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Informed Decision Making and Consent: Principles and Applications
Walter T. Lee MD, MHSc* and Tobi Pledger, DVM, MS, RT (R) MR)(CT)**
** MRI Technologist, Multidimensional Imaging Laboratory, Duke University Hospital, Durham, NC
Address correspondence to:
Walter T. Lee, Duke University Medical Center
Durham, NC 27710.
Email: firstname.lastname@example.org; Ph: 919-681-8449.
This manuscript has been read and approved by the authors.
Disclosures: The authors report having no significant financial or advisory relationships with corporate organizations related to this activity.
Historically there have been many examples of people being experimented on without their knowledge or consent. Medical treatments were given or withheld, surgeries were performed, and people were killed in various and sometimes extremely cruel ways. This was done in the name of scientific curiosity and advancement of medical knowledge. Codes of conduct were eventually created to prevent these types of activities from happening, but because they were not enforced they were often disregarded. The principle of patient/subject autonomy is the basis for the process of informed decision making and consent. This process has 3 essential components: information, comprehension, and voluntariness. The patient or research subject needs to be given information about the proposed procedure, including the expected benefits and risks, a description of what to expect during the procedure, and available alternative procedures. This information should be presented in a private environment, in language that is easily understandable. The patient/subject should be allowed time to consider the procedure and ask any questions he or she may have. After these 2 steps, if the patient/subject decides to proceed with the procedure, informed consent is given with the understanding that it can be revoked at any time the patient/subject chooses. It is important to be aware of the policies at your facility or institution regarding who can obtain informed consent and which procedures require it. The Institutional Review Board (IRB) is the best source of information about the informed consent process for research activities. Its purpose is to protect patient/subject safety and voluntariness, as well as to validate the scientific integrity of a proposed research activity. In the clinical setting, patient informed decision making and consent are also extremely important, from both ethical and legal perspectives.
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