Comprehension of informed consent for research: issues and directions for future study.
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Quality in, quality out. The consent process can be complete and realistic or it can be a sham. The key is in whether physicians listen to parents' questions and answer them. It must be certain that information is given on what is happening, that the parent is told what could happen in the specific treatment involved, and that the information given is up-to-date. The law views each family as a unique entity with its own personal bundle of hopes, fears, and concerns, and views the consent process in the light of this subjective standard. Would the family consent to this treatment if it was disclosed that the treatment might result in sterility, mental dysfunction, or limb loss? Is there a risk that this child could become severely brain-damaged? Are there alternative treatments? A parent's decision as surrogate for a child can only be as good as the information that physicians provide.
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The patient, as a health care consumer, has a fundamental right to determine what shall be done to his or her own body. The doctrine of informed consent has evolved to protect that right. This article represents a review of the literature regarding the informed consent process in medicine, with an emphasis on consent for anesthesia. A brief history of informed consent is provided, as well as discussion of the controversies surrounding the topic. Several court cases are cited, and the opinions of various authors reflect the wide range of legal and ethical implications associated with informed consent.
After a patient died in a Veterans Administration hospital, a resident physician asked the next of kin to sign two identical autopsy forms, one of which was stamped "Eye Donor." The family signed, despite orally objecting to donation of tissue. Nevertheless, the patient's eyes were removed because other hospital staff were unaware of the objection. The family sued the hospital and eye bank. The Federal District Court in Minnesota dismissed the case before trial on the basis that both defendants were immune from liability because of the Uniform Anatomical Gift Act. Clear policies communicated to staff and separate autopsy and donation forms can help to avoid confusion and legal difficulties.
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