The overall goal and responsibility of the Essentia Health IRB is to protect the rights and welfare of human subjects involved in research. The Essentia Health IRB ensures that those individuals participating in research are not subject to undue or inappropriate risks, that participation remains a voluntary right, and that the conduct of research is upheld as a privilege.
The IRB's primary authority and foundation are provided by the Code of Federal Regulations:
Office for Human Research Protections
45 CFR 46 - Protection of Human Subjects
U.S. Food and Drug Administration
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 312 - Investigational New Drug Application
21 CFR 812 - Investigational Device Exemptions
The regulations set forth in the Code of Federal Regulations are based largely upon, but not limited to, the following:
Belmont Report
Nuremberg Code
Declaration of Helsinki