Sneak Preview: Agencies Adopt Revisions to Human Subjects Rule

February 10, 2017 | By Jerry Ashworth | Post a Comment

xgran_bookshot(The following was excerpted from a recent article in the Federal Grants Management Handbook.) Several federal departments and agencies, in a joint final rule, adopted a revised federal policy for the protection of human subjects in research, which among other provisions, adds a new requirement for U.S.-based institutions engaged in cooperative research to use a single institutional review board (IRB) for research that takes place in the United States.

To protect human rights and welfare, research projects funded with federal grants that involve the use of human subjects are governed by requirements first imposed by the Department of Health and Human Services (HHS) in 1991. Governmentwide requirements for researchers and grantee institutions are spelled out in Title 45 of the Code of Federal Regulations, Subpart A of Part 46 “Human Subjects Protection,” which is known as the common rule in this subject matter area.

The uniform policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency that takes administrative action to make the policy applicable to such research (45 C.F.R. §46.101). This includes research conducted by federal civilian employees or military personnel, as well as research conducted, supported or otherwise subject to regulation by the federal government outside the United States.

Sixteen departments and agencies on Jan. 19 adopted the joint final rule that revised the long-standing common rule on human subject research. “This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay and ambiguity for investors,” the final rule states. “These revisions are an effort to modernize, simplify and enhance the current system of oversight.” Except for the provision on using a single IRB in cooperative research, the final rule becomes effective on Jan. 19, 2018.

(The full version of this story has now been made available to all for a limited time on Thompson’s Grants Compliance Expert site.)


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