What Is Pediatrics? Research, Subspecialties and Funding

Pediatrics is the branch of medicine and biomedical science devoted to the health of infants, children and adolescents. It is a clinical specialty, caring for patients from birth through the end of adolescence, and a research discipline that asks how growth, development and disease differ in young people and what that means for diagnosis, treatment and prevention. (The word comes from the Greek pais, child, and iatros, physician; the spelling paediatrics is standard in the UK and much of the Commonwealth.) This guide explains what pediatrics covers and how it divides into subspecialties, then adds the research-administration layer that generic overviews leave out: the ethical and regulatory rules for studies with children, how pediatric research is funded, the professional societies and journals that anchor the field, and typical training paths. It is educational, not medical advice.

What Is Pediatrics?

Children are not small adults. Their bodies handle drugs differently, their organs and immune systems are still maturing, the diseases they get differ from adult disease, and their ability to understand and consent to medical care changes as they grow. Pediatrics is organized around those differences. Three ideas run through the field:

• Development. Normal for a newborn is abnormal for a toddler or a teenager. Growth, motor and language milestones, puberty and cognitive development provide the reference points against which pediatricians judge health, and developmental science is a research area in its own right.
• Prevention and health supervision. Much of pediatric practice is well-child care: scheduled visits, growth monitoring, immunization and screening. Professional bodies publish schedules and guidance for this routine care. (For how well-child and problem-focused visits are distinguished for billing, see E/M coding for pediatrics: well-child vs problem visits, which is a coding guide rather than an overview of the specialty.)
• The family and the setting. A pediatric patient is usually accompanied by, and often legally represented by, a parent or guardian. Family, school, community and social conditions shape child health and shape how research with children must be designed and approved.

The Scope of Pediatrics

General pediatrics covers primary care of healthy children and the common illnesses of childhood. Around it sits a wide set of pediatric subspecialties, many mirroring adult specialties but adapted to young patients. Neonatology, the care of newborns, especially those born early or ill, is the youngest. Adolescent medicine addresses the transition toward adulthood, and an increasingly important research area is the transition of young people with chronic or congenital conditions into adult care.

Pediatrics also overlaps with public health and epidemiology, which study how disease patterns, vaccination coverage and environmental exposures affect populations of children (see What Is Epidemiology?), and with obstetrics, because maternal health and fetal development shape newborn outcomes (see What Is Obstetrics and Gynecology?). One well-known bedside tool from this boundary is the Apgar score, used to assess a newborn shortly after birth.

Major Pediatric Subspecialties

The list below is representative rather than exhaustive; the formal list of recognized subspecialties is maintained by the certifying boards, not by this site.

• Neonatal-perinatal medicine — critically ill and premature newborns.
• Pediatric cardiology — congenital and acquired heart disease in children.
• Pediatric hematology-oncology — blood disorders and childhood cancers; cooperative trial groups have long been central to this area (compare What Is Hematology?).
• Pediatric endocrinology — growth, puberty, diabetes and other hormonal conditions (see What Is Endocrinology?).
• Pediatric nephrology — kidney disease in children (see What Is Nephrology?).
• Pediatric gastroenterology, pulmonology and allergy-immunology — digestive, respiratory and immune conditions.
• Pediatric infectious diseases — childhood infection and vaccination.
• Pediatric neurology and developmental-behavioral pediatrics — seizure disorders, neurodevelopmental conditions and learning and behavior (see What Is Neurology?).
• Pediatric critical care, emergency medicine and hospital medicine — acute and inpatient care.
• Child abuse pediatrics, adolescent medicine and palliative care — the social, developmental and end-of-life dimensions of child health.

Surgical care of children (pediatric surgery and its subspecialties) is a related but separate set of fields. At the other end of the age range, pediatrics is the counterpart of geriatrics, which this site covers in What Is Geriatrics?.

How Pediatric Research Works

Pediatric research uses the same toolkit as the rest of clinical and biomedical science, with adaptations for age:

• Clinical trials. Randomized trials in children are harder to run than adult trials: smaller eligible populations (especially for rare diseases), the need for age-appropriate formulations and dosing, outcome measures that depend on age, and ethics review that is stricter than for adults. Multi-site networks and pooled designs are common solutions.
• Developmental pharmacology. Because absorption, metabolism and clearance of drugs change with age, dosing cannot be simply scaled down from adults. Many medicines used in children have historically been used off label, which is one reason regulators created incentives and requirements for pediatric studies (see below).
• Observational and population research. Birth cohorts, registries and surveillance studies follow children over time to study growth, exposures and outcomes; longitudinal design and long follow-up are characteristic of the field.
• Behavioral, developmental and educational research. Studies of cognition, language, parenting and school-based interventions often involve children as participants without any medical procedure, but are still human-subjects research.
• Basic and translational science. Developmental biology, genetics of childhood-onset disease, and neonatal physiology provide the mechanistic base.

Research With Children: Ethics and Regulation

Because children cannot give legally effective informed consent, research with them is a core case of research with vulnerable populations. In the United States, federally supported human-subjects research follows the Common Rule (45 CFR Part 46), whose Subpart D adds protections specific to children (see 45 CFR 46 Subpart D and the broader Common Rule subparts explained). FDA-regulated research follows parallel rules in 21 CFR Part 50 (see 45 CFR 46 vs 21 CFR 50 and the 21 CFR Part 50 entry). The ethical foundation is the Belmont Report, with its principles of respect for persons, beneficence and justice (see Belmont Report principles).

The Subpart D risk categories

Under Subpart D, an institutional review board (see What Is an Institutional Review Board?) can approve research involving children only if it falls into one of four categories:

• 45 CFR 46.404 — research that presents no greater than minimal risk to children.
• 45 CFR 46.405 — research involving greater than minimal risk but offering the prospect of direct benefit to the child participants, where the risk is justified by the anticipated benefit.
• 45 CFR 46.406 — research involving greater than minimal risk with no prospect of direct benefit to the individual child, allowed only if the risk is a minor increase over minimal risk, the procedures are reasonably commensurate with the children’s actual or expected situations, and the research is likely to yield generalizable knowledge about the children’s disorder or condition.
• 45 CFR 46.407 — research not otherwise approvable that addresses a serious problem affecting the health or welfare of children, which may proceed only after review at the federal level following consultation with experts and opportunity for public review and comment.

The concepts of minimal risk and its alternatives are compared in Minimal Risk vs Greater Than Minimal Risk.

Assent and parental permission

Subpart D distinguishes two things that adult research folds into one. Parental permission is a parent or guardian’s agreement to the child’s participation. Assent is the child’s own affirmative agreement. Under 45 CFR 46.408, the IRB decides whether children can assent, taking into account their ages, maturity and psychological state, and assent may be waived where the children lack the capacity or where the research holds a prospect of direct benefit important to their health that is available only in the research context. For research in the 46.404 and 46.405 categories, the permission of one parent is sufficient; for 46.406 and 46.407 research, the permission of both parents is required, unless one parent is deceased, unknown, incompetent or not reasonably available, or does not have legal responsibility for the child’s care and custody. The regulation also allows an IRB to waive parental permission in limited circumstances, such as research on conditions like neglect or abuse, where an appropriate substitute mechanism protects the children. Always read the regulation and your institution’s policy for the exact conditions. For the conceptual difference, see Informed Consent vs Assent; for who may agree on behalf of a person who cannot consent, see legally authorized representative consent.

State law adds another layer: the age of majority, the definition of a parent or guardian, and rules about minors who may consent to certain care on their own vary by jurisdiction, so local institutional and legal review matters.

FDA Requirements for Pediatric Studies of Drugs

Two United States laws drive most pediatric drug studies, and they work differently. The Best Pharmaceuticals for Children Act (BPCA) is an incentive: it encourages sponsors to study drugs in children voluntarily, in response to FDA requests for studies, and rewards completed studies. The Pediatric Research Equity Act (PREA) is a requirement: for certain drug and biologic applications, sponsors must assess the product in relevant pediatric populations unless FDA grants a waiver or deferral. Details such as the length of any exclusivity reward, which applications trigger PREA, and the timing of pediatric study plans change with legislation and should be checked against FDA’s current guidance rather than relied on from a summary. Separately, the rare pediatric disease priority review voucher program has lapsed and been reauthorized more than once; the priority review voucher entry tracks the concept. Outside the United States, the European parallel is the paediatric investigation plan (see paediatric investigation plan).

Who Funds Pediatric Research

In the United States the largest dedicated public funder is the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. NICHD was founded in 1962, and its stated mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. Its structure includes intramural and extramural research divisions and the National Center for Medical Rehabilitation Research, and it also administers NIH activity under the BPCA. Pediatric research is also funded by many other NIH institutes organized by disease or organ system (cancer, heart, kidney, mental health and others), by other federal agencies, by foundations and disease charities, by hospital and institutional funds, and by industry.

For early-career investigators, NIH operates a loan repayment program with a dedicated pediatric research track (LRP-PR) among its extramural tracks. For how grants themselves are managed, see this site’s grants management hub.

Societies, Journals and Professional Bodies

The American Academy of Pediatrics (AAP) was founded in 1930 by 35 pediatricians and today counts roughly 67,000 members. Its mission is to attain optimal physical, mental and social health and well-being for all infants, children, adolescents and young adults. The AAP publishes the journal Pediatrics, policy statements, the Red Book (an infectious disease and immunization reference) and Bright Futures (health supervision guidelines). Other bodies include subspecialty societies, the Pediatric Academic Societies meeting, the American Board of Pediatrics (which certifies pediatricians and subspecialists in the United States), and the World Health Organization and UNICEF at the global level. In the United Kingdom, the equivalent professional body is the Royal College of Paediatrics and Child Health.

Training Paths

In the United States, becoming a pediatrician typically means completing medical school, then a pediatric residency, then board certification. Subspecialists add a fellowship, and physician-scientists may pursue combined research training, a PhD, or an NIH career development award alongside clinical training. Non-physicians contribute to the field as nurses and advanced practice clinicians, child psychologists, developmental scientists, biostatisticians, epidemiologists and research coordinators. Training lengths and requirements vary by country and subspecialty; consult the certifying board for current details.

Pediatrics and Research Administration

For research administrators and compliance staff, pediatric studies create recurring tasks: confirming the IRB has assigned the correct Subpart D category, building assent and parental permission procedures and documents, handling age-based assent materials and re-consent when a child reaches majority, and addressing data and privacy concerns for minors. Sponsored projects offices also manage multi-site networks, pediatric drug study agreements and the budgets of long-term cohort studies. The related clinical research hub collects this site’s guidance on trial operations.

Frequently Asked Questions

What is pediatrics in simple terms?

Pediatrics is the medical specialty and research field concerned with the health, growth and development of infants, children and adolescents, including prevention, diagnosis and treatment of their illnesses.

What is the difference between a pediatrician and a pediatric subspecialist?

A general pediatrician provides primary care and treats common childhood conditions. A pediatric subspecialist has completed additional fellowship training in an area such as cardiology, oncology or neonatology.

Is pediatrics the same as paediatrics?

Yes. Paediatrics is the spelling used in the UK and many other countries; pediatrics is the American spelling.

Can children take part in clinical research?

Yes, under additional protections. In federally supported US research, an IRB must find the study fits a Subpart D category, parental permission is required, and the child’s assent is sought when the child is capable of giving it.

What is the difference between assent and consent?

Informed consent is a legally effective agreement by someone with the capacity and authority to give it. Assent is a child’s affirmative agreement to participate, which accompanies, but does not replace, parental permission. See Informed Consent vs Assent.

What is NICHD?

The Eunice Kennedy Shriver National Institute of Child Health and Human Development, an NIH institute founded in 1962 that supports research on human development, reproductive health, and the health of children and adolescents.

Why are so many drugs used off label in children?

Historically, drugs were often tested only in adults. BPCA and PREA were enacted to encourage and require pediatric studies. See What Is Off-Label Drug Use?.

How is this different from the E/M pediatrics coding guide?

That page covers how well-child and problem-oriented visits are billed. This guide covers the discipline and its research. Neither provides medical advice.