All research involving human subjects —including undergraduate honors college theses, and graduate theses and dissertations—must be reviewed for the protection of human subjects. The research must be approved by the Institutional Review Board before the research begins. The IRB—not the researcher—will apply federal regulations and Western Michigan University policy to determine if IRB oversight is required.
Federal regulations define “research” as “a systematic empirical investigation designed to develop or contribute to generalizable knowledge.” Federal regulations define “human subject” as “a living individual about whom an investigator conducting research obtains data through intervention or interaction, or identifiable private information.”
The new GDPR—General Data Protection Regulations go into effect on May 25, 2018. These regulations govern the collection of personal data from people physically located in the European Union (EU). As a result, research involving human subjects located in the EU will involve additional scrutiny to ensure GDPR compliance. The most important feature of this additional scrutiny will be securing informed consent for human subjects that complies with GDPR requirements. The OVPR and the HSIRB will work with the Office of the General Counsel to make sure that any collection of personal data for research purposes from persons in EU member states complies with GDPR requirements.
Common Rule Revisions Effective Jan. 21, 2019
Details of Common Rule changes as they effect WMU researchers.
Principal investigator responsibilities
The principal investigator is responsible for:
- The compliance of all co-investigators, student investigators and research associates with the IRB decisions, conditions and requirements.
Application for Initial IRB Review (as revised for Common Rule Jan 2019) - Reporting to the IRB any changes to the research protocol (e.g., research design of the study, recruitment procedures).
- Requesting renewal by completing the Application for Continuing IRB Review when contact with subjects will extend beyond the approval termination date.
- Reporting to the IRB chair any unanticipated adverse reactions or unanticipated events associated with the conduct of this research.
- Seeking clarification and advice from the HSIRB regarding ethical aspects of the research.
Committee oversight: The IRB is a local review board, established by the WMU 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.
WMU Policies
- Human Subjects Research Protection and the Institutional Review Board Policy
- Required Training for Human Subjects Researchers
- Research Subject Consent/Assent Document Approval Stamp Policy
- Registering with ClinicalTrials.gov Policy
WMU Procedures
- Identifying Risks
- Informed Consent Process
- IRB Common Practices
- IRB Info and Application Details
- IRB Process Map
- Recruitment of Human Subjects
Training requirements
All WMU personnel (faculty, staff and students) in their research are required to complete this CITI training program. Researchers must also complete any specific courses relevant to their research prior to the start of the project.
Human Subject forms
- Application for Initial IRB Review (as revised for Common Rule Jan 2019)—If a research project involves the collection of blood or blood products, additional questions must be answered and submitted with the IRB application form.
- Application for Continuing IRB Review
- Additional Investigators Form
- Class Research Project Form—to be completed and submitted by the instructor.
- Document Development Checklist
- Final Report Form
- Sample Consent and Assent Forms—to be customized by the researcher.
- Anonymous survey consent
- Assent of a child (7-12 years old)
- Assent of a child or ward (12-17 years or cognitively impaired)
- Permission of a parent or guardian (as revised for Common Rule Jan 2019)
- Anonymous online survey consent
- Template for Informed Consent Form (as revised for Common Rule Jan 2019)
- Template for Protocol Outline (as revised for Common Rule Jan 2019)
IRB meeting schedule
WMU IRB meetings are held at 8 a.m. on the third Wednesday of each month in the Emeriti Lounge, 211 West Walwood Hall, on East Campus. Details
Regulation links
- 21 CFR 50—the federal regulations governing human subject research that falls under the jurisdiction of the Food and Drug Administration.
- 21 CFR 56—the basic federal regulations governing institutional review boards under the jurisdictions of the Food and Drug Administration.
- 45 CRF 46—Subpart A is also known as the Common Rule because it serves as the federal regulations for 17 major federal agencies.
- Federalwide Assurance
- Office of Human Research Protections
Additional resources
- Ethical Principles—The three basic ethical principles that guide the HSIRB are respect for persons, beneficence and justice. They are derived from the Belmont Report.
- Declaration of Helsinke, by the World Medical Association (1964)
- Informed Consent Tips
- Nuremberg Code (1946)
Submit a concern
Use the WMU Reporting Hotline to submit concerns. Select “Make a Report” at the top of the page.
Contact
Julia Mays
(269) 387-8293
Associate Director Research Compliance