Mandated Ethics: Regulatory Innovation and its Limits in the Governance of Research Involving Humans

Harmonization of risk policy in research involving humans, following the adoption of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) in 1998, which extended the biomedical model of research ethics review to the social sciences and humanities, constitutes the focus of this portfolio dissertation. The articles in the portfolio examine the challenges that prospective ethics review poses to those research disciplines, the methods and ethics of which may differ from, or even be antagonistic to the biomedical model. The regulatory space of research involving humans is a highly dynamic field, and a place of significant tensions caused by the challenging political economy of the globalizing postcolonial and postindustrial world, progress in biomedical technologies, interdisciplinary structure of science, corporate interests, and the changing character of risks. These factors continuously influence the institution of research ethics review, supporting such processes as centralization and professionalization that are very prominent in the governance of research involving humans. Responding to the needs of research ethics committees, biomedical disciplines, and market pressures, these processes continue to constrain the reflexive and pluralistic elements of the policy framework, thus impoverishing the ethico-methodological foundation of the social sciences and humanities. This portfolio dissertation includes five articles that (1) provide an overview of the key elements of the Tri-Council Policy Statements ethical and regulatory framework, as well as the institution of prospective ethics review; (2) critically examine the processes of standardization, centralization, professionalization in research ethics review as impacting the initiatives at regulatory innovation, and (3) contribute in the development of the alternative models of ethical governance in research involving humans