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Health & Life Sciences - The Common Rule: HHS Notice of Proposed Rule Making

Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators

08/08/2011

On July 26, 2011, the Department of Health and Human Services in coordination with the Office of Science and Technology Policy (OSTP) announced an advance notice of proposed rulemaking (ANPRM) requesting comment on suggested modifications to the "Common Rule." The Common Rule sets forth the requirements for the review by local Institutional Review Boards (IRBs) of all human subjects research conducted by federally funded investigators.

Twenty years have passed since the Common Rule, codified at 45 CFR Part 46, was adopted by 15 U.S. Federal departments and agencies. This is the first effort since that time to consider major changes in the Common Rule. This ANPRM has major implications for all institutions and entities engaged in the nation's clinical research enterprise, and we suggest you will want to review the ANPRM carefully and consider submission of comments. Comments are due on or before September 26, 2011.

The intent of the ANPRM is to bring the Common Rule in line with shifts in the way research is conducted today and with changing views on balancing the level of research review with the level of research risk. The revised Common Rule would cover any human subjects research conducted at any institution receiving federal funds, not just federally funded research. Thus, the revision would extend the reach of the Common Rule to include research not now under the Common Rule.

The rule proposes the use of a single institutional review board for multi-site trials. Many will herald as a "breakthrough" the acknowledgement contained in the ANPRM that "the evaluation of a study's social value, scientific validity, and risks and benefits, and the adequacy of the informed consent document and process generally, do not require the unique perspective of a local IRB." The notice invites comment on how a single IRB might be selected and how or whether local oversight in certain areas might be retained.

The proposed rule suggests the need for new data security and information protection standards to protect against the re-identification of de-identified information collected as part of research. This mandate would be consistent with the Health Insurance Portability and Accountability Act (HIPAA). It would remove the responsibility from IRBs to review "informational risks" posed to human subjects. This is a major consideration for all investigators and institutions conducting clinical research. The impact of this change could range from providing a swifter more predictable path for clinical trial review to a problematic new mandate for compliance.

Another significant proposed change is the requirement that volunteers in studies in which biological material is collected be asked to consent to the use of such biospecimens in future research. The proposed rule walks through today's current practices, acknowledges the appropriateness of well crafted broad consents, but recognizes that given today's technology, such biospecimens are inherently identifiable. The proposal lands squarely in the camp of requiring consent for the use of specimens, whether excess specimens collected as part of a clinical encounter or specimens collected expressly for the purposes of research.

The proposed changes in the Common Rule hold major implications for academic institutions, investigators, industry, clinical research organizations, managers of biorepositories, patient advocacy organizations, and other stakeholders engaged in the nation's clinical research enterprise. A 60 day window is provided for comments, ending on September 26, 2011. (For reference to the full notice, see Federal Register Notice Vol. 76, No. 143. Tuesday, July 26, 2011; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm.)

B&D; Consulting is closely following all issues relating to this important Notice. We suggest careful consideration of the impact these proposed revisions to the Common Rule will have for all stakeholders engaged in human subjects research.

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