Ethical Conduct Of Clinical Research Involving Children

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Summary: Reviews Protocols for Research with Children a Subjects
Review: Ethical Conduct Of Clinical Research Involving Children edited by Marilyn J. Field, Richard E. Behrman (National Academies Press) In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies.

Ethical Conduct of Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and recommends steps that researchers, government agencies, and others can take to improve research conduct. The book argues that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular. The report looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children.
Those who care about and for children currently face a dilemma. We want children to benefit from the dramatic and accelerating rate of progress in medical care that is fueled by scientific research. At the same time, we do not want to place any children at risk of being harmed by participating in such research, even though their very involvement may be essential to improving the overall medical care of children. We also want to discourage research that is of minimal value. The concern is how best to balance these potentially conflicting objectives. Five important considerations should guide us as we seek to resolve our dilemma.
First, because of the inherent vulnerabilities arising from their immaturity, infants, children, and adolescents need additional protections beyond what is provided to competent adults when they participate in research. This principle underlies all others.
Second, the design of the research required to improve the health and well-being of infants, children, and adolescents must consider their physical, cognitive, emotional, and social development. Similarly, when children of any age become participants in such research, the protections provided must be appropriate to their stages of development.
Third, sharing in the advances in medical care for this vulnerable group includes a special emphasis on protecting them from harm caused by standard medical procedures and treatments based on research with adults when the benefits and risks for children of different ages have not been established through scientific research involving these populations. Except
when it is not feasible or reasonable, research with animals, and adults should precede studies with children to minimize research risks.
Fourth, the system for protecting infants, children, and adolescents involved in research, while ensuring such protection, should not unreason-ably impede research that may benefit them. The contribution of rules and regulations to desired outcomes as well as possible unintended negative consequences should be considered.
Finally, all of those responsible for research involving infants, children, and adolescents need to understand the special ethical issues that are relevant to the conduct of such research and the additional protection that must be provided. In certain cases, ethical standards will preclude some otherwise desirable research.
Overall, a satisfactory resolution of our dilemma can be achieved. Children involved in research can be appropriately protected as well as share fairly in the increasing benefits of biomedical science. This report suggests ways to balance sometimes conflicting objectives in ways that will contribute to children's health and well-being now and in the future.