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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:
What happens next:
The appropriate appointed Chair reviews the information on Form 129 to make a formal determination whether the project is considered human research according to DHHS or FDA regulatory definitions. The submitter will be notified in writing of the Chair's 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 purview of the ETSU IRB or ETSU/VA IRB
- You will need to submit a new study submission to the ETSU or ETSU/VA IRB.
- See New Study Instructions
Policy 5 (includes definitions,and information about case studies and student research). The following definitions will help you complete your Form 129:
- DHHS Definitions:
- Research (as defined in the Federal regulations (45 CFR 46): A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subjects (as defined in the Common Rule): 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.
- ETSU Definitions:
- Systematic Investigation: Typically a predetermined method for studying a specific topic, testing a specific hypothesis(es), answering a specific question or developing theory
- Generalizable: To develop or contribute to generalizable knowledge typically means that results or conclusions of the activity are intended to be extended beyond a single person or an internal program.
- FDA Definitions:
- Clinical Investigation: 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.
- Subject: 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.