Resources & Guidance

MUSC

• Clinical and Translational Research Center (NEXUS)
• Community Engaged Research Guidance
• eIRB 21 CFR Part 11 Compliance Information (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
• Patient-Outreach Recruitment
• Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
• Research Support Resources
• South Carolina Clinical and Translational Research Institute (SCTR)
• SUCCESS Center - Front Door to SCTR Programs
• State Approved Translation Services Vendors

Office for Human Research Protections

• 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)

Food & Drug Administration (FDA)

• 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)

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)

• 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
• Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research - DoD INSTRUCTION Number 3216.02 November 8, 2011(PDF)

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
• 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

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.
• DOE Human Subjects Protection Program
• Human Subjects Regulations, Orders, and Policies
• Protection of Human Research Subjects - DOE ORDER O 443.1C

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 (PDF)
• 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.
• 40 CFR Part 26 - Protection of Human Subjects

National Institutes of Health

• 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)

VA

• Working with the Ralph H. Johnson VA
• VA Charleston Health Care

Other Useful Links

• 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..
• Good Clinical Practice (GCP) Guidance (E6)

• Certificates of Confidentiality (CofCs) (Word Document)
• ClinicalTrials
• HIPAA - Health Insurance Portability and Accountability Act