HHS proposes updated rules to protect human research subjects in US studies

Issue: August 2011

The U.S. Department of Health and Human Services is proposing improvements to regulations governing research on human subjects, the agency announced in a news release.

The existing regulations, known as the Common Rule, were implemented in 1991.

The federal government is seeking public input on the proposed changes, which concern ethics, safety and oversight of human research.

“The adoption of the Common Rule two decades ago was a landmark event to ensure ethical practices and the safety of those individuals who participate in research,” Howard K. Koh, MD, MPH, HHS assistant secretary for health, stated in the release. “This regulatory review effort is primarily about enhancing protections for human subjects. The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

The existing regulations were drafted when most human subject research was performed at single sites within universities, colleges and medical institutions. The expansion of research into new scientific disciplines and settings and an increase in multi-site studies have revealed ambiguities in the existing rules and raised questions about the ability of current regulations to keep pace with the needs of researchers and subjects, according to the release.

The proposed changes address the adjustment of level of oversight to level of risk, use of a single review board to oversee domestic multi-site studies, updated forms and protocols for informed consent, mandatory data security and information protection standards, systematic methods of data collection and analysis, the extension of federal regulatory protections to research being conducted at institutions receiving funding from Common Rule agencies, and standardized guidance on federal regulations.

Reference:

www.hhs.gov/ohrp/humansubjects/anprm2011page.html

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