Research Involving Human Subjects Policy
Purpose
The University of Dayton is committed to the highest ethical principals in the conduct of human subjects research. The purpose of this policy is to promote the practice of research that protects the rights and welfare of human research subjects and adheres to all applicable laws, principles, best practices, and policies related to research with human subjects.
Scope
This policy applies to all University of Dayton faculty, staff, and students involved in research with human subjects without respect to funding or the source of the funding.
Policy History
I. Effective Date: September 24, 2025
II. Approval: September 24, 2025
III. History:
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Approved in its original form: September 24, 2025
IV. Maintenance of Policy: Director of Research Compliance, Institutional Review Board Chair, Office of Academic Research
Definitions
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) is conducting research:
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Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
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Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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.
Interaction includes communication or interpersonal contact between investigator and subject.
Policy
All research involving human subjects conducted by members of the University community, using University facilities or resources, or involving the use or disclosure of personal identifying information created or maintained by the University will be guided by the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”) and performed in compliance with applicable federal and state law.
The Institutional Review Board (IRB) is a university oversight committee established to protect the rights and welfare of human subjects involved in research activities. The University of Dayton maintains a Federalwide Assurance of Compliance (FWA) with the Office for Human Research Protections (OHRP) for federally-sponsored research. The authorized organizational representative for the IRB is the Vice President for Academic Research.
All research involving human subjects requires IRB review and approval prior to initiation. Research involving the use of human subjects is not authorized until adequate approvals have been obtained to protect the rights, health, and welfare of the subjects. The IRB has full authority to approve, require modifications to, or disapprove all research activities that fall within its jurisdiction and to conduct continuing reviews of the research activities at intervals appropriate to the degree of risk and as guided by federal regulations. If IRB approval lapses, all research activity, including data analysis, must stop unless the termination of study procedures creates a safety concern or ethical issue.
The IRB’s authority includes:
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Determining that the research is designed and conducted in an ethical manner that protects the rights, dignity, welfare, and privacy of research subjects;
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Approving, requiring modifications to secure approval, or disapproving all research involving human subjects;
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Suspending or terminating approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.