Bioethics and privacy right on genetic epidemiology

Kim, Jang Han

Abstract

Unlike the classical genetic study which dealt with the mendelian inheritances of relatively small number of patients, the genetic epidemiology study needs the large scaled genetic data base. The main ethical and legal problems of these kinds of studies are research design, informed consent, long term follow-up of research subjects, data sharing and benefit sharing. Classically, the informed consent was an important right but if these kinds of large scaled and long period studies were involved, the newly developing rights should be more stressed. The bioethics and biosafety act and governmental regulations for the genetic study and gene bank also shows those considerations. In EU, the general consent is considered acceptable if the approval of all future projects is fulfilled by a research ethics committee and the participants' right to withdraw samples at any times. In U.S.A., strict restriction is required for future experiments, but if the research involves no more than minimal risk to the subject, the waiver or alternation will not affect adversely the rights and welfare of subjects and the research could not be practicably carried out without the waiver or alteration, the specific future consents could be exempted. Long term follow up of research patients is needed to provide the newly developed information which would be helpful for the patients. Data sharing is needed to prevent the exclusive possession of genetic information. Benefit sharing is the newly coming up debates on how to manage the conflicts of interests between tissue-donors and scientific researchers. The context and inventory of human rights for the research is changing and still under construction.