“What did I just sign?”: On informed consent in China

My husband John had done everything the Human Subjects Committee asked. He reviewed the study with his departmental ethics representative, completed online training on human subjects, and, most importantly, created clear consent forms for his study, with this vital clause:

Right to Withdraw: Your participation in this study is completely voluntary. You have the right to withdraw from this study at any time, without penalty.

Prospective subjects would read the consent form and, if interested in participating, sign their name and then complete the questionnaire. The consent form listed the contact information for all researchers, including John, so they could contact them with any questions — by phone or e-mail.

Additionally, the consent form said the following:

We will conduct several 30-60 minute focus groups. The American treatment program will be discussed and the participants will be asked to comment on the program. If you are interested in being contacted about participating in the focus group, check here_______, and provide us with a means of contact:
phone__________________ email________________________ cell phone_________________

After John went to China, he distributed his consent forms — with the questionnaires — to parents of young children via a school teacher. To John’s surprise, out of 150 returned questionnaires, around 90 participants volunteered to participate in focus groups. We were thrilled — but surprised at the same time. Most studies in the US, including psychological studies like my husband’s, have difficulty recruiting participants, especially for discussion groups. Why was it so easy in China?

But when John called one of the focus group volunteers, something seemed wrong.

It was the second time he had called her that night. The first time, she said she was busy, and asked him to call back in a half an hour. So, that’s exactly what he did. Thirty minutes later, he got her on the phone — but it wasn’t the conversation he imagined.

“Who are you to collect our data? What company are you from?” she asks, with suspicion in her voice.

“I’m not from a company,” John says. “I’m a student in the US. And I’m contacting you because you gave your contact information on the form.”

“I just wanted to give Teacher Wei some good face, so I put my contact information there,” she said.

“I don’t need people who care about face,” John said. “If you’re not interested, you don’t need to come.”

“I’m going to report you to the head of the school,” she said, then hanging up the phone abruptly.

John stopped calling parents for the focus groups after that, instead only contacting people by e-mail. Not everyone left an e-mail address, so he only had around 13 people. In the end, he received 1 RSVP — but no one showed up for the meeting.

John did end up having focus groups, but they were arranged by his friends with children, who invited their friends with children over for dinner.

Consent forms came up once again, when John came to pick up completed questionnaires from another school. The school had sent out 80, but only received back a paltry 8 questionnaires. The school headmaster, Mrs. Zhou, put the blame on the consent forms.

“I think a lot of the parents didn’t understand the forms,” she said. “They made them nervous.”

And then later she added this: “Maybe next time, we can send these out without the consent forms — I think you’ll get a better response that way.”

I can just imagine the Human Subjects Committee at John’s school, shuddering at the suggestion.

In a perfect world, John would talk face-to-face with every prospective participant, and make sure they understood. In the real world, he had to collect at least 250 questionnaires, within a little over one month. So, he could only communicate the issues on paper, not in person.

But, right or wrong, the consent forms created confusion, and even affected the response.

To John, informed consent — and other ethical requirements of the human subjects committee — were foreign to him, from his experience growing up in China. He writes about this in his ethical autobiography:

For over 2,000 years, Confucianism is China’s leading traditional thought. Growing up with Chinese culture, I found my personal ethics are grounded in Confucian principles of filial piety, humanity, righteousness, ritual, and faithfulness.

….

The Confucian moral system was based upon empathy and understanding others, rather than ordained rules. From my experience, these ethical values are often implicit, and not directly communicated. This means that values education in China is not so institutionalized. My college, where I studied to be a teacher, offered no courses on ethics for teachers. When I later graduated and worked as a college-level teacher, no one informed me of the school’s ethical guidelines for teachers. I never encountered a human subjects committee during my master’s-level studies of psychology in China, and my master’s thesis did not require approval from an internal review board, as it did here in the US. As such, I had a more intuitive understanding of ethics, where it was more a way of living, rather than an institutional edict.

And, according to John, these things are just as new to the average Chinese. Still, he made me wonder if informed consent — as we presented it — is not appropriate for Chinese culture.

That’s the general idea behind Robert Levine’s paper, Informed Consent: Some Challenges to the Universality of the Western Model:

The National Commission grounded the requirement for informed consent in the ethical principle of respect for persons, which it defined as follows:

Respect for persons incorporates at least two basic ethical convictions: First, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy and thus in need of protection are entitled to such protections.

The author goes on to argue that the idea of personhood, and how it relates to informed consent, is not universal:

As an American, I am firmly committed to the Western vision of the person and deeply influenced by the American variant of this vision. As De Craemer has observed in his summary statement on the American perspective,

Taken as a whole, our [American] conception of personhood has at least one major paradoxical attribute. Although it places a high value on a universal definition of the worth, dignity and equality of every person, it tends to be culturally particularistic and inadvertently ethnocentric. To a significant degree, it rests on the assumption that ideas about personhood are common to many, if not most, other societies and cultures. Beyond that, it assumes that the American way of thinking about the person represents the way men and women of all societies and cultures should and do think about personhood when they are being supremely rational and moral.

Thus, it would not be prudent to trust an American to provide a universally applicable definition of informed consent. I suggest further that it would not be prudent to rely on any person situated in any culture to provide a a universally applicable definition of informed consent.

….

When one restates the principle of respect for persons in a form that reflects a peculiarly Western view of the person,it begins to lose its relevance to some people in Central Africa, Japan, Central America, and so on.

John’s whole informed consent process had a Western slant, even though he is Chinese. But it’s not surprising — he had to create the forms according the committee’s requirements. Otherwise, he wouldn’t get approval for the study. And, given this was his first study supported by a US academic institution, he never considered the ramifications of culture and informed consent.

But how do you get it right in China?

With research on informed consent, and how to culturally adapt it. I found only a small handful of papers on informed consent in China, but the most interesting — and relevant — was Informed Consent in Cross-cultural Perspective: Clinical Research in the Tibetan Autonomous Region, PRC. Take, for example, their discussion on how to show that illiterate women understood the consent process, and gave consent:

One suggestion from the US IRB offices was to use a finger or thumbprint. However, qualitative interviews uncovered that many participants feared that our asking for a fingerprint would be a reminder of negative experiences during the Cultural Revolution. Apparently citizens accused of political crimes during the Cultural Revolution (a fate that could potentially befall anyone) were forced to admit their guilt by affixing their thumbprint to a ‘‘confession.’’ Going further back into feudal Tibetan history, some Tibetans associated signing with a thumbprint as a negative reminder of relationships such as indentured servitude, which were sealed with a thumbprint. Some of the responses generated to the idea of indicating consent with a thumbprint included: ‘‘It is not so good to use the thumbprint method because, before, when we did something that we were punished for by law, then we would have to put our thumbprints. So this might make some people feel bad.’’ We were also told, ‘‘Signing the thumbprint does not make me happy. It brings bad memories.’’ Given these responses, we removed the thumbprint as an option for indicating consent and, on all three Pilot Studies, asked for either signature or verbal consent.

Makes fingerprinting take on a whole meaning, doesn’t it?

Maybe there’s a similar reason why that woman — who initially gave consent for the focus group — suspected John of foul play. Did a company or organization once ask her to sign something, and then use it to gather personal data? Or worse? Who knows, but there’s a story in there somewhere.

But I doubt she’d give her consent — informed or otherwise — to tell us anytime soon. 😉

Have you done research in China — and had issues with informed consent? Have you tried to culturally adapt it? What’s your experience? Or opinion? I’d love to hear from you.