Institutional Review Board (IRB)

Effective Friday, October 9, 2015, the Saint Francis Hospital and Medical Center Institutional Review Board can be accessed at https://stfrancis.imedris.net. Any submissions made to the IRB need to be made electronically.  

Videos are available to internal Saint Francis investigators and study staff in order to help them understand how the electronic IRB system works. Please view these videos prior to making a submission in iRIS. If you have questions, please contact the IRB office.

Click here to access the video page (Internal Saint Francis use only). 

We look forward to this new system, so please be patient with us as we work through this transition. 

Sincerely,
The IRB
 

The purpose of the Institutional Review Board (IRB) at Saint Francis Hospital and Medical Center (SFHMC) is to protect the rights and welfare of subjects participating in research. It is the policy of SFHMC 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 and Medical Center, Mount Sinai Rehabilitation Hospital, Collaborative Laboratory Services, Asylum Hill Family Medicine Center, Saint Francis Medical Group, Saint Francis Behavioral Health Group, and Saint Francis Care Medical Group. 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 does not have a reciprocal agreement with any other Institution's IRB, with the exception of a cooperative agreement between Saint Francis Hospital and Medical Center (SFHMC) IRB and 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 abides by the Saint Francis Hospital and Medical Center policies and procedures, Catholic Church Directives, Belmont Report, Food and Drug Administration (FDA), and the Office of Human Research Protections (OHRP) federal regulations.

The Saint Francis Hospital and Medical Center IRB has received Full Accreditation by the Association of Human Protection Programs, Inc. (AAHRPP). For more information on accreditation, go to www.aahrpp.org.