What is Research for purposes of compliance with the federal regulations protecting human subjects? The relevant DHHS regulations are 45 §46.102 Definitions. (d) 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.
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information
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.
Observation is neither an intervention nor an interaction.
Currently any faculty or staff employee or regular student of GVSU may serve as a Principal Investigator (PI).
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. 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.