Appendix D

History of Pediatric Health and NIH Structure and Organization

EARLY HISTORY OF PEDIATRIC HEALTH AND RESEARCH

To survive as a species, humans require healthy children who will grow to procreate and sustain the species as well as to produce food, create shelter, and defend their communities. The history of humans caring about pediatric health, therefore, dates arguably to pre-history.

Early History: 1700–1911

Children in the colonial United States faced a multitude of health threats. Prominent among them was smallpox, responsible for dreaded and devastating outbreaks in 1721, 1752, 1764, and 1775. The 1775 epidemic killed almost 8 percent of citizens living in Boston at the time, and survivors faced immense suffering and permanent scarring (Hasselgren, 2020). Inoculation and variolation were commonly practiced worldwide through the 18th century, including among George Washington’s Revolutionary War troops (and his British foes), but Edward Jenner’s experimentation with smallpox vaccination starting in 1796 triggered a transformation of children’s health both in Britain and subsequently in the United States, as vaccination slowly became widespread. Although Jenner’s approach to research likely would not meet research ethics standards today, the disease was eradicated in the United States by the middle of the 20th century and worldwide by 1980.

The history of organized pediatric health research in the United States began most clearly, however, with Dr. Abraham Jacobi, whom many medical

historians credit for creating the medical specialty of pediatrics in the late 19th century. Jacobi’s notion was revolutionary at the time, as previously medical specialists had focused solely on particular organ systems, with child health considered as part of obstetrics. In 1880, Dr. Jacobi helped found and served as the first president of a new section of the American Medical Association focused on diseases among children and then did the same when he founded the American Pediatric Society in 1888.

Concurrent with Jacobi’s efforts, the first children’s hospitals were formed in the United States. Modeled after comparatively recent institutions in Europe, Children’s Hospital of Philadelphia opened in 1855, and others followed in Boston, Washington, New York, and several other cities over the subsequent two decades.

The development of professional pediatric societies and children’s hospitals occurred simultaneously with key scientific discoveries that impacted the care of children’s illnesses and injuries. In 1854, John Snow recognized that a cholera outbreak in London was caused by contaminated water at public water sources, which led to the removal of water pump handles, ending the outbreak and, ultimately, over time, triggering the creation of clean public water supplies. Over the 1850s, 1860s, and 1870s, Louis Pasteur and others published groundbreaking work demonstrating the germ theory of disease, offering the first scientific evidence that some diseases were caused by microscopic pathogens. This discovery led to disease prevention strategies including clean food and water supplies, safe sewage disposal, and the development and dissemination of vaccines.

Early 20th Century: 1912–1945

Following dramatic medical advances in the late 1800s, the U.S. government took action to address children’s health in the country through the creation of the Children’s Bureau in 1912, the first government agency devoted to children’s health and development (Children’s Bureau, 2024). The small agency—in its first year it funded a staff of just 15—was charged with a broad agenda but focused especially in its early years on pediatric health topics such as infant mortality, orphaned children, juvenile delinquency, and child labor. It was initially led by Julia Lathrop, a Hull House colleague of Jane Addams and the first woman appointed to lead a U.S. government bureau.

As the world faced economic depression following the 1929 stock market crash, a landmark conference was held in the United States, the 1930 White House Conference on Child Health and Protection. That conference led to the release of the Children’s Charter, a proclamation for the rights of all children in the United States that had long-term effects to promote children’s health through the depression and into World War II. Additional

influential White House conferences on children were held decennially in 1940 and 1950.

NIH STAFF ROLES

National Institutes of Health (NIH) staff are civil servants who play a major role in carrying out the mission of NIH to enhance health, lengthen life, and reduce illness and disability (NIH, 2025). The staff roles are integral to grants management (NIH, 2024). NIH staff are tasked with reviewing, prioritizing, funding, and monitoring grant and contract activities, and closing out awards. In addition, they perform other roles associated with their positions, including administrative tasks, conferences, planning, and other functions. NIH staff with expertise in pediatrics and pediatric–related disciplines are ideal to oversee pediatric research projects and programs.

Program officers (POs) are responsible for scientific guidance based on their area of expertise as well as for management of grants, the development of research initiatives including notices of funding opportunities, input for funding decisions, and interaction with the extramural community. POs are the point of contact for applicants and grantees. They can advise applicants whether their proposed topic or research idea is suitable as well as on programmatic and scientific matters. POs are permitted to attend peer review study section meetings as observers but have no formal role in the peer review of applications. They can advise applicants about funding status and potential resubmission of an application following receipt of their summary statement or critique of their application.

Grant management specialists and officers (GMSs and GMOs) are responsible for business management, grant administration, and provision of budgetary technical assistance to applicants and recipients. The GMO in particular is the NIH official responsible for business management and other non-programmatic aspects of the award. There are many required grants administration policies, and the GMO is responsible for overall compliance in collaboration with the GMS and PO.

Scientific review officers (SROs) manage the study section or peer review for scientific and technical merit of applications. SROs actively match reviewers to the science of the applications being submitted, so expertise in any given area may vary from cycle to cycle depending on what applications are received. Study sections are composed of experts outside of NIH who review the technical and scientific merits of proposals. They are vetted for real and apparent conflicts of interest to assure the integrity of the review process. The SROs play a key role in ensuring that adequate pediatric expertise is available to review applications for pediatric research.

SROs are responsible for selecting scientists and experts to evaluate the applications. They are responsible for managing conflicts of interest. SROs facilitate the meetings and are responsible for ensuring fairness and

impartiality as part of the review process. They prepare summary statements which reflect the evaluations of the applications that are sent to the applicants.

Visibility of NIH Staff, Especially POs

The importance of visibility of NIH staff, particularly POs, should be acknowledged. POs should be public facing to encourage dialogue between applicants and NIH. This can be accomplished by attendance at appropriate disciplinary scientific meetings, via outreach, and through opportunities to connect with POs on a local, state, national, or international level. NIH-conducted conferences or workshops are also a valuable way to connect with POs and NIH staff. One former PO authored a paper reflecting on his NIH career, in which he succinctly described the role of the PO as well as offered suggestions to novices on how to have NIH grant success (Raju, 2019).

NIH CLINICAL CENTER

The NIH Clinical Center (CC) is composed of two major facilities: the Warren Grant Magnuson Clinical Center, opened in 1953, and the Mark O. Hatfield Clinical Research Center, added to the original facility in 2004 (NIH Office of Extramural Research, 2010). A unique feature of the Magnuson Building when it first opened was the co-location of patient care rooms and laboratories where clinical scientists conducted their research to confirm diagnoses, characterize disease processes, and explore effective treatments (NIH Clinical Center, n.d.-b). Conceived originally as a facility focused almost entirely on inpatients, the CC’s outpatient infrastructure was added in the 1980s (NIH Clinical Center, n.d.-c).

Background on the NIH CC

In 1944, the Public Health Service Act¹ authorized the establishment of the NIH CC to provide a “model environment for clinical research, patient care and training future generations of clinical scientists” (NIH Clinical Center, n.d.-a). The CC is the largest hospital devoted entirely to clinical research in the world and has historically been involved in groundbreaking research across multiple disease areas, including cancer, behavioral health, and infectious diseases (Gallin, 2011; NIH Almanac, 2024). CC successes include “pioneering the cure of cancerous solid tumors with chemotherapy; the use of nitroglycerin to treat heart attacks; identifying a genetic component in schizophrenia; conducting the first successful replacement of a mitral valve to treat heart disease; and creating blood tests to identify both acquired immune deficiency syndrome (AIDS) and hepatitis” (NIH Clinical Center, 2024). Many practices that began on the basis of NIH research at the CC have become the standard of care worldwide (Gandhi, 2016). The CC is also considered to be a premier institution for training the next generation of clinician–scientists and researchers (NIH Office of Extramural Research, 2010; NIH Scientific Management Review Board, 2014).

The CC is designed to support the broad missions of intramural research programs throughout NIH. Initially, “each of the several NIH Institutes was assigned a proportional fraction of the new beds, with the National Cancer Institute and what became the National Heart Lung and Blood Institute holding the lion’s share” (Nathan and Nathan, 2016, p. 2389). In 2025, institutes and centers (ICs) continue to drive the scientific agenda and clinical protocol development at the CC, with the CC managing resources and infrastructure (e.g., staff, facilities, and systems) for safe and high-quality patient care in support of clinical research studies and responding to usage requests from ICs (NIH, 2021).² As the CC is a research facility, only patients meeting the specific requirements of approved research protocols are admitted; but, unlike other hospitals, they do not have to pay fees for treatment and care. Most patients are referred by their clinicians, but approximately one-third self-refer via the Internet (NIH, 2021).

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¹ Public Health Services Act, Public Law 78-410, 78th Cong. (July 1, 1944).

² “Doing research in the NIH IRP differs from doing research in academia in that IRP scientists are not obligated to write and submit grant applications (indeed, they cannot serve as principal investigators of or derive salary support from federal grants); their salary and laboratory or research clinic support are provided by the intramural budgets of their respective NIH institutes. Instead of being funded by individual grants awarded for individual projects, their whole research and training program is evaluated approximately every four years by their institute’s Board of Scientific Counselors (BSC) and outside scientists appointed by the director of their respective institute. Generally based on the recommendations of the BSC, the Scientific and/or Clinical Director determines the level of funding and staffing they will receive over the ensuing four years for their entire research program” (Schor, 2023, p. 41).

Relevant Historical Changes to the NIH CC

Since the CC opened in 1953, it has undergone many changes that affected both its operations overall and pediatric research performed at the CC specifically. A summary of selected historical changes to the CC over the past few decades can be found in Box D-1.

REFERENCES

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