News Release

HHS Announces Simplified System for Research Protection Assurances

The U.S. Department of Health and Human Services (HHS) today announced a new simplified mechanism for all research institutions that receive HHS funding or support to obtain an assurance of compliance with HHS regulations for the protection of human subjects. A single Web-based "Federalwide Assurance" (FWA) will replace the several types of assurances under which research institutions had operated in the past.

"We are pleased to provide this robust and flexible simplification to our assurance system," said Bernard A. Schwetz, D.V.M., Ph.D., director of the Office for Human Research Protection. "It reduces the burden of regulatory compliance while strengthening the research community's ability to focus on protections for research subjects."

Because of the multiple types of assurances in use, HHS will allow research institutions to transition to the new system over the next 11 months. By Dec. 31, 2005, all institutions conducting HHS-funded human subjects research must hold an FWA approved by HHS' Office for Human Research Protections (OHRP). For more information, visit the OHRP assurance Web page at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

Nearly all federal departments and agencies that conduct or fund human subject research adhere to the Federal Policy for the Protection of Human Subjects, a set of identical regulations adopted by 16 departments and agencies in 1991 that is known informally as the "Common Rule." The Common Rule is based on the HHS regulations in force since 1974 and requires that federally supported research involving human subjects be covered by an assurance. The other Common Rule agencies now have the option of using -- or directing their grantees to use -- the HHS FWA, rather than operating their own assurance systems, and a large majority of the agencies are expected to rely on the FWA.

The Common Rule signatories group includes the Departments of Agriculture, Energy, Commerce, Defense, Education, HHS, Housing and Urban Development, Justice, Transportation, Veterans Affairs, the Agency for International Development, the Central Intelligence Agency, the Consumer Products Safety Commission, the Environmental Protection Agency, the National Aeronautics and Space Administration and the National Science Foundation.

OHRP is a component of the Office of the Secretary, Office of the Assistant Secretary for Health, Office of Public Health and Science. OHRP works to support and strengthen the nation's system for protecting those who volunteer to participate in research that is conducted or supported by HHS agencies.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last revised: February 10, 2005