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Jan-Mar2004-12(1)
SELECTED SUMMARY
Informed consent
Bashir Mamdani
Bashir Mamdani
Mazur D.J. Influence of the law on
risk and informed consent. BMJ 2003;327:731-5
Obtaining informed consent is now a routine part of
both clinical practice and research, but the focus on giving information about
risk has evolved differently in clinical and research settings. The law has
played a large part in informed consent in clinical practice. Consent in
clinical research has been codified in international regulations.
Informed consent related to clinical care
has evolved through legal cases
In clinical care, disclosure of risk developed from
the obligation on doctors to obtain their patients' consent before intervening
medically. Gradually the notion of consent evolved into informed consent, with
the emphasis being on information about risks. The professional standard of
consent to treatment has been espoused as a judicial concept since a British
case in 1767 in which the physician initially set the patient's femoral fracture
in accordance with practice at that time but at a follow up visit re-broke the
healing fracture and placed the re-broken bone in a newly invented mechanical
device with teeth. The judge concluded that obtaining a patient's consent was a
custom of physicians and ruled for the patient that consent should have been
obtained by the physician as part of his professional duties. Thus consent was
judged under 'professional standard of behaviour'.
Much later, the notion of information became linked
to consent. The term 'informed consent' was first introduced into the judicial
lexicon in 1957 in the written opinion of an appellate court judge in California
and a new judicial standard-the reasonable person standard-was established by
Judge Robinson in 1972 whereby the decision about whether a patient should have
been informed of a risk is based on whether a reasonable person in that
patient's position would want to be informed. Many countries have adopted this
standard or are moving towards it.
The primary use of the concept of informed consent
in the courts is in retrospective decision-making after an injury. Only
derivatively is informed consent a prospective view on what a physician should
say to a patient. Indeed, court views of informed consent also include a
therapeutic privilege for physicians not to inform a patient who may be harmed
by the disclosed information.
If a patient makes an explicit instruction not to
be told of risks, this request should be honoured. However, the question remains
whether family members or partners should be informed if the patient does not
want to be told about risks. Cultural issues may also arise, for example, in
Japan, the cultural practice has been not to inform a patient that he or she has
a terminal illness.
The courts, however, require information to be
disclosed to the patient in a discussion with the physician. Thus, simply
handing patients a consent form may not be considered enough by the courts
unless the issues are discussed with patients and they have an opportunity to
ask further questions.
Another issue is the fact that much of the
discussion of risks of invasive procedures still takes places when the patient
is admitted for the intervention. Informed consent in clinical care in the US is
usually obtained by the physician performing the procedure. But the hospital
also has a role in overseeing informed consent.
Informed consent in clinical research is
more regulated and requires more a structured approach to disclosing risk
information
The Declaration of Helsinki forms an important
basis for the conduct of research in humans. The Belmont report (1) rejects the
'professional standard' and 'reasonable person standard' and instead recommends
the use of the 'reasonable volunteer standard'. The need for patients to fully
understand is greater in clinical research because participation is voluntary,
alternatives may exist, and the participant may not benefit and could be harmed
by participation. As a result, more emphasis has been put on detailing
information that must be disclosed to people considering participating in a
clinical study. Informed consent forms contain an increasing array of
information. The US Code of Federal Regulations also specifies vulnerable groups
who need extra protection because the potential for their unethical use in
research. These groups include children, prisoners, pregnant women, and people
who are mentally disabled, economically or educationally disadvantaged. Clearly,
the concern is that these groups may not fully understand the nature of research
and the fact that research is not clinical care.
Judicial view does not provide an inclusive
enough for communicating risks and alternatives
The judicial system has played an important role in
developing informed consent. However, it cannot provide an all-inclusive
framework for the multiple problems that exist in communicating information
about risk for all the circumstances that physicians are confronted with in the
real world. We need to bring in perspectives from cognitive psychology, the
decision-making sciences, and consumers to help clinicians overcome a broader
range of conversational dilemmas.
Commentary
Informed consent became an integral part of
clinical practice in the 1970s. Initially, informed consent was taken more for a
perceived legal protection than with the intent to provide information to the
patient. This created some farcical situations. In 1973, while I was a fellow at
Cook County Hospital in Chicago, the hospital administration decreed that the
then current three or four patient consent forms for invasive procedures would
be replaced by more than 70 forms, each designed for a specific clinical
setting. Thus there were forms for performing a history and physical
examination, for starting an intravenous infusion, for transfusions, a special
one for biopsy of each organ etc. This flurry of legal activity was clearly
precipitated by the 1972 California decision referred to in the above article.
The hospital administration, inexperienced in the nuances of tort law,
overreacted. A lot of attention was placed on the form and not the substance of
the law.
In academic medicine, as teaching of medical ethics
became formalized, starting in the 1970s, moral principles of respect for
autonomy (the obligation to respect the decision-making capacities of autonomous
persons); non-malfeasance (the obligation to avoid causing harm); beneficence
(obligations to provide benefits and to balance benefits against risks): and
justice (obligations of fairness in the distribution of benefits and risks),
enunciated by Thomas Beauchamp and Daniel Callahan, assumed a central role.
Thirty years later, informed consent is still
written with the intent to protect the medical profession from lawsuits. Partly,
this results from the fact that informed consent becomes an issue only in
retrospect, as the above article points out. However, the law cannot script the
consent as it has scripted the Miranda warning given by the arresting officer to
a suspect-every word is loaded with meaning and shortening the recitation can
invalidate the arrest. Therefore, what should be included in an informed consent
is still a matter for debate and research. It is important to convey the
probability of success in simple language and, to point out the element of
uncertainty, without scaring the patient. The language should avoid medical
jargon. In the USA, the form must be readable and understandable to a person who
has studied up to the sixth grade. In India, where the majority possess only
rudiments of literacy, the language would have to be even simpler. Perhaps,
pictures would be more effective than words in conveying what procedure is being
planned.
We often assume that resources are infinite and
every patient has a right to decide and get any procedure done that is deemed
necessary. But, as we know, and as pointed out by Professor Bloche (2), in many
clinical situations, each choice is accompanied by substantial monetary and
social costs that are ignored by clinicians when discussing therapeutic options.
Should these not be spelled out and be a part of the consent process? Should
discussions involving allocation of scarce family financial resources or
assumption of responsibilities by other family members remain a matter for
family dynamics and not be 'medicalised' by being included in the consent
process? Should the family become involved only when there is cognitive
impairment? In India, a patient often lets someone else make decisions for care,
then, should this surrogate sign the form in addition to the
patient?
A great deal needs to be learned about the content
of the 'informed consent' form, the ways to explain the intricacies of risk in
modern medicine, the psychosocial processes involved in decision-making, before
we can be rest assured that a truly informed patient has made a wise
decision.
References
1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical guidelines for the protection of human subjects of research. Washington, DC: DHEW Publications, 1978,http://ohsr.od.nih.gov/mpa/belmont.php3 (accessed August 21, 2003).
2. Gregg BM. Rights and efficiency in American health law. Human Rights: Journal of the Section of Individual Rights and Responsibilities 1998;25:19.
1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: ethical guidelines for the protection of human subjects of research. Washington, DC: DHEW Publications, 1978,http://ohsr.od.nih.gov/mpa/belmont.php3 (accessed August 21, 2003).
2. Gregg BM. Rights and efficiency in American health law. Human Rights: Journal of the Section of Individual Rights and Responsibilities 1998;25:19.
BASHIR MAMDANI, 811, N. Oak Park Avenue, Oak Park,
Illinois 60302, USA. e-mail:bmamdani@comcast.net