VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

9.

TYPES OF REVIEW

9.1. Exempt The PI should submit a full application for review via IRBNet. Research that qualifies for exempt status will be reviewed by the Chair, a Co-Chair, or by a designated, qualified board member. 9.2. Expedited The categories of expedited review are established by the Department of Health and Human Services. These categories represent minimal requirements of review, and the VCOM IRB may call for a more stringent review of any study. The IRB may use the expedited review procedure to review research that complies with either or both of the following: • The research is found by the reviews to involve no more than minimal risk, and • There have been minor changes in previously approved research during the period for which approval is authorized. Under this review process, the review may be performed by at least two members deemed experienced in the particular research area by a Chair and/or the IRB administration. The reviewers may exercise all of the authorities of the IRB with the exception of disapproving the research. If at least one reviewer judges the proposed research to be lacking in areas of subject safety, he or she will inform IRB administration, and the proposed research will then be reviewed by an IRB Chair or, if necessary, in accordance with a full board review. 9.3. Full Board All research that does not meet the criteria for exempt or expedited review will be reviewed by the full Board at a regularly convened meeting. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. 9.4. Continuing For studies reviewed and approved by the full board continuing compliance is determined for a period appropriate to the risks involved in the study; this period cannot exceed one year. This continued compliance requires the PI to send a written progress report to the IRB for review. The PI will receive continuing review notices from IRBNet 60 and 30 days prior to the study expiration date. The progress report and any additional information or documentation required by the IRB will be the basis for review. All forms submitted by the PI and all discussion and decisions on the continued review of the study will be filed with IRB meeting records. Intervals for continuing review are often set for one year; however, the IRB may determine that more frequent intervals are appropriate. While continuing review is no longer required for studies granted Expedited approval, the IRB may determine an annual review is required to enhance the protection of research participants. In such cases, the IRB will document justification for this determination via Review Comment Form and IRBNet. The IRB will consider the following factors in determining the criteria for full board studies requiring more frequent review or Expedited studies requiring annual continuing review:

VCOM Institutional Review Board Policies and Procedures

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