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The Health Center holds a Federalwide Assurance which is an agreement
between the Health Center and the government, in particular the
Office for Human Research Protections
within the Department of Health and Human Services, that assures that whenever UCHC
engages in non-exempt human subjects research conducted or supported by any
federal department or agency that has adopted the Common Rule, UCHC will comply with the
terms of the assurance. UCHC applies the same standards to all
human subject research, regardless of the funding source. The Vice President for Health
Affairs, Dr. Peter Deckers, is the assurance signatory official who holds
ultimate responsibility to ensure compliance with the terms of our FWA.
The operational aspect of that responsibility has been delegated to the
Director of the Human Subjects Protection Office, Dr. Richard Simon,
who is designated as the Administrator of our FWA. Our FWA
number is 00006064 and the expiration date is June 8, 2009. The vision of the Human Subjects Protection Office of the University of Connecticut Health Center is to provide complete protection to all volunteer subjects enrolled in research studies and to have that protection be an integral part of a fluid process that responds to the needs of the subject, the researcher, and the institution. The primary mission of the Human Subjects Protections Office is to ensure that the rights and welfare of those who participate in research studies are protected. This mission is carried out by first ensuring that all research involving human subjects is reviewed and approved by the Institutional Review Board prior to initiation and subsequently by continuing review and monitoring of approved studies. These functions ensure that studies are being conducted in accordance with the ethical principles of autonomy, beneficence and justice as set forth in the Belmont Report, and in compliance with internal policies, and Federal regulation. The Human Subjects Protection Office (HSPO) has oversight responsibility of the Institutional Review Boards and support staff, the Research Compliance Monitors, the Research Adverse Events Committee, and the HSPO Scientific Review Committee. The HSPO cannot influence or change any decision made by the IRB. As outlined in the organizational chart, the HSPO reports to Vice President for Health Affairs through the Dean for Academic Affairs & Education and works closely with the Office of Research Administration & Finance and the Office of Research Compliance. The HSPO is comprised of the following individuals. Investigators and study personnel are encourage to call the office for assistance in preparing an application for the IRB or with any other questions, comments or concerns.
Human Subjects Protection Office Send questions, comments, suggestions to gibb@uchc.edu. |
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