When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?
If human subjects research conducted or supported by a non-HHS Common Rule department or agency involves collaborating institutions that do not hold an FWA or other applicable OHRP-approved assurance for federalwide use, OHRP does not require the collaborating institutions to obtain FWAs, but an FWA may be required by the non-HHS department or agency conducting or supporting the human subjects research. For such situations, while obtaining an FWA would be one option for the collaborating institutions to comply with the assurance requirement of the Common Rule ยง__.103(a) [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.103], obtaining an FWA would not be required by HHS. When requests for guidance on this topic are received by OHRP, OHRP will refer the requestor to appropriate officials at the conducting or supporting Common Rule department or agency for assistance in deciding on an appropriate assurance mechanism.
Related Questions
- How can I track Office for Human Research Protections (OHRP) receipt of my Federalwide Assurance (FWA) submission?
- Do international institutions seeking a Federalwide Assurance (FWA) have to comply with 45 CFR part 46?
- When do institutions collaborating in non-HHS research need to obtain a Federalwide Assurance (FWA)?
