POLICY

It is UAB policy that all human subjects research (including clinical investigations) under the UAB IRB jurisdiction be reviewed in a convened meeting of the IRB in accordance with applicable federal regulations unless the research qualifies for review under expedited or exempt categories.1 (See PRO122 Procedure for Initial Review of Proposed Research at the Convened IRB Meetings.) The IRB may utilize a primary review system during the conduct of its convened meetings to perform initial review, continuing review, and review of modifications or amendments to research. If a primary review system is utilized, primary reviewers must be identified for each protocol (see PRO144 Procedure for Formation and Assignment of IRB Member Primary Review Teams). The IRB has authority to approve, require modifications in, or disapprove all research activities within its jurisdiction. The IRB may only conduct business when a quorum is present (see PRO101 Procedure to Maintain IRB Member Roster and Quorum). IRB meetings will take place with all participating members physically present unless circumstances warrant use of teleconferencing or videoconferencing techniques. If such conferencing techniques are used for a convened meeting, the following conditions must be met:

1. Each participating IRB member will have received all the relevant materials prior to the meeting to allow adequate time for review and to request additional information, as needed (see PRO145 Procedure for Timing of Document Distribution for IRB Meetings);
2. Each participating IRB member will have the ability to actively and equally participate in the IRB discussions of all protocols; and
3. The IRB minutes will clearly reflect that the above two conditions are met.

No IRB member with a conflicting interest may participate in the initial or continuing review of a protocol. When a conflicting interest exists, and IRB member may provide information as requested by the IRB, but must be absent from the meeting during IRB deliberations and voting on matters which the conflict may potentially affect.

The IRB will perform substantive review of research in convened meetings; a majority of members must agree that the materials under review contain sufficient information for the protocol to receive approval by the IRB in accordance with the criteria in 45 CFR 46.111 and, if applicable, 21 CFR 56.111, 38 CFR 16.111, and E6 Good Clinical Practice Consolidated Guidance. In addition, when appropriate, the IRB will determine if the need for ancillary care, additional monitoring, counseling, and social support should be provided and if the informed consent document should include the additional elements of informed consent. When indicated, the IRB will perform review under 45 CFR 46 Subparts B, C, and D.

The convened IRB will assign a review interval at the time of initial and continuing review of research according to the degree of risk involved, but not a date later than 1 year from the date of the last approval. No provision for any grace period for conducting research past the expiration date of IRB approval will apply. In determining the appropriate review interval, the IRB will take into account the following factors without limitation:

1. Involvement of populations that may be vulnerable due to undue coercion or influence to make an informed decision to participate;
2. Novel or geographically remote performance sites;
3. Involvement of recombinant DNA (including gene transfer);
4. Use of waivers in the informed consent process;
5. Protocols with potential for heightened risks to subjects;
6. Previous problems with the research or investigators, including occurrence of unanticipated problems, non-compliance, administrative actions, and complaints of participants;
7. Recommendation from units supplying special approvals of the research (e.g., Radiation Safety committee, research pharmacy review, Institutional Biosafety Committee (IBC)).

By using the following criteria, the IRB will determine which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review.

1. Protocols randomly selected as part of the UAB IRB Post Approval Monitoring Plan;
2. Complex protocols involving unusual levels or types of risks to subjects;
3. Protocols conducted by Principal Investigators who previously have failed to comply with federal regulations or the requirements or determinations of the IRB; and/or
4. Protocols where indication of possible material changes occurring without IRB approval is present, based on information provided in continuing review reports or other sources.

Federal regulatory requirements for waiver or alteration of informed consent will apply to all protocols approved by the IRB. All research approved by the IRB will be conducted in accordance with any applicable UAB policy. All decisions and actions of the IRB relating to initial review, continuing review, or review of modifications or amendments of research will be transmitted promptly to the Principal Investigator in writing. Notification of deferral or disapproval of a protocol will contain the reasons for the decision and an invitation to the investigator to respond in writing or in person.