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.
- Clinical and Translational Research Center (NEXUS)
- Community Engaged Research Guidance
- Expedited Review - Retrospective studies: A New Path (PDF)
- Hollings Cancer Center (HCC)
- Human Research Participant's Brochure (English)(PDF)
- Human Research Participant's Brochure (Spanish)(PDF)
- MAP-R (MUSC Approval Plan for Research) Tool
- Research Support Resources
- South Carolina Clinical and Translational Research Institute (SCTR)
- SUCCESS Center - Front Door to SCTR Programs
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)
In addition, protocols following the International Committee on Harmisation - Good Clinical Practices (ICH-GCP) have additional requirements. Researchers are responsible for meeting specific requirements.
- Belmont Report - Ethical Principles and Guidelines for the protection of human subjects of research
- Protection of Human Subjects 45 CFR 46 - OHRP
- Protecting Human Research Subjects: Institutional Review Board Guidebook (NIH/OPRR)
- FDA Information and Regulations
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Protection of Human Subjects 21 CFR 50
- Institutional Review Boards 21 CFR 56
- Investigational New Drug Application 21 CFR 312
- Investigational Device Exemptions 21 CFR 812
- Code of Federal Regulations
- IRB Responsibilities for Reviewing Qualifications of Investigators, Adequacy of Research Sites, and the determination of Whether an IND/IDE is Needed(PDF)
- INDs - Determining Whether Human Research Studies Can Be Conducted Without an IND(PDF)
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
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
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
- Family Educational Rights and Privacy Act (FERPA)
- Protection of Pupil Rights Amendment (PPRA) (20 U.S.C. § 1232h; 34 CFR Part 98)
- 34 CFR Part 98 - Student Rights in Research, Experimental Programs and Testing
- HIPAA & FERPA - Joint guidance from Departments of Education and Health & Human Services
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.
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.
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
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)
- Stem Cell Information - Frequently Asked Questions (FAQs)
- Guidance for Investigators and Institutional Review Boards Regarding Research Involving Human Embryonic Stem Cells, Germ Cells, and stem Cell-Derived Test Articles (March 19, 2002)