The IRB has been formed to assure the DHHS that human subjects will be protected and that SFHMC will comply with DHHS Regulations for the Protection of Human Research Subjects (Title 45 Code of Federal Regulations, Section 46) and the ethical principles described in the "Belmont Report". The IRB also ensures compliance with regulations of the Food and Drug Administration, Title 21, Code of Federal Regulations, Sections 50 and 56.

The IRB is composed of 9 to 11 members representing diversity in gender, culture, profession, and discipline.

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. 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 (HIPPA), 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.

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