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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 51������.

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 51������, 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 51������ in connection with his or her institutional responsibilities.
• The research is conducted by or under the direction of any employee or agent of 51������ using any property or facility of 51������.
• The research involves the use of 51������’s non-public information to identify or contact human research subjects or prospective subjects.
• The research is a thesis, honors thesis, capstone or dissertation that involves human subjects. 

Note:

• Most funding organizations and foundations will not support a human subject research project until IRB approval has been received.
• Neither Lee Honors College nor the Graduate College will accept as a dissertation or thesis any research involving human subjects which was not reviewed and approved by the 51������ IRB prior to the research study being implemented and conducted.
• Journals and other publications often require the IRB approval letter for human subject research.
• 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

• Scientific basis for the project
• Study objectives
• Subject population(s)
• Methodology (study procedures)
• How data will be managed (data security plan)
• Evaluations and analysis plan
• Safety management and regulatory issues

The IRB must be assured that the application addresses the following areas. 

• ABSTRACT: Briefly describe the purpose of the study, the rationale, and the major design/methodologies

• PURPOSE/BACKGROUND INFORMATION: Provide the purpose of the study, the rationale, and a review of previously conducted research.  The information should be sufficient to allow the IRB to consider how the research is novel, place the proposed research in the context of previous research conducted, and consider the importance of the future findings.  If the proposed study is a student thesis or dissertation, this section should not be the complete review of literature from the thesis or dissertation document.  Lastly, this section should be written in a way individuals from a different academic discipline other than the proposed study can adequately consider the information presented.

• SUBJECT RECRUITMENT:  Describe in detail how you intend to contact and recruit participants.  Attach all written advertisements, posters, and oral recruitment scripts.

• INFORMED CONSENT PROCESS:  Describe the process by which informed consent will be obtained.  If the participant is a child or mentally challenged, explain how the parent(s)/guardian(s) will be contacted for consent and how the researcher will ensure that the participant comprehends and assents to the research. 

• RESEARCH PROCEDURE: Describe the method of data collection, instrumentation, location of data collection, and duration of the study.  Describe exactly what subjects/participants will do as part of the study.

• METHODOLOGY: Describe the design, analysis, and dissemination (e.g., thesis, dissertation, peer-reviewed journal, presentation).

• RISKS AND COSTS TO AND PROTECTIONS FOR SUBJECTS:  Describe the nature and likelihood of possible risks (e.g., physical, psychological, social, economic) so far as they are known.  Risks include mild discomforts, inconveniences, and potential for disclosure of sensitive information. Describe measures to be taken to protect subjects from possible risks or discomforts.  If there are no known risks indicate.

• BENEFITS OF RESEARCH: Briefly describe the expected or potential benefits of the research. Indicate benefits specific to the research participant, long term or more general benefits, and benefits to the knowledge base. If there are no direct benefits to the subjects/participants, please indicate. 

• CONFIDENTIALITY OF DATA:  Describe precautions to ensure the privacy of subjects and confidentiality of information.  Be explicit if data are sensitive.  Describe coding procedures for subject identification.  Include the method, location, and duration of data retention.  (Federal regulations require data to be maintained for at least 3 years after the study closes.  51������ policy requires this to occur at 51������). Your professional society may require you to keep it longer.

• FUTURE USE OF DATA:  Describe how data from this study may be used for future research and/or sharing of data and specimens with another institution. (Required under 45 CFR 46).

• APPENDICES:  Attach questionnaires, interview scripts, and data collection instruments, etc.  Attach coding sheets for videotapes or audiotapes and other data collection procedures. Attach a copy of all consent/assent documents, including non-English and Braille translations, if applicable.

 All research involving human subjects must be reviewed by the 51������ 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.

Application criteria

All 51������ IRB submissions must be completed using Cayuse, an online IRB protocol management system.  Researchers may access using their 51������ Credentials.

Note:  Students are not automatically given access to Cayuse.  If login fails and a “Forbidden” response is received, you can request access.

The Principal Investigator on a human subject research study must meet the criteria established under 51������ policy found at     /policies/human-subjects-research-protection.

4.1.3. Principal Investigator (PI): Primary responsibility for research with human subjects is vested in the principal investigator conducting a study. This includes responsibility to comply with the laws, regulations, and institutional policies that regulate research. Others engaged in the conduct of the research such as co-investigators and research staff share this responsibility.

• 4.1.3.1. The following are eligible to serve as PI:
• 4.1.3.1.1. Tenured/tenure track faculty
• 4.1.3.1.2. Faculty specialists
• 4.1.3.1.3. Full time professional staff on permanent appointment with 51������ that have appropriate credentials (less than full time permanent appointments are at the discretion of the 51������ IRB)
• 4.1.3.1.4. Research Scientist (at the discretion of the 51������ IRB)
• 4.1.3.1.5. Emeritus Faculty (with department appointment and at the discretion of the 51������ IRB
• 4.1.3.2. The following are not eligible to serve as PI:
• 4.1.3.2.1. Students may not serve as the principal investigator on a human research study.
• 4.1.3.2.2. Part-time faculty, adjuncts, research associates, visiting professors, and visiting scholars are not eligible to serve as the principal investigator; however, they may serve as a Co-Investigator on a human research study.

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, Expedited and Exempt. Research in all three categories must be submitted to the IRB for review.

Full board

Research not covered under the Exempt or Expedited review categories will be referred to the Full review.  A protocol may require a full board review because it presents more than minimal risks to subjects.  If identification of the subjects and their response may 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 does not qualify for an expedited review and a full review is required.

Full protocols must be submitted by the first Wednesday of the month to be reviewed at the IRB meeting held on the 3^rd Wednesday of the month, to allow adequate time for board members to read the proposal.  Investigators will be invited to attend the meeting.

The IRB meeting is not intended for investigators to defend their research, protocol or methodology; however, they may be asked to provide clarification or answer questions related to their protocol to assist the IRB in the review. 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 from 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

Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited do not require a convened committee meeting.  Expedited review is performed by the IRB chair, or one or more experienced IRB reviewers designated by the chair from among the members of the IRB.  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 full committee at a convened IRB.

All protocols approved under the expedited review procedure are reported to the full board at the next convened meeting. 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 full board has the right to reverse the expedited approval.

The following categories of research are eligible for expedited review, except as noted:

Summary of Expedited Categories:

1. Clinical studies of drugs and medical devices only when certain conditions are met
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.

6.     Collection of data from voice, video, digital, or image recordings made for research purposes.

7.     Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

8.     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.

9.      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.

10. 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.
11. Minor changes in previously approved research.
12. Other categories added to this list by DHHS and published in the Federal Register.

Any board member may request that an expedited 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.

Exempt

To qualify for review under the exempt category, the research must not be greater than minimal risk* and must fall into one or more of the exempt categories described below.  The IRB chair or vice chair will review the research protocol to make this determination. Exempt research at 51������ requires a protocol submission and IRB approval prior to implementing the study.

*Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

The following categories of research are eligible for exempt review, except as noted:

1. Educational settings involving normal educational procedures.
2. Educational tests, survey procedures, interview procedures or observation of public behavior unless: a) subjects can be identified and b) such disclosure results in risk.
3. 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.
4. Study of existing data or records if: a) sources are publicly available or b) subjects cannot be identified.
5. Federally funded research and demonstration projects designed to study public benefit or service programs.
6. Taste and food quality evaluation and consumer acceptance studies.

The IRB chair or vice chair makes the initial decision about what type of review is necessary, the IRB may request more extensive review.

Notification of decisions

The 51������ IRB decisions, conditions, and requirements are generated by Cayuse IRB and delivered to the researcher's 51������ email address.  If revisions are required researchers must edit their Cayuse submission.

Researchers will be 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 51������ may choose not to permit research that the IRB has approved; however, they may not permit research that the IRB has disapproved to be implemented. Final authority to approve a human subject research protocol rest with the 51������ IRB.

IRB meeting schedule and application instructions

Contact

Julia Mays
(269) 387-8293
Director of Research Compliance