Each of the UM Institutional Review Boards is a fully functioning, standing committee, which is independent of any other committee at the University or JHS. As assigned by the HSRO, each IRB shall review human subject research studies that fit (entirely or in part) any of the following:
The studies are conducted by employees or students of UM, JHS or affiliates
The studies are contdunted on UM or JHS premises
The studies utilize UM or JHS facilities or resources
The studies conducted at non-UM or JHS sites but UM or JHS personnel are engaged in research in connection with their institutional responsibilities.
Studies will be assigned to an IRB by staff members of the HSRO who serve as designees of the Associate Vice Provost for Human Subject Research. These assignments will be made by trained HSRO staff according to the expertise of IRB members and their work-load pursuant to the recommendations and guidance of the Associate Vice Provost for Human Subject Research and the chairs of each IRB.
Selection of an IRB panel by an investigator shall not be permitted; but an IRB Chair or IRB-designee, at his/her discretion, may recommend to the HSRO that the review of a research study be referred to another IRB panel if he/she determines that another IRB panel has more appropriate expertise or if IRB meeting schedules make the transfer appropriate. Upon such recommendation, the Associate Vice Provost for Human Subject Research or, in his/her absence, the Assistant Provost for IRB Affairs shall make the final decision on the IRB assignment.
Once an IRB has approved a study, all additional oversight and actions shall typically be performed by that same panel (i.e., continuing review, expedited review, and adverse event considerations). Each IRB is distinct and completely separate from the other IRB. If an issue affects more than one IRB (e.g., an investigator with studies open under more than one IRB is failing to comply with regulations), each IRB may address the issue separately or together, under the coordinating assistance of the Associate Vice Provost for Human Subject Research or the Assistant Provost for IRB Affairs.
Each IRB should include individuals with a broad range of expertise who are qualified to review the research through their education, experience, expertise and diversity. All appointments to an IRB will be reported to the Office for Human Research Protections (OHRP). The IRB roster shall identify the primary member(s) for whom each alternate member may substitute. The qualifications of each alternate member must be comparable to those of the primary member to be replaced. Alternate members are invited to attend IRB meetings and may participate in discussions but may vote only when replacing a voting member of the IRB. When an alternate member replaces the primary member, the alternate member will receive and review the same material that the primary member received. IRB meeting minutes shall document instances in which an alternate member replaces a primary member.
Each UM IRB shall have at least five members including at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. During the review of FDA-regulated products (drugs, biologics, and devices) at least one member present must be a licensed physician. A priority shall be placed on diversity of IRB membership, including race, gender, cultural backgrounds, sensitivity to community issues and community attitudes, and multiple professions representing the scope of research under IRB review. Priorities shall also be on having both sufficient lay (non-affiliated) representation to reflect the values of the community from which the research subjects are drawn and members with broad, scientific expertise.
At least one member of each IRB will not otherwise be affiliated with the University of Miami or Jackson Health System and may not be part of the immediate family of a person so affiliated. Members of the community such as clergy, teachers, attorneys, veterans or representatives of legally-recognized veterans organizations, and community and/or prisoner advocates shall be considered for appointments to the IRB. One IRB member may fulfill both criteria of non-scientist and non-affiliate at the same meeting.
IRB members should be committed to safeguarding the rights and welfare of human subjects. Members who do not adequately fulfill their responsibilities as judged by the IRB Chair, the Assistant Provost for IRB Affairs and/or the Associate Vice Provost for Human Subject Research may be asked to step down from IRB membership by the Associate Vice Provost for Human Subject Research.
Compensation may be provided to IRB members who are employees of the University of Miami in the form of salary support for service related to duties. Such compensation may be provided if the IRB duties constitute a significant fraction of the member's time and if compensation for that time is not otherwise provided from institutional and/or department or other resources. The Associate Vice Provost for Human Subject Research shall manage compensation standards for such services.
When acting in accordance with federal, state, and local regulations and the UM IRB Written Policies and Procedures, IRB member actions are covered by the University's self-insurance policy, which protects individuals from liability when performing within the course and scope of their IRB responsibilities and in accord with faculty and staff serving on all University Boards or Committees. Unaffiliated members of the IRB are also covered by this policy when performing within the course and scope of their IRB service.
The Associate Vice Provost for Human Subject Research and/or the Assistant Provost for IRB Affairs and/or the IRB chairperson may, at his/her discretion, recruit non-voting (ad-hoc) members to the IRB from among the academic or administrative staff of the University, whose presence at the meetings of the IRB would aid the IRB in conducting its duties. These ad-hoc members may take part in IRB meetings, participate in the discussions and make recommendations to influence decisions, but they may not vote on the decisions. Non-voting members shall not be included in determining or establishing a quorum at the meetings. IRB meeting minutes shall reflect the presence of non-voting members.
Each IRB is charged with evaluating the scientific merit when participants will be placed at more than minimal risk, determining risk-benefit ratio, and assessing the ethical and legal aspects of each project. These functions, operations, reviews, and requirements are in accordance with the requirements of 45 CFR 46 and FDA Parts 50 and 56.
The number and scope of IRBs shall be defined by the Associate Vice Provost for Human Subject Research based on evaluations of the thoroughness and timeliness of IRB actions. Determination of the appropriate number of IRBs shall take into account the volume, complexity and types of research reviewed, and the time/effort IRB members devote to IRB activities, given other responsibilities.