Legal and ethical considerations for genetic clinical research

Abstract

From the trend in modern medicine toward the study of genes and their contribution to the development of disease has evolved an increased awareness of ‘the diversity of genetic fingerprints among individuals’ [1]. The incorporation of this knowledge into the technologies of the pharmaceutical industry has led to the emerging field of ‘pharmacogenomics’; that is, the process of identifying the differences in genetic sequences between individuals and developing therapies [2] as ‘personal medicines’ [3]. For example, a drug used as a muscle relaxant during surgery, suxamethonium, was found to be lethal to patients who possessed a rare version of a gene involved in nerve transmission so that now those who receive this drug are tested for this specific gene [4]. Although pharmacogenomics promises great possibilities for the future of medicine, it does involve ethical and legal considerations that must be considered. Indeed, potential misuses of genetic information, such as discrimination in obtaining health insurance and in the workplace, need to be addressed. Genetic testing practices remain more advanced than the national and international laws governing the appropriate use of genetics. Although there is no national law in the United States that specifically addresses DNA and genetic privacy, several federal regulations would apply indirectly to the protection of this information and state legislators have successfully passed numerous state laws. Professional associations and private organizations have issued several guidelines for genetic testing practices. The purpose of this report is to provide a picture of the legal and ethical ramifications of genetic testing in clinical research. The genetic testing issue is presented herein in the categories of national, international, and state laws, policies, regulations and guidelines. Copyright © 2003 John Wiley & Sons, Ltd.