There are often questions and misconceptions regarding the need for IRB approval of MSU Extension Services projects. The MSU IRB provides the following information as a resource for Extension personnel who are unsure as to whether their projects require IRB approval.
- Extension projects, as in any other field, require IRB approval when the project meets the regulatory definitions for human subjects research. The relevant definitions from the regulations (45 CFR 46.102) are included below:
(l) Research means a systematic investigation, including research development, testing, and
evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. (The regulations also outline activities deemed
not to be research, such as scholarly and journalistic activities, public health surveillance activities, criminal justice or criminal investigative analysis, authorized operational activities for national security missions, etc.) See 45 CFR 46.102 for more details on these activities.
(e)(1) Human subject means a living individual about whom an investigator (whether professional
or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
(2) Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
(3) Interaction includes communication or interpersonal contact between investigator and subject.
(4) 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 that has been provided for purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
(5) Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
(6) An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
A few points concerning these definitions:
- The confusion specific to Extension projects comes with the fact that Extension to a large part is "service." However, the regulations state specifically that service programs are research under these regulations if the definition is otherwise met (see 45 CFR 46.102(l) above)
- Additionally, the regulations hinge on intent. If your intent is to conduct a service program and not to use any such information gathered in the conduct of that program for research purposes (e.g., publication, presentation, etc.), IRB approval is not needed because the project does not meet the regulatory definition of "research." However, if you have the intent to use the resultant data from your evaluation for research, the regulations apply and you must have IRB approval prior to conducting the research.
- There are also misconceptions in regard to Exemption of Extension projects from IRB regulations. There are Exempt categories of research defined in the regulations. However, these Exemptions relate to the specific research methods and the inherent risks involved. Extension projects are not explicitly Exempted from the regulations or requirements for IRB review. The determination as to the level of review must be made with an understanding of these regulations. Additionally, this determination should not be one made by the investigators themselves.
Individuals unsure as to whether IRB approval is needed for their project should contact their HRPP administrator.
Because of the questions surrounding the roles of IRBs and Extension agencies, the Journal of Extension published a few years ago several articles on IRB requirements as they relate specifically to Extension. These articles can be found on the JoE website at https://www.joe.org/journal-search.php by searching for the term "irb."
One of those articles, "What Cooperative Extension Professionals Need to Know About Institutional Review Boards" (Weigel, et. al, https://www.joe.org/joe/2004october/tt1.php) notes the following:
"Cooperative Extension is part of a university system and therefore falls under the same research policies and guidelines as other university units. Typically, if an Extension professional intends to publish or present the information gathered in the form of journal articles, trade articles, bulletins, fact sheets, workshops, or presentations, the project should first be approved by the IRB at the professional's institution. Information collected with no intent to publish it and used merely to evaluate the effectiveness of a program is usually not required to be reviewed by an IRB."