International Journal of Gynecology and Obstetrics (2006) 92, 192 — 197

www.elsevier.com/locate/ijgo

ETHICAL AND LEGAL ISSUES IN REPRODUCTIVE HEALTH

Conflict of interest: Legal and ethical aspects

B.M. Dickens *, R.J. Cook

Faculty of Law, Faculty of Medicine and Joint Centre of Bioethics University of Toronto, Toronto, Canada

Received 4 November 2005; accepted 4 November 2005

KEYWORDS Abstract
Conflict of interest;
Research conflicts; Conflicts of interest arise when those who owe conscientious duties to others appear
Fiduciary duty; to have personal interests that might tempt them to subordinate those duties to
Conflict of their self-interest. Conflicts of interest are distinguishable from conflicts of
commitment; commitment, which arise when individuals bear two or more mutually exclusive
Self-interest; duties to others. If persons in conflicts of interest favor their self-interest, they may
Disclosure of interest; violate binding legal duties such as fiduciary duties. Conflicts arise when, for
Fee-splitting instance, medical practitioners refer their patients to other practitioners in
exchange for payments (fee splitting), and when they gain secondary incomes such
as from testing patients’ samples in laboratories in which they hold ownership or
investment interests. Financial dealings with commercial sponsors may place
researchers in apparent conflicts of interest with research subjects. When conflicts
of interest are unavoidable, they may be resolved by appropriate disclosure.
D 2005 International Federation of Gynecology and Obstetrics. Published by Elsevier
Ireland Ltd. All rights reserved.

1. Introduction conflicting interests, obligations or loyalties. Ac-

A common reaction of professional and lay people
alike is that an act or decision affected by conflict
of interest is tainted or suspect. An act or decision
claimed to be taken to serve or promote another’s
benefit that is actually motivated by the actor’s or
decision-maker’s self-interest is indeed liable to be
unethical and, in some circumstances, may also be
illegal. However, acts and decisions taken in good
faith may nevertheless require resolution of
* Corresponding author. Tel.: +1 416 978 4849; fax: +1 416 978
7899.
E-mail address: bernard.dickens@utoronto.ca (B.M. Dickens).
0020-7292/$ - see front matter D 2005 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
doi:10.1016/j.ijgo.2005.11.002
cordingly, it should not be supposed that those who
must act under conflicting pressures are violating
ethical or legal principles.
A distinction is sometimes drawn between con-
flict of interest and conflict of commitment.
Conflict of interest is condemned when a person
bound to serve another’s interests, such as a
physician undertaking care of a patient, subordi-
nates the dependent person’s interests to his or her
own. For instance, an obstetrician who undertakes
induction or augmentation of labor in the clinically
judged belief that it is safer for the mother and/or
baby to avoid prolonged delivery has no conflict of
interest, but if induction or augmentation is pro-
Conflict of interest: Legal and ethical aspects
posed primarily to serve the obstetrician’s personal
convenience, it may be that he or she is giving way
to a conflict of interest, and acting unprofession-
ally. In contrast, a physician bound to give time both
to patient care and instruction of students faces a
conflict of commitment when lacking sufficient
time to attend properly to both duties. No interest
of the physician’s may be served by favoring the
interests of either patients or students in receiving
proper attention. In busy professional life, some
conflicts of commitment may be inescapable.
Conflicts often involve monetary or material
interests, such as in advising patients to take more
expensive over less expensive but equally suitable
treatment when the former promotes practi-
tioners’ incomes. The conflict can also promote a
practitioner’s leisure time, such as when less
follow-up care is undertaken than is clinically
indicated. Most obvious is a practitioner exploiting
a patient’s availability and vulnerability to gain
sexual gratification, which is grossly unethical and
a violation of civil and often criminal law.
2. Third parties’ interests
The difference between conflicts of interest and of
commitment is difficult to draw in some cases in
which interests of third parties may intervene in
patient care. Practitioners who have competing
claims on their time and attention from different
patients equally entitled to care usually have no
personal preference to favor one over another, and
only a conflict of commitment. However, if a
practitioner serves a personal judgmental, moral,
ideological or other preference in allocating care, a
conflict of interest arises.
For instance, if in a complicated pregnancy, a
practitioner feels a primary duty to preservation of
fetal interests over those of the pregnant patient in
presenting or undertaking treatment options, this
represents a conflict of interest [1]. To resolve such
a conflict, the FIGO Committee for the Ethical
Aspects of Human Reproduction and Women’s
Health requires that the woman’s wishes should
prevail, and that b[i]f maternal competence for
medical decision-making is impaired, health care
providers should act in the best interests of the
woman first and her fetus secondQ [2].
Pressures that distract practitioners from prima-
ry allegiance to their patients’ interests can also
arise from working in teams. Teamwork can well
serve patients’ interests to maximum advantage, in
ensuring continuity of care and availability of
different types of expertise. At times, however,
team dynamics and accommodation of team mem-
193
bers’ personalities, preferences and convenience
may take priority over patients’ best interests,
when their care is unduly delayed, by postpone-
ment to team members’ priorities, speeded or
otherwise compromised. Practitioners may also be
tempted, for instance to maintain the social ease of
professional working relationships, to cover up a
colleague’s deficient professional performance that
places patients or newborn babies at risk. Similarly,
practitioners may be subjected to departmental or
institutional pressures, such as for economy in use
of scarce resources.
For instance in a case of a patient’s hospital
death from a ruptured aneurism when his physician
had not undertaken available CT scan diagnosis, for
cost-containment reasons, the judge finding mal-
practice observed that bif it comes to a choice
between a physician’s responsibility to his or her
individual patient and his or her responsibility to the
medicare system overall, the former must take
precedence in a case such as thisQ [3]. The power to
allocate inadequate resources among patients in
equal need usually presents only a conflict of
commitment, but if administrative or other person-
nel distort practitioners’ clinical judgment exer-
cised in patients’ interests, by providing personal
incentives or disincentives for particular choices,
they place the practitioners in a conflict of interest.
3. Legal tests of conflict of interest
In ordinary commercial transactions, for instance of
buying and selling, whether of goods or services,
each party must be self-reliant, looking for any
required safeguards against making a poor bargain
to third parties rather than to the other party to the
transaction. This is summarized in the historic rule
caveat emptor, let the buyer beware. In contracts,
both parties are bbuyersQ, one of goods with money,
the other of money with goods, and each must
exercise his or her own caution against paying too
much or selling for too little, without trusting that
the other is asking or offering fair value.
Some transactions or relationships, however,
are legally considered different from ordinary
commerce, including those between health service
providers, particularly physicians, and their
patients. Patients seeking to preserve their lives
or health are not free to forgo the care that only
trained physicians can provide, and in most legal
systems, only physicians are licensed, and there-
fore have a monopoly, to provide such services.
Physicians offer care on the claim that they can be
relied upon to act ethically to protect their
patients’ health and other interests, including
194
confidences. Further, unlike the marketplace
where potential buyers can inspect goods and
make their own assessment of them before
purchase, patients usually lack medical informa-
tion to assess prospective care-givers or treat-
ments. They can make neither a diagnosis nor a
prognosis for themselves, nor can they know what
medical choices are indicated by their diagnosis or
prognosis, nor prescribe their own pharmaceutical
medications.
Laws attempt to redress physicians’ superior
power, derived from their knowledge and their
patients’ lack of knowledge, not only by require-
ments that patients be adequately informed of
their treatment choices [4], but also by holding
physicians to higher standards of disclosure and
integrity than apply in ordinary commerce. For
instance, if patients pay more than standard fees
for medical services, make unusually generous gifts
to their physicians, or leave them bequests at
death, legal systems often apply a presumption
that the more powerful party in the unequal
physician-patient relationship exercised undue in-
fluence. The surplus fees, gifts or bequests are
therefore voidable, unless the physicians can
discharge the legal burden of showing that the
patients acted independently, and took or at least
were able to take independent advice before
making payments, gifts or bequests.
Laws do not target physicians for special suspicion.
In similarly unequal relationships, between for
instance lawyers and clients, and ministers of religion
and congregants or penitents, excessive fees, greater
than token gifts, and bequests for instance to
ministers of religion or religious institutions, are
equally voidable. This is not due to physicians’,
lawyers’ or religious ministers’ abuse of power, but
because of the objective dependency and vulnera-
bility of the patient, client or congregant on the
other party’s medical, legal or spiritual knowledge.
Some legal systems describe physicians’ duties
to patients as fiduciary duties, which oblige
physicians to act conscientiously and in good faith
to protect not only patients’ health but also their
wider interests against the physicians’ self-inter-
est. The protective duty arises from the objective
circumstances of the relationship; that is, not only
when physicians actually have self-interests that
conflict with their patients’ interests, but when to
an outside observer they may reasonably or theo-
retically appear to have such interests. As a senior
British judge observed in the mid-19th century:
No one, having. . .duties [of a fiduciary nature] to
discharge, shall be allowed to enter into engage-
ments in which he has, or can have, a personal
B.M. Dickens, R.J. Cook
interest conflicting, or which possibly may conflict,
with the interests of those whom he is bound to
protect [5].
A Canadian court cited and echoed this a century
later, noting that:
The medical practitioner, like the lawyer or other
professional adviser is bound, then, to see to it that
in no circumstances will he allow his professional
duty to come into conflict with his personal
interests. And when a patient consults his physician
he is entitled in equity to assume that this adviser
has no pecuniary interest in the surgical operation
he advises or in the choice of the surgeon or in the
amount of the proposed surgeon’s fee [6].
This shows that fee-splitting creates an appear-
ance of conflict of interest, and is accordingly,
unlawful, as well as a violation of accepted profes-
sional ethics.
In addition to judge-declared law, for instance
through interpretation of implied terms of con-
tracts for care, setting standards in tort law or
finding fiduciary duties, many countries have
legislation that condemns inadequate resolution
of conflict of interest. In Ontario, for instance, the
Regulated Health Professions Act of 1991 governs 21
health professions, and binds each to apply the
Act’s Health Professions Procedural Code. The Code
prohibits any member of a regulated health pro-
fession from b[p]ractising the profession while the
member is in a conflict of interest,Q although each
profession’s disciplinary tribunal has some discre-
tion to determine what acts of the professional are
conflicted due to actual or apparent self-interest.
4. Conflicts in medical practice
It has been seen that both courts and professional
licensing authorities regard fee-splitting, or pay-
ment or receipt of commissions for referrals from or
to colleagues, as constituting a conflict of interest.
This is because such payments may create an
impression that the referring practitioners are
selecting the colleagues to whom they refer their
patients on the basis of the size of the fees they will
earn, rather than of the colleagues’ skill and
suitability to serve the patients’ best interests and
medical needs. Referring practitioners are
expected to have a personal disinterest in the
practitioners to whom referral of their patients is
appropriate, and be guided by their conscientious
clinical judgment of their patients’ interests.
More obviously conflicted than fee-splitting
referrals to other practitioners is self-referral,
Conflict of interest: Legal and ethical aspects
which takes slightly different forms. A typical form
arises when a practitioner employed in a public
hospital also maintains a private fee-paying clinic,
and informs patients he or she attends in the public
sector that their indicated treatment will be
available sooner or with greater attention in the
private clinic. Another form arises when a practi-
tioner owns or has a financial interest in a clinical
laboratory, and sends patients there for laboratory
services [7]. A financial interest would include
renting business space to a laboratory, or providing
business loans.
Some countries have laws that prohibit public-
sector employed practitioners from having financial
interests or working in private clinics, and bar
practitioners from having such interests in clinical
laboratories, because of conflict of interest. Prac-
titioners’ direction of clinical laboratories is not
necessarily unethical, since this may allow them to
set high standards of laboratory performance and
to monitor enforcement. A conflict of interest
remains, however, in that they may appear liable
to order more tests and more expensive tests than
their patients require.
A comparable concern arises when physicians set
up specialty hospitals. Where laws permit this, any
competition that draws patients and income from
community hospitals reflects the legitimate work-
ing of market forces, although it may undercut
community hospitals’ capacity to serve the general
needs of wider, impoverished populations [8].
Physician-owners will face ethical scrutiny if they
put themselves on the payroll of the facilities they
own, and receive exorbitant salaries as employees,
but if they act conscionably, any detrimental effect
on community or public hospitals raises only macro-
ethical or political concerns of public resource
allocation to health care.
There is no competition, of course, if physician-
owned clinics provide services not offered in public
facilities. In vitro fertilization (IVF), for instance, is
available in relatively few public health care
facilities, and tends largely or entirely to be a
private clinic service. Some clinics operate on a
not-for-profit or cost-recovery basis, but many are
overtly commercial. This in itself raises no special
conflict of interest concerns, but some clinic
practices may warrant attention. Excessive ovarian
stimulation to produce more ova than are likely to
be needed for patients’ treatment is suspect if its
effect is to leave surplus embryos available for
treatment of other patients who are incapable of
ovulation, or for research, such as into reproduc-
tive processes or stem cell development. IVF clinics
in research-oriented facilities may come under
special scrutiny.
195
Another concern is multiple implantation of
embryos created by IVF. Guidelines, for instance
by the UK Human Fertilisation and Embryology
Authority, that no more than three IVF embryos
be transferred to a woman in a single cycle are
being reduced to recommend no more than two,
and a case is growing to favor single embryo
transfer [9].
However, multiple transfer may increase short-
term rates of childbirth, and permit clinics a
competitive advantage to attract clients by adver-
tising a high rate of btake-homeQ babies. This
promotion of clinic interests may conflict, however,
with patientsT, newborns, and public interests. It
has been observed that:
The emphasis on pregnancy rates as a performance
indicator has provided a powerful incentive for
increasing the number of embryos transferred after
IVF. Such a policy, however, challenges safe prac-
tice, increases perinatal mortality and morbidity
and imposes a steep financial burden on maternity
and neonatal services [10].
Similar if not greater concerns arise from use of
ovulation-inducing drugs, which may result in high
multiple pregnancies from natural fertilization.
The FIGO Ethical Guidelines in the Prevention of
Iatrogenic Multiple Pregnancy, of 2000, recommend
that techniques of induction of ovulation and
embryo transfer should aim to achieve singleton
pregnancies, and that b[u]nder optimal conditions,
not more than two pre-embryos should be trans-
ferred although circumstances of age and other
clinical considerations may warrant three or, in
exceptional circumstances, fourQ [11]. The exercise
of clinical judgment on whether an exceptional
case exists for multiple transfer can create a
perhaps unavoidable appearance of conflict of
interest.
5. Conflicts in research studies
Under the intense scrutiny to which medical
research has been subjected in recent years,
research undertakings may seem replete with
conflicts of interest [12]. Non-investigator clini-
cians and students face, and are ethically expected
to resist, a conflict when offered bfinders’ feesQ to
identify any of their patients who meet a research
protocol’s entry criteria. If they put time and effort
into screening their patients’ records for suitability,
and genuinely believe that their patients’ recruit-
ment to a study would offer them advantages, they
are entitled to be remunerated for their time and
effort, whether or not they find suitable candi-
196
dates. If they are offered a per capita payment for
each patient recruited on the basis of patients’
known clinical diagnoses, however, clinicians and
students may unethically enrich themselves by
taking advantage of their privileged access to
patients’ information [13], even if patients can be
approached by means that do not violate their
confidentiality.
Clinician-investigators have an inherent conflict
of interest if they propose to recruit their own
patients into studies. Clinicians are bound by the
medical ethic to put first the interests of their
patients. Research subjects agree to serve the
interests of investigators. If clinicians propose to
become investigators on their own patients, they
are reversing the physician-patient relationship and
creating an investigator-subject relationship. How-
ever, because of patients’ deference to and depen-
dency on their clinicians, they may not really
understand, despite being told, that their clinicians
are not proposing interventions, including perhaps
the withholding of therapeutically-indicated treat-
ment, for their benefit, but that they are serving
their clinician-investigators’ interests. It is more
pernicious when the investigators themselves fail
to see how they have changed their patients’ roles,
and rights. University-based and similarly academ-
ically-based investigators are often asked to con-
duct studies sponsored by commercial or industrial
corporations such as drug companies, because,
unlike company employees committed to compa-
nies’ success and profitability, they are dedicated
only to scientific truth and excellence. Such inves-
tigators may receive lump sum or per diem pay-
ments for their work, but their returns are not
dependent on providing the sponsors with favorable
results. An evolving practice, however, has been for
investigators to accept payment of shares in
sponsoring companies, so that their returns are
tied to company profitability, or royalties tied to
market sales of products that result from their
research. They may accordingly appear to sacrifice
their integrity as scientists committed only to their
discipline, and to become indistinguishable from
company employees [14].
Further conflicts may arise when investigators
and/or their family members make personal pur-
chases of shares in companies whose profits they
anticipate rising from marketing of the products,
such as drugs or vaccines, they are researching.
They may, for instance, compromise research
subjects’ safety, or pressure them not to exercise
their right to withdraw from studies, in order to
complete the research and gain marketing approval
in advance of commercial competitors. Investiga-
tors may also become consultants to stock market
B.M. Dickens, R.J. Cook
investment advisors, to provide them with infor-
mation of whether the products they or their
institutional colleagues are investigating will be
market successes, or failures [15]. Similar concerns
arise in the commercial involvements, such as
consultancies with drug companies, of members
of governmental drug licensing agencies [16], and
the ethics of ethics review of research is called into
question when members of ethics review commit-
tees are paid fees for their services [17].
6. Resolution of conflicts of interest
One of two responses may resolve a conflict of
interest, namely avoidance and due disclosure when
avoidance is not necessary or not possible. Since
conflict of interest consists in bsome personal
interest sufficiently connected with. . .professional
duties that there is a reasonable apprehension that
the personal interest may influence the actual
exercise of the professional responsibilities. . .[and]
does not require proof of actual influence by the
personal interest upon the professional duty any
more than it requires proof of actual receipt of a
benefitQ [18], the breasonable apprehensionQ of
conflict is sometimes not preventable.
Avoidance of conflict of interest is often
possible. Clinicians offered finders’ fees by inves-
tigators seeking speedy recruitment of eligible
subjects for their studies, for instance, can
decline participation. Similarly, investigators can
receive lump sum payments for conduct of stud-
ies, or per diem payments for predetermined
numbers of days, rather than accept payments
graduated to the commercial success of the
sponsor or of the research outcomes. However,
avoidance by compelling regulatory agency scien-
tists and administrative personnel to abstain from
all contacts with commercial interests or agen-
cies, and with universities that have industrial
links, and to sell any family investments in
corporations possibly affected by regulatory deci-
sions, as the US National Institutes of Health has
proposed [19], may fail to consider the satisfac-
tory alternative of due disclosure.
Not every conflict can be reliably resolved by
disclosure or transparency [20]. For instance, if
physicians inform their patients of their financial
interests in conveniently located clinical laborato-
ries and of alternative services, patients may take
this as directing resort to the former. An approach
in this case, if prohibition of the interest is
excessive or dysfunctional, may be disclosure to a
governmental licensing authority and/or to a
professional association with disciplinary powers,
Conflict of interest: Legal and ethical aspects
along with evidence that interests are for quality
control purposes and that the volume and charges
for tests ordered are moderate. A feasible strategy
for physicians’ disclosure may be to inform pro-
spective patients before services are initiated of
the range of the physicians’ secondary financial or
other interests, and let the patients decide wheth-
er or not such interests are acceptable to them.
This follows the practice in teaching hospitals,
where patients are informed in advance of the
hospitalsT interests in engaging patients in educa-
tion by having some procedures undertaken on
patients by supervised students.
Disclosure of interests is more easily managed in
hierarchical institutions such as hospitals, universi-
ties and research institutes. Below chief executive
officers, everyone will be accountable to a superi-
or, and disclosure to that superior may discharge
the ethical duty of due disclosure, unless institu-
tional rules require disclosure to more senior
officers empowered to approve or disapprove the
apparently conflicting interests. In university set-
tings, however, this may affect the claim to
academic freedom, and raise issues of its proper
scope. Chief executive officers may be required to
disclose to boards of governors or comparable
overseers and guardians of institutional integrity.
Further, for licensed professionals, disclosures to
licensing authorities and to professional associa-
tions with powers of allowance and disallowance,
may resolve apprehensions of conflicts of interest
to legal and ethical satisfaction.
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