Introduction to Institutional Review Boards at Michigan State University

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• Section 1. Institutional Review Boards (IRBs)
• Section 2. MSU's IRBs
• Section 3. Definitions
• Section 4. Examples of Research with Human Subjects
• Section 5. Information Available at the Human Research Website
• Section 6. Contact Information

Section 1. Institutional Review Boards (IRBs)

Federal regulations and University policies require that all research involving human subjects be reviewed and approved by the University's Institutional Review Board before initiation to protect the rights and welfare of those human subjects.

Institutional Review Board's primary responsibility is to protect the rights and welfare of human subjects. They are also required to review and approve protocols against the following criteria:

• Procedures and research design do not unnecessarily expose subjects to risks.
• Risks to subjects are reasonable in relation to anticipated benefits, if any.
• Selection of subjects is equitable, taking into account special considerations for research involving vulnerable populations (e.g., pregnant women, prisoners, handicapped persons, etc.)
• Informed consent will be sought from each prospective subject or subject's guardian.
• Informed consent will be documented in writing (except in special circumstances).
• Where appropriate, adequate provisions are in place to monitor the collected data to ensure safety of subjects.
• Adequate provisions are in place to protect the privacy of subjects and maintain confidentiality of data.

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Section 2. MSU's IRBs

Michigan State University has three IRBs:

• Biomedical and Health institutional Review Board (BIRB)
• Community Research Institutional Review Board (CRIRB)
• Social Science/Behavioral/Education Institutional Review Board (SIRB)

The MSU IRBs review applications for research involving human subjects in keeping with ethical principles and federal regulations for the protection of human subjects, including regulations from the U.S. Department of Health and Human Services, the Food and Drug Administration, and other federal agencies.

The BIRB and SIRB are peer review committees, comprised of MSU faculty members, members unaffiliated with the University, a representative from the Office of the Vice President for Student Affairs and Services, a legal representative and a graduate student.

The CRIRB is a peer review committee comprised of members from MSU-East Lansing, the community campuses of MSU and IRBs from affiliated hospitals and institutions. The CRIRB reviews collaborative, multi-community research projects.

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Section 3. Definitions

Research means a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR 46.102(d)

Human Subject is defined as a living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. 45 CFR 46.102(f)

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving a human subject.

For projects to which FDA regulations and policies apply:

Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies. 21 CFR 50.3(c)

Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. 21 CFR 50.3(g)

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Section 4. Examples of Research with Human Subjects

• Interviews
• Telephone or mail surveys
• Behavioral or educational testing
• Observation of individual or group behavior
• Collection of blood or other biological samples
• Existing data (e.g., surveys, biological materials, medical records)
• Master theses and Ph.D. dissertations

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Section 5. Information Available at the Human Research Website

• Overview of MSU IRBsincluding the IRB mission statement and frequently asked questions.
• Applications for MSU IRBs, including the online IRB application system (for initial, renewal, and revision applications). Also available: forms for closure, unanticipated problems, and adverse events, instructions and reviewer materials.
• Education for investigators or other interested individuals including the online tutorial. Information for open forums and IRB conferences is also posted.
• Regulations and Guidelines such as applicable federal and state guidelines and the Human Research Protection Manual of IRB and University policies are available.
• HIPAA information is provided, such as the HIPAA regulations and the MSU Research Privacy Board information.
• Recent News of MSU IRBs including changes in procedures and announcements.
• Participants information such as a brief history, clinical trial information and information for kids are available for all interested individuals.
• Contacts lists the contact for the programs within Office of Regulatory Affairs, such as the MSU IRBs and ORA.
• Links includes many useful links to the Office for Human Research Protections website, the Office of Research Integrity website and other research related websites.

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Section 6. Contact Information

The IRB office is located at 202 Olds Hall, East Lansing, MI 48824-1047. Office hours are 8:00A.M. - 5:00 P.M. Monday - Friday. The IRB may be contacted by phone: (517) 355-2180, fax: (517) 432-4503 or email: irb@msu.edu. The website is http://www.humanresearch.msu.edu.

Investigators and participants are encouraged to contact IRB staff with any questions, concerns or suggestions. Investigators do not need to schedule an appointment to speak with an IRB staff member regarding any questions they may have regarding the MSU IRBs or the review process.

The IRB Chair is also available to meet with faculty, research staff, students or participants to discuss any questions, concerns or comments. The Chair may act as a liaison between investigator or participants and the IRB, bringing concerns of the investigators or participants to the Committee's attention.

If you would like more information about human subject research protections or want someone from the MSU Office of Regulatory Affairs to give a presentation to your group, please call Kristen Burt, Educational Program Coordinator, at (517) 884-6020 or send an email to burtkris@msu.edu.

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