5.3(A) Appointment of IRB Members
The Associate Vice Provost for Human Subject Research shall appoint IRB members and alternate members with the advice of the Assistant Provost for IRB Affairs. These appointments shall be based on candidate interviews, recommendations from institutional leaders and others including relevant academic department and IRB chairs, review of the candidate’s expertise, qualifications and accomplishments as demonstrated in his/her curriculum vitae and other academic documents deemed relevant, and pursuant to the needs for expertise within IRB panels.
IRB members and alternate members shall be appointed to one-year terms and are eligible for reappointment at one-year intervals. During the appointment period, an IRB member or alternate member may be removed at the discretion of the Associate Vice Provost for Human Subject Research. At least annually during each appointment year, the Associate Vice Provost for Human Subject Research shall decide upon reappointment with the advice of the Assistant Provost for IRB Affairs. This decision shall be based on recommendations from the IRB Chair and other relevant information sought as deemed necessary from IRB members, HSRO staff and others, and on review of IRB minutes. Additional criteria of satisfactory performance for the continuance of IRB member and alternate member appointments, and for their reappointment, shall include attendance at meetings and training sessions, success in required training and education, meeting preparation, professionalism in the review process, and diligence in accomplishing the needs of the IRB and the HSRO for timely and appropriate review and decision-making of all assigned research studies.
5.3(B) Authorities and Responsibilities of IRB Members and Alternate Members
IRB members and alternate members are appointed to serve the University of Miami and affiliated institutions as a whole. Members and alternate members must put their duty to protect the rights and welfare of human subjects above their own interest or that of their academic department.
IRB members are responsible for attending, for their full duration, all convened IRB meetings in a timely manner. If an IRB member cannot attend a meeting or a part of a meeting, he/she should notify the HSRO well in advance of the meeting to facilitate the preparation and attendance of an appropriate alternate IRB member.
All IRB members and alternate members should understand and apply the ethical principles of the Belmont Report and all federal, state and local regulations related to the protection of human research participants. Members and alternates should commit time and effort to receive training in these requirements. All members and alternate members shall be given copies of pertinent documents to review and understand including federal regulations and the University of Miami's Written Policies and Procedures for the Protection of Human Subjects in Research. Attendance at University of Miami seminars pertaining to human subject protections is encouraged. These seminars are intended to provide background and new information. In addition, IRB members and alternates are encouraged to attend relevant local and national meetings and may be provided support to do so.
IRB members (and alternate members when appropriate) are expected to serve as primary reviewers for assigned studies and to participate as general reviewers on all studies discussed at convened meetings. IRB members (and alternate members when appropriate) shall vote to approve, set conditions for approval, defer review to expedited reviewer or convened IRB or disapprove studies submitted to the IRB following discussion of these studies. IRB members (and alternate members when appropriate) may discuss and vote on other matters pursuant to UM Policies and Procedures such as compliance audit reports or reports of adverse events.
IRB members may be appointed as IRB-designees by the IRB Chair or Vice-Chair. IRB-designees are expected to conduct exempt and expedited reviews.
Upon recommendation of the Associate Vice Provost for Human Subject Research, the IRB Chair may appoint trained administrative staff members of the Human Subject Research Office as administrative-designees of the IRB. Administrative-designees have specific review and approval authority that is defined in other sections of these Policies and Procedures. These responsibilities are limited to such matters as non-human subject research, final reports and informational amendments.