The Essentia Health IRB reviews research projects which involve human subjects and evaluates all components to ensure adequate protection and informed, uncoerced consent.
The Essentia Health IRB processes for the protection of human research participants are guided by Federal Regulations. The Department of Health & Human Services (HHS) Office for Human Rights Protections (OHRP) oversees the operations of the IRB and the Food and Drug Administration (FDA) enforces regulations for the use of experimental drugs and devices.
The IRB tracks every research project’s progress, even before participants are recruited. Each project is reevaluated at least annually and the IRB works with investigators to modify projects to ensure adequate protection for its participant’s welfare.
The Essentia Health IRB is charged with the responsibility to review all proposed research in order to ensure that the rights of research participants are protected and that the risk of harm to participants is minimized.
Authority and Purpose
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:
Declaration of Helsinki
The Essentia Health IRB will:
- have at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;
- make every nondiscriminatory effort to ensure that the membership is not composed of entirely men or entirely women;
- include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas;
- include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution;
- not allow any member to participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
Through its Federalwide Assurance (FWA), Essentia Health commits to The Department of Health & Human Services (HHS) that it will comply with the requirements in the Protection of Human Subjects regulations at 45 CFR part 46.
Essentia Health FWA#: FWA00000635
To verify the status of Essentia Health's FWA, click here.
For more information regarding OHRP's role in the FWA, click here.