Institutional Review Board

 Please see new information on our Compliance page regarding financial conflicts of interest training for research personnel.

What is the IRB?
The Palmetto Health Institutional Review Board (IRB) is a board established in accord with Federal regulations to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the auspices of Palmetto Health. The IRB oversees compliance with Federal, State, and organizational guidelines relating to research with human subjects.

The IRB is responsible for reviewing all research involving human subjects, insuring the equitable selection of research subjects, ensuring that potential research-related risks are minimized, and that there is full disclosure so that volunteers can make an informed decision to participate.

Palmetto Health has two IRBs. Palmetto Health IRB #1 meets the first Friday of each month. Palmetto Health IRB #2 meets the third Friday of each month.

	Download our "Becoming A Research Volunteer" brochure

IRB Process
Not Human Subject Research reviews and Exempt Human Subject Research reviews are generally completed within 14 days. The time frame does not include the time a study is returned to the investigator for changes requested by the IRB staff or reviewer.

Expedited reviews are generally completed within 14 days. The timeframe excludes the time required for Scientific Review Committee approval and the time a study is returned to the investigator for changes requested by the IRB staff or reviewer.

Full committee reviews are generally completed within 30 days. The timeframe excludes the time required for Scientific Review Committee approval and the time a study is returned to the investigator for changes requested by the IRB staff or reviewer.

Flow Chart – IRB Process
IRB Meetings & Submission Deadlines

IRB Policies & Procedures
Human Research Protection Program Policy

Forms
Data Use Agreement
Impacted Services Agreement
Template for Informed Consent

Regulatory Authority
Palmetto Health is a registered IRB Organization with the Office for Human Research Protections (OHRP), (IORG0000425).
Palmetto Health IRB #1 is registered with OHRP, (IRB00000715).
Palmetto Health IRB #2 is registered with OHRP, (IRB00000915).
Palmetto Health has an approved Federalwide Assurance (FWA) with OHRP, (FWA00000128).
Palmetto Health IRBs are organized and operate in compliance with FDA regulations 21 CFR Parts 50 and 56, DHHS regulations 45 CFR Part 46, and the International Conference on Harmonization (ICH) and The Common Rule as appropriate. The IRBs also functions as the Privacy Board in compliance with portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164. PH IRB utilizes a 21 CFR Part 11 compliant, electronic IRB platform (eIRB) for protocol submissions.

Membership
The IRBs are composed of persons who are sufficiently qualified, through experience and expertise, to review the research presented to them. Each board includes at least one member whose primary concerns are in nonscientific areas and one member who is not affiliated with the institution, or part of the immediate family of a person who is affiliated with the institution.

Resources and Links

• ClinicalTrials.gov
• Collaborative Institutional Training Initiative (CITI)
• Department of Defense (DOD)
  • DOD Directive 3216.02
  • Department of the Navy SECNAVINST 3900.39D
• Department of Education (ED)
  • Protection of Human Subjects (34 CFR 97)
  • Student Rights in Research, Experimental Programs, and Testing (34 CFR 98)
  • Family Educational Rights and Privacy (34 CFR 99)
  • Disability and Rehabilitation Research: Research Fellowships (34 CFR 356)
• Department of Energy (DOE)
  • Protection of Human Research Subjects (DOE O 443.1B)
  • DOE Checklist for Use by Researchers Conducting Human Subject Research That Utilizes Personally Identifiable Information
• Department of Health and Human Services (HHS)
  • Food and Drug Administration (FDA)
    • Electronic Records; Electronic Signatures (21 CFR 11)
    • Expanded Access to Investigational Drugs for Treatment Use
    • Guidance Documents
    • Institutional Review Boards (21 CFR 56)
    • Investigational Device Exemptions (21 CFR 812)
    • Investigational New Drug Application (21 CFR 312)
    • Humanitarian Use Devices (21 CFR 814)
    • Protection of Human Subjects (21 CFR 50)
  • Health Insurance Portability and Accountability Act (45 CFR Parts 160-164)
  • Office of Human Research Protections (OHRP)
  • Protection of Human Subjects (45 CFR 46)
  • Expedited Review Categories
• Department of Justice (DOJ)
  • DOJ Confidentiality of Identifiable Research and Statistical Information (28 CFR 22)
  • Bureau of Prisons Research (28 CFR 512)
• eIRB
• Environmental Protection Agency (EPA)
  • Protection of Human Subjects (40 CFR 26)
• Health Sciences South Carolina (HSSC)
• International Council on Harmonisation
• SCResearch.org