Invasive Research and Ethics

Invasive Research and Ethics

LETTERS TO THE EDITOR and soul-searching that must have taken place before carrying out such a study. Hence, I am perhaps missing the justification fo...

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LETTERS TO THE EDITOR and soul-searching that must have taken place before carrying out such a study. Hence, I am perhaps missing the justification for the invasive procedures which was not stated in the article. I hope that somewhere in our organization we are debating this issue. We have worked hard for a long time to gain insight into the mental life of the child and to assist ourselves and others to question what we do to children. I trust we are not losing ground on that hard won foothold. Charles Keith, M.D. Associate Professor of Psychiatry Division of Child Psychiatry Duke University Medical Center

Letters to the Editor will be considered for publication. Such letters must be signed by all authors. Letters should, in general, not exceed 500 words. All letters are subject to editing and shortening. The Editor reserves the right to publish replies and solicit responses. Letters should be typed double-spaced, and submitted in duplicate to Melvin Lewis, M.D., Editor, Journal of the American Academy of Child Psychiatry, 333 Cedar Street, New Haven, CT 06510.

Invasive Research and Ethics To the Editor: I am writing to you to express concern about some recent developments in the area of biological research with children. What finally prompted this letter was the article entitled "Computed Tomographic Brain Scanning in Children with Developmental Neuropsychiatric Disorders" (Volume 20, Number 2, Spring 1981) written by one of the most productive, esteemed research groups in our field today. Their findings were provocative, challenging and may eventually lead to therapeutic breakthroughs. My concern is that many of the 85 children (averaging 8 to 10 years of age) in the study were subjected to a general anesthesia in order to obtain the CAT scan. There was little, if any, indication that the CAT scan results would lead to specific treatment for the individual children. Thus, it was a survey study of a large group of children for primarily research purposes. At the conclusion of the article, the hope was expressed that this type of study would expand to include other groups of children, including normals. To subject young, emotionally disturbed and normal children to invasive research procedures concerns me. The American Academy of Child Psychiatry's newly adopted ethical code cautions about our participating in activities which can jeopardize an individual child's development in order to serve research and institutional goals. In my experience as a child analyst, supervisor, and teacher, I feel there is abundant evidence of the tremendous anxiety, regressive pressures and potential traumata engendered by invasive medical procedures, e.g. intravenous medication, anesthesia, and loss of consciousness. For decades, this has been documented by clinicians. I feel awkwardly out-of-step since this research was done by respected scientists and published in our official journal. I have not been privy to the discussions

Ms. Caparulo and Drs. Cohen, Rothman, Young, Katz, S. Shaywitz, and B. Shaywitz respond Dr. Keith's letter provides an opportunity for continuing the important discussion of the ethics of clinical research with children. In our neuropsychiatric research program on autism and other developmental disorders, we have tried to exemplify how investigation can benefit the clinical care of children. Involvement with research studies can improve evaluation, the provision of treatment, and advocacy for educational and other services. The studies of computed tomography of the brain (ACTA scanning) were undertaken in the context of thorough psychiatric, neurological, pediatric, and educational evaluation of children with disorders of unknown etiology. The studies were aimed at increasing knowledge about individual children and the serious disorders from which they suffer. We hoped to determine if this newer method of brain imaging would reveal any patterns of structural abnormality that could guide further studies of pathogenesis or intervention. The computed tomography research formed an aspect of a broader research program which we believe complies with the spirit and letter of the consent process. The formal protocols are reviewed by the medical school Human Investigation Committee and the studies are open to the scrutiny of other physicians, nurses, site visitors, and, of course, concerned families. We study children who are living with their parents or, in those instances where a child is in a residential school, where parents are actively involved; parents almost always are well educated and middleor upper-middle-class; parents are thoroughly informed about potential gains and risks and are encouraged to accompany children during procedures 92


and to room-in during hospitalizations. Children are prepared for procedures and their teachers are involved, to the degree possible, in having childr en learn what to expect. The results of studies are made available to parents and other professionals involved with the child, through individual meetings and public presentations. Involvement with the researchers is not episodic but continues over many years. Finally, the publication of findings allows for professional review and discussion. The first computed tomography units were slower than those currently available. To obtain satisfactory images, children had to remain stationary for several minutes for each level of scanning; physicians used various sedatives and "pushed" the medication as needed. We were concerned that this approach could lead to overdosage, as had been reported in other centers, and decided on the more cautious course described in our report. An anesthesiologist evaluated the child before the procedure; when sedation was required, the anesthesiologist remained with the child, as during an operation, and medication was used judiciously and the child was closely monitored. Only a minority of children required anesthesia and there were no complications. Recently, faster tomography units have reduced the need for anesthesia. Disorders such as autism, aphasia, and Tourette's syn drom e are serious medical conditions which require the scientific attention of investigators who can use front-line methods. Only through basic advances in understanding the causes of these disorders are we likely to make substantial changes in their treatment or prognosis. In the pursuit of knowledge about the biology of autism and similar conditions, some children will experience procedures which are stressful; but a lifetime of a serious disorder is dreadful. In our research, we have tried to make these disorders an area of interest to various scientists, including neuroradiologists; to help focus new methods on the children; and to encourage the advancement of systematic research that can guide clinical practice. When we first started the studies using computed tomography, it was not known what these new images would reveal. As a research methodology, tomography may continue to contribute to the understanding of structural correlates of autism and other developmental disabilities. Newer methods of imaging-such as positron emission tomography and nuclear magnetic resonance-may have more to offer. Only further empirical studies will show whether a new method can help clarify an enigmatic disorder; it is essential that the use of new methods is thoughtfully considered and the information reported in the scientific literature. Over the past several years, consciousness about


ethical issues in human investigation has been raised and children probably have been protected from unjustified risks. However, poli cies asso ciated with concerns about the ethics of investigation have tended to constrain clinical research and to make it more difficult to perform. It is of interest that families of children with serious disorders, such as those who constitute the National Society for Autistic Children and the Tourette's Syndrome Association, have tried to en courage more research, not less. Dr. Keith correctly emphasizes the need to maintain high standards of sensitivity about the emotional lives of children participating in research; as clinicians and child psychoanalysts, we hope that these standards guide our work. However, there is a complementary ethical question which he does not raise. Child psychiatry has not had very much to offer the most seriously disturbed children. It is ethically imperative that we promote a spirit of scholarly research in our field. It would be easy to inhibit or virtually stop clinical research with children; there are forces moving in this direction. As physicians, we are obligated to inform the public and government about the need for more rigorous investigation which can place our clinical practice on an increasingly firm scientific basis. In summary, we agree with Dr. Keith that computed tomography and anesthesia may pose medical and psychological risks. As part of the effort to understand major and sometimes devastating disorders, these risks appear justified. It is important to discuss the ethics of human investigation and there has been no shortage of debate. On the other hand, the paucity of sustained clinical research in our field is an ethical issue which deserves further public and professional discussion. Barbara Caparulo, M.S. Donald J. Cohen, M.D. Stephen L. Rothman, M .D . J . Gerald Young, M.D. Jonathan D . Katz, M.D. Sally E. Shaywitz, M.D. Bennett A. Shaywitz, M.D. Yale University School of Medicine

Dr. Mahler Responds to Dr. Minde's Review To the Editor: I appreciated Dr. Klaus Minde's comments in his review of my two volumes of selected papers (Volume 20, Number 2, Spring 1981). I was struck, however, by the fact that Dr. Minde did not seem to know about several aspects of my work. There are three substan-