By David Borasky, PRIM&R board member
Recently, the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) met for the twenty-third time in seven years to, in the words of its charter, “provide expert advice and recommendations to the Secretary and the Assistant Secretary for Health (ASH) on issues and topics pertaining to or associated with the protection of human research subjects.” The committee is comprised of 11 experts in ethics, biomedical research, social/behavioral research, institutional review board (IRB) professionals, and subject advocates. In addition, representatives of the FDA and numerous Common Rule agencies participate in the discussions as ex officio members.Since its first meeting, the SACHRP has conducted in-depth examinations on a wide variety of topics related to human subject protections. To that end, SACHRP has convened various subcommittees to discuss topics such as accreditation, harmonization, and individuals with impaired decision-making abilities. In consultation with the numerous expert panels that have presented at their meetings, SACHRP continues to gather information and craft recommendations, many of which have successfully informed new and draft guidance documents issued by the Office for Human Research Protections (OHRP). At its most recent meeting, the SACHRP treated observers to several impressive presentations, including:
- A presentation on internet research and the ethical issues it poses. The presenters debated questions such as, “How will reviewing studies in the virtual world be challenging for institutional review boards (IRBs)?”
- A panel describing how various institutions have developed ethics consultation services for their research communities. This panel also considered the role of the IRB with respect to these consultations.
- One subcommittee worked with SACHRP to finalize a set of more than 20 frequently asked questions on IRB requirements for research involving biospecimens. Audience members listened in as the SACHRP worked to craft language on specimens that would meet OHRP, the Office for Civil Rights, and the HIPAA Privacy Rule’s standards.
- Finally, PRIM&R board members Pearl O’Rourke and Bill Freeman joined members of the Havasupai Tribe in making emotional presentations on the Havasupai DNA rights case.