Does My Project Need IRB approval?
The IRB has the sole authority to make a final determination of whether a proposed activity is human research according to DHHS or FDA regulatory definitions. Unless you are familiar enough with these regulations to be certain that the activity does not represent human research, the activity should be brought forward to the IRB for a determination.
Not sure if your project needs IRB approval?
- Download, complete, and sign Form 129. You do not need an IRB Manager account to submit this form.
- Submit your completed Form 129 to the IRB via to IRB@etsu.edu.
What happens next:
The Chair or IRB staff reviews the information on Form 129 to make a formal determination as to whether the project is considered human research according to DHHS or FDA regulatory definitions. The submitter will be notified in writing of the decision indicating that the project:
- IS NOT human research and does not require approval or purview of the ETSU IRB or ETSU/VA IRB; or
- IS human research, and therefore, subject to the purview of the ETSU IRB or ETSU/VA
- You will need to submit a new study submission to the ETSU or ETSU/VA IRB.
- How To Submit a New Study
What is research?
When considering what constitutes research with human participants, or using data/specimens from humans, ETSU uses the DHHS definition defined in the regulations. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A systematic Investigation is typically a predetermined method for studying a specific topic, testing a specific hypothesis(es), answering a specific question, or developing a theory. To develop or contribute to generalizable knowledge typically means that results or conclusions of the activity are intended to be extended beyond the group or program being studied.
What is a human subject?
If an activity or project meets the definition of research, the IRB considers whether there are human subjects involved. ETSU uses the DHHS definition defined in the regulations. A Human Subject is a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Interaction not only includes in-person but also includes virtual or remote interactions such as email correspondence, online surveys, and zoom interviews. Intervention includes physical procedures such as blood draws or MRI as well as manipulation of the subjects or their environment for research purposes such as educational presentations, simulations, or medical procedures.
Clinical researchSome clinical or biomedical research may be subject to FDA regulations, which has its own definitions and rules to follow. Instead of research, the FDA uses the term Clinical Investigation. A Clinical Investigation is any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under Section 505(i), 507(d) or 520 (g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. A human subject defined by the FDA is an individual who is or becomes a participant in research, either as a recipient of the test article or control. FDA regulations also define subjects as an individual on whose specimen a device is used. Note that when medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines unidentified tissue specimens as human subjects.
When a project requires ETSU IRB approval
All individuals engaged in research with human subjects that is sponsored by East Tennessee State University, conducted by or under the direction of any faculty, staff, or student or agent of ETSU in connection with his or her institutional responsibilities, or conducted by or under the direction of any employee or agent of ETSU using any property or facility of ETSU must obtain ETSU or ETSU/VA IRB approval before beginning any research activities.