The Institutional Review Board is a local review board, established by the Western Michigan University Board of Trustees in accord with federal regulations, to interpret and apply federal regulations, state law, and research sponsor requirements for the use of human subjects in research. The IRB is charged with the protection of the rights and welfare of human subjects in research conducted under the aegis of WMU.
When to contact the IRB for review
The IRB reviews research involving human subjects if one or more of the following apply:
- The research is sponsored by WMU, regardless of the location of the project.
- The research is conducted by, or under the direction of, any staff, faculty, student or other agent of WMU in connection with his or her institutional responsibilities.
- The research is conducted by or under the direction of any employee or agent of WMU using any property or facility of WMU.
- The research involves the use of WMU’s non-public information to identify or contact human research subjects or prospective subjects.
- The research is a thesis or dissertation that involves human subjects. Neither Lee Honors College nor the Graduate College will accept as a dissertation or thesis any research involving human subjects which was not reviewed by the IRB prior to the research being conducted.
Note: Most funding organizations and foundations will not support a research project until IRB approval has been received.
Note: Special consideration is required for research involving fetuses, pregnant or lactating women, human ova in vitro fertilization, prisoners, children, persons with cognitive impairment, or other potentially vulnerable groups.
Components of IRB review
The IRB must be assured that the application addresses the following areas.
- Project description: Include purpose, procedure, research design, location, and duration.
- Benefits of research: Indicate specific benefits to the subjects as well as more general benefits.
- Subject recruitment: Describe how participants will be contacted and recruited.
- Risks to subjects: Describe potential physical, psychological, and social risks, including discomforts or inconveniences.
- Protection for subjects: Describe how subjects will be protected from possible risks.
- Confidentiality of data: Describe how the privacy of subjects and confidentiality of information will be protected.
- Instrumentation: Include all questionnaires, interview scripts, and data collection instruments.
- Informed consent: Describe how informed consent will be obtained.
All research involving human subjects must be reviewed by the IRB. A flowchart has been developed to help researchers determine whether their project involves human subjects. If researchers are unsure whether their project involves human subjects, they should contact the research compliance office.
There are four parts to the WMU IRB submission:
- All sections of the Application for Initial IRB Review must be completed. WMU policy requires the principal investigator to be a 3/4 time or full-time faculty or staff member.
- A protocol that includes a complete description of the proposed research in non-technical language using this Template for Protocol outline.
- Consent and Assent Documents, in accordance with the Consent Document Development Checklist on Page 3 of the application form. Use the Sample Consent and Assent Forms templates at http://www.wmich.edu/research/forms/#compliance. All documents appropriate to the proposed research should be included. Consent and Assent Documents are written in the 2nd person and should be written in simple, non-technical language that can be easily understood by the prospective subjects. A written justification is required for all items excluded.
- Copies of all recruitment materials-including scripts, letters, or other documentation of what will be communicated during recruitment-questionnaires, interview protocols, assessment materials, experiment session outlines, and descriptions of materials that subjects will encounter. Commonly used tests and inventories, such as the Wechslers or Stanford-Binet intelligence tests and the MMPI personality inventory, need not be submitted.
Approval will be delayed for IRB applications that do not carefully attend to the application checklist and consent checklist. Please do not submit existing research, dissertation or thesis proposals in lieu of IRB applications.
See the IRB Meeting Schedule for details on how and where to submit application.
Categories of review
The Department of Health and Human Services defines three categories for IRB review: full board, expedited and exempt. Research in all three categories must be submitted to the IRB for review.
A protocol may require a full board review because of the level of risk to participants. The full board must review research where identification of the subjects and their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or would be stigmatizing or are greater than minimal risk or minimal risk but do not qualify for expedited.
Protocols must be submitted to the IRB office two weeks before the meeting date to allow adequate time for board members to read the proposal. The deadline for submission of a full board protocol is usually by 5 p.m. on the first Wednesday of each month.
If additional information from investigators is required requests shall be made prior to the meeting. Investigators will be invited to attend the meeting and may be asked to provide clarification or answer questions related to their protocol. The IRB meeting is not intended for investigators to defend their research, protocol or methodology. Meetings are scheduled for the third Wednesday of each month. At convened meetings of the board, proposals are approved, approved with revisions, or disapproved.
- A protocol may be distributed to a consultant or expert to advise the board in its review of a protocol.
- A quorum, constituted of a majority of IRB members, is required to convene a full board meeting, with at least one member of that quorum representing social and ethical non-scientific concerns.
- A protocol can be approved after receiving the approval of the majority of those members present at the convened meeting.
- The IRB at a minimum will conduct annual reviews of approved research. It is the responsibility of the researchers to inform the IRB of any changes in research design, adverse events, and to request annual renewal of IRB approval, if necessary.
Full board review process takes one month or longer and usually requires revisions. Full board approval indicates that although the research might involve risk to subjects, it is likely to make an important scientific contribution to a field of study.
Expedited review is performed by the IRB chair, or one or more experienced reviewers designated by the chair from among the members of the IRB. All protocols approved under the expedited review procedure are reported to the full board at the next convened meeting.
In conducting expedited review, the IRB reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research. A research activity may be disapproved only after review by the convened IRB. The full board has the right to reverse the expedited approval.
The following categories of research are eligible for expedited review, except as noted:
- Clinical studies of drugs and medical devices only when:
- Research on drugs for which an investigational new drug application is not required.
- Research on medical devices for which (i) an investigational device exemption application is not required or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows:
- From healthy, non-pregnant adults weighing at least 110 pounds with a total volume collected not exceeding 550 ml in an eight-week period and collection occurring no more frequently than twice per week.
- From other adults and children, considering the age, weight and the health of the subject, the collection procedure, the volume of blood to be collected, and frequency with which it will be collected not exceeding the lesser of 50 ml or 3ml/kg in an eight-week period and collection occurring no more frequently than twice per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves.
- Research involving materials (data, documents, records or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis) in a confidential manner.
- Collection of data from voice, video, digital or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or confidential research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB as follows:
- Where (i) the research is permanently closed to the enrollment of new subjects, (ii) all subjects have completed all research-related interventions, and (iii) the research remains active only for long-term follow-up of subjects.
- Where no subjects have been enrolled and no additional risks have been identified.
- Where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories No. 2-8 above do not apply but the IRB has determined and documented at a convened meeting that the research involves no more than minimal risk and no additional risks have been identified.
- Minor changes in previously approved research.
- Other categories added to this list by DHHS and published in the Federal Register.
IRB members participating in expedited review can either approve the research as expedited or refer it for full board review. At the next full board meeting the IRB chair shall inform members of research protocols that were approved as expedited. Any board member may request that the research project be re-reviewed by the full board. Members shall then vote on the request with a majority deciding the issue.
The expedited review process requires a minimum period of 10 days following receipt of an appropriately completed protocol by the IRB office.
Research that meets certain conditions may qualify for exemption from certain federal regulations. The IRB chair or vice chair will review the research protocol to make this determination. Exempt research at WMU requires a protocol submission and IRB approval prior to implementing the study.
The following categories of research are eligible for exempt review, except as noted:
- Educational settings involving normal educational procedures.
- Educational tests, survey procedures, interview procedures or observation of public behavior unless: a) subjects can be identified and b) such disclosure results in risk.
- Educational tests, survey procedures, interview procedures or observation of public behavior not exempt or under (2) if subjects are public officials or where confidentiality is required by federal law.
- Study of existing data or records if: a) sources are publicly available or b) subjects cannot be identified.
- Federally funded research and demonstration projects designed to study public benefit or service programs.
- Taste and food quality evaluation and consumer acceptance studies.
The IRB chair makes the initial decision about what type of review is necessary, the IRB may request more extensive review.
Notification of decisions
The IRB sends written notification to researchers regarding IRB decisions, conditions and requirements.
Researchers are also informed if the IRB votes to disapprove a research protocol. The written notification to disapprove a protocol will include a statement indicating the reasons for the IRB decision and give the principal investigator an opportunity to respond. The principal investigator may appeal the decision in writing only. Disapproval appeals are reviewed by the full board at the next convened meeting. After review of the appeal materials the IRB will vote on the disposition of the protocol. If the IRB upholds its vote to disapprove the decision may not be appealed again.
Administrative officials of WMU may choose not to permit research that the IRB has approved; however, they may not permit research that the IRB has disapproved. Final authority to approve a human subject research protocol rest with the IRB.
Associate Director of Research Compliance