IV. Meetings
4.1 Meetings:
The IRB shall meet once a month.
4.2 Minutes and Records
Minutes of IRB meetings and other written evidence of assurances and determinations will be retained in accordance with the requirements of all applicable federal or state laws and regulations. The minutes will be distributed to IRB members and other individuals designated by the IRB. Research protocols and all supporting documents submitted to or generated by the IRB and all informed consent forms utilized by a Principal Investigator shall be retained as specified by law for three (3) years following termination of the affected research.
4.3 Rules of Order
Meetings will be conducted in accordance with Robert's Rules of Order.
4.4 Quorum
Research proposals classified as "Initial" and "Continuing" (not eligible for the expedited review process) are reviewed at a convened meeting of the IRB with a quorum of the membership. Federal regulations define a quorum as a majority of the IRB voting members. No quorum will consist entirely of one professional or lay group, nor is there a quorum without a non-scientist member being present. No proxies shall be allowed in any voting procedure of the Board. Expedited review does not require a quorum.
4.5 Conduct at the Convened IRB Meeting
The discussion of each agenda item is lead by the Chair and designated reviewer (s), if applicable. At the end of the discussion, a vote is taken (for, against, abstention) and recorded in the minutes using the following format: For - _; Opposed-_; Abstained-_____ (Name). Proxy votes are not permitted. Only members who participate in IRB review and discussion vote on research protocols. If the research proposal is approved, the interval for continuing review, as appropriate to the degree of risk, is determined and documented in the IRB minutes.
4.6 Teleconference and Videoconferencing
Members may attend the IRB meetings via telephone or videoconference as long as the member receives and has the opportunity to review the material prior to a determination on a given protocol and can participate in the discussion. If a member cannot attend a meeting, the member must notify the IRB staff in advance. If there is an alternate for the member, IRB staff will notify the alternate and distribute the information to be reviewed for the meeting.
4.7 Information provided to the IRB Members
Members will be provided with necessary review materials at least five (5) days prior to the scheduled meeting, and are expected to review carefully all materials provided in connection with an IRB meeting. New IRB members must receive an IRB orientation training course (Please refer to section 3.14).
Each IRB member, unless otherwise noted, must receive the following minimum information prior to an IRB review of a research protocol. Materials provided only to the primary reviewers must be available to all members if requested and available at the IRB meeting:
- Complete Project Review Form Required for all types of Review
- If applying for Exempt Review must reference regulatory category and provide documentation supporting the "Exempt Review" process
- If applying for Expedited Review, must reference regulatory category and provide documentation supporting the "Expedited Review Process."
- A copy of his/her research protocol with a review of relevant literature, complete methodology, references and measures (if applicable.)
- Curriculum vitae, experience/and or documentation confirming professional qualifications for conducting the proposed research study
- Completed budget for short-term and long-term research initiative
- Subject recruitment materials with the criteria for selection and exclusion of subject
- Justification for the use of vulnerable categories of subjects (if applicable)
- Appropriate informed consent forms :and patient education materials
- Professional qualifications for the Principal Investigator to conduct the research including signature from department Chair
- Signatures from appropriate Departmental Chair (s) of cooperating Department if project requires multiple departments (Included in Review Form)
- Evidence that the individual proposing to conduct research is a Principal Investigator or authorized co investigator
- Provisions for managing adverse reactions
- Descriptor of necessary support services and facilities
- Sinai Health System Research Institute Project Feasibility Application
