Abstract

http://ssrn.com/abstract=1481992
 


 



Ethics Creep, Soft Law and Positivism: The Problems of Regulatory Innovation in the Governance of Human Subjects Research


Igor Gontcharov


Osgoode Hall Law School; Critical Research Laboratory in Law & Society, Osgoode Hall Law School

October 2, 2009


Abstract:     
This paper examines the conceptual basis for the governance of human subjects research in Canada, focusing on the REB (Research Ethics Boards, also known as, IRB, and REC in other countries). It explores the logic of the harmonization and standardization of the approaches to ethical oversight, which resulted in the rapid expansion of the system of research oversight (“REB mission creep”) from biomedical sciences to the areas of research involving humans, where physical harms are no longer obvious. It suggests that REB positivism, prevalent at the local level, provides a sufficient basis for understanding the phenomenon of ethics creep and the problems that accompany it. REB positivism, which applies a reductionist understanding of research and redefines research ethics in terms of universalism, methodological reductionism, solipsism, and approaches the unknown in terms of danger, rather than risk, helps to clarify why the localized interpretation of the general principles articulated in the Tri-Council Policy Statement (TCPS) have not lead to a reflexive mode of regulation.

Number of Pages in PDF File: 36

Keywords: REB, IRB, REC, TCPS, Common Rule, research ethics, regulation of research, research including humans, human subjects research, positivism, mission creep, ethics creep

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Date posted: October 5, 2009  

Suggested Citation

Gontcharov, Igor, Ethics Creep, Soft Law and Positivism: The Problems of Regulatory Innovation in the Governance of Human Subjects Research (October 2, 2009). Available at SSRN: http://ssrn.com/abstract=1481992 or http://dx.doi.org/10.2139/ssrn.1481992

Contact Information

Igor Gontcharov (Contact Author)
Osgoode Hall Law School ( email )
4700 Keele Street
Toronto, Ontario M3J 1P3
Canada
Critical Research Laboratory in Law & Society, Osgoode Hall Law School ( email )
2033 Ignat Kaneff Building
4700 Keele St.
Toronto, Ontario M3J1P3
Canada
HOME PAGE: http://www.criticalresearchlab.org
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