Academic journal article Health Law Journal

Canadian Governance of Health Research Involving Human Subjects: Is Anybody Minding the Store?

Academic journal article Health Law Journal

Canadian Governance of Health Research Involving Human Subjects: Is Anybody Minding the Store?

Article excerpt

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. …

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