VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

• Nature, probability and magnitude of anticipated risks to subjects; • Likely medical or psychological condition of the proposed subjects; • Overall qualifications of the PI and other members of the research team; • Specific experience of the PI and other members of the research team in conducting similar research; • Nature and frequency of adverse events observed in similar research; • Vulnerability of the population being studied; and • Other factors the IRB deems relevant. If the IRB finds any indications of noncompliance with protocol specifications or IRB requirements, the Board will have the authority to suspend or terminate the research. Any suspension or termination of approval will include a statement of the reasons and will be reported to the PI, the Provost, and, if necessary, the sponsor. Copies of suspension and termination letters will be kept in the meeting records. The IRB will pay particular attention to whether any new information or unanticipated risks have been reported that may affect the subjects’ willingness to participate. If this is the case, the IRB may require modifications to the consent form. If no subjects are participating in a study within one year of the last IRB review and/or approval, the continuing review protocol may be deactivated. If the PI requests reactivation of the protocol, he or she must submit a letter of explanation to the IRB Chair within 30 days of the deactivation notification. The IRB may then request that the PI appear at an IRB meeting to present a new plan of action for consideration of the study. For those expedited studies that require an annual review, review will be conducted by a Chair or a designated member. Research originally reviewed and approved under the “Old Common Rule” (prior to January 21, 2019) in either a full board or expedited capacity, is required to undergo annual review. 9.5. Modification A modification is a change in an approved research protocol. IRB review and approval is required before investigators can modify research protocols except when necessary to eliminate apparent immediate hazards to the subjects. Any proposed change to a previously approved project must be submitted as a modification request to that project and may be reviewed by a designated member or by the convened IRB, depending on a chair’s assessment of associated risk. Minor changes, those that do not significantly alter the risks/benefits balance or other study elements, may be approved by a designated member. Modifications that might increase the risk to human subjects in a study or otherwise represent a substantive change will be reviewed by way of expedited procedures, or by the convened IRB. If a modification requires convened IRB review, at least one primary reviewer is assigned, and the modification request is reviewed by the IRB.

VCOM Institutional Review Board Policies and Procedures

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