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Sponsored Programs and Research

Policy Title
Protection of Human Subjects
Policy Description
Winthrop University acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects participating in research. 
This policy assures that:
a.  The rights and welfare of the human subjects are adequately protected;
b.  The procedures used to obtain informed consent are adequate and appropriate;
c.  The risks to the human subject are reasonable in relation to the anticipated benefits to the subject.
Policy Procedures
Research that involves Winthrop personnel or resources must be approved by the Winthrop Institutional Review Board (IRB.) This policy applies regardless of whether the research is funded and regardless of whether the subjects are members of the Winthrop community. This policy applies to research conducted at other institutions by Winthrop faculty, staff, and students, even if that institution has its own review process.  A “human subject” means an individual about whom a researcher (whether professional, student or other) conducting research obtains (1) data through intervention with, interaction with, or observation of that individual, or (2) identifiable private information about that individual.
Internal Control Considerations
The Provost serves as the Authorized University Representative (AUR) who represents the University in any legal matters concerning IRB decisions. The AUR oversees the enforcement of IRB decisions in instances where members of the Winthrop community fail to follow proper protocols designed to protect human subjects or act in ways that could potentially harm human subjects.  The IRB will review suspected and alleged protocol violations, subject complaints, or violations of Winthrop IRB policies and/or applicable state and federal regulations.  Failure by the researcher to respond to IRB decisions on these matters in an appropriate manner will be referred to the AUR.  The Winthrop IRB has the authority to suspend or terminate approval of research that is not conducted in accordance with its requirements or that pose serious threat to human subjects and will report suspensions to the AUR.
Policy Author(s)
Sponsored Programs and Research
Effective Date
November 2003
Review Date
February 2017
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