The long arm of administrative law: applying administrative law principles to research ethics boards.

• Author: Hadskis, Michael
• Position: Canada - Special Issue: Canadian Governance for Ethical Research Involving Humans

1. Introduction

   Commentators have described the primary responsibility of research ethics boards (REBs) as that of ensuring that research projects involving human participants commence, or continue, only if the participants "are adequately informed, freely consent to participate, and ... are not exposed to unreasonable risks of physical, social, psychological and economic harms that might occur as a result of participation." (1) Whether REBs have the authority needed to perform this responsibility is a question that has animated much of the recent discussion over governance of the Canadian ethics review system. That discussion has been largely premised on a belief that the current system operates in an ad hoc fashion, without legislated mandates or enforcement mechanisms. (2) While this may accurately describe the system's evolution, it no longer represents the reality. REBs increasingly operate under mandates derived directly or indirectly from statute law. To the extent REBs derive their mandate from statute law, certain legal duties are likely owed to persons affected by their decision-making activities that deserve more attention than they have received to this point. These duties arise from administrative law, the domain of legal principle that governs the exercise of powers derived from delegated state authority. That administrative law should have an increasing influence on the development of research ethics review in Canada seems appropriate, given the important public interest role assigned to REBs, and the potential impact of their activities on members of the research community and participants in biomedical research alike.

   The paper is not an exhaustive treatment of the implications of administrative law for research ethics review in Canada. Rather, the goal is the more modest one of suggesting that this is an important area of legal concern that holds both promise and pitfalls, and should not continue to be neglected. The purpose of this overview, then, is two-fold: (1) to demonstrate the applicability of administrative law to much of what is currently occurring in research ethics review in Canada, particularly in university and hospital-based REBs; and (2) to show that administrative law can have a significant impact on the review of biomedical research and, consequently, on the interests of relevant stakeholders (researchers, research institutions, sponsors, research participants, the public, and REBs themselves).

   Biomedical research involving human subjects that takes place within Canada's public universities and hospitals is presently subject to two ethics regimes: the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (3) ("TCPS") and the Guideline for Good Clinical Practice E6 (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) ("GCP"). (4) While neither the TCPS nor the GCP have the status of self-applying legislation, there is considerable reason to believe courts would look to these instruments as establishing minimum standards for REB performance. (5) The key question is whether the REB in question is itself subject to administrative law obligations. University and hospital-based REBs operate in an area of some ambiguity in this regard. In our view, most would likely be subject to administrative law on one or more of the following bases: they derive their authority from parent statutes which permit university and hospital boards to create internal bodies with mandatory powers; they operate at least indirectly under government control, through research funding agreements; and they serve important public purposes within a statutory context. Part II of this paper explores these arguments.

   In addition to the TCPS and GCP (but often incorporating them), Canadian law-makers have enacted several statutory mandates regulating different facets of health research involving human subjects. The following legislative mandates authorize REB activities that should be subject to administrative law duties:

   the Clinical Trial Regulations, applying to tests of new pharmaceuticals; (6) personal health information legislation in Alberta and Ontario; (7) the regulation of medical professionals engaged in human participant research in Alberta and Quebec; (8) and the Quebec Civil Code provisions requiring ethics review for research involving minors or persons incapable of giving a competent consent. (9) University and hospital researchers may find themselves subject to one or more of these legislative regimes in addition to the TCPS and GCP. In Part III, we describe the first three of these regimes.

   Having concluded that many, if not most, Canadian REBs come within the scope of administrative law principles, Part IV discusses several principles that have particular relevance to the activities of REBs. (10) Part V addresses the nature of judicial review, and how and when courts may exercise their supervisory jurisdiction over REB activities. Brief concluding remarks are provided in Part VI.

2. The Applicability of Administrative Law to Research Ethics Review

   Administrative law is comprised of a set of common law principles (11) that govern the exercise of public power in Canadian society. Public power can be conceptualized as the making of authoritative decisions affecting the rights or interests of persons in civil society. Rule of law theory holds that statutes enacted by democratic legislatures acting within their constitutional powers are the sole source of legitimate authority to make such decisions. Developed by the superior courts through the mechanism of "judicial review", administrative law imposes two principal duties on decision-makers: (1) to make decisions in a procedurally just or fair manner; (2) to make decisions which in substance respect the jurisdiction conferred on them by legislators. This paper confines its discussion to the first set of duties, because they have the greatest impact on how decision-makers actually function.

   A person exercising a power delegated by statute is prima facie subject to administrative law. Since legislatures may lawfully delegate statutory power to any person of their choosing, it does not matter whether the empowered entity is public and subject to control of executive government, or private. Professional regulatory bodies, such as provincial law societies and colleges of physicians and surgeons, are private entities to which the legislature has delegated powers to be exercised in the public interest. A "statutory power" refers to something more than merely being incorporated under statute, which is true of all registered corporations and non-profit societies. It refers to a specific power to make authoritative decisions in the public interest. Activities of a private nature, such as contracting, are generally not subject to administrative law, regardless of whether the person engaging in the activity is a body incorporated under statute or an emanation of executive government.

   Administrative law obligations apply to decisions that hold the potential to seriously affect individual rights or interests. This threshold of "serious effect" is not high, and essentially means that courts will not intervene to protect minor or trivial harms to persons' interests. (12) With respect to research ethics review, those whose interests may be adversely affected include researchers, research institutions, sponsors of research, and the individual research participants. While the latter might encounter an obstacle with respect to their standing to seek judicial review of REB decisions (see Part V, below), there is little question that the interests of all the named stakeholders are sufficiently serious to meet this threshold. For researchers and the institutions that employ them, those interests include career paths and reputations.

   With these general principles in mind, we turn now to look more closely at the source and nature of the decision-making functions of university and hospital REBs. (13) The general position is well summarized by David Mullan:

   [T]here also exist many examples, particularly in the provincial domain, of bodies that owe their existence to statute and which, while structurally independent of government, nonetheless perform functions that are sufficiently governmental or public in their nature as to attract the attention of public law. Among the most prominent of these agencies of public policy are universities, hospital boards, and professional organizations. Despite their historic status as autonomous, self-governing bodies, they have been transformed over the years, largely through legislative appropriation and, in many instances, government funding, into bodies that possess an array of regulatory powers in matters of great significance to the polity at large. (14) While this passage implies, correctly we believe, that many decision-making activities undertaken at universities and hospitals are subject to administrative law, the situation is not entirely straightforward. The importance of self-governance to universities, especially in terms of protecting the value of academic freedom, has sometimes led Canadian courts to be reluctant to bring universities fully within the scope of public law. (15) In 1990, the Supreme Court of Canada surprised many by ruling that neither universities nor hospitals fall within the term "government" so as to make them subject to Canadian Charter of Rights and Freedoms. (16) The Court later ruled in Eldridge v. Vancouver General Hospital (17) that hospitals are subject to the Charter when providing health services to the public, because in doing so they are carrying out a specific government program. The precise ambit of the "government program" rule for hospitals, and for universities, remains uncertain. The scope of the Charter and of administrative law, as two important components of public law, closely track each...