Compliance

Human Subjects Institutional Review Board (HSIRB)

Undergraduates - General Information Guidelines



What is the HSIRB?

The HSIRB, or Human Subjects Institutional Review Board, is a University committee charged with protecting human research subjects by assuring that researchers at Western Michigan University 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.

What are Human Subjects?

Under , 46.102(f), A human subject means a living individual, about whom an investigator (whether professional or student) conducting research obtains

    1. Data through intervention or interaction with the individual, or
    2. Identifiable private information.

Intervention includes both physical procedures, by which data are gathered (for example, venipuncture), and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context, in which an individual can reasonably expect that no observation or recording is taking place, and information, which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information), in order for obtaining the information to constitute research involving human subjects.

What is Research?

Under , 46.102(d), Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

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.

How do I apply for HSIRB Approval?

Instructions and application materials

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.

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, even if you are conducting research for your thesis. As soon as you and your advisor have agreed on a preliminary project, call the research compliance office (269) 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.

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