Human Subjects Review

CIDR and the Human Subjects Division of the UW Office of Research have worked together to clarify the role of Human Subjects Review in Scholarship of Teaching and Learning projects at UW:

If I am examining student learning in my classroom, do I need Human Subjects Review?

• If the intent is to assess what is happening in your classroom, no.
• If the intent is to disseminate what you learn through your assessment, yes.
• What if the intent of the assessment changes?
• What are the Human Subjects concerns when students are the subject population for a study?

If the intent is to assess what is happening in your classroom, no.

The Human Subjects Division usually does not review procedures for program assessment because these projects are not defined as research. A department or clinic can conduct procedures to assess their programs. The purpose of these activities is to implement changes within the department based on the results of the program assessment.

These projects are generally not considered research because the results are not "generalized" or published beyond the department or clinic where the program assessments are conducted. Procedures that include surveys, questionnaires, interviews, and medical record review do not require Human Subjects review and approval when the scope of the project is limited to program assessment.

If the intent is to disseminate what you learn through your assessment, yes.

If the intent of your study includes using the data obtained beyond the department (for example, a presentation at a conference or journal publication) then Human Subjects review is necessary. If the intent at the outset of obtaining the data is to conduct research, the project requires Human Subjects review before the procedures are conducted. Sometimes the purpose of an activity includes both program evaluation and research. In that case, Human Subjects review is required.

What if the intent of the assessment changes?

Sometimes the intent of a study changes. For example, if data are initially obtained for the purpose of program assessment, and the investigators did not intend to use the data for research, then Human Subjects Review usually is not required. However, while examining the data, someone involved may have an "Aha!" moment because the data suggest implications that can be generalized beyond the department. Then the intent becomes research and the investigator needs to contact Human Subjects in order to determine the level of Human Subjects review required.

What are the Human Subjects concerns when students are the subject population for a study?

In the Human Subjects application process, it is important for researchers to distinguish between classroom procedures that are required, and research procedures, which are voluntary. It is also important for students/subjects to understand this distinction. When research procedures and coursework overlap, it may be necessary to contact the Human Subjects Division for advice on how to recruit subjects and consent subjects so that any potential for coercion can be minimized.

The default position for research is for potential subjects to be fully informed about the purpose, procedures and any risks for the research study before they provide their voluntary consent. It is important that this process includes an opportunity for potential subjects to ask questions. Usually this process includes subjects signing a written consent form, documenting the informed consent.

For more information on Human Subjects Review

The Human Subjects Division can also help you determine whether research studies qualify for a Certification of Exemption (exempt from institutional review, but requiring departmental review and administrative review by the Human Subjects Division), "minimal risk" review, or full committee review.

Visit the web site of the Human Subjects Division of the University of Washington Office of Research, which includes the Human Subjects Manualand an extensive Frequently Asked Questions section.