Illinois IRB Overview
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Illinois IRB Overview
The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects [45 CFR 46.111]. In fulfilling these responsibilities, the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires, measures, and recruitment documents are examples of documents that the IRB reviews.
View IRB Authority, Jurisdiction, and Relationships
IRB members are appointed by the Vice Chancellor for Research and Innovation after consultation with the IRB chairs and OPRS director. IRB members serve staggered three-year terms and are responsible for being informed on all IRB policies and procedures and applicable laws and regulations. IRB members are expected to review all new cases, to review continuing cases of more than minimal risk and other cases as assigned, and to attend and vote at IRB meetings. The following requirements for the composition of an IRB are based on federal regulations (see 45CFR §46.107-108):
- To promote complete and adequate review of research activities commonly conducted by the institution, each University of Illinois at Urbana-Champaign Institutional Review Board (IRB) shall have at least five members with varying backgrounds. If an IRB regularly reviews research that involves a vulnerable category of subjects (such as children, pregnant women, prisoners, people with handicaps, or people with mental disabilities), consideration will be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
- Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or of women.
- Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
- Each IRB shall include at least one nonaffiliated 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.
- No IRB member may participate in the initial or continuing review of any project in which the member has a conflict of interest, except to provide information requested by the IRB.
- An 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.
- When reviewing cases involving the Food and Drug Administration (FDA)-regulated articles, at least one physician must be present and eligible to vote on the case.
CONFLICT OF INTEREST: BOARD MEMBERS
UIUC IRB Members are responsible for determining any potential or perceived conflicts of interest (COI) regarding protocols reviewed by the IRB. If you hold any of the following roles or relationships to a study undergoing IRB review, you are considered to have a potential or perceived conflict:
- Principal Investigator (PI) or researcher listed on the Research Team Attachment
- A supervisory role over a researcher listed on the study
- Involved in research utilizing a competing technology such that the ability to render an objective assessment is compromised
- Family member (spouse or child) or any close personal relationship with a member of the study team
- A relationship, financial or otherwise, with the sponsor of the study.
You are also considered to have a conflict when you or a member of your immediate family has any of the following:
- Involvement in the design, conduct, or reporting of the research with the following exception:
- An IRB member who is listed on an IRB protocol, but whose study activities are limited to (i) the performance of commercial services for the investigator (or performing other genuinely non-collaborative services meriting neither professional recognition nor publication privileges), while (ii) adhering to commonly recognized professional standards for maintaining privacy and confidentiality, is not considered to have a conflicting interest.
- Ownership interest, stock options, or other financial interest related to the research unless:
- The value of the interest does not exceed $5,000 when aggregated for the immediate family.
- The interest is publicly traded on a stock exchange.
- The value of the interest does not exceed 5% interest in any one single entity when aggregated for the immediate family.
- No arrangement has been entered into where the value of the ownership interests will be affected by the outcome of the research.
- Compensation related to the research unless:
- The value of the compensation does not exceed $5,000 in the past year when aggregated for the immediate family.
- No arrangement has been entered into where the amount of compensation will be affected by the outcome of the research.
- Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright, or licensing agreement.
- Board or executive relationship related to the research, regardless of compensation.
- Any other reason for which you believe that you cannot provide an independent review.
If You Think You Have a Conflict:
- If you are assigned a protocol to review and you have a potential conflict with the protocol, tell OPRS staff immediately.
- At the start of an IRB meeting, and prior to the beginning of the Board’s discussion of the protocol under review, if you realize you have a conflict, please let OPRS staff know. You may remain in the room for the general discussion of the protocol, however, you must leave the meeting before the Board’s deliberation and vote. Your absence from the room will be recorded in the minutes of the meeting.
The University of Illinois at Urbana-Champaign's Federalwide Assurance number is #00008584 and expires on 10/18/2022.