Ascension St. John Hospital                           Institutional Review Board

STATEMENT OF COMPLIANCE

The Ascension St. John Hospital registered Institutional Review Board (IRB) operates in accordance to applicable laws, regulations, policies governing IRB operations, and the Religious and Ethical Directives for Catholic Health Care Services. This includes compliance with the International Conference on Harmonization (ICH/Good Clinical Practice (GCP)) guidelines consistent with the United States Food and Drug Administration (FDA) regulations under Title 21 CFR sections 50, 56, 312, and 812, as well as regulations under Title 45 CFR 46 of the Office for Human Research Protections (OHRP).

 

MISSION STATEMENT

The mission of the Ascension St. John Hospital Institutional Review Boards (IRB) is to promote the development of scientific research, to ensure a safe and ethical research environment, and to protect the rights and welfare of the human subjects involved in research activities conducted under its authority.