Sample records for act consent order

  1. 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...

  2. 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.

  3. 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.

  4. 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...

  5. 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.

  6. 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).

  7. 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...

  8. 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...

  9. 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...

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

    PubMed

    Russell, Pascale Sophie; Piazza, Jared

    2015-01-01

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

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 77 FR 66978 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9750-5] Proposed Consent Decree, Clean Air Act Citizen Suit... public comment. SUMMARY: In accordance with section 113(g) of the Clean Air Act, as amended (``CAA... 5 Generating Plant, a power plant located in Milam County, Texas. Under the proposed consent decree...

  17. 76 FR 56756 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

    ...:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or... requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree...

  18. 76 FR 45564 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal... Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or... requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree...

  19. 78 FR 23560 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file... Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or... requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree...

  20. 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...

  1. 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.

  2. 77 FR 14784 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ...., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on... of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose... inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent...

  3. 78 FR 42802 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act, Clean Air Act, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-17

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act, Clean Air Act, and Resource Conservation and Recovery Act On July 11, 2013, the Department of Justice lodged a proposed consent decree with the United States District Court for the Western District of Arkansas in the lawsuit entitled United States v....

  4. 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...

  5. 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...

  6. 76 FR 9610 - Notice of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

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

  7. 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.

  8. 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.

  9. 78 FR 70960 - Notice of Lodging of Consent Decree Under the Clean Air Act, Clean Water Act, and the Resource...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act, Clean Water Act, and the Resource Conservation and Recovery Act On November 20, 2013, the Department of Justice lodged a proposed consent decree with the United States District Court for the Central District of Illinois in the lawsuit entitled United States v....

  10. 76 FR 64379 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act Notice is hereby given that on October 7, 2011, a proposed Consent Decree in United States, et al. v. the... the Western District of North Carolina. The proposed Consent Decree in this Clean Water Act...

  11. 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...

  12. 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).

  13. 77 FR 38654 - Notice of Lodging of Consent Decree Pursuant to the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-28

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Pursuant to the Clean Water Act Notice is hereby given that on June 21, 2012, a proposed Consent Decree in United States v. Russell Stover... Clean Water Act. The Consent Decree requires the company to pay a civil penalty of $585,000 and perform...

  14. 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...

  15. 78 FR 21150 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on December 20, 2012, a proposed Consent Decree in United States v. Authority for the... of the Clean Water Act, 33 U.S.C. 1344, and the Rivers and Harbor Act, 33 U.S.C. 403, in connection...

  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. 76 FR 56757 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-14

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

  18. 77 FR 45605 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... Ave. NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal... or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or... the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should...

  19. 77 FR 517 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-05

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

  20. 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.

  1. 75 FR 1770 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ...:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM... parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or... the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should...

  2. 76 FR 45562 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    .... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... not named as parties or intervenors to the litigation in question. EPA or the Department of Justice... requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree...

  3. 78 FR 53143 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ...:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM... parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or... the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should...

  4. 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.

  5. 75 FR 42130 - Notice of Lodging of Consent Decree Under the Clean Air Act; Clean Water Act; Resource...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act; Clean Water Act; Resource Conservation and Recovery Act; Safe Drinking Water Act; Toxic Substances Control Act; and the Reporting Requirements of the Emergency Planning and Community Right-To-Know Act and the Comprehensive Environmental Response, Compensation, and...

  6. 76 FR 79172 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

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

  7. 78 FR 60280 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

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

  8. 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.

  9. 77 FR 1085 - Notice of Lodging of Consent Decree Under the Oil Pollution Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-09

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Oil Pollution Act Notice is hereby given that on December 21, 2011, a proposed Consent Decree in United States v. Marathon Pipe Line... resource damages under the Oil Pollution Act, 33 U.S.C. 2710, et seq., which arose from an alleged August...

  10. 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.

  11. 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.

  12. 75 FR 26275 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act... Hovnanian's violations of the Clean Water Act (``CWA'') as well as violations of state and federal National... by the Consent Decree. The proposed Complaint alleges three types of storm water violations...

  13. 14 CFR 13.77 - Consent order of compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 75 FR 79390 - Notice of Lodging of a Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... DEPARTMENT OF JUSTICE Notice of Lodging of a Consent Decree Under the Clean Water Act Notice is hereby given that on December 13, 2010, a proposed Consent Decree (``Decree'') in United States and the... would resolve claims against DeKalb County for the Clean Water Act violations involving its sanitary...

  19. 78 FR 1251 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act On December 21, 2012, the Department of Justice lodged a proposed consent decree with the United States... Oil Pollution Act, 33 U.S.C. 2702, 2706, and Section 128D of the Hawaii Environmental Response law...

  20. 78 FR 41423 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act On July 2, 2013, the Department of Justice lodged a proposed Consent Decree with the United States... 1002 of the Oil Pollution Act, 33 U.S.C. 2702 and similar Alaska state provisions. The natural resource...

  1. 78 FR 69875 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-21

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act On November 15, 2013, the Department of Justice lodged a proposed consent decree with the United States... against Suncor (U.S.A.) Inc. (``Suncor'') pursuant to the Oil Pollution Act, 33 U.S.C. 2701-2762. The...

  2. 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...

  3. 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.

  4. 75 FR 67719 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-03

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9220-1] Proposed Consent Decree, Clean Air Act Citizen Suit... suit to compel the Administrator to take final action under section 110(k) of the Act on Imperial... special characters and any form of encryption, and may be mailed to the mailing address above. FOR FURTHER...

  5. 77 FR 50531 - Notice of Lodging of Consent Decree Pursuant to the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Pursuant to the Clean Water Act In accordance with 28 CFR 50.7, 38 FR 19029, notice is hereby given that on August 15, 2012, a Consent Decree... (``Fitchburg'') violated Sections 309(b) and (d) of the Clean Water Act (``CWA''), 33 U.S.C. 1309(b) and (d...

  6. 76 FR 59738 - Notice of Lodging of Consent Decree Under the National Marine Sanctuaries Act, The Park System...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the National Marine Sanctuaries Act, The Park System Resource Protection Act, The Oil Pollution Act and The Clean Water Act Notice is hereby given that on September 19, 2011, a proposed Consent Decree in United States v. M/V COSCO BUSAN...

  7. 75 FR 11560 - Notice of Lodging of Consent Decree Under the Clean Water Act and Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act and Clean Air... for the Defendant's violations of the Clean Water Act, 33 U.S.C. 1251 et seq., and the Clean Air Act... including the installation of water effluent controls, the rerouting of air emissions through control...

  8. 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...

  9. 75 FR 71125 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... public comment. SUMMARY: In accordance with section 113(g) of the Clean Air Act, as amended (``CAA'' or the ``Act''), 42 U.S.C. 7413(g), notice is hereby given of a proposed consent decree to address a... section 110(k)(2) of the CAA, 42 U.S.C. 7410(k)(2), to take timely final action on a submission entitled...

  10. 75 FR 7627 - Notice of Lodging of Proposed Consent Decree Under the Federal Water Pollution Control Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    .... (``Defendants'') under the pre-treatment requirements of the Federal Water Pollution Control Act (Clean Water... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Federal Water Pollution Control Act Notice is hereby given that on February 16, 2010, a proposed Consent Decree was filed...

  11. 76 FR 27350 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on April 27, 2011, a proposed Consent Decree in United States v. Town of Greenwich... violation of the Town's National Pollutant Discharge Elimination System Permit issued under the Clean Water...

  12. 77 FR 1948 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ... Hospitality Associates, Inc., for violations of Sections 301, 308, and 402(p) of the Federal Water Pollution Control Act, as amended (the ``Clean Water Act'' or the ``Act''), 33 U.S.C. 1311, 1318 & 1342(p), and... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is...

  13. 77 FR 518 - Notice of Lodging of the Consent Decree Under the Resource Conservation and Recovery Act and the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-05

    ... DEPARTMENT OF JUSTICE Notice of Lodging of the Consent Decree Under the Resource Conservation and Recovery Act and the Clean Water Act Notice is hereby given that on December 22, 2011, a proposed Consent... Erie's Resource Conservation and Recovery Act (``RCRA'') violations stemming from its failure to meet...

  14. 76 FR 15998 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on March 14, 2011, a proposed consent decree in United States v. Consol Energy, Inc., et al., Civil Action No. 1:11-cv-00028, was lodged with the United States District Court for the...

  15. 77 FR 36003 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on June 11, 2012, a proposed Consent Decree in United States v. Siemens Industry, Inc.... Siemens Industry, Inc., D.J. Ref. 90-5-1-1-09287. During the public comment period, the proposed Decree...

  16. 75 FR 30859 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-02

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby given that on May 24, 2010, a proposed Consent Decree in United States, and South Coast Air Quality Management District v. Lifoam Industries, LLC, Civil Action No. 10-CV-03825-AHM- FFM was lodged with the...

  17. 75 FR 52371 - Notice of Lodging of Consent Decree Under The Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under The Clean Air Act Notice is hereby given that on August 12, 2010, a proposed Consent Decree in United States v. RP Baking, LLC. Civil... Justice, Washington, DC 20044-7611, and should refer to either: United States v. RP Baking, LLC, Civil...

  18. 78 FR 1251 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act, the Clean Water Act and the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Air Act, the Clean Water Act and the Resource Conservation and Recovery Act On December 31, 2012, the Department of....C. 7401 et seq.; the Clean Water Act, 33 U.S.C. 1301 et seq.; and the Resource Conservation and...

  19. 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...

  20. 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...

  1. 76 FR 61738 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... United States and the Allegheny County Health Department for violations of the Clean Air Act, 42 U.S.C... and the Allegheny County Health Department allege that Eastman violated the Clean Air Act by failing... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby...

  2. 78 FR 2260 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-10

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9769-3] Proposed Consent Decree, Clean Air Act Citizen Suit... public comment period. SUMMARY: On December 7, 2012, in accordance with section 113(g) of the Clean Air... promulgate emission standards for hazardous air pollutant emissions from brick and structural clay products...

  3. 75 FR 10503 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby... alleged violations of the Clean Air Act at the DEGs of Narrows, LLC facility in Narrows, Virginia. The complaint alleged that DEGs of Narrows, LLC violated the Clean Air Act, Sections 110, 112 and 502 of the CAA...

  4. 75 FR 42131 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby... Defendants' violations of the Clean Air Act, 42 U.S.C. 7411 et seq., and the New Jersey Air Pollution Control... compliance with regulations promulgated pursuant to the Clean Air Act. The Department of Justice will receive...

  5. 77 FR 48980 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9716-2] Proposed Consent Decree, Clean Air Act Citizen Suit... 16, 2011, Plaintiff filed a deadline suit to compel the Administrator to respond to an administrative..., avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address...

  6. 78 FR 68093 - Notice of Lodging of Consent Decree; Pursuant to the Resource Conservation and Recovery Act and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree; Pursuant to the Resource Conservation and Recovery Act and the Clean Water Act On October 28, 2013, the Department of Justice lodged a proposed Consent Decree (``Decree'') in the United States District Court for the Eastern District of Kentucky in the lawsuit entitled United States of...

  7. 77 FR 55861 - Notice of Lodging of Consent Decree Under the Oil Pollution Act of 1990 (“OPA”)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Oil Pollution Act of 1990 (``OPA'') Notice is hereby given that on September 4, 2012, a proposed Consent Decree in United States et... International under Section 1002 of OPA and Section 48-1-90 of the South Carolina Pollution Control Act, S.C...

  8. 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...

  9. 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...

  10. 78 FR 11682 - Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act of 1990 and the Clean...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Oil Pollution Act of 1990 and the Clean Water Act On February 12, 2013, the Department of Justice lodged a proposed consent... claims (1) for penalties and injunctive relief under Sections 301 and 311 of the Clean Water Act (``CWA...

  11. 77 FR 40084 - Notice of Lodging of Modification of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Modification of Consent Decree Under the Clean Water Act Notice is hereby given that on June 29, 2012, a proposed Modification of Consent Decree...'') to, among other things, implement injunctive relief measures at 126 water treatment plants (WTPs...

  12. 78 FR 44599 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On July 15, 2013, the Department of Justice lodged a proposed consent decree with the United States District Court for the Western District of Arkansas in the lawsuit entitled United States v. Lion Oil Company, Civil Action No. 1:13-cv-01059-SOH. The...

  13. 78 FR 40769 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-08

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On July 1, 2013, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of Kansas in the lawsuit entitled United States v. Kansas Department of Transportation, Civil Action No. 13-cv-04069. The...

  14. 78 FR 65384 - Notice of Lodging of Consent Decree Pursuant to the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Pursuant to the Clean Water Act On September 30, 2013, the Department of Justice lodged a proposed Consent Decree (``Decree'') in the United States District Court for the Western District of Tennessee in the lawsuit entitled United States of America v. ConAgra Foods, Inc., and ConAgra...

  15. 78 FR 23957 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On April 4, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of New Hampshire in the lawsuit entitled United States v. Torromeo Industries, Inc., Civil Action No. 1:10-cv-509-JL....

  16. 78 FR 79484 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On December 24, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Southern District of Indiana in the lawsuit entitled United States of America and the State of Indiana v. City of Crawfordsvill...

  17. 78 FR 42801 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-17

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On July 11, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Eastern District of North Carolina (Southern Division) in the lawsuit entitled United States v. City of Wilmington, N.C., New...

  18. 78 FR 79008 - Notice of Lodging of Proposed Consent Decree under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree under the Clean Water Act On December 19, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Connecticut in the lawsuit entitled United States v. City of West Haven, Connecticut, Civil Action No. 3:13-cv-0188...

  19. 78 FR 34406 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On June 3, 2013, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of Idaho in the lawsuit entitled United States v. Davisco Foods International, Inc., Civil Action No. 11-cv-00458-EJL CV...

  20. 78 FR 46369 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On July 23, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Western District of Texas in the lawsuit entitled United States and State of Texas v. San Antonio Water System, Civil Action No. 5...

  1. 77 FR 75446 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On December 13, 2012, the Department of Justice lodged a proposed a consent decree with the United States District Court for the Middle District of Pennsylvania in the lawsuit entitled United States v. Sewer Authority of the City of Scranton, Civil Actio...

  2. 78 FR 41422 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On July 3rd, 2013, the Department of Justice lodged a proposed consent decree with the United States District Court for the Western District of Arkansas in the lawsuit entitled United States v. Great Lakes Chemical Company, Civil Action No. 1:13-cv-01058...

  3. 77 FR 14830 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act Notice is hereby... Clean Air Act, 42 U.S.C. 7413(b). Defendant processes aluminum scrap and dross to produce various secondary aluminum products, a process that results in emissions of regulated air pollutants, including...

  4. 76 FR 79710 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is.... Metropolitan Water Reclamation District of Greater Chicago, Civil Action No. 1:11- cv-08859, was lodged with... sought penalties and injunctive relief under the Clean Water Act (``CWA'') against the Metropolitan Water...

  5. 75 FR 57980 - Notice of Extension of Comment Period on Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... DEPARTMENT OF JUSTICE Notice of Extension of Comment Period on Proposed Consent Decree Under the Clean Water Act Notice is hereby given that the comment period on the proposed Consent Decree (``Consent Decree'') in United States of America et al. v. City of Revere, Massachusetts, Civil Action No. 1:10-cv...

  6. 75 FR 43206 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is... times in the absence of a National Pollutant Discharge Elimination System Permit issued under the Clean Water Act, 33 U.S.C. 1251, et seq., and with respect to violations of the Oil Pollution Prevention...

  7. 78 FR 35315 - Notice of Lodging of Proposed Consent Decree Under The Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-12

    ... Clean Water Act (``CWA'') Sections 309(b) and (d) and 504, 33 U.S.C. 1319(b) and (d) and 1364, and the Florida Air and Water Pollution Control Act, Fla. Stat. Chapter 403, seeking penalties and injunctive... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under The Clean Water Act On...

  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. 75 FR 37837 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is..., Inc., (``Colaska'') was liable, pursuant to Section 309(b) and (d) of the Clean Water Act, 33 U.S.C... governing the discharge of storm water at a road and bridge construction site in Anchorage, Alaska during...

  11. 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.

  12. 78 FR 65385 - Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-31

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act On Wednesday, October 23, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Utah (Central Division) in the lawsuit entitled United States v. Newfield Production Company,...

  13. 76 FR 51397 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... the Clean Water Act, 33 U.S.C. 1251 et seq., at its sewer system and water pollution control plant. To... extensive work to its sewer system and water pollution control plant to eliminate violations of the Clean... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is...

  14. 78 FR 61867 - Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-04

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act On September 26, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Montana, Great Falls Division, in the lawsuit entitled United States v. Gros Ventre and Assiniboine Tribes...

  15. 75 FR 26274 - Notice of Lodging of Consent Decree Pursuant To the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Pursuant To the Clean Water Act Notice... Section 309(b) and (d) of the Clean Water Act, 33 U.S.C. 1319(b) and (d), and for violations of Section 301 (a) of the Clean Water Act, 33 U.S.C. 1311(a). The Complaint alleges that Defendant is liable for...

  16. 78 FR 73206 - Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act On November 23, 2013 the Department of Justice lodged a proposed Consent Decree (``Decree'') with the United States District Court for the District of Wyoming in the lawsuit entitled United States v. Bryan Pownall, Civil Action No. 13-CV-142-F....

  17. 77 FR 43860 - Notice of Lodging of Consent Decree Pursuant to the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... water, and applicable oil pollution prevention regulations, at Fairhaven Shipyard's two facilities at 50... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Pursuant to the Clean Water Act In... Companies, Inc. (``Fairhaven Shipyard'') violated Sections 301, 311, and 402 of the Clean Water Act, 33 U.S...

  18. 77 FR 40382 - Notice of Lodging of Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Safe Drinking Water Act Notice... civil penalties for alleged violations of the Safe Drinking Water Act (``SDWA''), 42 U.S.C. 300f through 300j-26, including violations of the National Primary Drinking Water Regulations (``NPDWRs''), at...

  19. 76 FR 9609 - Notice of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... the Environmental Protection Agency and the San Joaquin Valley Unified Air Pollution Control District... related to emissions of pollutants; install and operate required pollution control technology; undertake... DEPARTMENT OF JUSTICE Notice of Proposed Consent Decree Under the Clean Air Act Notice is hereby...

  20. 78 FR 24777 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On... States sought civil penalties and injunctive relief for violations of the Clean Water Act (``CWA''), 33 U...-wide operation program plan to maximize the treatment and storage of wet weather flow. The County will...

  1. 77 FR 14425 - Notice of Lodging of Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Safe Drinking Water Act Notice... penalties under the Safe Drinking Water Act (``SDWA''), 42 U.S.C. 300f-300j-26, resulting from violations of the National Primary Drinking Water Regulations (``NPDWRs'') at two trailer courts that Stricklin owns...

  2. 75 FR 12569 - Notice of Lodging of Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-16

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Safe Drinking Water Act..., pursuant to Section 1414(b) of the Safe Drinking Water Act (``SDWA''), 42 U.S.C. 300G-3(b), based upon Evenhouse's alleged violations of the SDWA and regulations thereunder at two separate community water...

  3. 77 FR 25751 - Amended Notice of Lodging of Consent Decree Pursuant to the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-01

    ... DEPARTMENT OF JUSTICE Amended Notice of Lodging of Consent Decree Pursuant to the Clean Water Act... claims against the City of Memphis under Section 301, 309, and 402 of the Clean Water Act, 33 U.S.C. 1311... of the Tennessee Water Quality Control Act (``TWQCA''). The April 24, 2012 Notice did not contain the...

  4. 76 FR 26768 - Notice of Lodging of a Consent Decree Under The Clean Water Act, The Clean Air Act, and The...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-09

    ... BP Exploration (Alaska) Inc. (``BPXA'')'s operation of oil pipelines on the North Slope of Alaska... Consent Decree in United States v. BP Exploration (Alaska) Inc., Civil Action No. 3:09-CV-00064-JWS was..., 1321, as amended by the Oil Pollution Act of 1990, 33 U.S.C. 2701 et seq.; the Clean Air Act (CAA), 42...

  5. 77 FR 71633 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... would resolve certain claims under Sections 301, 309, and 402 of the Clean Water Act, 33 U.S.C. 1251, et seq. and under the Mississippi Air and Water Pollution Control Law (``MAWPCL'') (Miss. Code Ann. Sec... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act On...

  6. 77 FR 44672 - Notice of Lodging of Consent Decree Under the Clean Water and Clean Air Acts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-30

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water and Clean Air Acts... a civil penalty of $1,750,000 to resolve its violations of the Clean Air Act and the Clean Water Act... of coke oven gas. Under the Clean Water Act, Plaintiffs allege that Shenango violated the effluent...

  7. 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.

  8. 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.

  9. 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.

  10. 75 FR 39041 - Notice of Lodging of Proposed Consent Decree Under the Solid Waste Disposal Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Solid Waste Disposal... the Solid Waste Disposal Act (as amended by the Resource Conservation and Recovery Act), 42 U.S.C... to wildlife, at its commercial oilfield waste disposal facility, located in Campbell County, Wyoming...

  11. 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

  12. 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...

  13. 78 FR 47411 - Notice of Lodging of Consent Decree Under the Clean Water Act, Emergency Planning and Community...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-05

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act, Emergency Planning and Community Right-to-Know Act, and Oil Pollution Act Notice is hereby given that on July 31... Enterprises, Inc. (``Defendants'') alleging violations of Sections 311(c) and (j) of the Clean Water Act...

  14. 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...

  15. 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

  16. 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...

  17. 75 FR 18239 - Notice of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... given that on March 31, 2010, two proposed Consent Decrees were lodged. United States et al. v. Shell... Southern District of Texas. United States v. Shell Chemical Yabucoa, Inc., Civil Action No. 3:10-cv-1268... in these Clean Air Act enforcement actions against Shell Chemical LP and Shell Chemical Yabucoa, Inc...

  18. 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.

  19. 77 FR 38830 - Notice of Lodging of an Amendment to Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-29

    ... Act (``CAA'' or ``Act'') at its thirteen portland cement production facilities in the United States... regulations. The proposed Second Amendment affects only three of the thirteen cement plants addressed in the Consent Decree: the Roberta, Alabama; Harleyville, South Carolina; and Atlanta, Georgia cement plants. The...

  20. 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...

  1. 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...

  2. 75 FR 49949 - Notice of Lodging of Consent Decree Under The Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under The Clean Water Act Notice is... Southern District of Texas. In this action, the United States alleges civil claims under the Clean Water...) improve pipeline operation and integrity management practices, and (3) enhance leak detection capabilities...

  3. 75 FR 45667 - Notice of Lodging of Consent Judgment Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... hereby given that on July 28, 2010, a proposed Consent Judgment in United States v. Nassau Chromium.... (hereinafter, the ``Act''), against Defendant Nassau Chromium Plating Co., Inc. (``Defendant''). The United..., New York, that sprays paint and applies chromium on, among other things, aluminum and steel parts, at...

  4. 78 FR 26655 - Notice of Lodging of Proposed First Amendment to Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-07

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed First Amendment to Consent Decree Under the Clean Water Act On April 30, 2013, the Department of Justice lodged a proposed first amendment to a consent decree with the United States District Court for the Northern District of Ohio in the lawsuit entitled United States, et al. v. City of Fostori...

  5. 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...

  6. 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...

  7. 77 FR 5570 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... Chapter, Hawai'i's Thousand Friends, and Our Children's Earth Foundation) filed a joint stipulation to... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is....O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to United...

  8. 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.

  9. 76 FR 46842 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ..., Section 301(a) of the Clean Water Act, 42 U.S.C. 1311(a), and Section 3005(a) of the Resource Conservation..., Michigan. Under the Consent Decree, Dow will implement an Enhanced Leak Detection and Repair (``LDAR'') Program which imposes leak monitoring and repair requirements more stringent than existing LDAR...

  10. 76 FR 68788 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... (``Dupont'') violations of (1) Sections 301(a), 309(b) and (d), and 402 of the Federal Water Pollution... Regulations Governing the Control of Water Pollution, 7 Del. Admin. Code Sec. 7201. The United States and... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is...

  11. 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...

  12. 78 FR 38362 - Notice of Lodging of Proposed Modification to Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... States v. American Sugar Refining, Inc. Civil Action No. JKB-12-1408. The Consent Decree in this Clean Air Act enforcement action against American Sugar Refining, Inc. (``ASR'') resolves allegations by the... 113(b) of the Clean Air Act, 42 U.S.C. 7413(b), for alleged environmental violations at ASR's sugar...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 75 FR 37838 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-30

    ... hereby given that on June 2, 2010, a proposed Consent Decree (the ``Decree'') in United States v. Granite... the same day, the United States alleged that Granite Construction Company (``Granite'') was liable... Section 402 of the Act, 33 U.S.C. 1342. Pursuant to the Decree, Granite will (1) pay a civil penalty of...

  1. 75 FR 51483 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-20

    ... given that on August 9, 2010, a proposed Consent Decree in United States v. Middlesex County Utilities... Air Pollution Control Act, N.J.S.A. 26:2C-1 et seq., at the Middlesex County landfill in East... to the United States and New Jersey, and shall upgrade the Middlesex County Landfill Gas Collection...

  2. 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...

  3. 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...

  4. 75 FR 68620 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-08

    ... pursuant to the Clean Water Act, 33 U.S.C. 1251 et seq, and the Pennsylvania Clean Streams Law, 35 P.S. Sec... P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, Attention: Nancy Flickinger... Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing...

  5. 77 FR 39493 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines, based on any comment submitted, that consent to this consent decree should be...

  6. 7 CFR 1.420 - Consent recommendation.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 1 2010-01-01 2010-01-01 false Consent recommendation. 1.420 Section 1.420... Conservation and Shortage Relief Act of 1990 (16 U.S.C. 620 et seq.) § 1.420 Consent recommendation. Any time before the Judge files the decision, the parties of record may enter a consent recommendation. Such...

  7. 7 CFR 1.420 - Consent recommendation.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 1 2011-01-01 2011-01-01 false Consent recommendation. 1.420 Section 1.420... Conservation and Shortage Relief Act of 1990 (16 U.S.C. 620 et seq.) § 1.420 Consent recommendation. Any time before the Judge files the decision, the parties of record may enter a consent recommendation. Such...

  8. 78 FR 26028 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-03

    ... Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will...

  9. 75 FR 38519 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

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

  10. 78 FR 23562 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    .... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will...

  11. 75 FR 71126 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    .... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be.... EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if... Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will...

  12. 75 FR 74048 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

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

  13. 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.

  14. 77 FR 46756 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

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

  15. 77 FR 2319 - Notice of Extension of Public Comment Period for Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-17

    ... Under the Clean Water Act On December 14, 2011, a proposed Consent Decree (``Decree'') was lodged with... States, et al. v. Metropolitan Water Reclamation District of Greater Chicago, Civil Action No. 1:11- cv.... EPA''), and the State of Illinois sought penalties and injunctive relief under the Clean Water Act...

  16. 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).

  17. 78 FR 14358 - Notice of Lodging of Proposed Consent Decree Under the Resource Conservation and Recovery Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... the United States District Court for the Northern District of New York in the lawsuit entitled United...; and Mountain Mart 108, LLC. The proposed Consent Decree resolves claims of the United States under the Solid Waste Disposal Act, as amended by various laws including the Resource Conservation and Recovery...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  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. 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...

  8. 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...

  9. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... available technology, to ensure that the person providing consent is the child's parent. (2) Existing... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... children, including consent to any material change in the collection, use, or disclosure practices to which...

  10. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  11. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  12. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  13. 16 CFR 312.5 - Parental consent.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... calculated, in light of available technology, to ensure that the person providing consent is the child's... Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS CHILDREN'S ONLINE... from children, including consent to any material change in the collection, use, and/or disclosure...

  14. 76 FR 77226 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-12

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

  15. 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.

  16. 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...

  17. 77 FR 14785 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    .... Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word... litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed... Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the...

  18. 78 FR 16667 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    .... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD- [[Page 16668... to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to... EPA or the Department of Justice determines that consent to the consent decree should be withdrawn...

  19. 78 FR 30919 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ..., excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file, avoiding... to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to... EPA or the Department of Justice determines that consent to this consent decree should be withdrawn...

  20. 77 FR 4320 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

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

  1. 75 FR 39014 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

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

  2. 76 FR 51030 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

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

  3. 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.

  4. 76 FR 43725 - Notice of Lodging of Consent Decree Under the Clean Air Act, Sections 113(b) and 304(a), 42 U.S.C...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Air Act, Sections 113(b) and 304(a), 42 U.S.C. 7413(b), 7604(a) Notice is hereby given that on July 13, 2009, a proposed Second Amendment Consent Decree in United States of America; Commonwealth of Pennsylvania; City of Philadelphia...

  5. 75 FR 159 - Notice of Lodging of Consent Decree Under the Residential Lead-Based Paint Hazard Reduction Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-04

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Residential Lead- Based Paint...'') under the Residential Lead-Based Paint Hazard Reduction Act, 42 U.S.C. 4851 et seq. (``Lead Hazard... of the disclosures or to complete one or more of the disclosure activities required by the Lead...

  6. 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...

  7. Consent, competency and ECT: a psychiatrist's view

    PubMed Central

    Taylor, P J

    1983-01-01

    Dr Taylor, an English psychiatrist, considers the issue of the symposium in the context of the Mental Health (Amendment) Act 1982. This, she says, gives little guidance on how judgment of a patient's competency or capability to consent to treatment should be made, although it specifies that unless compulsorily detained patients competently consent to ECT a special second medical opinion is required. Although some guidelines from the Department of Health may be offered before implementation of the Act in September 1983 all those working with psychiatric patients will have to consider the issues. After discussing her criteria for informed consent, some practical approaches for obtaining it and problems arising from these, and problems of surrogate consent, Dr Taylor concludes that there is no single or simple solution to the dilemma. She ends by asking: `Can refusal of ECT for severe depression ever be a competent decision?' PMID:6620319

  8. 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).

  9. 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...

  10. 75 FR 51267 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-19

    .... Steel Corporation's Granite City Works facility. Under the terms of the proposed consent decree, EPA has.... Steel Corporation's Granite City Works facility. Under the terms of the proposed consent decree, EPA has...

  11. 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...

  12. 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...

  13. Delegating Informed Consent.

    PubMed

    Koch, Valerie Gutmann

    2017-11-01

    Ten years ago, Megan Shinal sought the care of neurosurgeon Steven Toms for the surgical treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. In their twenty-minute meeting, Shinal did not make a final decision about which surgical approach she wished to pursue. Subsequently, she spoke with Tom's physician assistant once by phone and once in person, when she signed the consent form, which did not appear to designate which surgical approach she had chosen. During the operation-a total resection-Toms perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. The jury found that Toms had fulfilled his informed-consent obligations prior to performing the resection; however, in June 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania Medical Care Availability and Reduction of Error Act. The court found that the language of the act is unambiguous in its requirement that "a physician's duty to provide information to a patient sufficient to obtain her informed consent is non-delegable." Presumably, this rule of nondelegation applies beyond the surgical theater to other major treatment decisions. And it is unclear whether it applies to other professionals in a subordinate position to the treating physician, such as residents and fellows. © 2017 The Hastings Center.

  14. 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...

  15. 76 FR 78314 - Notice of Lodging Proposed Consent Decree

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... the Clean Water Act, 33 U.S.C. 1311 and 1344. The proposed Consent Decree resolves these allegations... Spring Street SE., Room 201, Gainesville, GA 30501. In addition, the proposed Consent Decree may be...

  16. 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...

  17. 77 FR 1509 - Notice of Lodging Proposed Consent Decree

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-10

    ... and 309 of the Clean Water Act, 33 U.S.C. 1311 and 1319. The proposed Consent Decree resolves these... Street, Room 1053, Santa Ana, California 92701-4516. In addition, the proposed Consent Decree may be...

  18. How many of our patients can really give consent? A perspective on the relevance of the Mental Capacity Act to dentistry.

    PubMed

    Holden, Alexander C L; Holden, Neil L

    2014-01-01

    The different ways that clinicians perceive adult patients with dental phobia is varied and diverse. From treating the dental phobia as a separate illness to dismissing it as a neurosis, sometimes little consequence is attached to its existence. True dental phobia is classed as a psychological illness and therefore comes under the remit and guidance of the Mental Capacity Act 2005. Failure to assess the impact of dental phobia upon an individual's capacity to consent could lead to allegations of negligence or even assault. This paper highlights the importance of considering the capacity to consent of some of the most vulnerable dental

  19. 76 FR 81967 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act Notice is hereby given that on Dec. 22, 2011, a proposed Consent... Comprehensive Environmental Response, Compensation and Liability Act, 42 U.S.C. 9607. The Consent Decree...

  20. Active parental consent in school-based research. An examination of ethical and methodological issues.

    PubMed

    Esbensen, F A; Deschenes, E P; Vogel, R E; West, J; Arboit, K; Harris, L

    1996-12-01

    To date, most school-based research has used passive parental consent. However, the Family Privacy Protection Act of 1995 aims to change these requirements. The proposed legislation requires written parental consent if minors are to be asked "sensitive" questions as part of any program or activity funded in whole or in part by the federal government. This act is representative of a growing trend toward restricting research involving minors. Whether or not this act is passed by Congress, two lines of concern are highlighted by this legislation. The first deals with ethical issues surrounding consent procedures. For instance, are parental rights compromised when active consent is not mandated? A second line of inquiry pertains to the effect of active consent procedures on response rates and sample bias. In this article, the authors discuss ethical issues surrounding passive and active consent procedures and then report response rates from two projects in which active consent procedures were implemented.

  1. 76 FR 75544 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-02

    ... Canyon Trust, San Juan Citizens Alliance, Our Children's Earth Foundation, Plains Justice, Powder River... Constitution Ave. NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree...

  2. 77 FR 41186 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-12

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OGC-2012-0554; FRL-9699-6] Proposed Consent Decree, Clean... August 13, 2012. ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ- OGC-2012-0554... (identified by Docket ID No. EPA-HQ-OGC-2012-0554) contains a copy of the proposed consent decree. The...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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.

  9. 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.

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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.

  15. [Preventing dangerous psychotic acting out].

    PubMed

    Bouchard, Jean-Pierre

    2015-01-01

    Delusions of having been wronged, of persecution, of having a mission or order to execute, are frequently the causes of dangerous psychotic acting out. The regular clinical assessment of these patients and their treatment is essential for preventing this acting out, which can have dramatic consequences on the potential victims. If there is a treatment indication but refusal on the part of the patient to cooperate, it is necessary to resort to treatment without the patient's consent.

  16. 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

  17. 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

  18. 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.

  19. 28 CFR 29.13 - No new conditions without consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false No new conditions without consent. 29.13 Section 29.13 Judicial Administration DEPARTMENT OF JUSTICE MOTOR VEHICLE THEFT PREVENTION ACT REGULATIONS § 29.13 No new conditions without consent. After the program has begun, new conditions under which a...

  20. 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.

  1. The Mental Capacity Act 2005: Considerations for obtaining consent for dental treatment.

    PubMed

    Modgill, O; Bryant, C; Moosajee, S

    2017-06-23

    The Mental Capacity Act 2005 provides a legal framework within which specific decisions must be made when an individual lacks the mental capacity to make such decisions for themselves. With an increasingly aged, medically complex and in some cases socially isolated population presenting for dental care, dentists need to have a sound understanding of the appropriate management of patients who lack capacity to consent to treatment when they present in the dental setting. Patients with acute symptoms requiring urgent care and un-befriended patients present additional complexities. In these situations a lack of familiarity with how best to proceed and confusion in the interpretation of relevant guidance, combined with the working time pressures experienced in dental practice may further delay the timely dental management of vulnerable patients. We will present and discuss the treatment of three patients who were found to lack the mental capacity necessary to make decisions about their dental care and illustrate how their differing situations determined the appropriate management for each.

  2. 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...

  3. Testing Consent Agreement for N-methylpyrrolidone

    EPA Pesticide Factsheets

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

  4. 78 FR 44598 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act, the Resource Conservation and Recovery Act, and the Clean Water Act On July 18, 2013, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Southern...

  5. 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

  6. 77 FR 45378 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on July 25, 2012, a proposed Consent... the ``Site''), pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act...

  7. 75 FR 20862 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on April 15, 2010, a proposed Consent... Comprehensive Environmental Response, Compensation, and Recovery Act, as amended (``CERCLA''), 42 U.S.C. [[Page...

  8. 77 FR 16066 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on July 21, 2009, a proposed Consent... Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA''), 42 U.S.C. 9606, 9607...

  9. 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.

  10. Can Broad Consent be Informed Consent?

    PubMed Central

    Sheehan, Mark

    2011-01-01

    In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. PMID:22102849

  11. 76 FR 61384 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... comment period, the Consent Decree may be examined on the following Department of Justice website: http...) 514-0097, phone confirmation number (202) 514-1547. In requesting a copy from the Consent Decree...

  12. 78 FR 79484 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act (``CERCLA''), the Clean Water Act (``CWA''), and the Missouri Rev. Stat. of the Missouri Clean Water Law On December 20, 2013, the Department of Justice lodged a proposed Consent Decree with the United...

  13. 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...

  14. 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

  15. 77 FR 33489 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on May 31, 2012, a proposed Consent Decree (the Consent Decree) in United States of America v. Minnie Moore Resources, Inc. et al, Civil...

  16. 77 FR 28897 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-16

    ...'s violation of the National Pollution Discharge Elimination System Permit (``NPDES Permit'') for its... its wastewater treatment system that will enable it to comply with the permit, which include upgrading... Department of Justice Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . A copy of the Consent Decree...

  17. 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  19. 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...

  20. 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...

  1. 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...

  2. 77 FR 31040 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... expert to audit the refrigeration system and recommend any necessary changes; and implement any changes..., the Consent Decree may also be examined on the following Department of Justice Web site, http://www... Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing...

  3. Can children withhold consent to treatment?

    PubMed

    Devereux, J A; Jones, D P; Dickenson, D L

    1993-05-29

    A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice.

  4. 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.

  5. 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.

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

    PubMed

    Behmer Hansen, Rosemary Talbot; Arora, Kavita Shah

    2018-06-14

    Since USA constitutional precedent established in 1976, adolescents have increasingly been afforded the right to access contraception without first obtaining parental consent or authorisation. There is general agreement this ethically permissible. However, long-acting reversible contraception (LARC) methods have only recently been prescribed to the adolescent population. They are currently the most effective forms of contraception available and have high compliance and satisfaction rates. Yet unlike other contraceptives, LARCs are associated with special procedural risks because they must be inserted and removed by trained healthcare providers. It is unclear whether the unique invasive nature of LARC changes the traditional ethical calculus of permitting adolescent decision-making in the realm of contraception. To answer this question, we review the risk-benefit profile of adolescent LARC use. Traditional justifications for permitting adolescent contraception decision-making authority are then considered in the context of LARCs. Finally, analogous reasoning is used to evaluate potential differences between permitting adolescents to consent for LARC procedures versus for emergency and pregnancy termination procedures. Ultimately, we argue that the invasive nature of LARCs does not override adolescents' unique and compelling need for safe and effective forms of contraception. In fact, LARCs may oftentimes be in the best interest of adolescent patients who wish to prevent unintended pregnancy. We advocate for the specific enumeration of adolescents' ability to consent to both LARC insertion and removal procedures within state policies. Given the provider-dependent nature of LARCs and the stigma regarding adolescent sexuality, special political and procedural safeguards to protect adolescent autonomy are warranted. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted

  7. 34 CFR 303.404 - Parent consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... obtained before— (1) Conducting the initial evaluation and assessment of a child under § 303.322; and (2... the child will not be able to receive the evaluation and assessment or services unless consent is... of the Act (34 CFR 300.571) and 34 CFR part 99 (Family Educational Rights and Privacy), both of which...

  8. Consent Decrees

    EPA Pesticide Factsheets

    EPAs Office of Enforcement and Compliance Assurance (OECA) cases and settlements webpage contains links to selected settlements resolving civil enforcement cases and, in some cases, complaints filed initiating civil judicial and administrative enforcement actions. Typically, the links are to settlements about which we have issued a press release. This is not a complete repository of all enforcement actions taken by or on behalf of EPA. Rather, it represents a subset of enforcement cases, taken civil judicially or administratively, which may be of national interest. Most of the settlements are civil judicial consent decrees resolving alleged violations of environmental laws (e.g., the Clean Air Act, the Clean Water Act). In some instances, the website includes significant enforcement actions resolved by the Environmental Appeals Board (EAB). In addition, please note that the cases and settlements webpage does not include:Most administrative enforcement actions; Most civil judicial cases resolving liability under CERCLA; Criminal enforcement matters.

  9. 78 FR 53784 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... Decree would require (1) Installation of process equipment to provide redundancy that will allow hot.../Consent_Decrees.html . We will provide a paper copy of the Consent Decree upon written request and payment... cents per page [[Page 53785

  10. 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.

  11. Informed Consent in the Changing Landscape of Research.

    PubMed

    Hammer, Marilyn J

    2016-09-01

    The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
.

  12. 77 FR 64353 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ..., Compensation, and Liability Act of 1980, 42 U.S.C. 9607, (``CERCLA''), to recover past response costs incurred....usdoj.gov/enrd/Consent_Decrees.html . We will provide a paper copy of the consent decree upon written...

  13. 77 FR 65205 - Amended Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-25

    ..., Compensation, and Liability Act of 1980, 42 U.S.C. 9607, (``CERCLA''), to recover past response costs incurred... site: http://www.usdoj.gov/enrd/Consent_Decrees.html . We will provide a paper copy of the consent...

  14. 17 CFR 230.437a - Written consents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Are filing a registration statement containing financial statements in which Arthur Andersen LLP (or a foreign affiliate of Arthur Andersen LLP) had been acting as the independent public accountant. (b... dispense with the requirement for the registrant to file the written consent of Arthur Andersen LLP (or a...

  15. 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.

  16. 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

  17. Voluntary Consent: Why a Value-Neutral Concept Won’t Work

    PubMed Central

    Wertheimer, Alan

    2012-01-01

    Some maintain that voluntariness is a value-neutral concept. On that view, someone acts involuntarily if subject to a controlling influence or has no acceptable alternatives. I argue that a value-neutral conception of voluntariness cannot explain when and why consent is invalid and that we need a moralized account of voluntariness. On that view, most concerns about the voluntariness of consent to participate in research are not well founded. PMID:22551878

  18. Informed consent in high-risk renal transplant recipients.

    PubMed

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

    2009-06-01

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

  19. Can children withhold consent to treatment?

    PubMed Central

    Devereux, J A; Jones, D P; Dickenson, D L

    1993-01-01

    A dilemma exists when a doctor is faced with a child or young person who refuses medically indicated treatment. The Gillick case has been interpreted by many to mean that a child of sufficient age and intelligence could validly consent or refuse consent to treatment. Recent decisions of the Court of Appeal on a child's refusal of medical treatment have clouded the issue and undermined the spirit of the Gillick decision and the Children Act 1989. It is now the case that a child patient whose competence is in doubt will be found rational if he or she accepts the proposal to treat but may be found incompetent if he or she disagrees. Practitioners are alerted to the anomalies now exhibited by the law on the issue of children's consent and refusal. The impact of the decisions from the perspectives of medicine, ethics, and the law are examined. Practitioners should review each case of child care carefully and in cases of doubt seek legal advice. Images p1459-a p1460-a PMID:8518645

  20. 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

  1. Parental Refusal to Consent for Evaluation: A Legal Analysis with Implications for School Psychologists

    ERIC Educational Resources Information Center

    Etscheidt, Susan; Clopton, Kerri; Haselhuhn, Charlotte

    2012-01-01

    The decision to begin the process for special education eligibility has complexities impacting children, parents, teachers, and schools. The Individuals with Disabilities Education Improvement Act (IDEA) eligibility provisions specify the need to obtain consent prior to evaluation and options when consent cannot be obtained. School psychologists…

  2. 76 FR 34982 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... of a proposed consent decree to address a lawsuit filed by WildEarth Guardians and Elizabeth Crowe in the United States District Court for the Northern District of California: WildEarth Guardians and...Earth Guardians and Elizabeth Crowe, and Respondent, the U.S. Environmental Protection Agency (EPA...

  3. 75 FR 80809 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... Department of Air Quality to the Tennessee Valley Authority's Paradise Fossil Plant in Drakesboro, Kentucky... and any form of encryption, and may be mailed to the mailing address above. FOR FURTHER INFORMATION... Fossil Plant in Drakesboro, Kentucky. Under the terms of the proposed consent decree, EPA has agreed to...

  4. The Capacity of a Mentally Challenged Person to Consent to Abortion and Sterilization

    ERIC Educational Resources Information Center

    Pollack, Daniel

    2005-01-01

    Federal law (Americans with Disabilities Act of 1990, P.L. 101-336) and state law concerning the capacity to consent demonstrate the many standards used to determine the severity of retardation and whether a mentally challenged person has the capacity to consent. This area of social policy is fascinating because it adds another layer of debate to…

  5. 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.

  6. 75 FR 39706 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-12

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act Notice is given that on July 1, 2010, a proposed Consent Decree in... against the City of Hastings under Sections 106 and 107(a) of the Comprehensive Environmental Response...

  7. 76 FR 66083 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Notice is hereby given that on October 18, 2011, a proposed complaint was filed and a proposed Consent Decree lodged in the case of United States and the...

  8. 75 FR 67767 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-03

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Notice is hereby given that on October 26, 2010, a proposed Consent Decree in The United States of America and the Coeur d'Alene Tribe v. Douglas Mining...

  9. 75 FR 80808 - Proposed Consent Decree, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... number EPA-HQ- OGC-2010-1060, online at http://www.regulations.gov (EPA's preferred method); by e-mail to... Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m... No. EPA-HQ-OGC-2010-1060) contains a copy of the proposed consent decree. The official public docket...

  10. 75 FR 17770 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-07

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Consistent with 28 CFR 50.7, notice is hereby given that on April 1, 2010, a Consent Decree in United States v. Exxon Mobil Corporation and Holcim (US) Inc...

  11. WASP (Write a Scientific Paper): Informed consent in research.

    PubMed

    Mallia, Pierre

    2018-05-03

    The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee. Copyright © 2018. Published by Elsevier B.V.

  12. Passive Consent for Clinical Research in the Age of HIPAA

    PubMed Central

    Littenberg, Benjamin; MacLean, Charles D

    2006-01-01

    BACKGROUND Federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) of 1996, intended primarily to protect individuals, have been described as significant barriers to the use of clinical registries and other population-based tools for health care research. Although these regulations allow for the waiver or alteration of usual consent procedures when the research meets certain specific criteria, waivers and alterations are rarely used in health care research. METHODS The Vermont Diabetes Information System is a multistate randomized trial of a quality improvement intervention that uses a novel alteration of informed consent to help ensure that the study sample is representative of the target population. Patients are notified by mail that they are eligible for the study and that they may opt out of the study, if they desire, by calling a toll-free number. RESULTS Seven thousand five hundred and fifty-eight patients were invited to participate. Two hundred and ten (2.8%) opted out. Three patients (0.04%) filed complaints, all of which were addressed satisfactorily. CONCLUSIONS Health Insurance Portability and Accountability Act and other federal regulations raise challenges to the use of clinical registries in research, but modifications to the consent process, including passive consent methods, are useful tools to overcome these challenges. It is possible to recruit a broad and representative population under current law while maintaining appropriate protections for research subjects. PMID:16637821

  13. 75 FR 1413 - Notice of Lodging of Consent Decrees Under The Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decrees Under The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Notice is hereby given that on December 18, 2009, two proposed Consent Decrees in the case of U.S. v. Mascot Mines, Inc., et al., Civil Action No. 08-383-EJL...

  14. 77 FR 5057 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on January 24, 2012, a proposed Consent Decree in United States v. E.I. DuPont De Nemours & Company, et al., Civil Action No. 1:12-cv...

  15. 76 FR 72216 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-22

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act (``CERCLA'') Consistent with Section 122(d)(2) of CERCLA, 42 U.S.C. 9622(d)(2), notice is hereby given that on November 7, 2011, a proposed Consent Decree in The General...

  16. Improving consent in patients undergoing surgery for fractured neck of femur.

    PubMed

    Thiruchandran, Gajendiran; McKean, Andrew R; Rudran, Branavan; Imam, Mohamed A; Yeong, Keefai; Hassan, Abdel

    2018-05-02

    Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of

  17. Informed consent and the readability of the written consent form.

    PubMed

    Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

    2017-11-01

    Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

  18. 76 FR 64378 - Notice of Proposed Consent Decree Pursuant to the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... DEPARTMENT OF JUSTICE Notice of Proposed Consent Decree Pursuant to the Comprehensive Environmental Response, Compensation and Liability Act Notice is hereby given that on October 4, 2011, a... action, filed pursuant to the Comprehensive Environmental Response, Compensation and Liability Act, the...

  19. 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.

  20. 75 FR 1082 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-08

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'') Notice is hereby given that on December 22, 2009 a proposed consent decree (``proposed Decree'') in United States v. Thoro Products Company, Civil Action No. 04-M-2330, was lodged with the United...

  1. 75 FR 49947 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'') Notice is hereby given that on August 6, 2010 a proposed consent decree (``proposed Decree'') in United States v. Central Rubber Co., et al., C.A. No. 3:10-cv-50193, was lodged with the United...

  2. 40 CFR 135.5 - Service of proposed consent judgment.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 22 2014-07-01 2013-07-01 true Service of proposed consent judgment. 135.5 Section 135.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PRIOR NOTICE OF CITIZEN SUITS Prior Notice Under the Clean Water Act § 135.5 Service of proposed...

  3. 40 CFR 135.5 - Service of proposed consent judgment.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 23 2012-07-01 2012-07-01 false Service of proposed consent judgment. 135.5 Section 135.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PRIOR NOTICE OF CITIZEN SUITS Prior Notice Under the Clean Water Act § 135.5 Service of proposed...

  4. 40 CFR 135.5 - Service of proposed consent judgment.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 22 2011-07-01 2011-07-01 false Service of proposed consent judgment. 135.5 Section 135.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PRIOR NOTICE OF CITIZEN SUITS Prior Notice Under the Clean Water Act § 135.5 Service of proposed...

  5. 40 CFR 135.5 - Service of proposed consent judgment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Service of proposed consent judgment. 135.5 Section 135.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS PRIOR NOTICE OF CITIZEN SUITS Prior Notice Under the Clean Water Act § 135.5 Service of proposed...

  6. 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

  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. Beyond informed consent.

    PubMed Central

    Bhutta, Zulfiqar A.

    2004-01-01

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

  9. 76 FR 53942 - Notice of Lodging of First Addendum to Consent Decree Under the Emergency Planning and Community...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... DEPARTMENT OF JUSTICE Notice of Lodging of First Addendum to Consent Decree Under the Emergency Planning and Community Right-To-Know Act, the Clean Water Act, the Resource Conservation and Recovery Act, the Federal Insecticide, Fungicide, and Rodenticide Act, the Comprehensive Environmental Response, Compensation, and Liability Act, the Safe...

  10. 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...

  11. [Consent and confidentiality in occupational health practice: balance between legal requirements and ethical values].

    PubMed

    Mora, Erika; Franco, G

    2010-01-01

    The recently introduced Italian law on the protection of workers' health states that the occupational health physician (competent physician) is required to act according to the Code of Ethics of the International Commission on Occupational Health (ICOH). This paper aims at examining the articles of legislative decree 81/2008 dealing with informed consent and confidentiality compared with the corresponding points of the ICOH Ethics Code. Analysis of the relationship between articles 25 and 39 (informed consent) and 18, 20 and 39 (confidentiality) of the decree shows that there are some points of disagreement between the legal requirements and the Code of Ethics, in particular concerning prescribed health surveillance, consent based on appropriate information (points 8, 10 and 12 of the Code) and some aspects of confidentiality (points 10, 20, 21, 22 and 23 of the Code). Although the competent physician is required to act according to the law, the decisional process could lead to a violation of workers' autonomy.

  12. The Influence of Partner Status and Sexual Behavior on College Women's Consent Communication and Feelings.

    PubMed

    Marcantonio, Tiffany; Jozkowski, Kristen N; Wiersma-Mosley, Jackie

    2018-05-09

    Sexual consent has permeated mainstream discourse as a mechanism used to decrease rates of sexual assault and increase sex-positive communication. Women's external consent behaviors are frequently examined; however, research exploring their internal consent and feelings associated with sexual activity are understudied. The purpose of this study was to understand how partner status and sexual behavior at most recent sexual activity influence women's external/internal consent and feelings during sexual activity. Three-hundred and ninety women completed a survey on consent, partner status, and most recent sexual behavior. Internal and external consent differed by partner status for women who engaged in vaginal-penile sex, but not genital and oral sex. Feelings associated with the sexual act were different within each behavior group and partner status. Women with a serious dating partner reported stronger feelings related to sexual activity, higher internal consent feelings, and increased use of non-verbal external consent cues. Partner status appears to influence factors of interest for vaginal-penile sex, but not genital and oral sex. Findings from this study can inform prevention efforts to increase sex-positive communication around consent.

  13. 77 FR 58409 - Amended Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... DEPARTMENT OF JUSTICE Amended Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act This Notice amends and replaces the original notice... Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA''), 42 U.S.C. 9601 et seq...

  14. 75 FR 1412 - Notice of Lodging of Consent Decree Under Comprehensive Environmental Response, Compensation and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under Comprehensive Environmental Response, Compensation and Liability Act Under 28 CFR 50.7, notice is hereby given that on January 4, 2010... (``EPA''), under the Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA...

  15. [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.

  16. 76 FR 385 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation and Liability Act In accordance with Departmental Policy, 28 CFR 50.7, notice is...) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C. 9607...

  17. 76 FR 5609 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-01

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on January 24, 2011, a proposed...'') under the Comprehensive Environmental Response, Compensation and Liability Act of 1980, 42 U.S.C. 9601...

  18. 77 FR 55499 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on September 4, 2012, a proposed... Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA''), 42 U.S.C. 9607(a), for...

  19. 75 FR 51482 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-20

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Notice is hereby given that on August 11, 2010, a... Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA''), 42 U.S.C. Sec. Sec. 9607(a...

  20. 75 FR 51483 - Notice of Lodging of Consent Decrees Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-20

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decrees Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Notice is hereby given that on August 4, 2010, two... Sections 107(a) and 113(g)(2) of the Comprehensive Environmental Response, Compensation, and Liability Act...

  1. 78 FR 11681 - Notice of Lodging Proposed Consent Decree

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Policy, 28 CFR 50.7, notice is hereby given that a proposed Consent Decree in United States v. Smith Farm... complaint filed by the United States against Smith Farm Enterprises, L.L.C., pursuant to Section 309 of the Clean Water Act, 33 U.S.C. 1319, to obtain injunctive relief and recover civil penalties from the...

  2. 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

  3. 75 FR 22626 - Notice of Lodging of Consent Decree With Big River Zinc Corporation Providing for Civil Penalties...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree With Big River Zinc Corporation... April 15, 2009, a proposed Consent Decree with Big River Zinc Corporation (``BRZ'') providing for civil penalties and injunctive Relief under the Clean Air Act in United States v. Big River Zinc Corp., Civil...

  4. Family attitudes, actions, decisions and experiences following implementation of deemed consent and the Human Transplantation (Wales) Act 2013: mixed-method study protocol

    PubMed Central

    Noyes, Jane; Morgan, Karen; Walton, Phillip; Roberts, Abigail; Mclaughlin, Leah; Stephens, Michael

    2017-01-01

    Introduction The Human Transplantation (Wales) Act 2013 (the Act) introduced a ‘soft opt-out’ system of organ donation on 1 December 2015. Citizens are encouraged to make their organ donation decision known during their lifetime. In order to work, the Act and media campaign need to create a context, whereby organ donation becomes the norm, and create a mechanism for people to behave as intended (formally register their decision; consider appointing a representative; convey their donation decision to their families and friends or do nothing—deemed consent). In addition, family members/appointed representatives need to be able to put their own views aside to support the decision of their loved one. The aim of this study is to evaluate initial implementation, outcomes and impact on families and appointed representatives who were approached about organ donation during the first 18 months. Methods and analysis Prospective mixed-method coproductive study undertaken with National Health Service Blood and Transplant (NHSBT), and multiple patient/public representatives. The study is designed to collect information on all cases who meet specified criteria (≥18 years, deceased person voluntarily resident in Wales and died in Wales or England) whose family were approached between 1 December 2015 and 31 June 2017). Data for analysis include: NHSBT routinely collected anonymised audit data on all cases; Specialist Nurse in Organ Donation (SNOD) completed anonymised form for all cases documenting their perception of the families’ understanding of the Act, media campaign and outcome of the donation approach; questionnaires and depth interviews with any family member or appointed representative (minimum 50 cases). Additional focus groups and interviews with SNODs. Anonymised donation outcomes and registration activity reports for Wales provide additional context. Ethics and dissemination Approved by NHSBT Research, Innovation and Technology Advisory Group on 23 October

  5. Family attitudes, actions, decisions and experiences following implementation of deemed consent and the Human Transplantation (Wales) Act 2013: mixed-method study protocol.

    PubMed

    Noyes, Jane; Morgan, Karen; Walton, Phillip; Roberts, Abigail; Mclaughlin, Leah; Stephens, Michael

    2017-10-12

    The Human Transplantation (Wales) Act 2013 (the Act) introduced a 'soft opt-out' system of organ donation on 1 December 2015. Citizens are encouraged to make their organ donation decision known during their lifetime. In order to work, the Act and media campaign need to create a context, whereby organ donation becomes the norm, and create a mechanism for people to behave as intended (formally register their decision; consider appointing a representative; convey their donation decision to their families and friends or do nothing-deemed consent). In addition, family members/appointed representatives need to be able to put their own views aside to support the decision of their loved one. The aim of this study is to evaluate initial implementation, outcomes and impact on families and appointed representatives who were approached about organ donation during the first 18 months. Prospective mixed-method coproductive study undertaken with National Health Service Blood and Transplant (NHSBT), and multiple patient/public representatives. The study is designed to collect information on all cases who meet specified criteria (≥18 years, deceased person voluntarily resident in Wales and died in Wales or England) whose family were approached between 1 December 2015 and 31 June 2017). Data for analysis include: NHSBT routinely collected anonymised audit data on all cases; Specialist Nurse in Organ Donation (SNOD) completed anonymised form for all cases documenting their perception of the families' understanding of the Act, media campaign and outcome of the donation approach; questionnaires and depth interviews with any family member or appointed representative (minimum 50 cases). Additional focus groups and interviews with SNODs. Anonymised donation outcomes and registration activity reports for Wales provide additional context. Approved by NHSBT Research, Innovation and Technology Advisory Group on 23 October 2015; Wales Research Ethics Committee 5 (IRAS190066; Rec Reference

  6. 77 FR 54926 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-06

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on August 28, 2012, a proposed... Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601 et seq., relating to the...

  7. 75 FR 61774 - Notice of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-06

    ... given that on September 28, 2010, a proposed Consent Decree in United States, et al. v. Murphy Oil USA... Oil USA, Inc. (``Murphy'') resolves allegations by the Environmental Protection Agency, the State of... General, Environment and Natural Resources Division, and either e-mailed to [email protected

  8. 78 FR 38073 - Notice of Lodging of Proposed Consent Decree Under Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree... for $4.25 (25 cents per page reproduction cost) payable to the United States Treasury. Maureen Katz...

  9. Informed Consent in Dentistry.

    PubMed

    Reid, Kevin I

    2017-03-01

    A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

  10. 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

  11. Competence to consent to treatment: a guide for the psychiatrist.

    PubMed

    Draper, R J; Dawson, D

    1990-05-01

    During the last decade there has been increasing pressure to legislate legal rights for psychiatric patients especially in relation to consent to treatment. The attempt to subject the irrationality of psychotic illness to the due process of rational laws has caused problems. Revision of the Ontario Mental Health Act (MHA) has already led to situations in which patients are being incarcerated without treatment because of review board decisions regarding dangerousness and competence. The test in the revised MHA is whether the patient is competent to give or withhold consent for treatment. Existing guidelines for determination of competence to consent to treatment rely upon observer judgement and are open to challenge on grounds of subjectivity. The medical directors of the ten Ontario provincial psychiatric hospitals have therefore developed a guide and schema to operationalize the MHA definitions, a novel feature of which is the examination of competence in such a way as to elicit and capture the patient's own responses upon which an objective determination is made.

  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. 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.

  14. 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.

  15. 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

  16. 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.

  17. Consenting options for posthumous organ donation: presumed consent and incentives are not favored

    PubMed Central

    2012-01-01

    Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and

  18. 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...

  19. 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.

  20. 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...

  1. 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.

  2. 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

  3. 77 FR 20848 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

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

  4. ANNOTATION TAKEN, IN THE PERSPECTIVE OF CRIMINAL AND CONSTITUTIONAL LAW, AS WELL AS IN CRIMINOLOGY, TO THE DECISION OF THE PORTUGUESE CONSTITUTIONAL COURT, OF JANUARY 13, 2011--WITH RESPECT TO THE PROBLEMS OF "CONSENT" AND "MEDICAL ACT".

    PubMed

    Bandeira, Gonçalo S de Melo

    2014-07-01

    1--Summary of the decision taken by the Portuguese Constitutional Court, of January 13, 2011; 2--Complete text of the decision of the Portuguese Constitutional Court, of January 13, 2011, Judge Maria João ANTUNES (Reporter), Judge Carlos Pamplona de OLIVEIRA, Judge José Borges SOEIRO, Judge Gil GALVÃO, Judge Rui Manuel Moura RAMOS (President)--in terms of the appositive declaration to the sentence n. 487/2010: t.c.http://www. tribunalconstitucional.pt, August 1, 2011; 3--Brief annotation to the problem of the "medical act"; 3.1--Plus some conclusions on the brief annotation to the problem of the "medical act"; 3.2--Brief annotation to the problem of "consent"--continuation of the previous comments; 4--Conclusions. It must never be forgotten that "consent" does not stand as the only cause of exclusion of unlawfulness.

  5. Improving informed consent: Stakeholder views.

    PubMed

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

    2017-01-01

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

  6. 26 CFR 302.1 - Statutory provisions and Executive order; section 212 of the International Claims Settlement Act...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADMINISTRATION TAXES UNDER THE INTERNATIONAL CLAIMS SETTLEMENT ACT, AS AMENDED AUGUST 9, 1955 § 302.1 Statutory provisions and Executive order; section 212 of the International Claims Settlement Act, and Executive Order...; section 212 of the International Claims Settlement Act, and Executive Order 10644. 302.1 Section 302.1...

  7. 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...

  8. 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

  9. 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

  10. 78 FR 70321 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ... cents per page reproduction cost) payable to the United States Treasury. Henry Friedman, Assistant...

  11. 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

  12. 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.

  13. 78 FR 20140 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library... $8.50 (25 cents per page reproduction cost) payable to the United States Treasury. Maureen Katz...

  14. 78 FR 37847 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-24

    ... request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library... $10.25 (25 cents per page reproduction cost) payable to the United States Treasury. Maureen Katz...

  15. 78 FR 34132 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-06

    ... payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ... cents per page reproduction cost) payable to the United States Treasury. Maureen M. Katz, Assistant...

  16. 77 FR 48541 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... given that on July 20, 2012, a proposed Consent Decree in United States v. Carmeuse Lime, Inc., Civil... 40 CFR 52.21; the New Source Performance Standards for Lime Manufacturing Plants (``Lime NSPS....344; the National Emission Standards for Hazardous Air Pollutants for Lime Manufacturing Plants...

  17. Improving informed consent: Stakeholder views

    PubMed Central

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

    2017-01-01

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

  18. 75 FR 32210 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ... or verify recovery of refrigerant from appliances it accepts for disposal. The Consent Decree...) purchase equipment to recover refrigerant or contract for such services and provide such service at no... provided in appendix A; and (4) keep a refrigerant recovery log regarding refrigerant that it has recovered...

  19. 77 FR 25750 - Notice of Lodging of Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-01

    ... damages and reimbursement of natural resource damage assessment costs. The Department of Justice will... Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural... Section, Environment and Natural Resources Division. [FR Doc. 2012-10390 Filed 4-30-12; 8:45 am] BILLING...

  20. 78 FR 14591 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ... cents per page reproduction cost) payable to the United States Treasury for a version without appendices...

  1. 78 FR 59718 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ--ENRD, P.O. Box... reproduction cost) payable to the United States Treasury. Thomas P. Carroll, Assistant Section Chief...

  2. 78 FR 57656 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library... $9.75 (25 cents per page reproduction cost) payable to the United States Treasury. Henry S. Friedman...

  3. 77 FR 32135 - Notice of Lodging of Consent Decree Under the Clean Air Act and the Emergency Planning and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... flare gas recovery systems and improved flaring efficiency, and enhanced controls for leak detection and... the monitoring data to a publicly available Web site on a weekly basis. The Consent Decree also... Department of Justice Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . A copy of the Decree may...

  4. 77 FR 60723 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-04

    ... to recover unpaid Title V permit fees; (4) mitigation of past violations by replacing four engines... Justice Department Web site: http://www.usdoj.gov/enrd/Consent_Decrees.html . We will provide a paper copy...

  5. 77 FR 76302 - Notice Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-27

    ... Utilities Company for violations of state and federal opacity, New Source Review, and Title V regulations at the company's electric generating station in Ghent, Kentucky. The proposed consent decree requires... Utilities Company, Civil Action No. 3:12-cv-00076-CFVT. The United States filed this lawsuit under the Clean...

  6. 75 FR 69125 - Notice of Lodging of Consent Decree Under The Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... the Decree, the United States alleges that the Slippery Rock University and the Commonwealth of... particulate emissions from boilers on the university campus. Pursuant to the Decree, Slippery Rock University... also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice...

  7. Informed consent: Part II.

    PubMed

    Murphy, E K

    1988-05-01

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

  8. Adolescents and consent to treatment.

    PubMed

    Dickens, B M; Cook, R J

    2005-05-01

    Adolescents, defined by WHO as 10 to 19 years old, can give independent consent for reproductive health services if their capacities for understanding have sufficiently evolved. The international Convention on the Rights of the Child, almost universally ratified, limits parental powers, and duties, by adolescents' "evolving capacities" for self-determination. Legal systems may recognize "mature minors" as enjoying adult rights of medical consent, even when consent to sexual relations does not absolve partners of criminal liability; their consent does not make the adolescents offenders. There is usually no chronological "age of consent" for medical care, but a condition of consent, meaning capacity for understanding. Like adults, mature minors enjoy confidentiality and the right to treatment according to their wishes rather than their best interests. Minors incapable of self-determination may grant or deny assent to treatment for which guardians provide consent. Emancipated minors' self-determination may also be recognized, for instance on marriage or default of adults' guardianship.

  9. 76 FR 76762 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-08

    ... refrigerant from appliances it accepts for disposal. The Consent Decree provides for a civil penalty of $3,500... Facility: (1) Purchase equipment to recover refrigerant or contract for such services and provide for such... verification (e.g., that all refrigerant that had not leaked previously was properly evacuated); (3) require...

  10. Informed consent for genetic research.

    PubMed

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

    2004-06-01

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

  11. 78 FR 69441 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ... $141 million. The publication of this notice opens a period for public comment on the Consent Decree..., DJ : 90-5-1-1-2767/1. All comments must be submitted no later than thirty (30) days after the...

  12. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?

    PubMed Central

    Steinsbekk, Kristin Solum; Kåre Myskja, Bjørn; Solberg, Berge

    2013-01-01

    In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach. PMID:23299918

  13. 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.

  14. 77 FR 51576 - Notice of Lodging of Proposed Fourth Amendment to the Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-24

    ... (with regard to the Philadelphia refinery).'' The publication of this notice opens a period for public... Decree may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of... a copy from the Consent Decree Library by mail, please enclose a check in the amount of $8.00 (25...

  15. 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

  16. 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.

  17. 75 FR 20863 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ... given that on April 16, 2010, a proposed Consent Decree in United States v. Mobil Oil Guam, Inc., and Mobil Oil Mariana Islands, Inc., Civil Action No. 10-00006, was lodged with the United States District... Defendants Mobil Oil Guam, Inc., and Mobil Oil Mariana Islands, Inc., resolves allegations by the U.S...

  18. 77 FR 30555 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-23

    ... Pollutants applicable to oil and natural gas production facilities, 40 CFR part 63, Subpart HH and Subpart... given that on May 16, 2012, a proposed Consent Decree in United States et al. v. Questar Gas Management... District of Utah. In this action the United States seeks civil penalties and injunctive relief for alleged...

  19. Autonomy in Depressive Patients Undergoing DBS-Treatment: Informed Consent, Freedom of Will and DBS’ Potential to Restore It

    PubMed Central

    Beeker, Timo; Schlaepfer, Thomas E.; Coenen, Volker A.

    2017-01-01

    According to the World Health Organization, depression is one of the most common and most disabling psychiatric disorders, affecting at any given time approximately 325 million people worldwide. As there is strong evidence that depressive disorders are associated with a dynamic dysregulation of neural circuits involved in emotional processing, recently several attempts have been made to intervene directly in these circuits via deep brain stimulation (DBS) in patients with treatment-resistant major depressive disorder (MDD). Given the promising results of most of these studies, the rising medical interest in this new treatment correlates with a growing sensitivity to ethical questions. One of the most crucial concerns is that DBS might interfere with patients’ ability to make autonomous decisions. Thus, the goal of this article is to evaluate the impact DBS presumably has on the capacity to decide and act autonomously in patients with MDD in the light of the autonomy-undermining effects depression has itself. Following the chronological order of the procedure, special attention will first be paid to depression’s effects on patients’ capacity to make use of their free will in giving valid Informed Consent. We suggest that while the majority of patients with MDD appear capable of autonomous choices, as it is required for Informed Consent, they might still be unable to effectively act according to their own will whenever acting includes significant personal effort. In reducing disabling depressive symptoms like anhedonia and decrease of energy, DBS for treatment resistant MDD thus rather seems to be an opportunity to substantially increase autonomy than a threat to it. PMID:28642690

  20. Autonomy in Depressive Patients Undergoing DBS-Treatment: Informed Consent, Freedom of Will and DBS' Potential to Restore It.

    PubMed

    Beeker, Timo; Schlaepfer, Thomas E; Coenen, Volker A

    2017-01-01

    According to the World Health Organization, depression is one of the most common and most disabling psychiatric disorders, affecting at any given time approximately 325 million people worldwide. As there is strong evidence that depressive disorders are associated with a dynamic dysregulation of neural circuits involved in emotional processing, recently several attempts have been made to intervene directly in these circuits via deep brain stimulation (DBS) in patients with treatment-resistant major depressive disorder (MDD). Given the promising results of most of these studies, the rising medical interest in this new treatment correlates with a growing sensitivity to ethical questions. One of the most crucial concerns is that DBS might interfere with patients' ability to make autonomous decisions. Thus, the goal of this article is to evaluate the impact DBS presumably has on the capacity to decide and act autonomously in patients with MDD in the light of the autonomy-undermining effects depression has itself. Following the chronological order of the procedure, special attention will first be paid to depression's effects on patients' capacity to make use of their free will in giving valid Informed Consent. We suggest that while the majority of patients with MDD appear capable of autonomous choices, as it is required for Informed Consent, they might still be unable to effectively act according to their own will whenever acting includes significant personal effort. In reducing disabling depressive symptoms like anhedonia and decrease of energy, DBS for treatment resistant MDD thus rather seems to be an opportunity to substantially increase autonomy than a threat to it.

  1. 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.

  2. 78 FR 24436 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... publication of this notice opens a period for public comment on the consent decree. Comments should be... United States v.CEMEX, Inc., D.J. Ref. No. DJ 90-5-2-1-09151. All comments must be submitted no later...

  3. 76 FR 53697 - Notice of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ... DEPARTMENT OF JUSTICE Notice of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on August 22, 2011, a proposed... Defendant Rexam Inc. (``Rexam''), pursuant to Section 107 of the Comprehensive Environmental Response...

  4. Care and Consent.

    ERIC Educational Resources Information Center

    Gottesman, Roberta

    1981-01-01

    Discusses the legal ramifications of informed consent for medical treatment of schoolchildren, including the problems posed by parents unwilling to give adequate medical protection to their children because of religious or other reasons. Covers the types of medical care that minors can receive without parental consent. (WD)

  5. 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.

  6. 75 FR 29584 - Notice of Lodging of Consent Decree Under the Resource Conservation and Recovery Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ...(a); and applicable Arkansas Pollution Control and Ecology Commission regulations in connection with Rineco's fuel blending facility located in Benton, Arkansas. The Consent Decree requires Rineco to apply...

  7. 78 FR 14591 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... pollution control technologies to reduce emissions of nitrogen oxides, sulfur dioxide, and particulate... comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment... Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc...

  8. 77 FR 25750 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-01

    ... injunctive relief to reduce emission of nitrogen oxides and volatile organic compounds. The Department of... to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment... the address given above. Robert Brook, Assistant Chief, Environmental Enforcement Section, Environment...

  9. 75 FR 42785 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-22

    ... given that on July 7, 2010, a proposed Consent Decree in United States of America, et al. v. Wise Alloys..., Alabama which contains two affected sources, the Alabama Reclamation Operations and the Alloys Cast House... should refer to United States of America, et al. v. Wise Alloys, LLC, Civil Action No. CV-10-TMP-1811-NW...

  10. 75 FR 27580 - Notice of Lodging of Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-17

    ... given that on May 10, 2010, a proposed Consent Decree (``Decree'') in United States v. The Pep Boys... (``CAA'') against The Pep Boys--Manny, Moe & Jack, and Baja, Inc., for violations of the mobile source.... The Pep Boys--Manny, Moe & Jack, and Baja, Inc., Civil Action No. 10-cv-00745, (D.D.C.), D.J. Ref. 90...

  11. Consent: a Cartesian ideal? Human neural transplantation in Parkinson's disease.

    PubMed

    Lopes, Manuel; Meningaud, Jean-Paul; Behin, Anthony; Hervé, Christian

    2003-01-01

    The grafting of human embryonic cells in Parkinson's disease is an innovative and hopefully useful therapeutic approach. However, it still concerns a very small number of patients and is only suggested as a research protocol. We present here a study of the problems of information and consent to research within the framework of this disease in which the efficacy of medical treatment is shortlived. The only French center to use this treatment (Hôpital H. Mondor in Créteil) has received authorization from the Comité Consultatif National d'Ethique (Consultative National Committee on Ethics). Eleven patients were treated between 1991 and 1998. The study of the results of a questionnaire sent to those patients showed the difficulties met in evaluating the perception of information despite intact intellectual capacities in people "prepared to risk everything." In France, the duty to inform patients during research procedures is regulated by the Huriet Act. However, it is not easy to guarantee genuine consent when preliminary information is given to patients psychologically impaired by the slow and ineluctable course of their disease. In these borderline cases, a valid consent seems to be a myth in terms of pure autonomy when considered with the Cartesian aim of elimination of uncertainty. The relevance of this concept of genuine consent probably makes more sense as aiming at a Cartesian ideal which is perhaps more in the spirit rather than in the letter. It is in that same spirit that, from the outset, we propose to define t he practical ways of answering the patients' request for information, even sometimes after consent has been given.

  12. 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.

  13. (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

  14. 78 FR 28242 - Notice of Lodging of Proposed Consent Decree Under the Safe Drinking Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ... per page reproduction cost) payable to the United States Treasury. Maureen Katz, Assistant Section...

  15. 77 FR 11158 - Notice of Lodging of Consent Decree Under the Toxic Substances Control Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... chlorinated paraffins and committed to submit premanufacture notices (``PMNs'') for medium and long-chain chlorinated paraffins, pursuant to TSCA Section 5. The proposed Consent Decree prohibits Dover Chemical from manufacturing any chlorinated paraffin product not placed on the TSCA Inventory via the PMN process. The...

  16. 75 FR 6231 - Securities Act of 1933; Securities Exchange Act of 1934; Order Regarding Review of FASB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ... Financial Accounting Standards Board (``FASB'') and its parent organization, the Financial Accounting... recognizing the FASB's financial accounting and reporting standards as ``generally accepted'' under Section...; Securities Exchange Act of 1934; Order Regarding Review of FASB Accounting Support Fee for 2010 Under Section...

  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. 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

  19. 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

  20. Greening the CWA consent decree - some examples of collaborative research amongst USEPA and municipalities

    EPA Science Inventory

    Combined sewer overflows (CSOs) violate the Clean Water Act Enforcement of CWA boils down to settlements with US cities – typically billions of dollars Green Infrastructure (GI) has come into view as part of consent decree settlements These settlements are a primary way to rehab...

  1. 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...

  2. 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...

  3. 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.

  4. 77 FR 66081 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-01

    ... District Court for the Western District of Michigan in the lawsuit entitled United States v. Kellogg USA... Implementation Plan, for violations at Kellogg's cereal and snack food manufacturing plants located in Battle Creek, Michigan and Grand Rapids, Michigan. The proposed Consent Decree requires Kellogg to reduce its...

  5. 77 FR 65714 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... operate at least eight wind turbines at the Landfill property. The publication of this notice opens a... of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ... cents per page reproduction cost) payable to the United States Treasury. Henry Friedman, Assistant...

  6. 78 FR 52971 - Notice of Lodging of Consent Decree Pursuant to the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... Defendant's coke production facilities located at 400 East Winchester Avenue in Ashland, Kentucky. The Defendant ceased operations at the coke facilities on June 21, 2011. Under this settlement between the... coke facilities are no longer in operation, the Defendant is not required, under this Consent Decree...

  7. 76 FR 56223 - Notice of Lodging of a Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... terms and conditions of National Pollution Discharge Elimination System permits that Indiana issued to... wet weather events, and some dry weather time periods, into ``waters of the United States'' and ``waters of the state.'' The proposed Consent Decree would require Elkhart to reduce its combined sewer...

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 34 Education 2 2013-07-01 2013-07-01 false Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  14. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 34 Education 2 2011-07-01 2010-07-01 true Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  15. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 34 Education 2 2012-07-01 2012-07-01 false Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  16. 34 CFR 300.300 - Parental consent.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 34 Education 2 2014-07-01 2013-07-01 true Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

  17. 78 FR 44598 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... Decree would require (1) installation of process equipment to provide redundancy that will allow hot... . We will provide a paper copy of the Consent Decree upon written request and payment of reproduction... cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages...

  18. 76 FR 49505 - Notice of Lodging of a Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-10

    ... or eliminate unlawful SSOs and CSOs into various rivers and streams, as well as discharges to... P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611. The comments should refer to... by mailing a request to the Consent Decree Library, P.O. Box 7611, [[Page 49506

  19. 77 FR 809 - Notice of Lodging of a Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-06

    ... terms and conditions of National Pollution Discharge Elimination System permits that Indiana issued to...,'' during wet weather events, and some dry weather time periods, into ``waters of the United States'' and ``waters of the state.'' The proposed Consent Decree would require South Bend to reduce its combined sewer...

  20. 76 FR 45617 - Notice of Lodging of the Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ...) violations stemming from its failure to properly operate and maintain its Combined Sewer Collection System..., implement approved operation and maintenance schedules of its sewers, conduct a pump station evaluation, as... from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611...

  1. 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...

  2. 77 FR 69517 - Order Granting Exmeptions From Specified Provisions of the Securities Exchange Act and the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ..., 2012: Investment Company Act of 1940; Release No. 30261/November 14, 2012] Order Granting Exmeptions From Specified Provisions of the Securities Exchange Act and the Investment Company Act and Certain...(C) and Section 38(A) of the Investment Company Act of 1940 Granting Exemptions From Specified...

  3. 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...

  4. 78 FR 39770 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... Decree would require (1) installation of process equipment to provide redundancy that will allow hot..._Decrees.html . We will provide a paper copy of the Consent Decree upon written request and payment of... reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature...

  5. 77 FR 71196 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... emissions of sulfur dioxide (SO 2 ) and nitrogen oxides (NO X ) through emission control requirements and... consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural..., Environment and Natural Resources Division. [FR Doc. 2012-28884 Filed 11-28-12; 8:45 am] BILLING CODE 4410-15...

  6. 77 FR 34064 - Notice of Lodging of the Consent Decree under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... Permit; (3) Arecibo violates its Small MS4 General Permit by discharging sewage and sewage sludge not...; and failing to properly operate and maintain its system; and (4) discharges untreated sewage from its... public has or may have come into contact with the sewage. The proposed Consent Decree addresses the...

  7. 78 FR 19529 - Notice of Lodging of Proposed Consent Decrees Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decrees Under the Comprehensive Environmental Response, Compensation, and Liability Act On March 26, 2013, the Department of Justice lodged two... provides certain covenants not to sue and other protections pursuant to the Comprehensive Environmental...

  8. 76 FR 72216 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-22

    ... DEPARTMENT OF JUSITCE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'') Notice is hereby given that on November 15, 2011, a... Pennsylvania. In this action under Section 107(a) of the Comprehensive Environmental Response, Compensation...

  9. 75 FR 57817 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-22

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act Notice is hereby given that on September 16, 2010, a proposed....; and MeadWestvaco Virginia Corp; under Sections 106 and 107 of Comprehensive Environmental Response...

  10. 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...

  11. 32 CFR 634.8 - Implied consent.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  12. 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

  13. Nudging, informed consent and bullshit.

    PubMed

    Simkulet, William

    2017-11-18

    Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  14. 76 FR 58507 - Proposed Settlement Agreement, Clean Air Act Citizen Suit

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-21

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

  15. 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...

  16. Minors' rights to consent to treatment: navigating the complexity of State laws.

    PubMed

    Vukadinovich, David M

    2004-01-01

    State laws recognize that a competent adult patient has the right to consent to or refuse medical treatment. While the law is clear with regard to the right of competent adults, state statutes are more complicated when the patient is a minor. While the law should, and does, attempt to balance the rights and obligations of parents and guardians against the access and privacy rights of minors, complicated state statutory schemes often fail to simultaneously address those contrasting goals in a consistent and uniform manner. The result is a confusing set of seemingly arbitrary and sometimes conflicting provisions that require the detailed attention of healthcare providers to ensure legal compliance. With the aim of helping healthcare practitioners meet their legal obligations, this Article examines state laws governing minor's consent rights byfocusing on the instances in which a minor's parent, guardian, or other authorized adult is permitted to consent to treatment on behalf of a minor and the instances in which a minor is authorized to act independent of adult intervention.

  17. Informed consent in surgical trials.

    PubMed

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  18. 78 FR 52972 - Re-Publication of Notice of Lodging of Proposed Third Amendment to Consent Decree Under the Clean...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... Decree Under the Clean Air Act On July 23, 2013, the Department of Justice lodged a proposed Third... Consent Decree resolving certain violations of the federal Clean Air Act, 42 U.S.C. 7401 et seq. by... Companies'') alleged by Plaintiff United States and Plaintiff-Intervenors the State of Alabama, the State of...

  19. "Negotiorum Gestio" in Family Medicine, Informed Consent Obtainment, and Disciplinary Responsibility.

    PubMed

    Birkeland, Søren

    2016-01-01

    Introduction. Negotiorum gestio (NG) denotes an action where a person well intendedly acts on behalf of another without obtaining the latter's prior consent. In broad terms, NG-like actions have played a considerable role in health care provision. In some settings, health care delivery with only little or presumed patients' consent has been the rule rather than the exception. However, bioethical principles regarding patient autonomy and obtainment of the patient's informed consent (IC) before intervention are now increasingly materialized in the law of many countries. Aim. To study legal consequences of NG in family medicine and IC handling options. Methods. Case law examination. Results. A disciplinary board case is described concerning a family doctor conducting unlawful NG by not coming up to legal IC requirements. Discussion and Conclusion. The practical and legal implications of IC and possible role of novel Shared Decision-Making approaches in coming up to regulation and bioethical demands are discussed. It is concluded that a doctor may run an unnecessary legal risk when conducting NG in decision-competent patients and furthermore it is suggested that novel Shared Decision-Making approaches could help in obtaining a rightful and practicable IC.

  20. 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.

  1. 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.

  2. Feelings of wantedness and consent during nonconsensual sex: Implications for posttraumatic cognitions.

    PubMed

    Artime, Tiffany M; Peterson, Zoë D

    2015-11-01

    Social-cognitive models of traumatic stress have urged researchers to investigate the complex changes in victims' systems of belief following trauma. Among victims of rape, posttraumatic cognitions related to self-blame, safety, trust, intimacy, control, power, and esteem are common negative outcomes; yet there is great variability in the degree to which rape victims exhibit these reactions, and this remains unexplained. Two possible factors that may be relevant to the development of these posttraumatic cognitions are the extent to which the nonconsensual sexual act was internally perceived as nonconsensual by the victim and the extent to which it was internally perceived as unwanted by the victim. Although felt consent and perceived wanting are often conflated and rated dichotomously, there is evidence that they are distinct and may be experienced on a continuum. This study sought to examine the relationships among felt consent, wantedness, and posttraumatic cognitions in a sample of 189 undergraduate female victims of rape. Results demonstrated that perceived consent and perceived wantedness had unique and opposite relationships with posttraumatic cognitions: Greater felt consent was a risk factor for characterological and behavioral self-blame and maladaptive self-beliefs, but greater feelings of wanting to have sex constituted a protective factor for characterological self-blame, maladaptive self-beliefs, and maladaptive world-beliefs. A suppression effect was also identified, which provided evidence that perceived consent and wantedness work in tandem in the cognitive processing of rape. Clinical and research implications are discussed, with an emphasis on the importance of understanding and honoring victims' perceptions. (c) 2015 APA, all rights reserved).

  3. 78 FR 41803 - Notice of Lodging of Proposed Amendment to Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-11

    ... original 2012 consent decree, the Metropolitan St. Louis Sewer District (``MSD'') agreed to undertake... specific combined sewer overflow control measures. MSD still is in the process of complying with the 2012...

  4. 76 FR 42138 - Notice of Lodging of Consent Decree Under The Resource Conservation and Recovery Act (RCRA)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-18

    ... generation, transportation, treatment, storage, handling and disposal of hazardous wastes, Fla. Admin. Code... Consent Decree, may also be examined on the following Department of Justice Web site, http://www.usdoj.gov...

  5. 77 FR 11158 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Notice is hereby given that on February 17, 2012, a proposed Consent Decree in In Re: Oil Spill by the Oil Rig ``Deepwater Horizon'' in the Gulf of Mexico, on April 20, 2010, MDL 2179, was lodged with the... discharge of oil into the Gulf of Mexico resulting from the April 20, 2010 blowout of the Macondo well and...

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

    PubMed

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

    2017-08-08

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

  7. 76 FR 45617 - Notice of Lodging of the Consent Decree Under the Resource Conservation and Recovery Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

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

  8. Let Archived Paraffin Blocks Be Utilized for Research with Waiver of Informed Consent.

    PubMed

    Kim, Yong-Jin; Park, Jeong Sik; Ko, Karam; Jeong, Chang Rok

    2018-05-01

    Advances in biomedical and genetic research have contributed to more effective public health improvement via bench-to-bed research and the emergence of personalized medicine. This has certainly showcased the importance of archived human tissues, especially paraffin-embedded blocks in pathology. Currently in Korea, undue legislative regulations of the Bioethics and Safety Act suspend and at times discourage studies from taking place. In this paper, the authors underline the value of paraffin blocks in the era of personalized and translational medicine. We discuss detailed clauses regarding the applicability of paraffin blocks from a legal perspective and compare Korea's regulations with those of other countries. The necessity for allowing waived consent and Institutional Review Board (IRB) approval will be argued throughout. The authors suggest that researchers declare the following to obtain IRB approval and waiver of informed consents: research could not be practically carried out without a waiver of consent; the proposed research presents no more than minimal risk of harm to subjects, and the waiver of consent will not adversely affect the rights and welfare of subjects; and research will not utilize a tissue block if only 1 is available for each subject, to allow future clinical use such as re-evaluation or further studies.

  9. 76 FR 12369 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-07

    ... DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act (Superfund) Notice is hereby given that on March 2, 2011, a... responding to the release or threat of release of hazardous substances at the Burnt Fly Bog Superfund Site...

  10. [Schizophrenia and informed consent to research].

    PubMed

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

    2015-10-01

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

  11. 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.

  12. 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...

  13. 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...

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

    PubMed

    Kara, Mahmut A; Aksoy, Sahin

    2006-09-01

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

  15. [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.

  16. Informed consent in psychotherapy.

    PubMed

    Beahrs, J O; Gutheil, T G

    2001-01-01

    The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

  17. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    PubMed

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  18. 76 FR 28459 - Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-17

    ... Response, Compensation, and Liability Act Notice is hereby given that on May 11, 2011, a proposed Consent Decree (the ``Decree'') in United States v. Alsol Corporation, SB Building Associates, Limited Partnership, SB Building GP, L.L.C., United States Land Resources, L.P., United States Realty Resources, Inc...

  19. 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.

  20. College students and sexual consent: unique insights.

    PubMed

    Jozkowski, Kristen N; Peterson, Zoë D

    2013-01-01

    Sexual assault continues to be a salient health concern, especially among college women. Because assault is often defined in terms of consent, prevention efforts hinge on promoting the definition and the obtainment of consent as a mechanism to reduce assault. Despite the focus on consent promotion, research specifically examining consent in general and among college students specifically is limited. College students (n = 185) were recruited to participate in an open-ended survey in which they were asked to report how they indicated consent and interpreted their partners' consent to engage in a range of sexual behaviors. Content analysis was utilized to qualitatively analyze responses. In the current study, data were assessed for emerging themes across all items. In examining participants' responses, four distinct themes emerged: (a) endorsement of the traditional sexual script; (b) women are responsible for performing oral sex; (c) men's consent to sex can be aggressive; and (d) men utilize deception to obtain consent to sex. Findings suggest that men are conceptualized as sexual initiators and women as sexual gatekeepers, and that men's sexual pleasure is primary whereas women's experience of pleasure is secondary. Findings articulate the need for more pointed research aimed at assessing sexual consent among college students.

  1. 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...

  2. 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...

  3. 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...

  4. Informed Consent to Treatment in Psychiatry

    PubMed Central

    Neilson, Grainne; Chaimowitz, Gary

    2015-01-01

    Summary Patients have a right to be informed and actively involved in their health care. Fundamental to a person’s dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It is important that psychiatrists have an awareness of the ethical underpinnings of consent and the legislated requirements related to consent, including precedent cases. Consent may change over time and for different conditions and circumstances. Consent must be an ongoing process.

  5. 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.

  6. 12 CFR 1272.6 - FHFA consent.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 9 2013-01-01 2013-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

  7. 12 CFR 1272.6 - FHFA consent.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 10 2014-01-01 2014-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

  8. 12 CFR 1272.6 - FHFA consent.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 9 2012-01-01 2012-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

  9. 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…

  10. Enhancing informed consent for research and treatment.

    PubMed

    Dunn, L B; Jeste, D V

    2001-06-01

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

  11. USign--a security enhanced electronic consent model.

    PubMed

    Li, Yanyan; Xie, Mengjun; Bian, Jiang

    2014-01-01

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

  12. 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

  13. 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.

  14. Ethics, informed consent, and assisted reproduction.

    PubMed

    Macklin, R

    1995-09-01

    Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

  15. Australian and Canadian mental health Acts compared.

    PubMed

    Gray, John Ellery; McSherry, Bernadette Maree; O'Reilly, Richard L; Weller, Penelope June

    2010-12-01

    The main objective of this paper is to compare the mental health Acts of the eight Australian jurisdictions and the 13 Canadian jurisdictions on three major issues: involuntary admission criteria, treatment authorization/consent and compulsory treatment in the community, in the light of international trends towards patients' rights. The legislation was examined against the background of rights instruments such as the Canadian Charter of Rights and Freedoms and the United Nations Convention on the Rights of Persons with Disabilities. It was found that some Canadian involuntary admission criteria require the likelihood of bodily harm whereas all Australian Acts have broad harm and deterioration criteria. Unlike all Australian jurisdictions, some Canadian jurisdictions allow for the refusal of treatment that may be required for discharge. In addition, Canadian community treatment orders are much more restrictive than in Australia because they require a person to have considerable previous hospitalization despite meeting the committal criteria. Australian jurisdictions can use community treatment orders as a least restrictive alternative to inpatient status without prior hospitalization. The paper concludes that there are significant philosophical differences regarding the purpose of involuntary admission between Australian and some Canadian jurisdictions where treatment refusal is possible. Australian mental health Acts have a relatively stronger 'treatment' focus than some Canadian Acts. The apparently stronger 'rights' focus of some Canadian laws (such as the permission of treatment refusal) can paradoxically result in a denial of liberty rights. The way in which the relevant legislation is shaped in both countries will increasingly be affected by international trends towards the rights of individuals with disabilities.

  16. Using informed consent to save trust.

    PubMed

    Eyal, Nir

    2014-07-01

    Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions.This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example,people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some common sense intuitions about informed consent. We should revise the argument, common sense morality, or both.

  17. 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.

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

    PubMed

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

    2016-01-01

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

  19. 76 FR 33364 - Notice of Lodging of Two Consent Decrees Under the Comprehensive Environmental Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... Environmental Response, Compensation and Liability Act Notice is hereby given that on June 1, 2011, two proposed consent decrees in United States and State of Nebraska v. Union Pacific Corp., Union Pacific Railway Co... District Court for the District of Nebraska. In that lawsuit, the United States and State of Nebraska seek...

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

    PubMed Central

    Verástegui, Emma L

    2006-01-01

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

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

    PubMed

    Verástegui, Emma L

    2006-12-13

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

  2. 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.

  3. [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.

  4. 78 FR 13706 - Notice of Lodging of Second Modified Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to United States and... Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, or by faxing or emailing a... Modified Consent Decree in United States and League of Women Voters of New Orleans, et al. v. Sewerage and...

  5. 78 FR 1882 - Notice of Lodging of Proposed First Amendment to Consent Decree Under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-09

    ... reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ--ENRD, P.O. Box... reproduction cost) payable to the United States Treasury. Maureen Katz, Assistant Section Chief, Environmental...

  6. Readability of Invasive Procedure Consent Forms.

    PubMed

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

    2015-12-01

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

  7. Informed consent comprehension in African research settings.

    PubMed

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

    2014-06-01

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

  8. What is presumed when we presume consent?

    PubMed Central

    Pierscionek, Barbara K

    2008-01-01

    Background The organ donor shortfall in the UK has prompted calls to introduce legislation to allow for presumed consent: if there is no explicit objection to donation of an organ, consent should be presumed. The current debate has not taken in account accepted meanings of presumption in law and science and the consequences for rights of ownership that would arise should presumed consent become law. In addition, arguments revolve around the rights of the competent autonomous adult but do not always consider the more serious implications for children or the disabled. Discussion Any action or decision made on a presumption is accepted in law and science as one based on judgement of a provisional situation. It should therefore allow the possibility of reversing the action or decision. Presumed consent to organ donation will not permit such reversal. Placing prime importance on the functionality of body organs and their capacity to sustain life rather than on explicit consent of the individual will lead to further debate about rights of ownership and potentially to questions about financial incentives and to whom benefits should accrue. Factors that influence donor rates are not fully understood and attitudes of the public to presumed consent require further investigation. Presuming consent will also necessitate considering how such a measure would be applied in situations involving children and mentally incompetent adults. Summary The presumption of consent to organ donation cannot be understood in the same way as is presumption when applied to science or law. Consideration should be given to the consequences of presuming consent and to the questions of ownership and organ monetary value as these questions are likely to arise should presumed consent be permitted. In addition, the implications of presumed consent on children and adults who are unable to object to organ donation, requires serious contemplation if these most vulnerable members of society are to be

  9. Dynamic axes of informed consent in Japan.

    PubMed

    Specker Sullivan, Laura

    2017-02-01

    Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. 75 FR 66791 - Notice of Lodging of First Amendment to Consent Decree Under the Clean Water Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-29

    ... capacity of its wastewater treatment plant. The First Amendment recognizes EPA and Ohio EPA's approval of... improvements at its wastewater treatment plant. In addition, the First Amendment requires Toledo to perform a... Consent Decree, eliminates pathogens from the wastewater being treated. The Department of Justice will...

  11. 42 CFR 50.205 - Consent form requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form... person who obtains the consent; and (4) The physician who will perform the sterilization procedure. (c... performing the sterilization must certify by signing the consent form, that: (i) Shortly before the...

  12. Proposed Administrative Penalty Order Against Cimarex Energy Company for Clean Water Act Violations

    EPA Pesticide Factsheets

    EPA is authorized to issue Orders assessing civil penalties for various violations of the Clean Water Act (“CWA”). EPA is providing notice of a proposed administrative penalty assessment against Cimarex Energy Company for alleged violations of the CWA.

  13. 76 FR 65534 - Notice of Lodging of Modification of Consent Decree Under the Resource Conservation and Recovery Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ...) of RCRA, 42 U.S.C. 6925(a); and applicable Arkansas Pollution Control and Ecology Commission... $1,350,000. The Consent Decree also requires Rineco to apply for a RCRA permit for the TMW and its...

  14. Readability of Invasive Procedure Consent Forms

    PubMed Central

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

    2015-01-01

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

  15. 75 FR 7627 - Notice of Lodging of Material Modification to Consent Decree under the Clean Air Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... proposed First Material Modification to Consent Decree (``First Decree Modification'') in United States, et al. v. Bunge North America, Inc., et al., Civil Action No. 2:06-cv-02209- MPM-DGB (C.D. Ill.) was... owned and operated by Bunge North America, Inc. and several affiliated entities (collectively referred...

  16. Informed Consent for Electroconvulsive Therapy--Finding Balance.

    PubMed

    Mankad, Mehul

    2015-09-01

    Informed consent underpins all medical decisions, including the decision to undergo electroconvulsive therapy (ECT). Written informed consent remains the standard before the initiation of ECT and requires the inclusion of several components to be considered valid. Prospective patients must be aware of risks and benefits of ECT as well as risks and benefits of alternate, and potentially less effective, interventions. Patients must also possess adequate decision-making capacity to make an informed choice about treatment. Consent for ECT may present unique issues, such as the interplay between potential cognitive adverse effects and informed consent. Options to address this concern include thorough explanation of this topic before the initiation of ECT, continued reassessment of consent during ECT, or some combination of approaches.

  17. July 2011 Memorandum: Improving EPA Review of Appalachian Surface Coal Mining Operations Under the Clean Water Act, National Environmental Policy Act, and the Environmental Justice Executive Order

    EPA Pesticide Factsheets

    Memorandum: Improving EPA Review of Appalachian Surface Coal Mining Operations Under the Clean Water Act, National Environmental Policy Act, and the Environmental Justice Executive Order, July 21, 2011

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

    PubMed

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

    2017-10-01

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

  19. 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.

  20. 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.

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