American Association for Cancer Research

AACR Cancer Policy Monitor

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November 2011

 

AACR ADDRESSES RULES GOVERNING HUMAN SUBJECTS RESEARCH

Joint comments with ASCO and AACI support framework for updating rules, but encourage wider harmonization efforts

The U.S. Department of Health and Human Services (HHS) is poised to modify rules governing human subjects research according to an Advanced Notice of Proposed Rulemaking (ANPRM) issued over the summer. In response, the AACR has collaborated with the American Society of Clinical Oncology (ASCO) and the Association of American Cancer Institutes (AACI) to submit joint, formal comments to the department expressing general support for most aspects of the proposed reforms, but also identifying specific concerns about some of the changes that might be forthcoming.

Specifically, HHS is seeking to standardize the regulations concerning research on human subjects, referred to as the “Common Rule,” by updating and amending the rule to bring it closer to the Health Insurance Portability and Accountability Act (HIPAA) standards, and by clarifying the types of research for which Institutional Review Board (IRB) reviews are necessary. The goals of the proposed rule changes are to both strengthen protections of human subjects and reduce the burden, delay and ambiguity for investigators.

In announcing the call for public comments, HHS officials acknowledged that the Common Rule, which was implemented in 1991, was written when research was predominantly conducted at a limited number of large research institutions, and each study generally took place at only a single site.

Expansion of human subjects research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects. Also, the dramatic changes in research that have taken place with proliferation of personalized genomic data and the growth of increasingly sophisticated technology warrant an updated and stepwise approach that recognizes the unique and, therefore, potentially identifiable personal genomic signatures that are becoming more common in medical datasets. Among many topics, the ANPRM sought stakeholder input on specific issues such as calibrating the level of IRB review to the level of risk, the use of a single IRB review for all domestic sites of multi-site studies, updating forms and processes for informed consent, establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data, and providing uniform guidance on federal regulations.

The AACR-ASCO-AACI comments voiced concerns about attempts to include the HIPAA Privacy Rule standards in the Common Rule, and encouraged the development and implementation of a single, uniform set of criteria across all federal agencies for meaningful protections to ensure the privacy of information used in research. The response also cautioned against moving too quickly to propose considerable changes to the way research is conducted using pre-existing data and de-identified biospecimens. Re-identification of such samples is difficult given the current limitations of science and technology, and a lack of publicly available genomic data on individuals.

The next step will be for HHS to issue a proposed rule about which the department also will seek public comment. It is unclear when a proposed rule might be issued, as the process can take months, even more than a year. The AACR, ASCO and AACI urged HHS to consider holding public stakeholder meetings to examine the issues in greater depth prior to issuing a proposed rule.

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