Informed consent for research: international perspectives.
Problems in obtaining and documenting informed consent are especially difficult to resolve in countries whose cultures differ considerably from those of most Western nations. Confusion between the research and therapeutic contexts are widespread. Two departures from widely accepted ethical standards are discussed: withholding information about the research and requiring a husband's permission for his wife to participate. Supporters of such departures claim that they are justified by the cultural context of the country in which the research is carried out. One program at the World Health Organization has developed guidelines stating that requiring partner agreement or authorization for an individual to participate in research violates the autonomy of research subjects and their right to confidentiality. A study carried out at one reproductive health clinic in Chile describes a process of obtaining informed consent to research that could serve as a model for US investigators interested in making informed consent a meaningful and ethically respectable aspect of their research activities. Research involving human subjects should adhere to a single, universally applicable standard of informed decision making by participants.
Macklin
R
R
Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.
D000328:Adult; D002677:Chile; D002986:Clinical Trials as Topic; D003466:Cultural Characteristics; D003657:Decision Making; D003906:Developing Countries; D004992:Ethics, Medical; D005260:Female; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008297:Male; D010358:Patient Participation; D018454:Spouses; D014944:World Health Organization