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IRB Tutorial

IRB Tutorial > Module 3

Investigator Responsibilities & Informed Consent

Investigators have the primary responsibility for protecting the rights and welfare of human research subjects and are responsible for complying with all applicable provisions of their institution's Assurance. Investigators are expected to be knowledgeable about the requirements of the DHHS regulations, applicable state law, their institution's Assurance, and institutional policies and procedures for the protection of human subjects.

Investigators are responsible for:
Conducting their research according to the IRB-approved protocol and complying with all IRB determinations.

A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by applicable federal, state, or local law. However, such activities may not be considered research nor may the data be used in support of research, except to the extent required under FDA regulations. Investigators should consult with the IRB to ensure that activities that meet the regulatory definition of non-exempt human subject research undergo IRB review and approval prior to the initiation of the activities.


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