from Part II - The Building Blocks of a Study
Published online by Cambridge University Press: 25 May 2023
This chapter focuses on informed consent, the cornerstone of conducting ethical human subjects research. It presents a brief history of the origins of informed consent to research and reviews codes, guidelines, and regulations that have been established in response to ethical violations carried out in the name of science. The chapter reviews the essential elements of consent (i.e., intelligence, knowingness, and voluntariness) and discusses challenges that researchers may encounter within each of these areas. Importantly, it approaches consent as an ongoing process rather than a one-time-event and presents practical and empirically supported strategies that researchers can apply to assess and enhance individuals’ capacity, understanding, and autonomy as it pertains to research participation. Additional topics discussed include assent to research that involves children, electronic and multimedia consent, and consent to research using biospecimens.
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