Resources & Guidance


Office for Human Research Protections

Food and Drug Administration (FDA)

Federal - Guidance on Additional Requirements of Federal Funding Agencies

Please note that protocols conducted by MUSC and sponsored by any of the following federal agencies have additional operational and review requirements:

  • Department of Defense (DoD),
  • Department of Education,
  • Department of Energy,
  • Department of Justice (DOJ) / National Institute of Justice (NIJ) / and Bureau of Prisons, and
  • Environmental Protection Agency (EPA)
  • Food and Drug Administration (FDA)
  • NIH - Guidance on Stem Cell Research
  • VA

In addition, protocols following the International Committee on Harmonisation - Good Clinical Practices (ICH-GCP) have additional requirements. Researchers are responsible for meeting specific requirements.

Department of Defense (DOD)

Department of Education

Department of Energy (DOE)

Department of Justice (DoJ)

Environmental Protection Agency (EPA)

National Institutes of Health


Other Useful Links

  • Researchers are responsible for complying with the International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) Guidelines (E6) when required by the sponsor..
  • Good Clinical Practice (GCP) Guidance (E6)