IRB Policy 250 - Full Board Review

Effective date: April 11, 2026 (revised version; originally adopted on October 08, 2021)

I. Policy Purpose 

This policy establishes the requirements and procedures for the full Institutional Review Board (IRB) review of research involving human participants that does not qualify for exempt or expedited review status. This policy ensures compliance with applicable federal regulations and the ethical principles of the Belmont Report. It applies to all SIUC faculty, staff, and students conducting human subjects research.

II. Policy Definitions 

Designated Reviewer refers to the IRB Chair or an IRB member appointed by the Chair to conduct reviews on behalf of the IRB. A designated reviewer may not disapprove research and must refer any research they cannot approve under an applicable review category to a convened meeting of the IRB. 

Full Board Review is a procedure in which prospective research is evaluated by a convened meeting of the IRB with a quorum present. Full board review is required for research involving more than minimal risk and for any research that does not qualify for exempt or expedited review.  

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  

Quorum means a majority of the IRB members, including at least one scientist and one non-scientist member, required to be present at a convened meeting before the IRB may conduct review of research. 

Vulnerable Population means groups requiring additional protections under federal regulations, including minors, pregnant persons, prisoners, and individuals with diminished decision-making capacity.

III. Policy Statement 

Research involving human participants that does not qualify for exempt or expedited review must undergo full board review. The primary criterion for full board review is the degree of risk to participants, including not only the research procedures themselves but also the interaction between those procedures and the populations studied. 

The IRB may require full board review of any research it determines warrants full board consideration, including research initially submitted for exempt or expedited review.

IV. General Procedures 

A. Submission and Initial Review 

Investigators must submit a complete application to the IRB, including copies of all study materials (e.g., protocol, informed consent documents, survey instruments, interview guides, recruitment scripts, and any other relevant materials) at least 10 business days prior to the scheduled meeting. The ORC will confirm receipt of a complete submission, schedule the application for review at the next convened meeting, and provide members with a copy of all study materials. 

Investigators must receive written approval from the IRB before beginning any research activities involving human subjects. The ORC will document all determinations in its records and inform investigators of the IRB's findings and actions in writing.

B. Convened Meeting and Quorum 

Full board review requires a convened meeting of the IRB with a quorum present. A quorum consists of a majority of IRB members, including at least one scientist and at least one non-scientist member. If quorum is lost during a meeting, review of any remaining applications must be postponed and rescheduled. 

IRB members with a conflict of interest in a research application must recuse themselves from the review, discussion, and vote on that application and may not count toward quorum for that application. IRB members are responsible for proactively disclosing potential conflicts to the IRB Chair prior to review.  

The IRB may convene meetings in person or through videoconferencing or other equivalent mechanisms. Proxy votes are not permitted. 

The ORC will prepare and maintain minutes of all convened meetings in accordance with 45 CFR 46.115, including documentation of attendance, actions taken, voting results, and a written summary of the discussion of controverted issues and their resolution.

C. Criteria for IRB Approval 

Before approving a research application, the IRB must determine that all of the following criteria are satisfied:

• Risks to participants are minimized through procedures consistent with sound research design that do not unnecessarily expose participants to risk, and, where appropriate, by using procedures already being performed on participants for diagnostic or treatment purposes.
• Risks to participants are reasonable in relation to anticipated benefits to participants and to the importance of the knowledge that may reasonably be expected to result from the research.
• Participants are selected equitably, and recruitment procedures are free of coercion or undue influence.
• Informed consent will be sought, and documented, from each participant or legally authorized representative in accordance with applicable federal regulations and institutional policy, unless an appropriate waiver or alteration has been justified.
• The research implements appropriate safeguards to protect the privacy of participants and the confidentiality of identifiable information.
• Where appropriate, the research includes adequate provisions to monitor data collected to ensure the safety of participants.
• When some or all participants are likely to be vulnerable to coercion or undue influence, additional safeguards are included to protect their rights and welfare in accordance with applicable federal regulations, including 45 CFR 46 Subparts B, C, and D.

D. Review Outcomes 

The IRB will make one of the following determinations regarding each application reviewed at a convened meeting. Research may not be approved unless a majority of voting members present at the convened meeting vote in favor of approval. 

Investigators who wish to appeal an IRB determination should refer to Policy 320.

E. Modifications to Approved Research 

Investigators must submit proposed changes to approved research to the IRB before implementation, except when changes are necessary to eliminate an apparent immediate hazard to participants. Investigators must report any such emergency changes to the IRB promptly. 

Changes that increase risk to participants or otherwise affect the basis for IRB approval require full board review. A designated reviewer may review minor changes (e.g., updating recruitment materials that do not change the study scope, adding a co-investigator with appropriate qualifications). Minor administrative changes (e.g., typographical corrections that do not alter meaning or scope) do not require resubmission but should be documented by the investigator and disclosed at the time of any subsequent continuing or modification review. See Policy 270 for amendment procedures.

F. Approval Period and Continuing Review 

The IRB grants approval for a period of one year from the date of the convened meeting. Based on the degree of risk or risk-to-benefit ratio, the IRB may specify a shorter approval period or require progress reports at specified intervals. 

Continuing review is required at least once per year and is conducted at a convened meeting of the IRB. Investigators must submit a request for continuing review confirming that the study remains active, that no unanticipated problems have occurred, and that the research complies with the approved protocol, applicable federal regulations, and institutional policies. 

A designated reviewer may conduct continuing review when one of the following conditions is met:

• The research is permanently closed to enrollment, all participants have completed all research-related activities, and the study remains active only for long-term follow-up.
• No participants have been enrolled and no additional risks have been identified.
• The remaining research activities are limited to the analysis of identifiable data or records. 

If approval expires before continuing review is completed, investigators must immediately cease all activities involving human subjects and obtain new approval before resuming any activity involving participants, including recruitment. The ORC will document and inform the IRB of all continuing review determinations.

G. Reporting and Records  

Investigators must promptly report any of the following to the IRB in accordance with applicable institutional policies:

• Unanticipated problems involving risks to participants or others.
• Adverse events or unexpected harm to participants.
• Breaches of confidentiality or data security incidents.
• Instances of noncompliance with the approved protocol or institutional requirements 

The IRB evaluates all reports in accordance with applicable policies. 

Research records must be retained in accordance with all applicable institutional and federal requirements.