Alternative Review Models

Institutional Review Boards (IRBs) were established to allow for an evaluation - independent of the research team - of the risks and benefits of proposed research activities to participants.  Fundamental to the IRB’s evaluation of these characteristics are knowledge of patient populations, local circumstances, and community attitudes about the research being proposed.  Consequently, IRBs were initially bodies that were geographically proximal to the research in question and were administered, most commonly, by the institution conducting the research.

Over time, clinical research became an inherently more complex activity and the desirability of decentralized institution-by-institution review for certain types of research has been questioned for both practical and philosophical reasons. First, for large, multi-site clinical trials, full review of a given protocol was generally carried out by each involved local IRB. These reviews, often numbering in the hundreds, created a time-consuming, and in the view of some, redundant, workload.  The notion of having a single IRB – often called a “central IRB” – review a protocol on behalf of multiple sites thus became a popular notion and was appealing to sponsors of trials for reasons related to the inherent efficiency of this approach. In other situations, a commercial IRB may be engaged by an institution or site to conduct review because the local infrastructure or expertise is insufficient to accommodate review institutionally.

Nonetheless, there remains disagreement about the relative value of IRBs that are administered directly by the institutions conducting the research under review versus by commercial firms, consortia, or other non-institutional entities. For example, while central IRBs offer greater efficiency and perhaps less costs overall, some fear that they are less able to consider truly local characteristics of the research environment and study population.  Commercial IRBs also, in the view of some, create the potential for conflicts of interest by the fee-for-service arrangement that generally underpins their business model, leaving the IRB beholden to the client paying for the review service.  Institutional IRBs, on the other hand, are also often characterized as being vulnerable to conflicts of interest by virtue of being staffed and funded by the institution proposing the research in question.  This characteristic, coupled with the inefficiencies alluded to above, have led some to advocate for greater use of the central IRB model.

To address this matter, the CRpac program is launching a dialogue on the characteristics and relative benefits of various models of IRB review. The aim is to produce a resource that will help institutions determine the model of review that may work best for particular areas of research. This process will include the convening of a national conference on this topic with other agencies and stakeholder groups.

Meetings and Conferences

National Conference on Alternative IRB Models: Optimizing Human Subjects Protections

Pertinent Resources, Policies, and Regulations

Department of Health and Human Services:

• Office for Human Research Protections Guidance on “Knowledge of Local Research Context”

• Office for Human Research Protections Guidance on “The Use of Another Institution’s IRB”

• Office of Protections from Research Risks Report on “Local IRB Review of Multicenter Clinical Trials”

• Alternative Models of IRB Review: Workshop Summary Report (November 2005)

• National Conference on Alternative IRB Models: Optimizing Human Subject Protection (November 2006)

Food and Drug Administration:

• Guidance on “Non-local IRB Review” (1998)

• Food and Drug Administration Guidance on Using a Centralized IRB Review Process in Multicenter Clinical Trials (2006)

National Institutes of Health:

• NCI Central IRB