Alternative models of IRB review have been a hot topic for well over a decade. Although local review remains the norm for most institutions, other mechanisms such as facilitated review are gaining momentum.
In 1992, the US Office for Protection from Research Risks (now the Office for Human Research Protections) urged caution, taking the position that local review was essential to the protection of human subjects. By 2000, the agency had become more accepting of non-local review, acknowledging that geographic proximity to the research site is not the only way to gain knowledge of the local research context. OHRP clarified in 2010 that it now supports the use of central IRB review to increase efficiency, reduce costs and enhance the protection of human subjects in multicenter research studies.
Facilitated review hinges on acceptance of an external IRB’s review by a subcommittee of the local IRB. The process typically involves reviewing the protocol, consent form and other critical documents, along with documentation related to the external IRB’s review. The subcommittee can either accept the external review, if all criteria for approval have been satisfied and there are no concerns regarding the local research context, or refer the study to the full committee for discussion, triggering the institution’s standard review process.
InfoEd clients participating in collaborative IRB review arrangements have a wide variety of options for handling and tracking facilitated reviews. One approach might be to establish a separate submission type with a streamlined application for initial review, particularly if the scope of the collaboration extends to reciprocal acceptance of submission forms. Standard process flows can be applied following submission to route. Focusing on the elements common to all protocols and maintaining consistency across submission types will enable comprehensive reporting and program evaluation. To make the most of any collaborative review model, it is important to ensure that metrics for facilitated reviews can be compared directly with the turnaround times and review outcomes of standard submissions.
If you would like more information, please submit an information request form.