Clinical Research Policy

IRB Review

Institutional Review Boards (IRBs) were initially conceived after World War II to conduct independent reviews of the risks and potential benefits of proposed research activities to participants. Fundamental to the IRB’s evaluation of risks and potential benefits is knowledge of populations, local conditions, and community attitudes about the research being proposed. Consequently, the first IRBs were bodies that were geographically proximal to the research sites and were often located within the institution(s) responsible for the research.

Over time, clinical research has become increasingly complex and the practicality and philosophy of an institution-based- review for certain types of research has been questioned. For large, multi-site clinical trials, each local IRB conducts initial and continuing reviews. These reviews, often numbering in the hundreds, create a time-consuming, inefficient, and in the view of some, redundant process. As written, the regulations permit a single IRB – often called a “central IRB” or “IRB of record” to review protocols on behalf of multiple sites. The efficiency of central IRB review is appealing to clinical trial sponsors. In some situations, a commercial IRB may be engaged by an institution or research site to conduct reviews because the local infrastructure or expertise is insufficient.

Despite enthusiasm for central IRBs, there is confusion about the optimal structure for central IRBs as well as how best to meet regulatory requirements. There are questions about the loci of responsibilities and whether the IRB or institutions will bear the blame if adverse events occur.

Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research - The public comment period closed on January 29, 2015