Paul B Miller, Charles Weijer Fidutiary Obligation in Clinical Research

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journal of law, medicine

ethics

INDEPENDENT

ioethics is currently witnessing unprecedented
debate over the moral and legal norms govern-
ing the conduct of clinical research. At the cen-

ter of this debate is the duty of care in clinical research,
and its most widely accepted speciﬁcation, clinical equi-
poise. In recent work, we have argued that equipoise
and cognate concepts central to the ethics of clinical re-
search have been left unnecessarily vulnerable to criti-
cism.

We have suggested that the vulnerability lies in

the conspicuous absence of an articulated foundation
in moral and legal theory of the physician-researcher’s
duty of care to the patient-subject. We have repeatedly
suggested that the requisite foundation is in the ethics
of trust and the law of ﬁduciaries.

Curiously, despite the absence of a published thor-

ough exposition of our position, some have preemp-
tively criticized our suggestion that the relationship
between physician-researcher and patient-subject is
ﬁduciary.

Others have offered their own accounts of

the implications of ﬁduciary law for the relationship.

We do not presently intend to critically analyze the
accounts of others. Rather, we provide the full articula-
tion of our suggestion that, as a matter of law, the re-
lationship between physician-researcher and patient-
subject ought to be considered ﬁduciary and the duty
of care likewise.

We proceed as follows: In Part I, we survey the law

on recognition of ﬁduciary relationships. In Part II, we
argue that a reasonable elucidation of principles gov-

erning recognition of ﬁduciary relationships supports
recognition of the ﬁduciary nature of the relationship
between patient-subject and physician-researcher.

Part III, we discuss select ﬁduciary obligations and
their relation to the distinctive structure of the ﬁduciary
relationship. Finally, in Part IV, we discuss the impli-
cations of these obligations for physician-researchers,
focusing on matters germane to the ongoing debate.

Part I – Establishing the Existence of a

Fiduciary Relationship

Those who enjoy intimate familiarity with ﬁduciary law
know that it has been plagued by doctrinal uncertainty
for well over thirty years. These doctrinal uncertainties
are pervasive, reﬂected in everything from criteria for
the establishment of the ﬁduciary relationship, to ﬁdu-
ciary obligations and remedies. Additionally, ﬁduciary
law is arguably the most doctrinally complex category
of obligation in private law. Accordingly, we think
it only appropriate to begin with a word of caution.
The law has evaded sustained analyses by serious and
dedicated scholars. Strong conclusions are not readily
forthcoming, especially where hastily drawn.

The very ﬁrst question of ﬁduciary analysis – whether

a given relationship is ﬁduciary – is fraught with com-
plexity. It ought to be recognized as having two di-
mensions, requiring independent answers. The ﬁrst
dimension is authoritative – is a given relationship
ﬁduciary? An adequate answer will depend solely on

Fiduciary Obligation in

Clinical Research

Paul B. Miller and Charles Weijer

Paul B. Miller, M.A., M.Phil., J.D., is a PhD candidate in the Department of Philosophy at the University of Toronto in To-

ronto, Ontario, Canada. Mr. Miller received his M.A. in Philosophy from the University of Toronto, his M.Phil. in History and

Philosophy of Science and Medicine from Cambridge University, and his J.D. from the University of Toronto. He is currently

developing a theory of ﬁduciary law for his doctoral thesis. Charles Weijer, M.D., Ph.D., F.R.C.P.C., is Associate Professor

and Canada Research Chair in Bioethics in the Department of Philosophy and Faculty of Medicine at the University of West-

ern Ontario in London, Ontario, Canada. He received his M.D. from the University of Alberta, and his Ph.D. in Experimental

Medicine from McGill University. Dr. Weijer is a Fellow of the Hastings Center in Garrison, NY.

dna fingerprinting & civil liberties • summer 2006

425

Paul B. Miller and Charles Weijer

consideration of available authority in the positive law.
The second dimension is normative – ought a given
relationship to be recognized as ﬁduciary? Here, an ad-
equate answer will depend on considerations of prin-
ciple. Normally, the two dimensions run together. This
is because for most categories of obligation in private
law, authoritative statements of law include reasonably
clear elucidation of underlying principles of liability. In
other words, the elucidation of principles more
or less plainly guides judgment determining
whether a particular relationship falls within
a general legal kind of relationship. Where we
are concerned whether a given relationship is of
a certain nature – say, contractual or conﬁden-
tial – considerations of authority and principle
thus run together. So, for example, in consider-
ing whether a relationship is one of conﬁdence,
one might consider whether relationships similar or
identical in kind have previously been so deemed, and
also, independently, whether underlying principles of
liability reﬂected in judgments suggest that it ought
to be so deemed. Where authoritative judgments elu-
cidate underlying principles of liability, one may have
separable but conjoined bases for determining whether
a certain relationship falls within a general legal kind
of relationship.

Unfortunately, ﬁduciary law is rather exceptional in

this regard. The ﬁduciary relationship has been recog-
nized in equity for over 250 years,

and is understood

to belong within any full juridical classiﬁcation of obli-
gations at private law.

Yet, despite its long-recognized

status as a distinctive kind of legal relationship, con-
sensus in the authoritative articulation of principles
underlying the liability of ﬁduciaries has proven elu-
sive. Certain relationships have long been recognized
as ﬁduciary, but courts and commentators have yet to
form any consensus on the principles governing the
recognition of ﬁduciary relationships.

Accordingly,

any sound effort to determine whether a given relation-
ship is ﬁduciary must consider independently the au-
thoritative and normative dimensions of the question.

We shall begin with the former. In consideration of

available authority in the positive law, is the relation-
ship between physician-researcher and patient-subject
ﬁduciary? In order to properly answer this question,
we need to consider how courts currently approach the
identiﬁcation of ﬁduciary relationships. In the absence
of a principled deﬁnition of the ﬁduciary relationship
and elucidation of its structure, courts currently largely
identify relationships as ﬁduciary simply in consid-
eration of lists of recognized categories of ﬁduciary
relationships.

The lists with which courts work have been com-

prised over centuries of litigation through an incho-

ate process of analogical reasoning.

Taking the re-

lationship between the trustee and beneﬁciary of an
express trust as paradigmatic, courts have, over time,
recognized certain other kinds of relationships to be
sufﬁciently similar to warrant recognition as ﬁduciary.
Relationships recognized accordingly as categorically
ﬁduciary include those between business partners,
joint venturers, director or ofﬁcer and corporation,

agent and principal, solicitor and client, parent and
child, guardian and ward, and doctor and patient.

None of the lists we have consulted include the re-

lationship between physician-researcher and patient-
subject. This cannot, however, be taken as evidence that
the relationship is not ﬁduciary. Any suggestion other-
wise is fallacious. As Chief Justice Mason famously
observed in Hospital Products Ltd v. United States Sur-
gical Corporation, ﬁduciary “law has developed case
by case, largely by analogy, it being accepted that the
categories of ﬁduciary relationships are not closed.”

Where a case directly treating the issue of classiﬁcation
is not to be found, the fact that a particular kind of re-
lationship has yet to be recognized as falling within the
general kind provides no reason either for or against it
being considered ﬁduciary. We are unaware of any case
which deals in a direct and sustained manner with the
question whether the relationship between physician-
researcher and patient-subject ought to be recognized
as a category of ﬁduciary relationship. As such, the au-
thoritative dimension of the question remains open. In
the absence of sound authority, no responsible lawyer
would issue a deﬁnite opinion that the relationship is,
or is not, ﬁduciary.

One might argue that the indeterminacy of authority

is not total. The fact that the physician-patient rela-
tionship is a recognized category of ﬁduciary relation-
ship

might be considered strong grounds for thinking

that the relationship between physician-researcher and
patient-subject would be considered likewise.

Surely

there are signiﬁcant similarities. Both relationships
involve medical professionals with socially sanctioned
powers to diagnose and treat illness in respect of pa-
tients in need of the beneﬁcial exercise of such power.
While intuitively appealing, this argument is prob-
lematic precisely because of the disjuncture of author-
ity and principle in the law on point. The categories

In consideration of available authority in

the positive law, is the relationship between

physician-researcher and patient-subject

ﬁduciary?

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INDEPENDENT

of relationship recognized as ﬁduciary have evolved
through a process of analogical reasoning. This process
of reasoning must be considered unprincipled precisely
because the courts have, to date, failed to deﬁne the
ﬁduciary relationship, and thus to unite disparate par-
ticular kinds of relationships as members of a general
kind. Accordingly, it is mere guesswork to suggest that
a particular kind of relationship (physician-researcher
and patient-subject) may be sufﬁciently similar to an-
other particular kind of relationship (physician-pa-
tient) recognized as of a general kind to itself qualify
as a member of that general kind. Unless and until the
courts provide a workable deﬁnition of the ﬁduciary re-
lationship, exercises in comparison of particular kinds
of relationship must be without direction.

Indeed, the failure of the courts to agree on prin-

ciples governing recognition of ﬁduciary relationships
has had the predictable consequence of creating a high
degree of jurisdictional variation in lists of recognized
categories of ﬁduciary relationship.

In the absence of

clear principles, courts of some jurisdictions (notably,
the United Kingdom and Australia) have been some-
what conservative, largely recognizing as ﬁduciary
only those kinds of relationship which have long been
so considered (e.g., trustee-beneﬁciary, agent-princi-
pal, solicitor-client, and director/ofﬁcer-corporation).
Indeed, courts of the United Kingdom and Australia
have failed even to recognize the physician-patient re-
lationship as ﬁduciary.

Courts of other jurisdictions

(Canada, most notably) have recognized that conser-
vatism is a potentially pernicious response to doctrinal
uncertainty, and accordingly have been more liberal
in recognizing new kinds of relationship as ﬁduciary
(e.g., doctor-patient, parent-child, and guardian-
ward). While understandable, this high degree of ju-
risdictional variation only heightens the peril of issuing
strong opinions whether, as a matter of authority, a
relationship yet to be considered for classiﬁcation is or
is not ﬁduciary. Such opinions risk parochialism in ad-
dition to the aforementioned risk of irresponsibility.

We are now in a position to turn to the normative di-

mension of the question. As a matter of principle, ought
the relationship between physician-researcher and pa-
tient-subject be recognized as ﬁduciary? This question
is difﬁcult to answer for the obvious reason that the
positive law does not supply a ready answer. That being
said, it is neither unanswerable, nor answerable only
by speculation. In the struggles of courts and com-
mentators to elucidate the principles governing recog-
nition of ﬁduciary relationships, we ﬁnd the basis for
our own work of elucidation. While this is neither the
time nor the place for thorough historical review and
philosophical assessment of the still ongoing quest for

clariﬁcation of these principles, a brief orientation is in
order by way of situating our own account.

Steps towards elucidation of principles governing the

recognition of ﬁduciary relationships have been taken
in various jurisdictions, especially in Canada. Cana-
dian courts have been particularly forward-thinking
in championing progression from categorical to prin-
cipled recognition of ﬁduciary relationships. They have
demonstrated remarkable awareness of the need for
elucidation of principles, in recognition that, as with
negligence liability,

so with ﬁduciary liability, “cat-

egories must never be closed.”

Canadian courts have

yet to replicate the success of Donoghue v. Stevenson by
articulating the principles governing ﬁduciary liability.
They have, however, made signiﬁcant movement in the
right direction.

Aware of the dangers of undue conservatism that

had developed in respect of the categorical approach,
Canadian courts adopted a “fact-based” approach to
determining the existence of ﬁduciary relationships.
Under this approach, relationships that do not have
recognized ﬁduciary status may, on a case-by-case
basis, be deemed ﬁduciary by virtue of their possession
of certain indicia of recognized ﬁduciary relationships.
Expressly out of concern for the ossiﬁcation of the law
under the categorical approach, Justice Wilson was
among the ﬁrst to argue that ﬁduciary relationships
ought to be identiﬁed in this way. In a in a much-cited
passage from her dissenting judgment in Frame v.
Smith, she stated that:

Relationships in which a ﬁduciary obligation have
been imposed seem to possess three general charac-
teristics:
1. The ﬁduciary has scope for the exercise of some

discretion or power;

2. The ﬁduciary can unilaterally exercise that power

or discretion so as to affect the beneﬁciary’s legal
or practical interests;

3. The beneﬁciary is peculiarly vulnerable to or at

the mercy of the ﬁduciary holding the discretion
or power.

In subsequent cases, the Supreme Court of Canada af-
ﬁrmed the fact-based approach and elaborated on the
above indicia of ﬁduciary relationships. In Lac Miner-
als v. International Corona Resources, Justice LaFor-
est, writing for the majority, emphasized disclosure of
conﬁdential information, trust, conﬁdence, and vul-
nerability.

In the same case, Justice Sopinka, in dis-

sent, suggested that the core indicia are “dependency
and vulnerability.”

In Hodgkinson v. Simms, Justice

LaForest, in a dissenting opinion, identiﬁed discretion,
inﬂuence, vulnerability and trust as “non-exhaustive

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427

Paul B. Miller and Charles Weijer

examples of evidential factors” to be considered in de-
termining whether a relationship is ﬁduciary.

The

court has not, to date, settled on a ﬁxed list of indicia,
or answered persistent questions about their relative
priority.

Under the fact-based approach, one would under-

standably be tempted to argue that the relationship
between physician-researcher and patient-subject
ought to be considered ﬁduciary. It evidently possesses
all of the indicia. Physician-researchers clearly wield
considerable powers. Patient-subjects regularly entrust
them to perform often invasive diagnostic, therapeutic
and experimental interventions. By their very nature,
the exercise of these powers may affect the patient-
subjects’ practical interests – namely, their medical
interests in good health. Further, patient-subjects are
clearly vulnerable – they are often vulnerable by vir-
tue of illness and disease, and they are always vulner-
able by virtue of vesting considerable power in physi-
cian-researchers. Patient-subjects must demonstrate
a high degree of trust in physician-researchers simply
because, in contrast to conventional medical care, their
participation in clinical research serves the public in-
terest in addition to their own. Finally, patient-subjects
must regularly disclose conﬁdential information such
as medical records for the effective exercise of power by
physician-researchers.

While valid, such temptation ought to be held in

abeyance. It seems likely that the relationship would be
deemed ﬁduciary on the fact-based approach, but we
are not yet in a position to determine whether it ought
to be so deemed. The reason is simple. While it is an ac-
cepted approach for identifying ﬁduciary relationships
(in Canada, at least), the fact-based approach must be
considered unprincipled precisely because, here too,
the courts have failed to articulate principles uniting
disparate particular kinds of relationships as members
of a general kind.

In the indicia, we have only descrip-

tive characteristics of the ﬁduciary relationship as a
general kind of legal relationship.

While practically

useful, such characteristics do not provide a principled
basis for the imposition of liability.

Despite this, the indicia are not without value. In-

deed, to their generally unrecognized credit, in work-
ing towards an accurate characterization of the ﬁdu-
ciary relationship, the Supreme Court of Canada has
done a great deal to advance the cause of a principled
approach. We are far better off with the indicia than
without them. Under the categorical approach, we
remain utterly in the dark about the similarities jus-
tifying analogies drawn between a given category of
relationship and the paradigmatic category. Under the
fact-based approach, we at least have an indication
of which similarities are relevant to the determina-

tion whether a particular relationship falls within the
general kind of legal relationship. In short, we know
something rather than nothing of the characteristics a
relationship must have to be considered ﬁduciary. The
guesswork endemic in the inchoate analogical reason-
ing of the categorical approach is thereby diminished.

Unfortunately, guesswork can only be entirely elimi-

nated with elucidation of principles governing the rec-
ognition of ﬁduciary relationships. The indicia suffer
from opacity and over-inclusiveness. For instance, it
remains unclear whether all trust relationships are ﬁ-
duciary, and if not, which relationships are and why;
whether all forms of power inequality suggest that a
given relationship is ﬁduciary, and if not, which form(s)
are relevant and why; whether all forms of vulnerabil-
ity suggest that a relationship is ﬁduciary, and if not,
which form(s) are relevant and why; whether all trans-
actions of conﬁdential information suggest the estab-
lishment of a ﬁduciary relationship, and if not, what
kind(s) and why. To overcome these problems, a fur-
ther step is required, one yet to be decisively taken by
the courts. That step is not the generation of a list that
is ﬁxed, more complete, or prioritized. The indicia give
us the basic ingredients of the ﬁduciary relationship.
A principled deﬁnition of the relationship is needed
through which the indicia are brought into coherent
relation in an expression of its distinctive nature.

A number of courts and commentators have at-

tempted to triangulate the indicia in elucidating a
principled deﬁnition of the ﬁduciary relationship.

Thorough review and assessment of these efforts is an
enormous task, one that lies well beyond the scope of
the present work. Accordingly, we simply offer a brief
overview of our own elucidation. Because we must offer
it without arguing its comparative merits, we do not
make any claims on that score. Nor do we pretend that
it is authoritative, precisely because of the above-noted
disjuncture of authority and principle in ﬁduciary law.
We claim only that it represents a reasonable elucida-
tion of the principles governing recognition of ﬁduciary
relationships.

A principled approach to the recognition of ﬁduciary

relationships must clearly deﬁne conditions for the es-
tablishment of the relationship. Further, because the
norms governing ﬁduciary relationships represent a
signiﬁcant departure from the individualism of norms
governing other private law relationships,

it must also

articulate and explain the distinctive structure of the
ﬁduciary relationship.

We suggest that a ﬁduciary relationship is estab-

lished where:

One party entrusts another with discretionary
power over the legal, economic or other practical

428

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INDEPENDENT

interests of a beneﬁciary, and the other party un-
dertakes, expressly or impliedly, to exercise
that power.

Clearly some requirements for the establishment of a
ﬁduciary relationship contained in our account stand
in need of explanation. Brieﬂy, the entrustment and
undertaking requirements signify that the ﬁduciary
relationship is voluntarily established through objec-
tive signiﬁcation of the respective intent of two parties
– the entrustor and ﬁduciary. Authorization lies at the
core of the relationship. In short, the subject of the re-
lationship is authorization of the ﬁduciary’s exercise of
discretionary power over the interests of a beneﬁciary
(the entrustor, or a third party for whose beneﬁt the
entrustor is legally entitled to act). In order for power
to be considered discretionary, latitude for judgment in
the exercise of power must rest with the power-holder.
The interests subject to the discretionary power are
broadly construed, however they must be practical (i.e.,
they must relate in a discernable and actual way to the
welfare of the beneﬁciary).

This brings us to the structure of the ﬁduciary re-

lationship. The ﬁduciary relationship has a distinc-
tive structure of recognized normative salience. It is
distinctive precisely in that it sets the ﬁduciary rela-
tionship apart from other private law relationships.
Important work in the philosophy of private law has
elucidated the default structural presupposition of pri-
vate law relationships, whereby the parties are treated
as equally independent in pursuit of their respective
interests and ends.

In ﬁduciary relationships, by con-

trast, structural inequality of power and dependence

disrupt the presumption of the equal capacity of the
parties to independently protect and pursue their re-
spective interests and ends in the relationship. In short,
the normative structure of the ﬁduciary relationship is
inequality and dependence generated by the transfer
of discretionary power. The basic idea is that structural
inequality and dependence inhere in a relationship in
which one party enjoys discretionary power over the
signiﬁcant practical interests of another.

We are now able to explain how our account of the ﬁ-

duciary relationship brings the aforementioned indicia
into coherent relation in an expression of its distinctive
nature. First, in our account, the ﬁduciary relationship
is understood as a distinctive kind of relationship of
trust. Some relationships involve a pervasive form of
trust associated with close personal bonds of love or
friendship. Others involve a delimited form of trust
centered on a particular transaction between persons
who usually do not share a close personal bond. Rela-
tionships of conﬁdence, centering on the transaction
of conﬁdential information, are one such kind of trust

relationship. Fiduciary relationships, centering on the
authorization to exercise discretionary power, are an-
other. Further, our account articulates the correlative
situation of the ﬁduciary and beneﬁciary as related in
and through authorization of the ﬁduciary’s exercise
of discretionary power over the beneﬁciary’s practi-
cal interests. It therefore unites the otherwise isolated
characterizations of the positions of ﬁduciary (as hav-
ing capacity for the exercise of discretionary power)
and beneﬁciary (as having interests subject to the inﬂu-
ence of an exercise of power). Further and ﬁnally, our
account provides a distinctive understanding of the
dependency and vulnerability of the beneﬁciary by lo-
cating these qualities in the normative structure of the
ﬁduciary relationship. Dependency and vulnerability
are not understood as including subjective properties
of the beneﬁciary, or accidental properties of the rela-
tive positioning of ﬁduciary and beneﬁciary. Instead,
dependency (together with inequality) is understood
as structurally inherent in the ﬁduciary relationship
as constituted in and through the authorization of one
party to exercise discretionary power over the interests
of another. Vulnerability is understood as arising from
the structural inequality of power and dependence of
the ﬁduciary relationship. As such, it is of a particular
kind; it is, namely, the beneﬁciary’s vulnerability to
having his interests compromised by misuse, exploita-
tion, carelessness or neglect in the ﬁduciary’s exercise
of discretionary power. As discussed in Part III below,
we understand this structural vulnerability to be the
foundation of the speciﬁc legal duties governing the
conduct of the ﬁduciary.

Part II – Why the Relationship between

Patient-Subject and Physician-Researcher

Ought to be Recognized as Fiduciary

Having introduced an account of the principles gov-
erning recognition of ﬁduciary relationships, we are
ﬁnally in a position to consider whether the relation-
ship between patient-subject and physician-researcher
ought to be recognized as ﬁduciary. We believe it ought
to be. In order to see why, we need to show how it meets
the requisite conditions of a ﬁduciary relationship.

Consider the entrustment and undertaking require-

ments, whereby it must be shown that the relation-
ship has been voluntarily established through objective
signiﬁcation of the respective intent of the entrustor
and ﬁduciary. Objective signiﬁcation of intent may be
either express or implied – that is, it may be made ex-
plicit in verbal or written form, or may be implicit in
the actions of the parties. With respect to the relation-
ship between patient-subject and physician-researcher,
the objective signiﬁcation of both parties’ intent will
almost always be express and in written form in the

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429

Paul B. Miller and Charles Weijer

informed consent documentation. Informed consent
documentation is conventionally understood as sat-
isfying the physician-researcher’s tort duty to obtain
consent to physical contact under the law of battery.
But, in the context of clinical research, written consent
does more than authorize physical interference. It also
details discretionary powers the physician-researcher
(ﬁduciary) undertakes to exercise. By signing the con-
sent form, the patient-subject or surrogate (entrustor)
authorizes the physician-researcher to exercise these
powers. In short, written consent serves also to au-
thorize the exercise of speciﬁed discretionary powers.
Of course, in the rare event that written consent is not
obtained, the parties can objectively signify their intent
in other ways. They may do so expressly through verbal

consent, or implicitly through their respective actions
– for example if, where consent is impossible, the pa-
tient-subject acquiesces to the physician-researcher’s
presumptive exercise of discretionary power.

We have said that authorization of the ﬁduciary’s

exercise of discretionary power over the practical in-
terests of a beneﬁciary lies at the heart of the ﬁduciary
relationship. Next, we need to establish the existence
and nature of the discretionary powers wielded by the
physician-researcher, and the patient-subjects’ inter-
ests subject to the exercise of these powers.

In consenting to participation in clinical research,

patient-subjects entrust physician-researchers with the
exercise of considerable discretionary powers. Among
other things, physician-researchers are usually autho-
rized to: collect and use conﬁdential information in-
cluding patient interviews, medical records, and chart
reviews for all facets of the clinical trial; investigate
and determine eligibility for study participation; ad-
minister therapeutic interventions including standard
and experimental drugs, diagnostic procedures, medi-
cal and diagnostic devices, and surgical techniques;
administer non-therapeutic interventions such as
withdrawal of bodily samples and performance of di-
agnostic procedures; and withdraw therapeutic and
non-therapeutic interventions in the event of discov-
ery of study ineligibility or adverse reaction(s). Addi-
tionally, physician-researchers are often authorized to
order alternate therapy or the resumption of standard

therapy in the event the study must be terminated or a
particular patient-subject withdrawn.

It is evident that these powers are considerable, and

could only be exercised by physician-researchers on the
basis of authorization provided by, or on behalf of, the
patient-subject. But in what way do they involve discre-
tion? The role for discretion is clear, even if it departs in
ways from its role in the exercise of power by physicians
in conventional practice settings.

Discretion is clearly evident in determinations of

study eligibility, wherein the physician-researcher must
make a judgment whether a patient may participate in
consideration of eligibility criteria and the patient’s
medical condition and history. Eligibility criteria are
stated in greater and lesser degrees of generality. They

are normally not self-interpreting. For example, crite-
ria for a trial might specify that patients with a history
of serious cardiac arrhythmia are to be excluded. The
physician-researcher must clearly exercise discretion
in determining whether a particular patient’s condition
qualiﬁes as “serious.” Further, eligibility criteria may
be incomplete, requiring supplementation through
the exercise of judgment. For instance, a physician-
researcher may judge that a patient with a condition
not amongst those listed for exclusion is nonetheless
at risk, and so ought to be excluded.

While eligibility

criteria guide enrollment decisions, they are neither
self-interpreting nor all-encompassing. They guide
judgment; they do not determine or exhaust it.

Discretion is also evident in respect of the admin-

istration of therapeutic and non-therapeutic inter-
ventions. Study protocols do precisely specify the
administration of therapeutic and non-therapeutic
interventions in clinical trials. They do not, however,
exclude the exercise of discretionary clinical judgment
by physician-researchers. First, physician-researchers
exercise discretion ex ante in the development and as-
sessment of protocols, balancing the interests of sci-
ence with patient-subjects’ interests in treatment and
protection from harm. Physician-researchers involved
in protocol development exercise ex ante discretion
in making study design decisions. Physician-research-
ers involved in the conduct but not the design of the
research exercise ex ante discretion in determining

Vulnerability is the most commonly cited of the aforementioned indicia of the

ﬁduciary relationship. As noted above, patient-subjects are often vulnerable

by virtue of being ill and in need of treatment. Does this provide further reason

for thinking that the relationship between physician-researcher and patient-

subject ought to be considered ﬁduciary? Not under our account.

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whether it would be medically responsible to conduct
the research at all in light of the protocol and the char-
acteristics of the proposed study population. Second,
physician-researchers exercise discretionary judgment
in determining whether to administer each procedure
according to protocol. The protocol does not render
the physician-researcher an automaton without capac-
ity for judgment or responsibility in relation to deci-
sions made in respect of it. Each time the physician-
researcher is to administer a procedure according to
protocol, she faces a choice requiring judgment – in
light of the medical circumstances of the patient before
her, ought she act according to the protocol or not? In
the usual case, a sound judgment to follow the protocol
will be made. But every act involves a choice requiring
the exercise of expert discretionary judgment, whether
scripted or not. In this way, the position of the physi-
cian-researcher is similar to that of the physician fac-
ing a patient and a set of treatment guidelines. Like
the physician, the physician-researcher must exercise
judgment in determining whether to act in accord
with, or against, a script. Third, discretion is clearly
exercised by physician-researchers in their decisions
whether to withdraw a patient-subject on the basis of
actual or anticipated adverse events. Fourth, discretion
must be exercised in making treatment decisions in the
event the study is terminated or the patient-subject is
withdrawn from study participation.

It is equally evident that signiﬁcant practical inter-

ests of the patient-subject are at the mercy of the phy-
sician-researcher’s exercise of discretionary power. A
variety of speciﬁc interests may be engaged at once.
Most obviously, the patient-subject’s medical inter-
ests in receipt of competent care and protection from
undue harm are subject to the physician-researcher’s
powers to administer therapeutic and non-therapeu-
tic interventions, to halt the trial or withdraw the pa-
tient-subject, and to make subsequent treatment rec-
ommendations. Whether or not the patient-subject
receives competent care will depend on decisions made
by the physician-researcher concerning the adminis-
tration and withdrawal of therapeutic interventions.
Whether or not he is protected from undue harm will
likewise depend on these decisions, in addition to those
relating to administration of non-therapeutic interven-
tions. Additionally, the patient-subject’s medical and
privacy interests are subject to the physician-research-
er’s powers to collect, use and disclose personal health
information. Whether these interests are secured or
advanced will depend on critical decisions made by the
physician-researcher in respect of the handling and use
of this information.

The signiﬁcance of both the discretionary powers

exercised by physician-researchers and the interests

of patient-subjects are perhaps best appreciated in
consideration of their situation within wider legal and
regulatory frameworks. While not strictly germane to
ﬁduciary law, this context provides a more fulsome
indication of just what is at stake in the relationship
between patient-subject and physician-researcher.
Considering ﬁrst the powers wielded by the physician-
researcher, we think it notable that the exercise of many
such powers is conditional on state and professional
sanction and oversight, in addition to the authoriza-
tion of the patient-subject. In particular, physician-
researchers may not administer therapeutic interven-
tions absent the professional license granted them
as physicians. In this, physician-researchers are in a
position identical to that of other ﬁduciary profession-
als such as lawyers. Considering next the interests of
patient-subjects, we think it notable that these are also
the subject of speciﬁc concern by the state and profes-
sional organizations. In many countries, including the
United States and Canada, the state makes the conduct
of clinical research conditional on the protection of
patient-subjects’ interests through independent evalu-
ation of research harms and beneﬁts (e.g., by IRBs and
DSMBs). Additionally, international professional or-
ganizations have overwhelmingly held that for clinical
research to be ethical, the interests of patient-subjects
must be duly protected and granted priority over com-
peting interests.

As with other ﬁduciary relationships,

pervasive professional self-regulation combined with
mechanisms of state sanction and oversight provide
compelling indication of the broader social importance
of the interests and powers at stake.

Remaining for consideration is the question of the

vulnerability of the patient-subject in his relationship
with the physician-researcher. Vulnerability is the most
commonly cited of the aforementioned indicia of the
ﬁduciary relationship. As noted above, patient-sub-
jects are often vulnerable by virtue of being ill and in
need of treatment. Does this provide further reason
for thinking that the relationship between physician-
researcher and patient-subject ought to be considered
ﬁduciary? Not under our account. While vulnerability
is a key characteristic of ﬁduciary relationships, it has
restricted signiﬁcance. The vulnerability that is of the
essence of the ﬁduciary relationship is structural, and
only structural, in nature. It is, in short, the vulner-
ability inherent in having one’s signiﬁcant practical
interests subject to the exercise of discretionary power
by another. In the relationship between patient-subject
and physician-researcher, as in other ﬁduciary rela-
tionships, circumstantial vulnerability is often present
(here, in the form of the medical needs of the patient-
subject). Whatever normative salience it might other-
wise have, circumstantial vulnerability lacks normative

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Paul B. Miller and Charles Weijer

salience in our account of the ﬁduciary relationship. As
such, a perhaps surprising implication of our account
is that the circumstantial vulnerability of the patient-
subject has no bearing at all on our ﬁnding that his
relationship with the physician-researcher ought to be
considered ﬁduciary. That is because it is the wrong
kind of vulnerability, and because the right kind of
vulnerability is an implication of, and not a condition
for, the establishment of ﬁduciary relationships. The
vulnerability that matters from the perspective of ﬁdu-
ciary law is a direct implication of the structure of the
ﬁduciary relationship. Where participation in clinical
research has been authorized through consent, the pa-
tient-subject thereby becomes vulnerable to the physi-
cian-researcher in her exercise of discretionary power
over his signiﬁcant practical interests. This structural
vulnerability provides the foundation for the obliga-
tions governing the conduct of physician-researchers
and other ﬁduciaries. It is, therefore, to these obliga-
tions that we now turn.

Part III – Fiduciary Obligations

Upon determining whether a particular relationship is
to be considered ﬁduciary, one need next consider the
ways the law governs the conduct of ﬁduciaries. Re-
grettably, the law on ﬁduciary obligations is but mod-
erately clearer than that on the recognition of ﬁduciary
relationships. The doctrinal uncertainties afﬂicting ﬁ-
duciary law are truly pervasive. They are perhaps most
vexing in relation to criteria for the establishment of
ﬁduciary relationships, but they are certainly no less
trenchant in respect of ﬁduciary obligations. Courts
and commentators remain divided on several key
points of law. There is, for example, division of opinion
on the relation between the ﬁduciary relationship and
ﬁduciary obligations.

This division of opinion is, in

turn, complicated by disagreement over fundamental
questions on the relationship between ﬁduciary and
non-ﬁduciary private law obligations.

There is also

disagreement over the scope of ﬁduciary obligation,
centered primarily on unsettled questions about the
boundaries between ﬁduciary law and other areas of
private law.

Finally, protracted debate continues over

the content of each particular ﬁduciary obligation.

All

of this is noted simply by way of further caution. As in
respect of the ﬁduciary relationship, so too in respect of
ﬁduciary obligations, the law evades cursory analysis.
One ought to beware the folly of presuming that its
elucidation and application will be straightforward.
That being said, the doctrinal contours of the law of
ﬁduciary obligations are unsettled, not indiscernible. It
is, at least, possible to identify the obligations that have
been imposed on ﬁduciaries, and to say something of
their foundation.

Fiduciary obligations are generally understood as

founded on the beneﬁciary’s vulnerability to the ﬁdu-
ciary. Despite variation in speciﬁcation of the nature
of this vulnerability, the conviction that it forms the
basis for imposition of ﬁduciary obligations is widely
held.

It should, therefore, be unsurprising that ﬁdu-

ciary obligations reﬂect the varying ways in which the
beneﬁciary is vulnerable to the ﬁduciary. It is our view
that these obligations are the normative reﬂex of the
structural vulnerability inherent in the ﬁduciary rela-
tionship.

The most obvious vulnerability of the beneﬁciary is

to exploitation through the misuse or abuse of power
by the ﬁduciary. The ﬁduciary may abuse the power
with which she has been entrusted to advance her per-
sonal interests at the expense of the interests of the
beneﬁciary (as where, for example, a corporate direc-
tor abuses her powers to divert assets from the cor-
poration for her personal enjoyment). Additionally,
the ﬁduciary may misuse the power with which he has
been entrusted, to advance the interests of others at
the expense of the beneﬁciary (as where, for example,
a lawyer uses information gathered in the course of
serving one client to advance the adverse interests of
another). Abuse and misuse of power by the ﬁduciary
are inherently exploitive to the extent that they neces-
sarily involve treatment of the beneﬁciary as a mere
means to meeting the ends of another. While all per-
sons are at risk of exploitation in their interactions with
others, the risk of exploitation is especially pronounced
in ﬁduciary relationships. This is because the very act
of entrusting discretionary power to another gener-
ates inequality of power and dependence limiting the
capacity of the beneﬁciary for self-protection.

The law protects the beneﬁciary from exploitation by

the ﬁduciary through subjecting the latter to a duty of
loyalty. Generally speaking, the duty of loyalty requires
the ﬁduciary to be faithful to the interests of the ben-
eﬁciary in the exercise of discretionary powers. It does,
however, have two distinct aspects.

First, and widely

recognized, is the requirement that the ﬁduciary avoid
or properly manage conﬂicts between pursuit of his
self-interest and fulﬁllment of his duty to protect or
advance the interests of the beneﬁciary. Second, and
generally under-recognized, is the requirement that
the ﬁduciary avoid or properly manage conﬂicts be-
tween his duty to the beneﬁciary and the pursuit of oth-
ers’ interests. As should be evident, these aspects of the
duty of loyalty correspond to the distinction between
abuse and misuse of power in the speciﬁcation of the
beneﬁciary’s vulnerability to exploitation.

While the heightened risk of exploitation is the most

obvious vulnerability of beneﬁciary to ﬁduciary, it is
by no means the only one. A number of commentators

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INDEPENDENT

have failed to recognize this, and have accordingly ad-
opted an overly restricted view of the scope of ﬁduciary
obligation. Many simply assume that exploitation is the
only distinctive ﬁduciary wrong, and accordingly that
the duty of loyalty is the ﬁduciary duty.

Others have

argued as much.

Yet the limited role for the duty of

loyalty in ﬁduciary law is evident in consideration of its
usual formulation. Most authorities state that the ﬁdu-
ciary is obliged to act “loyally” or “faithfully” in protect-
ing or advancing the best interests of the beneﬁciary.

In light of such formulations, it should be clear that
the duty of loyalty derives its normative import from
an analytically distinct anterior obligation, namely, the
ﬁduciary’s obligation to act in the best interests of the
beneﬁciary. This exact point has been emphasized by
the late distinguished private law scholar Peter Birks.

In an important article, Birks took note of the prevail-
ing doctrinal uncertainties bedeviling ﬁduciary law,
but rejected suggestions that ﬁduciary obligation is
exhausted by the duty of loyalty. As Birks recognized:

The obligation of disinterestedness cannot be sev-
ered from the obligation to protect and preserve. It
does not make sense without that principal obliga-
tion…The very formulation of the chief restatement
of this obligation shows that it is an obligation of
disinterestedness in the course of doing something:
The trustee shall not pursue any interest of his own
which might possibly conﬂict with his duty to the
beneﬁciary, scilicet his duty to promote and pre-
serve the interest of the beneﬁciary.

Birks concluded that the scope of ﬁduciary obligation
ranges beyond the duty of loyalty, embracing, at the
very least, a duty of care:

A trustee’s central obligation is the duty of active
care, and in the trustee’s case the duty of active care
is combined with the duty to act disinterestedly. In
other words, the core ﬁduciary obligation…is the
compound obligation to take active care and to do
so disinterestedly.

Birks has advanced our understanding of ﬁduciary law
immensely in demonstrating the limited signiﬁcance
of the duty of loyalty, and thus the broader scope of
ﬁduciary obligation. However, he has not settled out-
standing questions concerning the precise nature of
the other ﬁduciary obligations. Most obvious are ques-
tions concerning what Birks calls the “central” ﬁdu-
ciary obligation, namely the “duty of active care.” What,
precisely, does this duty require of the ﬁduciary?

One possibility, perhaps most obvious, is suggested

by the aforementioned usual formulations of the duty

of loyalty. In short, the duty is one of “active care,” re-
quiring the ﬁduciary to act in the best interests of the
beneﬁciary. Unfortunately, there is considerable varia-
tion amongst the usual formulations. The ﬁduciary
is variably said to be obliged “to act” so as to protect,
promote, preserve or secure the interests of the ben-
eﬁciary, or some combination thereof. These speciﬁca-
tions are not obviously equivalent. More importantly,
there is scant authority to suggest that ﬁduciaries are
held liable in the manner these terms suggest. That is,
there is no authority to suggest that a ﬁduciary will be
held liable simply for failing to advance the interests
of a beneﬁciary (e.g., a physician providing competent
but ultimately ineffective care), for failing to preserve
the interests of a beneﬁciary (e.g., a ﬁnancial advisor
providing sound investment advice that nonetheless
ends up diminishing the holdings of her client), or for
failing to protect the interests of a beneﬁciary (e.g., a
corporate director striving, but failing, to prevent a
successful hostile takeover bid that he rightly predicts
will harm the corporation). One might entrust another
with discretionary power over one’s interests in the
hope thereby that they will be protected, promoted, or
preserved. However, given that the exercise of ﬁduciary
powers is inherently discretionary, requiring judgment
in the face of uncertainty and under circumstances
beyond her full control, the ﬁduciary cannot be fully
responsible for the ultimate fate of the interests subject
to her power.

How else might we specify the “duty of active care”

of which Birks speaks? If the ﬁduciary is not fully re-
sponsible for the fate of the interests of the beneﬁciary,
when is she responsible, why, and to what extent? Just
how, precisely, is she obliged to act in the best interests
of the beneﬁciary? We suggest that the right approach
is to think carefully about the ways a beneﬁciary is
peculiarly vulnerable to a ﬁduciary solely on account
of the latter being entrusted with discretionary power.
Beneﬁciaries are surely vulnerable in many ways, for
many reasons. But, it would seem, they are vulner-
able in only a limited number of ways because of the
ﬁduciary’s entrustment with discretionary power over
their interests. In our minds, fairness demands that
the ﬁduciary be held responsible only for the vulner-
abilities so occasioned. This excludes a lot. It means
that ﬁduciary obligations cannot be deﬁned in such a
way as to make the ﬁduciary responsible for the impact
of wider vulnerabilities on the fate of the beneﬁciary’s
interests. So, for example, a physician ought not to be
held responsible for the harm suffered by her patient
on account of untreatable illness. Likewise, a ﬁnancial
advisor ought not to be held responsible for the depre-
ciation of a client’s investments caused by an unfore-
seeable stock market depression.

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Paul B. Miller and Charles Weijer

How might the “duty of active care” be speciﬁed in

light of this restriction on the scope of ﬁduciary ob-
ligation? We suggest that, in addition to the above-
mentioned peculiar risk of exploitation, there are at
least two additional ways in which the beneﬁciary is
vulnerable to the ﬁduciary because of the ﬁduciary’s
discretionary power over their interests. Each form of
vulnerability founds a distinct, and recognized, ﬁdu-

ciary obligation. Together, these obligations adequately
specify otherwise over-reaching statements to the ef-
fect that the ﬁduciary is obligated act in the best inter-
ests of the beneﬁciary.

The ﬁrst pertinent form of vulnerability is the beneﬁ-

ciary’s vulnerability to utter neglect by the ﬁduciary. We
have seen that a ﬁduciary relationship is established
where the ﬁduciary is entrusted with discretionary
powers over the practical interests of the beneﬁciary.
As the powers entrusted are discretionary in nature,
they require the ﬁduciary to exercise judgment as to
the course of action that is in the best interests of the
beneﬁciary. By virtue of the ﬁduciary having been en-
trusted with discretionary powers, the beneﬁciary is,
therefore, exposed to the risk that their interests will
be compromised by the ﬁduciary’s failure to exercise
discretion. In short, beneﬁciaries are exposed to the
risk that ﬁduciaries will neglect their interests entirely
by failing to exercise the judgment(s) they have been
entrusted to make.

The beneﬁciary’s vulnerability to neglect is not as

well recognized as his vulnerability to exploitation. Ac-
cordingly, it should be unsurprising that it founds an
often overlooked ﬁduciary obligation.

This obliga-

tion, which we will call the duty of discretion, requires
the ﬁduciary to exercise the discretion with which she
has been entrusted. In other words, the ﬁduciary is
obligated to exercise judgment on matters pertinent to
the interests of the beneﬁciary subject to her powers.
The duty has a number of implications. First, it bars the
ﬁduciary from delegating discretion to another. The
ﬁduciary is personally responsible for exercising judg-
ment, and cannot meet that responsibility by shifting
the onus of judgment to another. Second, it bars the
ﬁduciary from acting under dictation. True exercise of
discretion requires the ﬁduciary to make free and inde-

pendent judgments, a requirement obviously violated
where the ﬁduciary acts at the direction of another.
Third, and ﬁnally, the duty of discretion forbids the
ﬁduciary from fettering her discretion. Because true
exercise of discretion requires the ﬁduciary to make
free and independent judgments, the ﬁduciary will fail
to satisfy her duty of discretion where she subjects her
discretion to antecedent conditions.

These implica-

tions simply illustrate the rather
straightforward ultimate import
of the duty of discretion: in order
that the interests of the beneﬁciary
not be compromised through utter
neglect, the ﬁduciary is obligated
to exercise discretion in relation to
the powers with which she has been
entrusted.

The second pertinent form of

vulnerability is that of the beneﬁciary to carelessness,
ineptitude, and inattentiveness on the part of the ﬁdu-
ciary. By virtue of the ﬁduciary having been entrusted
with discretionary powers, the beneﬁciary is exposed to
the risk that his interests will be compromised by the
ﬁduciary’s failure to take reasonable care, to show rea-
sonable skill, or to demonstrate reasonable diligence in
her exercise of discretionary powers. For example, a pa-
tient entrusting a physician with powers of treatment is
vulnerable to the risk that the physician will cause her
harm through failure to take due care in the provision
of advice or treatment. A client entrusting a lawyer with
powers of legal representation is vulnerable to the risk
that his legal interests will be compromised because
the lawyer is unskilled in the area of law in question.
Further, a corporation that has entrusted a corporate
executive with powers of management is vulnerable to
the risk that the executive will shirk or otherwise insuf-
ﬁciently attend to his management responsibilities to
the detriment of the corporation.

The beneﬁciary’s vulnerability to carelessness, inept-

itude and inattentiveness on the part of the ﬁduciary
is better recognized than his vulnerability to neglect.
Indeed, it founds a well recognized obligation, that
being the ﬁduciary’s duty of care.

Debate continues

over the relationship between ﬁduciary and tort du-
ties of care, in particular, on the question whether and
to what extent they are overlapping.

That said, it is

relatively clear what the duty of care demands of the
ﬁduciary. It requires that the ﬁduciary demonstrate
reasonable care, diligence and skill in the exercise of
discretion.

The duty responds to the vulnerability of

the beneﬁciary by making the ﬁduciary responsible
for compromising his interests through carelessness,
ineptitude or inattentiveness in exercising the discre-
tionary powers with which she has been entrusted.

The beneﬁciary’s vulnerability to carelessness,

ineptitude and inattentiveness on the part of the

ﬁduciary is better recognized than his vulnerability

to neglect. Indeed, it founds a well recognized

obligation, that being the ﬁduciary’s duty of care.

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INDEPENDENT

We are now better positioned to understand state-

ments in case law and commentary to the effect that
ﬁduciaries are obligated to act in the best interests of
their beneﬁciaries. Birks was right to recognize that
these statements clearly imply that the duty of loyalty
is parasitic in nature. Fiduciary obligation clearly can-
not be exhausted by the duty of loyalty, simply because
that duty is analytically inseparable from the ﬁduciary’s
positive obligation to act in the best interests of the ben-
eﬁciary.

Yet the “core” duty of “active care” to which

Birks referred was left opaque. We have suggested that
requisite clariﬁcation is found in two recognized ﬁ-
duciary obligations, in turn understood as grounded
in the vulnerability of the beneﬁciary inherent in the
ﬁduciary relationship. Accordingly, the ﬁduciary is not
understood as fully responsible for the ultimate fate of
those interests of the beneﬁciary subject to her powers.
The ﬁduciary is not held to perfection, or even success
in protecting, preserving, or promoting the best inter-
ests of the beneﬁciary. Rather, the ﬁduciary is obliged
to exercise judgment in the best interests of the ben-
eﬁciary, and to demonstrate reasonable care, diligence
and skill in doing so.

Part IV – Implications for Current Debate

We have argued that a reasonable elucidation of the
principles governing recognition of ﬁduciary relation-
ships suggests that the relationship between physician-
researcher and patient-subject ought to be considered
ﬁduciary. We have also identiﬁed obligations imposed
on ﬁduciaries and discussed their foundation. As in-
dicated in the Introduction, our work takes part in a
wider debate over the moral and legal norms governing
the relationship between patient-subject and physi-
cian-researcher. What, then, are the implications of our
work? An answer requires brief review of the terms of
the debate.

The debate originated in criticism of policy restric-

tions on the use of placebo controls in clinical research.

It quickly expanded to criticism of clinical equipoise, a
widely endorsed moral concept on which some of the
policy restrictions are based.

Clinical equipoise was

originally offered as a research-friendly response to a
dilemma: When, consistent with her duty of care, is a
physician morally permitted to offer enrolment in a
clinical trial to a patient?

Clinical equipoise provides

that she may do so when the administration of the
various therapeutic procedures in the clinical trial is
consistent with competent medical care. It speciﬁes
this condition as a requirement that, at the outset of a
trial, there exist honest, professional disagreement in
the community of expert practitioners as to the pre-
ferred treatment. Clinical equipoise supports restric-
tions on the use of placebo controls in clinical research

where necessary to ensure patient-subjects are treated
in a manner consistent with competent care. Accord-
ingly, clinical equipoise requires adoption of an active
control in place of placebo in clinical trials investigat-
ing new treatments for serious conditions for which a
proven treatment exists. But it also allows that in many
cases, use of a placebo control is unproblematic. Pla-
cebo is used appropriately when there is no standard
treatment for the condition of study or if, as with mild
seasonal allergies or alopecia, despite the existence of
proven treatment, offering nontreatment is consistent
with competent medical care.

More recently, critics of clinical equipoise have

seemed to realize that it is properly understood as but
one possible speciﬁcation of an underlying obligation,
namely, the duty of care. Accordingly, they have begun
to criticize clinical equipoise and the duty of care in
conjunction. This line of criticism is most sustained in
the work of Franklin G. Miller and colleagues. In brief,
they suggest that clinical equipoise is fatally ﬂawed
to the extent that it speciﬁes an illusory duty.

While

the duty of care does apply to physicians in practice,
it does not apply in research.

According to Miller

and colleagues, the presumption that the duty of care
applies to physicians equally in practice and research
reﬂects a pervasive failure to appreciate a basic and
morally salient distinction between clinical practice
and research.

They assert that the goals of activities

determine the norms governing the conduct of par-
ticipants in them.

The norms governing the conduct

of physicians are therefore to be derived and distin-
guished on the basis of a distinction between the goals
of clinical practice and research respectively. Miller
and colleagues argue that the goal of clinical practice
is improvement of the individual health of patients. In
contrast, the goal of clinical research is development
of generalizable knowledge for the beneﬁt of society
and future patients. They claim that the duty of care
makes sense in light of the goal of clinical practice.

Because the goal of practice is the improvement of pa-
tient health, physicians can sensibly be said to operate
under a duty of care which requires them to act in
the best medical interests of patients while engaged in
that activity. The duty of care cannot sensibly be said
to apply to physicians in clinical research to the extent
that the goal of that activity is improvement of social,
not individual welfare.

There are serious historical and philosophical prob-

lems with the arguments made by F. G. Miller and
colleagues. We do, however, recognize that their work
has served an important purpose.

It has highlighted

the fact that clinical equipoise and cognate concepts
central to the ethics of research have been left unduly
vulnerable to criticism and confusion because of inad-

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435

Paul B. Miller and Charles Weijer

equate attention to the duty of care on which they are
based. As with any other concept in research ethics,
clinical equipoise deserves our approbation only if and
when its foundation in moral and legal theory is articu-
lated convincingly. Our present argument should not be
mistaken for an apologia for clinical equipoise. Indeed,
we have argued elsewhere that clinical equipoise fails
satisfactorily to specify the physician-researcher’s duty
of care to the patient-subject.

Rather, we claim only

to have partially fulﬁlled promises made elsewhere. We
have not yet articulated the moral foundations of the
duty of care, but we believe that we have provided con-
vincing articulation of its legal foundation. Miller and
colleagues are wrong to criticize clinical equipoise as
unfounded, but right to question its foundation. They
are simply wrong in suggesting that physicians do not
operate under a duty of care to patients in clinical re-
search. Now we know why. Physician-researchers op-
erate under a duty of care to patient-subjects precisely
because such a duty is an entailment of the inherent
vulnerability of the patient-subject in the ﬁduciary re-
lationship.

What are the implications for physician-researchers?

Brieﬂy, a clear implication is that physician-research-
ers cannot abdicate responsibility for the welfare of
patient-subjects to others, including and especially
IRBs and DSMBs. As ﬁduciaries, physician-research-
ers may generally be said to be obliged to act faithfully
in the best interests of patient-subjects. Our analysis of
ﬁduciary obligations indicates that this general formu-
lation of ﬁduciary responsibility yields three distinct
obligations – duties of loyalty, discretion and care. Let
us consider the implications of each.

Turning ﬁrst to the duty of loyalty, recall that it re-

quires the ﬁduciary to avoid or properly manage con-
ﬂicts between her self-interest and her duty to act in
the best interests of the beneﬁciary, and between her
duties to the beneﬁciary and to others. It should im-
mediately be noted that, on one possible reading, the
duty of loyalty appears to bar entirely physicians’ in-
volvement in clinical research with patients. This is
because, in seeming contrast to practice, clinical re-
search necessarily involves pursuit of interests other
than those of the patient. The public interest in pro-
duction of generalizable knowledge on the safety and
efﬁcacy of medical treatments is evidently often pur-
sued. But the private interests of industry, institutions
and researchers are also invariably at stake. Further-
more, pursuit of these interests inevitably materially
inﬂuences the conduct of clinical research. In order to
ensure scientiﬁcally valid results, treatment within a
clinical trial is restricted by design features of the study
protocol (e.g., randomization to treatment, masking of
treatment allocation, and ﬁxed schedules for treatment

provision). Further, patient-subjects typically undergo
non-therapeutic procedures administered to answer
the scientiﬁc question. In these ways, the demands of
science place the conduct of clinical trials in tension
with the physician-researcher’s duty to act in the best
interests of the patient-subject. To the extent that clini-
cal research invariably risks conﬂicts of the very kind
proscribed by the duty of loyalty, it may be thought
irreconcilable with it. Accordingly, the duty of loyalty
may be interpreted so as to effectively prohibit physi-
cians from engaging in research with patients.

Such an interpretation of the duty of loyalty is un-

derstandable in light of the righteous rhetoric ﬁduciary
law often inspires, but is nonetheless implausible. Were
the duty of loyalty really to require ﬁduciaries to act ex-
clusively in the interests of their beneﬁciaries, it would
set a standard of conduct no one could hope to meet.
Fiduciaries always exercise their powers in environ-
ments in which their own interests and those of others
ﬁgure prominently. Lawyers serving their clients have a
clear personal ﬁnancial interest in their work, and must
contend daily with the potentially competing interests
of the public in the justice system, as well as those of
their families, employers or partners, and other clients.
Likewise, physicians treating patients in conventional
practice settings have a clear personal ﬁnancial inter-
est in their work, and must with equal regularity face
potentially competing interests of HMOs, institutions,
other patients, and the public at large. Directors and
executives of corporations clearly have personal ﬁnan-
cial interests in their positions, and must regularly deal
with interests potentially competing with those of the
corporation, including the interests of different indi-
vidual and group shareholders, creditors, employees,
and the wider community.

It is not reasonable to suppose that the law sets im-

possible standards of conduct. What, then, should we
say the duty of loyalty requires? In our view, the opera-
tive element is the requirement that the ﬁduciary avoid
or properly manage conﬂicts. Because latent conﬂicts
are virtually unavoidable, the most plausible interpre-
tation is that the duty of loyalty requires ﬁduciaries to
avoid or properly manage actual conﬂicts, i.e., the real-
ization of latent conﬂicts. The ﬁduciary meets her obli-
gation to avoid conﬂicts by recognizing latent conﬂicts,
and investigating and adopting avenues through which
the potentially conﬂicting interests can be reconciled,
in awareness of her ultimate responsibility to put the
interests of the beneﬁciary before those of all others.
Where conﬂicts truly cannot be avoided, the ﬁduciary
is bound to manage them properly. Management re-
sponsibilities include, most prominently, disclosure of
the conﬂict to the beneﬁciary. With permission of the
court or consent of the beneﬁciary, the ﬁduciary is usu-

436

journal of law, medicine

ethics

INDEPENDENT

ally allowed to continue to exercise her powers despite
the conﬂict, subject to important conditions specifying
further the ﬁduciary’s management responsibilities in
relation to the conﬂict.

The most important is that the

ﬁduciary remains subject to the general obligation to
act in the best interests of the beneﬁciary.

As speci-

ﬁed by duties of discretion and care, the ﬁduciary thus
remains obliged to exercise judgment to ensure the
interests of the beneﬁciary are being fairly or reason-
ably served despite the conﬂict, and that risks to the
beneﬁciary’s interests associated with the conﬂict have
been minimized to the extent possible. It is important
to recognize that because consent must be speciﬁc to
be valid, the ﬁduciary remains, as a matter of principle,
obliged to avoid or properly manage conﬂicts other
than those consented to.

Thus clariﬁed, what does the duty of loyalty speciﬁ-

cally require of the physician-researcher? In our view,
the physician-researcher must be mindful of general
conﬂicts of interest latent in clinical research, and rec-
ognize speciﬁc latent conﬂicts relating to her protocol
in particular. This requires her to identify the range
and nature of the interests of various stakeholders in
the research, including the patient-subject, the public,
research sponsor, research institution, and research-
ers (herself included). In designing and implementing
the protocol, the physician-researcher must investigate
and adopt avenues through which potential conﬂicts
can be reconciled, in awareness of her ultimate respon-
sibility to put the interests of the patient-subject before
those of all others. In respect of design, she will achieve
the requisite reconciliation by ensuring that the study
design is both capable of producing valid results, and
consistent with the patient-subject’s interest in receiv-
ing competent care. In respect of implementation, she
will achieve it by ensuring that the study is continued
as long, but only as long, as it remains consistent with
competent care.

Turning next to the duty of discretion, the reader will

remember that it requires the ﬁduciary to personally
make judgments on matters pertinent to the interests
of the beneﬁciary over which she enjoys discretion-
ary powers. The duty means that the ﬁduciary is not
permitted to delegate or fetter her discretion, or to act
under the dictation of another. In short, the ﬁduciary
must remain free and independent in her judgment.
It might be thought that the duty of discretion, like
the duty of loyalty, presents an insurmountable barrier
to the involvement of physicians in clinical research.
To the extent that the administration of treatments in
clinical research is speciﬁed by study protocols, clini-
cal research seems inevitably to fetter the judgment
of the physician-researcher in a manner incompatible
with the duty of discretion. As with the duty of loyalty,

however, the seeming incompatibility is a matter of
mere appearance.

We argue that the judgment of the ﬁduciary must

be subjected to inordinate constraint for it to be con-
sidered fettered within the meaning of the duty of dis-
cretion. Background constraints ordinarily restrict the
judgment of ﬁduciaries. For example, the judgment of
corporate directors will always be restricted by vari-
able background conditions lying beyond their control
(e.g., market trends, changes in the environment, social
and political turmoil). To the extent that constraints of
this sort are an ordinary and inevitable feature of real-
world decision-making, they cannot be taken to be the
type barred by the duty of discretion. If they were, the
duty of discretion would set an impossible standard
of conduct for ﬁduciaries. Again, it is unreasonable to
interpret the law as imposing impossible standards of
conduct. The requirement that the judgment of the
ﬁduciary be free and independent must be understood
in relative, not absolute terms. Accordingly, the bar on
fettering discretion must be understood to operate only
on inordinate constraints.

The constraints imposed on the administration of

treatment in clinical research simply by virtue proto-
colization must be understood as being of the back-
ground variety. One simply cannot produce generaliz-
able results without adhering to some form of study
protocol. The conduct of clinical research therefore
invariably requires general constraints on the admin-
istration of treatment. That said, the judgment of the
physician-researcher remains in principle free and in-
dependent of inordinate constraints. Indeed, as dis-
cussed in Part II above, the physician-researcher re-
tains ample freedom to exercise judgment effectively to
protect the best interests of the patient-subject. While
she cannot opt-out of protocolization, the physician-
researcher is free to design the protocol so as to protect
the interests of patient-subjects in receipt of compe-
tent care. She is also free to judge whether particular
patient-subjects should be enrolled in light of study
eligibility criteria and the patient’s medical history. She
regularly decides freely whether to administer thera-
peutic and non-therapeutic procedures according to
protocol. Finally, the physician-researcher is free to
judge whether particular patient-subjects should con-
tinue to be enrolled in light of individual adverse events
or the disturbance of clinical equipoise. In short, the
physician-researcher retains the discretion requisite to
discharge of her obligation to ensure that the patient-
subject’s participation in research is consistent with
their interest in receiving competent care.

Turning ﬁnally to the duty of care, the reader will

recall that it requires the ﬁduciary to demonstrate
reasonable care, diligence and skill in the exercise of

dna fingerprinting & civil liberties • summer 2006

437

Paul B. Miller and Charles Weijer

discretionary powers over the interests of the beneﬁ-
ciary. The duty of care does not present any apparent
obstacles to the participation of physicians in clinical
research involving patients. But what does it require of
the physician-researcher? The duty of care qualiﬁes the
duty of discretion, discussed above. The physician-re-
searcher is not merely positively obliged to make judg-
ments in the best interests of the patient-subject. She
is also obliged under the duty of care to show reason-
able diligence, care, and skill in making those judg-
ments, and in acting on them. Reasonable diligence
requires cognizance by the ﬁduciary of her ongoing
responsibility to exercise judgment in the beneﬁciary’s
best interests, and attentiveness and commitment in
the discharge of that responsibility. The physician-re-
searcher may fail to be adequately diligent by neglect-
ing to reappraise her judgment when necessary, or
through general dereliction of her responsibility to do
the work requisite to making or implementing sound
judgments. Reasonable skill is shown in demonstrating
the knowledge and technical abilities requisite to mak-
ing and implementing judgments on matters requiring
expertise. The skill requirement may be violated where
the physician-researcher makes or implements a judg-
ment despite lacking requisite expertise and failing to
consult someone who enjoys it. The care requirement
is familiar from the law of negligence, but is heightened
in ﬁduciary law, differing also to the extent that it speci-
ﬁes a positive obligation (i.e., to exercise discretion in
the best interests of the beneﬁciary) rather than a nega-
tive one (i.e., to avoid causing another reasonably fore-
seeable harm). It requires the ﬁduciary to take care in
making and implementing judgments with mind to the
foreseeable detriment (understood as including harm
and lost opportunities for beneﬁt) she may thereby
bring to the interests of the beneﬁciary subject to her
powers. For the sake of convenience, we shall say that
the standard of reasonableness for the diligence, skill
and care components of the duty of care is that of the
reasonably prudent colleague operating under similar
circumstances.

Concluding Reﬂections

To be credible, analyses of the implications of ﬁduciary
law for the conduct of clinical research must confront
the doctrinal uncertainties endemic in the law, with
arguments drawn accordingly. We have endeavored to
do just that. We have argued that a reasonable elucida-
tion of the principles governing recognition of ﬁduciary
relationships suggests that the relationship between
physician-researcher and patient-subject ought to be
recognized as ﬁduciary. We have, however, allowed that
the matter is indeterminate as a matter of authority.
We have also worked through doctrinal uncertainties

in identifying and elucidating ﬁduciary obligations,
focusing in particular on duties of loyalty, discretion
and care. We have explained the implications of these
obligations for the conduct of physician-researchers,
paying mind to the ongoing debate over the moral and
legal norms governing the conduct of clinical research.
In short, we have argued that critics of clinical equi-
poise and cognate concepts err in asserting that physi-
cian-researchers do not operate under a duty of care
to patient-subjects. Our analysis reveals a strong legal
foundation for that duty in ﬁduciary law, embedded
in the juridical articulation of the terms governing a
particular kind of trust relationship.

We would be remiss were we not to mention sig-

niﬁcant questions that remain for further study. First is
that of the comparative merits of alternate legal foun-
dations of the duty of care. Some scholars have argued
in terms of the tort duty of care in negligence.

Critics

of clinical equipoise and cognate concepts will have to
confront these arguments. For our part, exploration
of the differences between tort and ﬁduciary duties
of care, and assessment of their comparative merits
as applied to the relationship between patient-subject
and physician-researcher, awaits further study. Second,
comparison of legal and moral foundations of the duty
of care is required, pending articulation of the latter.
Third, broader exposition of ﬁduciary law and its im-
plications for clinical research is required. Questions of
interest relating to exposition of ﬁduciary law include
those concerning ﬁduciary duties overlooked presently
(i.e., duties of conﬁdence and disclosure), and concern-
ing the nature and limits of consent in the ﬁduciary re-
lationship. Questions of interest relating to broader im-
plications of ﬁduciary law for clinical research include
those relating to the collection, use and disclosure of
personal health information for research purposes. Fi-
nally, here, as elsewhere,

we have focused exclusively

on the relationship between physician-researcher and
patient-subject, aware of the dangers of generalization.
Further work will explore questions concerning legal
frameworks apposite to other relationships between
researchers and research subjects.

Acknowledgements

Paul B. Miller’s research is supported by doctoral fellowship from

the Social Sciences and Humanities Research Council of Canada.

Charles Weijer’s research is supported by a Tier I Canada Research

Chair and a Canadian Institutes of Health Research operating grant.

The authors thank an anonymous reviewer for the Journal for their

helpful comments.

References

1. P. B. Miller and C. Weijer, “The Trust-Based Obligations of the

State and Physician-Researcher to Patient-Subjects,” Journal of

Medical Ethics, forthcoming.

2. T. Lemmens and P. B. Miller, “Avoiding a Jekyll-and-Hyde Ap-

proach to the Ethics of Clinical Research and Practice,” American

438

journal of law, medicine

ethics

INDEPENDENT

Journal of Bioethics 2, no. 2 (2002): 14-17, at 15; C. Weijer and P.

B. Miller, “Therapeutic Obligation in Clinical Research,” Hast-

ings Center Report 33, no. 3 (2003): 3; P. B. Miller and C. Weijer,

“Rehabilitating Equipoise,” Kennedy Institute of Ethics Journal

13, no. 2 (2003): 93-118, at 95, 110-112; P. B. Miller and C. Weijer,

“Will the Real Charles Fried Please Stand Up?” Kennedy Institute

of Ethics Journal 13, no. 4 (2003): 353-357, at 356.

3. E. H. Morreim, “The Clinical Investigator as Fiduciary: Discard-

ing a Misguided Idea,” Journal of Law, Medicine & Ethics 33, no.

3 (2005): 586-598.

4. H. S. Richardson and L. Belsky, “The Ancillary Care Responsibili-

ties 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; C. H. Coleman,

“Duties to Subjects in Clinical Research,” Vanderbilt Law Review

58 (2005): 387.

5. Our analysis is directed broadly at the relationship between phy-

sician-researcher and patient-subject. It does not presume a pre-

existing physician-patient relationship.

6. R. Cooter and B. J. Freedman, “The Fiduciary Relationship: Its

Economic Character and Legal Consequences,” New York Univer-

sity Law Review 66 (1991): 1045-1075, at 1045.

7. E. J. Weinrib, “The Juridical Classiﬁcation of Obligations,” in

Peter Birks, ed., The Classiﬁcation of Obligations (Oxford: Oxford

University Press, 1998): 37-55, at 44-46; A. Ripstein, “Authority

and Coercion,” Philosophy and Public Affairs 32, no. 1 (2004):

2-35, at 15-19.

8. 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 relation-

ship” 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”

Sir A. Mason, “Themes and Prospects,” in P. D. Finn, 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,” P. D. Finn, “The

Fiduciary Principle,” in T. G. Youdan, 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,” P. D. Maddaugh, “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.” J.

Glover, “The Identiﬁcation of Fiduciaries,” in P. Birks, 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.” D. W. M. Waters, “The

Development of Fiduciary Obligations,” in R. Johnson and J. P.

McEvoy, eds., Gérard V. LaForest at the Supreme Court of Canada

(Winnipeg: University of Manitoba, 2000): at 83. For an excellent

overview, see L. I. Rotman, Fiduciary Law (Toronto: Thomson

Carswell, 2005): at 1-7 and 17-52.

9. The list is just that – a list, with no evident ordering. Despite sug-

gestions 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.

10. D. A. DeMott, “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 T. Frankel, “Fiduciary Law,” California Law Review

71 (1983): 795-836, at 804-807. For a particularly insightful dis-

cussion of the problems with analogical reasoning, see Glover,

supra note 8, at 270-271.

11. Hospital Products Ltd v. United States Surgical Corporation

(1984) 55 A.L.R. 417 (Aust H.C.).

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

13. Indeed, a respected Canadian commentator argues that the cat-

egorization of the physician-patient relationship as ﬁduciary

embraces all relationships between medical practitioners and

patients in which the former exercise the socially sanctioned pow-

ers of a physician (e.g., powers to diagnose and treat illness). M.

V. Ellis, “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 Hon. Justice

H. Krever and M. R. Lewis, “Fiduciary Obligations and the Pro-

fessions,” in Fiduciary Duties – Law Society of Upper Canada

Special Lectures (Toronto: DeBoo, 1990).

14. See L. S. Sealy, “Fiduciary Obligations: Forty Years On,” Journal

of Contract Law 9 (1995): 36-53, at 39 and 44.

15. 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 P. Bartlett, “Doctors as Fiduciaries: Equitable

Regulation of the Doctor-Patient Relationship,” Medical Law

Review 5 (1997): 193-224; A. Grubb, “The Doctor as Fiduciary,”

Current Legal Problems 47 (1994): 311-340.

16. See L. MacMillan’s famous dictum: “the categories of negli-

gence are never closed.” Donoghue v. Stevenson [1932] A.C. 562

(H.L.).

17. 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 rela-

tionships 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.

18. Id., at 136.

19. Lac Minerals Ltd. v. International Corona Resources Ltd [1989]

2 S.C.R. 574, at 656.

20. Id., at 606.

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

409.

22. 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.

23. This point has been made repeatedly. See, for example, R. Flanni-

gan, “Fiduciary Obligation in the Supreme Court,” Saskatchewan

Law Review 54 (1990): 45-71, at 58-68; L. Hoyano, “The Flight

to the Fiduciary Haven,” in P. Birks, ed., Privacy and Loyalty

(Oxford: Oxford University Press, 1997): 167-248, at 179-189;

S. Worthington, “Fiduciaries: When is Self-Denial Obligatory?”

Cambridge Law Journal 58, no. 3 (1999): 500-508, at 505; S.

Worthington, Equity (Oxford: Oxford University Press, 2003):

at 130.

24. 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

dna fingerprinting & civil liberties • summer 2006

439

Paul B. Miller and Charles Weijer

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 an-

other.” R. Flannigan, “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 inﬂu-

ence over another, which dominance is based upon a conﬁdence

reposed in him by that other party.” R. C. Muir, “Duties Arising

Outside of the Fiduciary Relationship,” Alberta Law Review 3

(1964): 359-366, at 360; “A ﬁduciary relationship exists when-

ever 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 inter-

ests of another.” J. C. Shepherd, The Law of Fiduciaries (Toronto:

Carswell, 1981): at 93; “[Fiduciary relationships are]…relation-

ships that involve contractual delegation of broad power over

one’s property.” L. E. Ribstein, “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.

25. 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 par-

ticular 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 E. J. Weinrib, The Idea of Private Law

(Cambridge, MA: Harvard University Press, 1995): especially

at 8-21.

26. Weinrib, among others, has observed that ﬁduciary law has de-

veloped “without regard for, and indeed in the face of, the preva-

lent individualistic notions of consensual private ordering.” E. J.

Weinrib, “The Fiduciary Obligation,” University of Toronto Law

Journal 25 (1975): 1-22, at 21.

27. P. B. Miller, Essays Toward a Theory of Fiduciary Law (Ph. D.

Thesis, University of Toronto, in progress).

28. See, for example, A. Ripstein, “Kant’s Legal and Political Phi-

losophy,” in T. Hill, ed., A Companion to Kant’s Ethics (Oxford:

Blackwell, 2005); and A. Ripstein, “Justice and Responsibility,”

Canadian Journal of Law and Jurisprudence 17 (2004): 361-

386, especially at 368-373.

29. 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.

30. C. Weijer and A. Fuks, “The Duty to Exclude: Excluding People at

Undue Risk from Research,” Clinical and Investigative Medicine

17 (1994): 115-122.

31. “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), Declara-

tion of Helsinki: Ethical Principles for Medical Research Involv-

ing 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 dedi-

cated to the fulﬁllment of this duty” WMA, Declaration of Hel-

sinki, 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.

32. 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.

33. Many have argued that there is a necessary analytical relation

between the relationship and the obligations governing it. See,

for example, J. C. Shepherd, “Towards a Uniﬁed Concept of Fi-

duciary Relationships,” Law Quarterly Review 97 (1981): 51-79,

at 76; D. G. Smith, “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, L. S.

Sealy, “Fiduciary Relationships,” Cambridge Law Journal (1962):

69-81; P. D. Finn, Fiduciary Obligations (Sydney: Law Book Co.,

1977): at 1-5.

34. There are, for example, unresolved questions of this sort concern-

ing the relationship between ﬁduciary obligations and contrac-

tual obligations. See, for example, V. Brudney, “Corporate Gov-

ernance, Agency Costs, and the Rhetoric of Contract,” Columbia

Law Review 85 (1985): 1403-1444; F. H. Easterbrook and D. R.

Fischel, “The Corporate Contract,” Columbia Law Review 89

(1989): 1416-1448; B. Chapman, “Trust, Economic Rationality,

and the Corporate Fiduciary Obligation,” University of Toronto

Law Journal 43 (1993): 547-588; J. H. Langbein, “The Contrac-

tarian Basis of the Law of Trusts,” Yale Law Journal 105 (1995):

625- 676; V. Brudney, “Contract and Fiduciary Duty in Corporate

Law,” Boston College Law Review 38 (1996-1997): 595-666.

35. Debate has particularly surrounded the boundary between ﬁdu-

ciary law and tort in respect of ﬁduciary and tort duties of care.

See generally Hoyano, supra note 23. See also J. R. Maurice

Gautreau, “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; Worthing-

ton, Equity, supra note 20, at 148-154.

36. Debate has been particularly concentrated on the content of the

duty of loyalty. See, for example, J. H. Langbein, “Questioning the

Trust Law Duty of Loyalty: Sole Interest or Best Interest?” Yale

Law School Center for Law, Economics and Public Policy – Re-

search Paper No. 303 (April 2005); L. Smith, “The Motive, Not

the Deed,” Modern Law of Real Property and Trusts (London:

Butterworths, 2003): 53-81.

37. For example, “[The ﬁduciary relationship] is a relation in which

the principal’s interests can be affected by, and are therefore de-

pendent 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.” E. J. Weinrib,

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 abil-

ity of one party to exercise discretion at the expense of the other,

where that other is vulnerable.” G. K. Hadﬁeld, “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 discre-

tion in the interests of the person to whom it is owed.” Hospital

Products, supra note 11, at 454.

38. See Finn, supra note 33, at 199-258.

440

journal of law, medicine

ethics

INDEPENDENT

39. See, for example, Frankel, supra note 10; D. A. DeMott, supra

note 10; D. A. DeMott, “Fiduciary Obligation Under Intellectual

Siege: Contemporary Challenges to the Duty to be Loyal,” Os-

goode Hall Law Journal 30 (1992): 471-497; and Smith, supra

note 33.

40. See, for example, Worthington, supra note 23; J. D. McCamus,

“Prometheus Unbound: Fiduciary Obligation in the Supreme

Court of Canada,” Canadian Business Law Journal 28 (1997):

107-140.

41. 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.

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

note 36.

43. P. Birks, “The Content of the Fiduciary Obligation,” Israel Law

Review 34 (2000): 3-38, at 28.

44. Id., at 38. Compare Burrows, who similarly suggests the impor-

tance of attending to the anterior duty of care: “[Beyond the duty

of loyalty] an even more illuminating way of thinking about a ﬁ-

duciary duty is that it is a duty to look after another’s interests.” A.

Burrows, “We do this at Common Law but that in Equity,” Oxford

Journal of Legal Studies 22 (2002): 1-16, at 8. Unlike Birks, Bur-

rows seems to favor recognition of a single ﬁduciary obligation, in

this case, a positive duty of care in favor of the duty of loyalty.

45. Most notably, P. D. Finn, author of the ﬁrst and still best compre-

hensive treatise on ﬁduciary law, recognized the duty of discre-

tion (though he identiﬁed a number of obligations relating to

discretion rather than the singular one of which we speak). See

P. D. Finn, Fiduciary Obligations, supra note 33, at 20-37; see

also C. Harpum, “Fiduciary Obligations and Fiduciary Powers

– Where Are We Going?” in P. Birks, ed., Privacy and Loyalty

(Oxford: Oxford University Press, 1997): 145-168, at 160-167.

46. 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 corpo-

rate director may enter into a contract on behalf of the corpora-

tion, 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 P. D. Finn, Fiduciary Obliga-

tions, supra note 33, at 26-27.

47. 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 LaFor-

est; Worthington, Equity, supra note 20, at 148-149; Birks, supra

note 43, at 31.

48. 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.

49. There is, as yet, no consensus on standards of care, skill and dili-

gence, in contrast to the tort duty of care in negligence. Worthing-

ton 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 speci-

ﬁed as the levels of care, diligence and skill that would be exer-

cised by an ordinarily prudent ﬁduciary of the particular kind in

similar circumstances (e.g., corporate director, family physician,

etc). This recommendation seems eminently sensible. Unfortu-

nately, it and similar recommendations have been focused on

corporate directors, and reﬂected in corporate law statutes. The

broader implications of the reasoning supporting statutory re-

form 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 A. D. Harris, et al., Cases, Materials

and Notes on Partnerships and Canadian Business Corporations,

4th ed. (Toronto: Thomson Carswell, 2004): at 309-324.

50. 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 prac-

tical questions motivating this work, we do not discuss them

presently.

51. E. J. Emanuel and F. G. Miller, “The Ethics of Placebo-Controlled

Trials – A Middle Ground,” New England Journal of Medicine

345 (2001): 915-919; F. G. Miller and H. Brody, “What Makes

Placebo-Controlled Trials Unethical?” American Journal of Bio-

ethics 2, no. 2 (2002): 3-9.

52. F. G. Miller and H. Brody, “A Critique of Clinical Equipoise:

Therapeutic Misconception in the Ethics of Clinical Trials,” Hast-

ings Center Report 33, no. 3 (2003): 19-28.

53. B. Freedman, “Equipoise and the Ethics of Clinical Research,”

New England Journal of Medicine 317 (1987): 141-145.

54. C. Weijer and P. B. Miller, “When Are Research Risks Reasonable

in Relation to Anticipated Beneﬁts?” Nature Medicine 10, no. 6

(2004): 570-573, at 571-572.

55. H. Brody and F. G. Miller, “The Clinician-Investigator: Unavoid-

able but Manageable Tension,” Kennedy Institute of Ethics Jour-

nal 13, no. 4 (2003): 329-346, at 334.

56. F. G. Miller and D. Rosenstein, “The Therapeutic Orientation to

Clinical Trials,” New England Journal of Medicine 348 (2003):

1383-1386, at 1384.

57. S. Horng and F. G. Miller, “Is Placebo Surgery Unethical?” New

England Journal of Medicine 347 (2002): 137-139, at 137; F. G.

Miller, “Sham Surgery: An Ethical Analysis,” American Journal

of Bioethics 3, no. 4 (2003): 41-48 at 42.

58. Brody and Miller, supra note 55, at 332, citing with approval

H. Brody and F. G. Miller, “The Internal Morality of Medicine,”

Journal of Medicine and Philosophy 23 (1998): 384-410; Miller

and Brody, supra note 52, at 22.

59. Brody and Miller, supra note 55, at 334.

60. Miller and Brody, supra note 52, at 21.

61. Weijer and Miller, supra note 2, at 3.

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

Miller and Weijer, supra note 1.

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

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

65. Supra note 49.

66. T. Lemmens, et al., “‘CIOMS’ Placebo Rule and the Promotion

of Negligent Medical Practice,” European Journal of Health Law

11 (2004): 153-174; K. C. Glass and D. Waring, “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.

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

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