Institutional Review Board (IRB)

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Institutional Review Board

The Institutional Review Board (IRB) is a group that is tasked with safeguarding the rights and welfare of people participating in research. These participants’ rights, which include voluntarism and informed consent, are enumerated in various federal regulations and historical guidelines. The IRB must not only protect human subjects, but it must evaluate new and ongoing research with respect to science, law, ethics, and community attitudes. McLeod Health has a local IRB that reviews many research studies, but external IRB entities are also utilized when appropriate.

To learn more about IRBs and how they help protect people who participate in research, check out this video from the U.S. Department of Health and Human Services.

Membership

Diversity of IRB membership is important in order to sufficiently evaluate all types of human subject research. Membership cannot include just men or just women, nor can the Board be made up of members from only one profession. Additionally, there must be at least one member from a non-scientific area and one member who is not affiliated with the institution. Our Institutional Review Board consists of approximately 18 individuals who support McLeod’s dedication to research and patient protection. Click here for a list of our members.

Resources and Links

The Belmont Report

Clinical Trials Registry

National Institutes of Health (NIH)

Protecting Human Research Participants Online Training

Office for Human Research Protections (OHRP)

US Department of Health and Human Services (HHS)

US Food and Drug Administration (FDA)

Clinical Trials

McLeod Health participates in a variety of local and national research trials. Click here to learn more.

IRB Applications and Forms

These forms are also located on the McLeod Compass (Intranet).

Adverse Event/Serious Adverse Event (SAE) Form

Closure Form

Continuing Review Form

Criteria for IRB Approval (Supplemental Form)

Exemption Requests

Humanitarian Use Device (HUD) Application

Humanitarian Use Device (HUD) Per Use Form

New Protocol Application

Notice of CIRB (NCI) Protocol Application - NEW or TRANSFER

Permanent Closure Form

Physician Financial Disclosure Form

Protocol Deviation Form

Protocol Status Report

Research Determination Form (QI Checklist)

Revisions, Addendums, and Updates

IRB Meeting Dates for 2024

The Institutional Review Board will hold convened meetings on the dates listed below. Meetings will begin at 1:30 p.m. in Cancer Center Conference Room #2 (located on the 1st floor of the Cancer Center) unless communicated otherwise. Virtual meeting access is available to members and presenters through Microsoft Teams (for details, contact the IRB office at the numbers below). On meeting days, lunch will be available for IRB members starting at 1:00 p.m.

NOTE TO ALL PRINCIPAL INVESTIGATORS AND RESEARCH NURSES:

Please note the submission dates. All documentation must be electronically submitted to Toshia Jones, IRB Coordinator, by the submission deadline in order to be considered for approval at a subsequent meeting.

If you have any questions, please call the IRB Office at ext. 777-4899 (off campus, call (843) 777-4899) or email nkleckner@mcleodhealth.org.

Primary Meeting Location:
McLeod Center for Cancer Treatment and Research
1st Floor Conference Room #2
401 E, Cheves Street, Florence, SC 29506

Directions when coming from off-campus: Turn in at entrance sign 1 on the north side of Cheves Street. Park in the West Parking Garage next to the Cancer Center (take the first left after turning in at entrance sign l); or, if you prefer, you may use the free valet parking at the entrance of the Cancer Center. Walk through the automatic doors on the ground floor and continue down the concourse hall to the receptionist in front of the waterfall. Ask for the IRB meeting in Conference Room #2.