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• W340252552 abstract "... no aspect of research, from formulation of initial hypothesis down to final clinical acceptance, is devoid of ethical significance. (1) In Canada, as well as elsewhere, governments, sponsors, institutions, and researchers tend to view research ethics almost entirely through the lens of research ethics board (REB) review. According to these stakeholders, research ethics is REB review. In this paper, we aim to show that there is much more to research ethics; health research is a multi-stage process and each stage has unique ethical implications that may or may not fall under the mandate of the REB. We also aim to show that our current governance system fails to address those ethical issues lying outside of the mandate of the REB. Finally, we consider two possible explanations for this state of affairs: (1) the presumption that REBs can handle all of these issues; or (2) failure to recognize of the broader ethical issues associated with research involving human subjects. Ultimately, we reject both of these explanations in favour of a third: key stakeholders lack the foresight and political will to make the necessary changes. We begin by providing a moral geography of research involving human subjects. We describe the various stages involved in the planning and execution of research involving human subjects, and identify some of the ethical issues arising at each stage. We then explore the role of the REB within the process as a whole, contrasting the de jure role of the REB (as specified in the Tri-Council Policy Statement) with its de facto role in the current system. We conclude by calling for systematic efforts to redress the gaps in our current governance system. We note, however, that though many of our points apply to all research involving human subjects, some are clearly more relevant to the conduct of health research in general and clinical research in particular. This is partly an artefact of the authors' expertise and partly because our Network is centred on health research. But the focus on health research also allows us to simplify our remarks since taking into account the sometimes significant variances within different types of research involving human subjects would be very difficult within the ambit of a single paper. The problem: ethical tunnel vision Ten years ago, one of us concluded a report on the governance of research involving human subjects for the Law Commission of Canada with the following observations (among others): [W]ith respect to ethical conduct of HRIHS [health research involving human subjects] there [are] three central ethical objectives: a. The promotion of socially beneficial research b. The protection of research participants c. As an overarching aim, the maintenance of trust between the research community and society as a whole. These objectives enjoy broad social endorsement and are represented in the numerous international, national and professional codes and [sic] aimed at the conduct of ethical research involving humans. But when we compare these three objectives with what actually takes place in the name of ethical research, we find a narrowing of concerns that could aptly be described as ethical tunnel vision, in which the three ethical objectives are given the most minimal instantiation. In effect, our current governance processes for HRIHS reduce research ethics to a dangerously simplistic concern for REB approval that is often functionally an approval of consent forms. The result is that the REB approval process and informed consent bear far more moral weight than they can possibly sustain. (2) Though there has been some progress toward improving this situation over the last decade, these remarks remain all too true today. For the most part, governments, sponsors, institutions, and researchers continue to view research ethics almost entirely through the lens of REB review. …" @default.
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• W340252552 date "2011-06-22" @default.
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• W340252552 title "Research Ethics Broadly Writ: Beyond REB Review" @default.
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