Evolving Vaccine Trials:
Adaptive Informed Consent in the Global Context
By Brenda Everling
Santa Clara University senior Brenda Everling presented this paper at the 2011 National Undergraduate Bioethics Conference, Duke University, March 20, 2011.
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Imagine a village ravaged by pneumonia and far from the nearest clinic. A couple in the village has lost one child to the disease when they are approached by a pharmaceutical company representative asking them to enroll their newborn in a trial for a new pneumonia vaccine. They meet with a researcher who explains how the trial and the vaccine will work, then lists the risks and benefits of participating. Although the information is presented in their native language, the couple doesn't understand many of the concepts presented. They are particularly concerned that the researcher keeps asking them to sign a paper that she says allows her to vaccinate the child. Somewhat insulted, they explain that they have already given their word. They repeatedly ask the researcher to get permission from the village chief, but the researcher insists that only they can sign the form. Confused, but feeling obligated to this foreigner who is trying to help their daughter, they reluctantly sign. They are stunned and offended, when after giving the researcher what she wants, she provides no reciprocal gift. A year later, as the trial is ending, their child becomes ill, and is diagnosed by the research clinic; she has pneumonia. The couple is furious and confused because they thought their child had received the vaccine. How could she have gotten pneumonia?
This misunderstanding is the result of inadequate informed consent. Genuinely informed consent requires that participants fully understand (1) the structure and logistics of the trial—including the potential to receive a placebo or a dose insufficient to provide protection against the disease—and (2) the inherent safety risks of the trial. True informed consent also requires (3) that participants provide consent freely, not out of perceived obligation or coercion. While the researcher complied with relevant regulations and ethical obligations from her point of view, the couple felt violated because they didn't really understand the idea of a placebo, and they thought the implied permission given by their chief ensured the safety of their daughter. They also felt coerced by the researcher, who had pressed them to sign the paper despite their reservations. Thus, this trial failed on all three components of informed consent.
As in this example, inadequate informed consent in global vaccine trials can usually be attributed to cultural differences: in understanding of science and disease, in perceptions of proper decision-making processes, and in social constructions of power, authority and autonomy.
When autonomy is undermined, it interferes with individual rights, such as the right to know what one is consenting to and the right to non-interference when making a decision. In this paper, I propose a culturally sensitive process for achieving informed consent called "adaptive informed consent" that explicitly includes cultural sensitivity as a required step in designing trials. Implementation of adaptive informed consent through international agreement and regulation will promote ethical responsibility in the context of global vaccine trials by ensuring that trial participants' autonomy is respected and that their consent is genuine and fully informed.