Fiduciary Obligation in Clinical Research

Miller P. B. and Weijer C. , “The Trust-Based Obligations of the State and Physician-Researcher to Patient-Subjects,” Journal of Medical Ethics, forthcoming.

Lemmens T. and Miller P. B. , “Avoiding a Jekyll-and-Hyde Approach to the Ethics of Clinical Research and Practice,” American Journal of Bioethics 2, no. 2 (2002): 14–17, at 15; Weijer C. and Miller P. B. , “Therapeutic Obligation in Clinical Research,” Hastings Center Report 33, no. 3 (2003): 3; Miller P. B. and Weijer C. , “Rehabilitating Equipoise,” Kennedy Institute of Ethics Journal 13, no. 2 (2003): 93–118, at 95, 110–112; Miller P. B. and Weijer C. , “Will the Real Charles Fried Please Stand Up?” Kennedy Institute of Ethics Journal 13, no. 4 (2003): 353–357, at 356.

Morreim E. H. , “The Clinical Investigator as Fiduciary: Discarding a Misguided Idea,” Journal of Law, Medicine & Ethics 33, no. 3 (2005): 586–598.

Richardson H. S. and Belsky L. , “The Ancillary Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care that Researchers Owe their Subjects,” Hastings Center Report 34, no.1 (2004): 25–33; Coleman C. H. , “Duties to Subjects in Clinical Research,” Vanderbilt Law Review 58 (2005): 387.

Our analysis is directed broadly at the relationship between physician-researcher and patient-subject. It does not presume a preexisting physician-patient relationship.

Cooter R. and Freedman B. J. , “The Fiduciary Relationship: Its Economic Character and Legal Consequences,” New York University Law Review 66 (1991): 1045–1075, at 1045.

Weinrib E. J. , “The Juridical Classification of Obligations,” in Birks Peter , ed., The Classification of Obligations (Oxford: Oxford University Press, 1998): 37–55, at 44–46; Ripstein A. , “Authority and Coercion,” Philosophy and Public Affairs 32, no. 1 (2004): 2–35, at 15–19.

The authority for this point, at least, is overwhelming. See, for example: “There are few legal concepts more frequently invoked but less conceptually certain than that of the fiduciary relationship” per Justice LaForest, Lac Minerals Ltd. v. International Corona Resources Ltd. [1989] 61 D.L.R. (4th) 14 (S.C.C.) at 26; “The fiduciary relationship is a concept in search of a principle” Mason Sir A. , “Themes and Prospects,” in Finn P. D. , ed., Essays in Equity (Sydney: Law Book Co, 1985): at 246; “Our present uncertainty is thought to be exacerbated by the lack of a workable and unexceptionable definition of a fiduciary. We have no shortage of rival approaches, but none has carried the day,” Finn P. D. , “The Fiduciary Principle,” in Youdan T. G. , ed., Equity, Fiduciaries and Trusts (Toronto: Carswell, 1981): at 26; “Who is a fiduciary? The answer to this question, despite hundreds of years of litigation on the subject, is not at all clear,” Maddaugh P. D. , “Definition of Fiduciary Duty,” in Fiduciary Duties – Law Society of Upper Canada Special Lectures (Toronto: DeBoo, 1990): at 16; “It is not easy to predict where and when the next fiduciary relationship will be found. Across the common law world, there is an absence of agreed criteria for how the ‘fiduciary’ word should be used.” Glover J. , “The Identification of Fiduciaries,” in Birks P. , ed., Privacy and Loyalty (Oxford: Oxford University Press, 1997): 269–281, at 269; “[W]hile most lawyers would be able to pinpoint the prime obligation of the fiduciary…many would have difficulty saying what it is that actually makes a person a ‘fiduciary.’ The difficulty is likely to be regarded as having an added twist if the question is put as to when a ‘fiduciary relationship’ exists.” Waters D. W. M. , “The Development of Fiduciary Obligations,” in Johnson R. and McEvoy J. P. , eds., Gérard V. LaForest at the Supreme Court of Canada (Winnipeg: University of Manitoba, 2000): at 83. For an excellent overview, see Rotman L. I. , Fiduciary Law (Toronto: Thomson Carswell, 2005): at 1–7 and 17–52.

The list is just that – a list, with no evident ordering. Despite suggestions otherwise (see Morreim , supra note 3) there is, to date, no recognized classificatory schemata. This should be unsurprising in light of the ongoing and acknowledged struggle the courts have faced in articulating the principles governing the recognition of fiduciary relationships.

DeMott D. A. , “Beyond Metaphor: An Analysis of Fiduciary Obligation,” Duke Law Journal 37 (1988): 879–924, at 879. For criticisms of the analogical reasoning underlying the categorical approach, see Frankel T. , “Fiduciary Law,” California Law Review 71 (1983): 795–836, at 804–807. For a particularly insightful discussion of the problems with analogical reasoning, see Glover , supra note 8, at 270–271.

Hospital Products Ltd v. United States Surgical Corporation (1984) 55 A.L.R. 417 (Aust H.C.)

Norberg v. Wynrib [1992] 92 D.L.R. (4th) 229 (S.C.C.)

Indeed, a respected Canadian commentator argues that the categorization of the physician-patient relationship as fiduciary embraces all relationships between medical practitioners and patients in which the former exercise the socially sanctioned powers of a physician (e.g., powers to diagnose and treat illness). Ellis M. V. , “Medical Practitioners,” in Professional Fiduciary Duties (Toronto: Carswell, 1996). Substantially the same conclusion has been drawn by others, focusing on the inequality inherent in relations between professionals and laypeople. See Krever Justice H. Hon. and Lewis M. R. , “Fiduciary Obligations and the Professions,” in Fiduciary Duties – Law Society of Upper Canada Special Lectures (Toronto: DeBoo, 1990).

See Sealy L. S. , “Fiduciary Obligations: Forty Years On,” Journal of Contract Law 9 (1995): 36–53, at 39 and 44.

Sidaway v. Bethlem Hospital Board of Governors [1984] 1 Q.B. 493 (C.A.); Breen v. Williams (1996) 70 A.L.J.R. 772. For critical commentary, see Bartlett P. , “Doctors as Fiduciaries: Equitable Regulation of the Doctor-Patient Relationship,” Medical Law Review 5 (1997): 193–224; Grubb A. , “The Doctor as Fiduciary,” Current Legal Problems 47 (1994): 311–340.

See L. MacMillan's famous dictum: “the categories of negligence are never closed.” Donoghue v. Stevenson [1932] A.C. 562 (H.L.)

For example: “It is sometimes said that the nature of fiduciary relationships is both established and exhausted by the standard categories of agent, trustee, partner, director, and the like. I do not agree. It is the nature of the relationship, not the specific category of actor involved that gives rise to the fiduciary duty. The categories of fiduciary, like those of negligence, should not be considered closed” per Justice Dickson, Guerin v. Canada [1984] 13 D.L.R. (4th) 321 (S.C.C.), at 341; “An extension of fiduciary obligations to new ‘categories’ of relationship presupposes the existence of an underlying principle which governs the imposition of the fiduciary obligation…However, there has been a reluctance throughout the common law world to affirm the existence of and give content to a general fiduciary principle which can be applied in appropriate circumstances…The failure to identify and apply a general fiduciary principle has resulted in the courts relying almost exclusively on the established list of categories of fiduciary relationships and being reluctant to grant admittance to new relationships despite their oft-repeated declaration that the category of fiduciary relationships is never closed,” per Justice Wilson, Frame v. Smith [1987] 2 S.C.R. 99 (S.C.C.) at 135.

Id., at 136.

Lac Minerals Ltd. v. International Corona Resources Ltd [1989] 2 S.C.R. 574, at 656.

Id., at 606.

Hodgkinson v. Simms [1994] 3 SCR 377, 117 DLR (4th) 161 at 409.

That this approach is unprincipled is recognized implicitly in its name: being “fact-based,” the approach neither elucidates nor applies general principles to which recourse may subsequently be had. The determinations are “one-off” exercises in descriptive comparison.

This point has been made repeatedly. See, for example, Flannigan R. , “Fiduciary Obligation in the Supreme Court,” Saskatchewan Law Review 54 (1990): 45–71, at 58–68; Hoyano L. , “The Flight to the Fiduciary Haven,” in Birks P. , ed., Privacy and Loyalty (Oxford: Oxford University Press, 1997): 167–248, at 179–189; Worthington S. , “Fiduciaries: When is Self-Denial Obligatory?” Cambridge Law Journal 58, no. 3 (1999): 500–508, at 505; Worthington S. , Equity (Oxford: Oxford University Press, 2003): at 130.

The proposals range from simple to complex, narrow to broad, and are variable in their coverage of the indicia. See, for example: “The accepted fiduciary relationships are sometimes referred to as relationships of trust and confidence or confidential relations…The critical feature of these relationships is that the fiduciary undertakes or agrees to act for or on behalf of or in the interests of another person in the exercise of a power or discretion which will affect the interests of that other person in a legal or practical sense” per Justice Mason, Hospital Products Ltd., supra note 11, at 454; “The fiduciary duty arises where one party to the relationship (A) is reasonably entitled to expect of the other (B) that B will act in the interests of A, not in the interests of B or a third party and not merely having regard to A's interests” per Justice Richardson, DHL International (NZ) Ltd v. Richmond Ltd. [1993] 3 N.Z.L.R. 10 (N.Z.C.A.): at 23; “the source of the fiduciary obligation…is the trust which one person places in another.” Flannigan R. , “The Fiduciary Obligation,” Oxford Journal of Legal Studies 9, no. 3 (1989): 285–322, at 297; “a fiduciary relationship arises…where one party has dominance or influence over another, which dominance is based upon a confidence reposed in him by that other party.” Muir R. C. , “Duties Arising Outside of the Fiduciary Relationship,” Alberta Law Review 3 (1964): 359–366, at 360; “A fiduciary relationship exists whenever any person acquires a power of any type on condition that he also receive with it a duty to utilize that power in the best interests of another.” Shepherd J. C. , The Law of Fiduciaries (Toronto: Carswell, 1981): at 93; “[Fiduciary relationships are]…relationships that involve contractual delegation of broad power over one's property.” Ribstein L. E. , “The Structure of the Fiduciary Relationship,” University of Illinois College of Law – Law and Economics Working Papers Series, Working Paper No. LE03-003 (January, 2003): at 5.

We understand a reasonable elucidation of legal principles to be one capable of explaining and justifying the imposition of liability in consideration of the immanent character of the particular category of obligation in question (e.g., fiduciary law) and private law more widely. In this, we follow Weinrib's approach to theorizing private law. See Weinrib E. J. , The Idea of Private Law (Cambridge, MA: Harvard University Press, 1995): Especially at 8–21.

Weinrib, among others, has observed that fiduciary law has developed “without regard for, and indeed in the face of, the prevalent individualistic notions of consensual private ordering.” Weinrib E. J. , “The Fiduciary Obligation,” University of Toronto Law Journal 25 (1975): 1–22, at 21.

Miller P. B. , Essays Toward a Theory of Fiduciary Law (Ph. D. Thesis, University of Toronto, in progress).

See, for example, Ripstein A. , “Kant's Legal and Political Philosophy,” in Hill T. , ed., A Companion to Kant's Ethics (Oxford: Blackwell, 2005); and Ripstein A. , “Justice and Responsibility,” Canadian Journal of Law and Jurisprudence 17 (2004): 361–386, especially at 368–373.

As opposed to merely circumstantial inequality of power and dependence as, for example, might arise out of the physical or mental impairment of one of the parties.

Weijer C. and Fuks A. , “The Duty to Exclude: Excluding People at Undue Risk from Research,” Clinical and Investigative Medicine 17 (1994): 115–122.

“In medical research, considerations related to the well-being of the human subject should take precedence over the interests of science and society” World Medical Association (WMA), Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (as amended at the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000): paragraph 5; cited affirmatively in Council for International Organizations of Medical Science (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 2002), at Commentary on Guideline 8. See also: “It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and conscience are dedicated to the fulfillment of this duty” WMA, Declaration of Helsinki, Paragraph 2; and “It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject,” WMA, Declaration of Helsinki, Paragraph 10.

Perhaps this is the best way of making sense of Justice LaForest's suggestion that: “the rules set by the relevant professional body are of guiding importance in determining the nature of the duties flowing from a particular professional relationship.” Hodgkinson v. Simms [1994] 3 S.C.R. 377 (S.C.C.): at 409.

Many have argued that there is a necessary analytical relation between the relationship and the obligations governing it. See, for example, Shepherd J. C. , “Towards a Unified Concept of Fiduciary Relationships,” Law Quarterly Review 97 (1981): 51–79, at 76; Smith D. G. , “The Critical Resource Theory of Fiduciary Duty,” Vanderbilt Law Review 55 (2002): 1397–1497, at 1482–1486; and Flannigan , supra note 24, at 311. Others suggest that there is no necessary analytical relation between the fiduciary relationship and fiduciary obligations. See, for example, Sealy L. S. , “Fiduciary Relationships,” Cambridge Law Journal (1962): 69–81; Finn P. D. , Fiduciary Obligations (Sydney: Law Book Co., 1977): at 1–5.

There are, for example, unresolved questions of this sort concerning the relationship between fiduciary obligations and contractual obligations. See, for example, Brudney V. , “Corporate Governance, Agency Costs, and the Rhetoric of Contract,” Columbia Law Review 85 (1985): 1403–1444; Easterbrook F. H. and Fischel D. R. , “The Corporate Contract,” Columbia Law Review 89 (1989): 1416–1448; Chapman B. , “Trust, Economic Rationality, and the Corporate Fiduciary Obligation,” University of Toronto Law Journal 43 (1993): 547–588; Langbein J. H. , “The Contractarian Basis of the Law of Trusts,” Yale Law Journal 105 (1995): 625–676; Brudney V. , “Contract and Fiduciary Duty in Corporate Law,” Boston College Law Review 38 (1996–1997): 595–666.

Debate has particularly surrounded the boundary between fiduciary law and tort in respect of fiduciary and tort duties of care. See generally Hoyano , supra note 23. See also Gautreau Maurice J. R. , “Demystifying the Fiduciary Doctrine,” Canadian Bar Review 68 (1989) 1–29, at 14–18; Finn , supra note 7, at 28–29; Worthington , “Fiduciaries,” supra note 23, at 501–502; Worthington , Equity, supra note 20, at 148–154.

Debate has been particularly concentrated on the content of the duty of loyalty. See, for example, Langbein J. H. , “Questioning the Trust Law Duty of Loyalty: Sole Interest or Best Interest?” Yale Law School Center for Law, Economics and Public Policy – Research Paper No. 303 (April 2005); Smith L. , “The Motive, Not the Deed,” Modern Law of Real Property and Trusts (London: Butterworths, 2003): 53–81.

For example, “[The fiduciary relationship] is a relation in which the principal's interests can be affected by, and are therefore dependent on, the manner in which the fiduciary uses the discretion which has been delegated to him. The fiduciary obligation is the law's blunt tool for the control of this discretion.” Weinrib E. J. , supra note 26, at 4; “In many relationships in which one party is bound by a fiduciary obligation, the other party's vulnerability to the fiduciary's abuse of power or influence conventionally justifies the imposition of fiduciary obligation.” DeMott , supra note 10, at 902; “[W]hen would it be appropriate for courts to supply a default fiduciary obligation?…The inquiry must be into the ability of one party to exercise discretion at the expense of the other, where that other is vulnerable.” Hadfield G. K. , “An Incomplete Contracting Perspective on Fiduciary Duty,” Canadian Business Law Journal 28 (1997): 141–159, at 151; Justice Dawson held that “There is…the notion underlying all the cases of fiduciary obligation that inherent in the nature of the relationship itself is a position of disadvantage or vulnerability on the part of one of the parties which causes him to place reliance upon the other and requires the protection of equity acting upon the conscience of that other,” Hospital Products, supra note 11, at 488; per Justice Mason “The relationship between the parties…gives the fiduciary a special opportunity to exercise the power or discretion to the detriment of that other person who is accordingly vulnerable…It is partly because the fiduciary's exercise of the power or discretion can adversely affect the interests of the person to whom the duty is owed and because the latter is at the mercy of the former that the fiduciary comes under a duty to exercise his power or discretion in the interests of the person to whom it is owed.” Hospital Products, supra note 11, at 454.

See Finn , supra note 33, at 199–258.

See, for example, Frankel , supra note 10; DeMott D. A. , supra note 10; DeMott D. A. , “Fiduciary Obligation Under Intellectual Siege: Contemporary Challenges to the Duty to be Loyal,” Osgoode Hall Law Journal 30 (1992): 471–497; and Smith , supra note 33.

See, for example, Worthington , supra note 23; McCamus J. D. , “Prometheus Unbound: Fiduciary Obligation in the Supreme Court of Canada,” Canadian Business Law Journal 28 (1997): 107–140.

For example: “A director of a company is precluded from dealing, on behalf of the company, with himself, and from entering into engagements in which he has a personal interest conflicting, or which possibly may conflict, with the interests of those whom he is bound by fiduciary duty to protect; and this rule is as applicable to the case of one of several directors as to a managing or sole director” per Sir Baggallay, in North-West Transportation Co. v. Beatty [1887] 12 App. Cas. 593; “Under the fiduciary standard the fiduciary must act solely and selflessly in the interests of the beneficiary” per Justice Richardson in DHL International (NZ) v. Richmond Ltd. [1993] 3 N.Z.L.R. 10 (N.Z.C.A.): at 23.

A point that has, in turn, been taken up by Smith Lionel , supra note 36.

Birks P. , “The Content of the Fiduciary Obligation,” Israel Law Review 34 (2000): 3–38, at 28.

Id., at 38. Compare Burrows, who similarly suggests the importance of attending to the anterior duty of care: “[Beyond the duty of loyalty] an even more illuminating way of thinking about a fiduciary duty is that it is a duty to look after another's interests.” Burrows A. , “We do this at Common Law but that in Equity,” Oxford Journal of Legal Studies 22 (2002): 1–16, at 8. Unlike Birks, Burrows seems to favor recognition of a single fiduciary obligation, in this case, a positive duty of care in favor of the duty of loyalty.

Most notably, Finn P. D. , author of the first and still best comprehensive treatise on fiduciary law, recognized the duty of discretion (though he identified a number of obligations relating to discretion rather than the singular one of which we speak). See Finn P. D. , Fiduciary Obligations, supra note 33, at 20–37; see also Harpum C. , “Fiduciary Obligations and Fiduciary Powers – Where Are We Going?” in Birks P. , ed., Privacy and Loyalty (Oxford: Oxford University Press, 1997): 145–168, at 160–167.

As Finn notes, this is not to say that the fiduciary cannot accept conditions that effectively constrain her freedom where she does so pursuant to valid exercise of discretion. For example, a corporate director may enter into a contract on behalf of the corporation, and so accept conditions which effectively constrain his freedom, where at the time of entering the contract he exercised his discretion validly, i.e., freely and independently, in the best interests of the corporation. See Finn P. D. , Fiduciary Obligations, supra note 33, at 26–27.

See, for example, Nocton v. Ashburton [1914] A.C. 962 (H.L.) at 956–958 per Viscount Haldane LC; City Equitable Fire Insurance Co. Ltd. [1925] 1 Ch. 407 per Justice Romer; Canson v. Boughton (1991) 85 D.L.R. (4th) 129 (S.C.C.) at 142–143 per Justice LaForest; Worthington , Equity, supra note 20, at 148–149; Birks , supra note 43, at 31.

See, for example, Worthington , Equity, supra note 23, at 149–154; Birks , supra note 43, at 28 and 30–37; and Hoyano , supra note 23, at 200–203.

There is, as yet, no consensus on standards of care, skill and diligence, in contrast to the tort duty of care in negligence. Worthington points out that two divergent standards of care have been proposed, the first requiring that the fiduciary take the degree of care that an ordinarily prudent person would in the management of their own affairs, the second that the fiduciary take the degree of care that an ordinarily prudent person would in managing the affairs of another for whom they feel morally obliged to provide. Worthington, Equity, supra note 23, at 148. Things are no better in respect of the standards of skill and diligence. Justice Romer, in City Equitable Fire Insurance, supra note 47, suggests that the standard of skill is entirely subjective, with the requisite level of skill varying depending on the knowledge and experience of the fiduciary. The standard of diligence seems to have gone entirely undefined. Law reformers in certain countries, dissatisfied with the state of affairs at common law, have recommended objective standards in which the reasonableness requirements are specified as the levels of care, diligence and skill that would be exercised by an ordinarily prudent fiduciary of the particular kind in similar circumstances (e.g., corporate director, family physician, etc). This recommendation seems eminently sensible. Unfortunately, it and similar recommendations have been focused on corporate directors, and reflected in corporate law statutes. The broader implications of the reasoning supporting statutory reform in corporate law have yet to be realized in common law. On the fate of efforts to achieve reform through Canadian business corporations statutes, see Harris A. D. , Cases, Materials and Notes on Partnerships and Canadian Business Corporations, 4th ed. (Toronto: Thomson Carswell, 2004): at 309–324.

Indeed, we do not suggest that the scope of fiduciary obligation is exhausted by duties of loyalty, discretion and care. A significant body of case law and commentary suggests that there are other fiduciary duties, including, most notably, duties of confidence and disclosure. Because these duties are remote from the practical questions motivating this work, we do not discuss them presently.

Emanuel E. J. and Miller F. G. , “The Ethics of Placebo-Controlled Trials – A Middle Ground,” New England Journal of Medicine 345 (2001): 915–919; Miller F. G. and Brody H. , “What Makes Placebo-Controlled Trials Unethical?” American Journal of Bioethics 2, no. 2 (2002): 3–9.

Miller F. G. and Brody H. , “A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials,” Hastings Center Report 33, no. 3 (2003): 19–28.

Freedman B. , “Equipoise and the Ethics of Clinical Research,” New England Journal of Medicine 317 (1987): 141–145.

Weijer C. and Miller P. B. , “When Are Research Risks Reasonable in Relation to Anticipated Benefits?” Nature Medicine 10, no. 6 (2004): 570–573, at 571–572.

Brody H. and Miller F. G. , “The Clinician-Investigator: Unavoidable but Manageable Tension,” Kennedy Institute of Ethics Journal 13, no. 4 (2003): 329–346, at 334.

Miller F. G. and Rosenstein D. , “The Therapeutic Orientation to Clinical Trials,” New England Journal of Medicine 348 (2003): 1383–1386, at 1384.

Horng S. and Miller F. G. , “Is Placebo Surgery Unethical?” New England Journal of Medicine 347 (2002): 137–139, at 137; Miller F. G. , “Sham Surgery: An Ethical Analysis,” American Journal of Bioethics 3, no. 4 (2003): 41–48 at 42.

Brody and Miller , supra note 55, at 332, citing with approval Brody H. and Miller F. G. , “The Internal Morality of Medicine,” Journal of Medicine and Philosophy 23 (1998): 384–410; Miller and Brody , supra note 52, at 22.

Brody and Miller , supra note 55, at 334.

Miller and Brody , supra note 52, at 21.

Weijer and Miller , supra note 2, at 3.

Miller and Weijer , “Rehabilitating Equipoise,” supra note 2; Miller and Weijer , supra note 1.

See, for example, Finn , supra note 33, at 184–9 and 195.

See Gibson v. Jeyes (1801) 6 Ves. 266, at 278, per Lord Eldon.

Supra note 49.

Lemmens T. , “‘CIOMS’ Placebo Rule and the Promotion of Negligent Medical Practice,” European Journal of Health Law 11 (2004): 153–174; Glass K. C. and Waring D. , “The Physician-Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials,” Journal of Law, Medicine & Ethics 33, no. 3 (2005): 575–585.

Miller and Weijer , “Rehabilitating Equipoise,” supra note 2.