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  4. IRB policies — one new, one updated

IRB policies — one new, one updated

One new and one updated IRB policy were recently posted on the IRB’s website.

The revised policy, 2.3, relates to the use of single or central IRBs (xIRBs). This policy describes the process changes implemented as xIRB use has become more common in recent years. The 2018 Common Rule will mandate the use of an xIRB for all multi-site research subject to the rule. NIH-supported studies have been required to us a single IRB since January 2018.

The new policy, 7.12,  addresses Limited IRB Review. Limited IRB Review is required for certain exempt categories of research to confirm that, “when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”

Limited IRB review must be done for research reviewed under exempt categories 2c [Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) and the information is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained], and 3c (Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection, and the information is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained), per the 2018 Common Rule.

Note the rule also says such a review is also to be done for exempt categories 7 and 8 research, which pertain to broad consent for the storage and use of identifiable private information or specimens, but the UAMS IRB does not use these “broad consent” exempt categories to review such research at this time.

 

Posted by uamsonline on November 8, 2019

Filed Under: Institutional Review Board Members

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