38 CFR Part 16 - PROTECTION OF HUMAN SUBJECTS (Eff. until 1-19-18)
- § 16.101 To what does this policy apply?
- § 16.102 Definitions.
- § 16.103 Assuring compliance with this policy - research conducted or supported by any Federal Department or Agency.
- §§ 16.104-16.106 [Reserved]
- § 16.107 IRB membership.
- § 16.108 IRB functions and operations.
- § 16.109 IRB review of research.
- § 16.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
- § 16.111 Criteria for IRB approval of research.
- § 16.112 Review by institution.
- § 16.113 Suspension or termination of IRB approval of research.
- § 16.114 Cooperative research.
- § 16.115 IRB records.
- § 16.116 General requirements for informed consent.
- § 16.117 Documentation of informed consent.
- § 16.118 Applications and proposals lacking definite plans for involvement of human subjects.
- § 16.119 Research undertaken without the intention of involving human subjects.
- § 16.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
- § 16.121 [Reserved]
- § 16.122 Use of Federal funds.
- § 16.123 Early termination of research support: Evaluation of applications and proposals.
- § 16.124 Conditions.
Title 38 published on 08-Mar-2018 04:20
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 38 CFR Part 16 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2018-00997 RIN 0937-AA06 DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, CONSUMER PRODUCT SAFETY COMMISSION, DEPARTMENT OF EDUCATION, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION Interim final rule; delay of effective and compliance dates; request for comments. This interim final rule is effective on July 19, 2018. This interim final rule delays until July 19, 2018, the effective date and general compliance date of the final rule published in the Federal Register (82 FR 7149, Jan. 19 2017) and of the final rule published by the Consumer Product Safety Commission in the Federal Register (82 FR 43459, Sept. 18, 2017). To be assured consideration, comments must be received at one of the addresses provided below, no later than 11:59 p.m. Eastern Standard Time on March 19, 2018. 6 CFR Part 46 In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the “2018 Requirements.” The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.
GPO FDSys XML | Text type regulations.gov FR Doc. 2017-01058 RIN 0937-AA02 DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF EDUCATION, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION Final rule. This rule is effective on January 19, 2018. The compliance date for this rule, except for § __.114(b) (cooperative research), is January 19, 2018. The compliance date for § __.114(b) (cooperative research) is January 20, 2020. 6 CFR Part 46 The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
GPO FDSys XML | Text type regulations.gov FR Doc. 2015-30122 RIN 0937-AA02 DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF EDUCATION, DEPARTMENT OF JUSTICE, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION Notice of proposed rulemaking. The comment period for the NPRM published on September 8, 2015 (80 FR 53933), is extended by 30 days and thus will end on January 6, 2016. 6 CFR Part 46 The Department of Health and Human Services and the other Federal Departments and Agencies listed in this document are extending the comment period on the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking. The NPRM requests comment on proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM was published in the Federal Register on September 8, 2015.
GPO FDSys XML | Text type regulations.gov FR Doc. 2015-21756 RIN 0937-AA02 DEPARTMENT OF TRANSPORTATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, ENVIRONMENTAL PROTECTION AGENCY, DEPARTMENT OF DEFENSE, NATIONAL AERONAUTICS AND SPACE ADMINISTRATION, DEPARTMENT OF COMMERCE, DEPARTMENT OF AGRICULTURE, DEPARTMENT OF ENERGY, DEPARTMENT OF HOMELAND SECURITY, SOCIAL SECURITY ADMINISTRATION, DEPARTMENT OF VETERANS AFFAIRS, DEPARTMENT OF EDUCATION, DEPARTMENT OF JUSTICE, AGENCY FOR INTERNATIONAL DEVELOPMENT, NATIONAL SCIENCE FOUNDATION Notice of proposed rulemaking. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 7, 2015. 6 CFR Part 46 The departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The participating departments and agencies propose these revisions to the human subjects regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.