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Symposium: Bioethics in Scientific Research: Conflicts between Subject's Equitable Access to Participate in Research and Current Regulations

Balancing Access to Participation in Research and Protection from Risks: Applying the Principle of Justice¹

Institutional Review Board, Connecticut Children’s Medical Center, University of Connecticut, Hartford, CT 06106

²To whom correspondence should be addressed. E-mail: skiskad{at}ccmckids.org.

The problem for Institutional Review Boards (IRBs) of balancing access to participation in research with protection of research subjects has always been a difficult one. IRBs, charged with applying the "Common Rule," as well as the Belmont Principles, in their review of clinical research, are given little guidance on approaching this problem. This article argues that the third Belmont Principle, the Justice Principle, may provide a useful framework for considering this balance. The changing research environment is discussed in an historical context, and the Justice Principle is considered both in the context of individual rights, as well as the potential benefit to classes of people. The author further suggests that application of the Justice Principle be driven by findings derived from an analysis of the first 2 principles. This feedback model will enable a more formal application of the Justice Principle and less ambiguous, more transparent, decisions regarding the equitable selection of subjects. The author calls for more systematic attention to the Justice Principle by IRBs, and proposes a model that includes incorporating the deliberation of the other Belmont Principles into the Justice Principle.

KEY WORDS: • IRB • human subjects • Belmont Principles

This article has been cited by other articles:

				A. M. Ferris and G. S. Marquis Bioethics in Scientific Research: Conflicts between Subject's Equitable Access to Participate in Research and Current Regulations J. Nutr., April 1, 2005; 135(4): 916 - 917. [Full Text] [PDF]