Human Subjects Research – For the purpose of this policy “human subject research” means any activity that either meets the DHHS definition of “research” and involves “human subjects” as defined by DHHS; or meets the FDA definition of “research” and involves “human subjects” as defined by the FDA. FDA-regulated studies, or aspects of a study, will be reviewed by other IRBs, see Section 15 below.
Research as defined by DHHS - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components that constitute research activities under this definition.
In addition, student research (i.e., projects conducted by student investigators who gather data about living individuals outside the class) that involves obtaining data in a systematic investigation (see definition of “systematic investigation” below) about living individuals through intervention or interaction with those individuals, or through the collection of their identifiable private information, are subject to review by the CUHS, even if the activities are not designed to develop or contribute to generalizable knowledge. See Section16.5 for details on the procedures for CUHS review of student research.
Student research that is not designed to develop or contribute to generalizable knowledge is not considered “human subjects research” but is reviewed by the CUHS for ethical concerns as described in Section 16.5.
For the purposes of this policy, a “systematic investigation” is an activity that involves a prospective study plan that incorporates data collection (quantitative and/or qualitative; new data or existing) and data analysis to answer a research question. Investigations designed to develop or contribute to generalizable knowledge are those whose purpose is to generate data from which inferences may be drawn that would apply to individuals other than those participating in the study, thus informing scholarly dialogue on topics related to the research subject, or related policy discourse.
Human subject as defined by DHHS - a living individual about whom an investigator (whether professional or student) conducting research obtains
1. data through intervention 2or interaction 3with the individual, or
2. identifiable private information4.
Identifiable information as defined by DHHS - means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
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)]
• “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
• “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a medical device. [21 CFR 812.2(a)]
• “Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)]”
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)]
IRB - an Institutional Review Board established in accordance with and for the purposes expressed in this policy. The CUHS is the IRB of record for the University Area.
Minimal risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Certification - the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed