Ethics (Informed Consent and Conflicts of Interest)
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The aim of clinical trials is to obtain generalizable knowledge that can be used to advance healthcare. The ethical issues in clinical trials arise when human subjects, who may not directly benefit from the research, are faced with the risk of being exploited or harmed. Additional ethical challenges pertain to informed consent of subjects and conflicts of interest of physician-investigators. The current ethical standards for research are based on guidelines and laws which were a necessary response to historical abuses of participants in the name of science. In this chapter, a framework for evaluating clinical research for ethical deficits is discussed, as are challenges in upholding ethical principles, including in obtaining informed consent from research participants as well as in navigating conflicts of interest.
KeywordsBiomedical research ethics Informed consent Surgical innovation Emergency surgery Conflict of interest
We appreciate the outstanding work of Jukes Namm and Peter Angelos for authoring the first edition of this chapter.
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