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.

Children and young people have limited or no ability to make their own medical choices. Parents and guardians often are not given full information about treatment options. In the foster care system parents lose custody of their children and the children are not permitted to refuse treatment or have any meaningful input into the treatment they receive. Thus in the U.S.A we have a system of institutionalized injustice to minors entrusted to the Foster Care system. Coming from backgrounds of abuse and trauma, these emotionally vulnerable young people are exposed to physical, emotional, psychological and sexual abuse often occurs in youth psychiatric facilities. Often these young people have committed no crime but are detained against their will and decisions about their care is made based on the type of health insurance they have (public or private) rather than their health needs. In the U.S. institutions are often overcrowded, poorly maintained. This is both unjust and discriminatory. Not surprisingly foster children exposed to such situations are unable to adjust to independent living when they reach adulthood and end up in large numbers in the U.S. prison system as adults. In addition the pharmaceutical industry's successful marketing of drugs to this captive population of children has lead to children as young as two years old given mood stabilizers and antipsychotics even before they are even able to speak. It is estimated that over 8 million children are drugged in the U.S.A. with 1,300 deaths due to this practice. [ii]

The Court of Appeals case Rivers v. Katz[iii], governs compulsory inpatient treatment in New York. Rivers established that involuntary "patients" have the right to refuse treatment if they are capable of making rational decisions about treatment, however, if found "incapable," the court may order compulsory treatment based on its assessment of factors such as risks and benefits. Courts nearly always find incapacity and order compulsory treatment, without giving reasons, suggesting that "incapacity" is difficult to separate from a diagnosis of mental illness. The use of a capacity standard to deprive people of the right to control their own body and health discriminates based on disability, and violates U.S. obligations under Universal Declaration of Human Rights. [iv]

In situations of civil commitment[v] and compulsory mental health treatment the U.S. Supreme Court recognizes that although there are infringements of the liberty interest (a Constitutional Right) but asserts that these infringements are justified by state interests. [vi] These practices pose a serious violation of mental and physical integrity by their close connection with disability-based discrimination, as analyzed by UN Special Rapporteur on Torture Manfred Nowak.[vii]

To be in compliance of international recognized standards regarding the human right of informed consent the U.S.A. should ratify the CRPD, CRC and ICESCR without any reservations, understandings or declarations, and without further delay. It is important that the standard for review of disability-based discrimination under the U.S. constitution be consistent with the common standard under international law for discrimination based on race, sex and disability. In addition we should ensure that guardianship is abolished and replaced by a system of support for people to make their own decisions. There should be a comprehensive review at both the federal and state levels, with the participation of persons with disabilities to abolish all laws and mechanisms that restrict the legal capacity of any person especially those with disabilities, and to create supportive measures for the exercise of legal capacity that respect the will and preferences of the person.[viii]

For reference I summarize the Principles of the Universal Declaration on Bioethics and Human Rights below.

The Universal Declaration on Bioethics and Human Rights

Principles

Within the scope of this Declaration, in decisions or practices taken or carried out by those to whom it is addressed, the following principles are to be respected.

Article 3 Human dignity and human rights

1. Human dignity, human rights and fundamental freedoms are to be fully respected.

2. The interests and welfare of the individual should have priority over the sole interest of science or society.

Article 4 Benefit and harm

In applying and advancing scientific knowledge, medical practice and associated technologies, direct and indirect benefits to patients, research participants and other affected individuals should be maximized and any possible harm to such individuals should be minimized.

Article 5 Autonomy and individual responsibility

The autonomy of persons to make decisions, while taking responsibility for those decisions and respecting the autonomy of others, is to be respected. For persons who are not capable of exercising autonomy, special measures are to be taken to protect their rights and interests.

Article 6 Consent

1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.

2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law.

3. In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual's informed consent.

Article 7 Persons without the capacity to consent

In accordance with domestic law, special protection is to be given to persons who do not have the capacity to consent:

(a) authorization for research and medical practice should be obtained in accordance with the best interest of the person concerned and in accordance with domestic law. However, the person concerned should be involved to the greatest extent possible in the decision-making process of consent, as well as that of withdrawing consent;

(b) research should only be carried out for his or her direct health benefit, subject to the authorization and the protective conditions prescribed by law, and if there is no research alternative of comparable effectiveness with research participants able to consent. Research which does not have potential direct health benefit should only be undertaken by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden and, if the research is expected to contribute to the health benefit of other persons in the same category, subject to the conditions prescribed by law and compatible with the protection of the individual's human rights. Refusal of such persons to take part in research should be respected.

Article 8 Respect for human vulnerability and personal integrity

In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.

Article 9 Privacy and confidentiality

The privacy of the persons concerned and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, in particular international human rights law.

Article 10 Equality, justice and equity

The fundamental equality of all human beings in dignity and rights is to be respected so that they are treated justly and equitably.

Article 11 Non-discrimination and non-stigmatization

No individual or group should be discriminated against or stigmatized on any grounds, in violation of human dignity, human rights and fundamental freedoms.

Article 12 Respect for cultural diversity and pluralism

The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.

Article 13 Solidarity and cooperation

Solidarity among human beings and international cooperation towards that end are to be encouraged.

Article 14 Social responsibility and health

1. The promotion of health and social development for their people is a central purpose of governments that all sectors of society share.

2. Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, progress in science and technology should advance:

(a) access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good;

(b) access to adequate nutrition and water;

(c) improvement of living conditions and the environment;

(d) elimination of the marginalization and the exclusion of persons on the basis of any grounds;

(e) reduction of poverty and illiteracy.

Article 15 Sharing of benefits

1. Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the international community, in particular with developing countries. In giving effect to this principle, benefits may take any of the following forms:

(a) special and sustainable assistance to, and acknowledgement of, the persons and groups that have taken part in the research;

(b) access to quality health care;

(c) provision of new diagnostic and therapeutic modalities or products stemming from research;

(d) support for health services;

(e) access to scientific and technological knowledge;

(f) capacity-building facilities for research purposes;

(g) other forms of benefit consistent with the principles set out in this Declaration.

2. Benefits should not constitute improper inducements to participate in research.

Article 16 Protecting future generations

The impact of life sciences on future generations, including on their genetic constitution, should be given due regard.

Article 17 Protection of the environment, the biosphere and biodiversity

Due regard is to be given to the interconnection between human beings and other forms of life, to the importance of appropriate access and utilization of biological and genetic resources, to respect for traditional knowledge and to the role of human beings in the protection of the environment, the biosphere and biodiversity.

[i] Guardianship keeps people in institutions and negates the right of people with disabilities to exercise legal capacity, an aspect of the right to recognition as persons before the law, in violation of UDHR Articles 2 and 6, and ICCPR Article 26, and in violation of CRPD Article 12.

[ii] United States ex rel Law Project for Psychiatric Rights v. Matsutani, et al.

US District Court, District of Alaska, Case No. 3:09-cv-0080-TMB.

[iii] 67 N.Y.2d 485 (1986).

[iv] UDHR Articles 2, 3, 6 and 25, ICCPR Articles 7 and 26, CAT Articles 2 and 16, and CRPD Articles 12, 15, 17 and 25. CRPD Article 12 establishes that persons with disabilities have legal capacity on an equal basis with others in all aspects of life, including the right to make decisions about mental health treatment. See A/63/175, paragraphs 44 and 73-74.

[v] Civil commitment laws create a separate regime of detention and involuntary treatment applicable only to persons with psychosocial disabilities that is discriminatory in purpose and effect, contrary to U.S. obligations under UDHR Articles 2, 3 and 5, ICCPR Articles 2, 7 and 9, and CAT Articles 2 and 16, as well as CRPD Articles 14, 17 and 25.

[vi] Addington v. Texas, 441 U.S. 418 (1979) (civil commitment); U.S. v. Sell, Riggins v. Nevada, 504 U.S. 97 (1992).

[vii] See U.N. Doc. A/63/175 (2008), particularly paragraphs 40, 44, 47, 49, 50, 61-65, 73-74. This amounts to inadequate constitutional protection for persons with disabilities from practices that may constitute torture or ill-treatment, and violates U.S. obligations under UDHR Articles 2, 3 and 5, ICCPR Articles 2, 7 and 9, and CAT Articles 2 and 16, as well as CRPD Articles 4, 5, 15 and 17.

[viii] United States of America, Submission to the United Nations Universal Periodic Review Ninth Session of the Working Group on the UPR, Human Rights Council, 22 November 3 December 2010, Human Rights of Persons with Disabilities