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  4. Writing Contingencies: Keep the Criteria for Approval in Mind!

Writing Contingencies: Keep the Criteria for Approval in Mind!

The criteria for approval of research are spelled out in federal regulations and in UAMS IRB Policy 7.1. Please review these criteria and keep them in mind when drafting contingencies. Some institutions, in fact, require IRB members to specifically state which criterion draft contingencies are addressing. While we do not go quite that far here at UAMS, we do ask that contingencies that are sent back to PIs relate to these criteria. Things such as typos or other minor changes that do not affect the criteria for review are better handled in a note rather than a contingency. For example, if the consent form does not adequately describe the risks of the research, then the adequacy of the consent process is questionable (see criteria 4 and 5 in the policy), which merits a contingency. However, a consent form typo that does not change the meaning of anything in the form could be addressed in a note that recommends a correction the next time the consent form is amended.

Posted by Edith Paal on May 8, 2014

Filed Under: Institutional Review Board Members

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