When does a research institution need to be covered by an assurance of compliance with human subjects research protections?
All institutions engaged in human subjects research that is not exempt from the regulations, and is conducted or supported by any HHS agency must be covered by an Office for Human Research Protections-approved assurance of compliance (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The Federalwide Assurance (FWA) is the only new type of assurance accepted and approved by OHRP. An institution may extend its FWA to cover a collaborating individual investigator under certain conditions using the sample Individual Investigator Agreement or a comparable agreement developed by the institution.
Related Questions
- How will the Office for Human Research Protections (OHRP) respond to queries from an FWA institution about human subjects research conducted or supported by a non-HHS department or agency?
- When does a research institution need to be covered by an assurance of compliance with human subjects research protections?
- Do all researchers working with human subjects have to take a responsible conduct in research compliance training?
