An Exploration of Ethical Issues in Research in Children's Health and the Environment
Paulson, Jerome A., Environmental Health Perspectives
The consideration of ethical issues relating to pediatric environmental health is a recent phenomenon. Discussions of biomedical ethics, research on children, and environmental health research have a longer history. In the late 1990s, researchers at the Kennedy Krieger Institute in Baltimore, Maryland, undertook a study to compare the effectiveness of several methods of reducing lead risk in housing. In a preliminary finding in the case of Grimes v. Kennedy Krieger Institute, Inc., a Maryland court questioned the ethics of performing research on children when there is no prospect of direct benefit to those children and whether parents can consent to such research. This case dramatically raised the profile of ethical issues among the pediatric environmental health research community. To broaden the discussion of these issues and in response to the Kennedy-Krieger case, the Children's Environmental Health Network held a working meeting on 5 and 6 March 2004 to explore this topic. The articles in this mini-monograph were prepared by the authors as a result of the workshop and represent their opinions. This article is an introduction to the workshop and a summary of the articles to follow. Key words: bioethics, children, community-based research, confidentiality, environmental exposure, environmental health, environmental justice, ethics, financial disclosure, institutional review board.
Any discussion of medical ethics in the Western world rests on a foundation that is > 2,500 years old (Jonsen 2000; Pellegrino 1993). The consideration of ethical issues related to research, and specifically research related to environmental health, is a much more recent phenomenon (Soskolne 1993; Soskolne and Light 1996; World Health Organization 1996).
A research project was undertaken by the staff of the Kennedy Krieger Institute Inc. (KKI) in Baltimore, Maryland, to compare different approaches to reducing the risk of lead poisoning in dwelling units. Lawsuits were filed against the researchers and KKI alleging that the children sustained lead poisoning or were put at risk of lead poisoning because the research protocol required that some of the dwelling not be fully abated. In the case of Grimes v. Kennedy Krieger Institute, Inc., a court in Maryland rendered a preliminary opinion that nontherapeutic research on children was inappropriate (Court of Appeals of Maryland 2000; Glantz 2002). That opinion caused a great deal of distress and discussion in the environmental heath community (Bellinger and Dietrich 2002; Glantz 2002; Markowitz and Rosen 2002; Mastroianni and Kahn 2002; Mielke 2002; Mushak 2002; Needleman 2002; Nelson 2002; Phoenix 2002; Pinder 2002; Ryan and Farr 2002; Sharpe 2002). Partly in response to the Kennedy-Krieger episode and wanting to expand the discussion about ethical issues related to research in children's health and the environment, the Children's Environmental Health Network (CEHN), with funding from the Centers for Disease Control and Prevention and cooperation from the American Association for the Advancement of Science, held a working meeting to explore this topic. Meeting participants were drawn from four constituencies: parents, activists, scientists, and ethicists. (See Appendix 1 for a list of participants and their affiliations.) The articles that follow in this monograph were prepared by the authors as a result of the workshop and represent their opinions.
The foundations of medical ethics in Western culture go back to writings attributed to Hippocrates and deal primarily with the relationship between individual physicians and their individual patients. There is not much recorded modification of these concepts until the 18th century (Jonsen 2000; Pellegrino 1993; Seto 2001).
The origin of concern about ethical issues related to medical research is not very clear. In the late 19th century, William Osler and others believed that "every treatment is an experiment" (Jonsen 2000). …