Guidance on Exemption: Not Human Subjects Research

Version Date: August 3, 2011

Additional guidance regarding not human subject category of exemption.

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Projects That Do Not Constitute Research

The Institutional Review Board (IRB) is responsible for protecting the rights and welfare of human subjects in research. As a result, the first question a researcher should consider with respect to IRB review requirements is whether the project fits the definition of research. Under the federal Common Rule, “research” is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." In addition, the FDA has separate definitions for what constitutes research and therefore, if your project includes use of a drug, device or biologic, it may be subject to FDA regulations and require IRB review. Further information regarding the definition of research, as it relates to federal regulations and Engagement in Human Participants Research at UW-Madison.

While some activities are typically outside the realm of research (e.g. operational activities such as defined practice activities in public health and medicine, or internal management activities such as quality improvement, quality assessment and program evaluation), some of these activities may constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge. Often, determining whether a project constitutes research under federal and institutional regulations can be a complex process that involves assessing the project intent, design, mandates, expected outcomes, and dissemination of results. Further information about the differences between research activities, program evaluation, and quality improvement (PDF).

If there are no plans to publish or present a QI or program evaluation project and the sole intent is to evaluate or improve a process or function within a program or institution, IRB review is most likely not required. However, if you believe that your project does not constitute research, but are required by UW-Madison policy or a publisher to obtain an IRB determination, this application type (i.e. exempt from ongoing IRB oversight as not research) is appropriate. If the project includes a research question/hypothesis, an intent to publish, present or contribute to generalizable knowledge, or the project would not be conducted in the same way or at all if there was no potential for publication/presentation, the project is most likely considered research and another application type required.

Research Not Involving Human Subjects

Some project may be research studies that do not involve human subjects as defined by the Common Rule. According to 45 CRF 46.102(f):

"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.”

The IRB's role is to oversee research involving human subjects. As a result, studies that do not involve human subjects likely do not require IRB oversight. Some examples of this type of research are straightforward and easy to determine, e.g. analyzing de-identified tissue samples obtained from a commercial source, or analyzing data from deceased individuals. However, it is often difficult to determine whether a study involves human subjects or not. For assistance with this, please see the NIH decision tree (PDF).

If you are required by the UW-Madison policy "What are the criteria to be engaged in human subjects research at UW-Madison?", a funding agency, or a publisher to obtain and IRB determination, please submit an application to the IRB for this type of research. Studies that constitute research but do not involve human subjects as defined above are treated as exemption applications by the UW-Madison HS IRBs. Please contact the HS IRBs Office with questions about whether your project involves human subjects and subsequently requires IRB review.

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Keywords:EX, exemption, not human subjects, QI, QA, quality assurance, quality improvement, exemptions, cadaver, definition of research   Doc ID:19537
Owner:Stella K.Group:Health Sciences IRBs
Created:2011-08-03 19:00 CDTUpdated:2016-02-09 15:55 CDT
Sites:Health Sciences IRBs
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