In order to conduct research with human subjects, investigators at Duke must do two things:
- Become certified to conduct research with human subjects.
- Obtain approval for research protocols.
Both the certification of investigators and the approval of protocols are required of Duke by the federal Office of Human Research Protections and the Food & Drug Administration. Pertinent policies are discussed in Appendix P, in the section entitled “ Protecting Human Subjects in Nonmedical Research.” For information regarding human subjects in medical research refer to the Medical Center IRB policies.