Ascension St. John Research

Regulatory Charge

The St. John Hospital and Medical Center IRB was established to protect the rights and welfare of human research subjects. The IRB is charged with ensuring those individuals who participate in research are not subject to undue or inappropriate risks, that their participation remains a voluntary right, and that the conduct of the research is above reproach.

The basis for the St. John Hospital and Medical Center policies and IRB charge is found in the Code of Federal Regulations (CFR). The CFR requires that each institution engaged in the conduct of research involving human subjects provide a written assurance of compliance with the requirements set forth in those regulations. This document is referred to as a Federalwide Assurance (FWA) for the Protection of Human Subjects for Institutions Within the United States.

Governing Principles

The IRB's authority is founded in and guided by many sources, including regulatory statutes, institutional policies, ethical canons, and members own perceptions of community and professional standards.

While interpretive differences between these governing principles may exist, it should be noted that regulations offering the most stringent guidelines for the protection of human subjects must be followed. Furthermore, these principles are to be upheld without regard to whether the research is subject to federal regulation, with whom the research is conducted, or the source of support for the research.