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In accordance with federal regulations and institutional policies and obligations, any undertaking in which a University faculty, staff or student includes human participants in their research must be reviewed by the IRB. In some instances, this review must also comply with Food and Drug Administration (FDA) regulations:  21 CFR Part  50 (hyperlink: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50) and 21 CFR 56 (hyperlink: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=56).

Research that is not funded by a federal agency may also be subject to FDA regulations.

What research is regulated by the FDA?
All clinical investigations under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetics Act, as well as clinical investigations that support applications for research or marketing permits , including drugs for human use, medical devices for human use, biological products for human use, and related electronic products.

What is a clinical investigation?
Means any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the FDA or that results are intended to be submitted later to the FDA as part of an application for research or marketing permit.

What is a test article?
Any drug, medical device, human food, electronic product, or any article subject to regulation under the Act. For example:  A test article intended for use in the diagnosis, cure, treatment, prevention of disease. Or an article intended to affect the structure or any function of the body of humans or animals.

Investigator responsibilities (for devices):

  1. Determine if you need pre-market approval or an IDE(hyperlink to : http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812&showFR=1) for the study.
  2. Ensure Investigational device meets significant risk (SR) and/or nonsignificant risk (NSR) device studies.
  3. Follow IRB requirements and ensure protection of human participants.

If submitting an IRB application that includes devices, please complete a Biomedical Full Board application via eprotocol. Additional documents required include:  Investigator’s Assurance Letter of Permission or IRB approval from Off-Site Institution/Off-Site Research Agreement
Sponsor Protocol/Master Protocol, and Investigator’s Brochure. The Office of Research and Sponsored Programs is committed to assisting you throughout this process.