IRB: Ethics & Human Research

How to Make Consent Informed: Possible Lessons from Tibet

We wanted to develop an informed consent document and process that would be culturally acceptable and comprehensible to women with little or no formal schooling in Lhasa, Tibet, where the illiteracy rate is high. To do this, we conducted initial, in-depth interviews to elicit Tibetan women’s notions of research. We incorporated the information gleaned from this qualitative research into a first draft of the informed consent document and pilot tested it, then made major modifications to the document based on the results. A second round of pilot testing followed, which included recall testing for participants at the end of the review of the informed consent document. Finally, using the same document, we modified the process to ask questions after each major section of the document. Asking comprehension questions after each section resulted in statistically significant improvements in comprehension. This pilot study should be replicated with a larger, random sample of Tibetan women to see if such a simple, quick, low-cost approach will have equivalent results.

Key words/concepts: informed consent, comprehension, developing countries

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