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Engagement in Human Participants Research at UW–Madison
This policy defines when UW–Madison employees or agents engage in human participants research as well as certain activities that do not meet the definition of human participants research but nonetheless require UW–Madison IRB oversight. Any entities or individuals that rely on a UW–Madison IRB for oversight of human participants research are covered by this policy, including the William S. Middleton Memorial Veterans Hospital, the University of Wisconsin Hospital and Clinics, the University of Wisconsin Medical Foundation, State Laboratory of Hygiene, and the Morgridge Institute for Research. This policy is intended to be used with the guidance documents listed at the end of policy.
Any UW–Madison employee or agent who engages in human participants research under a UW–Madison appointment or affiliation is required to follow UW–Madison policies relevant to human participants research. This includes obtaining UW–Madison IRB approval or exemption prior to beginning any research activities involving human participants unless a UW–Madison IRB cedes IRB oversight to another institution. "Agents" include all individuals performing institutionally designated activities (including students) or exercising institutionally delegated authority or responsibility.
When UW–Madison Engages in Human Participants Research
The UW–Madison generally follows Office for Human Research Protection (OHRP) guidance regarding when individuals engage in human subject research for activities that do not fall under the purview of the FDA. UW–Madison engages in human subject research when any of its employees (including faculty, staff, students, or fellows) or agents or individuals at one of the institutions relying on a UW–Madison IRB conduct research involving human participants.
The UW–Madison does not “engage” in human participants research when an individual with a UW–Madison appointment conducts human participants research in his or her role as an employee of a non-UW–Madison entity or institution.
Such individual may not refer to their UW–Madison affiliation in any grant applications, publications, or other oral or written material, including any material presented in a public forum, related to the research; and the research may not be conducted using any UW–Madison resource, property or facility.
Additionally, such individual should take reasonable efforts to ensure that he or she is not improperly associated with the UW–Madison by a third-party in any of the materials identified above.
The UW–Madison applies the Common Rule definitions of “research” and “human subjects” to all projects, while the Food and Drug Administration (FDA) definitions are applied only to projects regulated by that agency. If a project falls under the jurisdiction of other federal agencies that have additional requirements, such as the Department of Defense (DOD), their regulations and guidance are applied to those projects as well.
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." Activities that 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.
Under the FDA regulations, the terms research, clinical research, clinical study, study, and clinical investigation are synonymous. Under FDA regulations activities are "research" when they involve:
Use of a drug other than the use of an approved drug (approved by the FDA for marketing) in the course of medical practice
Use of a medical device other than the use of an approved medical device (approved by the FDA for marketing) in the course of medical practice
Gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product.
Under the Common Rule, a "human subject" is 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 participants.
Under FDA regulations, "human subject" means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
If the research involves a medical device, individuals are considered "subjects" when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be either a healthy human or a patient.
Determinations Regarding Whether Activities Constitute Engagement in Human Participants Research
There are certain activities that require a sufficiently complex analysis such that the UW–Madison requires a UW–Madison IRB to determine whether they constitute human participants research. Most studies involving the use of coded private information or coded biological specimens require IRB review.
A UW–Madison IRB or its support office can require a formal submission to the IRB in order to make a determination regarding whether an activity constitutes engagement in human participants research. If it is unclear to a UW–Madison employee or agent whether he or she will engage in human participants research, then consultation with a UW–Madison IRB is required.
Non-Research Activities that Require IRB Oversight and/or Approval
Use of a Humanitarian Use Device (HUD) for treatment requires prospective IRB review and approval.
Non-emergent one-time use of an investigational drug, biologic, or device requires prospective IRB review and approval.
Emergency use of an investigational drug, biologic, device, or Humanitarian Use Device (HUD) requires IRB oversight.
Research Not Involving Human Participants that Requires IRB Oversight
Research that involves human fetal tissue must be reviewed and approved by a UW–Madison IRB.
Adopted By: All Campus IRB
Adoption Date: August 4, 2005
Revised: June 7, 2007
Revised: May 1, 2008
Revised: December 4, 2008
Revised: September 10, 2009
Revised: March 1, 2012 by the HRPP Advisory Committee
Revised: December 5, 2012 by HRPP Advisory Committee
Revised By: Cross-Campus Human Research Protection Program Advisory Committee
Revised: March 26, 2015
Copyright © 2015 University of Wisconsin System Board of Regents
- OHRP Guidance on Engagement of Institutions in Human Subjects Research
- Humanitarian Use Device Policy
- Using Specimens/Information from Decedents: The Common Rule and FDA Regulations
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- UW-Madison Policy for Human Embryo and Human Pluripotent Stem Cell Research
- Sending or Receiving Specimens/Data/Images Guidance
- Case Reports and Case Series Guidance
- Student Research
- Use of Human Fetal Tissue in Research
- De-Identified Publicly Available Datasets Guidance
- Guidance on Research vs. Quality Improvement and Program Evaluation
- Exemption Guidance
- Guidance on Exemption: Not Human Subjects Research