Informed Consent

N Engl J Med 2017; 376:856-867
Authors: Jeffrey M. Drazen, David P. Harrington, et al
“In the classic interaction in which informed consent is obtained for research, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and then asks the participant to read and sign a detailed written consent document. This traditional prototype is becoming outdated. Informed consent, which is ethically essential in most clinical research, respects persons’ rights to decide whether participation in the research is compatible with their interests, including their interests in protection from exploitation and harm. Required by ethical guidelines and regulations unless explicitly waived by institutional review boards, informed consent is thus a means of protecting the rights and welfare of participants while they contribute to the advancement of knowledge.”
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