An Institutional Review Board (IRB) is a formally designated group assigned to monitor and review any medical research involving human subjects. An Independent Ethics Committee (IEC) is a group of pharmaceutical industry stakeholders (doctors, nurses, social workers, etc.) who meet and discuss a clinical trial’s scientific, ethical, and legal ramifications and evaluate the benefit/risk factors involved.

Section 56.103 in Title 21 of the Code of Federal Regulations stipulates that any clinical investigation shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of this part.¹

IRBs and IECs safeguard the rights, safety, and well-being of clinical trial subjects.

IRBs and IECs are charged with guaranteeing the rights and safety of clinical trial subjects through review and approval of trial protocols, amendments, methods and documents. An IRB/IEC must review the following:

• Trial protocol/amendments

• Informed consent processes

• Investigator's Brochure

• Payments to subjects

• FDA Form 1572/CVs

• Subject recruitment procedures

• Subject information²

IRBs operate under United States Food and Drug Administration (FDA) regulations and have the authority to approve or disapprove research and ask for research modifications to lead to an FDA approval. Clinical trials conducted in the European Union are held accountable by IECs. Countries other than those in the European Union and the United States have individual committees and regulations. There are two types of IRBs and IECs, local and central. Local committees support individual research institutions and are responsible for reviewing only their clinical trials. Central boards oversee the review of clinical studies for multiple organizations.³

Per the FDA, each IRB/IEC should include five or more members and come from various backgrounds. One of these representatives should come from a non-scientific background and is referred to as a lay member. Another should be an independent member who is not affiliated with the clinical site or medical institution. All members should understand all aspects of the clinical trial process. Each aspect of a clinical trial must be approved by the IRB or IEC before any patient recruitment and enrollment are permitted to begin. Generally, a submission takes one month to receive approval, with expedited/exempt approvals returned in about two weeks. If there are any details of the study that do not align with IRB standards, the IRB refuses approval and suggests amendments to receive approval. ⁴

The number of IRBs increased substantially from 1995 to 2006 (491 to 2,728 IRBs) with a further increase in 2008 to 3,853 IRBs. Nationally, IRBs reviewed over a quarter-million research applications in 2007, of which 35% were new applications requiring full committee review.⁵

Both IRBs and IECs must retain all relevant records (e.g., written procedures, membership lists, minutes of meetings, etc.) at least 3-years after completion of the trial and make them available upon request from the regulatory authority(ies).⁴

1. U.S. Department of Health and Human Services Food and Drug Administration. Information Sheet Guidance For Sponsors, Clinical Investigators, And Irbs Waiver Of IRB Requirements For Drug And Biological Product Studies. Silver Spring, MD: U.S. Department of Health and Human Services Food and Drug Administration; 2017.

2. Institutional Review Boards (IRBs) or Independent Ethics Committees (IEC). Complianceonline.com. https://www.complianceonline.com/dictionary/institutional-review-boards.html. 

3. H S. How do Institutional Review Boards (IRB) and Ethics Committees (EC) impact clinical trials?. Clincierge. 2021. https://clincierge.com/irb-ec-critical-impact-on-clinical-trials/. 

4. Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice. University of Pennsylvania https://www.med.upenn.edu/ocrobjects/prod/ACRP/story_content/external_files/E6_R2_Section%203_IRB-IEC.pdf. 

5. Catania JA, Lo B, Wolf LE, et al. Survey of u.s. Human research protection organizations: workload and membership. J Empir Res Hum Res Ethics. 2008;3(4):57-69. doi:10.1525/jer.2008.3.4.57