Who, at my institution, is responsible for determining whether my proposed research involves human subjects but meets the criteria for one or more exemptions (46.101(b)) from regulatory requirements?
OHRP recommends that institutions adopt clear procedures under which the IRB (or some authority other than the investigator) determines whether proposed research is exempt from the human subjects regulations [see 45 CFR 46.101(b)]. Documentation should include the specific category justifying the exemption. (http://www.hhs.gov/ohrp/humansubjects/guidance/irb71102.pdf). Because NIH does not require IRB approval at time of application, claimed exemptions often represent the opinion of the PI, and justification provided for the exemption(s) by the Principal Investigator is evaluated during the peer review process.
Related Questions
- Who, at my institution, is responsible for determining whether my proposed research involves human subjects but meets the criteria for one or more exemptions (46.101(b)) from regulatory requirements?
- How can I determine whether research proposed in my application involves human subjects if I will only use human specimens (and/or cell lines, and/or data) for part of the project?
- Do all researchers working with human subjects have to take a responsible conduct in research compliance training?
