About IRBs

This page provides a brief overview of Institutional Review Boards (IRBs). For Frequently Asked Questions about the MSU IRB review process, please click here.

What is an IRB?
What is an IRB's composition?
Why is an IRB needed?
What is the authority of the IRB?
Are there different types of IRB review?
When is IRB review required?

What is an IRB?

An IRB is an institutional review board, established to review proposed human subject research. The IRB may approve, require modifications in (to secure approval), or disapprove research. At MSU, all human subject research (regardless of funding) must be reviewed and approved by an IRB before initiation.

At MSU, there are three IRBs:

What is an IRB’s composition?

An IRB must have at least five members, with diversity and varying backgrounds, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes. The IRB must include a member with a nonscientific background and a member nonaffiliated with the institution.

Members of MSU’s IRBs are nominated by deans and others and appointed by the Vice President of Research and Graduate Studies. IRB members include faculty from each of MSU’s colleges, MSU graduate students, members from CRIRB partner institutions, and non-affiliated, community members. For more information about MSU IRB composition, please visit section 5-3, “IRB Membership,” of the HRP Manual.

Why is an IRB needed?

Federal regulations, accreditation standards, institutional policies and MSU’s Federal Wide Assurance requires that an IRB review all proposed human subject research, regardless of funding, prior to the initiation of the research. The IRB’s purpose is to protect the rights and welfare of the potential research subjects by examining areas such as risks and benefits, informed consent, selection of subjects, privacy, confidentiality and anonymity.

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What is the authority of the IRB?

The authority of MSU IRBs is described in Section 4-2, “Authority of IRBs,” of the HRP Manual.

Are there different types of IRB review?

Yes, there are three “types” of IRB review: exempt, expedited and full review. The following section provides a short description of MSU IRBs’ procedures with reference to the appropriate sections of the HRP Manual.

What is exempt review?

Federal regulations identify specific categories of research activities that are exempt from the federal regulations on the protection of human subjects in research. It is important to note that while a project may be exempt from the regulations, the ethical principles of conducting research with humans still apply. At MSU, the investigator may not make the determination of exempt status. To request exempt status, investigators should submit an initial application to the IRB office selecting exempt as the category of review. The IRB staff will review the application and make the determination, consulting with the chair of the IRB, or the chair’s designate, as appropriate. If the project is exempt, IRB staff will send the investigator a PI Assurance document. Once the PI Assurance document is signed and returned to the IRB office, the exempt determination can be finalized, and an exempt determination letter may be issued. For more information on exempt research, please visit section 8-1, “Exemptions,” of the HRP Manual.

What is expedited review?

Federal regulations identify specific categories of research activities that may undergo an expedited review. The review may be conducted by the “IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB” (45 CFR 46.110(b), 21 CFR 56.110(b)). At MSU, two members are assigned to review expedited initial applications. Once both members approve the project, an approval letter may be issued. An expedited review procedure may also be used for minor changes in previously approved research during the period (of one year or less) for which approval is authorized. For more information on expedited review, please visit section 8-2, “Expedited Review Procedure,” of the HRP Manual.

What is full review?

Full review is required for initial applications that are not eligible for exempt or expedited review, initial applications that involve more than minimal risk, revisions that are non-minor changes, renewals of projects that initially required full board and disapproval of a project, regardless of review level. Prior to convened IRB review, a primary review procedure is used for full review projects. It is important to note that while a primary review procedure is used, in order for the research to be approved, a majority of members present at the convened IRB must vote for approval of the research project. For more information on full review, please visit section 8-3, “Full Review Procedure,” of the HRP Manual.

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When is IRB review required?

IRBs are required to perform initial and continuing review of human subject research. At MSU, proposed research projects involving humans must be reviewed and approved by an IRB (or determined to be exempt by the IRB office) prior to initiation of the research. After initial approval, continuing review (i.e. review of revisions, renewals, closures, and unanticipated problems that may involve risks to subjects or others) is also required. For definitions of “human subject” and “research,” please visit section 4-3, “Determination of Human Subject Research,” of the HRP Manual. For Frequently Asked Questions about theses processes at MSU, please click here.

What are revisions to an approved project?

Any proposed change or revision to an approved expedited or full review project that affects human subjects (with certain limited exceptions discussed below), must be reviewed and approved by the IRB prior to implementation of the change. When an immediate change in either a therapeutic or non-therapeutic research protocol is necessary to eliminate a hazard to subjects, the proposed change need not be reviewed by the IRB prior to its implementation. In such situations, however, investigators must report the change in protocol immediately thereafter to the MSU IRB. For more information on revisions, please visit section 8-6, “Revisions to an Approved Project,” of the MSU HRP Manual. For exempt research, minor changes that do not affect the exempt status may be made to the project. Investigators should contact the IRB office with any questions on whether a change affects the exempt status. For more information on exempt research and revisions, please visit section 8-1, “Exemptions,” of the HRP Manual.

What are renewals?

Under federal regulations, IRB approval is valid for a maximum period of one year. For expedited or full review projects, investigators who need to continue research, including data collection and analysis, beyond the expiration of IRB approval must submit and receive approval for renewal prior to the project’s expiration. The approval period will be listed on approval letters sent to investigators, including both the approval date and the expiration date. For more information on renewals, please visit section 8-7, “Renewed Approval,” of the HRP Manual. For exempt research, the project does not to be renewed. However, the IRB office will check in with investigators to determine if the project is ongoing three years after the exempt determination. For more information on exempt research and renewals, please visit section 8-1, “Exemptions,” of the HRP Manual.

What are closures?

As part of continuing review, a closure form must be submitted to the IRB when a project (exempt, expedited or full review) is complete (i.e., when data collection, follow-up and analysis are complete).

What are unanticipated problems involving risk to subjects or others?

Investigators must report all unanticipated problems that may involve risk to subjects or others to the MSU IRB (this includes exempt research). Any unanticipated problem that also constitutes an adverse event should also be reported to the IRB. The IRB chair, in consultation with the IRB, determines whether the reported unanticipated problem involved risks to subjects or others, whether the investigator satisfactorily resolved the problem, and whether corrective/protective actions are required. Unanticipated problems determined to involve risk to subjects and others will be reported to appropriate officials and government agencies pursuant to Section 4-8, “Reporting Policy,” of the HRP Manual. For more information on unanticipated problems, please visit section 9-1, “Unanticipated Problems,” of the HRP Manual.

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