We propose to hold a 2-day workshop on ethical oversight mechanisms and principles for health policy trials.
Health policy trials are experiments undertaken to assess the consequences, both desirable and undesired, of innovations in health policies, or to compare the relative merits and drawbacks of alternative health policies. These trials offer a much-needed source of evidence for innovation in health policy; but like all experiments with human subjects, they merit appropriate ethical review. In many respects, including the importance (when feasible) of randomized assignment, health policy trials resemble familiar clinical trials. But they have distinctive features as well. In view of these differences, we believe that health policy trials require a novel system for ethical oversight.
Over the last three years, with the support of the Wellcome Trust, the Riksbank (Sweden) and the VW Foundation, our international group of investigators (Bangladesh, Germany, Tanzania, and the United States) has developed draft proposals to this end through normative ethical research, relying in part on innovative social science methods for collaborative international deliberation.
In this workshop, we will explore the possibilities for bringing our findings and proposals to the attention of national and international agencies and authorities who might play a constructive role in implementing a system of ethical oversight for health policy research. Participants will include members of our research team and representatives of agencies and organizations that contribute to the development and operation of ethical oversight of experiments involving human subjects.