Research: Federal regulations (CFR Title 45, Part 46, 2009) define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This definition excludes instructional activities that are not designed to contribute in any way (e.g., through presentation or publication) to generalizable knowledge. Also excluded are activities related to routine course or program development/evaluation. Research includes all theses, dissertations, publications, and/or data- related external presentations. If results of a study are publicly disseminated in any way or will contribute to generalizable knowledge, then the study probably constitutes research and is within the IRB purview. If no dissemination is planned at the time the data is gathered but the possibility of future dissemination exists, the researcher is advised to submit the project for IRB review/approval before initiating the (research) project.
Generalizable Knowledge: Conclusions or insights which may be extended to populations outside the subset which is the focus of inquiry. Other characteristics of generalizable knowledge include, but are not limited to, the potential for replication and the potential to contribute to the knowledge base of the field of inquiry.
Human Participant or Human Subject: Federal regulations (CFR Title 45, Part 46, 2009) define a human participant as “a living individual from whom a researcher (whether a professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
Sensitive Topics: Topics relating to sexual attitudes, preferences or practices; the use of alcohol, drugs or other addictive products; pertaining to illegal conduct; that if released could reasonably damage an individual’s financial standing, employability, or reputation within the community; that would normally be recorded in a patient’s medical record and the disclosure could reasonably lead to social stigmatization or discrimination; pertaining to an individual’s psychological well-being or mental health.
Vulnerable Population: : Minors (under eighteen years of age); fetuses or products of labor and delivery; pregnant women (in studies that may influence maternal health); prisoners; individuals with a diminished capacity to give informed consent; individuals with special needs.
Additional definitions can be found in the IRB handbook.