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A. Thompson and A. Komparic
impact their quality of life, and expanding our
notions of effectiveness to include patient perspectives on what they think is effective is crucial
to improving our understanding of how drug
effectiveness is understood and assessed, and
what role drugs ought to play in the treatment of
health conditions [46, 47]. Recognition of the
importance of engaging with and elevating
patient perspectives for patient safety in the use
of medicines is exemplied by the establishment
of the rst ever Patient Safety Commissioner for
England—a role which aims to provide an independent point of contact for patients to voice
their concerns and to elevate patients’ concerns
and interests to health systems decision-makers
[48].
9 Duty toReport
It has been estimated that over 90% of adverse
drug events go underreported [49], including due
to forgetfulness or time constraints, as discussed
further below. While systems would be overwhelmed if every suspected or even expected
event were reported, effective pharmacovigilance
requires the cooperation of industry, regulators,
researchers, healthcare practitioners, and patients.
Healthcare practitioners are especially well positioned to identify and report ADRsthat are worrying and unexpected given their close
relationships with patients [50]. In addition to the
duty of disclosure of medication errors and safety
events to patients, healthcare practitioners have a
public health duty to report suspected ADRs to
the appropriate regulatory and/or scientic bodies, even if they lack an explicitly stated, corresponding legal duty in the jurisdiction in which
they practice [51]. This ethical duty is grounded
in healthcare practitioners’ professional obligations to protect and promote the public’s health,
which involves taking measures to protect the
public from harm. Analogous ethical duties to
report exist in the reporting of certain infectious
diseases by healthcare practitioners to public
health authorities. Although ADR reporting can
be burdensome for healthcare practitioners due to
the time, effort, administrative challenges associated with reporting, and the potential lack of
compensation, emphasis on the importance of the
duty to report for patient safety and contributing
to the evidence base for medicines may help mitigate these barriers. Efforts to digitize and streamline reporting processes as well as opportunities
to educate patients on patient-led and “citizen
science” reporting initiatives can help healthcare
practitioners uphold this important public health
duty [51].
The duty to report is also grounded in healthcare practitioners’ professional ethical obligations to contribute to professional and scientic
excellence, which they can uphold through
contributing to building the base of scientic evidence available to inform clinical, public health,
and regulatory decision-making. Adverse event
reporting is key to building a high-quality body
of real-world evidence concerning the safety and
effectiveness of pharmaceuticals, which contributes to informing future clinical decisions and
acting in patients’ best interests and thus benets
both patients who take medications as well as the
healthcare practitioners who prescribe and manage the use of medications.
Spontaneous ADR reporting also contributes
to identifying safety signals that may not have
been identied in pre-market clinical trials for
various reasons, including due to limited sample
sizes, nonrepresentative study populations, limited trial periods, and the use of surrogate end
points [46]. Identifying safety signals is important both for protecting the public from harm and
for equity. In particular, groups that are systematically underrepresented in pre-market trials
may be at greater risk of ADRs just by virtue of
the fact that they have been excluded from trials,
and as a result, there is very limited or no evidence concerning the safety or efcacy of the
pharmaceutical product for them [46, 52].
Moreover, groups that are often excluded from
pre-market trials may be at greater risk of
pharmaceutical- related harms due to one or multiple genetic, biological, behavioral, or social factors that affect their morbidity and mortality, how
they metabolize or react to pharmaceuticals, as
14 Ethics inPharmacovigilance
329
well as their capability to access pharmaceuticals
or adhere to pharmaceutical regimens. Failing to
increase the availability and quality of pharmaceutical safety and effectiveness information
available for these groups may contribute to or
exacerbate health inequities faced by certain
groups.
Healthcare practitioners’ duties to report are
stronger in cases where there is greater evidentiary uncertainty. For example, pharmaceuticals
used to treat rare diseases, pharmaceuticals used
in populations that are underrepresented in clinical trials, pharmaceuticals used in public health
emergencies, and other instances in which there
is limited evidence of safety and effectiveness,
are all cases where healthcare practitioners’
contributions to building the real-world evidence base, especially within the rst 5 years of
market use, are especially vital to help inform
and facilitate safe pharmaceutical use.
Furthermore, the duty to report supports healthcare practitioners’ integrity-related obligations,
discussed below, concerning the use of the highest quality evidence to inform clinical
decision-making.
10 Scientic Integrity
As users of, and contributors to the generation
of evidence concerning the safety and effectiveness of pharmaceuticals, healthcare practitioners ought to demonstrate integrity. Integrity is
a virtue, or an ethically desirable character trait,
which requires that healthcare practitioners be
dependable in their actions and decision-making, and that their actions and decision-making
be consistent with the ethical principles and
obligations to which they are bound as healthcare professionals [53–55]. With respect to
pharmacovigilance, healthcare practitioners can
demonstrate integrity in at least two main ways:
rst, by using the highest quality evidence possible to inform their pharmaceutical prescribing
and management decisions; and second, by
identifying, avoiding, and managing conicts of
interest that arise in practice and pharmacovigilance activities(Fig.14.4). Integrity is important
for contributing to the validity of the evidence
used to inform pharmaceutical use (such as by
reducing the potential for bias in the collection,
analysis, and reporting of data), thus helping
HIGHEST QUALITY OF
EVIDENCE
Appropriate methodology
Data transparency
Declarations of conflicts of
interest made publicly
Ethical conduct in research
and clinical practice
Use of appropriate
comparators and dosages in
drug trials
No falsification, fraud or
plagiarism
Fig. 14.4 Aspects of scientic integrity
PRACTITIONER INTEGRITY MINIMIZATION OF BIAS
Reports suspected and actual adverse
drug reactions to appropriate
pharmacovigilance bodies
When conducting industry-sponsored
research, ensures adequate involvement
in all aspects of research and reporting,
and that non-disclosure agreements will
not muzzle reporting of concerns
Manages or avoids conflicts of interest,
especially with industry
Uses independent and credible sources
of information/guidelines for clinical
practice and appropriate prescribing
Considers patient testimony when
evaluating medication safety and
effectiveness
Consider sources of conflicts of
interest in clinical and post-market
research
Awareness or elimination of
industry ghost-writing
Awareness that industry- funded
studies are more likely to have
favourable economic or clinical
outcomes
Communication of negative or
non-significant results and
publication of whole studies, not
many smaller ones, avoids
selective publication bias
330
A. Thompson and A. Komparic
mitigate key factors contributing to medication
errors. It is also important for building and
maintaining patient and public trust in healthcare practitioners and the safety and effectiveness of the pharmaceuticals they take. Some
initiatives of note are the American and
Canadian Choosing Wisely recommendations,
and the UK’s Prescribing Safely Assessment
[56, 57]
10.1 Duty toUse theHighest
Quality Evidence
Healthcare practitioners use pharmaceutical
safety, efcacy, and effectiveness data from preand post-market studies to inform pharmaceutical prescribing and management decisions.
Prescribers have an ethical obligation to use the
highest quality data possible in their practices
[58]. As discussed in the preceding section, this
duty is complimented by healthcare practitioners’ duties to contribute to professional and scientic excellence by reporting suspected ADRs
to build the real-world evidence base concerning
pharmaceutical safety, especially for new pharmaceuticals. While individual healthcare practitioners are usually not in a position to evaluate
all available evidence concerning every pharmaceutical that they use in practice, integrity
requires that they actively consider the validity
of the data and the credibility, or trustworthiness
of the data source for evidence that they use to
inform their clinical decision-making [59]. In
other words, the integrity of the science itself is
also an issue.
Healthcare practitioners should seek out the
most complete and highest quality evidence
available to inform their prescribing and medication management decisions. The ability to
appraise clinical evidence, including considering the validity of evidence and the credibility
of the evidence source, is a foundational professional competency for healthcare professionals;
this competency is grounded in professionals’
ethical obligation to maintain professional competence, or to ensure that their professional
skills and knowledge remain up-to-date with the
latest evidence and accepted standards of practice [60].
Clinical appraisal skills include assessing the
methodological soundness of clinical trials and
post-market studies as well as of resulting analyses and practice recommendations; to aid them in
this endeavor, healthcare practitioners should
seek out independent sources or organizations
where (ideally independent) groups of experts
and methodologists review and assess the quality
of evidence—including the methodological
soundness of research studies—to inform practice recommendations. Examples of sources
include Cochrane, vetted clinical practice guidelines or evidence syntheses or reviews developed
by professional or specialty organizations, organizations such as Choosing Wisely, or health
technology assessment organizations specializing in evidentiary assessment such as the United
Kingdom’s National Institute for Health and Care
Excellence (NICE) or Canada’s Canadian Agency
for Drugs and Technologies in Health (CADTH),
and patient safety organizations. However, even
in these contexts, and as discussed further below,
healthcare practitioners ought to do their due diligence by considering the credibility of the source
of the review or guidelines that they consult,
including remaining cognizant of potential conicts of interest, as well as the potential challenges in identifying conicts of interest.
Healthcare practitioners ought to also listen
to their patients’ testimonies, and where available, consider sources of evidence that account
for patient experiences concerning pharmaceutical use, safety, and effectiveness [61]; doing so
contributes both to better understanding how to
act in patients’ best interests as well as to more
equitable clinical practice [62]. Taking patients’
experiences of medication use seriously is especially important for ensuring that the experiences, values, and concerns of groups that are
underrepresented in clinical trials, or who are
otherwise marginalized or disadvantaged in
healthcare, are not overlooked or discounted in
ways that can create or exacerbate health inequities. Not reporting suspected adverse events also
can compromise the knowledge base in
pharmacovigilance.
14 Ethics inPharmacovigilance
331
10.2 Conicts ofInterests
Healthcare practitioners ought to be aware of
how conicts of interest can arise and impact
clinical decision-making, both with respect to the
generation of the pharmaceutical safety and
effectiveness evidence that they use, as well as in
their own pharmaceutical prescribing and management decisions and interactions with industry
representatives and stakeholders [63, 64].
Conicts of interest arise when a person in a
position of trust has a secondary interest (e.g., a
nancial, professional, or personal interest) that
could reasonably be assumed to unduly inuences their decision-making with respect to the
primary professional interest. Healthcare practitioners’ primary interests include the duty to act
in patients’ best interests and the duty to protect
and promote the public good, while for healthcare practitioners and researchers, primary interests include protecting research participants and
upholding scientic integrity [3, 4]. Identifying
and taking measures to avoid or manage actual or
perceived conicts of interest are ethically important as conicts of interest can impact clinical
decisions in ways that are harmful to patients and
public health. Furthermore, conicts of interest
can undermine patient and public trust both in the
integrity of healthcare practitioners, professions,
regulators, and industry, as well as in the safety of
the pharmaceutical products that they use.
As discussed in the preceding section, the
duty to use the highest quality evidence possible
requires that physicians consider how stakeholders’ vested interests can inuence pre- and postmarket study outcomes and resulting clinical
practice recommendations [7]. As discussed
above, healthcare practitioners should seek evidence, or evidence assessments and syntheses,
from credible, independent sources, rather than
primarily relying on information from pharmaceutical manufacturers and industry representatives and sources. Moreover, healthcare
practitioners ought to assess the credibility of
data sources by considering whether the sources
have relationships with industry or other vested
interests in particular study outcomes. Healthcare
practitioners should also be aware that identify-
ing and assessing conicts of interest may be difcult due to practices such as medical
ghost-writing, where pharmaceutical manufacturers or industry stakeholders hire medical writers, academics, and healthcare professionals to
write and publish scientic articles in scientic
journals in order to inuence the evidence base
and clinical practice [65].
Industry inuence can occur in the context of
assessing the safety, effectiveness, and especially
the comparative-effectiveness of pharmaceuticals, such as when so-called “me- too” pharmaceuticals offering only marginal improvements in
effectiveness over rst-in-class or existing products, but often at a far greatercost, are presented
as novel or safer and more effective than existing
products [66]. Although prescribing pharmaceuticals that are not rst-in-class can offer clinical
benets to patients, it is important that physicians
consider the quality and certainty of the evidence
concerning the risk–benet prole of a product
carefully, including patient accounts of side
effect proles. In addition to potentially being
harmful to patients where newly marketed products pose safety risks to patients, prescribing less
effective or cost-effective pharmaceuticals can be
harmful to both patients, who may face nancial
burdens due to higher out-of- pocket costs or copays or deductibles, as well as to insured individuals and society as it increases the nancial
burden to payers, whether public or private.
Integrity requires that physicians identify and
take steps to avoid or manage conicts of interest that arise in their prescribing and pharmaceutical management. This requires critically
evaluating under which circumstances it is
appropriate, and benecial to patients, to interact
with industry representatives or attend industrysponsored events or learning activities, including
in the course of continuing professional education and development activities aimed at maintaining professional competence around drug
safety and effectiveness [8]. Healthcare practitioners should be aware of their obligations with
respect to conicts of interests and interactions
with industry as outlined in codes of ethics and
professional guidelines in their jurisdiction (e.g.,
related to accepting compensation, professional
332
A. Thompson and A. Komparic
development, advising industry, or investing in
industry). Healthcare practitioners should also
be cognizant of the fact that industry associations may also have guidelines or codes governing industry representatives’ and organizations’
interactions with healthcare practitioners
[67–69].
11 Summary andConclusions
Healthcare practitioners play a vital role in facilitating effective and ethical pharmacovigilance, as
well as in translating evidence generated through
pharmacovigilance activities into clinical practice to improve the treatment and care of patients
and improve population health. Healthcare practitioners have ethical obligations grounded in
their obligations to act in their patients’ best
interests, to protect and promote the public good,
and to maintain their professional competence; in
turn, these obligations give rise to a host of ethical principles and considerations related to pharmacovigilance and the safe use of
pharmaceuticals. This chapter has outlined several of these key principles and considerations,
including: the duciary duty, the duty to protect
the public from harm, the duty to maintain professional competence, privacy, consent, disclosure,
equity, trust, inclusiveness, the duty to report, scientic integrity, the duty to use the highest quality
evidence, and conicts of interest.
Notably, pharmacovigilance requires healthcare practitioners to attend to their obligations to,
and the immediate needs of, the individual
patients that they treat and care for in their dayto- day practice; however, pharmacovigilance
also requires healthcare practitioners to take seriously their broader obligations to upholding public safety, as well as to contribute to the broader
endeavor of supporting professional and scientic excellence by contributing to generating
high-quality, real-world pharmaceutical evidence. As a result, pharmacovigilance is an area
of clinical practice that spans both clinical practice and public health and thus raises ethical
issues and considerations pertaining to both
domains in ways that other areas of clinical prac-
tice may not. Given the complexity of clinical
practice, and the interplay between obligations to
individual patients and to public health, healthcare practitioners may encounter ethical dilemmas in which they are tasked with discerning
between competing ethical obligations or duties
and courses of action. Safe and ethical pharmaceutical prescribing and management requires
that healthcare practitioners engage in ethical
reasoning and reection to determine the appropriate course of action when treating and caring
for their patients and executing their public
health-related duties. Reecting upon the ethical
principles and considerations outlined in this
chapter, and deliberating about difcult cases
with colleagues, including in inter-professional
teams, can aid in reasoning through challenging
scenarios and contribute to a more robust process
of ethical deliberation.
12 Case Studies
12.1 Case Study 1
The opioid crisis in Canada and other countries
has claimed many lives due to opioid overdoses
and has disproportionately impacted marginalized people. According to the Public Health
Ontario, more than 2800 Ontarians died from
opioid-related causes in 2021 alone [70].
Naloxone, a Schedule II medication according to
Canada’s National Food and Drugs Act, is used
to reverse opioid overdose and can be distributed
to the public free of cost without prescription,
provided that a pharmacist provides education on
its use, on how to identify overdoses, and on how
to perform resuscitation.
In 2019in a small town in Ontario, Canada, a
pharmacist was distributing naloxone kits doorto- door with the help of nonpharmacist employees. These employees received training on how to
use the kits and provide education to those receiving the kits, but they were not legally permitted to
distribute the kits. The pharmacist was motivated
to put these kits into the hand of community
members after visiting a shelter for homeless
people that refused to allow him in to provide
14 Ethics inPharmacovigilance
333
education to its clients. He was also aware that
illicit drug use comes with stigma and claimed he
was concerned that this stigma represents a signicant barrier to accessing naloxone as well as
the services of a pharmacist for an already marginalized group of people. The pharmacist distributed kits at community events and
door-to-door at several businesses in the vicinity
of the shelter with the help of his employees, who
were not always directly supervised by him as is
required by law.
The pharmacist was subject to a disciplinary
hearing by the Ontario College of Pharmacists,
the provincial regulator, for dispensing naloxone
kits without regard to individual need and/or clinical appropriateness and for improperly directing
or permitting nonpharmacist employees or agents
to dispense naloxone kits to patients in the community. The pharmacist pleaded guilty. The
College Panel found that he failed to “maintain a
standard of practice of the profession; failed to
provide an appropriate level of supervision to a
person or persons whom he was professionally
obligated to supervise; failed to carry out or abide
by an undertaking given to the College; and
engaged in conduct or performed an act relevant
to the practice of pharmacy that, having regard to
all the circumstances, would reasonably be
regarded by members of the profession as unprofessional” [2]. Additionally, the disciplinary
panel argued that “integrity and trust are paramount to the profession of pharmacy, as pharmacists are held in high regard for their role in the
provision of healthcare in Ontario. The Panel
observed that Member’s conduct tarnished the
reputation of the profession” [71].
There was a controversy at the time in Ontario
about access to the life-saving naloxone kits.
Many harm reduction advocates claimed that it
was too hard to access the drug, especially given
that drug-overdose deaths were highest in rural
settings where pharmaceutical care is more difcultto access than in urban centers, and where
issues of stigma might be greater given the higher
likelihood of being known to healthcare
professionals.
The pharmacist said to the press, “I am guilty
of misconduct…Despite that, I have certainly
saved lives with what I did” [72].
1. What are the key ethical and legal issues in
this case?
This case illustrates the difference
between ethics and the law. It is clear that
this pharmacist was aware that the drug he
was distributing should not have been distributed outside of the pharmacy context
and to people who are not technically considered patients of the pharmacy as was
specied in the legal regulations governing
these types of medications. His decision to
ignore the law and to provide naloxone to
the public in the community near his pharmacy was informed by his belief in the ethical primacy of saving lives, and possibly
also a commitment to equity and justice for
marginalized populations. While aiming to
save the lives of a marginalized population
is ethically admirable and even justiable,
the pharmacists’ actions raise questions
about who the patient is in community pharmacy practice, as well as whether he adequately considered his professional duty to
do no harm.
2. What are the possible negative consequences
of this pharmacist’s actions?
Naloxone has been shown to drastically
reduce deaths from overdoses in the community when distributed to people living with
addiction and when they are taught how to
administer it correctly. However, it is possible that harm may have been done because
the community outreach was conducted by
people not empowered to teach the correct
administration of naloxone. By distributing
the drug outside of the pharmacy, the pharmacist also forwent an opportunity to connect patients with the formal healthcare
system and the help it can provide to persons
living with addiction. Do these possible
harms outweigh the harms possibly avoided
by the pharmacist’s actions?
334
A. Thompson and A. Komparic
Additionally, one must consider the implications of these actions for the public’s trust
inboth the pharmacist and the profession as
a whole. What might this pharmacist’s other
patients think about his actions, and how
might this have impacted their therapeutic
relationship with the pharmacist? If the pharmacist is someone who disregards the law
and professional standards of practice, are
they still behaving in a trustworthy manner?
And might these actions tarnish the reputation of the profession as a whole? These are
additional potential harms that must be
weighed in this case.
3. What is the role of the professional regula-
tory body in addressing public health crises
such as the opioid crisis?
While the main goal of professional regulatory bodies is to govern the behavior of
their members, they are also charged with
maintaining public trust in their members
and the profession as a whole. Many healthcare professionals prioritize the dyadic
relationship between themselves and their
patients as a result of their duciary duty.
However, many codes of ethics for health
professionals also indicate that they are
committed to promoting the health of the
broader population or society. Additionally,
many professional bodies articulate competencies for their healthcare providers that
include competency in advocacy. One
could argue that there is a conict of commitment here between maintaining the reputation of the profession and engaging in
advocacy work that could redress public
health crises and expand access to potentially life-saving medications to a marginalized population.
4. What alternative actions could have been
taken to achieve the same goal of saving
lives?
The pharmacist in this case could have
engaged in advocacy that may not have had
such an immediate impact on the crisis, but
that would have allowed them to stay within
the boundaries of their professional ethics
and the law. For example, advocating for
changes to how naloxone is accessed in communities with very high illicit drug usage
rates, providing safe needle exchanges, or
even providing education in the community
could all be longer term but effective strategies. However, given the signicant rise in
overdose rates at the time, one could argue
that this would not be enough to make a difference to overdose rates in the short term
and that too is ethically problematic.
The Ontario College of Pharmacists could
also engage in advocacy around improving
access to care for people living with addiction, providing more training for its members
in addiction management and prevention, and
lobbying for legislative changes that could
improve the health of this marginalized population. Naloxone continues to become more
available in some jurisdictions as governments weigh the harms from overdose against
the harms of incorrect administration and
restricted access to this life-saving drug.
12.2 Case Study 2
In recent years, prescribing of antidepressants
for subsyndromal levels of depression has been
identied as an area where widespread overprescribing occurs, especially for elderly
patients. In recent systematic surveys, only
15% of adults ≥65years of age who were taking antidepressants had met criteria for major
depressive disorder (MDD) during the prior
year [74].
You are designing a multicenter, clusterrandomized clinical trial to compare the effectiveness of providing nudges to healthcare
practitioners via email and electronic health
records to encourage physicians to consider alternatives to prescribing SRI medication and prevent potentially inappropriate or prolonged
prescribing in antidepressant-naïve patients who
have fewer than 5 of the 9 symptoms for MDD.
Healthcare practitioners will not be masked to
the arm of the trial they are participating in. Because
14 Ethics inPharmacovigilance
335
the study is deemed to be of minimal risk to
patients, they will not be asked to provide consent
and will not even be made aware that they are participating in a trial. To ensure patients are receiving
appropriate care, healthcare practitioners will ask
that patients attend the clinic for administration of
the diagnostic questionnaire for MDD at least one
additional time in the next 4months.
Healthcare practitioners will be randomized to
different arms of the trial: (1) control group; (2)
group where they are given the prescribing guidelines and asked to justify their decision to prescribe in the electronic health record and; (3)
group where they are given the prescribing guidelines and a weekly email in which their prescribing rates are compared to other healthcare
practitioners’; (4) group where they receive both
the guidelines and emails as well as being asked
to justify their decisions on the electronic health
record.
1. How might this trial impact patients’ auton-
omy and/or dignity?
We should ask ourselves when designing
trials like this one whether patient choice in
treatment options is being limited in some
way. As models of care move toward shared
decision- making, a trial like this presumes
that prescribers are always making decisions without input from patients. It is worth
asking whether that is appropriate for this
class of medications, or for this (potential)
condition. Are there some medications and/
or conditions where shared decision-making is more or less important? What if a
patient really wants the medication and is
unwilling or unable to engage in clinically
proven alternative methods to improve low
mood, such as exercise? Are we respecting
the dignity of patients when we ask healthcare practitioners to withhold information
from their patients about research that
involves them and their personal health
information (e.g., about their health
outcomes)?
2. Is the burden on patients insignicant?
This trial is likely not terribly onerous for
most patients given that they are being asked
to return to the clinic only once within
4months. So, the nonclinical risks and burdens have been deemed low enough to proceed without obtaining explicit consent of
the patients. But what about the patient who
lives far away, or the patient who cannot
afford to pay for parking, or the patient who
works two jobs and cannot take time off
work easily? It is important that we do not
make assumptions about the extent of
patients’ nonclinical risks and burdens, as
these are often subjective and can vary across
sociodemographic groups, including in ways
that disproportionately burden already disadvantaged groups.
3. Will all patients benet equally from this trial
or its ndings?
Related to the question above, we need to
ask if the risks and burdens from this trial
might fall disproportionately on patients who
are already socially disadvantaged. Where
exercise is prescribed instead of medication,
it is important to note that not all patients
have access to safe places to walk in their
neighborhoods, just as some might not have
the time to exercise due to having to work
long hours or care for children or elderly
relatives. While the trial ndings may help
low-income patients who can avoid having to
pay for an unnecessary prescription medication, is it possible that those who are more
socially advantaged will benet more? As
such, does the trial risk exacerbating existing
inequities in access to care or health outcomes between certain sociodemographic
groups?
4. Is it ne not to disclose to patients that they
are participating in this trial?
While some research is sufciently low
risk that it is accepted that patients do not
need to be informed, particularly in situations where study recruitment could be a
challenge, some healthcare practitioners
might nd not disclosing the trial to patients
ethically problematic. This stems from
healthcare practitioners’ professional ethics
duty to respect patient autonomy and their
right to provide informed consent. However,
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A. Thompson and A. Komparic
healthcare practitioners could also be concerned that patients’ trust in their providers
might be compromised if patients were to
nd out that they were unwitting participants in research, even if it is low risk. So,
although it might not be a legal requirement
to disclose trial participation to patients,
some healthcare practitioners might deem it
ethically necessary. However, this could
cause problems in the context of a multicentre trial where adherence to protocols is necessary to provide consistency across trial
sites.
Acknowledgments Alison Thompson would like to
thank the Canadian Institutes for Health Research for
funding prior research into the ethical dimensions of drug
safety and effectiveness.
Ana Komparic would like to thank the Fondation
Brocher in Hermance, Switzerland, where she had the
opportunity to work on this chapter during a visiting
research stay.
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