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Calculating the Annual Approval and Review Period: How Long is a Year?IRBs frequently approve research for a year and then re-review the site within the year if re-approval is necessary for continuing the research. Even though this concept seems simple, a number of issues can arise regarding the date that the annual review period really begins . . . and ends. This spring, Quorum is going to begin calculating the annual review period in such a way that some "annual" review periods will appear to be less than a year. Beginning June 1, Quorum is going to calculate the annual approval and review period as beginning on the date that a site's materials are reviewed by the convened Board. Thus, if your site's materials are submitted to a Board meeting on November 1, 2006 and approved then the review period will begin on November 1, 2006 and end on October 31 of the next year. The matter becomes more complicated if the Board issues a conditional approval (an approval "with modifications") at the convened Board meeting of November 1. In this situation Quorum staff works with the site to satisfy the conditions or modifications imposed by the Board. Once the necessary information has been collected, Quorum staff typically submits the new information to the Board's expedited reviewers for approval. An "expedited reviewer" is an individual who is authorized to render Board approvals of certain straightforward matters outside of a convened Board meeting. Quorum has expedited reviewers available every day of the week. When a matter is submitted to the expedited reviewers, Quorum records the site's date of approval as the date that the expedited reviewers render a final, unconditional approval of the site's submission. If the matter is approved with modifications on November 1, for example, and a final approval is rendered by expedited review on November 5, then the approval date will be recorded as November 5. The approval documents will be issued with "November 5" listed as the date of approval. Even if the approval date is November 5, however, Quorum will calculate the annual review period as beginning on the date the materials were reviewed by the convened Board. In the hypothetical described above, the approval date on the site's approval documents will appear as November 5, the date of approval by expedited review. Despite this, however, the site's annual review and approval period will run from the date of the convened Board meeting, from November 1, 2006 to October 31, 2007. Under this approach, a site that is initially approved "with modifications" will have a review and approval period that is somewhat less than 365 days. The actual length of the review period will depend on how quickly the site can submit the information needed to satisfy the Board's conditions or modifications. We understand that it is important for a site to be approved as quickly as possible and to have as long a review period as possible, so if your site's submission is approved "with modifications" our staff will work with you to get your materials submitted for review as quickly as possible. Why is Quorum making this change? The evolving industry standard is to focus on review by the convened Board when calculating a researcher's annual review and approval period. Quorum is always striving to achieve both compliance and effective support of the study start-up process. Please don't hesitate to call the Site Support Team (1-877-472-9883 or 1-206-448-4082) or contact us through our website with any questions about this calculation of the annual review period. |
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