Students should start thinking about and planning for their honors thesis at the beginning of their junior year.
If it’s possible a project will fall under the category of “research involving human subjects,” a great deal of preliminary planning will be required. It’s never too early to learn about the ethical requirements of doing research that involves collecting data from or about people.
There are four important things to know up front:
- Federal laws protect people who are subjects in research. If a project involves people, the researcher must obey those laws.
- If a project involves people, Western Michigan University’s Lee Honors College will not accept the related thesis without HSIRB approval.
- Student researchers will need help and guidance from their advisors all the way through their projects, but especially early in the project development process.
- Students must be working under an approved HSIRB protocol to apply for and receive research funding from the Honors College. If HSIRB approval is not secured before data collection begins—and kept current during the entire time of data collection—the 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.
Contact an advisor
Choose and contact an advisor early in the thesis development process. This is essential because the advisor will be the principal investigator on the HSIRB protocol. WMU requires a faculty member to be the responsible party in any human subjects research project. As soon as the student and advisor have agreed on a preliminary project, the student should call the research compliance office at (269) 387-8293 to consult with staff about the project. The student should work closely with the advisor and research compliance coordinator to complete the HSIRB application.
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.
Human subjects definition
Under 46.102(f), a human subject means a living individual, about whom an investigator—whether professional or student—conducting research obtains either of the following:
- Data through intervention or interaction with the individual.
- Identifiable private information.
Intervention includes both physical procedures, by which data are gathered (e.g., 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 (e.g., 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.
Human subjects research definition
Human subjects research involves more than one might think. If a project’s subjects are living people, or if data is being collected from sources that could potentially identify a person, it is 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 and 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—speak with an advisor and research compliance officer to make sure a project doesn’t fall into this category.
If a project could qualify as research, talk to an advisor and research compliance officer before getting started.
The HSIRB is a University committee charged with protecting human research subjects by assuring that researchers at WMU 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.
- The Dark Side of Research on Human Subjects: Historical Events Which Led to the Formation of Human Subjects Institutional Review Boards
Submit an application at least one month prior to the time data collection should begin.
Data cannot be collected until approval is received.
Along with the 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 the study.
Required human subjects web-based training must be completed before HSIRB can approve a human subject research protocol.