If there is any question as to whether a project or activity constitutes human subject research, the principal investigator/project leader should contact the HSRO for an independent determination which shall be based on the following regulations, policies and the guidance provided by the OHRP in its Chart 1 (reprinted below). Such guidance is based on three questions which are:
a. Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge?
Pursuant to 45 CFR 46.102(d), research is defined as a systematic investigation including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge. A key to this definition is that there is a systemic design generally utilizing a scientific approach or protocol for the defined purpose of contributing to generalized knowledge. By this definition, research can encompass studies that are experimental or observational, surveys, tests and recordings 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. Research also includes "clinical investigations" as defined in 21 CFR 50.3(c) which must meet requirements in 21 CFR parts 312, 812, and 813 and require IRB review (21 CFR 56.103).
The definition of research may or may not include public health monitoring activities, internal management studies such as program evaluation, quality assurance or improvement, fiscal or program audits or marketing studies. These activities must be considered on a case-by-case basis to determine if they involve research and require IRB review. Research generally does not include journalism or political polls unless there is clear intent to contribute to generalized knowledge with a scientific protocol. However, the intent to publish may be an indication of intent to contribute to generalizable knowledge.
It is important to distinguish between “research” and the practice of accepted therapy since these may often occur together (such as when research is designed to evaluate the safety and/or efficacy of a therapy). The term “practice” usually refers to interventions designed solely to enhance the well-being of an individual patient or client. Such interventions are carried out with a reasonable expectation of success for purposes of diagnosis, preventive treatment or therapy to a particular individual. In contrast, “research” designates an activity designed to test a hypothesis, permit conclusions to be drawn and thereby to develop or contribute to generalizable knowledge which is usually expressed in theories, principles and statements of relationships. Research is usually described in a formal protocol that contains an objective and a set of procedures designed to reach that objective. If there is any element of research in an activity involving human participants, that activity shall undergo IRB review for the protection of human subjects.
If the activity is not definable as research, then 45 CFR 46 does not apply; but if the activity is definable as research, then a second question should be:
b. Does the research involve obtaining information about living individuals?
Within this definition, “Private Information” includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). “Identifiable Private Information” is that which contains one or more data elements that can be combined with other reasonably available information to identify an individual.
The “obtaining” of identifiable private information or identifiable specimens for research purposes constitutes human subject research. Conversely, research is not considered to involve human subjects when such research involves only coded private information or specimens if both of the following conditions are met:
1. the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; AND
2. the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
a) the key to decipher the code is destroyed before the research begins; OR
b) the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased; OR
c) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; OR
d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased
If an investigator unexpectedly learns the identity of one or more living individuals or now believes that identifying the individuals is important, then the research activity previously considered not to involve human subjects would now involve human subjects and IRB review and informed consent of the subject are required.
If the research does not involve human subjects, then 45 CFR 46 does not apply; but if the research does involve human subjects, then a third question should be:
c. Does the research involve intervention or interaction with human subjects?
Pursuant to federal regulation 45 CFR 46.102(f)(1),(2), human subject research is defined as research involving a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or from whom an investigator obtains identifiable private information. Within this definition, “intervention” includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subjects’ environment that are performed for research purposes. “Interaction” includes communication or interpersonal contact between investigator and subjects.
Since the University is covered by an approved FWA, all human subject research (as defined above) shall require review and approval by the IRB.
These written policies and procedures, and the IRB requirement to review and approve/disapprove studies, apply to projects/programs that fit the definitions of 'research' and 'human studies' as derived from federal regulations.