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yesterday i was conducting an audit at my site and the following scenario arose. according to the study consenting SOP, the illiterate participant will have an impartial witness in the session who will act on their behalf.when it comes to documenting the consent, the illiterate participant thump prints on every page. however the consenting staff writes the name of the participant and date for the participant.Besides all being done according to SOP, will this be deemed ethical?(staff writing name of the participant)what is the role of the impartial witness? what does GCP dictate here?

  • Khin Khin Maung Lwin 6 Sep 2010

    Dear all beloved colleagues,
    Greeting from Thai-Burma border!!
    I am working as research physician and also as monitor for consent process. We are mainly conducting research for malaria. There are many consent related issues around us.

    In our area, people are either migrant workers or their families or IDP (Internally Displaced Person).so .literacy, economic and health knowledge level are lower than other places.
    Some of our clinic days, we found eligible participant for current study but illiterate.Unlukily, we can't find the person for“witness who can read and write….. among patients and attendances of that day
    Patient in couple (wife and husband), both of them were willing to participate into the study, but we can’t recruit because of "literate WITNESS"
    Sometime, those people advised us
    ” Oh!!!…our daughter can read and write, should I ask her to come and sign?” (School going age= <18)

    :(

  • swandiga Steve Wandiga 6 Jul 2010

    ICH GCP 4.8.8 shows the parties that are signatories to the informed consent process. My interpretation would be that the impartial witness should write for the illiterate person and consenter should only sign where she or he is required to.

    The issue of thumbprint in all the pages raises the question about the rationale behind that procedure in those who created the SOP. What if a page with a thumbprint falls off, does this consitute a complete consent or not?

  • Ropar Ropar 1 Jul 2010

    Dear Daveline
    I do thin that there was a good reason as to why it was stated in GCP that a witness who is independent should be used, in this case the ombudusman in certain areas. Although there seems to be nothing wrong with the staff wrtiting the name of the participant, does it imply that the witness themselves was not literate? I think that it would be better to have the independent witness write the name of the participant as tis improves the internal validity of the process and ensures that there was no form of coercion.
    As we all know undue influence may happen even without the researcher or research team realizing, anything that can be done to minimize this and enhance and encourage "absolute" voluntariness should be encouraged and in this case allow the witness to write the name of the witness.

  • rravinetto Raffaella Ravinetto 30 Jun 2010

    Hi, in a similar situation we were told by the auditor that the name and date for the participants should have been written by the independent witness (who must be literate) rather than by the study staff. The logic behind was to assure that there was no "indirect" and even "non-voluntary" pressure by the staff on the patient.

    So, having this written by the independent witness may be a good solution, that could be acceptable to auditors/regulatory inspections.

    I fully agree with Moses that it is better to describe the detailed procedure in the SOP (or -even better?- in the protocol, which is submitted for approval to a local Ethics Committee).

  • phaikyeong phaikyeong 24 Jun 2010

    ICH GCP does not say that a thumbprint is required when a participant cannot read and write. It does say that an impartial witness should sign and date the consent form. However, having the illiterate participant is the norm in most cultures in the developing world and therefore deemed favourable.

    In my opinion, the consenting staff should not write and date for the illiterate witness. This is not a GCP issue or an ethical issue, rather it is of a practical one. This confuses the situation because an independent party looking at those consent forms would assume that the patient has written his own name and date but has not sign the consent form himself.

  • Dorcas Dorcas Kamuya - Expert Committee 24 Jun 2010

    To add to the above comments, writing of the participant name is quite an interesting point you raise. On the one hand, this can be viewed as an accountability mechanisms which is open to even external scrutiny. On the other hand, where what the participants are asked to participate in is sensitive e.g. involved on discussions that are about the trial/research/institution; having their names written may compromise the freedom by which they express themselves. Ethical Review Committees are therefore very important in advising how a study team should proceed in such situations.

  • Dorcas Dorcas Kamuya - Expert Committee 24 Jun 2010

    Dear Daveline,
    The situation you have described is very common in many developing countries. Informed consenting processes are very challenging where research is not well understood, and where education levels are low. What does signing the consent form mean? As a last point in a the process of consenting, the participant signs to indicate they have been given all the information about that study, their questions have been answered satisfactorily and they have made a free-will decision to participate in the study. The witness is attesting to this process of informed and free decision making; the staff confirms that they have given all the information and answered all the questions. For more discussions on this, please refer to this paper and similar others: Molyneux, C. S., N. Peshu, et al. (2004). "Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast." Soc Sci Med 59(12): 2547-25

  • kclspansis Sisira Siribaddana 24 Jun 2010

    Dear Daveline
    I am not sure what is your SOP is if the participant cant read or write and has difficulty in undersatnding we recomends an ombudsman who is an independent advocate of patients rights outside the study team, can be a nurse or a community representative who is educated. Pl see
    Sumathipala A, Siribaddana SH, Revisiting ‘freely given informed consent’ in relation to the developing world. Role of an ombudsman. A qualitative study. The American Journal of Bioethics 2004; 4(3): W1-W7

  • mamulla Moses 23 Jun 2010

    Greetings Daveline. What a good description of a situation we are all used to. Most of our study participants cannot read or write and we used this approach too. This is how I see it. GCP is guideline which needs to be interpreted to your specific situation - and this is what SOP's are for. In your SOP you have said this is how you are managing this at your site. To me this seems fine, ethical and very sensible. It would be good to see what others think?