Question

Compare the similarities and differences between institutional and independent IRBs

Answer 1

Federal guidelines use the term “IRB of record” most often. The IRB of record assumes primary responsibility for the review and approval of a clinical study. Any IRB overseeing human subject protections for a clinical study is considered the IRB of record.

An independent IRB is one that is not associated with an institution. The Central Institutional Review Board for the National Cancer Institute (NCI cIRB) is an example of an independent federal IRB while Pearl IRB is an example of an independent commercial IRB. Unlike a university that performs research, a contract research organization (CRO) or pharmaceutical company are establishments that may not have an internal IRB. These institutions would need to depend on an external independent IRB for review of their human subject studies.

Independent institutional review boards (IRBs) are playing an increasingly important role in the review of human subjects research. Many research institutions have been hesitant to use independent IRBs because regulatory recognition of their use has been inconsistent and clear guidance has been lacking. The authors review the evolution of the independent IRB and address how acceptance has differed between the two primary regulatory agencies, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The article briefly describes the history of independent IRBs, how they currently fit into the regulatory schemes of HHS and FDA, factors relating to the decision to use an independent IRB (including advantages and disadvantages of their use), factors to consider when selecting an independent IRB, practical guidelines for use of an independent IRB by a research institution, and contractual issues involved in implementing a relationship with an independent IRB.

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB has several consultants who advise the Board and are periodically involved in protocol review.