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 16 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 2021

Meetings begin at 1:30 p.m. in the Cancer Center Conference Room (1st floor of the McLeod Cancer Center) unless otherwise communicated to IRB members and guests.

NOTE TO ALL PRINCIPAL INVESTIGATORS AND RESEARCH NURSES:

Please note the submission dates. All documentation must be submitted electronically to Noah Kleckner, IRB Coordinator, by that date in order to be reviewed at the subsequent meeting.

If you have any questions, please feel free to call (843) 777-2013 or e-mail nkleckner@mcleodhealth.org.

IRB Policy and Procedures

These policies are located on the McLeod PolicyStat website.

Composition of the Board     C-10

Continuing Review     C-20

Children Involved in Research     C-30

Definitions     D-10

Expedited Review    E-10

Exempt Research     E-20

Expanded Access & Emergency Use of Investigational Drugs or Devices     E-30

Federal-Wide Assurance (FWA)     F-10

Humanitarian Use Device (HUD) Requirements     H-20

Initial Review/Approval     I-05

IRB Fees     I-10

Informed Consent     I-15

IRB Human Research Duties     I-20

IRB Membership and Responsibilities     I-30

Meetings     M-10

Member Training and Continuing Education Requirements     M-15

Minutes     M-20

Principal Investigator Responsibilities     P-10

Problems in Human Subject Research     P-30

Record Management & Retention     R-10

Research Involving Pregnant Women, Human Fetuses and Neonates     R-20

Signatory/Designee Authority     S-10

Suspension or Termination of Research by the IRB     S-20

Utilizing NCI CIRB     U-10