January 24, 2011 SACHRP Letter to the HHS Secretary: Recommendations Involving Informed Consent and Biospecimens, IRB Membership and Definition of Non-scientist

Dear Ms. Sebelius:

In accordance with the provisions of the charter for the Secretary’s Advisory Committee on Human Research Protections (SACHRP), I respectfully submit for your consideration a set of recommendations relative to Department of Health and Human Services (HHS) human subjects protection regulations at 45 CFR part 46. These recommendations were passed by SACHRP at their March, July and October 2010 meetings.

Recommendations Involving Informed Consent and Biospecimens

On October 5, 2004, SACHRP approved a recommendation establishing a Subpart A Subcommittee (SAS). SACHRP’s charge to this subcommittee was to review and assess all provisions of subpart A of 45 CFR part 46 (HHS’ codification of the Federal Policy for the Protection of Human Subjects, also known as the Common Rule) and relevant Office for Human Research Protections (OHRP) guidance documents, and based on this review and ongoing assessment, to develop recommendations for consideration by SACHRP in three categories: (1) recommendations on interpretation of subpart A provisions; (2) recommendations for development of new, or modification of existing, OHRP guidance; and (3) recommendations for possible revision of subpart A.

The goals of this review and assessment of subpart A of 45 CFR part 46 are threefold: (1) to enhance the protection of human subjects; (2) to reduce, where possible, regulatory burdens that do not contribute to the protection of subjects in a meaningful way; and (3) to promote scientifically and ethically valid research. To that end, the attached set of recommendations, terms and FAQs (Attachment A) on the topic of informed consent and research use of biospecimens is provided for your consideration. This material represents the culmination of lengthy SAS and SACHRP deliberation spanning two years.

Recommendation Regarding IRB Membership and Definition of Non-scientist under 45 CFR 46 and 21 CFR 56

On October 28, 2009, SACHRP approved a recommendation establishing a Subcommittee on Harmonization (SOH). SACHRP’s charge to this subcommittee was to identify and prioritize areas in which regulations and/or 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 will develop 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.

SOH recently examined the requirements for IRB membership and the definition of scientist and nonscientist under 45 CFR 46 and 21 CFR 56, and on October 20, 2010, SACHRP approved a recommendation and comment from this subcommittee (Attachment B). This material is presented for your consideration.

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

Sincerely,

/S/

Barbara E. Bierer, 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