Friday, February 10, 2012
One of the peculiarities of our current approach to regulating innovative medical activities is the importance placed on determining whether a novel approach to a problem constitutes “research with human subjects.” If an activity is characterized as research, it is typically subject to an extensive system of prospective ethical oversight, designed to ensure that the rights and well-being of the participants will be adequately protected. By contrast, innovative medical activities that do not meet the definition of research can often be conducted without any prior review or approval, regardless of the risks or uncertainties involved.
Recent proposals to roll out a cholera vaccination campaign in Haiti, a country that has been devastated by a deadly cholera epidemic for the past 15 months, have led me to wonder about the sharp line we draw between research and non-research in determining the necessity of prior ethical oversight.
Given that the primary intent of such a campaign would be to benefit the Haitian people currently at risk of developing cholera, rather than to develop “generalizable knowledge” for the benefit of future populations, it is unlikely that such a campaign would be considered “research” as that term is typically defined. Yet, even if it does not technically constitute research, a campaign to distribute cholera vaccines in Haiti clearly raises significant ethical issues for which prospective oversight seems warranted.
For example, while a vaccine campaign would undoubtedly provide real health benefits to some individuals, it also involves risks, including the potential diversion of resources from interventions that offer greater long-term health benefits (particularly the improvement of water and sanitation systems) and the possibility of creating a false sense of security that reduces individuals’ willingness to engage in behavioral change. In addition to risks, vaccine campaigns can have significant implications for social justice and equity, particularly when there are insufficient vaccines for the entire population and decisions must be made about how scarce resources will be prioritized.
As NPR reports, the Swiss arm of Doctors without Borders has cited some of these concerns in its decision not to participate in the Haitian vaccination campaign, calling the campaign a “distraction” from more pressing issues of water and sanitation control.
Considerations related to risk-benefit assessment, social justice, and other ethical matters are precisely the kind of issues that must be formally assessed by interdisciplinary committees before a proposal to conduct research with human participants is allowed to proceed. Yet, for activities that do not meet the definition of research, there is no agreed-upon mechanism for prior ethical oversight, even when the ethical issues are substantial and the evidence basis is scant.
In a 2009 report that I helped draft, the World Health Organization called on policy-makers to ensure that “most, if not all, emergency public health activities are subject to some form of ethical oversight, whether or not those activities are formally characterized as research.” Those responsible for the decision to launch a cholera vaccine in Haiti would be well advised to take these recommendations to heart.