Structure and Function

Federal and state regulations mandate that research involving human subjects be reviewed and approved by an Institutional Review Board (IRB), charged with providing guidance and oversight for human subjects research and for ensuring compliance with applicable laws, regulations, and policies. In matters regarding the participation of human subjects in research, the IRB serves as Seattle University’s decision-making authority, adhering to the guidelines of IRB policy, University policy, and state and Federal state regulations.

IRB members are appointed for staggered, three-year terms by the University Provost after consultation with the Chair of the IRB and the IRB Administrator, adhering to candidate qualifications and expertise as mandated by Federal requirements. The Provost also appoints the Chair from among experienced IRB members in good standing. At the end of a three-year term, the IRB Chair and the IRB Administrator will review the standing of each board member according to qualifications and needs of the Board, record of participation, and contribution to the IRB. Recommendations will be made to the Provost, who will officially reappoint members to additional terms. The IRB Chair together with the IRB Administrator will provide individual performance reviews to the University Provost at the end of each three-year term. Reappointments will be based on the needs of the board and each member’s qualifications, record of participation, and contribution to the board. The IRB Chair and the IRB Administrator will also conduct annual reviews of each member.Those who regularly fail to meet the expectations outlined below may be asked to step down prior to the end of his or her term, in which case an alternate or new member will be appointed, as necessary.

The IRB Administrator serves as a permanent non-voting ex-officio member and is responsible for the daily functioning of the IRB. In addition to regular responsibilities, the IRB Administrator will provide the Provost’s office with an annual report, documenting the activity of the IRB and human subjects research under the auspices of Seattle University over the past year. The IRB Administrator will also be responsible for notifying the Provost’s office of instances serious or on-going non-compliance, and handle reporting such instances to the Office of Human Research Protections, according to Federal regulations.

Under Federal regulations (45 CFR 46.107-108), an IRB must meet the following composition requirements:

1. To promote complete and adequate review of research activities commonly conducted by the institution, the Seattle University IRB must have at least five members with varying backgrounds. If the IRB regularly reviews research involving a vulnerable population (e.g., children, pregnant women, or people with disabilities), consideration will be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. The IRB should also have one member capable of serving as a prisoner advocate for protocols involving incarcerated or formerly incarcerated individuals.
2. Every nondiscriminatory effort will be made to ensure that the IRB represents a mix of men and women.
3. The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
4. The IRB must include at least one external member not otherwise affiliated with the University and who has no immediate family affiliated with the institution.
5. No IRB member may participate in the initial or continuing review of any protocol in which the member has a conflict of interest, except to provide information requested by the IRB.
6. The IRB may invite individuals with competence in a special area to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
7. The IRB may invite a Primary Investigator to present additional information or to answer questions that may assist the IRB in its decision-making process regarding a protocol.

All IRB members are responsible for being informed on all IRB policies and procedures, and the Common Rule. In addition, IRB members must:

1. Attend regular monthly meetings during the academic year.
2. Review select expedited protocols on a rolling basis. Review closely all full-board protocols within the framework of ethical considerations, scientific merit, and adherence to Federal regulations and Seattle University IRB policies and procedures. Specifically, IRB members must work to ensure that:

a)      Risks to subjects are minimized;

b)      Risks to subjects are reasonable in relation to anticipated or potential benefits;

c)       Selection of subjects is equitable;

d)      Information given to participants as part of informed consent is in accordance with appropriate laws, regulations, and best-practice standards;

e)      Informed consent is obtained and documented, or waived in accordance with Federal and Washington State laws and regulations. (Research activities conducted in other states or countries must comply with the regulations for those specific research locations, accordingly.)

f)       The research protocol includes a plan for data and safety monitoring;

g)      Subjects’ privacy and confidentiality are protected; and

h)      Appropriate additional safeguards are incorporated for any vulnerable populations.

In collaboration with the IRB Administrator, the board will also:

1. Notify investigators in writing of its decision to approve or disapprove the proposed research activity, or require modifications to secure approval. Any decision to disapprove a research activity must include in writing the reasons for its decision with reference to specific Federal guidelines for human subjects research (45 CFR 46), and provide the investigator an opportunity to respond.

2.       Conduct continuing review of approved research at intervals appropriate to the degree of risk, but not less than once annually (except for research classified as “Exempt”) and maintain authority to observe or have a third party observe the consent process and the research. Review proposed amendments, unanticipated problems or adverse events, and protocol deviations.

3. Determine if and when the IRB will:

a)      Require research progress reports;

b)      Audit and/or monitor the research and researchers for adherence to the Federal regulations and the SU policies and procedures, and review concerns from research subjects regarding the violation of their rights;

c)       Suspend or terminate approval of research found to be in non-compliance with IRB policy or Federal regulations, or that has been associated with unexpected harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional official, and other concerned parties.

In voting on IRB actions, a simple majority (half of quorum plus one) will typically prevail during meetings. However, in contraverted cases, the chair may require a super majority (three-fourths of quorum) to effect a decision.

Primarily, the IRB review process focuses on the ethical aspects of research; however, regulations also require the IRB to consider whether “the research design is scientifically sound and does not expose subjects to unnecessary risk.” Thus, the IRB may disapprove protocols in which flawed research design would create more than minimal risk to participants without yielding beneficial information.

In addition, if an approved research protocol raises possible concerns regarding institutional policy, values, or institutional liability, it may be forwarded to the Provost for further determinations, conditions, approval, or disapproval. The Provost may utilize institutional resources available to assist in the evaluation of the protocol prior to any determinations. The Provost will then notify the IRB Chair of any determinations, and the PI will be notified accordingly.