What is the role of an IRB member?
At Rutgers, The State University of New Jersey, our faculty, staff, and students in many academic disciplines, across all campuses and in international settings, conduct diverse research that involves human participants (or subjects) or their private information and/or biospecimens. Show The Rutgers Institutional Review Board (IRB) is a federally mandated committee that oversees the ethical conduct of human subjects research at all Rutgers campuses, University Hospital (Newark), Robert Wood Johnson University Hospital (New Brunswick), and Rutgers Cancer Institute of New Jersey (CINJ). Rutgers IRB members who are community partners and affiliated faculty/staff play an essential role in this review process and bring diverse backgrounds and experience to the review of research applications. The Rutgers’ Human Research Protection Program (HRPP) is the administrative office that supports the IRB for all Rutgers. The Rutgers IRB specializes in the review of both biomedical and social/behavioral/educational research. The HRPP staff are involved in the initial (pre) reviewing IRB applications, administrative support and scheduling for board meetings, post approval monitoring and education and outreach activities. The HRPP staff also provide initial training and ongoing education for all IRB members and HRPP staff. What is the role of an IRB Member?The IRB is charged with review of proposed research protocols to ensure that the rights of human subjects are protected and that risk of harm to subjects is minimized. The framework for protection of human subjects is set in Federal regulations. Committee members ensure compliance with Rutgers policies and procedures, federal regulations, and state and local laws relative to the review of human subjects research studies. This includes ensuring that our unaffiliated community partners have a role on the IRB and can provide their perspective to board decisions about how best to protect research participants no matter where the research is conducted, domestically and/or internationally. Diverse MembershipIn compliance with federal regulations, Rutgers IRB membership is diverse with respect to scientific background and expertise, gender, race, ethnicity, and affiliation. This allows for a better review of research proposals since each member brings unique expertise to the discussion. The board includes members who:
Community Partner MembersUnaffiliated community partner members play a vital role on the IRB. They bring fresh insight and perspective to board decisions about how best to protect research participants. The Community Member has the responsibility of bringing the perspective of the volunteer research participant to the review of protocols. Community partner members do not have a current affiliation with Rutgers nor have an immediate family member (spouse or child) affiliated with our institution. Most of the functional tasks, roles, and responsibilities of the various individuals and components of the IRB system are based on guidance from the Office for Human Research Protections (OHRP), as outlined in the OHRP Human Subject Assurance Training. Role of the Institution Consistent with federal regulations, the university as an institution is responsible for providing administrative oversight, support, and sufficient resources to maintain an effective IRB system. This includes, at a minimum, designating individuals to serve as Institutional Official and IRB Administrator, promoting an ethical research culture at the institution, and providing space and adequate staff to the IRB to support its functions and maintain institutional compliance with regulations. The university must provide the necessary resources so that the IRB Chair, IRB members, investigators, and relevant administrative personnel have access to and complete appropriate initial and continuing education related to the protection of human participants before reviewing or conducting research. The university encourages and promotes constructive communication among research investigators, the IRB, and human participants as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of research participants. As put forth in the federal regulations, to assure independence, and to avoid potential administrative influence, the IRB as a committee functions independently of the administrative authority of the institution. However, the institution may and should exercise appropriate administrative oversight to ensure that the procedures being implemented for the protection of the rights and welfare of human participants and for record keeping are in compliance with the requirements of 45 CFR 46 and the IRB’s own policies and procedures. The IRB’s role is to exercise independent judgment in the review of research; the institution’s role is to ensure that the IRB follows the rules and has the resources it needs to function. Federal regulations do allow that the institution may disapprove or terminate a project that an IRB has approved. However, the institution may not approve projects or procedures for individual projects that have been disapproved by the IRB. Role of the Institutional Official The Institutional Official (IO) is the individual authorized to act for the institution and obligates the institution to the terms of the Federalwide Assurance. Responsibilities include:
The Institutional Official makes appointments to the IRB, based on consultation with the IRB Chair, Administrator, and members. The latter receive suggestions from the campus and recommend possible members, based on the regulatory requirements for certain qualities and types of members, and their understanding of the expertise available at the institution and in the community. Based on those recommendations, the IO then makes appointments to the Board for varying terms. The IO may also elect not to renew an appointment if the member is not contributing effectively or simply to further advance diversity on the committee, or in unusual circumstances, to withdraw an appointment if an individual is not participating appropriately. The Institutional Official may not appoint a member over a formal vote by the IRB objecting to the appointment. IRB Administrator Responsibilities The IRB Administrator is designated by the Institutional Official to oversee and manage the IRB system and its operations, including working in collaboration with the Board in the development and maintenance of appropriate policy, procedures, processes, and records. Communication & Education
Record Keeping & Reporting
Monitoring & Oversight
Board (IRB) Responsibilities
IRB Member Responsibilities
IRB Chair Responsibilities The Chair of the IRB is designated by the Institutional Official, based on the recommendations of the IRB members and the IRB Administrator. The Chair’s responsibilities include all of those listed for IRB members in general, and in addition include: What is an IRB community member?The mission of an IRB community member is to help to protect the rights and welfare of those individuals volunteering as research subjects. Community members are not required to have a scientific background. In fact, most have no scientific background.
What is the role of an IRB chair?The IRB Chair/Director primarily oversees IRB Administration, runs meetings, and approves non-exempt and non-Not Human Subjects Research (NHSR) protocols. The Chair Elect and Past Chair can fill in for the current IRB Chair/Director when conflicts of interest arise or the current IRB Chair/Director is unavailable.
Who tends to be members of an IRB?Who Serves on an IRB? An IRB consists of at least five members of varying backgrounds. IRB members should have the professional experience to provide appropriate scientific and ethical review. An IRB must have at least one scientist member and at least one member whose primary concerns are nonscientific.
What are the requirements for IRB membership?What are the requirements for IRB membership?. have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;. make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;. |