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

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dc.contributor.advisorLiora Salter, R. L. Liora
dc.creatorGontcharov, Igor
dc.date.accessioned2017-07-27T12:40:52Z
dc.date.available2017-07-27T12:40:52Z
dc.date.copyright2016-11-25
dc.date.issued2017-07-27
dc.date.updated2017-07-27T12:40:52Z
dc.degree.disciplineLaw
dc.degree.levelDoctoral
dc.degree.namePhD - Doctor of Philosophy
dc.description.abstractHarmonization 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.
dc.identifier.urihttp://hdl.handle.net/10315/33459
dc.language.isoen
dc.rightsAuthor owns copyright, except where explicitly noted. Please contact the author directly with licensing requests.
dc.subjectLaw
dc.subject.keywordsResearch involving humans
dc.subject.keywordsResearch ethics
dc.subject.keywordsResearch governance
dc.subject.keywordsRegulatory ethics
dc.subject.keywordsResearch ethics boards
dc.subject.keywordsREB
dc.subject.keywordsResearch ethics committees
dc.subject.keywordsREC
dc.subject.keywordsInstitutional review boards
dc.subject.keywordsIRB
dc.subject.keywordsTri-Council Policy Statement
dc.subject.keywordsCommon Rule
dc.subject.keywordsKnowledge production
dc.subject.keywordsSociology of law
dc.subject.keywordsEthnography of law
dc.subject.keywordsProfessional ethics
dc.subject.keywordsRisk management
dc.subject.keywordsStandards
dc.subject.keywordsStandard setting
dc.subject.keywordsUnification
dc.subject.keywordsHarmonization
dc.subject.keywordsQualitative research
dc.subject.keywordsCommunity-based research
dc.subject.keywordsIndependent research
dc.subject.keywordsAlternative research
dc.subject.keywordsHuman subjects
dc.subject.keywordsHuman participants
dc.subject.keywordsPositivism
dc.subject.keywordsMandated science
dc.subject.keywordsMandated ethics
dc.subject.keywordsRegulatory innovation
dc.subject.keywordsBiomedical model
dc.subject.keywordsLegal transplants
dc.subject.keywordsMethodological censorship
dc.subject.keywordsResearch policy
dc.titleMandated Ethics: Regulatory Innovation and its Limits in the Governance of Research Involving Humans
dc.typeElectronic Thesis or Dissertation

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