Documents, Resources, & FAQs

For purposes of determining which projects require IRB review, Franklin University adheres to the definitions of ‘research’ and ‘human subject’ presented in the Department of Health and Human Services (DHHS) Code of Federal Regulations (45 CFR part 46):

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)]. 

Human subject means a living individual about whom an investigator (whether professional or student) conducts research and (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(e)(1)].

See also the guidance on Determining If an Activity Requires IRB Review and Approval.

The Department of Health and Human Services (HHS) regulations at 45 CFR part 46 stipulate substantive and procedural requirements for investigators and institutions engaged in research. You can read the Code of Federal Regulations regarding the Protection of Human Subjects here.

Check out the Office for Human Research Protections (OHRP) to learn more about protecting the rights, welfare, and wellbeing of human subjects involved in research.

Probably not. The Franklin University Evidence-Based Project Review Team will review all DNP Scholarly Project proposals to ensure, among other things, that they do not meet the federal definition of human subjects research (per 45 CFR Part 46) and require IRB review; however, IRB review may be required in some cases. See the DNP Scholarly Project and Institutional Review Board (IRB) guidance for more information.