Research in emergency situations: the role of deferred consent
Article Abstract:
Federal regulations that govern research in emergency settings must be changed. Patients in critical condition may be unable to provide informed consent for investigational treatments. The concept of deferred consent was proposed in 1980 to allow some uncommunicative, critically ill patients to participate in medical research. After a period of time, relatives of these patients must authorize permission for continued participation or the patient is withdrawn from the study. In 1993, federal agencies stipulated that deferred consent must fulfill the criteria required for informed consent waivers. These criteria require that interventions entail minimal patient risk. The minimal risk standard was originally intended to apply to interventions that would not directly benefit the patient. It is an irrelevant standard for emergency research that offers direct patient benefit.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1995
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The need to revise the Declaration of Helsinki
Article Abstract:
The Declaration of Helsinki needs to be revised to eliminate unintended errors and make the document consistent with contemporary ethical concepts. The document makes a distinction between therapeutic and non-therapeutic research where no such distinction should be made. Another provision says that using a placebo is unethical if there is a proven treatment. Another says that patients should be offered the best treatment for a disease, even if they live in developing countries that cannot afford such treatments. For these reasons, the document should be modified.
Publication Name: The New England Journal of Medicine
Subject: Health
ISSN: 0028-4793
Year: 1999
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Enforcing patient preferences: linking payment for medical care to informed consent
Article Abstract:
One method of preventing treatment to which the patient has not given is to tie the consent process to the third-party payment process. Insurers would not cover procedures that the patient or surrogate does not authorize. Certain conditions are presently and would continue to be excluded, including life-threatening emergency or patient waiver of the right to be informed. If this strategy were implemented, hospitals would create review boards to monitor informed consent, as many already do for questions of necessity, appropriateness and quality of health care.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1989
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