Research Ethics in 2020: Strengths, Weaknesses, Opportunities, and Threats

In this special issue of Health Law Review, it seemed especially appropriate to offer an ethics assessment of current (2010) and future state (2020) of governance for health research in Canada. It is ten years since McDonald report for Law Commission of Canada (LCC) on The Governance of Health Involving Human Subjects. (2) In last decade there have been significant developments in health research [e.g., genomics, biobanks, stem cell research, major cohort studies] and in mechanisms used to ensure adequate protection for research participants [e.g., accreditation in US, a second edition of Tri-Council Policy Statement on Ethical Conduct of Involving Humans (TCPS)], as well as significant problems reported at domestic and foreign research institutions. In addition to LCC report, there have been numerous commentaries on these developments including two special issues of HLR on research ethics governance published by our network and its precursor. (3) This paper proceeds in four parts. In introductory section, we explain what we mean by the Canadian governance for health research. We also offer a brief description of SWOT analysis, and offer a broad characterization of Canadian health research context as background for this analysis. In Part 2, we list what we see as strengths and weaknesses of our current of protection. In Part 3, we project ten years into future to consider potential opportunities and threats that are likely to beset our governance system. In Part 4, finally, we discuss our results, indicate limitations of our analysis, and draw some general conclusions. Part 1. Introduction Part 1 (a) The Canadian Governance System for Health It may seem strange to talk about a Canadian governance for (human) health research because system is a term that seems ill suited to complex set of standards, policies, procedures and practices that constitute participant protection in Canadian health research.4 There are macro-level actors who set general parameters (including governments, professional bodies and research sponsors), meso-level institutions (research institutions, sites where research is conducted) and individuals (including researchers and research workers). Moreover, there is an array of actual and potential authorities for Canadian research protection - international, federal provincial, institutional and professional - as well as a complex mix of domestic and international interests and interest groups - commercial, public, consumer, political, etc. that often act at cross-purposes. Despite these complexities, we believe there are insights to be gained from taking a systems view of our current patchwork of regulation and oversight. For purposes of this analysis, we take as our starting point Health Involving Human Subjects (HRIHS) lifecycle advanced in Research Ethics Broadly Writ: Beyond REB Review (5) by Anderson et al., which also appears in this issue of Health Law Review. In Anderson article, HRIHS lifecycle is described in terms of twelve linked and sequential stages that, together, offer a (admittedly idealized) description of various processes involved in conducting HRIHS: [ILLUSTRATION OMITTED] In our view, Canadian governance has a role to play at each stage in HRIHS lifecycle. However, as Anderson and co-authors note, there is a major gap between what governance is supposed to do, and what it actually does. Elucidating risks and opportunities posed by this gap is subject of this paper. Part 1 (b) SWOT Analysis SWOT and SWOT-type analyses are widely used in world of business and government. The basic idea is to assess internal capacity of an organization or [its strengths and weaknesses! to deal with external environments [opportunities and threats]. …

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