
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.
C
hildren 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 treat
me nt 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