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Ethical Conduct of Clinical Research Involving Children

NCJ Number
Marilyn J. Field, Richard E. Behrman
Date Published
444 pages
This Institute of Medicine (IOM) report reviews Federal regulations, reports, and research about desirable practices in clinical research involving children and offers recommendations for improvement.
The focus of the inquiry was primarily on clinical research involving preventive, diagnostic, treatment, or similar interventions. Following the introduction in chapter 1 that describes the origins of the study and discusses the importance of protecting human participants in research, chapter 2 focuses on the necessity of clinical research involving children and the challenges it presents. Chapter 3 describes the current Federal regulations governing the protection of children involved in clinical research and summarizes the categories of research involving children that are appropriate under Federal regulations. Chapter 4 considers the regulatory definition of “minimal risk” as it applies to research involving children and offers several recommendations on the assessment of potential harms posed to children by research protocols. It is advised that minimal risk be interpreted in relation to the normal experiences of average, healthy children and that risk be considered in relation to the risks encountered by children in their everyday lives. Chapter 5 focuses on the ethical concerns and legal requirements regarding children’s consent to participate in research. The IOM recommends that research protocols include descriptions of who will request permission and how it will be requested. Additionally, the process for requesting permission should be developmentally appropriate. Chapter 6 discusses the ethical principles and regulations regarding payments for children’s participation in clinical research and recommends policies that disclose the amount, the recipient, the timing, and the purpose of any payments. Chapter 7 examines compliance with, and enforcement of, Federal regulations governing the protection of children involved in clinical research while chapter 8 focuses on the roles and responsibilities of various agencies related to the protection of children who are research participants. The summary offers a complete list of the IOM’s recommendations regarding the ethical conduct of clinical research involving children. Boxes, figures, tables, footnotes, references, appendixes, index