IRB Membership Overview
The purpose of the Institutional Review Board (IRB) is to ensure the rights and welfare of humans participating as subjects in research are protected. The IRB is a collective body of scientist and nonscientist members who review research protocols and related materials (e.g. informed consent documentation and investigator brochures) to assure both in advance, and by periodic review, that appropriate steps are taken to protect human subjects in research.
In the United States, all research that involves people, their data, or their biospecimens must be approved by an IRB before it begins. IRB review ascertains human subject research meet high ethical standards, as well as federal and local laws.
The role of an IRB member is vital to the ethical review of human subject research. Members participate in ethical discussions relating to current studies and help represent the thoughts and concerns of the local community.IRB members gain experience reviewing medical, social, and behavioral research. IRB service also offers an opportunity to hear about current research in Rhode Island and network with the research community.
Lifespan's Human Research Protection Program (HRPP) supports the IRBs and provides ongoing assistance to all members. Lifespan has multiple IRBs and members generally serve on at least one of them. Members may also be asked to serve as alternate members for other boards on occasion.
IRB Membership Requirements
2018 Requirements (2018 Common Rule)
The requirements for IRB membership are addressed in the HHS regulations at 45 CFR 46.107 [NOTE: 45 CFR 46.304 requires a specialized IRB composition when research involving prisoners is being reviewed, including the presence of a prisoner representative].
46.107 IRB Membership
(a) Each IRB shall have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources), regulations, applicable law, and standards of professional conduct and practice. The IRB shall, therefore, include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB based on gender. No IRB may consist entirely of members of one profession.
(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concern are nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(f) An IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond, or in addition to, that on the IRB. These individuals may not vote with the IRB.
Time Commitments
Prior IRB experience is preferred, but not required.
Education and training are provided after membership designation and monthly thereafter.
- Reviewer education time commitment is relatively 30-60 minutes.
- Each IRB meets monthly for approximately 2 hours.
- Preparing for IRB meetings (reviewing protocols etc.); 2-4 hours per month.
- Expedited review assignments (optional); 1-2 hours per week.
This opportunity is for a term of three years with the option to renew. IRB committee members affiliated with Lifespan do not receive compensation for participation on the board. Unaffiliated IRB members, or members from the community, may be reimbursed for participation.
Responsibilities
- Establish and maintain knowledge of regulations and policies pertaining to human research
- Establish and maintain knowledge of Lifespan policies pertaining to serving as an IRB member
- Understand the Lifespan Conflict of Interest Policy for IRB Members and disclose potential or known conflicts of interest
- Review all materials received and/or electronically posted prior to meetings
- Attend regularly scheduled IRB meetings
- Engage in discussions and vote at IRB meetings
- When assigned, serve as a primary reviewer for scheduled reviews and a detailed review of the assigned study within the electronic system
- Maintain confidentiality of IRB discussions and all meeting materials
- Attend and participate in monthly board meeting educational training sessions, ad hoc webinars, and any in-person educational meetings
Completion of this application is estimated to average 30 minutes. All responses are confidential and will not be accessed or shared by any person not involved in the IRB member recruitment process at Lifespan.
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