Research ethics in 2020: strengths, weaknesses, opportunities, and threats.

• Author: McDonald, Michael

In this special issue of the Health Law Review, it seemed especially appropriate to offer an ethics assessment of the current (2010) and future state (2020) of the governance system for health research in Canada. It is ten years since the McDonald report for the Law Commission of Canada (LCC) on The Governance of Health Research Involving Human Subjects. (2) In the last decade there have been significant developments in health research [e.g., genomics, biobanks, stem cell research, major cohort studies] and in the mechanisms used to ensure adequate protection for research participants [e.g., accreditation in the US, a second edition of the Tri-Council Policy Statement on the Ethical Conduct of Research Involving Humans (TCPS)], as well as significant problems reported at domestic and foreign research institutions. In addition to the 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 the introductory section, we explain what we mean by "the Canadian governance system for health research". We also offer a brief description of SWOT analysis, and offer a broad characterization of the Canadian health research context as background for this analysis. In Part 2, we list what we see as the strengths and weaknesses of our current system of protection. In Part 3, we project ten years into the future to consider potential opportunities and threats that are likely to beset our governance system. In Part 4, finally, we discuss our results, indicate the limitations of our analysis, and draw some general conclusions.

Part 1. Introduction

Part 1 (a) The Canadian Governance System for Health Research

It may seem strange to talk about a Canadian governance system for (human) health research because "system" is a term that seems ill suited to the 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 the purposes of this analysis, we take as our starting point the Health Research 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 the Health Law Review. In the Anderson article, the HRIHS lifecycle is described in terms of twelve linked and sequential stages that, together, offer a (admittedly idealized) description of the various processes involved in conducting HRIHS:

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In our view, the Canadian governance system has a role to play at each stage in the HRIHS lifecycle. However, as Anderson and co-authors note, there is a major gap between what the governance system is supposed to do, and what it actually does. Elucidating the risks and opportunities posed by this gap is the subject of this paper.

Part 1 (b) SWOT Analysis

SWOT and SWOT-type analyses are widely used in the world of business and government. The basic idea is to assess the internal capacity of an organization or system [its strengths and weaknesses! to deal with external environments [opportunities and threats]. (6) SWOT analysis involves a process model to elicit individual expert perceptions of organization strengths, weaknesses, opportunities and threats. The strengths and weaknesses parts of the analysis are aimed at an organization's or system's current situation; with opportunities and threats the focus is on the projected future state of the organization or system. At the Network meeting, a variant, of this process was used with individual Network members identifying various SWOTs that were then the subject of group discussion. The ideas, reflections and insights generated were then refined and subjected to additional analysis and input by the authors in this paper.

Part 1 (c) The Current Context of Canadian Health Research

In the Report to the LCC, "four pervasive international factors" were identified as having major effects on health research in Canada:

1. Rapid scientific and technological innovation and advances

2. Multiple disciplinary and interdisciplinary research modalities

3. Commercialization and privatization

4. Globalization and harmonization7

   The past ten years have provided ample evidence of the importance of these factors.

   Canada has a strong and active cadre of researchers in public and private sector institutions working across the four pillars of health research-namely, biomedical; clinical; health systems and services; and social cultural, environmental factors that affect the health of populations8. Health research is advocated and supported by a variety of public sector organizations (CIHR, Genome Canada, provincial bodies, etc.), the private sector and not-for-profit agencies. In some areas, such as stem cell research, Canada has been an international pioneer, and the creation of Genome Canada has enabled Canada to remain competitive in the rapidly expanding area of genomics. The National Institute of Nanotechnology at the University of Alberta is another example of Canada's efforts to remain competitive globally in an emerging area of research. CIHR created an innovative Strategic Training Initiative in Health Research to increase Canadian capacity in health research. Rx & D has made strenuous efforts to promote Canadian health research in the face of increasing international competition from both developed and less developed countries. Still it has to be said that internationally there is fierce competition in the area of health research and Canada, while competitive, is but one player on a stage with many major actors including such heavy weights as the United States, the European Union and Japan, as well as emerging economic powers such as Brazil, China and India.

   Canada has a highly advanced health care system especially in acute and chronic care areas. The system is open to, and in many cases supportive of, health R&D. But due to financial and political pressures, infrastructure issues, and in some cases personnel shortages, it is increasingly difficult to meet the health care needs and demands of Canadians. This creates both synergies and tensions between clinical care and research goals depending significantly on whether health research is seen as a cost centre or a profit centre for institutions and governments funding health care, and whether there is a good fit between health care and health research in particular locales. For example, at the time of writing there are news reports discussing a possible free trade arrangement with the European Union. However, Europe is pressing Canada to accept an extension of patents for pharmaceuticals and end provincial requirements for minimum pricing . (9) The anxiety expressed by commentators is that this will significantly increase costs for provincial health care systems. Yet this could also provide a boost for Canadian health research by potentially attracting more investment in research. In short, Canada is a relatively small consumer of health R & D in terms of global markets and thus more driven by global than domestic demands. (10)

   These factors increase pressures for international harmonization with respect to governance arrangements for health research. These pressures come both from within (from health research institutions and researchers as well as provincial and federal governments) and from outside of Canada (from companies and countries wanting greater access both to markets and to talented researchers). Yet in terms of Canadian priority setting it is important to note that the pressures in Canada track markets more than they track health needs. There are enormous global as well as domestic disparities in terms of matching health care resources to health care needs. However, there have been some heartening recent developments in terms of addressing health care disparities, such as the Gates Foundation Global Health Disparities Initiative. Canadian health researchers, particularly at the University of Toronto and more recently at the University of British Columbia, have taken an active role in these efforts. (11) Domestically the creation of the C1HR Institute for Aboriginal Health Research is another instance of encouraging development.

   Part 2. Strengths and Weaknesses

   In Table 1 we list ethical strengths and weaknesses in the current Canadian arrangements for the protection of health research participants. This is followed by a brief discussion of each item.

1. Priority Setting

   As noted in the Anderson paper, priority setting is where many of the most important ethical decisions about research involving humans are made; decisions made here have significant impacts throughout the lifecycle. Priority setting is usually discussed in terms of scientific and economic priorities and not ethical ones. (12) For example, health research priorities tend to centre on the health problems of the most advantaged members of the global community. Nations (including Canada) often set a high priority on attracting the health research and development investments that will power their economies and may make regulatory changes that will facilitate such...