ABSTRACT

Impact of Bioethics Advisory Panels on Pediatric Research: Helpful or Harmful?

Vera Hassner Sharav, M.L.S.

This presentation will shed light on the advisory committee process, which increasingly is being used to affect changes in public health policy. The process is tainted by the actions of influential corporate stakeholders with the wherewithal to shape the committee agenda and scope of discussion. Advisory committee members are drawn from a pool of stakeholders in the biomedical research industry, including academia and government agencies. These panels do not represent the moral values of the community, nor do they represent the interest of the individuals and groups who will be directly affected by their recommendations. Advisory committees apply utilitarian arguments and rhetoric to suggest that they are acting for the future good of society.

An examination of recent advisory committee interpretations of existing regulations and their recommendations for change reveals the overarching influence of an egoistic ethic of participating stakeholder self-interests rather than a true utilitarian or any other moral calculus. An examination of recent recommendations affecting the health and safety of children (by the National Human Research Protection Advisory Committee and its Children’s Workgroup and the FDA’s Pediatric Advisory Committee) reveals that the advisory committee process operates in the manner of an “interest-group democracy,” wherein the voices of society’s most vulnerable and exploitable citizens are typically excluded despite the harsh reality that they are the ones most likely to suffer harm and least likely to benefit at the hands of biomedical researchers.

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