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

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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.

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Notes

  1. NICHD Global Network Research Grant # HD40613 in conjunction with The Bill and Melinda Gates Foundation.

  2. Very little modern scientific medical infrastructure exists in Tibet, despite a history of medical entrepreneurialism and experimentation. Tibetan scientific researchers have only been interacting with scientists from more developed regions of the PRC and from other industrialized countries for the past several decades. Tibet’s own “science of healing” (gso ba rig pa), based on the rgyud bzhi (the Four Tantras that form the basis of Tibetan medical theory and structure Tibetan medical education) developed its own research orientations at the Mentsikhang, or Medicine and Astrological Institute (established in 1916). However, while this research was empirical, it is different from the scientific empirical research that emerged over the past century in Western or iomedicine. Tibetan research consisted largely of developing new medical compounds and therapies based on the testing of potencies of various medicinal ingredients, in part through astrological calculations; minimal testing on human patients, and evidence of efficacy was often drawn from clinical observation of small cohorts of patients. Even after the introduction of biomedical hospitals, clinics, and practices in the TAR—first through the British presence in Tibet (McKay 2003), later through Chinese annexation and the training of ethnic Chinese and Tibetans, and, since liberalization and “opening up,” also through the introduction of national and international health development agendas—the creation of a medical research infrastructure that resembles anything like that found in developed, industrialized settings remained nascent. Today, medical schools in the region do not train physician researchers in anything but the most elementary research techniques based on simple collection of empirical data.

  3. Brand name Cytotec, prostaglandin E1 analogue, used in biomedicine to contract the uterus (Burns 2001).

  4. This information was provided by the Tibet Autonomous Region Bureau of Public Health, People’s Republic of China. The figures provided are as follows: for 2000–467/100,000 deaths/deliveries, with 45% due to postpartum hemorrhage; 2001– 325/100000 with 52% due to PPH; 2003—400/100000 with 49% due to PPH.

  5. Toni Huber.

  6. Good Clinical Practices (GCP) are a set of PRC standards and regulations dictating ethical medical practices, particularly as they relate to clinical trials and the development of new drugs. These GCP practices follow their US FDA and WHO counterparts, with specific additions and changes made in accordance with PRC social and political circumstances. Some of the specific issues covered by the GCP are: assessing clinical safety for drugs intended for long-term treatment of non-life threatening diseases, clinical safety data management, structure and content of clinical study reports, ethical factors in the acceptability of foreign clinical data, and a variety of considerations in the structuring and execution of clinical trials. These data are worthy of a separate article.

  7. Fitzgerald et al. (2003) note that 75–80% is an appropriate threshold for comprehension on an oral exam for inclusion in their research.

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Author information

Authors and Affiliations

  1. Department of Anthropology, History and Social Medicine, University of California, San Francisco, USA

    Vincanne Adams

  2. Safe Motherhood Programs, Department of Obstetrics, Gynecology and Reproductive Sciences University of California, San Francisco, USA

    Suellen Miller

  3. Department of Anthropology, Dartmouth University, Hanover, USA

    Sienna Craig

  4. Women’s Division, Mentsikhang Traditional Tibetan Medicine and Astrology Hospital, Lhasa, TAR, P.R. China

    Sonam

  5. Women’s Division, Lhasa Municipal Hospital, Lhasa, TAR, P.R. China

    Nyima

  6. Women’s Division, Lhasa Maternity Child Health Hospital, Lhasa, TAR, P.R. China

    Droyoung

  7. Harvard Associated Residency in Internal Medicine, Brigham and Women’s Hospital, Boston, USA

    Phuoc V. Le

  8. Pediatrics Global Health Equity Residency, Brigham and Women’s Hospital, Boston, USA

    Phuoc V. Le

  9. Maternal Fetal Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA

    Micheal Varner

Authors
  1. Vincanne Adams
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  2. Suellen Miller
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  3. Sienna Craig
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  4. Sonam
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  5. Nyima
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  6. Droyoung
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  7. Phuoc V. Le
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  8. Micheal Varner
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Corresponding author

Correspondence to Vincanne Adams.

Appendices

Appendix I: Informed Consent Form Version 1 with Questionnaire

We are members of a team of Providers and Researchers from the Tibet Autonomous Region (TAR), China, and America who are working together on maternal and child health in the TAR. Our project does two different kinds of work. Our team trains Shang-level health workers in maternal and child health, and delivery skills, using both western/biomedicine (chi-lu man; gya man) and Tibetan medicine (Bod gyi man). We are also doing research about maternal and child health problems and Tibetan medicine, with a particular focus on helping women with safe delivery.

We will now explain how we are planning to do this research, which will compare ZB 11 (zhi byed 11), a Tibetan medicine, with Misoprostol, a Western medicine. You might know this Tibetan medicine by the term “skye su rilbu” as well. We believe that both medicines can help reduce blood loss during delivery. Before that study can be done, we first need to a preliminary study comparing use of ZB 11 to no use of ZB 11. The main goal is to see whether or not ZB 11 reduces the amount of blood lost during pregnancy.

Before we start the research, we must first design a procedure for getting permission from patients to participate. In the West we call this “informed consent.” The first step of the research project will not begin until after a few months. Today, we will just ask you to listen to a description of the project and tell us what you understand or do not understand in this description.

Could we interview you about this process? (check here if verbal consent given)__________

In this research, we will tell women the following:

Purpose of the Study

All women bleed during delivery. This study will test to see if a Tibetan Traditional Medicine, Zhi B, works to reduce the amount of bleeding during the final stages of labor.

Procedures

If you choose to participate, here is what will happen:

  • you will choose a number from an envelope and this will determine if you will be in the group that gets the medicine or does not get the medicine; this process is like the Tibetan system of “gyan gyab.”

  • your health care during pregnancy and labor will be observed and notes will be taken on your care, but your name will be kept confidential;

  • your provider will use a drape to measure blood loss; this means the staff will place a soft plastic receptacle underneath your buttocks to measure the amount of blood that is lost during delivery. Remember that all women lose blood during a normal delivery. We will now show you a picture of the drape. After the blood is measured, it will be safely disposed of. We will compare the amount of blood lost between the two groups.

  • if, at any time during the delivery, your blood loss increases beyond safe levels, you will be given the normal treatment for this condition at this hospital even if you are in the “no medicine” group.

Potential Risks and/or Discomforts

We anticipate no risks or discomforts as a result of participation in this study. If you are in the “no medicine group” but your doctors are concerned that there are any complications with your delivery, they will give you the normal course of treatment for such conditions to ensure a safe delivery.

Potential Benefits

There may or may not be any direct benefit to you for participating in this study. Indirect benefits may come to many delivering mothers in Tibet, if we are able to show that Tibetan medicine works to reduce blood loss.

Please note that:

  • Your participation in this research is entirely voluntary;

  • You may decide not to take part or to withdraw from the study at any time without losing the benefits of your standard medical care;

  • Your decision with not affect your care providers

  • There is no cost to you for participating in this study

  • You will be paid to participate in this study

Other Questions

If you ever have questions about this study, you should contact Pasang Tsering at 6338824.

Consent Page

If you have read the informed consent, or had it read and explained to you, and you understand the information and voluntarily agree to join this study, please sign your name or make your mark below or give verbal consent.

  • _____ Yes _____ No

Volunteer’s name_____    Volunteer’s signature_____     Mark_____    Date_____

Witness’ name_____     Witness’ signature_____    Date _____

  1. 1.

    After having this read to you, do you feel you understand the research?

  2. 2.

    Would you be nervous or shy about participating?

  3. 3.

    Would you participate?

  4. 4.

    What is the goal of the research?

  5. 5.

    Is medical research important, in general?

  6. 6.

    Why or why not?

  7. 7.

    How is this research going to be done? (explain steps that can be remembered)

    1. a.

      What is the selection of patients based on?

    2. b.

      What medicine will be given?

    3. c.

      What will be measured?

    4. d.

      How will this be measured?

    5. e.

      Are you concerned about the collection of blood in this way?

  8. 8.

    If you are in the “no medicine” group and if you bleed too much from delivery, what will the doctors do?

  9. 9.

    If you decide you do not want to participate, can you ask to not be included in the study?

  10. 10.

    How much of the details of research should a patient know before participating in this study?

  11. 11.

    What risks will you take if you participate?

  12. 12.

    What benefits will come if you participate?

  13. 13.

    Will you be paid to participate in this research/must you pay to participate?

  14. 14.

    Does any part of the research seem confusing?

  15. 15.

    Do you have any suggestions for the researchers?

Questions for Patient:

Date:

Location:

Patient ID:

Age:

Education:

Language of Interview:

Profession:

Home:

Parity/#live births:

Where delivered last baby:

Current status (antenatal/postpartum):

Appendix II: Feasibility Study of Traditional Tibetan Medicine, Zhi Byed 11, to Prevent Post-Partum Hemorrhage: Informed Consent Document

Hello! How are you today? We are members of a team of medical providers and researchers from America and China’s Tibet Autonomous Region (TAR), who are conducting research on a traditional Tibetan medicine called zhi byed 11 (ZB 11). You might know this Tibetan medicine by the name “skye su rilbu” as well. It is believed that ZB 11 helps to reduce blood loss after delivery. So we are comparing using ZB 11 to not using ZB 11. The goal is to see whether or not ZB 11 reduces the amount of blood lost after the baby is born."

Purpose of the Study

All women bleed during delivery. While some bleeding is normal, too much bleeding can become a problem for the mother. This study will test to see if a Tibetan Traditional Medicine, Zhi byed 11, works to reduce the amount of bleeding after the baby is born.

Procedures

If you choose to participate, here is what will happen: when you are ready to have your baby, your doctor will draw an envelope from a box. Some of the envelopes contain ZB 11 and some of the envelopes contain “placebo,” medicine that has no medical effect, but is made to look just like ZB 11. You have twice as much chance of getting the ZB 11 as you do of getting the “placebo.” Neither you nor your doctor will know which you get.

Your doctor will give you the medicine when you are ready to have your baby.

Your doctor will use a plastic bag called a “drape” to measure the amount of blood you lose after your delivery

If, at any time during your delivery, your blood loss increases beyond safe levels, you will be given treatment for the condition no matter what medicine you received. At any time during your labor you will receive any medication that your provider believes is necessary for your health and the baby’s health.

Potential Risks and/or Discomforts

Every woman bleeds during delivery. There are always risks during any delivery, and ways to minimize risks. The medicine we are using, ZB 11, is not a new medicine. It has been used during deliveries for eight hundred years to help speed and aid childbirth and prevent blood loss. It is possible that those women who do not get ZB 11 may bleed more than those who get ZB 11. However, the difference in the amount of blood lost for any woman should be small. Please remember that no matter what medicine you get, if you begin to bleed too much then your doctor will give you prompt and appropriate treatment.

Potential Benefits

There may or may not be any direct benefit to you for participating in this study. If you get ZB 11, there is the possibility that you will lose less blood after delivery than those who do not get ZB 11. Indirect benefits may come to many delivering mothers in Tibet, if we are able to show that Tibetan medicine works to reduce blood loss.

Please note that:

  • Your participation in this research is entirely voluntary;

  • You may decide not to take part or to withdraw from the study at any time without losing the benefits of your standard medical care;

  • There is no cost to you for participating in this study;

  • You will not be paid to participate in this study;

Do you have any questions now?

Other Questions

If you ever have questions about this study, you should contact Pasang Tsering at 633-5561.

Consent

If you have read the informed consent, or had it read and explained to you, and you voluntarily agree to join this study, please sign your name or make your mark below.

  • _____ Yes _____ No

Patient’s name_____     Patient’s signature or mark_____     Date_____

Witness’ name_____     Witness’ signature_____     Date_____

Provider/Researcher’s name_____     Provider/Researcher’s signature_____     Date_____

Provider/Researcher’s address and contact information_____

Please note: Women who are consented but subsequently become ineligible before randomization (i.e., develop signs of any exclusion criteria after consent but before being given study drug) will receive only a screening form (ZB 01) and will be treated routinely as per hospital protocol.

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Adams, V., Miller, S., Craig, S. et al. Informed Consent in Cross-cultural Perspective: Clinical Research in the Tibetan Autonomous Region, PRC. Cult Med Psychiatry 31, 445–472 (2007). https://doi.org/10.1007/s11013-007-9070-2

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