What is an Institutional Review Board (IRB)?
Under federal regulations, an IRB is a group of individuals that has been formally designated to review and monitor research involving human subjects. In accordance with federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols (study plans) and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
CIRB members most commonly act under the authority of the regulations of the Food and Drug Administration (21 CFR §50 and §56) and the Department of Health and Human Services (45 CFR §46). Other federal agencies, such as the Environmental Protection Agency and Department of Defense, have their own regulations requiring the prospective review of proposed research by an IRB.
What is an independent IRB?
Traditionally, academic medical centers and hospitals maintained their own internal IRBs to review the research of the investigators affiliated with their institutions. In more recent years, as research has moved from academic medical centers into community-based clinics, nonaffiliated (or “independent”) IRBs have developed to provide review services to investigators who are not affiliated with an institution. Although it is difficult to produce a single definition of the term “independent IRB” due to the diversity of these entities, in general an independent IRB is a review board that is not owned or operated by the research organization for which it provides review services.
An independent IRB is subject to the same federal and state regulatory requirements applicable to all IRBs. A significant percentage of independent IRBs are accredited. In 1998, the Office of the Inspector General for the Department of Health and Human Services issued a report noting that independent IRBs offer a number of benefits, such as:
For more information see the OIG report: “Institutional Review Boards: The Emergence of Independent Boards.”
Do independent IRBs ever become involved with an institution’s research?
Although the greatest need for independent IRBs remains outside the academic and hospital setting, independent IRBs also have been used by many institutional researchers. Some research institutions have contracted with independent IRBs to provide outside review. Some institutional IRBs delegate jurisdiction and accept the review of an independent IRB when their institution is participating in a multi-center study. Some institutions have used independent IRBs as a “bridge” to an improved internal review system.
Federal regulators recommend that a written agreement be executed to document any arrangement by which an institutional IRB transfers jurisdiction to or shares jurisdiction with an independent IRB. More information can be found in the FDA’s “Information Sheet Guidances – Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,” found at www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm. A sample agreement (WORD DOC format) for an institution with a federal-wide assurance can be found at the OHRP website.
What is a central IRB?
The federal IRB regulatory requirements evolved at a time when most clinical trials were conducted at a single study site or at a small number of sites. In the intervening years, however, there has been substantial growth in the volume of multi-center trials and the size and complexity of late-stage clinical trials.
An IRB that provides review services for multiple sites participating in a trial is considered to be a “central” IRB, while an IRB that provides review only for the researchers of its organization is considered to be a “local” IRB. A large trial might have an independent IRB serving as the central IRB and providing review services for multiple sites (especially nonaffiliated sites) at the same time as one or more local IRBs are providing review services for the researchers of their organizations participating in the same trial.
An independent IRB frequently acts as a central IRB for multisite trials. However, the role of a central IRB also can be filled by an institutionally based IRB or by a regional IRB formed by a consortium of institutions. For more information on centralized review and alternative models of review, see the report “Alternative Models of IRB Review.“
Today, regulators and researchers are increasingly aware that multiple reviews by multiple IRBs in a single trial can result in unnecessary duplication of effort, delays, and increased expense in the conduct of multi-center clinical trials. Regulators also have realized that greater reliance on a centralized review process, in appropriate circumstances, has the potential to reduce IRB burdens and delays in the conduct of multi-center trials. For more information, see the FDA’s “Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials.“
What is an “accredited” IRB?
Certain IRBs have been “accredited” by private accreditation agencies. In an accreditation process, experts in a particular field define standards of acceptable performance for organizations in that field. Then the experts measure how well organizations meet the expectations. Accreditation is used often in education and medicine, but has also expanded into other areas. The accreditation of IRBs began several years ago.
One of the goals of accreditation is the improvement and continuing education of the organizations that seek it. Accreditation is usually voluntary and is granted for a specific period of time, generally three or more years, following which the organization must repeat the process. Accreditation is a long-term, continuous activity, both for the accrediting body and for organizations under review. Protecting the public is the goal of accrediting organizations.
Additional information can be found at the following websites: