Compliance

Human Subjects Institutional Review Board (HSIRB)

General Questions about HSIRB


All research involving human subjects must be submitted to HSIRB, even if you believe it is exempt from federal regulations. The HSIRB—not the researcher—determines if review 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.”

Since 1972, University policy has required that all research be reviewed regardless of funding source. If human subject data will be aggregated, analyzed, or summarized for publication (whether inside or outside the University), it requires HSIRB submission and review.

Who is eligible to be a principal investigator?
Any full-time faculty or staff employee of WMU may serve as a Principal Investigator. Students may serve as Student Investigators but not as Principal Investigators. Adjunct or part-time faculty may serve as Co-Principal Investigators, at the discretion of the Principal Investigator.

What are the levels of review?
Federal regulations divide human subject research into categories based on the level of risk to which subjects will be exposed by participating in the research. University policy uses two categories—expedited review and full board review:
Research that can be reviewed by an expedited process poses no more than minimal risk to the subject and falls into at least one of the federally defined categories. Examples include: research in educational settings; anonymous surveys; surveys collecting information that is not sensitive; analysis of voice recordings (e.g., of speech defects); studies involving moderate exercise; studies of existing data; and research on individual or group characteristics or behavior. Additional examples can be found on the web site in the "Guidelines for Human Subject Research at WMU".

Research that requires full board review may expose the subjects to greater than minimal risks. These research protocols will be reviewed by the full board at a convened meeting.

How do I submit a protocol for HSIRB review?
All of the information and forms you will need to apply for HSIRB review are available on this web site.

Complete the on-line application form, print it, and obtain the necessary signatures. Submit the original application form, the research protocol outline, all recruitment materials, consent/assent documents, and research instruments to: The Research Compliance Coordinator, 251W Walwood Hall, Mail Stop 5456. If the research will be conducted at a site other than WMU, a letter from officials at each research site granting permission to conduct the research must be included.

How many copies of the protocol do I have to submit and what are the deadlines?
Applications submitted for expedited review must include the original form and one copy of all of the materials. There are no deadlines for expedited submissions. They are reviewed on a continuous basis.

Applications submitted for full board review must include the original and 15copies of all of the materials. The submission deadlines for full board review (always the first Wednesday of the month) are listed at this website.

When can I begin data collection?
No research or subject recruitment may begin until HSIRB has given your research protocol full approval with no revisions. The first review of an expedited review may take 10 days or longer. You will probably be asked to make some revisions after your protocol has been reviewed. If you make all the revisions requested, the second review of your research should only take a day or two. A full board review can take one month or longer.

Can I change my protocol once it has been approved?
All changes in a research protocol must be approved before the change is incorporated into the protocol. Change requests should be submitted to the HSIRB office in memo form. Please include the protocol number (assigned at the time of initial review) to speed processing.

How do I extend the approval period?
If data collection or data analysis will extend beyond the termination date listed on the approval letter, complete the on-line “Project Approval Review Form” and submit it to the research compliance coordinator. Include any changes and adverse (or unanticipated) events not yet reported to the HSIRB.

Where do I submit my application?

Mail to: Research Compliance Coordinator
Office of Vice President for Research
1903 W. Michigan Ave.
Western Michigan University
Kalamazoo, MI 49008-5456

Or drop off at 251W Walwood Hall (East Campus)

Questions?
Research Compliance Office
Telephone: (269) 387-8293
Fax: (269) 387-8276
Email: research compliance coordinator

 
Office of the Vice President for Research
Western Michigan University
210 W Walwood Hall
Kalamazoo, MI 49008-5456 USA
(269) 387-8298 | (269) 387-8276 Fax