Potential Conflicts of Interest for REB Members

Wed, 08/11/2010
Patricia Kosseim, BCL/LLB; Heenan Blaikie (Law Firm)

Patricia Kosseim, BCL/LLB; Heenan Blaikie (Law Firm)

From a legal point of view, conflicts of interest need not be malicious, fraudulent, nor even intentional. Rather, conflicts of interest often exist completely unbeknownst to those concerned. This forum enables us to discuss and debate various conflicts of interest, so that we can recognize them, if they arise, and ultimately, deal with them accordingly.

For the purpose of this presentation, I will refer to the term "bias" as opposed to "conflict of interest". The former is a broader notion that covers a whole spectrum of grounds for challenging the impartiality of decision-makers, including conflicts of interest. The term "bias" is defined in Black’s law dictionary as follows: inclination: bent; prepossession; a preconceived opinion; a predisposition to decide a cause or an issue in a certain way, which does not leave the mind perfectly open to conviction. To incline to one side. Condition of mind, which sways judgment and renders judge unable to exercise his functions impartially in particular case. As used in law regarding disqualification of judge, refers to mental attitude or disposition of the judge toward a party to the litigation, and not to any views that he may entertain regarding the subject matter involved.

Bias may occur at two levels: individual or institutional. At the individual level, bias will affect the decision-making ability of individual board members at a particular instance under specific circumstances. Institutional bias will exist where the impartiality of the board as a whole is systematically affected in any given circumstances due to a fundamental flaw in the appointment process, an imbalance in its composition, or the financial dependence of its members. Any of these factors may influence the outcome one way or another on a repetitive basis. This presentation will deal only with individual bias.

A potential bias that compromises the impartiality of individual REB members includes cases where decision-making ability is or may be influenced by a pecuniary or proprietary interest, however slight, e.g., when an REB member holds shares, is employed by, is paid by, or may potentially enter a contract with the pharmaceutical sponsor of the research under review.

Occupational interest may also affect the impartiality of a decision-maker. For example, a hospital administrator or director may be or may be seen to be particularly motivated to please researchers and attract additional research funds in order to promote the institution’s reputation and prestige in the community. A hospital employee may possibly feel obliged to approve the research study proposed by a superior for fear of retaliation or reprisal.

Personal ties with the investigating researcher may cause additional difficulties. What happens when a lay member of a research ethics board is the spouse of a physician in the hospital? Can this lay member be truly impartial in evaluating the research protocol put forth by the spouse? And what about the protocol presented by the spouse’s colleague, whom the couple had over for dinner on Friday evening? Peer reviewers may find themselves in a difficult situation when asked to approve their colleague’s research protocol, suspecting that doing so will facilitate their chances of obtaining similar approval when their turn comes, i.e., the "scratch my back and I’ll scratch yours" syndrome. Conversely, rivalry and competitiveness between colleagues may create negative partiality when hidden agendas seek to undercut, rather than support, proposed research.

Prior connection with the research protocol may also introduce bias into the decision-making process. What about an REB member who was previously involved, by near or by far, in the preparation of the research grant application in its early stages or has somehow contributed ideas, comments, and suggestions along the way?

A fixed and unalterable predisposition may influence the decision-making process when, for example, a board member holds the strict view that all research on minors or incapable persons is morally impermissible. Another may hold the view that the Roman Catholic position is the only tenable moral position, or further yet, believe that the black letter law is the ethical solution in all cases. Consider the predisposition of a parent whose child has suffered serious side effects after treatment by hospital medical staff and whose life mission has now become to block all medical progress. This adamant disposition, which precludes the consideration of other possibilities, may be considered a form of bias.

Similar situations have been the subject of much jurisprudence wherein interested parties have sought to disqualify decision-makers and/or annul their decisions on grounds of bias. More particularly, this case law involves administrative boards or tribunals who, like courts, are bound by the rules of procedural fairness, albeit to varying degrees. The question of the hour is whether hospital REBs are also legally bound to the rules of procedural fairness. Regardless of the answer, the tests articulated by the courts, whether or not directly applicable to research ethics boards, can nonetheless provide important insight on how to evaluate potential situations of bias when they arise, and more importantly, how to determine what level of bias is acceptable or unacceptable.

It is a well-established tenet in common law that no one can judge his own cause: "nemo judex in sua causa". In accordance with this fundamental principle, adjudicators must avoid situations that may lead to bias or, at least, the appearance thereof, for, justice "should not only be done but, of course, should manifestly and undoubtedly be seen to be done".

Courts decided long ago that proof of bias is unnecessary to disqualify an adjudicator from hearing a case. Rather, it is sufficient to prove a "reasonable apprehension of bias" when challenging the impartiality of a decision-maker. In Szilard vs. Szasz [1954] S.C.R. 3, an arbitrator was disqualified and his award set aside when it was learned that he was jointly engaged in a real estate speculation with one of the parties. The Supreme Court of Canada enunciated the judicial reasoning which lies at the very root of the "reasonable apprehension" test:

"It is the probability or the reasoned suspicion of biased appraisal and judgment, unintended though it may be, that defeats the adjudication at its threshold. Each party acting reasonably, is entitled to a sustained confidence in the independence of mind of those who are to sit in judgment on him and his affair." (at pages 6-7)

Some 24 years later, the Supreme Court of Canada had further occasion to elaborate on the "reasonable apprehension" test in Committee for Justice and Liberty vs. The National Energy Board [1978] 1 S.C.R. 369. The issue was whether or not Mr. Crowe, then Chairman of the National Energy Board, should be disqualified from a three-member panel set up to hear competing applications for a necessary certificate to exploit and develop a Mackenzie Valley pipeline. Prior to his appointment to the Board, Mr. Crowe had actively participated in a Study Group created by a consortium of companies whose representatives merged efforts to explore the physical and economic feasibility of a northern natural gas pipeline. The project ultimately resulted in one of the competing applications submitted to the Board.

The Supreme Court of Canada held that Mr. Crowe’s prior involvement with the Study Group and his participation at the earlier stages of the project created a reasonable apprehension that he would be biased in favour of that particular application. Chief Justice Laskin, writing for the majority, confirmed the test set out in Szilard vs. Szasz and held that the impartiality of adjudicative bodies is especially important where the public interest is concerned:

"This test (the reasonable apprehension test) is grounded in a firm concern that there be no lack of public confidence in the impartiality of adjudicative agencies, and I think that emphasis is lent to this concern in the present case by the fact that the National Energy Board is enjoined to have regard for the public interest." (at page 391)

In dissent, Mr. Justice De Granpré would not have disqualified Mr. Crowe from the panel for, in his view, Mr. Crowe’s past involvement did not create a "reasonable apprehension of bias". According to De Granpré J., the apprehension of bias must be evaluated from the perspective of a reasonably informed bystander viewing the matter realistically and practically. It is this objective formulation of the "reasonable apprehension of bias" test that has been cited and followed by courts ever since:

"The apprehension of bias must be a reasonable one, held by reasonable and right minded persons, applying themselves to the question and obtaining thereon the required information. In the words of the Court of Appeal, that test is "what would an informed person, viewing the matter realistically and practically – and having thought the matter through – conclude. Would he think that it is more likely than not that Mr. Crowe, whether consciously or unconsciously, would not decide fairly." (at page 394)

The stringency with which this test must be applied will vary, depending on the role and function of the particular decision-maker in question. On the one hand, administrative boards that have primarily an adjudicative or quasi-judicial role will be expected to comply to the same standard of conduct as are courts, i.e., they must not give rise to any "reasonable apprehension of bias". On the other hand, administrative boards that have a policy-making or investigative role will be held to a more lenient standard: they must not prejudge the matter to such an extent that any representations to the contrary would be futile, otherwise known as the "close-minded" test.

This "flexible approach" to assessing the potential bias of decision-makers was developed by the Supreme Court of Canada in Newfoundland Telephone Co. Ltd. vs. Board of Commissioners of Public Utilities, (1992) 89 D.L.R. (4th) 289. In this case, the Newfoundland Telephone Company sought to exclude a commissioner of the Public Utilities Board (Mr. Andy Wells) from participating in a public hearing of the company’s costs and accounts. More specifically, Newfoundland Telephone claimed that Wells’ statements to the press criticizing its executive pay policies gave rise to a reasonable apprehension of bias. Prior to his appointment, Wells had been an advocate for consumers’ rights and, when appointed, publicly stated that he intended to play an adversarial role on the Board as a champion of consumer rights. Just before the commencement of the hearing, Wells publicly described the pay and benefits package of the Newfoundland Telephone Company as "ludicrous" and "unconscionable". He openly made the following remark:

"So I want the company hauled in here – all them fat cats with their big pension – to justify [these expenses] under the public glare ... I think the rate payers have a right to be assured that we are not permitting this company to be too extravagant." (cited at page 292)

The Court held that, although Wells’ remarks during the Board’s investigation process did not indicate that he had a closed mind, his public statements to the press during and after the hearing, "when viewed cumulatively, lead inexorably to the conclusion that a reasonable person apprised of the situation would have an apprehension of bias".

In summation, an administrative board performing an adjudicative or quasi-judicial function will be held to a "reasonable apprehension of bias" test, whereas an administrative body performing a policy-making or investigative function will be held to the more lenient "closed-mind" test.

The issue I would like to raise today is whether a hospital research ethics board can be considered as an administrative body and to what extent it is bound by the rules of procedural fairness. This issue raises two fundamental questions:

1. What is the status of hospital REBs?

2. What is their role?

The Quebec Act Respecting Health Services and Social Services has, as one of its aims, to "promote research and education so as to respond more adequately to the needs of the population". Certain public hospitals and/or research institutions designated by the Minister of Health and governed by the law and its regulations have, as part of their mission, to conduct and manage research activities. The Board of Directors of such public institutions may create a research ethics board (REB) and may delegate some of its authority and powers to such an REB to realize its mission in terms of research. In addition, Article 21 of the Civil Code of Quebec states, in its third paragraph, that:

An experiment of a group of minor persons or incapable persons of full age shall be carried out within the framework of a research project approved by the Minister of Health and Social Services, upon the advice of an ethics committee of the hospital designated by the Minister or of an ethics committee created by him for that purpose; [...]

Are these links between the State and hospital REB sufficient to render the latter an administrative body subject to the rules of procedural fairness?

If so, how strictly are institutional REBs bound by such rules? Does the REB make quasi-judicial decisions every time it approves or disapproves a research protocol? If the REB determines whether a research study may be conducted at the institution or whether the investigating researcher will obtain a desired grant by the funding agency, does it not thereby affect the rights and interests of the investigating researcher? If the REB’s role is to protect potential subjects, does it not affect the rights and interests of those subjects? When called upon to weigh these competing rights and interests, is the REB not in fact assuming a quasi-judicial role?

If, rather an REB is merely called upon to advise the Minister in certain limited circumstances only or is simply viewed as a vehicle used to facilitate the carrying out, promotion, management and monitoring of research activities within the institution, could one not argue that this is more of a policy-making or investigative role and thereby subject to the more lenient rule against bias?

Regardless of where one posits the role of the REB along the spectrum between purely adjudicative and purely administrative, members may wish to err on the side of prudence and comply with strict rules of impartiality by disclosing any potential bias from the outset and withdrawing from all deliberations in relation to those areas. This prudence may be justified for two reasons. Firstly, avoiding actual bias will enhance the reasonableness of the outcome, thereby reducing the risk of any litigious claims ex post facto against the REB, its members or the institution. Secondly, and more importantly than for fear of legal action, avoiding bias and any reasonable apprehension of bias maintains public confidence that members of hospital REBs do in fact operate ethically.