Informed consent.
In the last half century, informed consent has become a central tenet of all research involving human subjects. However, even after the worldwide adoption of regulations aimed at ensuring the protection of subjects, some abuses continue. The installation of oversight bodies, such as institutional review boards, has prevented the bulk of deliberate mistreatment; however, unintentional coercion is still a problem. Informed consent is not limited to obtaining a signature on a consent form, but a process of decision making designed to protect the rights of patients and subjects. It is a constant, ongoing exchange of information between researcher and subject. Although research is invaluable to the advancement of medicine and transplantation, researchers have the responsibility to protect their subjects' rights and autonomy. This paper provides an overview of informed consent, principles behind the process, and implications of current regulations to assist readers in their endeavor for sound and ethical research.
Zink
Sheldon
S
Center for Bioethics, Philadelphia, PA, USA.
Wertlieb
Stacey
S
Kimberly
Laura
L
D004282:Documentation; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D014481:United States; D035862:Vulnerable Populations