Full Board Review Process
Full Board Review Process
A Full Board Review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk or involves protected populations, such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.
The following categories of research require full IRB approval:
- Projects for which the level of risk is determined by the IRB Chair to be greater than minimal
- Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants
- Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals)
- Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).
Projects categorized as Full Board are reviewed at convened IRB meetings, which occur once a month. The submission deadline for Full Board applications is the first Wednesday of every month at 5 p.m. Applications submitted after the deadline will be reviewed at the next month’s scheduled meeting.
Upon submission, RIC, in consultation with the IRB chairperson, reviews the protocol to determine if it fulfills the criteria of Full Board Review. The protocol is assigned a primary reviewer for an initial review. The primary reviewer is responsible for the following: (1) comparing the detailed grant application or industry protocol with the IRB application; (2) informing the IRB of any discrepancies between the detailed protocol and the summary application materials; and (3) conducting an in-depth review. Prior to the meeting the researcher is notified if the protocol requires additional information or modifications. The changes are required prior to the convened meeting.
During the IRB meeting the primary reviewer will present a summary and concerns (if any) of the study. Upon the recommendation of the primary reviewer and IRB chairperson, the researcher may be required to be present during the IRB meeting to address issues or concerns of the board. Discussion and voting will follow.
The IRB can make one of the following four determinations regarding the protocol and consent forms:
- APPROVED: IRB approval indicates that the Board has concluded that the research and consent forms meet the federal criteria for approval.
- APPROVED PENDING THE SUBMISSION OF MINOR MODIFICATIONS: A vote for amendments required indicates the IRB has given RIC the authority to approve the minor revisions.
- DEFERRED: The IRB withholds approval pending submission of major revisions. The IRB may appoint one or more members of the IRB to discuss the reasons with the investigator. Once the required revisions are submitted by the researcher, the revised protocol is added to the next IRB meeting agenda for review.
- DISSAPPROVED: Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedures outweighs any benefit to be gained or if the proposed research does not meet the federal criteria for IRB approval.
Upon approval, RIC will notify the researcher and forward the standard Full Board approval letter. The letter will inform the researcher of the level of review and approval period that will not exceed one year after the convened IRB meeting. If a protocol was determined to require amendments, the approval period starts from the meeting date of the convened IRB at which the protocol was initially reviewed.
If the full board determined the protocol requires modifications to secure approval, RIC will send a revision letter to the researcher based upon the IRB’s discussion at the meeting. The letter describes the revisions requested by the IRB. If the researcher is a student, both the student and faculty advisor will be notified.
If the IRB determines that a protocol must be deferred or disapproved, RIC will draft a determination letter based upon the IRB’s discussion at the meeting. The letter lists the reasons for the decision.