FAQ - Definitions
Research is defined in the Code of Federal Regulations as a systemic investigation that includes research development, testing and evaluation, designed to develop or contribute to general knowledge.
Human Subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention, interaction, or through private information from and with the individual.
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between the investigator and subject that are performed for research purposes.
Any faculty or staff employee or regular student of GVSU may serve as a Principal Investigator (PI). If the PI is a student, there must be a regular faculty member who serves as advisor to the project and assumes primary responsibility for compliance with all relevant requirements, polices and procedures. Researchers not otherwise affiliated with GVSU must have a regular GVSU faculty member as co-PI, or be an approved investigator operating under an approved Affiliate Investigator Agreement form.
A physician may, as part of therapy practice of medicine, lawfully prescribe a different dosage for a patient, or otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the FDA. (37 Fed. Reg. 16503 (Aug. 15, 1972)). In addition, when a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. (44 Fed. Reg. 23,192, 23,193 (1979)).
The DHHS regulations (45 CFR § 46) apply to research involving human subjects conducted by DHHS or supported in whole or in part by DHHS. The FDA regulations (21 CFR §50 & § 56) apply to all research involving products regulated by the FDA, including research and marketing permits for drugs, biological products, or medical devices for human use, food and color additives, or electronic products. Federal funds do not need to be involved. When research involving products regulated by the FDA is funded by DHHS, both DHHS and FDA regulations apply. (HHS, Office of Human Research Protections, IRB Guidebook, Chapter II, Regulations and Policies, b., ii. Comparing FDA and DHHS Human Subjects Regulations, http://www.hhs.gov/ohrp/irb/irb_guidebook.htm, visited 9/3/06). For FDA purposes, off label use does not constitute research unless data collected will be used to support an application to FDA, 21 CFR § § 50 & 56 only applies to research regulated by FDA, which includes clinical investigations that support applications for research or marketing permits for products regulated by the FDA.
Under the federal regulations, “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 the HHS human subject protections policy, whether or not they are conducted or supported under a program which is considered research for other purposes." (45 CFR § 46.102(f)). Research must be systematic and data must be recorded, but in practice the distinction between research and standard therapy could be trickier. Consultation with the HRRC is recommended in cases of uncertainty.
Page last modified August 17, 2010