United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2018_register executive 2018-07-02 article Part II Rules and Regulations D09002ee1c7e5d1cc D09002ee1c7e5d59a United States Department of Homeland Security originator org United States Government Agency or Subagency United States Department of Agriculture originator org United States Government Agency or Subagency United States Department of Energy originator org United States Government Agency or Subagency United States National Aeronautics and Space Administration originator org United States Government Agency or Subagency United States Department of Commerce originator org United States Government Agency or Subagency United States Consumer Product Safety Commission originator org United States Government Agency or Subagency United States Social Security Administration originator org United States Government Agency or Subagency United States Agency for International Development originator org United States Government Agency or Subagency United States Department of Housing and Urban Development originator org United States Government Agency or Subagency United States Department of Labor originator org United States Government Agency or Subagency United States Department of Defense originator org United States Government Agency or Subagency United States Department of Education originator org United States Government Agency or Subagency United States Department of Veterans Affairs originator org United States Government Agency or Subagency United States Environmental Protection Agency originator org United States Government Agency or Subagency United States Department of Health and Human Services originator org United States Government Agency or Subagency United States National Science Foundation originator org United States Government Agency or Subagency United States Department of Transportation originator org United States Government Agency or Subagency In a final rule published on January 19, 2017, a number of federal departments and agencies revised to the Federal Policy for the Protection of Human Subjects (often referred to as the "Common Rule"), which each department and agency adopted into regulations in its part of the Code of Federal Regulations (CFR). The Consumer Product Safety Commission (CPSC) adopted the same changes in a final rule published on September 18, 2017. The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. The Department of Housing and Urban Development (HUD) published an interim final rule adopting the same regulatory changes on January 26, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to here as the "2018 Requirements." On April 20, 2018, the federal departments and agencies listed here published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional 6-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances during such continued delay period. Through this final rule, we are adopting the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the "pre-2018 Requirements") until January 21, 2019. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019). Those three provisions are: The revised definition of "research," which deems certain activities not to be research covered by the Common Rule; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research. Institutions taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study's duration. 83 FR 28497 https://www.govinfo.gov/app/details/FR-2018-06-19/2018-13187 2018-13187 fr19jn18-13 RIN 0937-AA05 4150-36-P https://www.govinfo.gov/app/details/FR-2018-06-19/2018-13187 https://www.govinfo.gov/content/pkg/FR-2018-06-19/html/2018-13187.htm https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf Human Research Subjects Reporting and Recordkeeping Requirements Research 24 p. 28497 28520 83 FR 28497 Title 10 Part 745 10 CFR Part 745 Title 14 Part 1230 14 CFR Part 1230 Title 15 Part 27 15 CFR Part 27 Title 16 Part 1028 16 CFR Part 1028 Title 20 Part 431 20 CFR Part 431 Title 22 Part 225 22 CFR Part 225 Title 24 Part 60 24 CFR Part 60 Title 29 Part 21 29 CFR Part 21 Title 32 Part 219 32 CFR Part 219 Title 34 Part 97 34 CFR Part 97 Title 38 Part 16 38 CFR Part 16 Title 40 Part 26 40 CFR Part 26 Title 45 Part 46 45 CFR Part 46 Title 45 Part 690 45 CFR Part 690 Title 49 Part 11 49 CFR Part 11 Title 6 Part 46 6 CFR Part 46 Title 7 Part 1 7 CFR Part 1 RIN 0937-AA05 Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period; Federal Register Vol. 83, Issue RULE 2018-13187 II DEPARTMENT OF HOMELAND SECURITY DEPARTMENT OF AGRICULTURE DEPARTMENT OF ENERGY NATIONAL AERONAUTICS AND SPACE ADMINISTRATION DEPARTMENT OF COMMERCE CONSUMER PRODUCT SAFETY COMMISSION SOCIAL SECURITY ADMINISTRATION AGENCY FOR INTERNATIONAL DEVELOPMENT DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT DEPARTMENT OF LABOR DEPARTMENT OF DEFENSE DEPARTMENT OF EDUCATION DEPARTMENT OF VETERANS AFFAIRS ENVIRONMENTAL PROTECTION AGENCY DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL SCIENCE FOUNDATION DEPARTMENT OF TRANSPORTATION 2018-07-19 2019-01-21 4150-36-P 2018-13187 Final rule.

In a final rule published on January 19, 2017, a number of federal departments and agencies revised to the Federal Policy for the Protection of Human Subjects (often referred to as the "Common Rule"), which each department and agency adopted into regulations in its part of the Code of Federal Regulations (CFR). The Consumer Product Safety Commission (CPSC) adopted the same changes in a final rule published on September 18, 2017. The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. The Department of Housing and Urban Development (HUD) published an interim final rule adopting the same regulatory changes on January 26, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to here as the "2018 Requirements." On April 20, 2018, the federal departments and agencies listed here published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional 6-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances during such continued delay period. Through this final rule, we are adopting the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the "pre-2018 Requirements") until January 21, 2019. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019). Those three provisions are: The revised definition of "research," which deems certain activities not to be research covered by the Common Rule; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research. Institutions taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study's duration.

Effective date: This rule is effective on July 19, 2018. Compliance dates: The general compliance date for the 2018 Requirements in 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), which were delayed in the interim final rule published in the Federal Register (83 FR 2885, Jan. 22, 2018), and adopted by HUD through an interim final rule published in the Federal Register (83 FR 3589, Jan. 26, 2018), with the exception of Sec. ___.114(b), is further delayed until January 21, 2019. The compliance date for Sec. ___.114(b) (cooperative research) remains January 20, 2020. Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; email Jerry.Menikoff@hhs.gov. Human Research Subjects Reporting and Recordkeeping Requirements Research Protection of Human Subjects: Delay of General Compliance Date , Jerry.Menikoff@hhs.gov https://www.aamc.org/download/480840/data/aamcissuesjointletteroncommonrule.pdf https://www.amia.org/sites/default/files/AMIA%20Letter%20Regarding%20the%20Common%20Rule.pdf https://www.gpo.gov/fdsys/pkg/FR-1997-05-13/pdf/97-12699.pdf https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/ https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment/a/august/2/2017/index.html https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html Vol. 83, no. 118 Office of the Federal Register, National Archives and Records Administration 2018-06-19 continuing daily deposited born digital 179 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-06-19 P0b002ee19b458304 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19jn18 https://www.govinfo.gov/app/details/FR-2018-06-19 https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/FR-2018-06-19.pdf https://www.govinfo.gov/content/pkg/FR-2018-06-19/xml/FR-2018-06-19.xml fdlp 28351 28520 DGPO 2018-07-02 2024-06-01 FR-2018-06-19 machine generated eng FR FR-2018-06-19 83 118