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Submission Guidelines

Meeting Deadlines | Submission Guidelines | Board Composition & Expertise | Compliance with HHS and FDA

To ensure that investigator's submission for their research protocols has sufficient information about the research protocol for the IRB to conduct a thorough review and that the submission is handled efficiently by OPRS, investigators should:

  • Items requiring review by the convened IRB must be submitted by 4:30 p.m. two weeks prior to the scheduled IRB meeting day.

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  • Submit all research protocols and other items requiring review by the IRB on the appropriate form(s) available in hard copy from OPRS or on this web site.

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  • Submissions with an incorrect form or no form will be returned to investigators without review.

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  • Submissions that require review by the convened IRB will be placed on the agenda for the IRB meeting based not only on the submission date, but also based on which IRB has the requisite expertise for the review and on the type of protocol submission.

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  • Submission of amendments to previously approved research that are minor in nature may be submitted at anytime. Generally minor changes are those that do not affect the risk-benefit assessment and do not change the purpose of the research, the procedures involved in the research or the subject population.

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  • Research protocols that were initially reviewed under expedited procedures (involve no more than minimal risk and are in one or more specific categories listed in the federal regulations) may subsequently be reviewed under expedited review procedures if no changes have been made with that affects risk level . If your research fit these criteria, the continuing review may be submitted prior to the expiration date without observing the submission deadlines for IRB meetings.

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  • Allow 4-6 weeks prior to your protocol's expiration date for the IRB to conduct the continuing review and for you to respond to any questions or concerns they may have.

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