David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Medicine and Philosophy 27 (5):523 – 545 (2002)
Historically the primary role of the Institutional Review Board (IRB) has been "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in research" (U.S. FDA, 1996). However, there is much to suggest that IRBs have been unable to fulfil this mandate, particularly in regard to the matter of informed consent. Part of the problem in this regard is that the competing interests of other stakeholders often undermine the IRB's capacity to serve the best interests of research subjects. This paper proposes an alternative view of the role of the IRB. It begins by treating the interests of other stakeholders as legitimate matters of concern for IRBs. Hence the process established to review and monitor human research should be treated as an exercise in social justice in which the interests of all legitimate stakeholders must be represented and considered. A variation of Rawls' (1971) heuristic "the veil of ignorance" is employed to explore the dynamic relationship between knowledge and interests that ensues when the role of the IRB is characterized in this manner. Inadequacies in the informed consent process are taken as illustrative of the inability of IRBs as they are presently construed to attend to the interests of research subjects. The major normative implication of the analysis offered here is that the role of the IRB must be expanded to include the granting of a provisional proxy consent on behalf of prospective research subjects. This provision is necessary, it is argued, if the interests of research subjects are to be fairly assessed by IRBs as a matter of social justice. It is necessary as well to ensure that an adequate standard of informed consent is attained. Somewhat paradoxically it is argued competing sets of interests the IRB must serve, rather than as the primary concern of the IRB.
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Dennis John Mazur (2007). Evaluating the Science and Ethics of Research on Humans: A Guide for Irb Members. Johns Hopkins University Press.
Carl E. Schneider (2010). The Hydra. Hastings Center Report 40 (4):9-11.
Michael Owen (2006). Conflict and Convergence: The Ethics Review of Action Research. [REVIEW] Journal of Academic Ethics 4 (1-4):61-75.
Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
Dave Wendler (2000). Informed Consent, Exploitation and Whether It is Possible to Conduct Human Subjects Research Without Either One. Bioethics 14 (4):310–339.
Alan Wertheimer (2013). Is Payment a Benefit? Bioethics 27 (2):105-116.
Aamir M. Jafarey (2002). Conflict of Interest Issues in Informed Consent for Research on Human Subjects: A South Asian Perspective. Science and Engineering Ethics 8 (3):353-362.
Daniel R. Ilgen & Bradford S. Bell (2001). Conducting Industrial and Organizational Psychological Research: Institutional Review of Research in Work Organizations. Ethics and Behavior 11 (4):395 – 412.
Sonja Grover (2003). On the Limits of Parental Proxy Consent: Children's Right to Non-Participation in Non-Therapeutic Research. [REVIEW] Journal of Academic Ethics 1 (4):349-383.
Added to index2009-01-28
Total downloads7 ( #304,000 of 1,726,249 )
Recent downloads (6 months)1 ( #369,877 of 1,726,249 )
How can I increase my downloads?