Guidance on Institutional Review Board Approval of Research With Conditions

摘要

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a guidance document entitled "Guidance on IRB Approval of Research with Conditions." The guidance document provides OHRP's first formal guidance on this topic. The document, which is available on OHRP's Web site at http://www.hhs.gov/ohrp/policy/conditionalapproval2010.html or http://www.hhs.gov/ohrp/policy/conditionalapproval2010.pdf, is intended primarily for institutional review boards (IRB), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft guidance document from 12 individuals and organizations, and those comments were considered as the guidance was finalized.