Summer/Fall 1999

By Adam Horvath
Chair, Simon Fraser University Research Ethics Review Committee

hen I was asked to talk about the "Institutional Response" I was for a moment tempted to ask what, more precisely, was the organizer’s plan or fantasy about the kinds of things this talk might cover. The moment of temp- ation passed, however. I dared not risk the possibilities that I would miss my chance to address this group on the issues I thought were central to the universities as we contemplate the ramifications of the Tri-Council document.

I am speaking to you (like Janus) from two competing perspectives: on one hand, as the Chair of the Ethics Committee (soon to be known as REB) of a mid-size university with a strong research tradition but no medical or dental faculties, and on the other hand — and more importantly — as an academic with a vital vested interest and commitment to research on issues involving humans. I am also expressing my views as an academic with a firm conviction that the ethos of our profession imposes upon all of us an obligation to engage in research, pursue significant independent scholarship, and search for genuine knowledge, as well as the responsibility to uphold the highest ethical standards in the land.

My goal this morning is not to propose solutions, but rather to highlight competing principles and identify challenges and perhaps note some opportunities that the Tri-Council directives present to universities. I see this document as the most recent signpost on the changing landscape, not so much of our appreciation of the ethical issues in research involving humans — but more immediately as a manifestation of the changing relationships among the major stakeholders determining policies in academia.

Let me begin by identifying what I believe are the three major issues or challenges that flow from the document:

• The articulation of a unified set of ethical principles that could govern research involving human subjects across a broad variety of populations and diverse traditions of scientific inquiries.
• The proposal to establish a common procedural and structural framework to evaluate and adjudicate the ethical propriety of research involving human subjects across all Canadian Universities and in all disciplines within these institutions.
• Within the document, there is a formal statement to the effect that researchers owe to society, by virtue of benefiting from public funding, an ETHICAL responsibility to conduct research that benefits Society. Thus not only the PROCESS (i.e., how the research is conducted) but also the CHOICE of research topic and the QUALITY of the investigation have an ethical dimension.

I realize that this meeting is primarily focussed on the implementation aspect of the new policy; but it seems to me that in order to respond wisely to the document, we need to understand both the concep- tual and the historical context of these issues. We also need to be mindful that we are participating in an evolving process, which is bound to have cascading consequences for the way academia in general, and human research in particular, will evolve in Canada.

Let me discuss, in greater detail, how I believe these changes proposed in the Tri-Council document will challenge our traditional notions of the conduct of research.

As I noted above, the premise of the document is that one unified set of principles will be applicable across diverse disciplines. At the most general level, the logic of such a proposal is indisputable inasmuch as the "subject" — our fellow human being, has the same rights and privileges regard- less of the purpose of the scien- tific inquiry we recruit them to participate in. It should also be noted, however, that our current practices are also rooted in the same general principles as the ones spelled out in the Tri-Council document. The difference between the current and proposed schema lies not so much in divergence of the very broad and general principles, but in the fact that currently the universally accepted "bedrock" premises are interpreted within the context and cultures of the different broad fields of practice (i.e., Social Sciences and Medicine) whereas the Tri-Council opposes discipline- based REBs and advocates a universal continuum based on notions of balancing risks and benefits.

The attraction of the new model is the perceived simplicity, universality, and — one gets a strong sense from the document — accountability. The risk or challenge in implementing this Procrustean ideal is that the broad universal principles underlying our system of research ethics acquire meaning only in the complexity of the context in which the research is practised. For instance, the notion of "free and informed consent" in practice has very different criteria for a psychologist, an economist dealing with CEO’s of banks, and an anthropologist working on a site which involves land that is claimed by First Nations People. De-contextualizing the ethical principles and removing the task of evaluation from experts in the cognate field rest on the assumption that the very basic premises of ethical conduct can be explicated to the level of specific decisions about an individual project, without recourse to and reliance on the long history of praxis within the cognate field. This is a challenging proposition that seems to be at odds with XXth -century notions on ethics as well as practices in the field of jurisprudence wherein decisions about "right conduct" are evaluated in particular contexts as, for example, criminal vs. civil vs. tax laws. To press the analogy perhaps to its limit: theft is a "no-no" (as a general rule), but what constitutes theft (how are the facts and consequential actions determined) is very different in criminal, corporate and family law. While the analogy is admittedly far-fetched, it is important to note that what makes a law just is this very principle of contextual and precedential sensitivity. Our institutional response to the ideal of single set of principles applied across disciplines by a REB of homogeneous composition is a challenge we need to consider carefully.

This leads me to the second issue, which is the ideal of a procedural uniformity, based on the fundamental principle of risk/ benefit analysis. It rests on the assumption that this core principle (risk/benefit assessment) can be accom- plished to a similar degree of reliability and accuracy across different disciplines. It appears to me that, while such analysis is possible (in the short term) and is probably desirable in the biological sciences, where the research is of an applied nature, the benefits are clearly stated as the goal of the inves- tigation, and the risks can be clearly estimated, it is not at all certain that this task can be achieved with any degree of respectability in the social sciences. In the first place, the risks are often difficult to quantify, and the benefits are equally — if not more so — vaguely contemplated. Moreover, estimation of the "benefits", as ordinarily construed, may be highly contentious in the case of research invol- ving unpopular or controversial subjects. As universities respond to this challenge, they must also consider the likely scenario that most likely one (small) group will incur the "risk" insofar as there is any. Whereas the benefit — if it materializes — will likely profit another generation or a group that the subjects are not even part of. This dilemma becomes more acute when we consider the notion of the rights of the collective, as identified in the Tri-Council document. In Sociology and Social Psychology particularly, the group or collective that has proprietary right to decide if a piece of research should or should not go ahead, may be practically impossible to resolve, and an attempt to make a decision in this matter by persons who do not belong to the group in question may create more problems (by implicitly assigning ownership) than it solves. Last, but far from least, the universities, in their response, have to take account of the variability of cultural norms about collective rights, as well as standards of consent (i.e., who is entitled to agree or consent on behalf of groups and individuals). If our implementation of some of these noble principles is not informed by these ethnic differences in society/community, the consequences in loss of trust by important segments of the community may be serious. I would like to emphasize that I see this as a concep- tual rather than a technical challenge. It seems to me the question is NOT whether we could find a formula to resolve ownership; the dilemma is to what extent this notion of collective veto will serve those we seek to protect. I am tempted to underscore the obvious; traditions and practices within academic fields have evolved quite respectable praxis for meeting some of these challenges; how will our universities manage to take advantage of these context-informed procedures within the new framework?

The last issue I would like to highlight is the reciprocity between a society as the host and sponsor of our scientific work and the commitment of the scientist to earn this privilege on one hand, and notions of academic freedom on the other.

Notwithstanding the often voiced ideal of independent institutions of higher learning, universities have traditionally, with few exceptions, been sponsored throughout the ages. In Canada, until about 50 years ago, the major sponsors were religious organi- zations, with a few private insti- tutions sustaining themselves through the generosity of their alumni. After the Second World War, government took over the sponsorship for all practical purposes. While academia and government have thus became partners, we have been fortunate: intellectual independence of academia in Canada has not been subject to the kinds of pressures that some universities in the developing world and Europe have experienced. Yet by using targeted funds and manipulating budget allocations, governments traditionally had a significant role in some aspects of university policies. In the current economic climate, the arm’s-length rela- tionship between universities and government with respect to policy and intellectual pursuit is, I think you will agree, changing. In this context, the funding arm of the government’s concern about the social responsibility associated with the ETHICAL practice of research takes on an added dimension. I will try to make clear later that "social respon- sibility" is not an unambiguous term, nor is it unfamiliar to universities or their ethics boards. What is new is the entrance of the funding arm of the federal government as a major player in the determination of what researchers’ social responsibilities are and thus the possibility of intermingling social policy and determining what may not be researched "ethically". As I noted before, it seems to me that the independence of the university has, in any strict sense, always been a cherished myth. We are not a self-sustaining institution, never were, and there has been historically a tradition of some level of reciprocity between academia and its "sponsor", be it a religious order, private foundation or the state. While this has been traditionally true, it is also the case that the freedom of the researcher to peruse important issues based on her or his judgments and expertise has been traditionally highly prized in institutions of higher learning. I think it is fair and not overly paranoid to state that this prized independence has taken something of a back seat in the current hard eco- nomic climate, and there is an increasing tendency to justify the existence of the institution in terms of reciprocal econo- mic benefit. This being the case, at an individual level, most of us, I think, would like to believe that academic freedom exists at least to the degree that, if we are capable of convincing someone with a source of funds that our research has merits, we will be able to pursue a line of research unimpeded by political or policy considerations. The valuation process (i.e., what is worth funding) is ideally isolated from direct pressure from the source of funds (i.e., from threats to academic freedom) by a tradition of peer evaluation that has history and credibility in academic circles. In contrast, when such process is not in place — as is the case in some medical research, there appear to be greater ethical risks — as illustrated by the recent case at the Hospital for Sick Children in Toronto.

In contrast, the ethical review process is traditionally not blind, nor is it peer- based, and it is configured to be more directly responsive to societal and professional norms. The proposal we are to implement conflicts with these two processes: the scientific/social value and the ethical consideration of the research project. Insofar as the REB structure does not conform to the standards developed for peer review, it may become a threat to academic freedom as we traditionally understand it. More- over, it appears that the merits of the proposal will be judged twice: once by the traditional peer evaluation procedure and a second time (or concurrently) by the REB. This may be an unfair "double jeopardy"and, inasmuch as it is true that in many instances the Councils are both sources of funds and ultimately the authors of the Code, this too may represent a redefi- nition of academic freedom.

Let me conclude that we came together neither to bury nor to praise Cæsar, but to examine the legacy of this manifesto and chart the course of the Republic in light of the evolving realities. It is clear that we have a new partner, or rather that our old partner, the federal government, is joining us at the table of ethics decision-making. The three funding agencies have in the past, embedded as they were in their own research tradi- tions, developed different procedures to implement the generic ethical principles and developed standards and practices to ensure the protection of the rights of individuals participating in research. Likewise, universities of diverse struc- tures have developed a variety of practices in different institutions and disciplines to implement these same goals. The marriage of these traditions, within and across institutions, ought not to be a mechanical process, nor should it be one based on the assumption that uniformity and simplicity are the only criteria of institutional development. Careful consideration ought to be given to the protection of our other "goods", including the commitment to do research without undue restrictions on individual scholars, and freedom to pursue matters of scientific importance. The myth (and I believe that in the historical context it has always been a myth) of the autonomy of the institution of the university and the limits of academic freedom are about to be re-defined as a result of the imple- mentation of this document at least as, if not more dramatically, than the ethical conduct of researchers dealing with human subjects. Let our institutional response reflect the care and concern we have for both the highest possible ethical standards in our universities and the values we hold dear as academics pursuing knowledge and truth, wherever we find it.