Has the Office for Human Research Protection (OHRP) reviewed the GAIN data submission and release policies and procedures?
The Office for Human Research Protection (OHRP) has reviewed the GAIN data submission and release policies and procedures and has concluded that the GAIN Database does not constitute human subjects research as defined within 45 CFR Part 46, since GAIN will not receive the key-code to identify any individuals within the GAIN Project Dataset(s) from GAIN Contributing Investigators. Furthermore, investigators requesting access to GAIN Project Datasets will only receive de-identified data from the GAIN Database, and therefore will not be conducting human subjects research as defined within 45 CFR Part 46. This determination does not negate any existing local (institutional or state-level) requirements for the on-going review of research.
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?
- Has the Office for Human Research Protection (OHRP) reviewed the GAIN data submission and release policies and procedures?
- How can I track Office for Human Research Protections (OHRP) receipt of my Federalwide Assurance (FWA) submission?
