Thursday, February 2, 2012

IRB Review Times as a Quality Indicator

In 2009, AAHRPP began collecting IRB review times as part of the application process. The initial response from many was “we don’t collect that,” or “we can’t collect that,” usually reflecting the fact that their electronic systems were not set up to calculate review times. Three years later, the tide has turned, now collecting HRPP metrics is standard practice and people want even more information about review times.

AAHRPP looks at five parameters related to review time: time from submission of the protocol to review and time from submission to approval by the convened IRB, time from submission to review using the expedited procedure, time from submission to approval using the expedited procedure, and time from submission of a protocol to a determination of whether the research is exempt. AAHRPP uses calendar days to describe review time.

One question that arises is how to define the starting and stopping points for review times. Should the clock start when the protocol application is submitted initially—complete or not—or after all required information is received? At the other end of the review time are IRBs that cannot give final approval of a protocol until other committees send their approval, even though these IRBs might have completed their review and approved the protocol. AAHRPP’s definition is a simple one: from initial submission to the time the researcher receives approval to begin the research. Recognizing that review times are complex, involving different components and steps, AAHRPP encourages organizations to build into their analysis of review times all the elements that influence the work flow. Review times have at least three main components: time the IRB staff devotes to handling the application, time with the reviewer, and time for the researcher to respond to questions and requests for more information and to make changes. These times are not simple to calculate because protocols go back and forth between the IRB and the researcher.

Electronic systems can be configured to collect these component times. If any component appears problematic, the factors related to the workflow in that that component can be addressed, such as increase IRB staff, require reviewers to get reviews in on time, or encourage researchers to respond promptly.

Whether using the time from submission to approval, or conducting a more complex analysis of the workflow components, review time is an important quality indicator. Faster does not necessarily mean higher-quality reviews, but inefficient, sluggish systems are not beneficial to the research enterprise or research participants. Complete and comprehensive reviews conducted in an efficient manner are the ultimate goal.

Knowing, analyzing, and understanding your IRB review times, and acting accordingly to implement changes is the way to meet that goal. Organizations should track review times and formally analyze them to determine if, and where, improvement are needed including allocation of resources and personnel, education of IRB staff, IRB members, or researchers and research staff, or enhancement of electronic systems. And don’t just look at means or medians; analyzing outliers can produce valuable information, and are sometimes the situation on which the reputation of your IRB is based. Long IRB review time is the most common complaint of researchers. Being knowledgeable about your review times and able to justify or improve your metrics is an important part of quality improvement for your HRPP.

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