title: International clinical trials with applicability to mentally impaired individuals: the conundrum of third world sites.
abstract: Research on the effectiveness of treatment programs in early stages of severe mental illness raise significant ethical questions when conducted in industrialized countries that have adequate protections for the human subjects of biomedical and behavioral research. Before embarking on similar trials in developing countries, researchers face formidable barriers that must first be addressed and overcome. The challenges to external sponsors of research in conducting ethically responsible clinical trials in developing countries include at least the following: the existence of alternative belief systems regarding the causes and treatment of mental illness; difficulty in implementing the results of successful research in resource-poor countries; providing for adequate prior ethical review in the host country of the proposed study; and problems in ensuring that voluntary, informed consent is properly obtained from research subjects or their legally authorized representatives. Global justice demands that we not adopt one ethical standard for rich countries and another for resource-poor countries.
authors.affiliation: Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, NY 10461, USA. macklin@aecom.yu.edu
authors.forename: R
authors.initials: R
authors.lastname: Macklin
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003431:Cross-Cultural Comparison; D003906:Developing Countries; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007872:Legal Guardians; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D019989:Persons with Intellectual Disabilities / Q000331:legislation & jurisprudence*