Roles and Responsibilities
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 of Human Research Protection (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 support to the IRB to support its functions and maintain institutional compliance with regulations.
The University must provide the necessary resources so that the IRB Chairperson(s), 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 the 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 records 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 Assurance. Responsibilities include:
- Designating one or more IRBs that will review research covered by the institution's FWA;
- Providing sufficient resources, space, and staff to support the IRB's functions;
- Making available training and educational opportunities for the IRB and investigators;
- Setting the "tone" for an institutional culture of respect for human participants;
- Ensuring effective institution-wide communication and guidance on human participants research;
- Ensuring that all staff engaged in the conduct or oversight of human participant research receive training in human participants research ethics; and
- Serving as a knowledgeable point of contact for OHRP, or delegating this responsibility to the IRB Administrator or other appropriate individual.
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.
Roles and Responsibilities of the IRB Administrator
The IRB Administrator is an individual 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 Responsibilities
- Promoting communication among research administrators, department heads, investigators, human participants, and institutional officials to maintain a high level of awareness regarding the ethical conduct of research and to safeguard the rights and welfare of participants.
- Maintaining access to the institution's Assurance, copies of pertinent Federal regulations, policies, and guidelines related to the involvement of human participants in research, and institutional policies and procedures.
- Educating the members of its research community in order to establish and maintain a culture of compliance with Federal regulations and institutional policies relevant to the protection of human participants.
Record Keeping & Reporting Responsibilities
- Ensuring that IRB records are being maintained per federal regulations and that the records are accessible, upon request, to authorized federal officials. The IRB Administrator shall oversee procedures for the retention of University IRB records and documents for at least three (3) years past completion of the research activity.
- Ensuring certification of IRB approval of research to the appropriate federal agency, as required.
- Ensuring that changes in approved research, during the period for which IRB approval has already been given, are not initiated without IRB review and approval, except when necessary to eliminate apparent, immediate hazards to the participant.
- Ensuring prompt reporting to the IRB of all proposed changes in a research activity.
- Ensuring the prompt reporting to the IRB, appropriate institutional officials, OHRP, and any sponsoring Federal department or agency head of: a) any unanticipated problems involving risks to participants or others; b) any serious or continuing noncompliance with the regulations or requirements of the IRB, and c) any suspension or termination of IRB approval for research.
Monitoring & Oversight Responsibilities
- Ensuring that appropriate oversight mechanisms have been implemented to ensure compliance with the determinations of the IRB.
- Ensuring that all cooperating performance sites conducting research primarily under the direction of the institution have appropriate OHRP-approved assurances and provide certifications of IRB approval to the appropriate federal authorities.
- Ensuring that cooperative IRB review arrangements are documented in writing, in accordance with OHRP guidance.
Board (IRB) Responsibilities
- Reviewing proposed research at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in non-scientific areas, except when exemption or expedited review procedures are applicable. In order for the research to be approved, it must receive the approval of a majority of those members present at the meeting.
- Reviewing, approving, requiring modifications in (to secure approval), or disapproving all research activities, including changes in previously approved human participants research.
- Requiring that information given to participants as part of the informed consent process is in accordance with 45 CFR 46.116. The IRB may require that information, in addition to those required elements specified in 45 CFR 46.116(a), be given to participants when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of the participants.
- Requiring documentation of informed consent or waiving documentation in accordance with 45 CFR 46.117.
- Notifying investigators in writing (via email or letter) through the IRB Administrator, of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of research activity. If the IRB formally disapproves a research activity, it will include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
- Certifying IRB review and approval for all Federally-sponsored research involving human participants that will be submitted by the IRB Administrator to the appropriate Federal department or agency, as required. Compliance will occur within the time and manner prescribed for forwarding certifications or IRB review to DHHS or other Federal department or agency.
- As its discretion, inviting individuals with competence in special areas to assist in the review of issues that require expertise beyond, or in addition to, that available on the IRB.
IRB Member Responsibilities
- Being familiar with the requirements of the Federal regulations, applicable state laws, the University’s Assurance, and institutional policies and procedures for the protection of human participants.
- Having effective knowledge of subject populations and other factors involved in determinations of risks and benefits to participants as well as informed consent.
- Being able to judge the adequacy and accuracy of information in the informed consent document, recruitment, advertising, and any other materials to be presented to participants.
- Having the professional competence necessary to review the specific research activities presented for approval.
- Preparing for and actively participating in the review processes in full board meetings as well as participating in expedited and exempt reviews as assigned.
- Promoting positive communication and awareness on campus of the role of the IRB and ethical research principles in regard to human participant research.
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:
- Maintaining an in-depth knowledge of the regulations and regulatory guidance, and expertise in the review of human participants research.
- Providing leadership and oversight, in partnership with the IRB Administrator, for the policies, procedures, practices, and functioning of the IRB and human participants research at the institution.
- Designing and leading training for IRB members, and supporting orientation for new members.
- Providing campus training and educational events coordinated by the IRB office for faculty, staff, and students.
- Facilitating Board meetings and serving as the lead reviewer for full board reviews;
- Serving as the lead reviewer for Expedited and Exempt reviews, in concert with the distributed review process involving other members of the IRB.