IRB: The basics

Institutional Review Boards:  The Basics 

What do they do?

The responsibilities of IRBs fall into two main categories:  initial review and continuing  review of research involving human subjects.

Initial Review:  IRBs review and approve a research plan before the research is carried out.  This review encompasses the research protocol, the informed consent document to be signed by subjects, any advertisements to be used in recruiting subjects, and other relevant documents.  In carrying out this review, the board seeks to ensure any risks subjects may incur are warranted in relation to the anticipated benefits, that informed consent documents clearly convey the risks and the true nature of research, advertisements are not misleading, and the selection of subjects is equitable and justified.  IRBs focus much attention on the informed consent document as it is the vehicle for providing information to potential research subjects.

Continuing Review:  The continuing review process is multifaceted and includes required reviews "at an interval appropriate to the degree of risk but not less than once per year."  In addition to this continuing review, study amendments and reports of unexpected adverse experiences by subjects are received periodically and reviewed to ensure that the risk-benefit ratio of the research has not changed and remains acceptable.

Why were they established?

As public awareness and concern about the treatment of human subjects in research increased, the need for additional review mechanisms was evident.  These concerns grew from stories of the abuse of subjects during the World War II trials at Nuremburg, the promotional distribution of thalidomide resulting in numerous children born with birth defects, the administration of cancer cells to chronically ill and senile patients at a hospital in New York, and others.  A 1966 article by Henry Beecher brought prominent attention to human research abuses in medical schools and hospitals citing 22 cases involving highly questionable ethics.  The formal requirements for the establishment of IRBs were outlined in regulations stemming from the National Research Act of 1974 and in FDA regulations issued in 1981.

Where are they located?

An estimated 3,000-5,000 IRBs can be found across the country.  They are most commonly associated with hospitals and academic centers.  Boards also exist in managed-care organizations, government agencies (such as the National Institutes of Health, the Centers for Disease Control, and State governments), or as for-profit entities that are independent of the institutions in which the research takes place.

How are they organized?

Federal regulations require that boards have at least five members with varying backgrounds.  At least one member must have primarily scientific interests, one must have primarily nonscientific interests, and one must be otherwise unaffiliated with the institution in which the IRB resides.  A quorum, with at least one member whose interests are primarily nonscientific present, is needed for voting.