Institutional Review Board
The primary role of the Institutional Review Board (IRB) is to ensure the ethical treatment of research participants. All research involving human participants must receive IRB approval in accordance with federal regulations set forth by the Department of Health and Human Services and the Food and Drug Administration. Research involving human subjects at UW Oshkosh will be guided by the ethical principles outlined in the 1979 Belmont Report: respect for persons, beneficence, and justice.
The Institutional Review Board (IRB) reviews all human subjects research in which the institution is engaged.
Definition of Human Subjects
Federal regulations define human subjects (45CFR46.102(e)(1)) as a living individual about whom an investigator (whether professional or student) conducting research obtains:
(1) Researcher obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(2) Researcher obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Identifiable Information can be linked to a specific individual either directly or indirectly through coding systems. Please see the IRB Identifiers Chart.
What is Research?
Federal regulations define Research (45CFR46.102(l)) as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”.
To be considered a systematic investigation the concept of a research project involves the following:
- Designed to test a hypothesis or attempt to answer research questions.
- Methodologically driven, that is, it collects data or informaiton in an organized and consistent way.
- The data or information are analyzed in some way, be it quantitative or qualitative data.
- Conclusions are drawn from the results.
“Generalizable Knowledge” is information where the intended use of the research findings can be applied to populations or situations beyond that studied. This usually includes one or more of the following concepts:
- The knowledge contributes to a theoretical framework of an established body of knowledge.
- The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study.
- Publication, presentation or other distribution of the results is intended to inform the field of study.
- The results are expected to be generalized to a larger population beyond the site of data collection or population studied.
- The results are intended to be replicated in other settings.
- Project is designed to draw general conclusions, inform public policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations).
The following activities are deemed not to be research in the revised 2018 Common Rule regulation:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
When is UWO engaged in research?
In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain:
(1) information or biospecimens from the subjects of the research through intervention or interaction with them
(2) identifiable private information about the subjects of the research; or
(3) the informed consent of human subjects for the research.
Office located in Dempsey Hall Suite 214