Ethical Principles Governing Research in Child and Adolescent Psychiatry KERIM MUNIR, M.B., M.P.H., AND FELTON EARLS, M.D. Abstract. This paper examines the ethical principles governing research in child and adolescent psychiatry. The guidelines for protection of children and adolescents as research subjects are discussed. These include the principle of nonmaleficence and beneficence (the risk-benefit ratio), the principle of autonomy (informed consent and confidentiality), and the principle of justice (fair distribution of benefits and burdens of research). In the light of recent national efforts to help promote responsible research practice, the ethical standards relating to the protection of scientific integrity as well as research advocacy, training, and stewardship are also discussed. J. Am. Acad. Child Adolesc. Psychiatry, 1992, 31, 3:408-414. Key Words: ethics, child and adolescent psychiatry, research. The 1990s will very likely be host to an intensification of child and adolescent mental health research. This new fer- ment in the field has been heralded by a recent report of the Institute of Medicine (10M) calling for an urgent provision of resources to develop a "critical mass" of well-trained research personnel to fund a wide range of basic and clinical research projects and to broaden the number of "centers of excellence" in child and adolescent psychiatry (10M, 1989a). The 10M report has become the foundation for a national research plan submitted to Congress (U.S. Depart- ment of Health and Human Services [USDHHSj, 1990) and recently approved for implementation (USDHHS, 1991). It is timely, then, to examine the ethical standards that govern the conduct of research in child and adolescent psy- chiatry. The first part of this paper describes the ethical principles relating to protection of subjects in pediatric and mental health research in general. These guidelines alone do not ensure responsible conduct of research. In the light of national efforts promoting improved practice, the paper highlights the recommendations of another 10M report on regulation of the research environment (10M, 1989b). Fi- nally, the paper discusses the ethics of research stewardship and training critical for the implementation of the national research plan in the future (USDHHS, 1990). The ethical principles introduced in this article only guide research applications. The use of the principles in specific cases is the responsibility of individual investigators and their institutions. A seriously deficient knowledge base on the causes and effective treatment of child and adolescent Accepted July 6, 1991. Dr. Munir is Assistant Professor of Psychiatry, Division of Child and Adolescent Psychiatry, the Cambridge Hospital, Harvard Medical School, and Dr. Earls is Professor of Human Behavior and Develop- ment, Department of Maternal and Child Health, Harvard School of Public Health and Professor of Child Psychiatry, Harvard Medical School. The authors thank Drs. Leon Eisenberg, Myron L. Belfer, and James C. Beck for their valuable comments. This work was supported by NIMH grant K07-MH00826-02 (to K.M.). Reprint requests to Dr. Munir, Division of Child and Adolescent Psychiatry, the Cambridge Hospital, 1493 Cambridge Street, Cam- bridge, MA 02139. 0890-8567/92/3103-O408$03.00/0©1992 by the American Acad- emy of Child and Adolescent Psychiatry. 408 mental disorders makes research a top priority in the field. Nonetheless, a clear understanding of ethical principles is necessary to sustain this effort toward the ultimate goal of improving the mental health of children and adolescents. Protections for Subjects The Declarations of Helsinki (World Medical Associa- tion, 1975) and the Nuremberg Code (Trials of War Crimi- nals, 1946-49) are the international charters that guide human investigations and medical experiments (Beauchamp and Childress, 1983). They declare unequivocally that the "concern for the interests of the subject must always prevail over the interests of science and society." They state that "the voluntary consent of the human subject is absolutely essential.' They also state explicitly that an individual must understand the nature of the proposed research well enough to make an informed decision. They demand that the purpose and content of an investigation as well as its duration, poten- tial effects on the subjects' health, and all the inconveniences associated with the research be disclosed well in advance to potential subjects (Beauchamp and Childress, 1983). The USDHHS federal regulations guide all human inves- tigations in the United States (USDHHS, 1983a). These federal regulations define a subject as a "living individual about whom an investigator conducting research obtains (1) data through intervention or interaction or (2) identifiable private information." All organizations applying for funding from the Public Health Service are required to appoint Insti- tutional Review Boards (IRBs) to ensure protection for re- search subjects. Regardless of the federal requirements, most institutions have their local IRBs comprised of clinicians, researchers, patient advocates, lay members, and others knowledgable in the fields of law and ethics. There are three basic principles that underlie the judg- ments made by the IRBs: (1) the duty of nonmaleficence and beneficence (assessment of the risk-benefit assumed by each subject); (2) the principle of autonomy (informed consent, protection of privacy, and confidentiality); and (3) the principle of justice (the fair distribution of benefits and burdens of research and the equitable selection of subjects). Each one of these principles presents special problems in both pediatric and mental health research. J.Am. Acad. Child Adolesc. Psychiatry, 31 :3, May 1992