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I work in a rural community in Malawi for a clinical trial based at the main District Hospital in the area. Often i come across women who are illiterate and i'm expected and bound by GCP to get an informed consent from them without cutting any corners. I find this very difficult and challenging. GCP tells us that in a case where the participant is unable to sign for themselves there should be an impartial witness, and this is someone with no ties to the study and should be a person chosen,confindently, by the participant. This is a challenge because these women come from villages very far off and they don't know anyone at the hospital at that time, in such a case how do you involve a witness? i end up not enrolling the participant for fear of being found guilty of bending the rules. This then affects our numbers, the PI is not concerned about such issues, they are usually driven by their deadlines and so if the sample size is not reached on target this affects the project. How then do you ensure that informed consent is properly administered without any shortcuts?

Reply

  • bakarisafiya Bakari Safiya 12 Jun 2014

    as a layperson in the ethics committee i want to know what is consent Auditors or patient advocates apart from the consent form or process?

  • evelynudedi Evelyn Lifa- Udedi 4 Oct 2012

    Dear Johnstone,
    do you think you can share your SOP with us so that we might learn from it. I may just run it past my Line manager/ PI and see if we could adopt the same approach. Thanks a lot for the information you are sharing everybody.

  • johnstonethitiri Johnstone Thitiri 27 Sep 2012

    Hi all. I am from Kenya. This topic is a true daily challenge for us here. The setting seems same as one described in Malawi. In my trial currently, my SOP has identified 3 possible ways of getting a witness in order of priority;
    1. A relative/friend of choice accompanying participant
    2. Other participant/ patient in hospital who is literate, is willing to stand in as witness and is ACCEPTED by the prospective participant.
    3. Member of staff in the hospital, not involved in the trial (especially support staff)

    I like Ptindana's call for scholarly insight into the use of witness and if/how this results in respect and autonomy for participants.

    In the end, informed consent being a continuous process, it goes beyond the formal signing of a document by a "witness" to pass audits and inspections.

  • okellosamwel Samwel Okello 20 Sep 2012

    Thanks all. This is a very healthy and educative discussion.As reseachers, we must ensure that we meet regulatory and ethical requirements for the consenting process. I agree with Amina that a witness can be chosen by you,and subject to approval by the participant but the witness must meet thresh hold of being IMPARTIAL as recomended by ICH GCP.

  • brytcisale Bright Chisale 18 Sep 2012

    C Magata thanks for your link, looks interesting.

  • cmagata C Magata 10 Sep 2012

    Hello all. What an interesting discussion. I just wanted to add the link to this article about impartial witnesses: http://www.cgirb.com/irb-insights/the-role-and-use-of-impartial-witnesses-in-the-informed-consent-process/ which talks about SOPs for impatrial witnesses and recruiting witnesses.

  • evelynudedi Evelyn Lifa- Udedi 7 Sep 2012

    Thank you Amina, Raffaella, Gibbi and Ptindana.

    Guys your inputs are greatly appreciated and yes Amina, ICH GCP says impartial witness but like i mentioned about it is some what difficult for the participants to just accept someone that they dont know even if the person is chosen by you.

    It really is important that PIs take this into consideration, this can make our job a lot easier. Using people form the nearby community is possible because most studies have what we call Community Advisory Groups,however these people are found deep within the villages, some of which are 39km away from the District Hospital, so you see to use them as impartial witnesses may be a little tricky.

    I'm grateful for the suggestion of using other nurses, hospital support staff or teachers not having any link to the study. I honestly did not think of that. I will discuss this with my PI and hear what he says about it, i'll be sure to keep you updated about the situation here.

    Thanks again

  • ptindana ptindana 7 Sep 2012

    Dear Evelyn,

    Thank you very much for sharing your experiences. Indeed the issues you raise are relevant to consent processes in many developing world settings.

    They highlight the need for research teams (PIs and field/frontine staff) to anticipate these practical ethical challenges prior the recruitment process and plan/develop appropriate responses.

    In hospital-based studies, some research projects use nurses who are not directlty involved in the potential participants' care as witnesses. This however requires identifying these nurses earlier, providing them with adequate information about the proposed research and ensuring that they will be willing and available to serve as witnesses when the need arises.

    In community-based studies, teachers in the locality have also served as witneses and this also requires prior arrangemenent.

    As some have also suggested, engaging the community meaningfully prior to the initiation of the project could be helpful in identifying potential witnesses.

    I think we also need more scholarship on the role of witnesses in the consent process. Is their role merely a ritual? How does this role actually RESPECT and PROTECT the participants?

    It would be interesting to hear how others have approached these issues. We may be familiar with what the guidelines say but what actually happens on the ground? There are no straight-forward answers but there is alot we can learn from others' experiences so please share :-)

  • gsey Gibbi Sey 6 Sep 2012

    Informed consent is the heart beat of GCP. In my opinion you should not exclude illiterate participants but we as researchers should be aware of their vulnerability.
    An impartial independent witness is key in your case. I agree with Raffaella and Amina. You may also thing of involving the community. Could you have community volunteers or maybe a retired nurses, teachers who have no link with the study but understand your official language and the language of the study participants and is willing to give some of her/his free time. Or better still interact with the community and see if they may offer a better solution that does not violate ICH-GCP
    The hospital may have other support staff who have no link with your study, is it possible to ask them to help?

  • rravinetto Raffaella Ravinetto 6 Sep 2012

    Dear Evelyn,

    in similar situations, you can try to identify in advance literate people who live close to the study site, and who might be available for witnessing the informed consent of illiterate patients, if needed.

    It is of course important to ensure that the witness has fully understood the importance and specificities of his/her role, and to verify that his/her presence is really accepted by the concerned patient (in other words, the concerned patient must feels free to accept or refuse the presence of the witness). Choosing as potential witnesses persons of the same sex of the study patients can help, as well as choosing persons with some previous experience in health-related tasks, or active members of local associations etc.

    This procedures has also some shortcomings, but on the other side it would be unfair excluding illiterate patients from the study, because of illiteracy. I hope that we will get also other opinions, this is a really crucial topic!

    Raffaella

  • aawasthi amina awasthi 6 Sep 2012

    This is a very interesting point! However, and do correct me if I'm wrong, but I believe ICH-GCP (4:9) says the witness has to be impartial - not specifically that they have to be chosen confidentially by the participant themselves? So, for example, you could find a witness for them as long as that person was not employed by you or part of the study team, and as long as the participant approved them?

    Could participants act as witnesses for one another, perhaps?

    Of course it may be the case that your study has more specific requirements than the GCP requirements here, so this may not be applicable.

    I'd be really interested to hear your thoughts!

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