Should the informed consent procedure be a rigid rule?

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    Hong CHEN

    Hi all,
    My research topic is pretty sensitive, it is to look at the needs of advanced cancer patients (65 years or older) and their family carers for end of life care in China. It is a qualitative study using semi-structured, open-ended interviews.
    I am preparing for my pilot study and have designed the consent forms and info sheet according to western literature and pracitce, which has been approved by the ethics committee of my university. But now faced with the reality in China, I have deep doubt that it will work the same way in China as in UK in terms of how to obtain the informed consent from the participants. My question is:
    What if some people are willing to participate and all that except signing that piece of paper? It may be culturally unacceptable and uncomfortable to sign papers in general. Is it alright to have the consent form signed after the interview when trust has been built and through the talk the interviewees are convinced that it does no harm to themselves and it is sort of benefitial to participate?



    Hi reading the item…..consent can be given verbally not only in written form…..

    Should it not be in a paper form for the purpose of your reserach paper submission? what does your supervisor think? More questions than answers.

    Hong CHEN

    Hi all,

    Thanks for your replies. I just finished my pilot study in China. It turned out that verbal informed consent was more appropriate both culturally and practically for Chinese participants. With a few participants, I got their verbal consent at the beginning of the interviews and confirmed with them again at the end of the interviews, and both were recorded as evidence. Now I have to report to the ethics committee on this issue and get their approval to use verbal informed consent in my forthcoming main study. I think i also have come across literature that is in favor of verbal consent in qualitative interviewing study.

    Keep in touch.



    There are two aspects to your question. You might want to break your ethical considerations apart on them. The first is the question of cultural relativism of ethics. The second is your IRB and their acceptance of alternative methods for meeting the requirement for documentation of informed consent. Permit me to provide my thinking on these points.


    On the first issue — Situaitonal ethics. In one sense, all ethical considerations are situational but the principals that should be applied to reach an ethical decision are not. Therefore, there are many different ways to express “yes” or willingness to participate, but only one ethical desiderata that “respect” expects we will seek consent. China, unfortunately, has been, for years, a site for unethical, nonconsensual clinical research. The attractiveness of compliant, racially homogeneous, and geographically isolate populations were simply too tempting for international pharmaceutical companies. If anything, the history of ethical lapses in China should demand higher standards of ethical behavior by researchers today. Understand, as you clearly do, the importance and role of social power divisions, educational levels and understanding of respondents, source of community power and influence, the nature and role of “agreement and disagreement in the culture. If your IRB is relatively sophisticated and experienced in transcultural research, it will understand and trials by you of different consent formats are not part of the formal human subjects review.


    There is no requirement for a specific “form” or method of informed consent. Only that the elements deemed minimally necessary for informed consent to be given should be present and proof of their acceptance evident. Remember that these are the minimums requireed. If the culture in which you are seeking informed consent might need more elements of confirmation and affirmation, then include them. The requirement is for “documentation” of fully informed consent. This can be written, visual, audio, first-person or third-person (i.e., a witness). Again, a well trained IRB should accept these forms of documentation.


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