9.2 Best Practices Regarding Human Subjects

Background

The following document outlines the best practices for working with “human subjects,” the Office of Research Assurances (ORA), and the Institutional Review Board (IRB). Many SDC faculty deliver studio or capstone courses that necessitate or encourage interaction with outside individuals to help develop class project(s) and/or to assist with their research.  These individuals may be faculty members in other departments or institutions; private clients; industry leaders; community members; government officials; or others.  As these individuals may be considered “human subjects,” [1] it is advisable that faculty directing such courses reference the WSU Institutional Review Board’s (IRB) “Determination of Human Subject Research Flowchart” and proceed accordingly.

Best Practices

The below descriptions summarize best practices for three common scenarios in classes:

  1. If the class activities directly (or indirectly) involve human subjects and faculty intend to use the results of these activities in research,[2] faculty must submit a “Human Subject Application” to the IRB.  Typically, SDC faculty will use the “Exemption Determination Application.”  Studio/capstone work should not begin until there is exemption certification from the IRB.
  2. If the class activities directly (or indirectly) involve human subjects but faculty do not intend to use the results of these activities for research, an Office of Research Assurances (ORA) review still may be necessary.  Examples of human subjects, or “special populations,” that may require approval regardless of research intentions include children, pregnant women, substance abusers, and Native American Tribes with whom WSU has agreements.  Please contact the ORA directly to determine the legal limits of communication with special populations.
  3. As long as direct or indirect class activities and results involving human subjects are used within the time frame of the course, and provided those human subjects are not “special populations” as defined by the ORA, it is unnecessary to submit a “Human Subject Application” to the IRB.

[1]A human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains data intervention or interaction with the individual or identifiable private information.

[2] The IRB defines research as 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 the WSU IRB, 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.  Research is understood to include all theses, dissertations, publications, and/or presentations.