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 equivalent protection standards to all human subject research, regardless of the funding source. Dr. Wesley Byerly, Associate Vice President for Research Integrity and Regulatory Affairs 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 Program, Dr. Richard Simon, who is designated as the Administrator of our FWA. Our FWA number is 00006064 and its expiration date is August 3, 2021.
The vision of the Human Subjects Protection Program 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.
- HSPP Full Description (Word)
The primary mission of the Human Subjects Protections Program 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 Director of the Human Subjects Protection Program (HSPP) has oversight responsibility of the Institutional Review Boards and Regulatory Specialists, the Research Compliance Monitor, the Education and Development Specialist, and the HSPP Scientific Review Committee. The Director of the HSPP cannot influence or change any decision made by the IRB. As outlined in the organizational chart (PDF), the HSPP reports to the Associate Vice President for Research Integrity and Regulatory Affairs, who in turn reports to the Vice President for Research, Innovation and Entrepreneurship.
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.
The HSPP is inclusive of the following individuals.
- Dr. Richard Simon, Director, 860-679-1631, firstname.lastname@example.org
- Ms. Deborah Gibb, Deputy Director, 860-679-3054, email@example.com
- Ms. Patricia Gneiting, Regulatory Specialist Panel 2, 860-679-4849, firstname.lastname@example.org
- Mr. Stephen MacKinnon, Regulatory Specialist, Panel 1, 860-679-8729, email@example.com
- Mrs. Mayra Cagganello, Education Specialist, 860-679-8802, firstname.lastname@example.org
- Ms. Julia Schmidt, Research Compliance Monitor, 860-679-7555, email@example.com
- Dr. Kai Chen, IRB Co-Chair Panel 1, 860-679-3433, firstname.lastname@example.org
- Dr. Upendra Hegde, IRB Co-Chair Panel 2, 860-679-4249, email@example.com
- Dr. Julian Ford, IRB Co-Chair Panel 1 & 2, 860-679-8778, firstname.lastname@example.org
- Dr. Julie Wagner, Chair, Scientific Review Committee, 860-679-4508, email@example.com