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            "text": "procedure to review minor changes in previously approved research during the period covered by the original approval. Reviews are done on an ongoing basis, meaning that the review is accomplished independently of the IRB meeting schedule."
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            "text": "9.1 Procedures",
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            "text": "Researchers seeking expedited review will submit an application package to the OSP. In turn, OSP staff will conduct a preliminary screening of the application package, and once the screening has been completed and any issues with the screening have been addressed, OSP staff will consult with the IRB Chair to determine who will be responsible for the expedited review. The expedited review may be carried out by the IRB Chair, an IRB member designated by the Chair, or the HRPP specialist serving as an alternate IRB member when an IRB member is unavailable to complete the review in a timely manner. It is preferable, however, that an IRB member complete the review."
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            "text": "If the IRB member selected for an expedited review has a conflict of interest with the project in question, it is the responsibility of the IRB member to notify the Chair and OSP staff and recuse themselves. If an IRB member is unable to complete a review because of conflict of interest, or for any other reason, the Chair will approach another IRB member to complete the review. Consultants may assist the IRB Chair and other IRB members in making decisions in expedited review, but expedited review cannot be performed solely by persons who are not voting members of the IRB."
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            "text": "Expedited reviewers only approve research that meets the federal criteria for approval. Also, expedited reviewers ensure that the study's informed consent process and documentation meet the requirements as specified in 45 CFR § 46.116 and 21 CFR § 50.25. Expedited reviewers exercise all the authority of the IRB in completing their review, except that the reviewers may not disapprove research. A research activity may be disapproved only after full Board review. Expedited reviewers should take into account any protective measures included in the research design as part of the process of determining if the proposed research involves no more than minimal risk. However, some social and behavioral studies involve more than minimal risk, even though they include such protective measures."
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            "text": "The expedited reviewer, with input from other IRB members and OSP staff as applicable, provides feedback for any clarification needed and documents the issues discussed on a reviewer checklist provided by OSP staff. The expedited reviewer records their determinations on the checklist and returns it to OSP staff."
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            "text": "OSP will provide an updated list of research protocols approved under the expedited review procedure to the IRB at each scheduled meeting, and all IRB members will have access to all files containing expedited review applications and decisions. Any IRB member may request additional information from the Chair or OSP staff regarding the expedited determination of any particular protocol."
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            "text": "9.2 HHS Guidelines for Expedited Review",
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