Informed Consent of the research participant is the most fundamental value of research with human participants of the modern era, and, consequently, one of the most highly regulated.
Most federal agencies adhere to the "Common Rule." The Common Rule (45 CFR 46) consolidated and unified the regulations for obtaining informed consent across most federal agencies. Research at ATSU-MO, usually falls under the Common Rule, unless involving a FDA investigational product (drug, biologic or device).
Informed consent has 3 elements:
- Provision of information
- Asserting comprehension
- Voluntary agreement of the participant
