View Rule

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.

Statement of Need:

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.

Summary of the Legal Basis:

None.

Alternatives:

None.

Anticipated Costs and Benefits:

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.

Risks:

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.