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(p. 1) Ethics and Research with Children: Introduction to the Second Edition 

(p. 1) Ethics and Research with Children: Introduction to the Second Edition
Chapter:
(p. 1) Ethics and Research with Children: Introduction to the Second Edition
Author(s):

Eric Kodish

and Robert M. Nelson

DOI:
10.1093/med-psych/9780190647254.003.0001
Page of

date: 18 March 2019

Children are both vulnerable subjects who need protection from research risks and therapeutic orphans who have been denied access to the benefits of research. In the United States, federal mandates over the past 20 years have promoted the inclusion of children in clinical research and provided investigators and the pharmaceutical industry with new financial incentives to study drugs in children (National Institutes of Health, 1998; U.S. Food and Drug Administration, 2004). This policy shift contradicts a long tradition of protecting children from the peril of research. Like all policy decisions, the move to conduct more research with children carries potential benefits and drawbacks. Despite years of debate and controversy, fundamental ethical questions about pediatric research persist. The twin goals of access and protection are not easily reconciled. The participation of children in research raises troubling questions that are not easily answered.

The goal of this book is to promote more thoughtful attention to the complex ethical problems that arise when research involves children. To that end, the chapter authors present and discuss a wide range of cases in pediatric research ethics. Each chapter is based on a case, a story that relates to research with children. Following the case is an ethical analysis designed to provide insights and suggest answers to the questions raised. Each chapter concludes with a set of questions for further discussion that are intended to present a constructive challenge to the reader. The first edition (Kodish, 2005) followed a similar format. Although over 10 years have elapsed, many of those cases remain fresh and the analysis up-to-date. As such, this book serves to supplement and not (p. 2) replace the first edition. The reader is encouraged to select those chapters which may be of more or less interest depending on the topics raised by the specific case that is discussed. Our purpose is to stimulate moral reflection on the most challenging, and sometimes controversial, issues in pediatric research ethics. Simple answers do not exist for the thorny questions raised by this topic and these cases; however, this book, like the field of bioethics, can at least serve to ask the right questions. Rather than providing a dry summary of historical, policy, or legal considerations around pediatric research ethics, the goal in this volume is to work “up from cases,” capturing the relevant ethical issues in the compelling real-life circumstances that present themselves to those engaged in making decisions. In other words, this book is written with the hope and belief that moral discourse about challenging cases can help us to do the right thing.

With the dramatic shift in policy goals, mandates, and incentives comes a need for attention to the ethics of pediatric research. The cases in this volume review fundamental ethical issues that provide a foundation for the ethics of research involving children and examine such concepts as the proper terminology to refer to research subjects; best interests; risk, harm, and wrong; permission, assent, and consent; the ethics of subject selection; and the impact of technology on ethical issues as they relate to children in research. The concluding chapter reviews aspects of these core concepts as a supplement to the individual chapters, and together the chapters provide the tools for discussion and serve as a guide for the reader in the case-specific ethical analyses.

The Value of Cases

This book is subtitled A Case-Based Approach and formatted so that each chapter centers on a particular case, for several reasons. First, as clinicians by training and temperament, education for us has always been about cases. In clinical medical education, cases are the units through which knowledge is transmitted. Good teachers know how to use a case to make a point, and the format of this book emerges from our experience as teachers on rounds and in the classroom. Second, for medical ethics to be practical, it must tell the stories of patients and subjects, of physicians and investigators. A theoretical book on pediatric research ethics might make for an excellent dissertation but would not fulfill the need for a hands-on resource to assist those who are grappling with the real issues. Finally, a format using cases paired with analysis allows for us to maximize the quality of work in this edited volume. The gifted and diverse contributors to this book had the freedom to select their own case in pediatric research ethics, giving them an opportunity to analyze issues that they (p. 3) find most engaging. This strategy was designed to provide the reader with the best possible understanding of pediatric research ethics.

Narrative bioethics has emerged as a way to enrich the “principles”-based approach (Hunter, 1994; Murray, 1997). The foundation for this case-based approach to medical ethics is recounted in The Abuse of Casuistry, by Jonsen and Toulmin (1988), who provide arguments that support reasoning up from cases rather than down from principles. This book also traces the history, from popularity to decline and resurrection, of the case-based approach to ethics and moral reasoning. Of note, The Abuse of Casuistry had its genesis in the deliberations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research over the Report on Research Involving Children (1977) and the Belmont Report (1978), upon which current US federal regulations governing research ethics are based. Thus it seems only appropriate to continue in this spirit with this book.

The perils of a case-based approach also deserve mention. Each chapter in this book analyzes hard questions that required answers in real time. Investigators, institutional review boards (IRBs), parents, and children must make decisions prospectively and do not have the benefit of hindsight that the authors and readers of this book sometimes possess. This limitation of a case-based approach must be acknowledged, but it does not mitigate the value of learning from cases. Revisiting difficult decisions that were made at a time the outcome was not known can be a very powerful educational strategy indeed.

How to Use This Book

A wide range of interested readers will find this book helpful. Students of medical ethics and those taking the National Institutes of Health–required courses in research integrity may use this as a textbook or resource. Members of IRBs are charged with making many of the difficult decisions we describe in the chapters that follow. This book can serve as a guide and companion to those important deliberations. Pediatric investigators who have responsibilities for both scientific discovery and the protection of the children they study may find ideas in these cases that will illuminate the difficult challenges they may face. Similarly, pediatricians providing medical care for children are confronted with requests from older children and parents for advice about research participation. The cases and analyses in this book can be a resource for these clinicians. The book will also be helpful for pharmaceutical industry sponsors designing or conducting clinical trials involving children and federal officials administering research policy. In summary, we hope that all individuals engaged in the delicate (p. 4) balancing of protecting children from research risk and assuring access to research for children will find the book useful.

Finally, we hope that this book will be of use to parents and children faced with a decision about whether to take part in research. Despite the current emphasis on risk-benefit analysis by IRBs, informed parental permission and assent represent an important aspiration for how things should be in pediatric research ethics. Although shaped by social and cultural factors, decisions such as these are ultimately personal and value driven. Children and their families respond in a wide variety of ways to questions about altruism, community, and risk. Through reading these cases and analyses, parents and older children may deepen their understanding and be empowered to make the decisions that are right for them.

This book is not intended to be a historical, legal, or regulatory document. We recognize that good ethics start with good facts. We have done our best to get the facts right and have cited sources when available. The point of this book, however, is the ethics that can be learned from the cases. This disclaimer, then, must be emphasized. Although the editors and contributors take full responsibility for the moral analysis presented here, the authenticity of the facts are only as good as the publicly available reference materials and cited scholarship we have been able to provide. Although we have done our best to get the facts right, the reader must understand both the limits we describe here and the priority given in this book to ethical analysis.

To assist students and teachers using this book in the classroom setting, each chapter includes a list of questions for discussion. These questions are found after the ethical analysis at the conclusion of each chapter, prior to the references. The format for each of the following chapters, then, includes three sections: case description, ethical analysis and discussion, and questions for discussion. Some students and instructors may wish to review and discuss the questions prior to reading the ethical analysis and discussion to stimulate independent thinking. Others may prefer to use the questions after having read the analysis of the case.

Many ethical dilemmas have no “right” answer. On this basis, it is often said that doing ethics well means asking the right questions. The questions for discussion that accompany each chapter have been developed in this spirit. The Socratic method provides a wonderful pedagogical tool for teaching medical ethics; we hope that the questions found here will engage readers and catalyze the magic of the educational process. We have provided this text, but that is only the beginning. The magic happens when readers work with the text. If this book can help students to become independent askers of the right questions, it will have met the editors’ definition of success.

(p. 5) Conclusion

The development of a pediatric ethics that is based on genuine respect for children and their best interests requires that the justification for pediatric research go beyond pure utilitarian motivation. The research imperative is founded on a commitment to progress, and that powerful force can be a distorting influence for many investigators, physicians, children, and families. This may place children at risk for harm in clinical research; more important, the overwhelming power of the research imperative and the hope that it offers can quickly dominate respect for a particular child and family. Pediatric ethics depends on this respect, even if it requires that such respect come at the expense of progress against childhood diseases. Individual beneficence must take precedence over collective notions of beneficence, and the pediatric research community must remember that our responsibilities to individual children outweigh more speculative concerns about potential benefits to future generations of children.

The American Academy of Pediatrics (2018) vision statement declares: “We believe in the inherent worth of all children. They are our most enduring and vulnerable legacy.” The conduct of research involving children challenges us to struggle with this vision. Knowledge gained from research is part of our commitment to the legacy but must be acquired in a way that recognizes the vulnerability of children and respects their inherent worth. This book is one effort to produce work that is worthy of this vision. Ultimately, we hope this volume will provide the thoughtful guidance for pediatric research ethics that children deserve.

Disclaimer

The material presented in this chapter is intended for educational purposes only. Statements of fact and opinions expressed are those of the author(s) and, unless expressly stated to the contrary, are not the opinion or position of any company, institution or third party entity.

References

American Academy of Pediatrics. (2018). AAP agenda for children. Retrieved from https://www.aap.org/en-us/about-the-aap/aap-facts/AAP-Agenda-for-Children-Strategic-Plan/Pages/AAP-Agenda-for-Children-Strategic-Plan.aspx

Hunter, K. M. (1994). Narrative and medical knowledge. Baltimore, MD: Johns Hopkins University Press.Find this resource:

(p. 6) Kodish, E., Ed. (2005) Ethics and Research with Children: A Case-Based Approach. New York, NY: Oxford University Press.Find this resource:

Jonsen, A. R., & Toulmin, S. (1988). The abuse of casuistry. Berkeley: University of California Press.Find this resource:

Murray, T. H. (1997). What do we mean by “narrative ethics”? Medical Humanities Review, 11(2), 44–57.Find this resource:

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1977). Research involving children: Report and recommendations. DHEW Publication No. (OS) 77-0004, Appendix. DHEW Publ. No. (OS) 77-0005. Washington, DC: Author.Find this resource:

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1978). Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC: U.S. Government Printing Office.Find this resource:

National Institutes of Health. (1998). NIH policy and guidelines on the inclusion of children as participants in research involving human subjects. Bethesda, MD: Author.Find this resource:

U.S. Food and Drug Administration. (2004, February 27). One Hundred Seventh Congress: Best Pharmaceuticals for Children Act. Washington, DC: Author. Retrieved July 27, 2004, from http://www.fda.gov/cder/pediatric/#bpcaFind this resource: