Forbidden harms and permissible benefits
Subtitle: the moral status of third parties in clinical research
By: by Carrie F. Thiessen
Published: 2009
Language: eng
Number of pages: 251
Description: The crux of this dissertation is the premise that third parties, non subjects, have moral status that ought to be recognized in the ethical conduct of medical research. In Paper 1, my co-authors and I use logistic regression to analyze perceptions of research-related benefits and harms in Rakai, Uganda. An overwhelming majority of respondents regarded population-based research as both a great personal and community benefit. The data also suggest that the research creates substantial positive "spill-over effects" for individuals in the host communities, including those who elected not to participate. Variations in participant, decliner, and community opinion leader responses suggest that investigators should engage in broad community consultation to accurately assess perceptions of research. Clinical research also has the potential to harm third parties. I argue in Paper 2 that when clinical research imposes significant, reasonably foreseeable, and unavoidable physical risks upon one or more third parties, investigators have an obligation to obtain third-party consent. In some cases, the risk is collective: an individual cannot accept the risk without imposing it upon multiple third parties. I suggest the adoption of a deliberative process as a means of legitimizing collective research-related risks.

My account of third-party consent can be expanded to address community-mediated harms; unlike other justifications for community consent, it is acceptable to ethical individualists. I defend an IRB-mediated approach to assessment of subject and third-party risk and outline procedures for investigators to solicit individual and collective third-party consent. Although research ethics guidelines permit competent adult subjects to accept risk in exchange for potential societal benefit, they prohibit tradeoffs between subject risk and community benefit. In paper 3, I appeal to the legitimacy of agent-relative reasons and social capital literature to defend a distinction between "community" and "societal" benefit. Nevertheless, I argue that a subject should be permitted to request that an investigator transfer some benefits to which she is entitled to a member of her community, even if doing so renders her risk-benefit ratio less favorable than currently considered ethical. I develop the Subject-Relative Value Principle to guide decisions about the permissibility of subject risk-community benefit tradeoffs.
Notes: "May 2009."

Thesis (Ph.D., Committee on Higher Degrees in Health Policy)--Harvard University, 2009.

Includes bibliographical references.