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80 Jacqueline YAP, Tony GIN
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General Principles of Bioethics
Ethics is a generic term for various ways of understanding
and examining the moral life. Morality refers to norms about
right and wrong human conduct that are so widely shared that
they form a stable social consensus and are usually referred to
as common morality. Professional moralities with standards
of conduct that are generally acknowledged by members of
a profession are often referred to as codes of behaviour or
professional ethics [1]. Medical ethics refers to the health care
professional’s code of conduct in the practice of medicine.
Medical ethics has its origin in the “Hippocratic Oath”, which
focused primarily on the proper conduct of physicians in their
professional capacity, and this served the profession admirably
till the 20th century. e horrors and atrocities committed
by the Nazi regime in medical experimentation on humans
exposed the need for additional principles to guide practice
and research. e Nuremberg Code of 1947 was the first set of
principles that was written to preserve the rights of patients
in all medical settings including the humane treatment of
prisoners of war [9]. e World Medical Associations in
their 18th meeting in Helsinki, Finland, in 1964 further
strengthened this code by the Declaration of Helsinki, which
was amended and updated at subsequent meetings, the latest
in Tokyo in 2004 [56].
Since then, there have been tremendous advances in medical
therapeutics and technology, which along with the abuses in
human experimentation have led to the emergence of bioethics
as a distinct field over the last few decades.
Pain medicine as a specialty has grown tremendously over
the last three decades. ere are many ethical dilemmas
that confront a physician and it is therefore important that
GENERAL PRINCIPLES OF
BIOETHICS
Core principles of bioethics
CLASSIFICATION OF BIOETHICS
AND ITS RELEV
ANCE IN P
AIN
MEDICINE
Clinical ethics
Researc
h ethics
Organisational ethics and public
health ethics
CONCLUSION
REFERENCES
Ethics in Pain Medicine
7
Ramani VIJAYAN
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82 Ramani VIJAYAN
a practising physician be fully cognisant of these
issues and uses the guidelines that are available to
resolve them.
Core principles of bioethics
e four core principles or tenets of bioethics are:
1. Respect for autonomy; 2. Non-maleficence; 3.
Beneficence; and 4. Justice. ese four principles
are fundamental whether we are discussing clinical,
research, organisational or public health ethics.
Respect for autonomy
e word autonomy comes from the Greek autos
(“self”) and nomos (“rule”) or self-rule. is principle
is about respecting a patient’s wishes and facilitating
and encouraging a patient’s input into the medical
decision process. It includes an obligation on the
part of the health care professional to truthfully
answer queries regarding options for investigation
and treatment along with the associated risks and
benefits. It requires that health care professionals do
not interfere with the effective exercise of patient’s
autonomy. e issue of informed consent lies at the
heart of this principle.
Non-malecence
is principle asserts that health care professionals
have an obligation not to act in ways that inflict
harm or injury to patients. In medical ethics it is
closely associated with the maxim primum non
nocere, “Above all (or first), do no harm”.
Benecence
Beneficence is defined as a physician’s duty to
“take positive steps to help patients and not merely
refrain from harmful acts” [49]. Beneficence and
non-maleficence are closely linked. Trying to do
good often entails risks and we therefore have to
consider at the same time the principle of non-
maleficence: to avoid doing harm. In essence, it is
evaluating the risk to benefit ratio, which should be
patient-centered.
Justice
In the context of health care, justice implies an
impartial and fair approach to treatment and the
distribution of resources. Disparities in care based
on race, gender and socioeconomic status are
examples of lack of justice.
Classication of Bioethics
and Its Relevance in Pain
Medicine
Bioethics has emerged as a major specialty in
the last few decades. It has a broader scope than
traditional medical ethics and includes clinical
ethics, research ethics, organisational ethics and
public health ethics.
Clinical ethics
Clinical ethics is a major component of bioethics
and is concerned with ethical issues encountered
in the care of patients. Several ethical issues may be
unique to the field of pain medicine.
Consent in clinical practice may assume a variety
of guises, from an explicit, fully informed dialogue
to a tacit, implied authorisation. A significant
aspect of the consent process is to provide choice
for the patient and this can be particularly
difficult in patients with chronic pain who are
seeking a “cure” for their problems. Lack of
education and understanding of the process of
“pain management rather than cure” can lead to
inevitable disappointments with treatment. ese
patients with persistent pain are vulnerable to
media offerings on the internet with assurances of
miracle cures and may force their physicians to try
aggressive interventional techniques against their
better judgement. is can sorely test the principles
of beneficence and non-maleficence.
ere is also the other side of the coin. Some health
care systems pay handsome remunerations for
interventional procedures and very little for other
therapies with the end result that unnecessary,
expensive interventional procedures for chronic
pain management are performed with no clear cut
indication and may result in only short-term pain
relief.
In addition, chronic pain patients may have
psychological problems, which can develop as a
reaction to the pain or the lack of relief. When this
occurs either as a result of iatrogenic or traumatic
injury, anger at the system can add to the depression.
is can worsen when these symptoms are not
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Ethics in Pain Medicine 83
recognised by the primary physician and patients
are treated psychiatrically rather than medically thus
increasing patients’ suffering. Pain management can
be particularly challenging in this vulnerable group
of patients. A careful interdisciplinary evaluation of
the patient can be very useful in managing such
patients.
e International Association for the Study of Pain
(IASP) recognises other vulnerable groups of patients
with pain, such as those who cannot communicate
verbally (infants, mentally incompetent, elderly
with dementia, patients in intensive care) and cancer
patients, particularly at the terminal stage who need
proper pain management [16]. Disparities in care
based on racial origin, gender and socioeconomic
status are examples of lack of justice. Studies by
Todd et al. showed that Hispanics were half as likely
to receive analgesia as non-Hispanics for fractures
in the emergency rooms. Even when opioids were
given, they were given two-thirds of the dose that
white patients received [53, 54].
Patient autonomy and self-determination is a
fundamental principle of bioethics. ere can,
however, be a difference in the Western and East
Asian concept of autonomy. e Western principle
assumes a subjective conception of the good and
promotes the value of individual independence,
while the Asian or East Asian principle of autonomy
often requires family determination, presupposes an
objective conception of the good and upholds the
value of harmonious dependence [24]. Physicians
need to understand the importance of the family in
decision-making.
Placebo analgesia
As pain is a subjective experience, self-report is
considered the most valid indicator of pain. When
patients seek treatment, they have a right to expect
that their physician will be honest and provide
appropriate therapy. ere are anecdotal reports
that some physicians administer placebos in an
effort to determine whether a patient’s condition
is organic or functional. e use of placebo pain
medication cannot be justified on either a clinical
or ethical basis.
In clinical trials, the placebo response encompasses
all the therapeutic effects that take place in the non-
treatment arm of the study. It is also an important
component in any therapeutic intervention [4].
However, the intentional clinical use of placebos
under the pretence of using specific therapies has
been strongly criticised on ethical grounds because
of deception of patients involved. Administering
placebos deceptively does not contribute to
understanding the patient’s problem. ere is
widespread belief that placebos do not result in
any harm; however, there is evidence that placebos
can mimic active analgesic agents in their ability to
produce side effects and even toxic reactions [5].
When placebos are used as part of a clinical or
therapeutic trial, the patient must be informed and
prior consent obtained after adequate explanation.
At the completion of the trial, patients should be
fully informed about the nature of the treatment
received and then be free to seek the treatment of
their choice. e American Pain Society position
statement on the use of placebos in pain management
is a valuable resource document [50].
Evaluating patients with disability
Patients with persistent pain, particularly when pain
is due to injury at work, often apply for disability
benefits. is often sets up a conflict between
the patient, treating physician and disability
adjudicator. In clinical situations, patients with
persistent pain frequently communicate the brief
that they are severely incapacitated by the pain
and ask physicians to support their claims. With
no tool to evaluate the extent of disability due to
pain alone, pain physicians are placed in an ethical
dilemma. ere is the dilemma of integrating the
patient’s subjective report of pain with objective
evidence of tissue damage, which is often lacking.
In addition the physician is torn between his role
as a clinician and that of an adjudicator for social
security organisations responsible for awarding
compensation. Guidelines for evaluating disability,
a subject that is inadequately researched, may help
practitioners with this ethical issue [43, 44].
Cancer pain relief
Over 70% of patients with cancer suffer from pain
as the disease progresses. e medical profession
has a strong moral need to do all that can be done
to control pain and alleviate suffering. To do justice
to suffering patients all over the world, the World
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84 Ramani VIJAYAN
Health Organization (WHO) published cancer pain
management guidelines, which provided a single,
easily understood, worldwide standard for treating
cancer pain [55]. However, the non-availability
or poor availability of potent opioids in many
developing countries of the world goes against the
basic ethical principle of justice [30]. Despite many
initiatives, potent opioids continue to be not readily
available in many parts of Asia, with implications
of serious under-treatment of cancer pain [31]. It
is perhaps the moral responsibility of physicians
to educate drug control legislators and help them
understand the importance of pain control.
Every patient has a right to know the cause of his illness
so that informed decisions can be taken regarding
treatment. Yet, in many instances, particularly in
Asia, family members request physicians not to
inform the patient about the diagnosis of cancer.
is conflicts with the principle of autonomy and
the patient’s need to make informed decisions about
setting goals of care. ese are difficult ethical issues
that need to be addressed on an individual basis.
Physicians should be cognisant of the difference
in attitudes in different cultures regarding who is
involved in making decisions. A study undertaken
to determine the differences in attitudes of elderly
subjects from different ethnic backgrounds towards
disclosure of the diagnosis showed that Korean-
Americans (47%) and Mexican-Americans (65%)
were significantly less likely than European-
American (87%) and African-Americans (88%) to
believe that a patient should be told the diagnosis of
metastatic cancer [7].
Ethical communication with the patient and his
family are key issues in the management of patients
with chronic pain, particularly in patients with
malignant disease. Patients suffering from advanced
illness need careful assessment at varying points as
their illness progresses. Information given to patients
and their families should be accurate and conveyed
in a compassionate manner. Due to the emotional
stress of the illness, the patient and relatives probably
need to hear the information several times. All
members of the team caring for these patients should
provide the same information. In this context, it is
critical for counsellors to demonstrate cultural and
religious sensitivities, particularly when addressing
end-of-life issues [32].
ere is anecdotal evidence that patients have
substantial difficulty in refusing chemotherapy
treatment for cancer. ere is occasionally pressure
both from physicians and family members to
undergo chemotherapy, a modality that is described
as distressing and capable of seriously compromising
the quality of life. ese pressures do not give
autonomy to patients and have an impact on the
decision making of vulnerable patients [35].
End of life issues
e ethical and legal implications of decisions to
withhold and withdraw life-sustaining technology
have been widely debated. is is particularly so
when the prognosis is poor and there is innate
futility in continuing with therapy [40]. As a
significant life passage, dying is an event that is
deeply influenced by cultural mores and practices.
Making end-of-life decisions is never easy, and
when the cultural background of doctor and
patient differ, communications about these issues
may become even more difficult.
Blackhall et al. examined the attitudes of people
aged 65 and older from different ethnic groups
towards forgoing life support. A survey of 200
respondents from each of four ethnic groups was
done. European-American, African-American,
Korean-American and Mexican-American (800
total) followed by in-depth ethnographic interviews
with 80 respondents [8]. European-Americans
were the least likely to both accept and want life-
support. Mexican-Americans were generally more
positive about the use of life-support and were
more likely to want such treatments. Interviews
revealed that this was due to their belief that life-
support would not be suggested if the case was truly
hopeless. Korean-Americans were also more positive
regarding life-support. However, they did not want
such technology personally; the decision for life-
support would most likely be made by their family.
Compared with European-Americans, African-
Americans felt that it was generally acceptable to
withhold or withdraw life-support, but were more
likely to want to be kept alive on life-support.
Interviews documented a deep distrust towards the
health care system and a fear that it was based on
one’s ability to pay.
Ethnicity with its different cultural practices is
strongly related to attitudes and personal wishes
for the use of life-support in the event of coma or
terminal illness. is relationship is complex and
can be contradictory as seen in the above study.
In treating dying patients, who by virtue of their
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Ethics in Pain Medicine 85
physical and emotional situation are frail and
vulnerable, physicians must meet a high standard
of professional and ethical care that recognises
the patients’ inherent worth as human beings
[33]. One must seek to do the best for the patient
and the family, which includes respecting the
patient’s autonomy through gentle truth-telling,
helping the patient and family to set treatment
goals, providing symptom control and continuing
attentive care throughout the course of the illness.
An interdisciplinary team approach can lessen the
burden on the primary physician.
Advance directives
e ethical legitimacy of advance directives by
patients depends on the patient’s autonomy, the
ability of a patient while competent to delegate
decision-making authority to a chosen surrogate
[42]. e surrogate, also defined as the patient’s
proxy, if called upon, is obligated to follow the wishes
expressed by the patient while competent. Advance
directives and formal appointment of proxies are
not common in Asia even when patients are aware
of the terminal nature of their illness. is could
be attributable either to the penchant for denial of
the diagnosis or the lack of knowledge that such
legal instruments of advance care planning exist.
e burden of making decisions therefore falls on
the family and it is important that the family be
given adequate information to make decisions.
Occasionally, the family can fall back on the
patient’s decision given verbally to a family member
while competent. However, whether the family will
follow the patient’s wishes is another matter as it is
an emotionally difficult time for them.
Fin et al. conducted an elegant study on whether
the patient-proxy relationship existed on a
contractual to covenantal continuum [25]. Using
three structured vignettes of three distinct disease
trajectories, they surveyed 50 patient-proxy pairs
and 52 individuals who had acted as proxies for
someone who had died. eir data showed that the
patient-proxy relationship exists in a contractual
to covenantal continuum and variables, such as
disease trajectory, the clarity of prognosis and
the quality of patient’s instructions, result in
statistically significant differences in responses. e
use of interpretative or covenantal judgement was
desired by patients and proxies when the prognosis
was grim, even if the initial instructions were to
pursue more aggressive care. Advance care planning
should take into account both the exercise of
patient autonomy as well as the burdens placed on
the proxy. Deviation from the patient’s instructions
should not be viewed as a violation of patient’s
autonomy.
It is also important to understand patients’
perspectives on the quality of end-of-life care.
Quality end-of-life care is increasingly recognised
as an ethical obligation of health care providers.
A total of 126 participants from three patient
groups: dialysis patients, people with human
immunodeficiency virus infection and residents
of a long-term care facility were interviewed face
to face to determine what they would consider as
quality end-of-life care [47]. Participants identified
five domains of quality end-of-life care: receiving
adequate pain and symptom management,
avoiding inappropriate prolongation of dying,
achieving a sense of control, relieving burden and
strengthening relationships with loved ones.
The principle of double eect
In medicine, as in all human endeavours in general,
good is sought while harm is avoided. Medical
professionals try to benefit their patients while
not harming them. ese are the basic ethical
principles of beneficence and non-maleficence.
However, occasionally one cannot benefit a patient
without causing some harm. is is the principle
of double effect. Double effect occurs when the
primary intent of an intervention to do good, may
have undesirable and unintended secondary effects.
e classic example of the double effect principle
is opioid administration (palliative analgesia) to
a terminally ill patient to provide pain control,
despite the drug’s possible secondary effects of
respiratory depression that might hasten death in
such patients. An action to secure a desired effect
can be justified even if it has predictable unwanted
associated effects [23].
Using double effect reasoning, Cavanaugh and
other authors argue that death-hastening or death-
causing palliative analgesic administration to a
terminally ill patient is ethical and, at times, even
obligatory [15, 52]… is is totally different from
physician-assisted suicide and euthanasia that are
outside the bounds of acceptable behaviour for
physicians and remain illegal in most jurisdictions.
Pain and fear of pain at the end of life is one of
the driving forces behind the recurrent debate
about legalisation of physician-assisted suicide.
e morally, legally and professionally accepted
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86 Ramani VIJAYAN
alternative is excellent end-of-life care, and pain
specialists in particular have an obligation to use all
available means to relieve pain [39].
Research Ethics
In the wake of the rapid development of medical
research over the past half a century, investigators,
clinicians and ethicists have raised numerous
concerns about the ethical conduct of research.
It was in essence the barbaric attitude of medical
researchers during the Nazi regime that initially
triggered the formulation of the Nuremberg Code
with further refinements and national codes over
the years; the most widely cited ethical guides
being the Declaration of Helsinki and the National
Commission for the Protection of Human Subjects
of Biomedical and Behavioural Research [19, 38].
Informed consent
e single most important protective mechanism
to emerge from these codes is the requirement
for informed consent from participants. It is well
understood that this should not just be a formality,
but participants should be informed about the
design of the study, potential benefits and risks
associated with research. Participation should be
voluntary, with no financial incentives, and subjects
should be free to withdraw from any trial at any
time.
Increasing attention to pain management
has brought with it a rapid growth in clinical
pain research. Informed consent may appear
straightforward, but investigators often face
significant challenges in fulfilling the requirements.
e first challenge is the qualitative one in which
there is uncertainty about the kind of information
patients want. e subjective, multidimensional
nature of pain and the diverse effects of pain on
quality of life mean that pain research affects patients
in different ways [21, 46]. Both pharmacological
and non-pharmacological pain research may offer
a variety of risks and potential benefits. ere may
be increased pain in placebo controlled trials with
the burden of travel or questionnaires and increase
in side effects.
In general, when patients make choices related
to health care, the kinds of information that are
important are related to their age, sex and education
level [6, 10]. e other challenge is the quantitative
one, which arises when decisions are made about
how much information patients expect. ere is of
course information that investigators must always
disclose. However, the degree of detail that patients
expect when making clinical decisions varies
widely and could depend on age, sex, income and
education [10, 14].
Investigators must understand patients’ information
needs for both ethical as well as for scientific
reasons. Subjects’ concentration and attention
spans will also limit the amount of information
that can be understood in the informed consent
process. It has been shown that both patients and
research subjects, particularly older adults, are
able to recall only a fraction of the information
presented [48]. erefore, it is important that
investigators make the best possible use of patients’
attention by discussing the information that is
most important to them. Information should also
be provided in a written format for patients to read
at their convenience.
In addition, adequate information will reduce the
chances of refusal to participate. is will in turn
reduce selection bias and increase the value of the
study. A very interesting study was undertaken to
determine the kind and amount of information
that a research subject would like in order to make
a decision to enrol in pain research [11]. Forty
patients who were currently taking opioids for non-
cancer pain were asked to participate in a telephone
interview. Each of the participants was presented
with five brief hypothetical vignettes of clinical pain
research and they were asked to comment on their
information needs regarding all aspects of the study.
For information on medication, the majority of
patients wanted to know the frequency with which
the study medication should be taken and results
of previous studies of medication safety. About half
of them wanted to know about previous results
of the medication’s efficacy and a smaller number
wanted to know the medication for breakthrough
pain while on the study. e major reasons given
for inconvenience were additional study visits
and the time taken to complete questionnaires.
Information on specific and general side effects
of study medication was also high on the list of
information needs. e majority of patients said
that they would want to know how the knowledge
generated by the study might benefit them. ese
results should help investigators provide the
information that patients expect.
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Ethics in Pain Medicine 87
Study design
Informed consent is the most widely recognised
mechanism of protecting human subjects in
research. However, it is being recognised that
there are limits to what the informed consent can
accomplish. Another, and more far-reaching, way
to protect human subjects involved in research
is to ensure that the study design is as consistent
as possible with patients’ preferences and goals.
e study should be designed such that it offers
a subject a reasonable balance between risks and
benefits. In short, an ethical design of clinical pain
research needs to be important for patients: i.e.
the potential benefits for subjects, the benefits for
future patients, the risks and burdens of research
participation, and the voluntary nature of a subject’s
choice of whether to enrol [12].
Recent studies have shown that there are substantial
opportunities to improve end-of-life care.
Improving it will require solid evidence on which
to base clinical and policy decisions that can only
be obtained by focused research effort. However,
research that involves patients near the end of their
life creates numerous ethical challenges that clinical
investigators should be aware of [13]. Inclusion
of dying patients in research makes providers
uncomfortable. Moreover, dying patients are
especially vulnerable, adequate informed consent is
difficult to obtain, it is difficult to balance research
and clinical roles, and the risks and benefits of
palliative research are difficult to assess. ere is
therefore an argument for special ethical guidelines
for the conduct of such research and this should be
the focus of discussion among investigators.
Privacy and condentiality
Assuring privacy and protecting the confidentiality
of research findings is important and expected by
all participants. Specific measures taken to protect
health information, particularly in epidemiological
research, should include keeping records under lock
and key, limiting access to confidential records,
discarding personal identifiers from data collection
forms and computer files whenever feasible, and
training staff on the importance of privacy and
confidentiality [18].
Sham/placebo surgery
Placebo has a well-known therapeutic potential
and this explains why placebo controlled trials
are considered necessary for showing efficacy of
a new drug treatment. Interventional therapeutic
techniques are rapidly gaining ground in pain
management. As any interventional technique has
its benefits and risks, the question arises whether
placebo or sham surgery should be included to show
the superiority of these techniques. Is it ethical to
have sham surgery as a control?
Innovative surgical procedures typically are
introduced into clinical practice without rigorous
evaluation of their efficacy. ere have been few
recent randomised clinical trials comparing new or
standard surgery with a sham surgery control. From
certain perspectives, sham-controlled surgery trials
are valuable when the outcome measures are based
on inherently subjective reports of patients, such
as pain, symptom improvement or quality of life.
However, the main reason for the paucity of such
trials is that sham surgery has been widely considered
by surgeons and bioethicists as unethical.
In the 1950s, ligation of the internal mammary
artery was widely adopted for the treatment of
angina pectoris till two sham-controlled trials
to evaluate this procedure were reported in the
literature [17, 20]. is procedure was abandoned
after these trials, which were applauded by Beecher
in his article “Surgery as placebo” [2] in which he
advocated the use of sham surgery to rigorously
evaluate surgical procedures by controlling for
placebo effect. However, these particular trials were
conducted without full informed consent; patients
were not told about the double-blind nature of the
trial, a situation that would not be permissible in
clinical trials in this day and age.
Despite this widespread belief that sham surgery
is unethical, there is another argument that it
is unethical not to use sham surgery to evaluate
a surgical procedure before introducing it into
clinical practice [36]. A recently published report
of a sham-controlled trial of arthroscopic surgery
for osteoarthritis of the knee affords an opportunity
to closely examine the ethics of sham surgery
[37]. is randomised placebo controlled clinical
trial demonstrated that two surgical procedures
produced no greater improvement than a sham
operation. All patients who consented to the study
were aware that there was a possibility that they
may not have any surgery. Ethical analysis of the
sham control revealed several important issues.
ere was scientific and clinical value in this study
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88 Ramani VIJAYAN
as arthroscopic surgery for arthritis is a common
procedure that had been introduced into clinical
practice without rigorous evaluation of its efficacy;
there was methodological rationale for sham control
as the major outcome measure was relief of pain;
the risk of sham surgery was minimised and the
risk was balanced by the potential value of scientific
knowledge to be gained from the research; and all
subjects gave informed consent.
Miller concludes that sham surgery is not
inherently unethical. It is important not to confuse
the ethics of clinical research with that of the ethics
of clinical medicine. Ethical judgements should
be case specific and depend on the rationale for
using sham surgery. is might be necessary when
rigorously evaluating an interventional modality in
pain management.
Developing animal models for pain research
e Committee for Research and Ethical Issues of
the IASP [16] identified the following guidelines for
pain research in conscious animals. Development
of animal models for studying acute and persistent
pain during the 1980s and 1990s has led to
enormous insight into the mechanisms of pain.
Ethical guidelines include: 1. All experiments
must be reviewed beforehand by scientists and
lay persons to clarify the potential benefits for
improved understanding of pain and there must be
continuing justification for the investigation. 2. If
possible the investigator must try the pain stimulus
on him or herself. 3. Physiological and behavioural
assessment of any deviations from normal behaviour
should be measured. 4. e pain stimulus must
be the minimum necessary for the experiment. 5.
Pain-relieving agents or procedures should be used,
as long as this does not interfere with the aims of
the investigation. 6. Paralytic agents should not be
used without a general anaesthetic. 7. e duration
of the study must be as short as possible with a
minimum number of animals. All animal research
should be monitored by each institution’s Animal
Care and Research Committee, which approves the
study and has overall responsibility for the humane
treatment of animals in research and for minimising
their discomfort.
Inequities in global health research: ethical
issues
National and international bodies concerned
with research ethics need to confront a great
ethical challenge: the enormous inequities in
global health research [3]. Less than 10% of the
world’s research resources are earmarked for 90%
of the health problems [27]. Although 93% of the
world’s burden of preventable mortality occurs in
developing countries, too little research funding
is targeted to health problems, including chronic
pain, in these countries [28].
is divide in research funding is mirrored by
concerns regarding a divide in the proportion
of publications arising from medical research in
developing countries. A survey of articles published
in five high-impact general medical journals
was undertaken with the objective of describing
the developing world’s contribution to research
literature over a single year [51]. e key finding
in this survey was that only 6.5% of articles in
these journals have authors from countries where
90% of the world’s population lives. ere is severe
under-representation of biomedical research from
a vast section of the world in these journals. In
addition, there were a small but significant number
of articles with data from the developing world
without a single author from these countries; these
are troublesome findings and a separate ethical
issue in itself.
e reasons for under-representation may include
research barriers, such as lack of funding, poor
facilities, limited technical support and inadequate
training, in addition to poor command of English.
e authors rightly argue that strengthening
the health research capacity in the developing
world and providing reasonable opportunities for
publications arising from the developing world are
critical, not only for achieving biomedical research
equity but also for advancing medical science.
ese remarks are probably true for pain research
in the developing world.
Other issues in research ethics
In pain research as in any other field of biomedical
research, the fundamental ethical principle is
that of honesty in the conduct of the study and
publication of research findings. Fraud in science
is defined by the intention to deceive as compared
with error or carelessness and is commonly
classified as fabrication, falsification or plagiarism.
For academic and career advancement, where
there is permanent pressure for publication and on
time, and competition is exceptionally high, there
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Ethics in Pain Medicine 89
is a tendency for scientists to cut corners. ere is
also pressure from funding sources to publish only
positive results and to avoid critical evaluation
of results. Surveys have shown that scientific
misbehaviours are more common than generally
perceived [34].
Organisational ethics and public
health ethics
Organisational ethics and public health ethics are
relatively recent concepts in medical ethics. ey
encompass the ethical values and practices of an
organisation or institution. e basic elements of an
organisational ethics programme are consultation,
education, and policy development and review.
e most recognised one is the hospital research
ethics committee.
The institutional review board system
e purpose of research ethics committees or
institutional review boards is to ensure that studies
involving human research participants are designed
to conform to relevant ethical standards and the
rights and welfare of participants are protected.
eir role is to ensure that studies have a favourable
balance of potential benefits and risks; that
participants are selected equitably in the interests of
justice; and that procedures for obtaining informed
consent are adequate. Institutional review boards
generally require periodical reports as the study
progresses and have ethics guidelines pertaining to
scientific misconduct.
Other roles of ethics committees
Hospitals ethics committees have other roles besides
reviewing and vetting research studies. Besides
clinical and research ethics, health care ethics
committees need to deal with organisational ethics.
As it is new field, they may need guidance from
professional ethicists with a background of business
ethics and social justice. Health care organisations
need guidelines for a wide range of issues involving
patient services (e.g. rationing resources), business
and professional integrity (e.g. conflicts of interest),
business and service plans (mergers and joint
ventures), employee rights and responsibilities, and
the organisation’s role in the community [26, 57].
Sustained attention to ethics contributes to the life
of and adds value to any organisation.
New methods of financing and managing hospitals
have also caused concern regarding how these
changes will affect the care of patients and allocation
of resources. One of the greatest challenges is an
equitable distribution of financial resources in the
interest of justice for all [29]. Other challenges
include placing guidelines for internal whistle-
blowing, so that staff members have an avenue for
reporting unethical professional conduct in a non-
threatening environment [41].
Conclusion
Bioethics forms a framework for the proper practice
of medicine. In the past, personal and professional
experiences helped physicians answer the various
ethical issues that confronted them in their practice.
It is increasingly recognised that bioethics should be
taught in medical schools in an organised manner
and all physicians, in whichever field they work in,
should be familiar with the ethical principles that
guide one’s professional conduct [45].
It is important to recognise the importance of
ethics in pain medicine. Ethical analysis can clarify
the physician’s duties and responsibilities, both
as a clinician as well as a research investigator, in
the doctor-patient relationship. It is “a roadmap
that allows us to keep practicing in the face of
an increasingly complex and often confusing
environment without losing our way and ending
up in trouble” [22].
References
Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 5th edn. New York: Oxford University Press, 2001.
Beecher HK. Surgery as placebo. JAMA 1961;176:1102–7.
Benatar SR, Singer PA. A new look at international research ethics. BMJ 2000;32:824–6.
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