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This chapter examines the changes in policies regarding children in research between 1966 and 2003. It reviews Henry Beecher’s famous article, Ethics and Clinical Research, which described 22 projects published after World War II that he found to be of questionable ethics; Paul Ramsey’s examination of the ethical problems in medicine; debates over the moral permissibility of children’s participation in nontherapeutic research; the government’s policy shift from an exclusive focus on protecting children from research risks to promoting greater access by children in research during the early 1990s; and international research ethics. It is shown that new policies have encouraged pediatric pharmacological testing and have led to some improved pediatric labeling.

This chapter examines the ethics of payment in pediatric research that does not offer the prospect of direct benefit (nontherapeutic research). It addresses the ethical objection that payment perverts motivation, and that this can have two adverse consequences: it may distort the voluntariness of the parent’s permission and the child’s assent; and it may lead to an unjust recruitment or selection of subjects. It is argued that it is morally permissible to provide payment for participation in pediatric research. Related issues that need to be resolved to decide what is a fair price for the participation of children in nontherapeutic research are discussed.

This chapter examines the extent to which pediatric researchers reported race and ethnicity (R/E) data; the representation of Black, Hispanic, and Asian children and their parents in pediatric medical research; the extent to which language may be a barrier in pediatric research; and how R/E data were collected in pediatric research. Collecting R/E data in medical research was difficult because the data were not presented in a standardized format. Black children and their parents were overrepresented, while Hispanic children and their parents were underrepresented in pediatric research. Black subjects had greater overrepresentation in clinical trials than in nontherapeutic research, and a greater representation in research that was potentially stigmatizing. Language barriers existed in pediatric research, and the most number of Hispanic and Asian participants were enrolled in research in which translation services are available.

This chapter examines whether Subpart D of the federal regulations on human subject protections provides appropriate protection for all children, when research offers no prospect of direct benefit (also known as ‘nontherapeutic research’). It shows that Subpart D provides greater protection for healthy children and allows children who have a disorder or condition to be exposed to greater risk of harm. This double standard is unjust because the distribution of burdens falls disproportionately on children with a disorder or condition. Suggestions for revising the federal regulations are presented.

This chapter presents an overview of the informed consent requirements and waivers in pediatric research under current federal regulations. These consent policies were adopted by the Food and Drug Administration in April 2001 with the exception of parental waivers under Code of Federal Regulations section 46.408. The moral bases for these requirements are examined: whether the current policies are consistent with these moral foundations, and if not, how the policies should be modified.

Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that accepts federal funds. The requirement to document IRB review and the procurement of informed consent (IC) in published research reports is more recent. This chapter examines to what extent research published in three peer-reviewed pediatric journals documented IRB approval and IC, and to what extent the researchers who failed to document IRB and IC stated that they had obtained appropriate IRB review and consent from subjects. It was observed that a small but significant number of pediatric research protocols failed to obtain IRB approval or a waiver.

Typically regarded as a quiet time in American medical education, the interwar period was in fact highly dynamic. Medical research advanced and medical schools grew in size, wealth, and complexity. The values associated with the Flexnerian revolution became generalized—particularly the commitment of medical schools to research. If American medical schools after World War II were to grow so large as to dwarf pre-World War II medical schools, that was because a solid institutional infrastructure was already in place that could effectively utilize the massive infusion of federal and private funds.

The idea of children's ‘assent’ to medical research became part of English law in 2004. However, this overrides English legal traditions of children's consent. Although this chapter concentrates on English law and guidance, it has international relevance. English law integrates with European law and also has influence over more than a billion people in the fifty-four British Commonwealth countries. Ethics guidance in England on consent to research influences international projects, based in Britain and conducted in Europe and in every other continent. Discussions about children's consent and assent illuminate meeting points between law and childhood studies across the world. This chapter examines contrasting meanings of consent and ‘assent’, and reviews the related law and ethics. It discusses whether children's consent or their assent offers them best support and protection while they are considering whether to take part in research, and while they are research subjects. It gives examples of some present problems, which indicate the need for broader understanding of children's consent.

This chapter examines the issue of whether phase I pediatric oncology trials offer the prospect of direct benefit. Phase I research is carried out to determine toxicity; the possibility of direct benefit is secondary to the objectives of the study. Focusing exclusively on whether phase I trials could be interpreted as offering the prospect of direct benefit fails to acknowledge the moral relevance of the researchers’ intent. If intentions matter, then phase I studies cannot be said to offer the prospect of direct benefit.

This chapter examines four ethical issues raised by clinical asthma research involving children subjects: (1) to what extent are clinical asthma trials designed as placebo-controlled trials as opposed to active-drug controlled trials?; (2) do placebo-controlled trials in a condition like asthma place the research subjects at increased risk of harm?; (3) are the new guidelines promoting increased access of children to research changing the enrollment pattern of children in research?; and (4) are the new guidelines achieving their goal of garnering useful information about medication safety, efficacy, and dosing for children as a class? It is argued that children are a vulnerable population in clinical research and need additional protection. This means that the former recommendations of the National Commission to perform research first on animals, second on adults, and only then on children should be maintained. It also means that when children are involved, highest scientific and ethical standards must be maintained.

This chapter outlines the provisions of the World Medical Association's Declaration of Helsinki, which was developed as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.

Fourteen 407 panels have been convened in the more than two decades since passage of Subpart D. The first two were in the early 1990s, and the remainder since 2001. This chapter provides a brief history of the first ten 407 panels, and then examines three of the last four panels. It concludes with several observations that can be gleaned from an historical and ethical analysis of the 407 process: observations that may be instructive for future 407 panels and for the protection of pediatric research subjects.

This chapter explores in more detail four very different domains where incentives have been controversial: plea bargaining, recruiting medical research subjects, the loan policies of the International Monetary Fund, and motivating children to learn. Each of these cases illuminates a web of concerns surrounding the ethics of incentives and illustrates how legitimate and illegitimate incentives can be differentiated. The chapter argues for the usefulness of taking up the question of the ethical use of incentives in very different contexts. Sensitivity to context increases the complexity of the issues but never in exactly the same ways in every case. Despite this diversity, the controversies in each case revolve around the same central questions identified in the last chapter on evaluating incentives.

The Code of Federal Regulations (CFR) 45 part 46, Federal Policy for the Protection of Human Subjects, were developed based on reports published by the National Commission (for the Protection of Human Subjects of Biomedical and Behavioral Research). Subpart A of 45 CFR 46 is known as the Common Rule since it has been adopted by sixteen federal agencies and departments of the US government. Subpart D provides additional protections for research involving children. This chapter examines in detail 45 CFR Part 46 as it applies to children subjects. It argues that even after 20 years, the regulations to protect human subjects remain quite viable and useful, although a few modifications may be necessary.

The ties formed between the federal government and academic medical centers during World War II irrevocably altered the scale of medical research in the United States. Over the next two decades, staggering growth in the research enterprise occurred, the result of a massive infusion of federal dollars. Although some schools received much more money than others, ultimately all were transformed. To many observers, the 1950s and 1960s were lithe days for the “researcher”, as research grew to overshadow teaching and clinical practice at many academic medical centers. The ascendancy of American medical research occurred as part of the more generalized expansion of science and higher education in the United States produced after the the war by federal spending.

This chapter considers the scope and limits of consent to participate in research. Following discussion of a famous historical case of clinical research without informed consent, it examines the therapeutic misconception and the justifiability of research without consent.

Medical schools had long been responsible for the quality of care rendered civilians, but during World War II they took direct responsibility for the military's medical care as well. The proportion of faculty that enlisted in the armed services was much higher than that of the general profession. At the country's 52 general hospital units and 20 evacuation hospital units, the medical personnel, which numbered about 2,500, came almost entirely from academic medical centers. At home, schools were extremely short-staffed, but they nonetheless increased the production of doctors to meet both military and civilian needs. In addition, they conducted an extraordinary amount of war-related medical research, which enabled a dramatic reduction in death and suffering among troops in combat.

With the passage in 1965 of Medicare and Medicaid, a new era began—one in which the clinical activities of medical schools began to hypertrophy, swelling out of proportion to their other duties. This effect was not expected at the time Medicare and Medicaid legislation was enacted, nor did it happen immediately. Nevertheless, in the years that followed, clinical service rapidly grew to become their most conspicuous activity and most important source of income. In the process, their link to the university weakened, their commitment to academic values decreased, their tradition of charity eroded, and they became enmeshed more firmly than ever in the health care delivery system. If research had once been the master, that role at most medical schools was increasingly assumed by patient care—to the increasing subordination of both research and teaching.