior radiologist to extrapolate reasons for disagreement. Methods to improve agreement were similarly ascertained. Sixty one cases with total of 82 data-pairs were evaluated (35 data-pairs in visit 5, 47 in visit 9). Both radiologists showed moderate agreement in target response (n = 82; ĸ = 0.477; 95% confidence interval [CI]: 0.314-0.640-), nontarget response (n = 82; ĸ = 0.578; 95% CI: 0.213-0.944) and overall response evaluation in both visits (n = 82; ĸ = 0.510; 95% CI: 0.344-0.676). Further assessment demonstrated "Prevalence effect" of Kappa in some cases which led to underestimation of agreement. Percent agreement of overall response was 74.39% while percent variation was 25.6%. Differences in interpreting RECIST 1.1 and in radiological image interpretation were the primary sources of variation. The commonest overall response was "Partial Response" (Rad A:45/82; Rad B:63/82). Inspite of moderate interobserver agreement, qualitative interpretation differences in some cases increased interobserver variability. Protocols such as Adjudication, to reduce easily avoidable inconsistencies are or should be a part of the Standard Operating Procedure in imaging institutions. Based on our findings, a standard checklist has been developed to help reduce the interpretation error-margin for future studies. Such check-lists may improve interobserver agreement in the preadjudication phase thereby improving quality of results and reducing adjudication per case ratio. Improving data reliability when using RECIST 1.1 will reflect in better cancer clinical trial outcomes. A checklist can be of use to imaging centers to assess and improve their own processes. Copyright © 2018. Published by Elsevier Inc.

The role of consent in medical research: breaking or building walls? A call for legislative reform.

PubMed

Dangata, Yohanna Yanshiyi

2011-12-01

Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.

Sexual and reproductive health care for adolescents: legal rights and policy challenges.

PubMed

English, Abigail

2007-12-01

Laws developed over the past half century have significantly improved adolescents' access to essential sexual and reproductive health care. These laws allow many adolescent minors to give their own consent, protect confidentiality, and provide financial support for the care. The consent requirements for adolescents to receive health care are contained primarily in state court decisions and in statutes known as "state minor consent laws," which are based on either the minor's status or the services sought. Confidentiality protections for adolescents' health information are contained in these minor consent laws, in the federal medical privacy regulations known as the "HIPAA Privacy Rule," and in state medical privacy laws. Other significant laws include statutes providing for the emancipation of minors, court decisions delineating the mature minor doctrine, regulations protecting adolescents' access to confidential family planning services in publicly funded programs, and court decisions interpreting the constitutional right of privacy. Special considerations apply to consent and confidentiality questions pertaining to family planning, contraception, and pregnancy-related care for minors. In addition to the explicit provisions of state minor consent laws, many of the most important considerations are articulated in court decisions based on the constitutional right of privacy and the confidentiality requirements that are part of the federal Title X Family Planning Program and Medicaid.

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

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

NONE

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

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.

Hanford Single-Shell Tank Leak Causes and Locations - 241-BY and 241-TY Farm

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

Girardot, Crystal L.; Harlow, Donald G.

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

Pre-operative Duplex Ultrasonography in Arteriovenous Fistula Creation: Intra- and Inter-observer Agreement.

PubMed

Zonnebeld, Niek; Maas, Tommy M G; Huberts, Wouter; van Loon, Magda M; Delhaas, Tammo; Tordoir, Jan H M

2017-11-01

Although clinical guidelines on arteriovenous fistula (AVF) creation advocate minimum luminal arterial and venous diameters, assessed by duplex ultrasonography (DUS), the clinical value of routine DUS examination is under debate. DUS might be an insufficiently repeatable and/or reproducible imaging modality because of its operator dependency. The present study aimed to assess intra- and inter-observer agreement of DUS examination in support of AVF surgery planning. Ten end stage renal disease patients were included, to assess intra- and inter-observer agreement of pre-operative DUS measurements. All measurements were performed by two trained and experienced vascular technicians, blinded to measurement readings. From the routine DUS protocol, representative measurements (venous diameters, and arterial diameters and volume flow in the upper arm and forearm) were selected. For intra-observer agreement the measurements were performed in triplicate, with the probe released from the skin between each. Intraclass correlation coefficients were calculated for intra- and inter-observer agreement, and Bland-Altman plots used to graphically display mean measurement differences and limits of agreement. Ten patients (6 male, 59.4±19.7 years) consented to participate, and all predefined measurements were obtained. Intraclass correlation coefficients for intra-observer agreement of diameter measurements were at least 0.90 (95% CI 0.74-0.97; radial artery). Inter-observer agreement was at least 0.83 (0.46-0.96; lateral diameter upper arm cephalic vein). The Bland-Altman plots showed acceptable mean measurement differences and limits of agreement. In experienced hands, excellent intra- and inter-observer agreement can be reached for the discrete pre-operative DUS measurements advocated in clinical guidelines. DUS is therefore a reliable imaging modality to support AVF surgery planning. The content of DUS protocols, however, needs further standardisation. Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

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.

The ethics of HIV "cure" research: what can we learn from consent forms?

PubMed

Henderson, Gail E

2015-01-01

The advent of HIV "cure" research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV "cure" research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV "cure" research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes.

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

[End of life non-therapeutic intensive care for organ preservation and donation: legal and ethical issues].

PubMed

Baumann, Antoine; Ducrocq, Xavier; Audibert, Gérard; Coudane, Henry; Mertes, Paul-Michel; Claudot, Frédérique

2012-10-01

Stroke is presently the first cause of brain death in France. In this context, the question of elective non-therapeutic ventilation and resuscitation arises, aiming at enabling the patients for whom a decision to stop all the therapeutics has been made to evolve towards brain death and organ donation. In 2010, the French society of intensive care has released guidelines regarding stroke management including strategy on this topic. The question has also been referred to the Ethics Committee of Nancy university hospital by a chief-nurse of our hospital and we report here its conclusions and propositions. A workgroup was appointed and has tackled the major issues: the justification, the risks for the patient and the society, the expression of the patient's consent, the legality of this care benefiting only a third party, and the practical details. Elective intensive care following decision to stop any treatment after severe stroke seems to be justified with regard to public health as well as individual or collective ethics, providing the patient has expressed his/her consent or his/her non-opposition before stroke occurrence. In France there is no legal frame regulating this practice, no information of the general public, and a public debate has yet to be initiated. Regarding the practical details, a priori agreement of the organ procurement organisation, patient's consent, and approval of the consultant required by the law of April 22, 2005 relating to Patients' rights and to the end of life to rule out any conflict of interest, have to be checked before referring the patient to ICU. Advance directives drafting must be developed and their scope extended to organ donation and elective resuscitation. Therefore, fair information of the general public and clarity and transparency of the procedures are needed. The prolongation of the French moratorium on Maastricht III type non-heart beating organ donation - grounded on fears of possible conflicts on interest - seems obsolete with regard to the increasing respect of the patient's autonomy and to the risk of harmfulness entailed by elective resuscitation before death. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Commercial biobanks and genetic research: ethical and legal issues.

PubMed

Anderlik, Mary

2003-01-01

Human biological material is recognized as an important tool in research, and the demand for collections that combine samples and data is increasing. For-profit companies have assumed a leading role in assembling and managing these collections. The emergence of commercial biobanks has raised significant ethical and legal issues. The growing awareness of the importance of human biological material in research has been accompanied by a growing awareness of the deficiencies of existing archives of tissue. Commercial biobanks are attempting to position themselves as a, if not the, solution to problems that include a lack of public trust in researchers and lack of financial resources to support the prospective creation of collections that meet the highest scientific and ethical standards in the non-profit sector. Broad social and policy questions surrounding the operation of commercial biobanks have been raised however. International documents, in particular, suggest discomfort with the idea of gain from the mere transfer or exchange of human genetic material and information. Commercial involvement in the development of useful products from tissue is generally not condemned, so long as there is attention to scientific and social norms. Views on the acceptability of commercial biobanks vary. Specific issues that arise when commercial biobanks are permitted--in the areas of consent, recruitment, confidentiality, and accountability--are also relevant to the operation of public and private, non-profit biobanks. Although many uncertainties remain, consensus seems to be forming on a number of issues. For example, there appears to be agreement that blanket consent to future unspecified research uses, with no conditions, is unacceptable. Indeed, many of the leading commercial biobanks have been attentive to concerns about consent, recruitment, and confidentiality. Unfortunately, the binding nature of assurances in these areas is unclear, especially given the risk of insolvency. Hence, accountability may be the most important area of concern in relation to commercial biobanks. A few countries have enacted general legislation providing for comprehensive regulation of biobanks, for example, through licensure. Efforts to achieve harmonization of standards at the international level, and cautions against an approach that focuses on biobanking for genetic research alone, are to be applauded.

Consent Processes for Mobile App Mediated Research: Systematic Review.

PubMed

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

2017-08-30

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

Consent Processes for Mobile App Mediated Research: Systematic Review

PubMed Central

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

2017-01-01

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

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.

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

PubMed

Verástegui, Emma L

2006-12-13

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

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

PubMed Central

Verástegui, Emma L

2006-01-01

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

How MFN clauses used in the health care industry unreasonably restrain trade under the Sherman Act.

PubMed

Wright, Beth Ann

When used in the health care industry, an MFN clause is a contractual agreement that guarantees a health insurer the same best price as their market competitors. MFN clauses have the effect of unnecessarily raising consumer costs, reducing choice among providers, constraining access to care and preventing the development of alternative health care delivery models. The purpose of this paper is four-fold. First, to design a four-quadrant matrix to evaluate the pro-competitive and anticompetitive purposes and effects of MFN clauses under Section 1 of the Sherman Act. Second, to defeat the jurisprudential presumption that MFN clauses are pro-competitive in the health care industry and to recommend that this presumption be abolished. Third, to examine the U.S. Department of Justice's paradigmatic shift over the last decade toward prosecuting large insurers who employ MFN clauses resulting in U.S. Consent Decrees. Fourth, to outline the indicia of a meritorious claim against an insurer who employs an MFN clause.

Developing a policy for paediatric biobanks: principles for good practice

PubMed Central

Hens, Kristien; Van El, Carla E; Borry, Pascal; Cambon-Thomsen, Anne; Cornel, Martina C; Forzano, Francesca; Lucassen, Anneke; Patch, Christine; Tranebjaerg, Lisbeth; Vermeulen, Eric; Salvaterra, Elena; Tibben, Aad; Dierickx, Kris

2013-01-01

The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions. PMID:22713814

Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

PubMed Central

Panikkar, Bindu; Smith, Natasha; Brown, Phil

2013-01-01

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

Reading Level and Comprehension of Research Consent Forms: An Integrative Review.

PubMed

Foe, Gabriella; Larson, Elaine L

2016-02-01

Consent forms continue to be at a higher reading level than the recommended sixth to eighth grade, making it difficult for participants to comprehend information before enrolling in research. To assess and address the extent of the problem regarding the level of literacy of consent forms and update previously published reports, we conducted an integrative literature review of English language research published between January 1, 2000, and December 31, 2013; 35 descriptive and eight intervention studies met inclusion criteria. Results confirmed that developing forms at eighth-grade level was attainable though not practiced. It was found that risks of participation was the section most poorly understood. There was also a lack of consensus regarding the most effective method to increase comprehension. Further research using standardized tools is needed to determine the best approach for improving consent forms and processes. © The Author(s) 2016.

[Ethical considerations in genomic cohort study].

PubMed

Choi, Eun Kyung; Kim, Ock-Joo

2007-03-01

During the last decade, genomic cohort study has been developed in many countries by linking health data and genetic data in stored samples. Genomic cohort study is expected to find key genetic components that contribute to common diseases, thereby promising great advance in genome medicine. While many countries endeavor to build biobank systems, biobank-based genome research has raised important ethical concerns including genetic privacy, confidentiality, discrimination, and informed consent. Informed consent for biobank poses an important question: whether true informed consent is possible in population-based genomic cohort research where the nature of future studies is unforeseeable when consent is obtained. Due to the sensitive character of genetic information, protecting privacy and keeping confidentiality become important topics. To minimize ethical problems and achieve scientific goals to its maximum degree, each country strives to build population-based genomic cohort research project, by organizing public consultation, trying public and expert consensus in research, and providing safeguards to protect privacy and confidentiality.

Diagnostic Reproducibility: What Happens When the Same Pathologist Interprets the Same Breast Biopsy Specimen at Two Points in Time?

PubMed Central

Jackson, Sara L.; Frederick, Paul D.; Pepe, Margaret S.; Nelson, Heidi D.; Weaver, Donald L.; Allison, Kimberly H.; Carney, Patricia A.; Geller, Berta M.; Tosteson, Anna N. A.; Onega, Tracy; Elmore, Joann G.

2017-01-01

Background Surgeons may receive a different diagnosis when a breast biopsy is interpreted by a second pathologist. The extent to which diagnostic agreement by the same pathologist varies at two time points is unknown. Participants and Methods Pathologists from 8 U.S. states independently interpreted 60 breast specimens, one glass slide per case, on 2 occasions separated by ≥9 months. Reproducibility was assessed by comparing interpretations between the two time points; associations between reproducibility (intra-observer agreement rates) and characteristics of pathologists and cases were determined and also compared with inter-observer agreement of baseline interpretations. Results Sixty-five percent of invited, responding pathologists were eligible and consented; 49 interpreted glass slides in both study phases resulting in 2,940 interpretations. Intra-observer agreement rates between the two phases were 92% (95% CI 88%-95%) for invasive breast cancer, 84% (95% CI 81%-87%) for ductal carcinoma in situ (DCIS), 53% (95% CI 47%-59%) for atypia, and 84% (95% CI 81%-86%) for benign without atypia. When comparing all study participants' case interpretations at baseline, inter-observer agreement rates were 89% (95% CI 84%-92%) for invasive cancer, 79% (95% CI 76%-81%) for DCIS, 43% (95% CI 41%-45%) for atypia, and 77% (95% CI 74%-79%) for benign without atypia. Conclusions Interpretive agreement between two time points by the same individual pathologists was low for atypia, and similar to observed rates of agreement for atypia between different pathologists. Physicians and patients should be aware of the diagnostic challenges associated with a breast biopsy diagnosis of atypia when considering treatment and surveillance decisions. PMID:27913946

Diagnostic Reproducibility: What Happens When the Same Pathologist Interprets the Same Breast Biopsy Specimen at Two Points in Time?

PubMed

Jackson, Sara L; Frederick, Paul D; Pepe, Margaret S; Nelson, Heidi D; Weaver, Donald L; Allison, Kimberly H; Carney, Patricia A; Geller, Berta M; Tosteson, Anna N A; Onega, Tracy; Elmore, Joann G

2017-05-01

Surgeons may receive a different diagnosis when a breast biopsy is interpreted by a second pathologist. The extent to which diagnostic agreement by the same pathologist varies at two time points is unknown. Pathologists from eight U.S. states independently interpreted 60 breast specimens, one glass slide per case, on two occasions separated by ≥9 months. Reproducibility was assessed by comparing interpretations between the two time points; associations between reproducibility (intraobserver agreement rates); and characteristics of pathologists and cases were determined and also compared with interobserver agreement of baseline interpretations. Sixty-five percent of invited, responding pathologists were eligible and consented; 49 interpreted glass slides in both study phases, resulting in 2940 interpretations. Intraobserver agreement rates between the two phases were 92% [95% confidence interval (CI) 88-95] for invasive breast cancer, 84% (95% CI 81-87) for ductal carcinoma-in-situ, 53% (95% CI 47-59) for atypia, and 84% (95% CI 81-86) for benign without atypia. When comparing all study participants' case interpretations at baseline, interobserver agreement rates were 89% (95% CI 84-92) for invasive cancer, 79% (95% CI 76-81) for ductal carcinoma-in-situ, 43% (95% CI 41-45) for atypia, and 77% (95% CI 74-79) for benign without atypia. Interpretive agreement between two time points by the same individual pathologist was low for atypia and was similar to observed rates of agreement for atypia between different pathologists. Physicians and patients should be aware of the diagnostic challenges associated with a breast biopsy diagnosis of atypia when considering treatment and surveillance decisions.

Is the National Registration website (Australian Health Practitioner Regulation Agency) effective in tracking Australian medical graduates' rural work?

PubMed

Playford, Denese; Power, Phoebe; Boothroyd, Alarna; Manickavasagar, Usha; Ng, Wen Qi; Riley, Geoff

2013-10-01

This study compared rural location identified through the National Registration (AHPRA) registry with location obtained through labour-intensive personal contact. Longitudinal cohort study with two methods to identify the work locations of medical graduates from The Rural Clinical School of Western Australia (RCSWA). Consenting alumni from the University of Western Australia and the University of Notre Dame Fremantle participating in RCSWA between 2002 and 2009 inclusive and available to contact in 2011. Percentage location matches between two contact methods. There was 80% agreement for principal suburb, 92% agreement for principal city and 94% agreement for principal state between RCSWA personal contact and the AHPRA registry. AHPRA identified nearly two times as many graduate locations. However, there was only 31% agreement for a rural placement location (of any length). In more detail, for year-long rural placement, personal contact was 88% concordant with AHPRA; work six months or more were less concordant (44% agreement); work less than six months were not concordant (4% agreement). AHPRA data matched RCSWA alumni data only for graduates in full-time rural work. Since medical alumni spend up to 10 years in pre-vocational and vocational training, which includes many rural options, personal contact was able to pick up the myriad of rural choices, whereas the AHPRA database was not sensitive enough to identify them. Until graduates have stably finished training, the optimal method to identify rural work is through personal contact but statistical correction for missing data needs to be considered. © 2013 The Authors. Australian Journal of Rural Health © National Rural Health Alliance Inc.

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.

Patient Privacy, Consent, and Identity Management in Health Information Exchange

PubMed Central

Hosek, Susan D.; Straus, Susan G.

2013-01-01

Abstract The Military Health System (MHS) and the Veterans Health Administration (VHA) have been among the nation's leaders in health information technology (IT), including the development of health IT systems and electronic health records that summarize patients' care from multiple providers. Health IT interoperability within MHS and across MHS partners, including VHA, is one of ten goals in the current MHS Strategic Plan. As a step toward achieving improved interoperability, the MHS is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This article contributes to that effort by identifying gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to bring about improved quality and efficiency of care through health information exchange. Major challenges include (1) designing a meaningful patient consent procedure, (2) recording patients' consent preferences and designing procedures to implement restrictions on disclosures of protected health information, and (3) advancing knowledge regarding the best technical approaches to performing patient identity matches and how best to monitor results over time. Using a sociotechnical framework, this article suggests steps for overcoming these challenges and topics for future research. PMID:28083296

Development and pilot study of an essential set of indicators for general surgery services.

PubMed

Soria-Aledo, Victor; Angel-Garcia, Daniel; Martinez-Nicolas, Ismael; Rebasa Cladera, Pere; Cabezali Sanchez, Roger; Pereira García, Luis Francisco

2016-11-01

At present there is a lack of appropriate quality measures for benchmarking in general surgery units of Spanish National Health System. The aim of this study is to present the selection, development and pilot-testing of an initial set of surgical quality indicators for this purpose. A modified Delphi was performed with experts from the Spanish Surgeons Association in order to prioritize previously selected indicators. Then, a pilot study was carried out in a public hospital encompassing qualitative analysis of feasibility for prioritized indicators and an additional qualitative and quantitative three-rater reliability assessment for medical record-based indicators. Observed inter-rater agreement, prevalence adjusted and bias adjusted kappa and non-adjusted kappa were performed, using a systematic random sample (n=30) for each of these indicators. Twelve out of 13 proposed indicators were feasible: 5 medical record-based indicators and 7 indicators based on administrative databases. From medical record-based indicators, 3 were reliable (observed agreement >95%, adjusted kappa index >0.6 or non-adjusted kappa index >0.6 for composites and its components) and 2 needed further refinement. Currently, medical record-based indicators could be used for comparison purposes, whilst further research must be done for validation and risk-adjustment of outcome indicators from administrative databases. Compliance results in the adequacy of informed consent, diagnosis-to-treatment delay in colorectal cancer, and antibiotic prophylaxis show room for improvement in the pilot-tested hospital. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Emerging issues in paediatric health research consent forms in Canada: working towards best practices

PubMed Central

2013-01-01

Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. Conclusions The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. PMID:23363554

The perspectives of researchers on obtaining informed consent in developing countries.

PubMed

Newton, Sam K; Appiah-Poku, John

2007-04-01

The doctrine of informed consent (IC) exists to protect individuals from exploitation or harm. This study into IC was carried out to investigate how different researchers perceived the process whereby researchers obtained consent. It also examined researchers' perspectives on what constituted IC, and how different settings influenced the process. The study recorded in-depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Although the concept and application of the doctrine of IC should have been the same, irrespective of where the research was carried out, the process of obtaining it had to be different. The setting had to be taken into consideration and the autonomy of the subject had to be respected at all times. In areas of high illiteracy, and where understanding of the subject was likely to be a problem, there was an added responsibility placed on the researcher to devise innovative ways of carrying out the study, taking into consideration the peculiarities of the environment. The ethical issues for IC were the same, irrespective of where the research was conducted. However, because the backgrounds, setting, and knowledge of populations differed, there was the need to be similarly sensitive in obtaining consent. The problems of obtaining genuine IC were not limited to developing countries.

Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective.

PubMed

Nabulsi, Mona; Khalil, Yvette; Makhoul, Jihad

2011-07-01

Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. To explore such perceptions and attitudes in Lebanese parents. 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term 'randomisation' hindered parental approval of participation. Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.

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.

Is Consent Based on Trust Morally Inferior to Consent Based on Information?

PubMed

Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

2017-07-01

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the moral values essential to valid consent - autonomy, voluntariness, non-manipulation, and non-exploitation - and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. © 2017 John Wiley & Sons Ltd.

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

PubMed Central

2015-01-01

Abstract The advent of HIV “cure” research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV “cure” research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV “cure” research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes. PMID:25406579

Validity and reliability of an occupational exposure questionnaire for parkinsonism in welders.

PubMed

Hobson, Angela J; Sterling, David A; Emo, Brett; Evanoff, Bradley A; Sterling, Callen S; Good, Laura; Seixas, Noah; Checkoway, Harvey; Racette, Brad A

2009-06-01

This study assessed the validity and test-retest reliability of a medical and occupational history questionnaire for workers performing welding in the shipyard industry. This self-report questionnaire was developed for an epidemiologic study of the risk of parkinsonism in welders. Validity participants recruited from three similar shipyards were asked to give consent for access to personnel files and complete the questionnaire. Responses on the questionnaire were compared with information extracted from personnel records. Reliability participants were recruited from the same shipyards and were asked to complete the questionnaire at two different times approximately 4 weeks apart. Percent agreement, kappa, intraclass correlation coefficient (ICC), and sensitivity and specificity were used as measures of validity and/or reliability. Personnel files were obtained for 101 of 143 participants (70%) in the validity study, and 56 of the 95 (58.9%) participants in the reliability study completed the retest of the questionnaire. Validity scores for items extracted from personnel files were high. Percent agreement for employment dates and job titles ranged from 83-100%, while ICC for start and stop dates ranged from 0.93-0.99. Sensitivity and specificity for current job title ranged from 0.5-1.0. Reliability scores for demographic, medical and health behavior items were mainly moderate or high, but ranged from 0.19 to 1.0. Most recent job/title items such as title, types of welding performed, and material used showed substantial to perfect agreement. Certain determinants of exposure such as days and hours per week exposed to welding fumes demonstrated mainly moderate agreement (kappa= 0.42-0.47, percent agreement 63-77%); however, mean days and hours reported did not differ between test and retest. The results of this study suggest that participants' self-report for job title and dates employed are valid compared with employer records. While kappa scores were low for some medical conditions and for caffeine consumption, high kappa scores for job title, dates worked, types of welding, and materials welded suggest participants generated reproducible answers important for occupational exposure assessment.

Dynamic consent: a patient interface for twenty-first century research networks

PubMed Central

Kaye, Jane; Whitley, Edgar A; Lund, David; Morrison, Michael; Teare, Harriet; Melham, Karen

2015-01-01

Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes. PMID:24801761

An audit of parents'/guardians' wishes recorded after coronial autopsies in cases of sudden unexpected death in infancy: issues raised and future directions.

PubMed

Cohen, M C; Blakey, S; Donn, T; McGovern, S; Parry, L

2009-07-01

In the U.K., cases of sudden unexpected death in infancy are under the jurisdiction of the Coroner and consent for a post-mortem is not required. Prior to the Human Tissue Act 2006 (HTA) there was also no requirement to request retention of tissue (blocks and slides). The HTA stipulates that parental/ guardian consent is mandatory to retain or dispose of all tissues after the Coroners' purposes have been fulfilled. In 2007, in order to avoid confusion with the consent needed for hospital post-mortems, a new form was introduced by Sheffield Children's Hospital NHS Foundation Trust (SCH) called Record of parents'/guardians'wishes regarding samples taken at a Coroner's post mortem. This version specifically asks if blocks and slides may be retained as part of the medical record, or are to be disposed of, and for parental agreement (or not) for the frozen tissue, blocks and slides to be used for education, audit, quality control and medical research. One hundred and nineteen Coroners' postmortems covering the years 2006-2007 were reviewed. All parents/guardians (P/G) were contacted and the outcomes of P/G wishes recorded by SCH staff, Coroners' Officers (CO) and Police Family Liaison Officers (PFLO) were analysed and compared (44% from CO were outstanding at the time of audit). Any delay in recording P/G wishes by these three groups was also compared. In 2006, parental agreement to the use of blocks and slides for education, audit, quality control and medical research was 94%, 77% and 75% for SCH, CO and PFLO, respectively. In 2007 it was 84%, 37% and 100% for the same groups. Permission for the retention of frozen tissue given to SCH, CO and PFLO was 90%, 62% and 100% in 2006 and 90%, 44% and 100% in 2007, respectively. Cases where parents did not wish for the retention or use of tissue (including blocks and slides) were 3%, 15% and 0% in 2006 for SCH, CO and PFLO respectively, and 0% for all groups in 2007. Training of staff in all aspects of post-mortem and bereavement care is essential for ascertaining parental wishes. Families should be provided with the knowledge that allows them to make informed choices. The analysis of the results of the audit supports this view.