Documenting our Q & A's whilst doing the introduction to informed consent course
This discussion spaces allows us to document our experiences of completing the Introduction to informed consent course. On Friday the 28th November 2014 , Lesley Henley has made herself available to discuss informed consent with us. Please feel free to post any questions you had when completing the course here. And we will pose these to Lesley.
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The National Bioethics Advisory Committee (NBAC) 2001 report states that "research in developing countries should address local health needs and should involve community representative throughout and ensure culturally appropriate informed consent process." My question is; who chooses a community representative and how can we be sure that the community representative will serve the interests of the community he/she represents and not serve his/her own interests?
The informed consent literature stipulates that an impartial witness can be used in case of an illiterate participant and a definition of an impartial witness is given in the literature. Additionally, it states that an impartial witness can be (1) appointed by the community to be a representative of the potential participant; (2) a member of staff unrelated to the study; and (3) a family member. My question is; who has the right to appoint or choose an impartial witness?
I disagree with the first point that an impartial witness can be appointed by the community to be a representative of the potential participant. I think the best and right person to identify an impartial witness ought to be the potential participant himself/herself so that he/she exercises his/her right to autonomy by appointing a person of his/her choice. And for the second point, there could be a potential conflict of interests if a member of staff unrelated to the study was chosen to be an impartial witness by the potential participant - I am aware of research centers that allow members of staff working on other research projects to act as impartial witnesses for illiterate participants in some of the research centers' studies. In these scenarios, I believe there are still vested interests in the members of staff who act as impartial witnesses since they are part and parcel of the research center's activities. Therefore, I would recommend that impartial witnesses are appointed/chosen by the individual potential participants and that they should never be members of staff at the research site regardless of whether they are unrelated to the study being conducted.
I have some reservations on special circumstances for consent. The course material states that in some instances the head of a household qualifies to sign consent even if they are only 16 years old. It also states that if a16 year old is the parent of a child that the researcher wishes to enroll, they may be able to give consent. Of course, there is a caution that it is essential to check the country's regulations with regards to the age of majority.
Personally, I tend to differ with these special circumstances for consent. My opinion is that if the country's regulations state that the legal age of adulthood is 18, nobody should be allowed to give consent before they reach the age of 18. Therefore, it would be unacceptable for any head of a household to sign consent even if they are only 16 years old since being a head of a household is sometimes ceremonial and cultural and may not imply maturity. I also disagree with allowing "emancipated minors" who are parents of children to give consent - the fact that one has given birth to a child does not mean that they can autonomously and rationally make an informed decision to enroll their child in a study. There is certainly a reasonable justification for setting the minimum age of adulthood and this must be respected at all costs.
From our discussion session on Friday, 28th November, the local consensus on the question of a community representative was as follows:-
In the South African context community leaders could be informed of a study, and engaged in information-sharing, but should not give consent for individuals. One of the research teams described their approach to a hybrid community advisory board/group, whereby representatives emerge from within the community through awareness; this helps ensure a “safe space”. The representative is therefore voluntary; however sometimes a person's role may evolve into something different (e.g. they become a recruiter for a particular study, which is reimbursed). In general it is important that research teams engaged with community groups respect the individuality of members. However, there is a challenge that groups may become politicised.
From our discussion session on Friday, 28th November, the local consensus on the question of an impartial witness was as follows:-
Ideally the participant happens to bring someone literate with them. Alternatively, if possible (during pre-screening) they can be asked to bring someone literate they are comfortable with to screening. Overall the group had difficulty with the ethics of a staff member being the witness - the participant should be the one identifying a witness. However, if there is another staff member who is truly not involved with the study, in practice they are involved if the participant agrees. Another option is to use fellow participants (again if the participant agrees). Theoretically there could be deferred consent – verbal consent is obtained initially and later the participant brings a literate witness. This would be very dependent on the type of trial and has not been used by anyone present. In general it was agreed important to explain the role of the witness to staff, participants and the witness, as often it is not well understood by all parties. Literacy of the witness should also be assured.
From our discussion session on Friday, 28th November, the local response on the question of special circumstances was as follows:-
It was agreed that, regardless of what happens in other contexts, the South African regulatory requirements on special circumstances/children should be adhered to. However, there is definitely a challenge with child-headed households - the ethics of excluding or including children in these circumstances, and consensus was not achieved.
I liked the fact that participants are supported and encouraged to return for follow up appointments, even when costs to attend a follow up appointment could pose a challenge to the study team.
From doing the course, I understand and agree that an impartial witness needs to be someone who is responsible and who the consent taker can trust (ie verifiable). It is not just getting someone to sign on a document, they must read the consent form carefully.