HHS announces proposal to change rules protecting human research subjects

The U.S. Department of

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Health and Human Services recently announced that the federal government is contemplating changes to the regulations overseeing research on human subjects. Of particular interest to the historical community is the impact the proposed rules might have on the operations of institutional review boards.

Before making changes to the regulations – which have been in place since 1991 and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research.

The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 26 Federal Register. The proposed changes are designed to strengthen protections for human research subjects. The deadline for submitting comments is September 26, 2011.

For how the ANPRM might affect the historical community, especially the intrusion of institutional review boards (IRBs) into history work, click here to read an analysis by Robert Townsend, Deputy Director of the American Historical Association.

To view the ANPRM, please visit http://www.hhs.gov/ohrp.

To submit a comment, visit http://www.regulations.gov, enter ID number (HHS-OPHS–2011–0005), and click on “Submit a Comment.”

For additional information about the changes under consideration, including frequently asked questions and a side-by-side analysis comparing the proposed changes with the existing rules, visit
http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html.

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject 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.

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