Know Participant Rights

By definition, the research participant is the person at greatest risk in the research environment - both from the research procedure and from possible abuse in the research relationship. Ethical standards have been developed to control the risk and avoid abuse. The Belmont principles and report were developed in response to the Tuskegee syphilis study. The Belmont Principles of Respect for Persons, Beneficence, and Justice underlie the design of all clinical studies in the US , including the IC process. Derived from the principles are a set of rights defined ethically in the Belmont Report, contractually in the Informed Consent Document (ICD), and legally in 45CFR46 (21CFR for FDA studies).