Are investigators involved in human subjects research that is described by one or more of the exemptions in 45CFR46 required to comply with the education requirement?
Yes. Investigators who conduct human subjects research that is exempt from Institutional Review Board (IRB) review and approval (six exempt categories defined in 45 CFR part 46.101(b)) must comply with the education requirement. NOTE: From September, 2002 through March 9, 2005 NIH investigators conducting human subjects research meeting the criteria for Exemption 4 in the HHS regulations did not provide documentation of training. Effective January 10, 2005 (coincident with NIH implementation of the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, available at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf, PDF – 24 KB) all new, competing applications will require documentation of completion of the educational requirement for each investigator involved in the design and conduct of NIH-funded human subjects research prior to award. As stated above, the requirement applies both to human subjects research and exempt human subjects research.
Related Questions
- Does the education requirement apply to new Key Personnel involved in human subjects research whose names are added on non-competing Progress Reports?
- How often do investigators involved in the design and conduct of human subjects research need to complete the education?
- Must investigators obtain IRB approval before involving human subjects in nonexempt research?
