U.S. Department of Health & Human Services
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Will the Office for Human Research Protections forward reports received from FWA-holding institutions to non-HHS federal funding agencies or departments?
The Office for Human Research Protections (OHRP) receives reports from institutions holding a Federalwide Assurance (FWA) of:
(i) unanticipated problems involving risks to subjects or others;
(ii) serious or continuing noncompliance with the Common Rule or the requirements or determinations of the IRB; or
(iii) suspension or termination of IRB approval.
If the human subjects research is conducted or supported by a Common Rule department or agency other than HHS, OHRP will not forward the report(s) to that other agency. However, OHRP will remind the FWA-holding institution in writing of the institution’s responsibility to notify the conducting or supporting department or agency head in accordance with the requirements of §__.103(b)(5) [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.103] of the Common Rule.
Last Reviewed: 06/17/2011
Related Questions:
- How does the Office for Human Research Protections (OHRP) handle allegations or indications of noncompliance when the research is not HHS-supported or conducted?
- How does 45 CFR part 46 relate to the human subjects regulations used by non-HHS federal funding agencies?
- Do the human research regulations apply to non-U.S. institutions?
- Does approval of an institution's assurance of compliance by the Office for Human Research Protections (OHRP) mean that the institution is in full compliance with the Department of Health and Human Services (HHS) Protection of Human Subjects regulations?
- When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?
