Research and Innovation

Human Subjects in Research

COVID-19 represents a new risk to research participants. Infection prevention requires a multi-layered approach. No one infection control plan or piece of personal protective equipment is 100% effective and similarly human subjects protections must occur at multiple levels across the University.

Human subjects research at WMU now allows in-person data collection, with all necessary precautions being followed.

The IRB is responsible for considering the risks and benefits for participants engaged in research and will evaluate whether risks to participants have been minimized, that the risks are reasonable in relation to anticipated benefits, and the importance of the knowledge that may reasonably be expected to result. In-person research activities that are approved require additional precautions at this time to protect both the participant and the research staff. As of July 6, 2021, the research restart plan is no longer required; however your IRB protocol for in-person data collection must include your safety plan and the procedures you will put in place to minimize the potential for transmission of COVID-19.

When feasible, all data collection that can be conducted remotely should be done so. WebEx can be used to replace face-to-face meetings or Qualtrics can be used to conduct surveys online instead of in person. Both are available to all WMU faculty, students, and staff.

WebEx provides; web conferencing, personal meeting rooms, screen sharing, interactive training environments, large-scale online events, and integration with W-Exchange email. The WebEx instance/subscription at WMU meets HIPPA requirements, a Business Associate Agreement has been signed which is critical in meeting compliance. The technology is in place for compliance, but how WebX is used is also part of compliance. For example, you can safely record sessions, but if you download and share that, that's outside of the WebEx environment and non-compliant. You also also need to take precautions to make sure unauthorized people don’t overhear any conversations you’re having via WebEx. Lastly users should use the “schedule a meeting option,” rather than “start a meeting,” just to be extra-sure that uninvited attendees do not enter the meeting. For security purposes, we highly recommend developing the habit of locking the room/meeting in both your personal room as well as scheduled meetings.

Qualtrics platform for survey design, features intuitive drag-and-drop tools, more than 100 question types, and pre-built survey templates.

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 went 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 ORI and the WMUIRB 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 affect 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.
Reporting to the IRB any changes to the research protocol (e.g., research design of the study, recruitment procedures) through a Cayuse Modification Submission.
Requesting renewal by completing the Renewal Submission through Cayuse when contact with subjects will extend beyond the approval termination date.
Reporting to the IRB chair and the associate director of research compliance any unanticipated adverse reactions or unanticipated events associated with the conduct of this research through the Cayuse Incident Submission.
Seeking clarification and advice from the WMU IRB regarding ethical aspects of the research.
Assuring all investigators on the project have completed the WMU IRB training on human research protections through the CITI program.

Committee oversight: The IRB is a local review board, established by the WMU Board of Trustees in accordance 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

WMU Procedures

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

Beginning November 1, 2021 all WMU IRB submissions must be done through Cayuse IRB using WMU credentials (Bronco Net ID). If the login fails and you receive a "Forbidden" response, you can request access.

Additional Investigators Form
Change in Principal Investigator
Sample Consent and Assent Forms—to be customized by the researcher.

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 Helsinki, by the World Medical Association (1964)
Informed Consent Tips

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
Director Research Compliance