Compliance

Human Subjects Institutional Review Board (HSIRB)

Undergraduates - Honors Thesis Protocol Approval



What is it, who needs it, and where to get it.

Your junior year has just begun, and you know you should start thinking about your honors thesis. Where human subjects research is concerned, a great deal of preliminary thinking and planning is required. Ask yourself, "Will my study falls under the category of "research involving human subjects?" If you think it might, now is the time to begin to learn about the ethical requirements of doing research that involves collecting data from or about people. This article will get you started.

There are four important things to know up front.

    1. Federal laws protect people who are subjects in research (and, if your project involves people, you must obey those laws).
    2. If your project involves people, LEE HONORS COLLEGE WILL NOT ACCEPT YOUR THESIS WITHOUT HSIRB APPROVAL.
    3. You will need help and guidance from your advisor all the way through your project, but especially early in the project development process.
    4. You must be working under an approved HSIRB protocol to apply for and receive research funding from the Honors College. If you do not receive HSIRB approval before you begin collecting data, and keep your approval current during the entire time you collect data, your project will not qualify as an honors thesis. No one wants to put in all the work required for a thesis project, and not get credit for the thesis.

Who can help me through this process?

Choose and contact your advisor EARLY in you thesis development process. This is essential because your advisor will be the "Principal Investigator" on your HSIRB protocol. WMU requires a faculty member to be the responsible party in any human subjects research project. As soon as you and your advisor have agreed on a preliminary project, you should call the research compliance office (387-8293) and consult with staff about your project. You should work closely with your advisor and the research compliance coordinator to complete the HSIRB application.

What is considered research involving human subjects?

Human subjects research involves more than you might think. If your subjects are living people, or if you are collecting data from sources where people can be identified, you are doing human subjects research. Medical research involving procedures performed on patients or volunteers must , of course, have HSIRB approval. Some other examples of research that requires HSIRB review include:

  • Interviews, telephone surveys, mail surveys
  • Behavioral or educational testing
  • Observation of individual or group behavior
  • Research involving materials about identifiable people (e.g., existing data, documents, archives, or databases)
  • Other (This might be your project.)

If you think your project could qualify as research, talk to your adviser and talk to someone in the compliance office.

What is HSIRB?

HSIRB is a University committee charged with protecting human research subjects by assuring that researchers at Western work under an approved protocol. FEDERAL AND UNIVERSITY REGULATIONS REQUIRE THAT ALL INVESTIGATORS (FACULTY AND STUDENTS) WHO WILL CONDUCT RESEARCH WITH HUMAN SUBJECTS OR MATERIALS OF HUMAN ORIGIN DO SO ONLY WITH HSIRB APPROVAL.

How do I apply for HSIRB Approval?

You should submit your application at least one month prior to the time you plan to begin data collection. Remember!! YOU CANNOT COLLECT DATA BEFORE YOU RECEIVE APPROVAL.

What should I include in the Protocal?

Along with your application submit any survey or testing instruments, interview questions, intervention scripts, brochures or recruiting materials, site approval letters, and consent documents that will be used in your study.

Questions? Contact Research Compliance at (269) 387-8293.

 
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