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What is Informed Consent?

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Engaging in an informed-consent process between a clinical doctor and a patient should be an essential part of the standard of care in medicine. Informed consent is a process, not just a formality, and engaging in that process is of the essence of good medical care. Information must be provided to the patient in a timely manner and in accordance with the accepted standard of practice among members of the profession with similar training and experience. A health care professional may be legally liable if a patient does not give "informed consent" to a medical procedure and it results in harm to patient even if the procedure is properly performed. In a legal case Meador v. Stahler and Gheridian (Middlesex Superior Court C.A. No. 88-6450, Mass. 1993) a woman, Mary Meador, and her family were awarded approximately $1.5 million for damages resulting from a cesarean section which Meador claimed she neither wanted nor needed. As many patients do, Mary Meador signed a pro forma informed consent paperwork after being told that the cesarean section would only be done in case of an emergency. The minimal requirements of pro forma standard informed consent [i] are that the physician must obtain the patient's consent after informing the patient of the material risks of the proposed procedure. Meador's physicians did meet this minimal requirement. But the physicians in this case did not give Mary Meador the benefit of a dialogue to discuss the decision to have surgery rather than a vaginal birth and disregarded her wishes to give birth vaginally even when she was well into labor. Dr. Harold J. Bursztajn, Associate Clinical Professor and Co-Director, Program in Psychiatry and the Law, Harvard Medical School at the Massachusetts Mental Health Center, was the forensic psychiatrist providing testimony regarding the Post Traumatic Stress suffered by Mary Meador when the cesarean surgery was performed against her wishes and without the expedient circumstances of an emergency to justify the need for surgery. There were residual physical complications of the cesarean section as well as feeling of helplessness and horror that resulted from the sudden devastating loss of control the patient felt when the surgery was performed against her wishes. A thorough and ongoing informed-consent process must be one in which medical doctors engage in a positive process of discussion with patients and families, so that grief, misplaced blame, and feelings of helplessness, powerlessness, and abandonment do not lead to a bad outcome and precipitate a malpractice lawsuit. Adequate informed-consent process is not just a risk management process, it is good medical practice.

In the medical field, good clinical practice is to adhere to the standards of informed consent. Informed consent as practiced in hospitals and clinics in the United States is reviewed and approved by an Institutional Investigational Review Board (IRB). [ii] But as the case above demonstrates, a simple adherence to the letter of the law, without true adherence to the actual principles of fully informed consent, is not sufficient for true quality medical care. General guidelines, such as those proposed by the AMA require patients to be informed of:

1) the nature of their condition and the proposed procedure,

2) the purpose of the procedure,

3) the risks and benefits of the proposed treatments,

4) the probability of the anticipated risks and benefits,

5) alternatives to the treatment and the associated risks and benefits,

6) the risks and benefits of not receiving the treatment or procedure.

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