Introducing a New Paradigm for Ethical Research in the Social, Behavioral, and Biomedical Sciences: Part I
21 Pages Posted: 22 Apr 2006
During the past thirty years, considerable attention and resources have been focused on various aspects of the ethics of research involving human participants. However, the presumptive basis on which the entire enterprise of research ethics is based - The Belmont Report - has received little serious scrutiny during this time. Conceptually, The Belmont Report occupies a unique position: because it is outside traditional disciplines that deal with issues of morality and moral reasoning - e.g., moral philosophy, social and political philosophy, legal ethics, and anthropology - it appears to be unassailable to judgments from those disciplines. Yet, despite this separation from these more traditional disciplines, the Report relies on their principles, without necessarily being sufficiently informed by them. Indeed, The Belmont Report's influence is nearly hegemonic in that within IRBs and the broader research ethics community all discussions must start (and sometimes end) with it in order to be considered morally legitimate. The Belmont Report is treated as immutable to appeals to the philosophical requirements of the principles upon which it claims to be based. Moreover, within its implementation, it straddles a line between normative and practical ethics, leaving both unsatisfied.
The statutory requirements of the federal regulations governing human subjects research (45CFR46) draw from and underscore Belmont's principles. Belmont is the only statement of ethical principles recognized as a legitimate foundation for ethical review processes in the contract required by the US government for institutions receiving government funds for research. Consequently, almost all U.S. universities and other research institutes hold their research practices to Belmont's definitions of the ethical. IRB review process and professional codes of conduct tacitly or explicitly incorporate the principles of The Belmont Report. IRB reviews are to document that risks to participants are minimized within a study's design (beneficence), that benefits and burdens of research participation are equitably distributed (justice), and that the informed consent of participants is prospectively acquired and documented (respect for persons). We think that the time has come to examine this influential report and how it might be supplanted by a more cogent, logical, and ethical guide for research. In this Part I of our project, we both discuss some of the valuable ideas in The Belmont Report and examine problems with The Belmont Report's analyses of ethical principles.
These suggest that Belmont's core principles must remain foundational for the enterprise of ethical research. However, their specification and application has at times verged from the spirit and philosophical foundations of these principles. We argue that the principled model for ethical decision-making specified and implied in The Belmont Report distorts the philosophical requirements of the ethical principles of beneficence, respect for persons, and justice in both their conceptual specification and practical application. Specifically, we argue that: the conception of beneficence relies on a simplistic conception of benefits and risks that cannot accommodate the various goods and harms that are legitimately given weight in risk/benefit calculations made by research participants; the conception of respect for persons relies on a superficial view of choice; and the conception of justice involves a conceptual mistake that conflates the harms of exploitation with those of disrespect for persons.
Keywords: ethics, research ethics, coercion, consent, respect for persons, justice, exploitation
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