Human Subjects Protection Office
UConn Health holds a Federalwide Assurance which is an
agreement between this institution and the government, in
particular the Office for
Human Research Protections within the Department of Health
and Human Services, that assures that whenever UConn Health
engages in non-exempt human subjects research conducted
or supported by any federal department or agency that has
adopted the Common Rule, UConn Health will comply with the
terms of the assurance.
While the assurance is applicable to federally funded research,
UConn Health applies the same protection standards to all human subject research, regardless of the
funding source. Dr. Frank M. Torti, 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
its expiration date is June 4, 2017.
The vision of the Human Subjects Protection Office at UConn
Health 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
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 Monitor,
the Education and Development Specialist,
and the HSPO Scientific Review
Committee. The HSPO cannot influence or change any decision
made by the IRB. As outlined in the
chart (PDF), the HSPO reports to Executive Vice President for Health
works closely with the Office of Research Administration and
Finance and the Office of Research Compliance.
The HSPO is comprised of the following individuals.
Investigators and study personnel are encouraged to call the
office for assistance in preparing an application for the IRB or
with any other questions, comments, suggestions and/or concerns.