VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

In addition, the following documents will be maintained and filed with the above records: • Records of continuing review activities. • Copies of all correspondences between the IRB and the PIs. • A list of IRB members, to comply with 45CFR46.108(a)(2). • Written procedures for the IRB in the same detail as described in 45CFR46.108(a)(3) and 45CFR46.108(a)(4). • Statements of significant new findings provided to subjects, as required by 45CFR46.116 (c)(5) (see Section 14. Informed Consent ). • Research protocols and responsibilities of investigators. These records, including the meeting minutes, will be retained for at least three years. All records related to research that is conducted will be retained for at least three years after the completion of the research. The records will be easily accessible for inspection and copying by authorized representatives of DHHS. Principal Investigators will be responsible for maintaining appropriate records on the protocols and data of their research activities as well. The PIs should maintain these records for a minimum period of three years following the completion of the research. 8.1. Voting In order for a research protocol to be approved, it must receive the approval of a majority of the members present at the meeting. The voting process proceeds as follows: The chair may entertain a motion and a second that the IRB take a certain action regarding a given protocol. The actions the IRB may take are as follows: approval, approval with contingencies, deferral (tabled), or disapproval. For a thorough discussion of these options, see Section 9. Types of Review . After a motion has been made and seconded, there should be an opportunity for discussion before a vote is taken. Those members physically present for the vote shall be recorded as either voting for, against, or abstaining. Members who are recused from the vote (e.g., due to conflict of interest) must physically leave the room, will not be counted in the aforementioned tally, and shall be identified by name in the minutes. 8.2. Member Recusal When an IRB member has a conflict of interest that requires him/her to recuse himself/herself from discussion of and voting on a particular protocol, that member should leave the meeting room for the duration of the discussion and vote except as requested to address questions raised by other members. If the member’s recusal causes a loss of quorum, the vote must be postponed to another meeting. For this reason, IRB members should notify the chair and IRB administration prior to the meeting if they have a conflict of interest related to a specific protocol slated for review at the meeting, and every effort should be made to ensure adequate members in attendance. 8.3. Principal Investigator Attendance The Principal Investigators are strongly encouraged to be in attendance during the portion of the IRB meeting at which their protocols are discussed. The investigators may answer questions raised by the IRB; however, they must not be present for the final deliberation and vote.

VCOM Institutional Review Board Policies and Procedures

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