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. Undue Influence is defined as excessive, unwarranted, inappropriate, or improper reward to obtain compliance, especially with vulnerable subjects. This process presents both an opportunity and a responsibility to gather systematic and comprehensive information about the proposed research. For the investigator, it is a means to examine whether research is properly designed.