Culture, Medicine and Psychiatry

, Volume 31, Issue 4, pp 445–472

Informed Consent in Cross-cultural Perspective: Clinical Research in the Tibetan Autonomous Region, PRC

  • Vincanne Adams
  • Suellen Miller
  • Sienna Craig
  • Sonam
  • Nyima
  • Droyoung
  • Phuoc V. Le
  • Micheal Varner
Original Paper

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.

Keywords

Informed consent Cultural competence Tibet Clinical trials protocols 

References

  1. Adams, Vincanne, Suellen Miller, Sienna Craig, Arlene Samen, Nyima, Lhakpen, Sonam, Droyoung and Michael Varner 2005a The Challenge of Cross-Cultural Clinical Trials Research: Case Report from the Tibet Autonomous Region, People’s Republic of China. Medical Anthropology Quarterly 19(3):267–289.CrossRefGoogle Scholar
  2. Adams, Vincanne, Suellen Miller, Jennifer Chertow, Sienna Craig, Arlene Samen, and Michael Varner 2005b Having A ‘Safe Delivery:’ Conflicting Views from Tibet. Health Care for Women International 26(9): 821–851.CrossRefGoogle Scholar
  3. Benatar, S.R. 2002. Reflections and Recommendations on Research Ethics in Developing Countries. Social Science and Medicine 54(7): 1131–1141.CrossRefGoogle Scholar
  4. Benitez, Oscar, Dominique Devaus, and Jean Dausset 2003 Audiovisual Documentation of Oral Consent: A New Method of Informed Consent for Illiterate Populations. The Lancet 359: 1406–1407. April 20.CrossRefGoogle Scholar
  5. Bhutta, Zulfiqar A. 2004 Beyond Informed Consent. Bulletin of the World Health Organization 81(10): 771–777.Google Scholar
  6. Burns, M. 2001 Misoprostol for Obstetric and Gynecologic Uses: A Literature Review. 2nd Edition. Path & Engender Health, April.Google Scholar
  7. Dickens, B.M. and R.J. Cook 2003 Challenges of Ethical Research in Resource-Poor Settings. International Journal of Gynecology and Obstetrics 8(1):79–86.CrossRefGoogle Scholar
  8. Emanuel, E.J., D. Wendler, J. Killen, and C. Grady 2004 What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. Journal of Infectious Disease 189: 930–337.CrossRefGoogle Scholar
  9. Fitzgerald, Daniel W., Delile Marotte, Rose Irene Verdier, Warren D. Johnson, Jr., and Jean William Pape 2003. Comprehension During Informed Consent in a Less-Developed Country. The Lancet 360:1301–1302. October 26.CrossRefGoogle Scholar
  10. Flory, James, and Ezekiel Emanuel 2004 Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A systematic Review. Journal of the American Medical Association 292(13): 1593–1601. October 6.CrossRefGoogle Scholar
  11. Friedland, Barbara, C. Elizabeth McGrory, S’phindhile Magwaza, Mabitso Marumo, Alana de Kock, Mohlatlego H. Sebola and Nicol Coetzee, 2002 Informed Consent in a Phase II Trial of the Potential Microbicide, CarraguardTM: Lessons Learned. Presented at XIVth International AIDS Conference. July 7–12, Barcelona, Spain.Google Scholar
  12. Gray, Bradford H. 1978 Complexities of Informed Consent. Annals of the American Academy of Political and Social Science 437:37–48CrossRefGoogle Scholar
  13. Harrington, Anne, ed. 1997 The Placebo Effect: An interdisciplinary Exploration. Cambridge, MA: Harvard University Press.Google Scholar
  14. ICM/FIGO 2004 Joint Statement: Management of the Third Stage of Labour to Prevent Post-partum Haemorrhage. Journal of Midwifery and Women’s Health 49(1): 76–77.CrossRefGoogle Scholar
  15. Johns Hopkins Bioethics Institute 2005 Pilot Project Interviewing Participants in Research Projects in Developing Countries: Why Do Participants Join, and What Do They Understand?” http://www.hopkinsmedicine.org/bioethics/research/ire
  16. Karim Q.A., S.S.A. Karim, H.M. Coovadia and M. Susser 1998 Informed Consent for HIV Testing in a South African hospital: Is it Truly Informed and Truly Voluntary? American Journal of Public Health 488: 637–640.CrossRefGoogle Scholar
  17. Kaptchuk, T. 1998a Powerful Placebos: The Dark Side of the Randomized Controlled Trial. Lancet 351: 1722–1725.CrossRefGoogle Scholar
  18. Kaptchuk, T. 1998b Intentional Ignorance: A History of Blind Assessment and Placebo Controls in Medicine. Bulletin of the History of Medicine 72(3): 389–433.CrossRefGoogle Scholar
  19. Kaufert, Joseph 1996 Culture and Informed Consent: The Role of Aboriginal Interpreters in Patient Advocacy in Urban Hospitals, pp. 89–93. Issues in the North – Manitoba: Canadian Circumpolar Institute.Google Scholar
  20. Lerner, Barron H. 2004 Beyond Informed Consent: Did Cancer Patients Challenge their Physicians in the Post-World War II Era? Journal of the History of Medicine and Allied Sciences 59(4):507–521.CrossRefGoogle Scholar
  21. McKay, Alex 2003 Himalayan Medical Encounters: The Establishment of Western Biomedicine in Tibet. Paper presented at the Tibetan Medicine Panel of the 10th Annual International Association of Tibetan Studies Conference, St. Hugh’s College, Oxford University, Oxford, England, September 6–12.Google Scholar
  22. Miller, S., V. Adams, S. Craig, P.V. Le, Sonam, Nyima, Droyoung, Lhakpen and M. Varner 2004a Informed Consent in the Land of Snows. Presented at the American Public Health Association Meeting, November.Google Scholar
  23. Miller, S, S. Craig, P.V. Le, Nyima, Lhakpen, Sonam, Droyoung, V. Adams and M. Varner 2004b Making Consent Informed: Experiences with an RCT in Tibet. Hastings Journal of Ethics (under review, submitted with revisions).Google Scholar
  24. Pace, C., C. Grady and E.J. Emanuel 2004 What We Don’t Know About Informed Consent. Science and Development Network (SciDev.net) http://www.scidev.net/dossiers/index.cfm?fuseaction=specifictopics&dossier=5&topic=9
  25. Piquemal, Nathalie 2001 Free and Informed Consent in Research Involving Native American Communities. American Indian Culture and Research Journal 25(1):65–79.Google Scholar
  26. Saldov, Morris 1998. Cultural Barriers in Oncology: Issues in Obtaining Medical Informed Consent From Japanese-American Elders in Hawaii. Medical Anthropology Quarterly 13(3): 265–279.Google Scholar
  27. Sankar, Pamela 2004 Communication and Miscommunication in Informed Consent Research. Medical Anthropology Quarterly 18(4): 429–446.CrossRefGoogle Scholar
  28. Shapiro, H.T. and E.M. Meslin (National Bioethics Advisory Commission) 2001 Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries. New England Journal of Medicine 345(2):139–142. July 12.Google Scholar
  29. Sreenivasan, Gopal 2003 Does Informed Consent to Research Require Comprehension? Viewpoint. The Lancet 362: 2016–2018. December 13.CrossRefGoogle Scholar
  30. Wax, Murray L. 1991 The Ethics of Research in American Indian Communities. American Indian Quarterly 15(4):431–456.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Vincanne Adams
    • 1
  • Suellen Miller
    • 2
  • Sienna Craig
    • 3
  • Sonam
    • 4
  • Nyima
    • 5
  • Droyoung
    • 6
  • Phuoc V. Le
    • 7
    • 8
  • Micheal Varner
    • 9
  1. 1.Department of AnthropologyHistory and Social Medicine, University of CaliforniaSan FranciscoUSA
  2. 2.Safe Motherhood Programs, Department of ObstetricsGynecology and Reproductive Sciences University of CaliforniaSan FranciscoUSA
  3. 3.Department of AnthropologyDartmouth UniversityHanoverUSA
  4. 4.Women’s Division, Mentsikhang Traditional Tibetan Medicine and Astrology HospitalLhasa, TARP.R. China
  5. 5.Women’s Division, Lhasa Municipal HospitalLhasa, TARP.R. China
  6. 6.Women’s Division, Lhasa Maternity Child Health HospitalLhasa, TARP.R. China
  7. 7.Harvard Associated Residency in Internal MedicineBrigham and Women’s HospitalBostonUSA
  8. 8.Pediatrics Global Health Equity ResidencyBrigham and Women’s HospitalBostonUSA
  9. 9.Maternal Fetal MedicineUniversity of Utah School of MedicineSalt Lake CityUSA

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