The Institutional Review Board’s (IRB) purpose and responsibility is to protect the rights and welfare of human subjects. The IRB reviews and oversees such research to ensure that it meets well established ethical principles and that it complies with federal regulations at 45 CFR 46 and 21 CFR 50 and 56, that pertain to human subject protection, as well as any other pertinent regulations and guidelines, such as the Good Clinical Practice (GCP) Guideline (E6) of the International Conference on Harmonisation. If the research is exempt from IRB review per 45 CFR 46 Section 101(b)(1-6) or 101(i) but involves human subjects or materials, the IRB strongly encourages that the research be reviewed in order to ensure that the subjects are appropriately protected.
IRBs are guided by the ethical principles applied to all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, titled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report"). These principles are defined in the Belmont Report as follows:
Beneficence -- The sum of the benefits to the subject and the importance of the knowledge to be gained so outweigh the risks to the subjects as to warrant a decision to allow the subject to accept these risks.
Autonomy -- Legally effective informed consent is obtained, unless the requirements for waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations.
Justice -- The selection of subjects is equitable and is representative of the group that will benefit from the research.
Assurance of Independence
The IRB has the mandate to act as an independent entity within the corporate structure of FirstHealth of the Carolinas. All decisions made by the Board are binding and cannot be overturned or overruled by FirstHealth of the Carolinas’ administration. The actions of the IRB, its chairperson, members and administrative staff in matters of human subject protection derive from the authority vested under federal regulations, separate and distinct from FirstHealth of the Carolinas.