Medical Research with Children: Ethics, Law and Practice

Research on children poses special problems to humanity: how does one go about pursuing medical knowledge, directly or indirectly beneficial to all children, in a way that does not jeopardize the interests of any individual child? Is it ethical to perform tests or procedures on a child who may not be able to give fully informed consent? There are many ethical and legal principles involved, with enough inconsistencies to bewilder any pediatric researcher about to begin a clinical study. A multitude of guidelines have been developed over the years since the Nazi atrocities, both by national and international associations and by various governmental legislatures. Yet these guidelines often tried to define what is legal in research on children, not what is ethical (unfortunately, the two do not always coincide). While there has been extensive debate on the latter subject, most notably by ethicists Paul Ramsey and Richard McCormick, very few definitive answers are available to practitioners of medical research in this regard. Medical Research with Children: Ethics, Law, and Practice does a commendable job in remedying this lack. The text is based on the discussions of a working group convened to study "the question afresh and publish a Report designed to encourage reflection and, perhaps, to help members of Research Ethics Committees in the discharge of their duties." They met in England twenty-five times over three years. Group members included physicians, philosophers, lawyers, and other related professionals , giving the volume a noticeably balanced outlook. The goals were clearly stated in the Introduction and are certainly achieved. The working group decided to consider only research on live-born children from the moment of birth to the age of 16 years, thus avoiding the topic of research on the fetus or on fertilized eggs. While this may be considered a drawback in that most of the active debates are on these topics, delving into these issues would have caused only confusion and would have masked the highlights of the rest of the discussions. There are ten chapters, all organized so that a member of the medical academic community can progress from the simplest of ethical ideals and conclude with some workable guidelines. Chapters 1 through 5 set the arguments in before the reader. Various ethical and technical terms are defined, and possible implications are presented. Philosophical and legal inquiry is kept brief and concise, allowing the medical community easily to understand and …