Many different factors assist in determining if your project requires IRB review and approval prior to initiation.
Is the project "regulated research"?
Regulated by OHRP: Is the project, or any portion of it, being federally funded, or taking part in a university or hospital? If yes, the project is regulated research and is subject to the Common Rule / OHRP regulations 45 CFR 46 and likely requires IRB review and approval if the project is research involving human subjects by the following definitions:
Human subject 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.
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.
Regulated by FDA: Does the project, regardless of funding, involve a clinical investigation intended to support applications for research or marketing permits of products regulated by FDA, including but not limited to, drugs intended for humans, medical devices, dietary supplements, biological products for human use, and/or electronic products? If yes, the project is regulated research and it is subject to FDA regulations 21 CFR if it involves human subjects using the following definitions:
Human subject means an individual who is or becomes a participant 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.
Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of 21 CFR 58 regarding nonclinical laboratory studies.
Voluntary Review: Sometimes a privately funded non-regulated project, involving human subjects, will be designed to produce generalizable knowledge, which the investigator or sponsor may wish to publish, or build regulated research upon in the future. In this scenario, sponsors and/or investigators may elect to undergo a "voluntary review" by an IRB to determine that the project, although not regulated research, meets the same scrutiny of human subjects protections.
E&I offers assistance in determining whether or not your project requires IRB review and approval.
|Last Updated ( Friday, 07 April 2017 10:17 )|