Must investigators obtain training in the protection of human subjects?
The HHS regulations for the protection of human subjects (45 CFR part 46) do not require investigators to obtain training in the protection of human subjects in research. However, an institution holding an OHRP-approved Federal Wide Assurance (FWA) is responsible for ensuring that its investigators conducting HHS-conducted or supported human subjects research understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects.