What is Informed Consent?

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.

Informed consent should define risks and potential benefits, but also take into consideration alternative treatments. Informed consent is an agreement to do something or to allow something to happen, made with complete knowledge of all relevant facts, such as the risks involved. A healthcare provider or facility may be held responsible for an injury caused by an undisclosed risk. Thus it is especially necessary to get prior informed consent for any invasive procedure or an experimental procedure that may involve human subjects. In many situations, the failure to obtain informed consent is a form of medical negligence, and may even give rise to a cause of action for battery. In any medical trials or experiments that receive federal funding, informed consent must be obtained from any human participant or subject obtaining informed consent is an absolute necessity.

The administrative duty of obtaining the signature on the consent form is not the same as obtaining the consent, which is actually done by the physician. The signature means that the nurse witnessed the patient sign but remember informed consent is NOT the form. True informed consent is explaining to the patient all their rights including their right to not have treatment as well as all pertinent information regarding the treatment or procedure. [iii] Often in legal cases brought to court there was a signed form but some important information was not shared with the patient that would have caused the patient to decline the treatment or undergoing the procedure.

Thus in clinical or research studies additional informed consent must be used to protect the human rights of the subjects. This is especially true if the human subject is going to undergo any evaluation, testing, treatment or procedure that is not part of standard medical care. When the human subject or patient involvement in the clinical or research study might in some way modify or impact the course of their care then they must be provided a study-specific informed consent. There are specific criteria defined by the Institutional Human Investigation Committees. A patient can choose to leave the study at any time for any reason and the patient does not have to give a reason. In addition it is imperative that their decision to withdraw will not impact their further medical care. These standards of informed consent are applicable even when "no standard of treatment" for their condition is even available.

The principle of Free, Prior and Informed Consent is an important human right which has been addressed in many international and domestic laws and practices. The U.S. is party to the Universal Declaration of Human Rights (UHDR), the International Covenant on Civil and Political Rights (ICCPR), the Convention against Torture (CAT), and the International Convention on the Elimination of Racial Discrimination (CERD), all of which must be applied without discrimination based on disability. The U.S. has signed but not yet ratified the Convention on the Rights of Persons with Disabilities (CRPD), as well as the Convention on the Rights of the Child (CRC) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). The human rights of patients are also delineated in the Universal Declaration on Bioethics and Human Rights [iv].

For those who are disabled the human right of informed consent has been repeatedly violated in the U.S. Despite the enactment of the Americans with Disabilities Act (ADA) which prohibits discrimination based on disability in employment, by state and local governments, and in public accommodations, and despite other enactments such as the Rehabilitation Act (of which Section 504 prohibits disability-based discrimination by federal agencies), the Fair Housing Act Amendments, and the Individuals with Disabilities Education Act (IDEA). Despite the policy of non-discrimination articulated by these laws, there are many aspects of federal and state law and policy that are contrary to the principles of the ADA but remain in force.

Often guardianship and the use of surrogate decision-makers is used to circumvent informed consent rather than making an honest attempt to discern the wishes of the person. [i] To refuse to recognize the individual patient's human right to informed consent is contrary to the recognition of the legal capacity of persons with disabilities on an equal basis with others, as required by CRPD Article 12 (to which the U.S. is a signatory) and constitutes discrimination based on disability under UDHR Articles 2 and 6, and ICCPR Article 26.