Director, Office for Human Research Protections

0937-AA02 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0937 Office of Assistant Secretary for Health OASH 0900 Department of Health and Human Services HHS Federal Policy for the Protection of Human Subjects; Final Rules

The final rules would revise current human subjects regulations in order to strengthen protections for research subjects while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector 45 CFR 46 21 U.S.C. 289 Yes

Since the Federal Policy for the Protection of Human Subjects (often referred to as the Common Rule) was promulgated by 15 U.S. Federal departments and agencies in 1991, the volume and landscape of research involving human subjects have changed considerably. Research with human subjects has grown in scale and become more diverse. Examples of developments include: an expansion in the number and type of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques for use with human biospecimens; and the growing use of electronic health data and other digital records to enable very large data sets to be analyzed and combined in novel ways. Yet these developments have not been accompanied by major change in the human subjects research oversight system, which has remained largely unchanged over the last two decades. The proposed revisions are needed to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects.

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The quantified and non-quantified benefits and costs of all proposed changes to the Common Rule are the following: (1) Over the 2016-2025 period, present value benefits of $2,629 million and annualized benefits of $308 million are estimated using a 3 percent discount rate; and, present value benefits of $2,047 million and annualized benefits of $291 million are estimated using a 7 percent discount rate; (2) present value costs of $13,342 million and annualized costs of $1,564 million are estimated using a 3 percent discount rate; and, present value costs of $9,605 million and annualized costs of $1,367 million are estimated using a 7 percent discount rate.

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If this regulation is not published, the rules overseeing federally funded or conducted human subjects research will not be modernized, strengthened or made more effective.

]]> ANPRM 07/26/2011 76 FR 44512 ANPRM Comment Period End 10/26/2011 NPRM 09/08/2015 80 FR 53931 NPRM Comment Period End 12/07/2015 Final Action 12/00/2016 Includes Retrospective Review under E.O. 13563. Undetermined Undetermined No Undetermined No No Jerry Menikoff Director, Office for Human Research Protections 0937 Office of Assistant Secretary for Health OASH 240 453-6900 jerry.menikoff@hhs.gov 1101 Wootton Parkway, Suite 200, Rockville MD 20852