Human Subject Research is federally regulated to insure protection for all human subjects. The Institutional Review Board (IRB #00000616) of the University of Illinois College of Medicine at Rockford has a separate Federalwide Assurance (FWA #00005607),from U. S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP), and reviews all human subjects’ protocols conducted on or by faculty and students associated with the COM-R.
What is human subject research?
There are two federal agencies that provide the definitions of “human subject research.”
1. “Research” as defined by DHHS regulations means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]
2. “Human Subject” as defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]
1. “Research” as defined by FDA regulations, means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
2. “Human Subject” as defined by FDA regulations means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]
Policy and Procedure Manual