Canadian governance of health research involving human subjects: is anybody minding the store?

Publication: Health Law Journal

Publication Date: 01-JAN-01

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COPYRIGHT 2001 Health Law Institute

Abstract (1)

From an ethical perspective, good governance involves the translation of collective moral intentions into effective and accountable institutional actions. With respect to the use of human subjects in Canadian health research, I contend that there have been many good intentions but very little in the way of appropriate governance arrangements. Hence, the question, "who minds the store?" is especially acute with respect to the protection of vulnerable individuals and groups that are typically recruited as subjects for health research in Canada.

Beyond diagnosing failures in governance and their causes, I offer suggestions for significant reforms, including evidence-based ethics assessment, independent oversight, and greater participation of research subjects in governance. I will close with some more general reflections on ethics, law, and governance.

I. Introduction

The topic of this paper is one that should be much more central in discussions of bioethics and health law than it currently is. This is the topic of ethically responsible and accountable governance. Governance in the context that I will be discussing--the treatment of human subjects in health research--falls into the broad area of institutional ethics and more narrowly institutional bioethics. (2) In ethics and bioethics, a great deal of attention has been focussed on the opposite ends of the broad spectrum of ethical issues: the personal and the political, or in often used terms, "micro" and "macro" level concerns. Much less concern has been shown in academic literature and in public discussions for the institutional or meso-level. Yet it is in norms, practices, and cultures of institutions that the political and personal most often meet. The everyday realities of life as a patient and health care provider or research subject and researcher are framed by the institutional settings of health care and researc h institutions. Moreover, the success of health policies set at macro-levels depends crucially on institutional action at the meso-level.

In this paper I consider the state of institutional ethics as exhibited in current Canadian governance arrangements for health research involving the use of human subjects. This paper is based on research that my colleagues and I did for the Law Commission of Canada under the title The Governance of Health Research Involving Human Subjects. (3) The paper has three parts. In the first part, I characterize the state of governance in this area. That characterization leads to the question raised in the subtitle: "is anybody minding the store?" In the second part, I offer suggestions for addressing the major shortcomings in current governance arrangements for health research involving human subjects. In effect, I set out what I see as the key features of an adequate regime for ethical governance of Canadian health research involving human subjects. In the third and final part, I address two key issues. The first is why ethical governance for this area requires an evidence-based ethics of research. The second is ho w we can make a principled determination of whether we have the right amount and kinds of governance.

Along the way, I will offer various comments or, to use a term familiar to readers of this publication, obiter dicta on more general ethical, legal, and political issues.

My first obiter dictum is on the methodological approach that my colleagues and I used in our study for the Law Commission. (4) We started with a descriptive account--what is the state of governance for health research involving human subjects--and moved to the normative--the ethical lessons both practical and theoretical. Now this may seem unusual for a project headed by an analytically trained philosopher. In my earlier career as a political philosopher and philosopher of law my inclination would have been to first produce a theory of institutional responsibilities for governance as a template to assess actual practices. Now as an applied ethicist, I take a more empirical approach: starting with a rich description of social phenomena and then developing a normative approach that addresses the social and institutional realities of the situation. In line with this more empirically informed methodology, I will discuss the development of an evidence-based ethics in the final part of this paper.

Part I. The Current State of Canadian Governance for Health Research Involving Human Subjects

In our study of governance, we addressed two major questions:

(1) How is Canadian health research involving human subjects governed in terms of "ensuring ethical research processes?"

(2) How effective are these governance relationships in terms of "consistently achieving effective governance of ethical research?" (5)

The approach we took to answering these questions was both multi-disciplinary and inter-disciplinary -- multi-disciplinary in that we looked at the state of governance through several disciplinary lenses (law, ethics, sociology, etc.) and interdisciplinary in our effort to produce a unified account or picture of the area. A major part of our research was based on qualitative analyses of interviews conducted with Research Ethics Board (REB) members and university administrators at five major Canadian universities and with individuals from national organizations with governance responsibilities in this area. (6)

A. Governance

As indicated in my remarks about methodology, I developed a generalizable normative account of governance in response to a descriptive analysis of current governance arrangements. In broad ethical terms, I see good governance as involving the translation of collective moral intentions into effective and accountable institutional actions. (7) This translation is made in part through the establishment of oversight arrangements. (8) Thus, the usual definitions of governance offered by policy analysts centre on oversight processes; for example, one Canadian authority describes governance in terms of "the processes by which human organizations, whether private, public or civic, steer themselves." (9) Governance issues also arise in regard to the interactions of the many organizations and groups involved in health research using human subjects: public and private research institutions, research sponsors, research regulators, researchers, research subjects and the general public. So it is fair to ask, "who is respon sible for what aspects of the protection of human subjects in health research?" That is, governance issues arise with respect to the appropriate division of responsibilities for the protection of human subjects amongst the agencies and organizations that conduct, sponsor, and regulate research.

Conceptualising the ethical challenges in governance in terms of translating collective moral intentions into action has the advantage of focussing attention on two key areas: first, on the moral intentions of the collective agents--in particular on content (what is intended) and motivation (why it is intended)--and second on appropriate implementation and potential obstacles to implementation, particularly organizational barriers to effective and appropriate action. The first set of issues leads to questions about the ethical nature and limits of actions by the various organizations (and their members) that play roles in health research involving human subjects. Here, I think it is fair to say, there is broad general agreement on three main objectives:

(1) the promotion of socially beneficial research;

(2) respect for the dignity and rights of research subjects; and

(3) as an overarching aim, the maintenance of trust between the research community and society as a whole and, particularly, actual and potential research subjects. (10)

However, such consensus on broad objectives does not guarantee agreement on the specific responsibilities of particular agents or agencies. The United States, for example, has established very specific responsibilities, with a strong regulatory process backed by arm's-length processes of verification; Canada has by and large relied on guidelines with only self-verification by researchers and research institutions. Moreover, there is a major moral risk that agencies and agents will try to push responsibilities away from themselves on to others. Within organizations this deflection of moral responsibilities may be up, down or sideways. Amongst organizations, it can involve the unfair and inappropriate off-loading of responsibilities from the regulator to the regulated or the reverse.

This brings me to the second area of major concern, namely, putting collective intentions into effect. Any realistic account of the implementation of governance must take into account typical obstacles to putting collective moral intentions into action. As we note in our study, a central concern with respect to governance is the management of "agency risk," i.e., the tendency of agents to pursue their own agendas rather than those mandated by or for their organizations. (11) Thus, in asking whether anybody is minding the store, I am raising a question about how well the multiple institutions involved in health research deal with the many institutional and personal agendas encountered in such research, whether these be increased profits, more research funding, health advances for specific groups, enhanced individual and institutional prestige, or maintenance of power.

As I argued in a November2000 lecture at the Royal Society of Canada Conference on Science and Ethics, such oversight implies a multi-tiered normative relationship amongst moral agents. (12) At tier or level one there are agents with various normative responsibilities, for example researchers who have moral and legal responsibilities with respect to subjects participating in their research. Governance relations enter the normative picture when there are other moral agents at tier two or higher levels charged with various oversight responsibilities, for example to evaluate, approve, or monitor the performance of agents (in this case, researchers) on the first tier. That is, the second tier is instituted to promote appropriate actions at the first level. It does this sometimes through direct accountability and oversight relationships (as well as incentive/disincentive structures) and at other times through indirect oversight (e.g.,...

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