Webinar Recording Now Available: CTTI’s Framework for Evaluating the NIH Single IRB Policy

A recording is now available of a CTTI webinar held on Thurs., Jan. 16, which provided a recap of resources available to help implement a sIRB model, as well as an overview of a recent project CTTI undertook to develop a framework that could help in evaluation of the NIH’s single IRB (sIRB) policy. The webinar was led by Cynthia Hahn (Integrated Research Strategy), Stephen Rosenfeld (Secretary’s Advisory Committee on Human Research Protections), and Heather Pierce (Association of American Medical Colleges).

CTTI has been involved in driving adoption of sIRBs for over a decade, but its recent work with the NIH is especially critical this month as changes to the Common Rule take effect, requiring all multi-site research studies to use a sIRB for review.

To develop its evaluation framework, CTTI conducted a literature review and interviews with a diverse set of stakeholders engaged in the process of sIRB adoption.

The webinar outlined the framework’s recommendations for measuring and continuously improving the sIRB model, including:

• Creating a database of organizations that are implementing the sIRB model, as well as which organizations are serving as an sIRB.
• Developing and testing a survey instrument to help evaluate sIRB function and collect metrics.
• Establishing, defining, and routinely collecting and sharing metrics, such as sIRB review time and time spent performing other sIRB-related activities. The team pointed out that although many metrics are quantitative, it is also important to have qualitative metrics to assess the overall quality of the sIRB process. Routine sharing of these metrics would serve to encourage improvement and eliminate unnecessary duplication.

Explore CTTI’s existing resources and recommendations for sIRB adoption on the CTTI website.