ETHICAL BOUNDARIES IN RESEARCH: PUBLIC HEALTH AND CLNICAL RESEARCH CASE STUDIES

Steele Auditorium

Introduction. This is a presentation of two controversial research studies. Using these two studies, the audience will explore the ethical boundaries of clinical and public health research. Case presentation. Study 1) The Kennedy Krieger lead paint study included 108 houses in 5 groups of children living in Baltimore homes. Three of the groups were children living in homes that used new lead abatement procedures but the extent and cost of abatement varied between the 3 groups. The 2 comparison groups were made up of children living in housing that had been abated by the city of Baltimore and children living in housing built after 1978. Study 2) In the 1990s the National Institute of Health and the Centers for Disease Control funded clinical trials funded to determine if there were less expensive ways to prevent transmission of perinatal HIV transmission by using lower doses of AZT. Research was conducted in Africa, Thailand and the Dominican Republic. Some women were given doses of AZT that were less than the doses used in the United States at that time. Other women received placebos. Deviation From the Expected. These two cases created much controversy among researchers and bioethicists. In the first case some children continued to be at risk of some lead exposure and in the second case study some women did not receive the dosage of AZT known to be effective in the United States. Discussion. Study 1) Is it ever ethical to conduct research on less expensive interventions that may not be as effective as existing treatment, but are more cost effective and likely to be more widely implemented? Study 2) What are the ethical boundaries for using placebos and lower doses in studies designed to find less expensive treatment/prophylaxis? Conclusion. Research that may meet real world and community specific conditions--as well as research funding constraints--may challenge traditional research ethics. Before dismissing or championing such research designs, all ethical considerations should be explored and understood. These two case studies represent controversial designs where the limits of ethical research may have been stretched and from which ethical boundaries can be described. Grants. None