Office of Research Integrity

Resources & Guidance

Guidance for Principal Investigators

VAMC Research - Important Notice to Principal Investigators performing research at the VAMC. While your study has been approved by the MUSC IRB, you MAY NOT begin work on your research study at the VAMC until you have received VAMC R&D approval.

Informed Consent and HIPAA Forms Reminder! Only the original stamped consent and HIPAA forms should be used to make copies for study enrollment. You may not use any consent of HIPAA form that does not have the current IRB stamp of approval date on it. If you have any questions concerning this procedure, please call 792-4148.

MUSC

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

  • 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)

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

Office for Human Research Protections

Food and Drug Administration

Department of Defense (DOD)

Researchers are responsible for communicating with their DoD Program Officer to ensure that all DoD requirements are met prior to starting an IRB approved study

Department of Energy (DOE)

Researchers are responsible for communicating with their DoE Program Officer to ensure that all DoE requirements are met prior to starting an IRB approved study

Department of Education

Researchers are responsible for communicating with their Department of Education Program Officer to ensure that all requirements of the Department of Education are met prior to starting an IRB approved study

Department of Justice (DoJ)

Bureau of Prisons (BOP)

Researchers are responsible for communicating with the Bureau of Prisons (the Bureau) to ensure that all Bureau requirements are met prior to starting an IRB approved study.

Code of Federal Regulations (CFR) Title 28 Judicial Administration Part 512 - Research

BOP Program Statement on Research

National Institute of Justice (NIJ)

Researchers are responsible for communicating with their NIJ Program Officer to ensure that all NIJ requirements are met prior to starting an IRB approved study.

Human Subjects and Privacy Protection

For NIJ-funded research, data must be submitted to the National Archive of Criminal Justice Data (NACJD)

Environmental Protection Agency (EPA)

Researchers are responsible for communicating with their EPA Program Officer to ensure that all EPA requirements are met prior to starting an IRB approved study

International Conference on Harmonisation (ICH)

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

National Institutes of Health

ClinicalTrials.gov

HIPAA - Health Insurance Portability and Accountability Act