Human Subjects in Research

Link to current COVID-19 information as it relates to WMU researchers.

Detailed COVID-19 answers to the question of human subject interactions.

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 is reopening in phases, with all necessary precautions being followed.

All human subject research that can be conducted remotely should continue to be conducted remotely. Those professional service relationships (e.g., clinical services, practicums, etc.) where research would not add any additional risks to participants in a study, in-person studies are allowed.

The IRB suggests revising your protocol to hold your study visits remotely, if feasible, using WebEx to replace face-to-face meetings or Qualtrics 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 WebXx 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 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.

Starting March 1, 2020 all Human Subject IRB submissions must be emailed to ovpr-hsirb@wmich.edu. In addition, IRB forms must be used (application, protocol outline template, consent document(s) templates) and can be found below.

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

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

Starting March 1, 2020 all Human Subject IRB submissions must be emailed to ovpr-hsirb@wmich.edu. IRB forms must be used (application, protocol outline template, consent document(s) templates).

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
Change in Principal Investigator
Class Research Project Form—to be completed and submitted by the instructor.
Final Report Form
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