Medical Decision Making: Informed Consent in Pediatrics and Pediatric Research
Written by:
Beth Newbury Whitstone, RN, BSN
Cardiology Research Nurse
Medical College of Wisconsin/ Children's Hospital of Wisconsin
Edited by: Mona Barmash
Posted: September 15, 1999
Updated: March 26, 2004
Informed consent refers to the active
involvement of a patient in understanding and agreeing to medical
treatment. This idea has only formally developed over the past
century. Before that time, the traditional model of medicine placed
the responsibility for treatment decisions mainly in the hands of
physicians. It was generally assumed that since most people lacked
medical training, they would be unable to understand all of the
benefits and risks of proposed treatments and to make choices about
them.
The concept of informed consent has its roots in
the 1891 Supreme Court declaration that individuals have a right to
self-determination. In 1914, a patient sued his physician because
the doctor performed an unauthorized surgical procedure on the man (Schloendorff
v. Society of New York Hospital). This case led to the following
statement by Justice Cardozo: "Every human being of adult years and
sound mind has a right to determine what shall be done with his own
body".
A corollary to this idea was that a patient also
had the right to refuse treatment. Several more recent historical
events, including the Nuremberg trials and court cases such as Salgo
v. Leland Stanford Jr. University Board of Trustees and Canterbury
v. Spence, firmly rooted the idea that physicians should disclose
all information necessary for patients to make decisions, and should
obtain permission before proceeding with treatment. Public awareness
about the concept of patient autonomy has steadily increased, and an
atmosphere of shared medical decision-making has evolved.
Our culture now accepts and even expects that
patients will participate in making decisions about their medical
care. In order to do so, patients and families must first understand
what is involved in medical decision-making. A main component of the
shared decision-making model is the doctrine of informed consent.
What exactly is informed consent?
From a legal standpoint, informed consent means that
"physicians should disclose to patients all information 'material'
to making a decision whether to undergo or forgo a proposed
treatment or diagnostic procedure" (Lidz et al, 1988). Practically
speaking, it means that whenever possible, the patient has been told
about and understands all of the risks and potential benefits of a
treatment.
In order to give informed consent, the patient
must possess decision-making capacity. The conclusion that a patient
is decisional is based on the judgment of medical providers, and is
not the same as the legal concept of "competence". Decision-making
capacity refers to the idea that a patient has the ability to
understand the proposed treatment and its alternatives, including
risks and benefits, and make an informed choice about whether or not
to have the treatment.
Informed Consent in Pediatrics
When the decision-making model is applied to the area
of pediatrics, the concept of informed consent changes. Because most
children don't have a legal right to consent to their own treatment,
the authority still lies in the hands of parents or legal guardians
who give their permission for treatment to take place. Since the
parent or guardian is agreeing to treatment not for themselves, but
for their child, the concept becomes that of informed permission, or
"consent by proxy". This lack of power makes children
especially vulnerable, and therefore in need of special attention in
treatment and research.
If a physician feels that a parent does not
possess decision-making capacity, he or she has an obligation
to involve others for assistance in making treatment decisions. This
could include an assessment by a psychologist or psychiatrist to
evaluate the competence of the parent. In the event that a parent is
found to lack decision-making capacity, the courts may become
involved. A guardian ad litem (someone who is appointed by the
courts to protect the safety and welfare of the child) may be
assigned solely to make medical decisions for the child. In most
cases where this happens, the parent retains custody of the child.
There are several situations in which minors may
make their own health-care decisions. One example of this is
legal emancipation. Once a minor is declared by a court to be
emancipated, he or she is treated as an adult for all purposes
including medical treatment and informed consent.
Legally, emancipated minors include those who are
self-supporting and/or not living at home, married, pregnant or a
parent, or in the military. Similarly, some states give health-care
decision-making authority to mature minors who are otherwise
unemancipated, such as those who are seeking treatment for certain
medical conditions such as pregnancy, sexually transmitted diseases,
or drug or alcohol abuse. In these unique situations, a minor is
able to give consent to treatment without permission of the parent
or guardian.
Signing Consent Forms for Treatments/Procedures
There are several essential steps in this process.
First, informed consent requires that parent(s) be given all the
information necessary to understand what a proposed course of
treatment will entail. This includes practical issues such as how
long the treatment will last or the amount of time it takes to do
the procedure, what exactly is involved in the treatment or
procedure, and how long it will take until the child can resume
his/her normal activities. The parent should not be afraid to ask
specific questions.
Next, the patient and parents must be told
about all alternative treatments, including the option of no
treatment, and what could be expected to happen if each of the
alternatives were chosen. Potential risks and benefits of all
treatments must be disclosed in order to make an informed choice,
and the parent must weigh them. In emergencies, it is not always
possible to have a full discussion of all the aspects of each
treatment or procedure. However, whenever possible, the parent
should have a thorough understanding of all proposed treatments,
their alternatives, and the potential risks and benefits of each
before the consent form is signed.
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Questions for Parents to Ask
Before Consenting to Treatment
- Have you told us about all of the possible
options?
- What are the risks of this treatment?
- How many other patients have you treated
with this condition? What have their outcomes been like?
- (When referring to a procedure) How many of
these procedures have you performed?
- (If in a teaching hospital) Will you be
doing the procedure yourself, or will a resident or fellow be
performing it?
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In the event that these questions are not answered
to the parent's satisfaction, it is not unreasonable to ask for more
information. This might even include seeking a second opinion from
another physician.
Pediatric Research
Until recent years, children were not included in
research most of the time. However, due to the recognition of the
need for pediatric-based research and subsequent policy developments
at both the Food and Drug Administration (FDA) and the National
Institutes of Health (NIH), there has been a significant increase in
the past few years in research involving children.
For example, many medications commonly used in
children have never actually been tested in the pediatric
population. In response to this, the FDA has written new regulations
stipulating that any medication used to treat children needs to be
tested on children. In the same way, the NIH recently established
guidelines for the inclusion of children in all NIH-supported
clinical research trials.
Because of these developments, we can predict a
dramatic increase in the number of future clinical studies involving
children, and it seems likely that many parents of children with
chronic health conditions can expect to be asked to participate in
research at some point.
It is important for families to understand the
differences between treatment, therapeutic research, and
non-therapeutic research:
Treatment refers to actions that have a proven
benefit for a particular condition. Examples of this include
antibiotics to treat bacterial infections, placement of a cast for
broken bones, and providing intravenous fluids to treat dehydration.
Because these treatments are routinely accepted to be beneficial, a
separate consent form may or may not be obtained. A separate consent
form usually is obtained for most invasive procedures such as
surgery or lumbar puncture.
Therapeutic research involves treatments
that may improve the child's condition and thus be of benefit to him
or her personally, but has not yet been proven to work. Examples of
this include clinical drug trials and the use of experimental
medical devices.
Nontherapeutic research does not normally
benefit the research subject directly, but is done to provide
information about future treatments to others. An example of this
might be a study of different coping mechanisms in chronic illness.
Both therapeutic and nontherapeutic research
provides useful and important information. However, parents
should be aware that they always have the option not to participate
in research.
When an investigator or the investigator's
representative approaches a family about participation in a clinical
study, there are several obligations that should be met:
- Information about the study must be provided in
understandable language.
- The investigator must make a judgment about
whether the child and family understand the information they have
been given, and about whether the family members have
decision-making capacity.
Finally, it is the responsibility of the
investigator to ensure that the child and family realize that they
have the freedom to choose the option of not participating in the
research without fear that quality of care will be affected.
Parents who choose to participate in clinical
research have responsibilities as well. One major responsibility is
to read and understand the entire form, paying special
attention to the sections related to potential risks. Parents
should weigh the potential risks of participation against the
potential benefits to the child, and whether those risks seem to be
reasonable.
Parents are also obligated to ask questions about
anything they do not understand. A good consent form will answer the
following questions:
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Questions to Ask
- Who are the investigators?
- Why has my child been asked to participate?
- What is the purpose of the study? Is this
therapeutic or nontherapeutic research?
- What exactly is involved? What do I/my
child have to do?
- What are the risks? Will it cost us
anything to be involved in this study?
- What are the possible benefits to us? Is
there any financial compensation for participating in this
study?
- Who should be contacted if we have further
questions?
- How will the information from this study be
used?
- Will our identities be kept confidential?
Who will have access to the information?
- If we choose to end our participation in
this study, what are the consequences? Will our child's care
be affected in any way?
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Before the form is signed, the patient and/or
parent need to understand the answers to these questions. Once a
form has been signed, patients/parents should be given a copy of it.
If a family has made the commitment to participate in research, they
have a responsibility to follow through on their responsibilities.
However, if participation in any study becomes too much of a burden,
patients/parents should understand that consent may be withdrawn
at any time without affecting quality or quantity of care.
Summary
In conclusion, when parents are asked to give
permission for either medical treatment or clinical research for
their children, they should take special care to understand what
they are signing. All questions should be answered to the
satisfaction of both parent and child, and benefits and risks
weighed. An important goal in any medical treatment decision,
including the decision to participate in research, should be
consensual agreement to the plan and informed permission to proceed.
For additional information, please see:
Informed
consent for pediatric research: Is it really possible?. E. Kodish. The
Journal of Pediatrics, Volume 142, Issue 2, Pages 89 - 90
Do
they understand? (part I): parental consent for children participating in
clinical anesthesia and surgery research.Tait AR, Voepel-Lewis T,
Malviya S. Anesthesiology. 2003 Mar;98(3):603-8.
Regulations Requiring Manufacturers to Assess the
Safety and Effectiveness of New Drugs and Biological Products in
Pediatric Patients; Final Rule
U.S. Department of Health and Human Services
NIH Policy and Guidelines on the Inclusion of
Children as Participants in
Research Involving Human Subjects
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Katz, J., Informed consent: must it remain a fairy
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This article was reviewed prior to publication by:
Elizabeth Tong, MS, RN, CPNP, FAAN
Clinical Nurse Specialist Pediatric Cardiology
The Medical Center at the University of California
San Francisco, CA
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