Sample records for consent orders

  1. 49 CFR 1503.423 - Consent orders.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  2. Dibasic Esters; Final Enforceable Consent Agreement and Testing Consent Order

    EPA Pesticide Factsheets

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

  3. 29 CFR 6.43 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  4. 29 CFR 6.32 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  5. Consent Agreement and Consent Order

    EPA Pesticide Factsheets

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

  6. 29 CFR 6.18 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  7. 75 FR 29782 - Notice of Proposed Consent Decree and Proposed Order on Consent Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

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

  8. 77 FR 64519 - Magnesium Elektron; Analysis of Agreement Containing Consent Orders To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

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

  9. 75 FR 10798 - Richard J. Stanton; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-09

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

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

    EPA Pesticide Factsheets

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

  11. 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...

  12. 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.

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

    EPA Pesticide Factsheets

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

  14. 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...

  15. 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...

  16. 38 CFR 1.492 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  17. 42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  18. 38 CFR 1.492 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

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

    EPA Pesticide Factsheets

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

  20. 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.

  1. 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...

  2. 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...

  3. 75 FR 42752 - Nestle' HealthCare Nutrition, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-22

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

  4. 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...

  5. 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...

  6. 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...

  7. 77 FR 58838 - ABCSP, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

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

  8. 77 FR 52322 - McClellan Air Force Base Superfund Site Proposed Notice of Administrative Order on Consent

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

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

  9. 19 CFR 210.76 - Modification or rescission of exclusion orders, cease and desist orders, and consent orders.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  10. 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

  11. 14 CFR 13.77 - Consent order of compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  12. 14 CFR 13.77 - Consent order of compliance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  13. 14 CFR 13.77 - Consent order of compliance.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  14. 14 CFR 13.77 - Consent order of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  15. 14 CFR 13.77 - Consent order of compliance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  16. Testing Consent Order On 4 Nonylphenol, Branched

    EPA Pesticide Factsheets

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

  17. 2015 Clean Air Act Vehicle and Engine Enforcement Case Resolutions

    EPA Pesticide Factsheets

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

  18. Testing Consent Order on Alkyl Phthalates

    EPA Pesticide Factsheets

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

  19. 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.

  20. 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.

  1. 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.

  2. Testing Consent Order on Dilsodecyl Phenyl Phosphite

    EPA Pesticide Factsheets

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

  3. Testing Consent Order for Acrylic Acid

    EPA Pesticide Factsheets

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

  4. 45 CFR 672.11 - Informal settlement; consent agreement and order.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  5. 45 CFR 672.11 - Informal settlement; consent agreement and order.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  6. 45 CFR 672.11 - Informal settlement; consent agreement and order.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  7. 45 CFR 672.11 - Informal settlement; consent agreement and order.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  8. 45 CFR 672.11 - Informal settlement; consent agreement and order.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  9. 22 CFR 128.11 - Consent agreements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  10. 22 CFR 128.11 - Consent agreements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  11. 22 CFR 128.11 - Consent agreements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

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

    PubMed

    Shahvisi, Arianne

    2016-02-01

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

  13. Testing Consent Order for Octamethylcyclotetrasiloxane

    EPA Pesticide Factsheets

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

  14. Testing Consent Order for Sodium Cyanide

    EPA Pesticide Factsheets

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

  15. 29 CFR 1921.8 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  16. Testing Consent Order on Mesityl Oxide

    EPA Pesticide Factsheets

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

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

    EPA Pesticide Factsheets

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

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

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

    Copland, John R.

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

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

    EPA Pesticide Factsheets

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

  20. 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.

  1. Testing Consent Order on Refractory Ceramic Fibers

    EPA Pesticide Factsheets

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

  2. 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.

  3. 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.

  4. 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

  5. C.I. Disperse Blue; Testing Consent Order

    EPA Pesticide Factsheets

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

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

    PubMed

    Dougall, A; Fiske, J

    2008-07-26

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

  7. 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.

  8. Should consent be required for organ procurement?

    PubMed

    Zambrano, Alexander

    2018-06-08

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

  9. 78 FR 77106 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-20

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

  10. 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.

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

    PubMed

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

    2015-01-01

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

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

    EPA Pesticide Factsheets

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

  13. 29 CFR 502.40 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  14. 29 CFR 501.40 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  15. 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.

  16. 77 FR 26438 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

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

  17. 78 FR 65313 - Actavis, Inc. a corporation, and Warner Chilott PLC; Analysis of Agreement Containing Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

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

  18. 78 FR 5207 - Certain Led Photographic Lighting Devices and Components Thereof; Commission's Final...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

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

  19. 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...

  20. 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...

  1. 28 CFR 76.20 - Consent Order or settlement prior to hearing.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  2. 28 CFR 76.20 - Consent Order or settlement prior to hearing.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  3. 28 CFR 76.20 - Consent Order or settlement prior to hearing.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  4. 28 CFR 76.20 - Consent Order or settlement prior to hearing.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  5. 75 FR 37806 - Twitter, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

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

  6. 77 FR 66595 - U.S. Air Force Broadcast of Consent Order, and Determination of Interest Level for a United...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

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

  7. 77 FR 25953 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the 1980...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

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

  8. 40 CFR 52.1190 - Original Identification of plan section.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  9. 40 CFR 52.1190 - Original Identification of plan section.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  10. 40 CFR 52.1190 - Original Identification of plan section.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  11. 40 CFR 52.1190 - Original Identification of plan section.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  12. 40 CFR 52.1190 - Original Identification of plan section.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  13. 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...

  14. 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...

  15. 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...

  16. 29 CFR 801.66 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  17. 29 CFR 500.232 - Consent findings and order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  18. 77 FR 1491 - Sigma Corporation; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-10

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

  19. 77 FR 73655 - Epic Marketplace, Inc., and Epic Media Group, LLC; Analysis of Proposed Consent Order To Aid...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-11

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

  20. 77 FR 25901 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the 1980...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

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

  1. 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...

  2. 42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  3. 42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  4. 42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  5. 42 CFR 2.62 - Order not applicable to records disclosed without consent to researchers, auditors and evaluators.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  6. 77 FR 50508 - Brain-Pad, Inc; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

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

  7. 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.

  8. 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.

  9. 76 FR 71564 - ScanScout, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

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

  10. 77 FR 35389 - EPN, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

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

  11. 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...

  12. 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.

  13. 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

  14. Gaining informed consent for blood transfusion.

    PubMed

    Whitmore, Emma; Gerrard, Rebecca; Coffey, Kairen

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

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

    ERIC Educational Resources Information Center

    Chilton, Bradley; Chwialkowski, Paul

    2014-01-01

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

  16. 40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  17. 40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  18. 40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  19. 40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  20. 40 CFR 799.18 - Chemicals subject of test rules or consent orders for which the testing reimbursement period has...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  1. The extent of surgical patients' understanding.

    PubMed

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

    2014-07-01

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

  2. 78 FR 27258 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

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

  3. 78 FR 70321 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

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

  4. 78 FR 55756 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

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

  5. 78 FR 41953 - Notice of Lodging of Proposed Consent Decree under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-12

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

  6. 77 FR 61640 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

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

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

    PubMed

    Parekh, S A

    2007-01-01

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

  8. 78 FR 24778 - Notice of Lodging of Proposed Consent Decree Under the Resource Conservation and Recovery Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

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

  9. 78 FR 42547 - Notice of Lodging of Proposed Consent Decree under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-16

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

  10. 77 FR 71449 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

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

  11. 77 FR 70811 - Notice of Lodging of Proposed Consent Decree Under the Formerly Utilized Sites Remedial Action...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

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

  12. 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...

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

    PubMed

    D'Cruz, L

    2010-07-24

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

  14. 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

  15. 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.

  16. 78 FR 63494 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act and the Emergency Planning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

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

  17. 78 FR 35315 - Notice of Lodging of Proposed Third Amendment to Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

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

  18. 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.

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

    PubMed

    Iltis, Ana

    2006-08-01

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

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

    PubMed

    Garwood-Gowers, Austen

    2013-09-01

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

  1. Balancing the quality of consent.

    PubMed Central

    Hansson, M O

    1998-01-01

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

  2. 77 FR 26474 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Approval of 2011 Consent...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

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

  3. Revised Tijeras Arroyo Groundwater Current Conceptual Model and Corrective Measures Evaluation Report - February 2018.

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

    Copland, John R.

    The U.S. Department of Energy (DOE) and the management and operating (M&O) contractor for Sandia National Laboratories beginning on May 1, 2017, National Technology & Engineering Solutions of Sandia, LLC (NTESS), hereinafter collectively referred to as DOE/NTESS, prepared this Revised Tijeras Arroyo Groundwater Current Conceptual Model (CCM) and Corrective Measures Evaluation (CME) Report , referred to as the Revised CCM/CME Report, to meet requirements under the Sandia National Laboratories-New Mexico (SNL/NM) Compliance Order on Consent (Consent Order). The Consent Order became effective on April 29, 2004. The Consent Order identifies the Tijeras Arroyo Groundwater (TAG) Area of Concern (AOC) asmore » an area of groundwater contamination requiring further characterization and corrective action. In November 2004, New Mexico Environment Department (NMED) approved the July 2004 CME Work Plan. In April 2005, DOE and the SNL M&O contractor at the time, Sandia Corporation (Sandia), hereinafter collectively referred to as DOE/Sandia, submitted a CME Report, but NMED did not finalize review of that document. In December 2016, DOE/Sandia submitted a combined and updated CCM/CME Report. NMED issued a disapproval letter in May 2017 that included comments on the December 2016 CCM/CME Report. In August 2017, NMED and DOE/NTESS staff held a meeting to discuss and clarify outstanding issues. This Revised CCM/CME Report addresses (1) the issues presented in the NMED May 2017 disapproval letter and (2) findings from the August 2017 meeting.« less

  4. Is consent in medicine a concept only of modern times?

    PubMed Central

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

    2001-01-01

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

  5. 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...

  6. 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...

  7. 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...

  8. 19 CFR 210.75 - Proceedings to enforce exclusion orders, cease and desist orders, consent orders, and other...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed Central

    Wertheimer, Alan

    2014-01-01

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

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

    PubMed

    Hallinan, Dara; Friedewald, Michael

    2015-01-01

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

  11. Planned Parenthood League of Massachusetts v. Attorney General.

    PubMed

    1997-03-18

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

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

    PubMed

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

    2016-06-01

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

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

    PubMed

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

    2016-07-01

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

  14. 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.

  15. 78 FR 55076 - Ganley Ford West, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

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

  16. 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...

  17. 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...

  18. 76 FR 11277 - In the Matter of Collaborative System Products and Components Thereof (II); Notice of Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-01

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

  19. 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.

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

    PubMed

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

    2009-11-01

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

  1. Informed consent and nudging.

    PubMed

    Simkulet, William

    2018-06-19

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

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

    PubMed

    Carter, Adrian; Hall, Wayne

    2008-02-01

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

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

    PubMed

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

    2012-06-01

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

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

    PubMed

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

    2017-06-01

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

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

    PubMed

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

    2018-05-01

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

  6. 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...

  7. 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.

  8. Use of altered informed consent in pragmatic clinical research.

    PubMed

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

    2015-10-01

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

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

    PubMed

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

    2017-03-01

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

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

    PubMed

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

    1998-04-01

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

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

    PubMed

    Xafis, Vicki

    2015-11-17

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2017-01-01

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

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

    PubMed Central

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2018-01-01

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

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

    PubMed

    Edmunds, Emme; Gupta, Ankit

    2016-05-01

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

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

    PubMed

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

    2009-01-01

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

  17. 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.

  18. 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

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

    PubMed

    Taua, Chris; Neville, Christine; Hepworth, Julie

    2014-12-01

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

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

    PubMed

    Meynen, Gerben

    2010-11-01

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

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

    PubMed Central

    2010-01-01

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

  2. 14 CFR 16.109 - Orders terminating eligibility for grants, cease and desist orders, and other compliance orders.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

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

    PubMed

    Fallat, Mary E; Hardy, Courtney

    2018-05-01

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

  4. 40 CFR 24.02 - Issuance of initial orders; definition of final orders and orders on consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  5. 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.

  6. 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

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

    PubMed

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

    2009-07-21

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

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

    PubMed Central

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

    2009-01-01

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

  9. Physician perspectives on legal processes for resolving end-of-life disputes.

    PubMed

    Chidwick, Paula; Sibbald, Robert

    2011-01-01

    In order to understand how to effectively approach end-of-life disputes, this study surveyed physicians' attitudes towards one process for resolving end-of-life disputes, namely, the Consent and Capacity Board of Ontario. In this case, the process involved examining interpretation of best interests between substitute decision-makers and medical teams. Physicians who made "Form G" applications to the Consent and Capacity Board of Ontario that resulted in a decision posted on the open-access database, Canadian Legal Information Institute (CanLii), were identified and surveyed. This purposive sample led to 13 invitations to participate and 12 interviews (92% response rate). Interviews were conducted using a prescribed interview guide. No barriers to the Consent and Capacity Board process were reported. Applications were made when physicians reached an impasse with the family and further treatment was perceived to be "unethical." The most significant challenge reported was the delay when appeals were launched. Appeals extended the process for an indefinite period of time making it so lengthy it negated any perceived benefits of the process. Benefits included that a neutral third party, namely the Consent and Capacity Board, was able to assess best interests. Also, when decisions were timely, further harm to the patient was minimized. Physicians reported this particular approach, namely the Consent and Capacity Board has a mechanism that is worthwhile, patient centred, process oriented, orderly and efficient for resolving end-of-life disputes and, in particular, determining best interests. However, unless the appeal process can be adjusted to respond to the ICU context there is a risk of not serving the best interest of patients. Physicians would recommend framing end-of-life treatment plans in the positive instead of negative, for example, propose palliative care and no escalation of treatment as opposed to withdrawal.

  10. 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.

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

    PubMed

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

    2008-10-01

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

  12. 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.

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

    PubMed

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

    2018-06-22

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

  14. 49 CFR 209.209 - Hearing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  15. 49 CFR 209.209 - Hearing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

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

    PubMed

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

    2016-09-01

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

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

    PubMed

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

    2015-01-01

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

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

    PubMed

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

    2013-05-28

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

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

    PubMed Central

    2013-01-01

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

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

    PubMed

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

    2016-06-01

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

  1. 75 FR 57080 - In the Matter of Aerotest Operations, Inc. (Aerotest Radiography and Research Reactor); Order...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

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

  2. Settlement of Clean Water Act Violations

    EPA Pesticide Factsheets

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

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

    PubMed

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

    2017-02-01

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

  4. 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.

  5. 76 FR 15313 - Chitika, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

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

  6. 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.

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

    EPA Pesticide Factsheets

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

  8. 29 CFR 1608.8 - Adherence to court order.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  9. 29 CFR 1608.8 - Adherence to court order.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  10. 78 FR 13673 - HTC America, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Wolfman, Samuel; Shaked, Tali

    2008-12-01

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

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

    PubMed

    Douglas, Thomas M; Douglas, Nicholas M

    2009-10-01

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

  14. Research subject privacy protection in otolaryngology.

    PubMed

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

    2004-03-01

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

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

    PubMed

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

    2018-05-02

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

  16. SH Bell Site Boundary Map

    EPA Pesticide Factsheets

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

  17. 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

  18. In re Visbeck.

    PubMed

    1986-02-04

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

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

    PubMed

    Jafarey, Aamir M

    2002-07-01

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

  20. 77 FR 65550 - Compete, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-29

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

  1. 17 CFR 155.4 - Trading standards for introducing brokers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  2. 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...

  3. 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...

  4. 76 FR 2908 - Nonprofit Management LLC and Jeremy Ryan Claeys; Analysis of Proposed Consent Order To Aid Public...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-18

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

  5. 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...

  6. 17 CFR 155.3 - Trading standards for futures commission merchants.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  7. 17 CFR 155.3 - Trading standards for futures commission merchants.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  8. 75 FR 28654 - In the Matter of Certain Restraining Systems for Transport, Components Thereof, and Methods of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

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

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

    PubMed

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

    2015-01-10

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

  10. 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.

  11. 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.

  12. S.H. Bell Section 114 Information Request

    EPA Pesticide Factsheets

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

  13. Taiwan Policy Act of 2013

    THOMAS, 113th Congress

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

    2013-01-25

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

  14. 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...

  15. 78 FR 73895 - In the Matter of FMRI, Inc., Muskogee, Oklahoma Facility

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-09

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

  16. Governing the postmortem procurement of human body material for research.

    PubMed

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

    2015-03-01

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

  17. "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.

  18. Should informed consent be based on rational beliefs?

    PubMed Central

    Savulescu, J; Momeyer, R W

    1997-01-01

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

  19. Should informed consent be based on rational beliefs?

    PubMed

    Savulescu, J; Momeyer, R W

    1997-10-01

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

  20. Red Hill Administrative Order on Consent

    EPA Pesticide Factsheets

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

  1. Affirming the importance of the Taiwan Relations Act.

    THOMAS, 113th Congress

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

    2014-02-28

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

  2. Immediate Establishment of Syrian War Crimes Tribunal Resolution

    THOMAS, 113th Congress

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

    2013-09-09

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

  3. Western Hemisphere Drug Policy Commission Act of 2014

    THOMAS, 113th Congress

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

    2014-05-09

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

  4. 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.

  5. 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”).

  6. Emergency research without consent under Polish law.

    PubMed

    Rózyńska, Joanna; Czarkowski, Marek

    2007-09-01

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

  7. 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...

  8. 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...

  9. 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.

  10. 75 FR 79377 - NBTY, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

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

  11. 32 CFR 228.11 - Restrictions on the taking of photographs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  12. 32 CFR 228.11 - Restrictions on the taking of photographs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  13. 32 CFR 228.11 - Restrictions on the taking of photographs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  14. 32 CFR 228.11 - Restrictions on the taking of photographs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  15. 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”).

  16. 76 FR 26729 - Ceridian Corporation; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-09

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

  17. 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...

  18. 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.

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

    PubMed

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

    2016-01-01

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

  20. 29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

  1. 29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

  2. 29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

  3. 29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

  4. 29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

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

    EPA Pesticide Factsheets

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

  6. 76 FR 39105 - Beiersdorf, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... size. Part II covers any representation that a drug, dietary supplement, or cosmetic causes weight or..., about the health benefits of any drug, dietary supplement, or cosmetic, unless the representation is non...

  7. 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...

  8. 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...

  9. 12 CFR 509.203 - Answer, consequences of failure to answer, and consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the party lacks sufficient information to admit or deny each allegation of fact. A statement of lack... allowed may request that the Office exercise its discretion to vacate such a default Order. A default...

  10. Camp Minden Fact Sheet April 2014

    EPA Pesticide Factsheets

    Two groups of PRPs which include GD/ATK and Hercules Inc. signed Administrative Orders on Consent with the EPA that will remove and dispose approximately 3.7 million pounds of explosive material at the Explo Systems, Inc Camp Minden, Louisiana site.

  11. Clinical research involving minors in international and serbian regulations.

    PubMed

    Planojević, Nina; Zivojinović, Dragica

    2013-07-01

    Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

  12. Pastoral power and gynaecological examinations: a Foucauldian critique of clinician accounts of patient-centred consent.

    PubMed

    Cook, Catherine; Brunton, Margaret

    2015-05-01

    Invasive non-sedated clinical procedures such as gynaecological examinations are normalised; however, there is limited research highlighting the relational and technical skills required for clinicians to ensure patients' continued consent. A considerable body of research emphasises that women dislike examinations, leading to their non-compliance or a delayed follow up for gynaecological and sexual health problems. However, medical research focuses on 'problem' women; the role of clinicians receives limited appraisal. This article draws on interviews with sexual health clinicians in New Zealand, from metropolitan and provincial locations. The gynaecological care of women in New Zealand attained international notoriety with the 1988 publication of Judge Cartwright's inquiry into ethical shortcomings in cervical cancer research at the National Women's Hospital. Judge Cartwright's recommendations included patient-centred care in order to ensure informed consent had been received for clinical procedures and research participation. This article's critical analysis is that, although clinicians' language draws on humanistic notions of patient-centredness, Foucault's notion of secularised pastoral power enables a more nuanced appreciation of the ethical work undertaken by clinicians when carrying out speculum examinations. The analysis highlights both the web of power relations present during examination practices and the strategies clinicians use to negotiate women's continued consent; which is significant because consent is usually conceptualised as an event, rather than an unfolding, unstable process. © 2015 The Authors. Sociology of Health & Illness © 2015 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

  13. Minors' capacity to refuse treatment: a reply to Gilmore and Herring.

    PubMed

    Cave, Emma; Wallbank, Julie

    2012-01-01

    Re R and Re W allow a parent to consent to treatment a competent minor refuses, but the cases have not been tested post-Human Rights Act 1998. Gilmore and Herring offer a means by which they might be distinguished or sidelined. They interpret Gillick to say that in order to consent a minor need only have a full understanding of the particular treatment. They argue that the minors in Re R and Re W were refusing all treatment which requires a separate assessment of capacity-an assessment which was not made. We fear that this distinction would not be workable in clinical practice and argue that their interpretation of Gillick is flawed. From a clinician's point of view, competence cannot always be judged in relation to a specific treatment, but instead must relate to the decision. We show that a decision can incorporate more than one treatment, and more than one decision might be made about one treatment. A minor's understanding of a specific treatment is not always sufficient to demonstrate competence to make a decision. The result is that whilst there might be situations when a parent and a minor both have the power to consent to a particular treatment, they will not share concurrent powers in relation to the same decision. Consequently, a challenge to Re R and Re W, if forthcoming, would need to take a different form. We emphasise the necessity to minimise the dichotomy between legal consent and how consent works in medical practice.

  14. 77 FR 15803 - Notice of Lodging of Stipulated Order Regarding Modification of Consent Decree in United States v...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ... Decree in United States v. Kentucky Utilities Company Under the Clean Air Act Under 28 CFR 50.7, notice... Decree (``Stipulated Order'') between Kentucky Utilities Company (``Kentucky Utilities'') and the United... provisions of the Clean Air Act, 42 U.S.C. 7401, et seq., in connection with its operation of the E.W. Brown...

  15. Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023.

    THOMAS, 113th Congress

    Rep. Ryan, Paul [R-WI-1

    2013-03-15

    Senate - 10/16/2013 Ordered held at desk by unanimous consent. Pursuant to the order of 10/16/2013. (All Actions) Notes: Provisions of this budget resolution were included in H.J.RES.59. Tracker: This bill has the status Resolving DifferencesHere are the steps for Status of Legislation:

  16. 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”).

  17. 77 FR 71632 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

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

  18. 78 FR 23784 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-22

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

  19. Calling for an end to attacks on Syrian civilians and expanded humanitarian access.

    THOMAS, 113th Congress

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

    2014-03-14

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

  20. 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...

  1. 77 FR 28388 - Myspace, LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-14

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

  2. 76 FR 15311 - Legacy Learning Systems, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

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

  3. 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...

  4. 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...

  5. Intensive Care Unit Physician's Attitudes on Do Not Resuscitate Order in Palestine.

    PubMed

    Abdallah, Fatima S; Radaeda, Mahdy S; Gaghama, Maram K; Salameh, Basma

    2016-01-01

    There is some ambiguity concerning the do-not-resuscitate (DNR) orders in the Arabic world. DNR is an order written by a doctor, approved by the patient or patient surrogate, which instructs health care providers to not do CPR when cardiac or respiratory arrest occurs. Therefore, this research study investigated the attitudes of Intensive Care Unit physicians and nurses on DNR order in Palestine. A total of 123 males and females from four different hospitals voluntarily participated in this study by signing a consent form; which was approved by the Ethical Committee at Birzeit University and the Ministry of Health. A non-experimental, quantitative, descriptive, and co-relational method was used, the data collection was done by a three page form consisting of the consent form, demographical data, and 24 item-based questionnaire based on a 5-point-Likert scale from strongly agree (score 1) to strongly disagree (score 5). The Statistical Package for Social Sciences (SPSS) software program version 17.0 was used to analyze the data. Finding showed no significant relationship between culture and opinion regarding the DNR order, but religion did. There was statistical significance difference between the physicians' and nurses' religious beliefs, but there was no correlation. Moreover, a total of 79 (64.3%) physicians and nurses agreed with legalizing the DNR order in Palestine. There was a positive attitude towards the legalization of the DNR order in Palestine, and culture and religion did not have any affect towards their attitudes regarding the legalization in Palestine.

  6. Medical decision-making capacity in cognitively impaired Parkinson's disease patients without dementia.

    PubMed

    Martin, Roy C; Okonkwo, Ozioma C; Hill, Joni; Griffith, H Randall; Triebel, Kristen; Bartolucci, Alfred; Nicholas, Anthony P; Watts, Ray L; Stover, Natividad; Harrell, Lindy E; Clark, David; Marson, Daniel C

    2008-10-15

    Little is currently known about the higher order functional skills of patients with Parkinson disease and cognitive impairment. Medical decision-making capacity (MDC) was assessed in patients with Parkinson's disease (PD) with cognitive impairment and dementia. Participants were 16 patients with PD and cognitive impairment without dementia (PD-CIND), 16 patients with PD dementia (PDD), and 22 healthy older adults. All participants were administered the Capacity to Consent to Treatment Instrument (CCTI), a standardized capacity instrument assessing MDC under five different consent standards. Parametric and nonparametric statistical analyses were utilized to examine capacity performance on the consent standards. In addition, capacity outcomes (capable, marginally capable, or incapable outcomes) on the standards were identified for the two patient groups. Relative to controls, PD-CIND patients demonstrated significant impairment on the understanding treatment consent standard, clinically the most stringent CCTI standard. Relative to controls and PD-CIND patients, PDD patients were impaired on the three clinical standards of understanding, reasoning, and appreciation. The findings suggest that impairment in decisional capacity is already present in cognitively impaired patients with PD without dementia and increases as these patients develop dementia. Clinicians and researchers should carefully assess decisional capacity in all patients with PD with cognitive impairment. (c) 2008 Movement Disorder Society.

  7. Cabin Fee Act of 2014

    THOMAS, 113th Congress

    Rep. Hastings, Doc [R-WA-4

    2014-06-17

    House - 06/19/2014 Ordered to be Reported by Unanimous Consent. (All Actions) Notes: For further action, see H.R.3979, which became Public Law 113-291 on 12/19/2014. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. 75 FR 80051 - The Dannon Company, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

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

  9. 76 FR 75883 - Facebook, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

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

  10. 78 FR 9355 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; Removal of the Mount...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... of the Environment (MDE) for the purpose of removing Mount Saint Mary's College 1979 Consent Order....regulations.gov Web site is an ``anonymous access'' system, which means EPA will not know your identity or...

  11. 77 FR 58837 - CarePatrol, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

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

  12. 78 FR 18629 - Notice of Lodging of Proposed Partial Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-27

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

  13. 40 CFR 57.403 - Written consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  14. Clinical Research Involving Minors in International and Serbian Regulations

    PubMed Central

    PLANOJEVIĆ, Nina; ŽIVOJINOVIĆ, Dragica

    2013-01-01

    Background: Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be – it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative’s consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors’ position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative’s consent is acceptable only for therapeutic research, because these can bring benefits to everyone’s health, including a minor in which those are conducted – this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other’s behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors’ participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model. PMID:24455493

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

    PubMed

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

    2008-10-23

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

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

    PubMed

    Pieper, I J; Thomson, C J H

    2014-01-01

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

  17. 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...

  18. 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...

  19. 77 FR 12588 - Long Fence & Home, LLLP; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... homeowners can realize by replacing their windows, including the home's geographic location, size, insulation... window of a specific composition in a building having a specific level of insulation in a specific region..., energy savings, energy [[Page 12590

  20. 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...

  1. 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...

  2. 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

  3. Peace Corps Volunteer Service Improvement Act of 2011

    THOMAS, 112th Congress

    Rep. Ros-Lehtinen, Ileana [R-FL-18

    2011-07-29

    House - 09/21/2011 Ordered to be Reported by Unanimous Consent. (All Actions) Notes: For further action, see S.1280, which became Public Law 112-57 on 11/21/2011. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  4. [Medical treatment without patient's consent and against her will].

    PubMed

    Margolin, Jacob; Mester, Roberto

    2014-01-01

    This is a case of a pregnant woman with labor pain, who was admitted to hospital and refused any life-saving medical examination and treatment in spite of the danger to her fetus and herself. There was immediate danger and shortage of time to organize the hospital ethics committee meeting in order to obtain permission to treat the competent patient by force, according to the Israeli Patient Rights Act of 1996. Hence, an urgent application to the District Court was submitted. The District Judge came to the hospital, and the legal procedure was conducted in the medical ward. After hearing all the parties involved, a legal decision was issued, giving the medical staff the permission to perform any examination and give the patient any necessary medical intervention in order to prevent damages to the fetus and the patient, in spite of the lack of informed consent. The case description is followed by a discussion of the legal ways of treating competent patients who refuse life-sustaining treatment by force and against their will.

  5. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya.

    PubMed

    Okello, George; Jones, Caroline; Bonareri, Maureen; Ndegwa, Sarah N; McHaro, Carlos; Kengo, Juddy; Kinyua, Kevin; Dubeck, Margaret M; Halliday, Katherine E; Jukes, Matthew C H; Molyneux, Sassy; Brooker, Simon J

    2013-05-16

    There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors' experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. National Institute of Health NCT00878007.

  6. Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya

    PubMed Central

    2013-01-01

    Background There are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya. Methods Data collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors’ experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial. Results Early meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period. Conclusions A range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa. Trial registration National Institute of Health NCT00878007 PMID:23680181

  7. Kate Puzey Peace Corps Volunteer Protection Act of 2011

    THOMAS, 112th Congress

    Rep. Poe, Ted [R-TX-2

    2011-06-23

    House - 09/21/2011 Ordered to be Reported by Unanimous Consent. (All Actions) Notes: For further action, see S.1280, which became Public Law 112-57 on 11/21/2011. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  8. 78 FR 49763 - Certain Sleep-Disordered Breathing Treatment Systems and Components Thereof; Commission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-15

    ... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-879] Certain Sleep-Disordered Breathing... Consent Order and Termination of the Investigation AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has determined not...

  9. District of Columbia Financial Efficiency Act of 2013

    THOMAS, 113th Congress

    Rep. Issa, Darrell E. [R-CA-49

    2013-07-23

    House - 07/24/2013 Ordered to be Reported by Unanimous Consent. (All Actions) Notes: For further action, see H.R.3343, which became Public Law 113-71 on 12/26/2013. Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  10. 40 CFR 721.10029 - Isocyanate compound, modified with methoxysilane (generic).

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... to those contained in the corresponding section 5(e) consent order. (ii) Hazard communication program...) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanate compound, modified with methoxysilane (PMN P-01-918) is subject to reporting under...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 75 FR 68306 - Modification of Significant New Uses of 2-Propen-1-one, 1-(4-morpholinyl)-

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... protective equipment (including gloves demonstrated to be impervious) and respiratory personal protective... remaining potential risks, the modified consent order: Requires the use of dermal personal protective... , including any personal information provided, unless the comment includes information claimed to be...

  17. 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

  18. 77 FR 25235 - Significant New Use Rules on Certain Chemical Substances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

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

  19. 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

  20. 40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

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

    PubMed

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

    2011-03-01

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

  2. Addiction and autonomy: can addicted people consent to the prescription of their drug of addiction?

    PubMed

    Foddy, Bennett; Savulescu, Julian

    2006-02-01

    It is often claimed that the autonomy of heroin addicts is compromised when they are choosing between taking their drug of addiction and abstaining. This is the basis of claims that they are incompetent to give consent to be prescribed heroin. We reject these claims on a number of empirical and theoretical grounds. First we argue that addicts are likely to be sober, and thus capable of rational thought, when approaching researchers to participate in research. We reject behavioural evidence purported to establish that addicts lack autonomy. We present an argument that extrinsic forces must be irresistible in order to make a choice non-autonomous. We argue that heroin does not present such an irresistible force. We make a case that drug-oriented desires are strong regular appetitive desires, which do not compromise consent. Finally we argue that an addict's apparent desire to engage in a harmful act cannot be construed as evidence of irrational or compulsive thought. On these arguments, a sober heroin addict must be considered competent, autonomous and capable of giving consent. More generally, any argument against legalisation of drugs or supporting infringement of the liberty of those desiring to take drugs of addiction must be based on considerations of harm and paternalism, and not on false claims that addicts lack freedom of the will.

  3. From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

    PubMed Central

    Manta, Christine J.; Ortiz, Jacqueline; Moulton, Benjamin W.; Sonnad, Seema S.

    2016-01-01

    Objective This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making. Methods Sixty in person interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information and open ended questions to determine reactions, clarity of information and suggestions for improvement. Results While 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read. Recurrent suggestions included: specific formatting changes to enhance readability, a need for additional sources of information, mixed attitudes towards inclusion of risk information and the recognized importance of physician-patient conversations. Conclusion This study provides evidence from the patient perspective that consent forms are too complex and fail to achieve comprehension. Future studies should be conducted using patients’ suggestions for form redesign and inclusion of supplemental educational tools in order to optimize communication and safety to achieve more informed health care decision making. PMID:27490160

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

    PubMed

    Bliss, Sally E; Macauley, Robert C

    2015-01-01

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

  5. 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

  6. 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.

  7. 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...

  8. 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...

  9. 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

  10. 77 FR 16224 - Billion Auto, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... Social Security number, date of birth, driver's license number or other state identification number or... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes... advertised, the rate be stated as an ``annual percentage rate'' using that term or the abbreviation ``APR...

  11. 77 FR 16225 - Ramey Motors, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ..., like anyone's Social Security number, date of birth, driver's license number or other state... include competitively sensitive information such as costs, sales statistics, inventories, formulas..., the rate be stated as an ``annual percentage rate'' using that term or the abbreviation ``APR.'' In...

  12. Update on Kansas City Middle Blue River Green Infrastructure Pilot Project - seminar

    EPA Science Inventory

    In 2010, Kansas City, MO (KCMO) signed a consent degree with EPA on combined sewer overflows. The City decided to use adaptive management in order to extensively utilize green infrastructure (GI) in lieu of, and in addition to, structural controls. KCMO installed 130 GI storm con...

  13. 77 FR 12590 - Winchester Industries; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... homeowners can realize by replacing their windows, including the home's geographic location, size, insulation... insulation in a specific region). The performance standard imposed under this Part constitutes fencing-in... costs, heating and cooling costs, U-factor, solar heat gain coefficient, R-value, K-value, insulating...

  14. 77 FR 12586 - Serious Energy, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... the home's geographic location, size, insulation package, and existing windows. Consumers who replace... insulation in a specific region). The performance standard imposed under this Part constitutes fencing-in... costs, heating and cooling costs, U-factor, solar heat gain coefficient, R-value, K-value, insulating...

  15. A joint resolution to consent to certain amendments enacted by the legislature of the State of Hawaii to the Hawaiian Homes Commission, Act, 1920.

    THOMAS, 113th Congress

    Sen. Schatz, Brian [D-HI

    2013-03-21

    Senate - 07/15/2013 Placed on Senate Legislative Calendar under General Orders. Calendar No. 133. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  16. 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...

  17. 78 FR 79028 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... finding or (ii) as to which the self-regulatory organization consents, the Commission will: (A) By order... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71156; File No. SR-NSCC-2013-13] Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing of Proposed Rule Change...

  18. 78 FR 77181 - Self-Regulatory Organizations; The Options Clearing Corporation; Advance Notice Concerning the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-20

    ... finding or (ii) as to which the self-regulatory organization consents, the Commission will: (A) By order... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71083; File No. SR-OCC-2013-807] Self-Regulatory Organizations; The Options Clearing Corporation; Advance Notice Concerning the Governance...

  19. 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...

  20. 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.

  1. 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...

  2. 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...

  3. 12 CFR 19.131 - Notice of charges and answer.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... PROCEDURE Disciplinary Proceedings Involving the Federal Securities Laws § 19.131 Notice of charges and... associated person. The notice must indicate the type of disciplinary action being contemplated and the... representative shall be deemed to have consented to the issuance of a disciplinary order. (b) All proceedings...

  4. Update on Kansas City Middle Blue River Green Infrastructure Pilot Project

    EPA Science Inventory

    In 2010, Kansas City, MO (KCMO) signed a consent degree with EPA on combined sewer overflows. The City decided to use adaptive management in order to extensively utilize green infrastructure (GI) in lieu of, and in addition to, gray structural controls. KCMO installed 130 GI sto...

  5. 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.

  6. 78 FR 7431 - Cbr Systems, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-01

    ... include any sensitive personal information, like anyone's Social Security number, date of birth, driver's... limited to, the following: name, address, email address, telephone number, date of birth, Social Security... collects personal information, such as fathers' Social Security numbers, and the company collects...

  7. 77 FR 2543 - Upromise, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... involves the advertising, marketing, and operation of an optional feature of that Toolbar, the ``personalized offers'' feature. That feature modified the Toolbar to provide targeted advertising to the... available, low-cost measures to assess and address the risks to consumer information; (3) failed to ensure...

  8. Legal aspects of administrating antipsychotic medications to jail and prison inmates.

    PubMed

    Dlugacz, Henry; Wimmer, Christopher

    2013-01-01

    The administration of antipsychotic medications to jail and prison inmates involves two related components: conducting the informed consent process in a coercive environment and, where consent is not obtained, forcible administration of medication if needed. In the United States, both involve common law, statutory, and constitutional principles. Obtaining informed consent in correctional institutions is complicated. Patients in correctional institutions lack access to alternate sources of information, and depend on the correctional system completely - a system which they may distrust. This may influence the patient's view of the administering physician. Where consent cannot be obtained, forcible administration may be legally permissible for two primary reasons: to restore a criminal defendant to competency in order to stand trial and to ameliorate severe symptoms of mental disability, particularly when they threaten the safety of self, others, or in some instances, property. The interests at stake for the individual and the government, and the legal standards developed to balance these interests, differ between the two situations. When considering challenges to forcible medication of inmates serving a prison sentence, the United States Supreme Court has treated the interest of the institution in maintaining security as paramount. By contrast, when considering challenges to forcible medication of pretrial detainees, the Court's concern for the fair trial rights guaranteed by the Sixth Amendment has seemingly led it to moderate its emphasis on security. However, this distinction is not stable and may in fact be breaking down, as the recent case of Jared Loughner demonstrates. This article discusses the various federal, state, and international legal standards applicable to both informed consent and forcible medication, and their implementation in the correctional setting, focusing on issues related to the United States. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2017-03-01

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

  11. 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

  12. 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.

  13. The writing of informed consent in accessible language: difficulties.

    PubMed

    Fernandes, Nurimar C

    2015-06-01

    In order to assess the adequacy of informed consent terminology of research projects developed at the Clementino Fraga Filho University Hospital (Federal University of Rio de Janeiro) , we conducted a review study on the terminology found in 55 projects (2008-20013) . Such projects belonged to different medical specialties and were all registered in the hospital's Ethics in Research Committee. Patients had difficulty in understanding the meanings of 76 medical terms and expressions; only 12 of them could be replaced. On the other hand, the present study reached the conclusion that, in most cases, the writing with scientific terms is essential in items such as justification/objectives and procedures, being insurmountable obstacles to the participants of this research and patients' understanding.

  14. Acute cardiomyopathy with MCAT abuse.

    PubMed

    Redfern, Andrew; Sampson, Caroline; Giovannelli, Marco

    2015-02-01

    Consent This article has been accepted for publication as a letter rather than a case report due to an inability to contact the patient to gain written or verbal consent for publication. The letter has been anonymised, and the author affiliations are available by request to the Editor-in-Chief. The manuscript has undergone extensive review by JICS editors and the Editor-in-Chief of another medical journal in order to ensure that the principles behind its publication strictly adhere to the guidance of the Committee on Publication Ethics. Caldicott Guardian approval for its publication has been given by the Executive Medical Director of the Trust in which the patient was treated. All reviewers believe that the message being imparted justifies its publication albeit in an anonymised form.

  15. Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals.

    PubMed

    Lawton, Julia; Snowdon, Claire; Morrow, Susan; Norman, Jane E; Denison, Fiona C; Hallowell, Nina

    2016-04-11

    Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur. To address these potential difficulties, we undertook a qualitative evaluation of the internal pilot of a trial (Got-it) involving women who had a retained placenta (RP). We explored the experiences and views of women and staff about the information and consent pathway used within the pilot, in order to provide recommendations for use in future peripartum trials involving recruitment in emergency situations. In-depth interviews were undertaken with staff (n = 27) and participating women (n = 22). Interviews were analysed thematically. The accounts of women and staff were compared to identify differences and similarities in their views about recruitment and consent procedures. Women and staff regarded recruitment as having been straightforward and facilitated by the use of simplified (verbal and written) summaries of trial information. Both parties, however, conveyed discordant views about whether fully informed consent had been obtained. These differences in perspectives appeared to arise from the different factors and considerations impinging on women and staff at the time of recruitment. While staff placed emphasis on promoting understanding in the emergency situation of RP by imparting information in clear and succinct ways, women highlighted the experiential realities of their pre- and post-birthing situations, and how these had led to quick decisions being made without full engagement with the potential risks of trial participation. To facilitate informed consent, women suggested that trial information should be given during the antenatal period, and, in doing so, articulated a rights-based discourse. Staff, however, voiced opposition to this approach by emphasising a duty of care to all pregnant women, and raising concerns about causing undue distress to the majority of individuals who would not subsequently develop a RP. By drawing upon the perspectives of women and staff involved in the same trial we have shown that they may operate within different experiential and ethical paradigms. In doing so, we argue for the potential benefits of drawing upon multiple perspectives when developing information and consent pathways used in future (peripartum) trials. ISCRTN 88609453 .

  16. 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.

  17. 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...

  18. 76 FR 20669 - Oreck Corporation; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... use, in killing virtually all bacteria, viruses, germs, mold and allergens that exist on carpets and... reduces the risk of or prevents other illnesses or ailments caused by bacteria, viruses, molds, and... also alleges that Oreck claimed that the Oreck Halo's UV-C light is effective against germs, bacteria...

  19. 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...

  20. 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...

  1. 49 CFR Appendix I to Part 511 - Final Prehearing Order

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... to Rule 21 of the Administration's Rules of Practice for Adjudicative Proceedings, on the day of , 19..., graphs, models, schematic diagrams, and similar objects that will be used in opening statements or... prior to signing. It will control the course of the hearing, and it may not be amended except by consent...

  2. 77 FR 16228 - Key Hyundai of Manchester, LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... Social Security number, date of birth, driver's license number or other state identification number or... information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes... consumer credit. It also requires that if any finance charge is advertised, the rate be stated as an...

  3. 77 FR 12591 - THV Holdings LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... homeowners can realize by replacing their windows, including the home's geographic location, size, insulation... having a specific level of insulation in a specific region). The performance standard imposed under this... consumption, energy savings, energy costs, heating and cooling costs, U-factor, solar heat gain coefficient, R...

  4. 77 FR 12584 - Gorell Enterprises, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-01

    ... location, size, insulation package, and existing windows. Consumers who replace single or double-paned wood... a building having a specific level of insulation in a specific region). The performance standard... consumption, energy savings, energy costs, heating and cooling costs, U-factor, solar heat gain coefficient, R...

  5. 77 FR 2724 - CVS Caremark Corporation; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-19

    ... Medicare drug plans and Medicare Part D drugs. CVSC currently owns multiple subsidiaries, including RxAmerica, that offer Medicare Part D prescription drug plans. Medicare Part D is a prescription drug... Part D benefits, beneficiaries must enroll in a Medicare drug plan administered by an insurer or other...

  6. 78 FR 55717 - TRENDnet, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Pennsylvania Avenue NW., Washington, DC 20580, either in person or by calling (202) 326- 2222. You can file a... interested persons. Comments received during this period will become part of the public record. After thirty..., increases consumers' susceptibility to physical tracking or stalking, and reduces consumers' ability to...

  7. Guidance: Revised Model CERCLA Section 122(g)(4) De Minimis Contributor CD and AOC and New Model ATP Provisions for De Minimis Settlements

    EPA Pesticide Factsheets

    Cover memorandum and four attachments containing model language for de minimis settlement consent decrees and/or administrative orders and ability to pay provisions in de minimis settlements for ability to pay and non-ability to pay parties.

  8. 78 FR 3427 - Motorola Mobility LLC and Google Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... such circumstances ``simply requires those making promises to keep them.'' \\16\\ \\15\\ See, e.g... FEDERAL TRADE COMMISSION [File No. 121-0120] Motorola Mobility LLC and Google Inc.; Analysis of... from breaches by Google and its subsidiary Motorola Mobility, Inc. (``Motorola'') of Motorola's...

  9. 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...

  10. 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...

  11. 76 FR 57043 - Andrew N. Finkel; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ... personal information, like anyone's Social Security number, date of birth, driver's license number or other... heightened security screening. As a result, we encourage you to submit your comments online. To make sure... respondent developed and sold in Google's Android Marketplace. Respondent claimed that Acne Pwner effectively...

  12. 78 FR 75350 - Goldenshores Technologies, LLC and Erik M. Geidl; Analysis of Proposed Consent Order To Aid...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-11

    ... that your comment does not include any sensitive personal information, like anyone's Social Security... heightened security screening. As a result, we encourage you to submit your comments online. To make sure... Flashlight App'') to consumers for use on their Android mobile devices. The Brightest Flashlight App...

  13. 78 FR 76182 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... finding or (ii) as to which the self-regulatory organization consents, the Commission will: (A) By order... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-71030; File No. SR-OCC-2013-18] Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing of Proposed Rule Change Concerning the...

  14. 75 FR 5322 - Indoor Tanning Association; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ... represented that tanning causes the skin to generate vitamin D and has health benefits, but that respondent... or performance, or health-related risks or benefits, of any covered product or service; or about the sources, performance, efficacy, or health-related risks or benefits of vitamin D; unless the...

  15. 28 CFR 549.80 - Authority to conduct autopsies.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... this section, the Warden may order an autopsy or post-mortem operation, including removal of tissue for... person (e.g., coroner, or next-of-kin, or the decedent's consent in the case of tissue removed for...-of-kin that they may telegraph the institution collect with their response. Where permission is not...

  16. 28 CFR 549.80 - Authority to conduct autopsies.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... this section, the Warden may order an autopsy or post-mortem operation, including removal of tissue for... person (e.g., coroner, or next-of-kin, or the decedent's consent in the case of tissue removed for...-of-kin that they may telegraph the institution collect with their response. Where permission is not...

  17. 75 FR 48338 - Intel Corporation; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ... integrated into chipsets as well as discrete graphics cards. NVIDIA has been at the forefront of developing... to connect peripheral products such as discrete GPUs to the CPU. A bus is a connection point between... platform. Intel's commitment to maintain an open PCIe bus will provide discrete graphics manufacturers...

  18. 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...

  19. 78 FR 46952 - Relief-Mart, Inc.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... information, like anyone's Social Security number, date of birth, driver's license number or other state... involves respondent's marketing and sale of memory foam mattresses. According to the FTC's complaint... marketing of VOC-free mattresses. It prohibits respondent from making zero-VOC claims unless the VOC...

  20. 12 CFR 390.74 - Civil money penalties.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Civil money penalties. 390.74 Section 390.74... Proceedings § 390.74 Civil money penalties. (a) Assessment. In the event of consent, or if upon the record... civil money penalty upon the party concerned. The assessment order shall be effective immediately upon...

  1. 75 FR 16123 - Dave & Buster’s, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-31

    ... computer networks or to conduct security investigations, such as by employing an intrusion detection system and monitoring system logs; (b) failed to adequately restrict third-party access to its networks, such... reasonable and appropriate security for personal information on its computer networks. Among other things...

  2. 75 FR 45114 - Rite Aid Corporation; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ..., among other things, approximately 4,900 retail pharmacy stores in the United States (collectively, ``Rite Aid pharmacies'') and an online pharmacy business. The company allows consumers buying products in... obtained by all Rite Aid entities, including, but not limited to, retail pharmacies. The security program...

  3. 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...

  4. 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).

  5. 49 CFR 1503.657 - Appeal from initial decision.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... AND ENFORCEMENT PROCEDURES Rules of Practice in TSA Civil Penalty Actions § 1503.657 Appeal from... order of the TSA decision maker have been entered on the record. (b) Issues on appeal. A party may... appeal with the consent of the TSA decision maker. If the TSA decision maker grants an extension of time...

  6. 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...

  7. 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...

  8. 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...

  9. Performance results from Small- and Large-Scale System Monitoring and green Infrastructure in Kansas City - slides

    EPA Science Inventory

    In 2010, Kansas City, MO (KCMO) signed a consent degree with EPA on combined sewer overflows. The City decided to use adaptive management in order to extensively utilize green infrastructure (GI) in lieu of, and in addition to, structural controls. KCMO installed 130 GI storm co...

  10. 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...

  11. 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.

  12. 77 FR 48858 - Significant New Use Rules on Certain Chemical Substances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

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

  13. 75 FR 57169 - Significant New Use Rules on Certain Chemical Substances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-20

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

  14. 12 CFR 390.74 - Civil money penalties.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Civil money penalties. 390.74 Section 390.74... Proceedings § 390.74 Civil money penalties. (a) Assessment. In the event of consent, or if upon the record... civil money penalty upon the party concerned. The assessment order shall be effective immediately upon...

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

    Dotson, Patrick Wells

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2015-04-01

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

  18. An Analysis of Organ Donation Policy in the United States.

    PubMed

    Ahmad, Ghazi; Iftikhar, Sadia

    2016-05-02

    There is currently an organ shortage crisis in the United States. This paper analyzes the magnitude of the problem, the organ procurement programs in other developed countries as compared to the US, and discusses the changes that can be made to address this problem. With the opt-in or explicit-consent method currently practiced in the US, less that one third of the population consents to organ donation. In order to narrow the gap between the demand and supply of organs, steps need to be taken to improve the organ procurement infrastructure. The public needs to be educated about the dire need, the benefits and risks in organ donation, and living vs. deceased donation. [Full article available at http://rimed.org/rimedicaljournal-2016-05.asp, free with no login].

  19. Revisiting Postoperative Vision Loss following Non-Ocular Surgery: A Short Review of Etiology and Legal Considerations.

    PubMed

    Mendel, Ehud; Stoicea, Nicoleta; Rao, Rahul; Niermeyer, Weston; Revilla, Stephen; Cluse, Marcus; Sandhu, Gurneet; Todaro, Gerald J; Bergese, Sergio D

    2017-01-01

    Postoperative vision loss (POVL) following non-ocular surgery is a serious complication where the causes are not fully understood. Studies have identified several causes of POVL as well as risk factors and prevention strategies. POVL research is made difficult by the fact that cases are often subject to malpractice claims, resulting in a lack of public access to case reports. This literature review was conducted in order to identify legal issues as a major barrier to studying POVL and address how this affects current knowledge. Informed consent provides an opportunity to overcome legal challenges by reducing malpractice litigation through educating the patient on this outcome. Providing pertinent information regarding POVL during the informed consent process has potential to reduce malpractice claims and increase available clinical information.

  20. A randomized trial comparing concise and standard consent forms in the START trial

    PubMed Central

    Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen

    2017-01-01

    Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12 PMID:28445471

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

    PubMed Central

    2012-01-01

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

  2. Using Google AdWords for international multilingual recruitment to health research websites.

    PubMed

    Gross, Margaret S; Liu, Nancy H; Contreras, Omar; Muñoz, Ricardo F; Leykin, Yan

    2014-01-20

    Google AdWords, the placement of sponsored links in Google search results, is a potent method of recruitment to Internet-based health studies and interventions. However, the performance of Google AdWords varies considerably depending on the language and the location of the target audience. Our goal was to describe differences in AdWords performance when recruiting participants to the same study conducted in four languages and to determine whether AdWords campaigns can be optimized in order to increase recruitment while decreasing costs. Google AdWords were used to recruit participants to the Mood Screener, a multilingual online depression screening tool available in English, Russian, Spanish, and Chinese. Two distinct recruitment periods are described: (1) "Unmanaged", a 6-month period in which ads were allowed to run using only the AdWords tool itself, with no human intervention, and (2) "Managed", a separate 7-week period during which we systematically sought to optimize our recruitment campaigns. During 6 months of unmanaged recruitment, our ads were shown over 1.3 million times, resulting in over 60,000 site visits. The average click-through rate (ratio of ads clicked to ads displayed) varied from 1.86% for Chinese ads to 8.48% for Russian ads, as did the average cost-per-click (from US $0.20 for Chinese ads to US $0.50 for English ads). Although Chinese speakers' click-through rate was lowest, their rate of consenting to participate was the highest, at 3.62%, with English speakers exhibiting the lowest consent rate (0.97%). The conversion cost (cost to recruit a consenting participant) varied from US $10.80 for Russian speakers to US $51.88 for English speakers. During the 7 weeks of "managed" recruitment, we attempted to improve AdWords' performance in regards to the consent rate and cost by systematically deleting underperforming ads and adjusting keywords. We were able to increase the number of people who consent after coming to the site by 91.8% while also decreasing per-consent cost by 23.3%. Our results illustrate the need to linguistically and culturally adapt Google AdWords campaigns and to manage them carefully to ensure the most cost-effective results.

  3. Disclosing details about the medical treatment of a deceased public figure in a book: Who should have consented to the disclosures in Mandela's Last Days?

    PubMed

    McQuoid-Mason, D J

    2017-11-27

    A recently published book by the head of Nelson Mandela's medical team made personal disclosures about his treatment of the late president in his final years up until his death. The author claimed that he had written the book at the request of family members. This was contested by some family members and the executors of Mandela's estate, and the book was subsequently withdrawn by the publishers. The Mandela book case raises ethical and legal questions about who should consent to publication of medical information about public figures after their death. The ethical rules of conduct of the Health Professions Council of South Africa (HPCSA) state that confidential information about a deceased person should only be divulged 'with the written consent of his or her next of kin or the executor of his or her estate'. 'Next of kin' is not defined, however, and problems arise when family members and the executors are divided about giving such written consent. It is recommended that in such cases the specific order of priority for consent by relatives in the National Health Act be followed. However, conduct that is unethical under the rules of the HPCSA may not necessarily be actionable under the law. For instance, the law does not protect the confidentiality of deceased persons, and generally when people die their constitutional and common-law personality rights - including their right to privacy and confidentiality - die with them. This means that the next of kin or executors of the estates of deceased persons may not bring actions for damages on behalf of such persons for breaches of confidentiality arising after their deaths. The next of kin may, however, sue in their personal capacity if they can show that the disclosures were an unlawful invasion of their own privacy. Conversely, if the privacy of interests of the next of kin are not harmed where there has been publication without their consent, they will not be able to sue for damages.

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

    PubMed

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

    2012-06-11

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

  5. 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

  6. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

  7. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

  8. 21 CFR 50.25 - Elements of informed consent.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

  9. A systematic literature review on security and privacy of electronic health record systems: technical perspectives.

    PubMed

    Rezaeibagha, Fatemeh; Win, Khin Than; Susilo, Willy

    Even though many safeguards and policies for electronic health record (EHR) security have been implemented, barriers to the privacy and security protection of EHR systems persist. This article presents the results of a systematic literature review regarding frequently adopted security and privacy technical features of EHR systems. Our inclusion criteria were full articles that dealt with the security and privacy of technical implementations of EHR systems published in English in peer-reviewed journals and conference proceedings between 1998 and 2013; 55 selected studies were reviewed in detail. We analysed the review results using two International Organization for Standardization (ISO) standards (29100 and 27002) in order to consolidate the study findings. Using this process, we identified 13 features that are essential to security and privacy in EHRs. These included system and application access control, compliance with security requirements, interoperability, integration and sharing, consent and choice mechanism, policies and regulation, applicability and scalability and cryptography techniques. This review highlights the importance of technical features, including mandated access control policies and consent mechanisms, to provide patients' consent, scalability through proper architecture and frameworks, and interoperability of health information systems, to EHR security and privacy requirements.

  10. Mothers' perceptions of their child's enrollment in a randomized clinical trial: poor understanding, vulnerability and contradictory feelings.

    PubMed

    Carvalho, Adriana Assis; Costa, Luciane Rezende

    2013-12-10

    Little is known about the views of mothers when their children are invited to participate in randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand mothers' perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation. This is a qualitative study based on semi-structured interviews with mothers accompanying children under 3 years old presenting severe early childhood caries. Their responses were analyzed using content analysis. We identified one major theme from 15 mothers' responses - "Understanding of, attitudes toward, and feelings about consenting to participate in a RCT involving advanced behavior guidance techniques and about randomization" - that was derived from the following subcategories: confusion in defining techniques, questions after signing the consent form, lack of knowledge about the techniques, acceptance or questioning of the drawing, sharing responsibility with the child during the drawing, and feelings of faith in God, fear, powerlessness to choose, and relief from or an increase in pressure. Despite mothers' misunderstanding, vulnerability, and contradictory feelings, they were willing to overlook their thoughts in order to complete their children's dental treatment.

  11. 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

  12. 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.

  13. 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.

  14. 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%.

  15. 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.

  16. Evaluating Active Parental Consent Procedures for School Programming: Addressing the Sensitive Topic of Suicide Prevention.

    PubMed

    Totura, Christine M Wienke; Kutash, Krista; Labouliere, Christa D; Karver, Marc S

    2017-02-01

    Suicide is the second leading cause of death for adolescents. Whereas school-based prevention programs are effective, obtaining active consent for youth participation in public health programming concerning sensitive topics is challenging. We explored several active consent procedures for improving participation rates. Five active consent methods (in-person, students taking forms home, mailing, mailing preceded by primers, mailing followed by reminder calls) were compared against passive consent procedures to evaluate recruitment success, as determined by participation (proportion who responded yes) and response (proportion who returned any response) rates. Participation acceptance rates ranged from 38 to 100% depending on consent method implemented. Compared with passive consent, active consent procedures were more variable in response and participation rates. In-person methods provided higher rates than less interpersonal methods, such as mailing or students taking consents home. Mailed primers before or reminder calls after consent forms were mailed increased response but not participation rates. Students taking consents home resulted in the lowest rates. Although passive consent produces the highest student participation, these methods are not always appropriate for programs addressing sensitive topics in schools. In-person active consent procedures may be the best option when prioritizing balance between parental awareness and successful student recruitment. © 2017, American School Health Association.

  17. Undergraduate Consent Form Reading in Relation to Conscientiousness, Procrastination, and the Point-of-Time Effect.

    PubMed

    Theiss, Justin D; Hobbs, William B; Giordano, Peter J; Brunson, Olivia M

    2014-07-01

    Informed consent is central to conducting ethical research with human participants. The present study investigated differences in consent form reading in relation to conscientiousness, procrastination, and the point-of-time (PT) effect among undergraduate participants at a U.S. university. As hypothesized, conscientious participants and those who signed up to participate in a research study more days in advance and for earlier sessions (PT effect) read the consent form more thoroughly. However, procrastination was not related to consent form reading. Most importantly, consent form reading in general was poor, with 80% of participants demonstrating that they had not read the consent form. Conscientious participants were more likely to self-report reading the consent form, irrespective of their measured consent form reading. The article closes with suggestions to improve the process of obtaining informed consent with undergraduate participants. © The Author(s) 2014.

  18. 78 FR 55763 - National Environmental Policy Act; Santa Susana Field Laboratory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... inform the analysis and consultation. These include surveys for wildlife, critical habitat, rare plants..., Coca, and Delta. Area II and the LOX Plant portion of Area I were acquired by NASA from the U.S. Air... Oxygen [LOX] Plant) of SSFL (pursuant to the 2007 Consent Order).'' As part of the environmental review...

  19. 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...

  20. 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...

  1. 78 FR 10211 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... upon written request and payment of reproduction costs. Please mail your request and payment to... money order for $253.75 (25 cents per page reproduction costs for 1,015 pages for the entire Decree plus... is $28.75 (25 cents per page reproduction costs for 115 pages). Henry Friedman, Assistant Chief...

  2. 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.

  3. 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.

  4. 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.

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. The Impact of Authentic Leadership on Ethical Behavior

    DTIC Science & Technology

    2016-05-25

    56 APPENDIX C - INFORMED CONSENT AND SURVEY INSTRUMENT ...................57 APPENDIX D - DOD PRINCIPLES OF...BEHAVIOR 1 UNCLASSIFIED Chapter 1 Introduction The U.S. Army has been a principled organization since its inception...George H. W. Bush signed Executive Order 12674 on April 12, 1989. This set out 14 basic principles of ethical conduct that Department of Defense

  10. 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...

  11. 78 FR 46949 - Essentia Natural Memory Foam Company, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... information, like anyone's Social Security number, date of birth, driver's license number or other state.... This matter involves respondent's marketing and sale of memory foam mattresses. According to the FTC's... marketing of VOC-free mattresses. It prohibits respondent from making zero-VOC claims unless the VOC...

  12. Consolidated Quarterly Report: Number of potential release sites subject to corrective action

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

    Cochran, John R.

    2017-04-01

    This Sandia National Laboratories, New Mexico Environmental Restoration Operations (ER) Consolidated Quarterly Report (ER Quarterly Report) fulfills all quarterly reporting requirements set forth in the Resource Conservation and Recovery Act Facility Operating Permit and the Compliance Order on Consent. The 12 sites in the corrective action process are listed in Table I-1.

  13. 40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  14. 40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  15. 40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  16. 40 CFR 799.5025 - Testing consent orders for mixtures without Chemical Abstracts Service Registry Numbers.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  17. 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...

  18. 76 FR 80915 - Environmental Management Site-Specific Advisory Board, Northern New Mexico

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ...), Ed Worth and Lee Bishop Welcome and Introductions, Ralph Phelps 3:15 p.m. Environmental Cleanup.... Consent Order Update 6 p.m. Public Comment Period, Ralph Phelps 7 p.m. Adjourn, Lee Bishop and Ed Worth... presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a...

  19. 10 CFR 2.338 - Settlement of issues; alternative dispute resolution.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... who is expected to try the case for each party be present and that the parties, or agents having full... facts; (2) An express waiver of further procedural steps before the presiding officer, of any right to... rights to seek judicial review or otherwise to contest the validity of the consent order; (3) A statement...

  20. 10 CFR 2.338 - Settlement of issues; alternative dispute resolution.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... who is expected to try the case for each party be present and that the parties, or agents having full... facts; (2) An express waiver of further procedural steps before the presiding officer, of any right to... rights to seek judicial review or otherwise to contest the validity of the consent order; (3) A statement...

  1. 77 FR 16227 - Frank Myers AutoMaxx, LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... FEDERAL TRADE COMMISSION [File No. 112 3206] Frank Myers AutoMaxx, LLC; Analysis of Proposed... ``Frank Myers AutoMaxx, File No. 112 3206'' on your comment, and file your comment online at https... April 16, 2012. Write ``Frank Myers AutoMaxx, File No. 112 3206'' on your comment. Your comment...

  2. The Cultural Phenomenon of Identity Theft and the Domestication of the World Wide Web

    ERIC Educational Resources Information Center

    Caeton, Daniel A.

    2007-01-01

    Through a critique of the rhetorical configurations of identity theft, this article contributes to the emerging body of theory contending with the social effects of digital information technologies (DIT). It demonstrates how the politics of fear manipulate technosocial matrices in order to derive consent for radical changes such as the…

  3. 77 FR 63833 - Equifax Information Services LLC; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... late on their mortgage payments. Such prescreened lists are ``consumer reports'' because information... Equifax violated Section 604(c) of the FCRA by furnishing consumer reports to persons that it did not have reason to believe had a permissible purpose to obtain a consumer report. The proposed complaint alleges...

  4. 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...

  5. Calling on the government of Iran to fulfill their promises of assistance in this case of Robert Levinson, one of the longest held United States civilians in our Nation's history.

    THOMAS, 113th Congress

    Rep. Deutch, Theodore E. [D-FL-21

    2013-12-10

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

  6. 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...

  7. 77 FR 17479 - Star Pipe Products, Ltd.; Analysis of Proposed Consent Order To Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... largest sellers of DIPF in the United States are Star, McWane, Inc. (``McWane''), and Sigma Corporation (``Sigma''). DIPF are used in municipal water distribution systems to change pipe diameter or pipeline... projects. The end users of DIPF are typically municipal and regional water authorities. DIPF prices are...

  8. 43 CFR 3931.100 - Boundary pillars and buffer zones.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... otherwise specified in writing by the BLM. Boundary and other main pillars may be mined only with the BLM's prior written consent or on the BLM's order. For in-situ operations, a 50-foot buffer zone from the..., mine out and remove all available oil shale in such boundary pillar, both in the lands covered by the...

  9. 43 CFR 3931.100 - Boundary pillars and buffer zones.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... otherwise specified in writing by the BLM. Boundary and other main pillars may be mined only with the BLM's prior written consent or on the BLM's order. For in-situ operations, a 50-foot buffer zone from the..., mine out and remove all available oil shale in such boundary pillar, both in the lands covered by the...

  10. 43 CFR 3931.100 - Boundary pillars and buffer zones.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... otherwise specified in writing by the BLM. Boundary and other main pillars may be mined only with the BLM's prior written consent or on the BLM's order. For in-situ operations, a 50-foot buffer zone from the..., mine out and remove all available oil shale in such boundary pillar, both in the lands covered by the...

  11. 43 CFR 3931.100 - Boundary pillars and buffer zones.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... otherwise specified in writing by the BLM. Boundary and other main pillars may be mined only with the BLM's prior written consent or on the BLM's order. For in-situ operations, a 50-foot buffer zone from the..., mine out and remove all available oil shale in such boundary pillar, both in the lands covered by the...

  12. 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...

  13. 40 CFR 721.10237 - Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  14. 40 CFR 721.10237 - Formaldehyde, polymers with acetone-phenol reaction products and phenol, sodium salts.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  15. 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...

  16. 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...

  17. Factors affecting consent in pediatric critical care research.

    PubMed

    Menon, Kusum; Ward, Roxanne E; Gaboury, Isabelle; Thomas, Margot; Joffe, Ari; Burns, Karen; Cook, Deborah

    2012-01-01

    Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors. A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters. We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88). This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient's care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.

  18. 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.

  19. 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

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

    PubMed

    Allmark, P; Mason, S

    2006-08-01

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

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

    PubMed

    Lad, Pramod M; Dahl, Rebecca

    2014-06-01

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

  2. 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.

  3. 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

  4. 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.

  5. 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.

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

    PubMed

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

    2015-11-01

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

  7. The Effects of Requiring Parental Consent for Research on Adolescents' Risk Behaviors: A Meta-analysis.

    PubMed

    Liu, Chao; Cox, Ronald B; Washburn, Isaac J; Croff, Julie M; Crethar, Hugh C

    2017-07-01

    Requiring parental consent may result in sampling biases that confound scientific conclusions and stifle the representation of children most at risk for adverse outcomes. This study aims to investigate whether active parental consent, compared with passive parental consent, creates a bias in response rate, demographic makeup, and adverse outcomes in adolescent samples. A meta-analysis was performed on peer-reviewed articles and unpublished dissertations from 1975 to 2016 in five computerized databases ERIC, PsycINFO, MEDLINE, PubMed and ProQuest. Quantitative studies were retained if they included the following keywords: active consent (or informed consent or parental consent), passive consent (or waiver of consent), risk behavior, adolescen*. Fifteen studies were identified with a total number of 104,074 children. Results showed (1) response rates were significantly lower for studies using active consent procedure than those using passive consent procedure (Z = 3.05, p = .002); (2) more females, younger participants, and less African-Americans were included in studies using active consent procedures than studies using passive procedures (Z = -2.73, p = .006; Z = -12.06, p < .00001; Z = 2.19, p = .03, respectively); (3) studies with passive consent procedures showed higher rates of self-reported substance use than studies using active consent procedures (Z = 3.07, p = .002). Requiring active parental consent can lead to a systematic bias in the sample where the population under study is misrepresented. Institutional review board committees should collaborate with researchers to find solutions that protect minors without silencing the voice of high-risk youth in the literature. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  8. Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

    PubMed Central

    Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

    2012-01-01

    Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

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

    PubMed Central

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

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

  10. Commentary on "Waiting in Araf". Informed consent: issues and regulations.

    PubMed

    Catlin, A

    1998-01-01

    Children have the right to safety and appropriate consideration of their physical, emotional, and psychological needs in regards to treatment or research decisions. Parents have an equal right to be honored in their parenthood and respected for what they would want as the best thing for their child as a member of the family. When children are mature enough, they should be offered the opportunity of assenting or dissenting to research participation. Until such time, parents may make what they feel to be the best decisions. If a nurse feels that these principles are being violated, he or she should attempt to seek further clarification. In order to obtain information about an ongoing research project, it would be appropriate to contact the IRB or a member of the hospital ethics committee. In most cases, a satisfactory explanation will be found. In the rare case that patient's rights are truly being violated, the American Nurses Association Code of Ethics requires that nurses report incompetent, unethical, or illegal practices (ANA, 1994). Nurses who "whistle-blow" may or may not be protected against retaliation. Some states in the U.S. have developed laws that prohibit the discharge of an employee who reports unethical practices. One might expect that in some countries a nurse might not only endanger her position for such reporting but endanger his or her life as well. Ulusoy reports on research done on children without knowledge or consent of parents. Although this case took place long ago, it is certain that there are still countries in which informed consent is undeveloped and such practices continue. Nurses in developed countries with established consent policies can be hopeful that such activity is no longer seen here. As international collaboration in nursing research grows, nurses in developed nations can work to provide educational opportunities regarding the consent process for colleagues across the globe.

  11. 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.

  12. Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.

    PubMed

    Lawton, J; Hallowell, N; Snowdon, C; Norman, J E; Carruthers, K; Denison, F C

    2017-05-24

    Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial (trial registration number: ISCRTN 88609453 ). Date of registration 26/03/2014.

  13. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy

    PubMed Central

    Borello, Alessandro; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Results Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Conclusions Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding. PMID:28352847

  14. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

    PubMed

    Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

    2016-01-01

    Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

  15. 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

  16. Sterilizing the mentally-handicapped: who can give consent?

    PubMed

    1980-01-26

    Due to the vulnerable position of the mentally handicapped individual, the question of whether the state or any other interested 3rd party should intervene in procreative rights even with consent will depend to a great extent on the ability and autonomy of the individual to make the decision. There are 3 elements to consent: 1) it must be voluntary; 2) it requires that the individual has sufficient information to make a decision; and 3) it is imperative that the person providing the consent have the mental competence to appreciate exactly what is being consented to and the implication of the consent. Consent can be either personal consent or it may be "3rd party" consent. The 3rd party consent is used when an individual is incapable of providing personal consent. It is crucially important that those mentally handicapped individuals who are capable of making a decision do make such a decision when they agree to undergo sterilization. There is nothing inherent in mental handicap that prevents an individual from providing competent consent to a sterilization. The situation when someone other than the individual to be sterilized consents to the procedure poses more problems. Some glaring problems that arise when 3rd party consent on behalf of full-time residents in state institutions is allowed are the following: 1) state coercion behind such decisions is too easily concealed; 2) persuasion can be brought to bear on parents who already bear the stigma of a mentally handicapped child; and 3) administrative convenience may too easily be substituted for the benefit to the individual.

  17. Planned Parenthood League of Massachusetts v. Bellotti.

    PubMed

    1989-02-07

    The Planned Parenthood League of Massachusetts instituted a class action suit challenging the constitutionality of a statute requiring minors seeking an abortion to obtain parental consent or to persuade a judge of their maturity to give informed consent or that abortion would be in their best interest. In order to invoke judicial review, the plaintiffs moved their suit to federal court. The District Court dismissed the case on grounds that federal review power would interfere with state administration. On appeal, the First Circuit Court of Appeals decided that the plaintiffs could proceed with their action. The Circuit Court found that federal adjudication would not unduly interfere with state administration and remanded the case for further proceedings. Although it affirmed the statute's validity, the circuit court ruled that the plaintiffs must be allowed the opportunity to demonstrate the statute's unconstitutionality.

  18. Norwood Hospital v. Munoz.

    PubMed

    1991-01-15

    Norwood Hospital petitioned the Probate and Family Court of Norfolk County, Masssachusetts, for an order authorizing it to administer blood to Munoz, a Jehovah's Witness and mother of a minor child, without her consent. On appeal, the Supreme Judicial Court of Massachusetts held that Munoz had a constitutional and common law right to refuse a blood transfusion. The doctrine of informed consent requires a doctor to disclose to competent patients information sufficient to enable them to make an informed judgment on whether to receive medical treatment. While this right can be outweighed by certain interests, including protection of innocent third parties, that interest only outweighs the parent's choice where there is compelling evidence that the child will be abandoned. The record here revealed strong family support for Munoz' decision, and the family's willingness and means to care for the child.

  19. Revisiting Postoperative Vision Loss following Non-Ocular Surgery: A Short Review of Etiology and Legal Considerations

    PubMed Central

    Mendel, Ehud; Stoicea, Nicoleta; Rao, Rahul; Niermeyer, Weston; Revilla, Stephen; Cluse, Marcus; Sandhu, Gurneet; Todaro, Gerald J.; Bergese, Sergio D.

    2017-01-01

    Postoperative vision loss (POVL) following non-ocular surgery is a serious complication where the causes are not fully understood. Studies have identified several causes of POVL as well as risk factors and prevention strategies. POVL research is made difficult by the fact that cases are often subject to malpractice claims, resulting in a lack of public access to case reports. This literature review was conducted in order to identify legal issues as a major barrier to studying POVL and address how this affects current knowledge. Informed consent provides an opportunity to overcome legal challenges by reducing malpractice litigation through educating the patient on this outcome. Providing pertinent information regarding POVL during the informed consent process has potential to reduce malpractice claims and increase available clinical information. PMID:28695122

  20. The Limits of Surrogates' Moral Authority and Physician Professionalism: Can the Paradigm of Palliative Sedation Be Instructive?

    PubMed

    Berger, Jeffrey T

    2017-01-01

    With narrow exception, physicians' treatment of incapacitated patients requires the consent of health surrogates. Although the decision-making authority of surrogates is appropriately broad, their moral authority is not without limits. Discerning these bounds is particularly germane to ethically complex treatments and has important implications for the welfare of patients, for the professional integrity of clinicians, and, in fact, for the welfare of surrogates. Palliative sedation is one such complex treatment; as such, it provides a valuable model for analyzing the scope of surrogates' moral authority. Guidelines for palliative sedation that present it as a "last-resort" treatment for severe and intractable suffering yet require surrogate consent in order to offer it are ethically untenable, precisely because the moral limits of surrogate authority have not been considered. © 2017 The Hastings Center.

  1. 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.

  2. Community pharmacists' experience with pharmacogenetic testing.

    PubMed

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

    2015-01-01

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

  3. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    PubMed

    Lee, Stacey B

    2010-06-15

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections.

  4. [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.

  5. Maximizing Patient Recruitment and Retention in a Secondary Stroke Prevention Clinical Trial: Lessons Learned from the STAND FIRM Study.

    PubMed

    Thayabaranathan, Tharshanah; Cadilhac, Dominique A; Srikanth, Velandai K; Fitzgerald, Sharyn M; Evans, Roger G; Kim, Joosup; Gerraty, Richard P; Phan, Thanh G; Bladin, Christopher F; Nelson, Mark R; Frayne, Judith H; Thrift, Amanda G

    2016-06-01

    Recruitment and retention of patients in a clinical trial is important for generalizability and robustness of findings. We aimed to investigate features of a study design that were associated with recruitment and retention in a Phase II and Phase III trial of a secondary prevention program for stroke. Following informed consent in hospital, Phase II participants were randomized to intervention or usual care. Baseline clinical assessments were conducted at home approximately 3 months after discharge. In Phase III study, informed consent was obtained at home. We compared the characteristics of participants recruited and retained to 12 months for both phases. Interviews with study nurses were undertaken in order to ascertain their opinions of features of study design. Triangulation was used to identify the features of study design that nurses thought had improved recruitment and retention. All 24 eligible participants were recruited to the Phase II pilot study (100% recruitment), with 67% retention at 12 months. In Phase III study, 570 participants were recruited, and 93% of these participants had reached their 12-month assessment (n = 532) and were still participating. Consistent with the greater patient retention in Phase III study, nurses reported that patients' willingness to participate was greater when consent was obtained at home. Following a change in the consent process from hospital to home, more participants continued participation to 12 months. Pilot studies can provide important data to improve study design and better understand potential barriers to recruitment and retention. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  6. The moral concerns of biobank donors: the effect of non-welfare interests on willingness to donate.

    PubMed

    De Vries, Raymond G; Tomlinson, Tom; Kim, H Myra; Krenz, Chris D; Ryan, Kerry A; Lehpamer, Nicole; Kim, Scott Y H

    2016-01-01

    Donors to biobanks are typically asked to give blanket consent, allowing their donation to be used in any research authorized by the biobank. This type of consent ignores the evidence that some donors have moral, religious, or cultural concerns about the future uses of their donations - concerns we call "non-welfare interests". The nature of non-welfare interests and their effect on willingness to donate to a biobank is not well understood.In order to better undersand the influence of non-welfare interests, we surveyed a national sample of the US population (in June 2014) using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants' willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns. Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness.Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors' non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations.

  7. 78 FR 56183 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; Imperium, LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-12

    ... Proposed Parental Consent Method; Imperium, LLC Application for Approval of Parental Consent Method AGENCY... Trade Commission requests public comment concerning the proposed parental consent method submitted by... Parental Consent Method, Project No. P-135419'' on your comment, and file your comment online at https...

  8. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

  9. 42 CFR 441.257 - Informed consent.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

  10. 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.

  11. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

    PubMed

    Kim, Eun Jin; Kim, Su Hyun

    2015-06-01

    This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

  12. [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.

  13. [Deferred consent for inclusion of patients unable to give their consent in studies in the field of emergency medicine].

    PubMed

    Kompanje, E J O; Jansen, T C; Le Noble, J L M L; de Geus, H R; Bakker, J

    2008-09-20

    Respect for individual autonomy, expressed in the concept of informed consent, is a basic principle in research with humans. Many patients in intensive care are unable to give consent because of mental incapacity, and this can be further complicated in emergency research, in which the treatment or experiment needs to be initiated without delay. In those situations consent can be deferred. Randomization is done without prior consent, followed by patients' or relatives' consent at a later stage. Butwhat should one do with the data if the patient dies at an early stage after randomization before consent could be obtained? Should the data be used or not? Should the relatives be asked for consent for using the data? The Dutch Central Committee on Research involving Human Subjects (CCMO) states that asking for consent after the patient has died makes no sense, because with the death of the patient the research has ended. Relatives do not have the authority to give consent for the use of medical data after the patient has died. Data can be used anonymously in the final analysis of the trial. We propose a flowchart for this procedure.

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

    PubMed Central

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

    2016-01-01

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

  15. Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture

    PubMed Central

    2014-01-01

    Background Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Discussion Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients. There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Summary Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner. PMID:24495473

  16. Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture.

    PubMed

    Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

    2014-02-04

    Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient's best interest, and doing no harm in decision-making for patients.There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.

  17. 78 FR 2398 - Motorola Mobility LLC and Google Inc.; Analysis of Proposed Consent Order to Aid Public Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-11

    ... responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any ``[t]rade... overnight service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news...

  18. Concerns regarding Direct-to-Consumer Hearing Aid Purchasing

    ERIC Educational Resources Information Center

    Kimball, Suzanne H.

    2010-01-01

    An individual over age 18 can purchase a hearing aid online or through mail order if they sign a waiver declining a medical evaluation, while those under 18 are required to be seen by a physician to obtain medical consent. However, in many states there is nothing to prevent a parent or caregiver from purchasing hearing aids for their child from a…

  19. The End of Democracy and the Modes of Resistance in Education

    ERIC Educational Resources Information Center

    Reis, Carlos Sousa; Formosinho, Dores; Del Dujo, Ágel García

    2017-01-01

    Our scope is to show how democracy has been trivialized as a concept and, more worryingly, as a mystified practice of consented servitude, which supposedly would bring to its very end. In fact, for the emblematic occidental societies, democracy has, at the best, been reduced to a consumerist way of life, under the capitalist liberal order, and the…

  20. 40 CFR 799.5000 - Testing consent orders for substances and mixtures with Chemical Abstract Service Registry Numbers.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

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