What should investigators do when considering changes to an exempt study that could make it nonexempt?
Investigators should consult with the appropriate institutional authority whenever questions arise about whether planned changes to an exempt study might make that study nonexempt human subjects research. OHRP recommends that institutions have policies in place that designate the individual or entity authorized to determine whether human subjects research qualifies for exemption under HHS regulations at 45 CFR 46.101(b). OHRP recommends that investigators not be given the authority to make an independent determination that human subjects research is exempt. The person(s) authorized to make the determination should be knowledgeable about the human subject protection regulations. In addition, the institution should ensure the appropriate communication of such a policy to all investigators.
