Institutional Review Board

The purpose of the Institutional Review Board (IRB) at Trinity Health Of New England is to protect the rights and welfare of subjects participating in research. 

The purpose of the Institutional Review Board (IRB) at Trinity Health Of New England is to protect the rights and welfare of subjects participating in research. It is the policy of Trinity Health Of New England that the involvement of human subjects in research is not permitted until the IRB has reviewed and approved the research protocol regardless of the source of funding. This means that no contact with subjects, including recruitment and obtaining consent, can be initiated until the research has been approved, although researchers may contact organizations from which subjects will be recruited. Furthermore, unless the consent process has been specifically waived by the IRB in accordance with 45 CFR 46.116, and the Health Insurance Portability and Accountability Act (HIPAA), no subjects may be included in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. All ethically minded individuals should take an interest in protecting the rights and welfare of research participants, without whom we could not advance our knowledge.

The IRB reviews research protocols from Saint Francis Hospital, Mercy Medical Center, Saint Mary's Hospital, Johnson Memorial Hospital and Mount Sinai Rehabilitation Hospital. In accordance with federal regulations, the IRB has the authority to approve, require modification in (to approve), disapprove, terminate, or suspend research at these sites.

The IRB is free of Institutional influence: no Institutional Official or Committee can override the decision of the IRB to disapprove a study or suspend study enrollment. The IRB does not review research conducted by physicians in private practice or research done off-site at other Institutions.

The IRB does not consider the decision of another IRB when reviewing protocols. The IRB has a cooperative agreement with the University of Connecticut Health Center (UCHC) IRB. When research is being conducted at multiple sites, the research must be reviewed by this IRB. The IRB also has an institutional authorization agreement with Yale University for all Oncology research protocols.

The IRB abides by the Trinity Health Of New England policies and procedures, Catholic Church Directives, Belmont Report, Food and Drug Administration (FDA), and the Office of Human Research Protections (OHRP) federal regulations.

The Trinity Health Of New England IRB has received Full Accreditation by the Association of Human Research Protection Programs, Inc. (AAHRPP). For more information on accreditation, go to www.aahrpp.org.

Trinity Health Of New England (TH Of NE) Institutional Review Board (IRB) reviews human research submissions from the 5 following hospital members:

• Saint Francis Hospital 
• Mercy Medical Center
• Saint Mary's Hospital
• Johnson Memorial Hospital
• Mount Sinai Rehabilitation Hospital