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PEDIATRICS Vol. 107 No. 6 June 2001, pp. 1451-1455
Advances in genetic research promise great strides
in the diagnosis and treatment of many childhood diseases. However,
emerging genetic technology often enables testing and screening before the development of definitive treatment or preventive measures. In
these circumstances, careful consideration must be given to testing and
screening of children to ensure that use of this technology promotes
the best interest of the child. This statement reviews considerations
for the use of genetic technology for newborn screening, carrier
testing, and testing for susceptibility to late-onset conditions.
Recommendations are made promoting informed participation by parents
for newborn screening and limited use of carrier testing and testing
for late-onset conditions in the pediatric population. Additional
research and education in this developing area of medicine are
encouraged.
ABSTRACT
Top
Abstract
Introduction
Recommendation
References
The Human Genome Project formally began in 1990 with an
original goal of mapping and sequencing the complete set of human genes
by the year 2005. Remarkably, the sequencing of the human genome
essentially was complete in early 2000. The ultimate purpose of the
research is to develop more effective strategies for disease prevention
and treatment. However, the first practical applications of this
knowledge will be expanded possibilities for genetic testing for
individual evaluation and population screening. Although pediatricians are familiar with genetic testing for specific indications and rare
conditions, new generations of genetic technology will detect persons
at increased risk for common conditions, such as cancer, hypertension,
and Alzheimer disease.1 Although genetic research
offers great promise for improvements in child health, the use of new
genetic tests in children must be considered carefully. In the absence
of clearly beneficial treatments or effective preventive strategies,
genetic testing of children and adolescents may not be justified. This
statement reviews the potential uses of genetic testing in children and
offers guidance for pediatricians on the appropriate applications of
this technology. This statement draws on analyses of ethical issues in
genetic testing by a number of influential bodies, including the
National Academy of Sciences,2 the President's Commission
for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research,3 the Institute of Medicine
(IOM),4 and the Working Group on Genetic Testing for the
National Human Genome Research Institute.5
Medical testing is familiar to physicians in the routine practice of
medicine. A legitimate question may be raised whether genetic testing
is sufficiently different from other forms of testing to justify
additional scrutiny. Several aspects of genetic testing should be
considered in this regard.6 First, genetic information is
familial. Thus, the test results of one person have direct health
implications for others who are genetically related. Second, the risks
of genetic testing may not be obvious because the primary risks are
psychological, social, and financial. The psychosocial risks include
guilt, anxiety, impaired self-esteem, social stigma, and insurance and
employment discrimination. Third, genetic information often has limited
predictive power. Our genes interact with our environments in complex
ways, often making predictions impossible about whether disease will
develop or the severity of its manifestations. Finally, many genetic
conditions remain difficult to treat or prevent, meaning the value of
genetic information may be limited for altering the clinical care of
the person. Genetic testing is not unique in any of these respects, but
the cumulative complexity of these issues requires that genetic testing
receive careful consideration. Given these concerns, detailed
counseling, informed consent, and confidentiality should be key aspects
of the genetic testing process, particularly when the benefits are uncertain. Because young children are unable to discern the value of
genetic information for their own lives, particular care must be
exercised by parents and pediatricians when making decisions about
genetic testing for children.
The American Academy of Pediatrics (AAP) believes pediatricians can
best help children and parents by working to promote child and parent
understanding of relevant information, ensure privacy and
confidentiality for test results to the extent permissible by law, and
provide or refer children for counseling and testing only when it is in
the best interest of the child or when the legitimate interests of the
parents or family can be promoted without anticipated harm to the
child. This statement addresses 3 potentially problematic applications
of genetic testing and screening: newborn screening, carrier testing
and screening, and predictive testing for late-onset disorders.
The purpose of newborn screening for genetic disorders is to limit
the morbidity and mortality attributable to selected inherited diseases. Because newborn screening programs are organized through state governments, substantial variability in testing exists between states.7 As new genetic tests become available, extensive consideration will be given to the introduction of these tests into
newborn screening programs. Consistent with earlier guidelines on the
issue, the IOM report4 recommends that 3 principles govern
the introduction of new tests and the maintenance of established tests:
1) identification of the genetic condition must provide a clear benefit
to the child; 2) a system must be in place to confirm the diagnosis;
and 3) treatment and follow-up must be available for affected newborns.
The challenges of introducing new tests have been brought into focus by
discussions about the appropriateness of newborn screening for cystic
fibrosis (CF). In 1983, the Task Force on Neonatal Screening of the AAP
advised against the introduction of state programs until the validity
of screening tests and the relative benefits and risks of newborn
screening for CF had been evaluated.8 A key question has
been whether detection of CF in the neonatal period improves the
long-term pulmonary or nutritional status of affected children. The
effects of false-positive results on parental anxiety also are a
serious concern.9-13 In addition, a small percentage of
parents may have a persistent misunderstanding of their child's risk
for developing CF after a false-positive newborn screen, and
false-positive results may influence parental reproductive
decisions.14 Thus, the justification for newborn screening
for CF has been a subject for debate, although several states,
including Wyoming and Colorado, have initiated programs. A long-term
study in Wisconsin demonstrated nutritional benefits to early detection
of CF, and reports on the effects of screening for pulmonary function
are anticipated.15 Similarly, 19 states have introduced
newborn screening for congenital adrenal hyperplasia, and a number of
studies are under way to evaluate the sensitivity and specificity of
different approaches used by these programs16,17 and their
impact on the health of affected children.
The AAP recommends that new newborn screening tests be introduced in a
carefully designed manner that facilitates evaluation of the risks and
benefits of screening, including the efficacy of follow-up and
treatment protocols. The Wisconsin program for evaluating CF screening
was a model in this regard. Furthermore, the AAP concurs with the IOM
recommendation that established programs be reviewed periodically to
consider the addition, elimination, or modification of current
screening modalities.4
A persistent ethical issue in newborn screening is whether screening
should be voluntary or mandatory. Whether programs are voluntary or
mandatory has significant implications for informed responses to test
results and for the integration of new tests into established programs.
A voluntary approach in this context entails an informed
decision by parents about newborn screening. Wyoming and Maryland are
the only 2 states that require informed consent for newborn screening,
although 13 other states require that parents be informed about newborn
screening before testing.18 A mandatory
approach in this context requires an explicit refusal of screening by
parents who object to this intervention. All states except South Dakota
permit parental refusal of newborn screening for religious or personal
reasons.18
The principal ethical justification offered for mandatory screening is
the claim that society's obligation to promote child welfare through
early detection and treatment of selected conditions supersedes
parental prerogatives to refuse this simple medical intervention.19 An opposing argument maintains that parents traditionally have broad discretion for making health care
decisions for their children. Although parents do not have the
prerogative to forgo effective treatments for life-threatening conditions, they generally have the prerogative to pursue a variety of
options in less threatening circumstances, including options that some
medical professionals would consider unwise. Furthermore, it is argued
that the great majority of parents will continue to be supportive of
newborn screening when they are informed adequately of the risks and
benefits.20 With continued broad public support,
approaches involving informed consent (that is, parental permission21) may fulfill the important goals of the programs and enhance program quality while respecting traditional parental prerogatives to be informed participants in health care decisions for their children. In a study of newborn screening in
Maryland involving informed consent, the majority of women preferred
that permission be asked before screening, and the informed refusal
rate was only 5 per 1000 infants.22 In the Maryland study,
the consent process typically took 5 minutes or less of staff time.
Additional research to develop and evaluate models of parental
education and consent will be valuable.
Two potential advantages of obtaining informed consent for newborn
screening include more prompt and efficient responses to positive
results and an ability to incorporate experimental tests into
established screening programs. Under current programs, the information
provided to parents about newborn screening is often minimal. A
significant source of problems in newborn screening programs is slow or
uninformed responses to test results by parents and
physicians.23 If an informed consent process promotes more
thorough understanding of the implications of the tests, slow or
inappropriate responses to positive results may decrease. Second,
advances in genetic research will offer many additional tests for
consideration by newborn screening programs.24 The
relative risks and benefits of new tests will be uncertain until
adequate clinical research has been conducted. In these circumstances,
experimental tests should be offered on a voluntary basis with informed
consent. Experimental tests could be integrated more easily in
screening programs that routinely sought informed consent for newborn
screening tests.
The IOM report suggests that it is appropriate for states to mandate
the offering of "established tests (eg, phenylketonuria, hypothyroidism) where early diagnosis leads to improved treatable outcomes."4 The AAP Committee on Genetics concurred that state governments should mandate the offering of tests
(although some members of the Committee expressed the opinion that
testing should be mandated).16 Consistent with the recent
report of the Newborn Screening Task Force,25 the AAP
recommends that states evaluate an informed consent process for newborn
screening tests to foster parental education and promote informed
responses to test results. Given the established efficacy of newborn
screening programs, it will be essential to demonstrate that expanded
education and consent function to enhance the quality of these
programs. Carefully conducted pilot programs to document benefits and
costs of newborn screening and the frequency and consequences of
informed refusal of newborn screening tests will be important. In
addition, research to develop an efficient and effective informed
consent process for newborn screening is necessary. Attention should be given to the education of women and couples about newborn screening before the immediate postpartum period. Publication and peer review of
this research will be appropriate before substantial changes in state
health policy on this issue to ensure that efficacy of screening
programs is not impaired. Informed consent in this context need not
involve a signed consent form for tests of established value, but must
include basic information on the purpose of screening and the
importance of prompt responses to abnormal results.
Medical technology permits the identification of persons who are
carriers for mutations in genes responsible for a variety of
conditions, including Tay-Sachs disease, muscular dystrophy, sickle
cell anemia, CF, and thalassemia major. Carrier testing and counseling
of prospective parents can permit informed reproductive choices. A
significant concern raised by carrier screening programs is the
possibility for individual and community misunderstanding of the
carrier state. Confusion about the difference between being an
asymptomatic carrier for a genetic condition and being affected with
the condition may lead to stigma and discrimination, as well as to
adverse psychological reactions in those being
screened.26-28 An historical example is provided by the
carrier screening programs for sickle cell disease in the 1970s in the
United States that were not preceded by adequate broad-based education.
The subsequent misunderstanding of the benign nature of being a sickle
cell carrier by employers, insurance companies, government agencies,
and the community being screened led to many cases of discrimination
and stigmatization.3
To date, carrier testing or screening has not been applied extensively
to children or adolescents in the United States. Theoretically, carrier
testing or screening before the initiation of sexual activity would
increase the reproductive choices of those found to be carriers in
comparison with carrier testing during pregnancy. However, children and
adolescents may be more psychologically vulnerable than adults to
knowledge of carrier status, and it remains uncertain whether testing
at younger ages would result in changes in future reproductive
behavior. Of note, however, a report of 2 decades of carrier screening
in high school students in Montreal, Quebec, suggests that many persons
can effectively use the genetic information in later reproductive
decisions.29 Additional research is necessary to
thoroughly evaluate these issues in the US health care system and in a
variety of different cultures and ethnic communities.30
The AAP does not support the broad use of carrier testing or screening
in children or adolescents. Carrier testing for the pregnant adolescent
or for the adolescent who is planning a pregnancy and who has been
fully informed of the benefits and risks of carrier testing may be
appropriate.
In some circumstances, carriers will be identified through newborn
screening programs. For example, newborn screening for sickle cell
disease will identify infants who are carriers (in addition to those
who are homozygous for the disease). Reporting the infant's carrier
status to parents has the theoretical advantages of informing parents
that they may be at risk for bearing an affected child (if both parents
are carriers) and of enabling the family to be aware of the child's
future reproductive risk. However, identification of infants as
carriers may lead to misinterpretation by parents and others, resulting
in changes in the parent-child relationship and social discrimination.
Furthermore, parents should have the opportunity to obtain or refuse
their own testing for carrier status (newborn screening should not be
used as a surrogate for parental testing). Finally, it remains to be
determined whether newborn screening results can be used effectively
years later when the person is making reproductive decisions. The AAP
concurs with the IOM recommendations that newborns not be screened for the purpose of determining carrier status.4 Carrier status results that are obtained incidentally should be conveyed to parents who have undergone previous counseling and have given consent. Newborn
screening tests should be conducted with adequate parental education,
including information about implications for genetically related
persons.
Genetic technology provides the means to diagnose disorders that
develop beyond infancy, including some that become manifest only in
adulthood. Examples of late-onset diseases with a high degree of
predictability based on genetic tests include myotonic dystrophy,
hemochromatosis, polycystic kidney disease, Huntington disease, and
some cancers. Furthermore, it soon may be possible to identify genetic
factors that increase the probability that common disorders, such as
coronary artery disease, diabetes, stroke, hypertension, Alzheimer
disease, forms of colon and breast cancer, several psychiatric
conditions, and some rheumatoid diseases, will develop.
For some of these conditions, knowledge of risk status may help persons
reduce morbidity or risk of mortality. In addition, members of at-risk
families may benefit psychologically from learning that they are not
mutation carriers or from a reduction in uncertainty if they are found
to be mutation carriers. However, a reduction in morbidity or mortality
as a result of genetic testing has not been demonstrated for many
conditions for which predispositional testing is
available.31,32 Whether current recommendations for
prevention or early detection will be effective in this high-risk
population remains unclear. Furthermore, the knowledge of increased
risk status may trigger adverse psychological responses and,
potentially, discrimination by insurers, employers, or others. For
these reasons, the rapid introduction of BRCA1/BRCA2 (which confer
increased risk for breast and ovarian cancer) and HNPCC (or hereditary
nonpolyposis colon cancer, which confers increased risk for colon
cancer) mutation testing into clinical medicine for adults has been
discouraged.33,34 The complexities of genetic testing and
the uncertain risks and benefits of the results support the use of
detailed genetic counseling for predictive testing for late-onset
disorders. Many adults choose not to be tested for late-onset
conditions, indicating that we cannot presume that children would want
or will benefit from such testing.35,36 Further, testing
in childhood inappropriately eliminates the possibility of future
autonomous choice by the person and risks stigma and discrimination.
Unless there is anticipated benefit to the child, pediatricians should decline requests from parents or guardians to obtain predispositional genetic testing until the child has the capacity to make the
choice.37,38
The Human Genome Project will foster the development and rapid
introduction of genetic tests into clinical practice. The number of
genetic counselors and geneticists is insufficient for these professionals to take primary responsibility for managing this technology.39 As a result, primary care physicians will need to expand their knowledge of genetics and the benefits and risks
of genetic testing.40
INTRODUCTION
Top
Abstract
Introduction
Recommendation
References
NEWBORN SCREENING
CARRIER SCREENING
PREDICTIVE TESTING FOR LATE-ONSET DISORDERS
GENETIC SERVICES
RECOMMENDATIONS
Top
Abstract
Introduction
Recommendation
References
Committee on Bioethics, 2000-2001
Robert M. Nelson, MD, PhD, Chairperson
Jeffrey R. Botkin, MD, MPH
Eric D. Kodish, MD
Marcia Levetown, MD
John T. Truman, MD
Benjamin S. Wilfond, MD
Liaisons
Christine E. Harrison, MD
Canadian Paediatric Society
Alessandra Kazura, MD
American Academy of Child and Adolescent Psychiatry
Ernest Krug III, MD
American Board of Pediatrics
Peter A. Schwartz, MD
American College of Obstetricians and Gynecologists
Section Liaisons
G. Kevin Donovan, MD, MLA
Section on Bioethics
Mary Fallat, MD
Section on Surgery
Consultant
Ian H. Porter, MD
Staff
Darcy Steinberg, MPH
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FOOTNOTES |
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The recommendations in this statement do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate.
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ABBREVIATIONS |
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IOM, Institute of Medicine; AAP, American Academy of Pediatrics; CF, cystic fibrosis.
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REFERENCES |
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Top
Abstract
Introduction
Recommendation
References
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-thalassemia
disease carriers in high schools.
Am J Hum Genet
1996;
59:793-798 [Medline]Statement of reaffirmation:
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