Any activity that meets either the Department of Health and Human Services’ (DHHS) definitions of “research” and “human subjects” OR the Food and Drug Administration’s (FDA) definitions of “clinical investigation” and “human subjects” requires review and approval by the IRB.
The DHHS regulatory definitions (45 CFR 46) of research and human subjects must be met in order to require IRB review. If a project meets the regulatory definition of ‘research’ but not ‘human subjects’, then IRB review is not needed. And, vice versa, if a project meets the definition of ‘human subjects’ but not ‘research’ then IRB review is not needed.
Research means 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 this policy, 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.
The following offers further information on what constitutes systematic investigation and generalizable knowledge (note: these are not regulatory definitions but rather guidance):
Generalizable knowledge includes results or outcomes (conclusions) gained from a systematic investigation, which are intended to be extended beyond a single individual (relevant beyond the specific participant population) or internal program that may be published, archived, presented, or viewed. Also included are activities where there is an intent to publish the results in a peer-reviewed journal or to present at regional or national meetings, as well as theses or dissertation projects.
A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
The FDA regulatory definition (21 CFR 56) is as follows:
A human subject (FDA for medical devices) is a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease. [21 CFR 812.3(p)] (Medical Devices)
For additional guidance regarding activities that MAY or MAY NOT require IRB review and approval, see the Guidance: Examples of Activies that Do and Do Not Require UNC Charlotte IRB Review and Approval document.
Students conducting projects specifically to fulfill class/course requirements should review the Guidance: Examples of Activities that Do and Do Not Require UNC Charlotte IRB Review and Approval document and consult with their class/course instructor BEFORE beginning the IRB review process.