Research governance, bio-politics and political will: recent lessons from Newfoundland and Labrador.

• Author: Pullman, Daryl
• Position: Special Issue: Canadian Governance for Ethical Research Involving Humans

Introduction

For the past several years the province of Newfoundland and Labrador has been taking halting steps to introduce the legislative mechanisms necessary to establish a Provincial Health Research Ethics Board (PHREB). If and when that legislation is in place the PHREB will be responsible for the governance of all health research involving human subjects conducted in the province. However, the process has not been without its difficulties. In what follows I summarize briefly some of the circumstances that led to this provincial initiative, some of the steps and missteps that have occurred so far, and identify some lessons learned as we continue to struggle forward in this regard. Before embarking on this brief review, however, it is worth pausing for a moment to reflect on some reasons as to why lessons learned in Newfoundland and Labrador might be important to the rest of the country.

Why Newfoundland and Labrador?

Several reasons can be given as to why a Newfoundland and Labrador case study might prove instructive. First, if the PHREB initiative is successful, Newfoundland and Labrador will be the first jurisdiction in Canada to establish in law a comprehensive governance structure for all health research involving human subjects. The precedent setting nature of this initiative makes it interesting in and of itself. Second, Newfoundland and Labrador can serve as a microcosm of the systemic problems that might be encountered in other Canadian jurisdictions. The population of Newfoundland and Labrador is small (just over 500,000), the majority of health researchers in the province are located in the province's single university, and the amount of health research conducted in the province is relatively small. On the face of it then, it would seem that efforts to establish a comprehensive governance structure should be less onerous in Newfoundland and Labrador than might be experienced in jurisdictions that include more institutions, more research, and a greater number of competing interests. Indeed, there has been broad general support for the PHREB initiative in all quarters. Nevertheless, we are still without legislation in spite of four years of concerted effort. The reasons for this failure may prove instructive. Finally, Newfoundland and Labrador might serve as a test case for the country with regard to research governance, similar to the manner in which Saskatchewan was a test case with regard to comprehensive health insurance. When Saskatchewan demonstrated that comprehensive health insurance was a realistic possibility the federal government came on board and other jurisdictions followed suit. If Newfoundland and Labrador can demonstrate that a comprehensive, effective, and efficient system of governance for health research is possible, similar results at the national level may ensue. Conversely, if the practical problems of implementation are insurmountable here, it does not bode well for a larger national initiative.

Background Circumstances

Memorial University of Newfoundland is the only university in the province. With a Faculty of Medicine, a large Faculty of Arts, and Schools of Nursing, Pharmacy, and Social Work, among others, this institution houses the vast majority of investigators involved in health related research in the province. However, it wasn't the activities of university based researchers or even those of other non-affiliated researchers in the province that served as the impetus to establish the PHREB. Rather, it was concern about the activities of outside researchers who have been visiting the province to conduct their studies. Occasionally these investigators have collaborated with local researchers either formally or informally. However, in some cases they visited communities to collect biological samples, health records and related data, and returned to their home institutions. (1) At times it was only when research results were published or when the national media reported an interesting study that had been conducted in the province, that local researchers and health officials learned of the existence or nature of this research. (2)

Things came to a head in the late 1990s when...