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it is interesting to me to consider why mothers agree to their children being in a research trial. We are in rural india and healthcare access is not easy. These mothers are not educated and we need to use witnesses as they cannot read consent forms. We train our staff well and think about the forms, but I am not sure they still really understand they have a choice and there reasons for taking part are likely to be about getting better care. There are nice publications on this and these are important for us to read as researchers. I am not sure there is an easy solution but something to be in our minds. What do others think?
What I came to find as an important part on conducting community based Clinical trials is making sure that the community is well informed through the community sensitization meeting.In our case we used the same informed consent form which in actual fact contain the conduct of the trial in summary.
We made sure all difficult parts were well addressed by a competent person and this reduced misconception and we got a maximum community participation.
I do not know the Indian context, but I am not sure that this problem can be always successfully solved out when working with vulnerable populations.
I am especially thinking of resource-limited countries with no access to free health care (user-fees in place): in this case, a poor patient or a mother can agree to participate in a trial, because in the trial they get medicines and quality health care for free, while outside the trial they cannot.
In this sense, their "freedom to choose" will be very limited, irrespectively of the level of comprehension. Providing free care to all patients screened for a trial could be a way to reduce this risk, but it will be not financially feasible in many cases, and especially with chronic disease.
Still, you have pointed at a crucial ethical challenge!
I think that outside of the advantages they get (free medicines and quality health care whenever their children fall sick), mothers often consent to participate in trials in resource-limited areas because of the ability of the medical staff in explaining to them the purpose of the trial, its' later benefice for the community, and the minimized or low negative impact on their children's well being (especially for non therapeutic trials).
While agreeing to discussion points above, may I add a small point for reflection. The fact that one has not gone to school does not mean that they cannot understand. Sure there are concepts that they do not know, because you can only learn them in school, but it is up to the researchers to find ways to simply these in ways that community members understand. That often may mean understanding the community well, the languages they use to describe concepts etc. It is always amazing how clever and knowledgeable communities once they are appropriately engaged in these discussions. But we all may not have the time, resources and skills to do this ...but this need not be a reason not to find these mix of resources, many health research donors are very keen to see how communities are engaged in research, to help address these ethical challenges you have highlighted.
Agree with Raffaela that considering and incorporating communal benefits maybe one way to address the issue of health care benefits as "inducement" to study participation.
Thanks for generating this discussion..please can you direct me to the publications that you refer to? Many thanks.