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Responsibility
All research involving human subjects (as defined below), and all other activities, which even in part involve such research, regardless of sponsorship, must be reviewed and approved by the institution's IRB(s). No intervention or interaction with human subjects in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol. Specific determinations as to the definition of "research" or "human subjects", and their implications for the jurisdiction of the IRB under institutional policy, are determined by the IRB.
The IRB's 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.
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