The Belmont Report considers the third principle of Justice. During the 19th and early 20th century, the burden of serving as research subjects fell largely upon poor ward patients, while the benefits of knowledge and improved medical care flowed primarily to private patients. This violated the basic ethical principle of Justice. This opportunity is provided when adequate standards of informed consent are met. Specific items for disclosure generally include the research procedure, the purposes of the procedure, the risks and anticipated benefits, alternative procedures where appropriate, the provision to ask questions, and the freedom to withdraw at any time.
Comprehension is the second of the three elements of the informed consent process.
It is critical that the subject understand the information conveyed. Since the ability to understand is a function of intelligence, maturity, language, it is necessary to adapt the presentation of information to the subject s capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. Voluntariness is the third of the three elements of the informed consent process. Coercion is defined as an overt threat of harm to obtain compliance.