Informed consent from vulnerable populations

I came across this article on Ebola, the high fatality rate disease that has outbreak in West Africa in recent months. The use of an experimental serum ZMapp has raised certain critiques for ethical reasons. I found very clear and appealing the way the writer explains the problems when it comes to ethical testing and deployment of a new treatment.

The trick to informed consent is that it has to be meaningful. It’s not enough to just tell subjects about the study; they need to understand what that means, and to be capable of saying or signing a document saying, “Yes, I understand, and I’m still willing to participate.” This leads us to a second major concern for ethical research: the treatment of vulnerable populations. There are some groups of people who by definition are unable to give meaningful informed consent. These include children, institutionalized persons (prisoners and those confined to mental health institutions), and anyone else who might not be capable of understanding the full implications of their decision to participate in a study.

First, the author emphasizes not only the importance of obtaining informed consent from subjects, but also the fact that such consent must be meaningful. Secondly, the treatment of vulnerable populations, i.e. those who are not entirely able to give meaningful informed consent. Although this article mainly refers to sanitary research, these circumstances are also possible within social science. These include children, disabled population or demented elderly population.

Another interesting piece of this article is the reference to informed consent when doing research in developing countries:

Most social scientists who do research in developing countries – myself included – have similar stories of subjects not understanding why they are being asked to sign an informed consent form; in their minds, agreement to talk to me is consent. Signing a document also leaves a record, which many subjects fear might somehow be used against them by political authorities, foreign spies, or others who are up to no good.

Finally, the way in which the Ebola dilemma seems to be solve by the World Health Organization:

The World Health Organization announced today that they are forming a panel of ethicists to consider whether and how ZMapp might be distributed among Ebola patients. There is no doubt in anyone’s mind that the urgency of Ebola, its high fatality rate, and the need to deliver effective treatment as quickly as possible must be taken seriously. Here’s hoping that the WHO ethicists can come to a quick conclusion, that ZMapp can be manufactured quickly, and that the drug will be responsibly distributed in a way that informs patients and their families to the fullest extent possible and allows researchers to learn more about how it works and doesn’t work in human populations. A cure for Ebola would be a wonderful thing indeed.

This may be seen as a possible solution to address other research ethical issues, i.e. the creation of a panel of ethicists.


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