Federal Law defines "human subjects" as living individuals about whom an investigator (whether professional, faculty, staff, or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information." [45CFR46.102(f)]
The overwhelming majority of human subjects research at Towson University is behavioral in nature (involving questionnaires, surveys, interviews, focus groups, etc.)
A. The individuals studied must be living. Gathering historical information may be research but it is not under the IRB's jurisdiction.
B. The information has at least one of the following characteristics:
1. It is gathered through intervention or interaction with the individuals studied, and/or
2. It contains identifiable private information.
C. Thus, observation of individuals without interaction or identity determination does not count as "human subjects research".
Example: Watching crowds and counting the numbers of individuals wearing Old Navy Jackets who pass by does not count as "human subjects research", but as marketing information.
D. Studying identifiable public figures without interaction or the collection of private information is not "human subjects research".
Example: Comparisons of album covers or magazine advertisements are not "human subjects research" by this definition.
E. Collection of identifiable private information in a form which cannot be associated with an individual is not necessarily research.
Example: Asking students to anonymously evaluate a course is an example of private information not associated with individuals.
F. It is "human subjects research" if the intervention or interaction with living humans would have occurred (and in the same fashion) even without this project, but the information being obtained for the project is collected in a form which can be connected with the individual studied.
Example: If I routinely give my students a personality indicator test as a way of forming study groups, it is only considered "human subjects research" if I can connect the information with the individuals involved AND if I plan to generalize beyond the classroom with it.
Applications for IRB review need to be submitted to all organizations involved. This includes the Towson University IRB if the researcher is an employee or student of Towson University, OR if the research will be gathered on individuals who are employees or students of Towson University. In addition, all researchers need to follow the IRB regulations of outside organizations where data might be collected.
Example: If research is being done by a Towson University faculty member using patients at St. Joseph's Hospital as research subjects, both the IRB at Towson University AND the Hospital's IRB need to review it.
Example: If a researcher who is NOT affiliated with Towson University decides to recruit Towson University students or staff to be human subjects, both the IRB at Towson University AND the researcher's institution's IRB need to review it.
Once received by the IRB, decisions are made about:
If it requires approval, the Board reviews it, using either the expedited or full board review process.
Once approved, the research proceeds.