Use of Human Subjects in Research

In order to conduct research with human subjects, investigators at Duke must do two things:

  1. Become certified to conduct research with human subjects.
  2. 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.