Cultural differences raise consent issues in multinational research

IC must translate not just language, but concepts to different culture

As more institutions become involved in international research, informed consent becomes a more difficult process.

While emphasis often is put on the linguistic challenges of consent — creating a document that correctly outlines the details of the study in multiple languages — there are cultural translation issues as well. What one culture means by "consent," "risk," or even "research" may be very different from how another culture interprets those concepts.

Vincanne Adams, PhD, a professor of medical anthropology at the University of California, San Francisco, says it's important that IRBs understand the potential for these types of cultural translational issues and to be prepared to deal with them.

As an example, she points to a project she became involved with in 2000, an effort to collaborate with health officials in China and Tibet on a randomized clinical trial comparing the benefits of a traditional Tibetan drug with a biomedical drug to control postpartum hemorrhage.

In the process, she says, the team sought to help Tibetans set up their own infrastructure for conducting research using standards acceptable to the international health community.

And along the way, Adams says her group has encountered challenges in cultural translation, as well as in educating their IRBs about the differences between Tibetan medical culture and their own.

"We had to negotiate with them," she says of her efforts to facilitate even the earliest stages of the project with her own IRB. "It just took months and months and months to process it all and convince the committee — they were receptive to it — to go through the process of spelling it all out and explaining.

"They were not obstructive, they're just a bureaucratic institution," Adams says. "They didn't want to stop the project; they just wanted to make sure that we were meeting ethical standards. And so it just takes a lot of work."

Creating an IRB

The team of clinicians, researchers, and medical anthropologists began collaborating with physicians and public health professionals in Lhasa, the capital of the Tibet Autonomous Region (TAR), one of the least developed regions of China. The TAR has its own medical schools for both biomedicine and for traditional Tibetan medicine, which operates on principles that involve balancing three elements within a patient known as "humors": wind, bile and phlegm, and the physical elements of earth, fire, water, air, and space.

The team decided to look at the issue of postpartum hemorrhage because it is a significant risk to new mothers, who often give birth at home without medical help.

The project was set up to compare a Tibetan medicine called zhi byed bcu gcig 11 (ZB11) to the Western drug misoprostol, which has similar indications, risks, and benefits.

First, however, the group had to create the necessary research infrastructure, setting up a research committee with the Chinese government and with contacts at the three hospitals in Lhasa and at the traditional Tibetan Medical College. That committee set up a three-phase project, beginning with a feasibility study, then a study comparing ZB11 to first a placebo and then to misoprostol. Each phase would require IRB approval not just in the United States, but in the home country, according to guidelines set up by the National Institutes of Health, which was funding the study, Adams says.

"It delayed our project by a year and a half to two years," she says. "Anytime you're working in a foreign country, to create a system that's based on a requirement of the U.S. government is a very tricky thing, especially in a country like China."

But during that lengthy process, she says, there was an opportunity to do a very thorough exploration of cross-cultural informed consent. She outlined the process in a paper published recently in the journal Culture, Medicine and Psychiatry.1

Linguistic challenges

Adams, who has been working in Asia for more than 20 years, says that with a process of this complexity — in this case including contributors in the United States, China, and Tibet — there is always a linguistic challenge. All the documents had to be translated into English, Chinese, and Tibetan, as did the training programs for those associated with the research project.

In general, Tibetan health providers were trained in Chinese, the language of their own biomedical training. However, to speak with participants, who generally spoke only Tibetan, it was necessary to find translators fluent in all three languages, a difficult task.

Beyond language issues, Adams says the Tibetan culture posed unique challenges to the traditional Western ideas of research. In Tibet, most research historically had been conducted by physicians on their own patients, mixing their own medicines and observing the results. Even today in medical institutions, control groups and standardized protocols are not the norm.

Some research concepts were particularly tricky to negotiate, involving long explanations to Tibetan researchers and participants — and flexibility on the part of American IRBs that reviewed the informed consent process, she says:

• Disclosing risk. In early ethnographic interviews, Adams' team learned that Tibetans rarely discuss the potential risks of a medical intervention, because they believe that if a patient envisions himself experiencing harm, it could agitate the wind humor, causing a harmful outcome.

"The concern was that we would basically create a negative environment and a perception of fear among our participants that was unnecessary," she says.

Trying to balance Western obligations to disclose risk with Tibetan concerns led them to present only the most critical information, eliminating details about the risks of delivery in general, or descriptions of hemorrhage.

They stated in the informed consent that all women bleed during delivery, and if a woman seemed to be bleeding excessively, she would be treated at the hospital.

• Randomization. Adams says there's no direct translation for the concept of randomization in the Tibetan language, and that many Tibetans understand "chance" differently than Westerners, believing that past actions, or even past lives may have an effect on present outcomes.

"Our IRB at one point wrote back that we should use flipping a coin as an example," she says, noting that that action has no cultural significance in Tibet. "They were trying to be helpful but they didn't have any understanding of the cross-cultural context."

To try to get the point across, ethnographers referred to a traditional Tibetan practice of drawing lots to distribute resources throughout a community. It's more complex than a coin flip but does involve a certain amount of randomization.

The pilot informed consent document stated: "This process is similar to the Tibetan system of drawing lots, or gyan gyab. But unlike gyan gyab, you will not know which group you are in. Only the doctors will know."

• Placebo. Tibetan medicine holds that the so-called "placebo effect" is a necessary component of good medical treatment — that using the right words or attitude will help a medicine be more successful. In addition, all substances are thought to be either potentially helpful or harmful, making it difficult to explain the role of a placebo in a controlled trial. In fact, there has only recently been a Tibetan term for placebo, and it translates literally as "mind-healing drug," which could raise potential problems for IRB review since it suggests that the drug has healing properties.

In the end, they referred to a pill that "has no medical effect but is made to look just like ZB11."

Throughout this process, there were lengthy negotiations with the IRBs in the United States, some of whom had not wrestled with these types of issues before, Adams says.

"I think IRBs have a lot to learn," she says. "I think some institutions that have a large body of faculty who do international work are probably more prepared for this. I know our institution was not like that. They're very focused on research in the U.S. and it's a whole new thing to be doing these kinds of international work."

In her own case, she says she spent a lot of time talking to the staff in the IRB office and writing lengthy cover letters explaining the team's plans.

Adams says IRBs whose researchers are starting to delve into these areas should think carefully about how to bring cross-cultural expertise to their committees. She says her own IRB had an advantage because it included an anthropologist.

"I think recognizing a broader understanding of flexibility and how to accommodate different cultural understandings of risk and vulnerability, in ways that don't hamper the ability to do the research but augment it, would be great."

Reference

  1. 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 2007;31:445-472.