Human Research
This article was originally published in SRA
Executive Summary
US simplifies process for assuring compliance with HHS regulations
US simplifies process for assuring compliance with HHS regulations
Institutions conducting research involving human subjects supported by any agency of the US Department of Health and Human Services (HHS) now have the option of using a single, web-based ‘Federalwide Assurance’ (FWA) of compliance with HHS regulations rather than operating their own assurance systems. The new arrangement was announced by the HHS on 9 February 20051, and will be phased in by the end of the year.
Most federal agencies that support human subject research adhere to the Federal Policy for the Protection of Human Subjects, known informally as the ‘Common Rule', which requires that such research be covered by an assurance. The provision of the FWA will reduce the burden of regulatory compliance while strengthening the research community's ability to focus on the protection of human subjects, the Office of Human Research Protections said.
References
1. OMB Approval of the Federalwide Assurance (FWA), IRB/IEC Registration Form, and Related Documents, Office for Human Research Protections press release, 10 February 2005, http://www.hhs.gov/ohrp/news/