title: Informed Consent in cross-cultural perspective: clinical research in the Tibetan Autonomous Region, PRC.
abstract: Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People's Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.
authors.affiliation: Department of Anthropology, History and Social Medicine, University of California, San Francisco, USA. adamsV@dahsm.ucsf.edu
authors.forename: Vincanne
authors.initials: V
authors.lastname: Adams
authors.forename: Suellen
authors.initials: S
authors.lastname: Miller
authors.forename: Sienna
authors.initials: S
authors.lastname: Craig
authors.lastname: Sonam
authors.lastname: Nyima
authors.lastname: Droyoung
authors.forename: Phuoc V
authors.initials: PV
authors.lastname: Le
authors.forename: Micheal
authors.initials: M
authors.lastname: Varner
mesh_terms: D003431:Cross-Cultural Comparison; D054521:Cultural Competency / Q000941:ethics*; D003469:Culture; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007258:Informed Consent / Q000941:ethics*; D007802:Language; D038861:Medicine, Tibetan Traditional; D016595:Misoprostol / Q000627:therapeutic use*; D010120:Oxytocics / Q000627:therapeutic use*; D010353:Patient Education as Topic / Q000941:ethics; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D018609:Tibet
chemical_list: D010120:Oxytocics; D016595:Misoprostol