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Vincanne Adams, PhD, Medical Anthropology, UCSF, 3333 California St., suite 485, San Francisco, CA 94143-0850, Suellen Miller, CNM, MHA, PhD, School of Public Health, University of California, Berkeley, 308 Warren Hall, UC-Berkeley, Berkeley, CA 94720, Sienna Craig, Cornell University, Room 307, Hotel Kyichu, 18 Beijing Middle Road, Lhasa, Tibet, China, Phuoc Le, School of Public Health, UC Berkeley, 74 Barnes Ct. #7D, Stanford, CA 94305, 9162961331, phuocvanle@hotmail.com, and Michael Varner, MD, OBGYN, University of Utah, Room 2B306, Maternal-Fetal Medicine University of Utah Health Sciences Center, 50 North Medical Drive, Salt Lake City, UT 84132.
Background: To decrease maternal deaths due to postpartum hemorrhage, a team of anthropologists, clinicians, and researchers are conducting the first RCT of a Tibetan traditional medicine vs. Misoprostol. Clinical research is unknown in Tibet; therefore we needed to develop a comprehensible, culturally appropriate informed consent document for the often uneducated and/or illiterate Tibetan prenatal participants.
Methods: We undertook a rigorous, step-wise approach of qualitative research. First medical anthropologists familiar with Tibetan culture conducted extensive ethnographic interviews with Tibetan women to understand their perceptions on research, Tibetan medicine, Western biomedicine, childbirth, illness, and other relevant topics. We used this information to develop simple explanations of the proposed research. During successive rounds of pilot testing we were able to further simplify the concepts and language, adding pictures to clarify difficult concepts, such as randomization.
Results: The final IC form was short, written in simple language, had culturally appropriate drawings, and nearly 70% of potential participants in pilot testing understood the purpose of the study, what the risks of participating were, that they could drop out of the study at any time, and that they would not have to pay to participate nor that they would be paid to participate. We achieved this high percentage of comprehension among participants despite having a 40% rate of women with no education.
Conclusions: Effort is necessary to assure that participants, unfamiliar with Western biomedical research, understand what they are consenting to when they accept to participate in a study.
Learning Objectives:
Keywords: International MCH, Cultural Competency
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.