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 Clinical 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 conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book 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. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

Protecting the rights and welfare of those who volunteer to participate in research is a fundamental tenet of ethical research. A great deal of progress has been made in recent decades in changing the culture of research to incorporate more fully this ethical responsibility into protocol design and implementation. In the 1960s and 1970s, a series of scandals concerning social science research and medical research conducted with the sick and the illiterate underlined the need to systematically and rigorously protect individuals in research (Beecher 1966; Faden and Beauchamp 1986; Jones 1981; Katz 1972; Tuskegee Syphilis Study Ad Hoc Advisory Panel 1973). However, the resulting system of protections that evolved out of these rising concerns-although an improvement over past practices-is no longer sufficient. It is a patchwork arrangement associated with the receipt of federal research funding or the regulatory review and approval of new drugs and devices. In addition, it depends on the voluntary cooperation of investigators, research institutions, and professional societies across a wide array of research disciplines. Increasingly, the current system is being viewed as uneven in its ability to simultaneously protect the rights and welfare of research participants and promote ethically responsible research.