Informed Consent, Parental Permission, and Assent in Pediatric Practice

Committee on Bioethics

sons. Indeed, some patients have specific legal enti-

The statement on informed consent, parental permis-
tlements to either consent or to refuse medical
5i0?l, and patient assent has a long and extraordinary
intervention. Although physicians should seek pa-
history. The first draft of this document, prepared by
rental permission in most situations, they must focus
William G. Bartholome, MD, was presented to the
on the goal of providing appropriate care and be
original American Academy of Pediatrics (AAP) Com-
prepared to seek legal intervention when parental
mittee on Bioethics in 1985. Bill put his soul into the
refusal places the patient at clean and substantial
manuscript and has watched over it carefully ever
risk.2 In cases of serious conflict, physicians and fam-
since. Now, a decade later, those who have worked on
ilies should seek consultative assistance and only in
its continued development and urged its adoption as
rare circumstances look to judicial determinations.
Academy policy applaud its publication. No one is more
We now realize that the doctrine of “informed
gratified than its primary author and champion. Those
consent” has only limited direct application in pedi-
who have had the privilege to know Dr Bartholome
atnics. Only patients who have appropriate deci-
share his sense ofaccomplishment, but cannot help but
sional capacity and legal empowerment can give
experience a cruel sense of irony. Just as the work Bill
their informed consent to medical cane. In all other
considers his most important contribution has become
situations, parents on other surrogates provide in-
available for public appreciation, Dr Bartholome suffers
formed permission for diagnosis and treatment of
fr om a serious illness that threatens his life.
children with the assent of the child whenever ap-
Bill always wanted “the experience, perspective, and
propniate.
power of children” to be taken most seriously. Through
In this statement, the AAP provides an updated
the years of the statement’s revisions and re-presenta-
analysis of 1) the concept of informed consent; 2) the
tion within the Academy, Bill “had faith in the power
ethics of informed consent and the concept of the
of the text and the ideas it contained, that its time
. . .
right to refuse treatment; 3) the concept of “proxy
would come.” The statement embodies Bill
consent”; 4) the concepts of parental permission and
Bartholome’s dedication to children. Throughout his
child assent; and 5) informed consent of adolescents.
career, he worked to make medicine and medical re-
search safer and more friendly for children. The AAP
CHANGES IN MEDICAL DECISION-MAKING
and its Committee on Bioethics, on behalf of all our
The authority to make medical decisions used to
colleagues, extend heartful thanks to Dr William G.
Bartholome for helping us more fully appreciate that lie squarely in the hands of physicians. However,
complex social changes have resulted in acceptance
c/hildren
“intelligent,
are in the process
observant,
of becoming,
capable, and
in his words,
responsible of the idea that patients have a night to know about
persons” who deserve our utmost respect. their health, to know about available diagnostic and
treatment options and their risks and probable ben-
efits, and to choose among the alternatives.3 Many
AN OVERVIEW now regard traditional practices based on the theory
Since the 1976 publication of an AAP policy state- that “doctor knows best” as unacceptably paternal-
ment on the legal concept of informed consent in istic.4 Society recognizes that patients or their sunro-
pediatric practice, the concept has evolved and be- gates have a night to decide, in consultation with
come more formal.’ A better understanding now ex- their physicians, which proposed medical intenven-
ists as to how physicians should collaborate with tions they will or will not accept. Decision-making
patients and parents in making these decisions. Pa- power or authority is increasingly seen as something
tients should participate in decision-making com- to be shared by equal partners in the physician-
mensurate with their development; they should pro- patient or physician-surrogate relationship. For
vide assent to cane whenever reasonable. Parents and many patients and family members, personal values
physicians should not exclude children and adoles- affect health care decisions, and physicians have a
cents from decision-making without persuasive nea- duty to respect the autonomy, rights, and prefer-
ences of their patients and their surrogates.5
This statement has been approved by the Council on Child and Adolescent
Health. ETHICS AND INFORMED CONSENT
The recommendations in this statement do not indicate an exclusive course
The doctrine of informed consent reminds us to
of treatment or procedure to be followed. Variations, taking into account
individual circumstances, may be appropriate.
respect persons by fully and accurately providing
PEDIATRICS (ISSN 0031 4005). Copyright © 1995 by the American Acad- information relevant to exercising their decision-
emy of Pediatrics. making nights. Experts on informed consent include

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314 PEDIATRICS Vol. 95 No. 2 February 1995
at least the following elements in their discussions of or her patient exist independent of parental desires
the concept:6 on proxy consent.’#{176}

I Provision
. of information: patients should have PARENTAL PERMISSION AND SHARED
explanations, in understandable language, of the RESPONSIBILITY
nature of the ailment on condition; the nature of Decision-making involving the health care of
proposed diagnostic steps and/on treatment(s) young patients should flow from responsibility
and the probability of their success; the existence shared by physicians and parents. Practitioners
and nature of the risks involved; and the exis- should seek the informed permission of parents be-
tence, potential benefits, and risks of recom- fore medical interventions (except in emergencies
mended alternative treatments (including the when parents cannot be contacted). The informed
choice of no treatment). permission of parents includes all of the elements of
2. Assessment of the patient’s understanding of the standard informed consent, as outlined previously.
above information. Usually, parental permission articulates what most
3. Assessment, if only tacit, of the capacity of the agree represents the “best interests of the child.”
patient or surrogate to make the necessary deci- However, the Academy acknowledges that this stan-
sion(s). dard of decision-making does not always prove easy
4. Assurance, insofar as is possible, that the patient to define. In a pluralistic society, one can find many
has the freedom to choose among the medical religious, social, cultural, and philosophic positions
alternatives without coercion or manipulation. on what constitutes acceptable child rearing and
child welfare. The law generally provides parents
The goals of this consent process include the de- with wide discretionary authority in raising their
velopment of the patient’s comprehensive under- children.” Nonetheless, the need for child abuse and
standing of the clinical situation, and the timely ex- neglect laws and procedures makes it clean that par-
encise, by the patient, of active choices regarding the ents sometimes breach their obligations toward their
circumstances.7’8 children. Providers of cane and services to children
have to carefully justify the invasion of privacy and
INFORMED CONSENT AND THE RIGHT TO psychologic disruption that come with taking legal
REFUSE TREATMENT Steps to override parental prerogatives.
Health cane providers should engage in the pro-
cess of informed consent with patients before under- THE DEVELOPMENT OF THE CHILD AS PERSON
taking any medical intervention. Patients generally AND THE CONCEPT OF ASSENT
have a moral and legal right to refuse proposed Decision-making involving the health cane of older
medical intervention, except when the patient has children and adolescents should include, to the
diminished decision-making capacity or must un- greatest extent feasible, the assent of the patient as
dergo legally authorized “involuntary” treatment. well as the participation of the parents and the phy-
Respect for competent patients’ autonomy ordinarily sician. Pediatricians should not necessarily treat chil-
extends even to the refusal on discontinuation of their dren as rational, autonomous decision makers, but
own life-sustaining treatment.9 they should give serious consideration to each pa-
tient’s developing capacities for participating in de-
cision-making, including nationality and autonomy.
PROBLEMS WITH THE CONCEPT OF “CONSENT”
If physicians recognize the importance of assent,
BY PROXY
they empower children to the extent of their capaci-
In attempting to adapt the concept of informed ty.’2 Even in situations in which one should not and
consent to pediatrics, many believe that the child’s does not solicit the agreement or opinion of patients,
parents or guardians have the authority or “right” to involving them in discussions about their health care
give consent by proxy. Most parents seek to safe- may foster trust and a better physician-patient rela-
guard the welfare and best interests of their children tionship, and perhaps improve long-term health out-
with regard to health care, and as a result proxy comes.
consent has seemed to work reasonably well. Assent should include at least the following ele-
However, the concept encompasses many ambigu- ments:
ities. Consent embodies judgments about proposed
interventions and, more importantly, consent (liter- 1 Helping
. the patient achieve a developmentally
ally “to feel or sense with”) expresses something for appropriate awareness of the nature of his or hen
one’s self: a person who consents responds based on condition.
unique personal beliefs, values, and goals. 2. Telling the patient what he or she can expect with
Thus “proxy consent” poses serious problems for tests and treatment(s).
pediatric health care providers. Such providers have 3. Making a clinical assessment of the patient’s un-
legal and ethical duties to their child patients to derstanding of the situation and the factors influ-
render competent medical cane based on what the encing how he on she is responding (including
patient needs, not what someone else expresses. Al- whether there is inappropriate pressure to accept
though impasses regarding the interests of minors testing or therapy).
and the expressed wishes of their parents or guard- 4. Soliciting an expression of the patient’s willing-
ians are rare, the pediatrician’s responsibilities to his ness to accept the proposed cane. Regarding this

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AMERICAN ACADEMY OF PEDIATRICS 315
 final point, we note that no one should solicit a make health care decisions.” First, certain minors are
patient’s views without intending to weigh them deemed “emancipated” and treated as adults for all
seriously. In situations in which the patient will purposes. Definitions of the emancipated minor in-
have to receive medical care despite his on hen dude those who are: 1) self-supporting and/on not
objection, the patient should be told that fact and living at home; 2) married; 3) pregnant or a parent; 4)
should not be deceived. in the military; on 5) declared to be emancipated by a
court. Second, many states give decision-making au-
As children develop, they should gradually be-
thonity (without the need for parental involvement)
come the primary guardians of personal health and to some minors who are otherwise unemancipated
the primary partners in medical decision-making,
but who have decision-making capacity (“mature
assuming responsibility from their parents. minors”) or who are seeking treatment for certain
Just as is the case with informed consent, the em- medical conditions, such as sexually transmitted dis-
phasis on obtaining assent should be on the interac-
eases, pregnancy, and drug or alcohol abuse.’8 The
tive process in which information and values are situations in which minors are deemed to be totally
shared and joint decisions are made. The Academy
or partially emancipated are defined by statute and
does not in any way recommend the development of
case law and may vary from state to state.’9 Legal
new bureaucratic mechanisms, such as “assent
emancipation recognizes a special status (eg, inde-
forms,” which could never substitute for the rela-
pendent living) on serious public and/or individual
tional aspects of consent or assent.
health problems that might not otherwise receive
appropriate attention (eg, sexually transmitted dis-
THE PATIENT’S REFUSAL TO ASSENT (DISSENT)
ease).
There are clinical situations in which a persistent
refusal to assent (ie, dissent) may be ethically bind- PRACTICAL APPLICATIONS
ing.’3 This seems most obvious in the context of The following illustrations may help practitioners
research (particularly that which has no potential to when applying the concepts developed above. These
directly benefit the patient).’4 A patient’s reluctance examples are intended to provide a focus for discus-
or refusal to assent should also carry considerable sion and clarification and do not suggest new legal
weight when the proposed intervention is not essen- standards for pediatric practice.
tial to his or her welfare and/or can be deferred In cases involving the following kinds of medical
without substantial risk. care for infants and young children, the Academy
Medical personnel should respect the wishes of encourages physicians to seek the informed permis-
patients who withhold or temporarily refuse assent sion of the parents before: 1) providing immuniza-
in order to gain a better understanding of their situ- tions; 2) performing invasive diagnostic testing for a
ation or to come to terms with fears or other concerns congenital cardiac defect; 3) beginning long-term an-
regarding proposed care. Coercion in diagnosis or ticonvulsant therapy to control a seizure disorder; 4)
treatment is a last resort.’5 initiating serial casting to correct congenital “club-
foot”; on 5) undertaking surgical removal of a “sus-
ETHICAL CONFLICT AND ITS RESOLUTION picious” neck mass.
Social forces tend to concentrate authority for Even in pressing situations, informed permission
health care decisions in the hands of physicians and should be sought for actions such as performing a
parents and this tendency diminishes the moral sta- lumbar puncture to evaluate the possibility of men-
tus of children.’2 Thus, those who care for children ingitis. (In this situation, if parents deny permission
need to provide for measures to solicit assent and to for the procedure, one should obtain permission
attend to possible abuses of “raw” power over chil- from the parents to initiate treatment based on rea-
dren when ethical conflicts occur. This is particularly sonable clinical judgment, rather than delaying care
important regarding the initiation, withholding, or or risking liability for performing the lumbar punc-
withdrawing of life-sustaining 1617 Exam- tune without appropriate authorization).
ples of mechanisms to resolve ethical conflicts in- In cases involving the following kinds of medical
dude additional medical consultation(s); short-term care for older school-age children, the Academy en-
counseling or psychiatric consultation for patient counages physicians to seek the assent of the patient
and/on family; “case management” or similar mul- as well as the informed permission of the parents: 1)
tidisciplinany conference(s); and/or consultation venipuncture for a diagnostic study in a nine-year-
with individuals trained in clinical ethics on a hospi- old; 2) diagnostic testing for recurrent abdominal
tal-based ethics committee. In rare cases of refractory pain in a 10-year-old; 3) psychotropic medication to
disagreement, formal legal adjudication may be nec- control an attention-deficit disorder in a third grader;
essary. 4) an orthopedic device to manage scoliosis in an
11-year-old; 5) an “alarm” system to treat nocturnal
LEGAL EMANCIPATION AND INFORMED enunesis in an eight-year-old; on 6) surgical repair of
CONSENT a malformed ear in a 12-year-old. In some cases,
The traditional notion of informed consent cleanly treatment may proceed over the objection of the pa-
applies to patients who have reached the legal age of tient. However, physicians and parents should real-
majority, except when the patient has been deter- ize that overruling the child may undermine their
mined to be incompetent. In addition, laws designate relationship(s) with the child.
two settings in which minors have sole authority to In situations such as the following that involve

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316 INFORMED CONSENT, PARENTAL PERMISSION, AND ASSENT
adolescents and young adults, the Academy en- LIAISON REPRESENTATIVES

counages physicians to obtain the informed con- Elena A. Gates, MD

sent of the patient, in most instances: 1) perfor- American College of Obstetricians and

mance of a pelvic examination in a 16-year-old; 2) Gynecologists

Serge Melancon, MD
diagnostic evaluation of recurrent headache in an
Canadian Paediatric Society
18-year-old; 3) a request for oral contraceptives for
fertility control in a 17-year-old; 4) proposed long- SECTION LIAISON
term oral antibiotics administration for severe acne Anthony Shaw, MD
in a 15-year-old; or 5) surgical intervention for a Section on Surgery
bone tumor in a 19-year-old. Such patients fre- CONSULTANTS
quently have decision-making capacity and the William Gibson Bartholome, MD
legal authority to accept or reject interventions, Rebecca Dresser, JD
and, in that event, no additional requirement to
REFERENCES
obtain parental permission exists. However, the
I . American Academy of Pediatrics Task Force on Pediatric Research,
Academy encourages parental involvement in
Informed Consent, and Medical Ethics. Consent. Pediatrics. 1976;57:
such cases, as appropriate. 414-416
Review of the limited relevant empirical data 2. Lantos JD. Treatment refusal, noncompliance, and the pediatrician’s
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Consent. New York, NY: Oxford University Press; 1986
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cian involve parents after appropriate discussion York, NY: Oxford University Press; 1989
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with the adolescent elicits his or her permission to
Clinical Practice. New York, NY: Oxford University Press; 1987
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legal entitlement to authorize treatment, the phy- informed consent. Arch Intern Med. 1988;148:1385-1389
sician may have a legal obligation in some junis- 8. President’s Commission for the Study of Ethical Problems in Medicine
and Biomedical Research and Behavioral Research. Making Health Care
dictions to obtain parental permission or to notify
Decisions: A Report on the Ethical and Legal Implications of Informed Consent
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sent. An adolescent’s refusal of consent in cases Printing Office; 1982: Vol 1
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binding. If “conflict resolution” fails, formal legal New York, NY: The Free Press; 1978:1498-1507
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CONCLUSION New Haven, CT: Yale University Press; 1985
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20. Brock DW. Children’s competence for health care decision-making. In:
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AMERICAN ACADEMY OF PEDIATRICS 317
 Informed Consent, Parental Permission, and Assent in Pediatric Practice
Committee on Bioethics
Pediatrics 1995;95;314

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 Informed Consent, Parental Permission, and Assent in Pediatric Practice
Committee on Bioethics
Pediatrics 1995;95;314

The online version of this article, along with updated information and services, is located on
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