Does your research or project qualify for an “Exempt” determination?
All Research Activities Must Fit Within Six Federal Categories
For a study to be eligible for exemption all of the research activities must fit in one or more of the six categories listed below. In some cases, all but one of the activities will fit in the categories.
Risk Assessment Considerations
Research eligible for exemption usually involves little or no risk to subjects. Some reviews apply the “minimal risk” standard when conducting exempt review. When determining “minimal risk” all the risks associated with the study must be identified. Department of Health & Human Services defines “minimal risk” to mean “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” [45 CFR 46.102(2)(i)].
Exemption Applications that Do Not Meet the Definition of Human Research
The exemption process is further complicated because occasionally an activity that is sent to the IRB using an Exemption Application Form does not meet the federal definitions of “research” or “human subject”.
In analyzing whether activities involve human subjects research, it is important to focus on the federal definitions of “human subject” and “research”.
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.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Research is defined as 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.