Informed Consent

This chapter explores various issues related to informed consent in research including the elements of consent; the moral and legal foundations of consent; research without consent; medical records research; emergency research; consent by parties other than the subject; documentation of consent; general (or broad) consent; tiered consent; readability of consent forms; opt-in vs. opt-out consent; deception in research; payment for research participation; information disclosure standards; (mis) understanding of information disclosed during consent; the therapeutic misconception; the difference between decision-making capacity and legal competence; assent; coercion and undue influence; the relationship between consent and trust; the right to withdraw from research; and empirical studies of informed consent. Although the federal regulations provide considerable guidance pertaining to informed consent, ethical issues still arise due to controversies concerning the interpretation of the regulations, conflicts between ethical principles (e.g., respect for human dignity vs. beneficence) and the need to acknowledge local customs and traditions concerning consent. The chapter argues that trust plays a key role throughout the consent process and that reflecting on the importance of promoting trust can help us address ethical issues pertaining to consent.