November 20, 2019 - Letter to the HHS Secretary

Dear Mr. Azar:

On behalf of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration recommendations relevant to the Department of Health and Human Services (HHS) human subjects protection regulations at 45 CFR part 46. These recommendations were presented to SACHRP by SACHRP’s Subcommittee on Harmonization, and were approved at the meeting held October 16, 2019.

SACHRP’s charge to the Subpart A Subcommittee (SOH) is to identify and prioritize areas in which regulations and guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination. The Subcommittee develops recommendations for consideration and possible adoption by SACHRP, to harmonize and simplify these guidelines and regulations. The goal of this subcommittee effort is to reduce unnecessary burdens on research efforts, thus resulting in better allocation of research resources and promoting the safety and welfare of human subjects.

During the October SACHRP meeting, this committee approved the following set of recommendations for consideration: Considerations Surrounding Charging Subjects to Participate in Clinical Trials.

On behalf of SACHRP, I would like to thank you for your consideration of these recommendations.  The committee, the Subpart A Subcommittee and the Subcommittee on Harmonization have been working in pursuit of their charges, and remain dedicated to continuing this work to human subjects protections for the benefit of all Americans.

             Sincerely,

             /s/

Stephen Rosenfeld, M.D.
Chair, Secretary’s Advisory Committee
on Human Research Protections
(SACHRP)

cc:        Jerry Menikoff, M.D., J.D., Executive Secretary, SACHRP
            Julia Gorey, J.D., Executive Director, SACHRP