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 Indian Journal of Medical Ethics Online First Published January 7, 2020

ARTICLE

Medical ethics in laboratory medicine: A review, with an oath for pathologists

SWARUPA BHAGWAT, SANJAY A PAI

Abstract Introduction
The basic tenets of medical ethics are: autonomy of the The significance of laboratory medicine is seen from the fact
patient, beneficence, non-maleficence and justice. These that 66 % of clinical decisions were based on laboratory tests
are usually interpreted in the light of the practice of clinical as shown by a recent study (1). Laboratory investigations also
medicine but also apply to pathology and laboratory medicine, a form an important component of biomedical research. Though
field in which there is often no direct patient contact. We wished the principles of medical ethics-autonomy, beneficence,
to evaluate these basic tenets of medical ethics with respect to non-maleficence and justice (2), are thought of largely in the
context of clinician-patient interaction, they also include the
laboratory medicine and to provide insights into some of the
pathologist-patient interaction. Baron has pointed out that
issues that laboratory physicians, in routine practice and in
the pathologist’s ethical responsibilities extend well beyond
academia, face on a regular basis. This was done by using the
the primary patient, and also include responsibilities to other
published literature related to the topic of medical ethics, with
patients, the referring physician, colleagues and staff, students,
a special focus on laboratory medicine, as well as the authors’ research subjects and animals, and the public (3).
interpretations and opinions, based on their experience. We
conclude that the idea of autonomy of the patient or research Ethical issues related to laboratory medicine are not as
participant is pertinent with respect to specimens, autopsies commonly addressed as those in other spheres of medicine
and in legal issues such as consent for publication in the (4-8). This is probably because of the lack of direct contact
media and social media.  Beneficence is relevant with respect of pathologists with patients. Issues unique to laboratory
to laboratory values in reports, financial issues and in research medicine include the use of residual samples for research,
autopsies and the use of microscopic images.
and education. The concept of non-maleficence is important from
the point of view of doing no harm, communication with patients The fundamental bioethical principles and the core virtues
and colleagues, reducing/containing error and misdiagnosis in of honesty, integrity and reliability must be practised by a
medicine, screening for disease and in over diagnosis. Justice is pathologist to safeguard the health as well as the rights of
applicable to issues of distribution of resources and manpower, patients and research participants (7). It is obvious of course,
and their equitable usage. Many of the tenets, however, need to that these principles of ethics are not mutually exclusive;
be interpreted in the light of local laws and customs which differ some concepts (eg beneficence and non-maleficence) overlap.
across the world. We conclude with an Oath for pathologists and On occasion, one principle may conflict with the other ─ the
laboratory physicians. physician/pathologist, then, has to take a measured decision,
after considering the possible harms versus the expected
Key words: medical ethics, misconduct, autonomy, beneficence, benefits of the decision taken in the interest of the patient (4).
non-maleficence, justice, informed consent, medical research,
Wijeratne and Benatar add that certain virtues such as
oaths
compassion, discernment, trustworthiness, integrity and
conscientiousness (5) are essential in the quest to achieve the
high standards that good medical and laboratory practice
must reach.
Authors: Swarupa Bhagwat ([email protected]), Department of Despite these commonalities, there are apt to be differences
Transfusion Medicine, Seth GS Medical College and King Edward Memorial
Hospital, Parel, Mumbai 400 012 INDIA; Sanjay A Pai (corresponding between nations - sometimes significant - based on their
author - [email protected]), Department of Pathology and Laboratory history, political beliefs, economic and socio-cultural differences
Medicine, Columbia Asia Referral Hospital, Malleswaram, Bengaluru, 560 055 and mores, as well as those on the medico-legal front.
INDIA.
To cite: Bhagwat S, Pai SA. Medical ethics in laboratory medicine: A review, We discuss the basic tenets of medical ethics as applied to
with an oath for pathologists. Indian J Med Ethics. Published online on laboratory medicine.
January 7, 2020. DOI: 10.20529/IJME.2020.02.
Manuscript Editor: Vijayaprasad Gopichandran
Autonomy of the patient /research participant
Peer reviewers: Two anonymous reviewers
Autonomy is the right to decide for oneself. Informed consent
©Indian Journal of Medical Ethics 2020
is the expression of this principle (2).

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Indian Journal of Medical Ethics Online First Published January 7, 2020

Laboratory tests require the patient/ research participant to after a medical event may bring back painful memories of
undergo those investigations voluntarily. Implied consent is the suffering of a loved one – thus not only violating medical
a consent which is not expressly granted by a person, but is ethics but also common sense and humanity (22).
implicitly granted by a person’s actions and the circumstances
of the situation. Implied consent is usually considered sufficient We believe in the principle of solidarity (19) or altruism. Today,
for most investigations as the patient presents himself/herself we benefit from the largesse of research participants of the
voluntarily to the laboratory. An exception to this is in HIV past (albeit involuntarily, and often without their consent).
testing, where, as per WHO guidelines, written consent and We owe it to the next generation to contribute our residual
counselling is essential prior to testing (9). biological samples for future use. Since no harm can come
to the individuals concerned (as there is no further invasive
Autonomy and research samples procedure), it is exigent on us to do so.
A research project which involves collection of body
One way of tackling this issue is to consider seeking a broad
specimens also requires informed consent of the research
consent which may be applicable in future, provided an EC
participant. This consent must clearly explain the purpose of
permission is taken as well, to act as an appropriate check.
the study as well as benefits and harms of participating in the
Furness and Nicholson suggest, based on a study with opinions
research study (4). Approval from the Ethics Committee (EC) is
from patients, that it may be more practical to assume implied
necessary for all such studies. However, some issues arise after
consent in most cases and to avoid using tissue only from
the completion of the study.
those who specifically record their objections (22).
Can research be performed on the residual samples? Should
Autonomy and autopsies
the research be restricted to the disease that the patient has
had? Or can it be used for research on other diseases? Does Medico-legal autopsies do not require consent from family
the biological material belong to the patient once it is removed members. In clinical autopsies, consent from the family is
from the body? The ownership of the paraffin blocks (and mandatory. Because the autopsy is an invaluable teaching tool
indeed, any biological material) is among the trickier and more and its benefits could be passed on to future generations of
contentious of ethical issues in the laboratory (10-22). Ideally, patients and their doctors, one can easily make the case that
any research on the tissue samples should be done after taking autopsies should be made compulsory in many cases. This
the informed consent of the patient who owns the tissue, and/ would be consistent with a Cartesian approach, which posits
or after obtaining approval from the EC, under the existing that because the body is no longer alive, thinking has stopped
Indian laws. and the body is merely an object. However, sociocultural values
predominate and it is the practice to follow the wishes of the
If the patient (or the EC) denies permission for the storage of relatives of the deceased (23). The family must be informed,
his or her tissue for research purposes, that decision must be and consent taken, about tissues being retained for academic
respected. It goes without saying that confidentiality must and diagnostic purposes. That autopsy rates have declined is
always be maintained. The pathology laboratory thus plays the
in itself a serious issue (24). One could argue that by the act
role of guardian, rather than proprietor, of stored body samples
of not promoting autopsies, physicians and pathologists are
(12, 17, 21).
doing a disservice to science, to learning and to society and by
There is much literature on the perspectives of those who implication, are behaving unscientifically.
believe that patient consent is essential before the scientist
Ethical issues regarding autopsy and organ retention have
uses surplus material, and those who believe that it is not
achieved great importance in the UK, and possibly in other
required (19,20).
countries, after the Alder-Hey episode (where children’s organs
van Diest argues that the time and expense involved in getting were removed from the body and retained by the pathologist,
repeat consent would be better spent in research (19). The without parental consent), early in this century (25).
excess material must be used to benefit science. He adds this
Autonomy and legal issues
can be done, provided confidentiality is maintained and all of
the excess sample is not used up (in the eventuality that the Healthcare providers must keep a patient’s personal health
patient may need it in the future). He adds that the principle information private unless directed by a court of law to release
of solidarity (ie helping others) is of greater importance than the information (26), or if it is a notifiable disease
the right of self-determination (of patients deciding what
Care should be taken not to discuss the test results in public
needs to be done with their own excess tissue). On the other
places such as the cafe or elevators. Disclosure of certain
hand, Savulescu’s stance is that consent is a must to maintain
reports may have serious personal and social consequences
confidentiality as well as patient autonomy. He also believes
in the form of psychological trauma and social stigma, eg HIV
that seeking consent would help build public confidence in
testing, paternity testing, testing for genetic disorders and for
scientific research and act as a check against the abuse or
drugs of abuse. Adequate counselling is required before the
misuse of samples (20).
results are revealed. The results of genomic and DNA testing
However, it is often not practical to contact patients years should be revealed only to the patient and the attending
after their diagnosis. In addition, contacting a family long physician. The information must be revealed to parents when

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 Indian Journal of Medical Ethics Online First Published January 7, 2020

the patient is a minor. In research settings, confidentiality to publish the fruits of their research, so that society benefits.
of laboratory results of the research participants should be This research must be published only in legitimate scientific
ensured by maintaining anonymity. journals; predatory journals (pseudojournals) often stoop
to unethical practices. Because these journals are often
While all journals agree that EC approval is essential for
not indexed in standard indexing bases, the data – often
experimental studies and most journals desire patient consent
on patients or animals who have undergone potentially
for case reports, editors are often flexible about the latter, if
dangerous procedures – is lost to the scientific world (30, 31).
patient consent is not possible due to logistic reasons. In fact,
BMJ states that “Images – such as ....pathology slides...may be Failure to publish a paper when a researcher is in the know of
used without consent so long as they are anonymised .... ....” an important finding, even if it is a negative finding, is unethical
(27). Socio-cultural differences may also mean that the manner because it could lead to a waste of resources and time and also
of ethics approval may be non-uniform among nations and this potentially puts other patients at risk, if another researcher
can further cloud the issue. decides to pursue the same hypothesis subsequently. Similarly,
we believe that it is a professional obligation for pathologists/
This, to us, echoes what Tranberg et al, and we, believe in - that
physicians to teach students, colleagues, and the public. After
patient consent is not necessary for the majority of images
all, the word “doctor” is derived from the Latin word docere, to
used for teaching and research, provided confidentiality is
teach.
maintained (28).

The ease with which images can be disseminated, and the Non-maleficence
easy availability of the images to the physician and the public, This is the principle of Primum non nocere. No intentional harm
makes it crucial to take great care while using social media or injury should come to the patient or research participant
such as Facebook, Instagram and WhatsApp. Common sense either through acts of commission or omission.
and the principles of privacy are sufficient to address this. As
there is no formal peer review system, unscientific information Non-maleficence and communication
may be placed in cyberspace. Even if the post is taken down, Good communication between the pathologist and clinician
it is likely that some files will remain on some sites, in their is essential for patient safety (32). Direct communication
uncorrected versions (29). Crane and Gardner recommend between pathologist and patient is rather limited. Again, local
that patient-specific data must be modified if it does not practices vary and in the private sector, at least in India, the
alter the context of the message being transmitted (29). They pathologist is often the first person the patient communicates
point out that generations of textbooks have carried images with, at the time of collecting the laboratory report. A recent
for educational purposes and conclude that the benefits of report on this subject raises the issue of a fee for service for a
sharing images outweigh the risks. patient-pathologist meeting (33), with the editorial that such
an act would be unprofessional. That financial considerations
Beneficence may adversely influence the practice of anatomic pathology
Healthcare providers have a duty to be of benefit to the patient have also been raised by Murphy (34).
as well as to take positive steps to prevent harm. Non-maleficence and error in medicine
Beneficence and laboratory reports Because of the complex, multistep nature of laboratory
Beneficence implies that the laboratory physician has to be medicine, occasional errors are inevitable. How must these
proactive and offer medical advice that extends beyond the errors be dealt with, and who must the error disclosure be
mere act of diagnosis. Thus, a report must be appropriately made to? The topic of error in medicine – both, in general, as
worded and may recommend the taking of a second opinion well specifically in laboratory medicine – has been addressed
Failure to inform a critical value could violate the principle of now for the past two decades. There have been specific
Primum non nocere. references to error in medicine, ever since the report by the
Institute of Medicine (now known as the National Academy
Beneficence and financial issues of Medicine) in 1999 (35). The initial report, has been followed
“Cuts” or fee-splitting by pathologists with physicians who refer in 2015, with a report which dealt with error in diagnosis (36).
patients to them are a common problem in India and probably Error in pathology has been the subject of research in the
elsewhere. Kickbacks are unethical and there should be no recent past (37-40). In one study of laboratory directors, while
place for such a practice in any ethical health system. Fee- most admitted to having made errors and having admitted
sharing between physicians only results in the patient ending them to their clinical colleagues, very few disclosed them to
up paying more. Thus, the concept of beneficence also overlaps patients (37).
with the idea of non-maleficence.
Whereas, ideally, the pathologist must disclose the error to the
Beneficence and research and education patient, the practice is generally for the treating physician to
Research and teaching must also be seen through this ethics do so. There are unresolved issues, which cloud the matter. The
lens. It behoves all physicians to have an inquiring mind and exact definition of error itself – as interpreted by pathologists –
is sometimes nebulous (39). Pathologists also believe that many

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Indian Journal of Medical Ethics Online First Published January 7, 2020

patients — as well as physicians — may not be in a position to Finally, while the concept of “harm” or non-maleficence usually
understand the context and the mechanics of the medical error. refers to the living, it is vital that we offer the same principles of
respect to the body, while we deal with the dead at autopsies.
Lack of training in communicating with patients – and of
course, the fact that pathologists often do not interact with
Justice
their patients and hence are unable to build a patient-doctor
relationship only makes the issue more complex (40). Regional Justice is fairness and equality and fair distribution of
practices also add to the complexity of the issue. resources in society
Laboratory personnel should treat all patients fairly and
Given the fear of litigation as well as trial by media and social without discrimination. They have duties towards the patient
media and of the rising problem of violence against doctors as well as towards society (4). Distributive justice in the
(41), it is not surprising that there is no consensus among allocation of scarce resources is achieved by preventing
pathologists about the appropriate approach. unnecessary laboratory investigations, thus preventing
wastage of manpower, reagents, cost and time. There should
In a retrospective study, it is not uncommon to unearth
be equitable access to laboratory investigations for all patient
erroneous diagnoses made in the past. There are also obvious
groups. The approach will, of course vary vastly between
ethical concerns, which arise when one retrospectively learns
countries with Universal health coverage and those where
of an error committed earlier by a colleague, or by oneself.
private healthcare is common. Ideally, all laboratory tests,
How does one deal with such error that has happened in the
should be available without discrimination either because of
recent past? Should one inform the patient of the error? What
race or gender or cultural /socioeconomic/ personal beliefs.
are the legal implications of such a disclosure? What does one
The reality is different. However, there should be a balance
do if one realises that a particular colleague is responsible
between individual good and societal common good.
for a significantly large number of errors? These are no easy
Occasionally, laboratory staff are pressurised to deviate from
answers to these difficult questions (42). the routine workflow to favour “very important persons”. Such
situations should be handled in a balanced manner so that no
Non-maleficence and screening for disease harm is caused to other patients and there is no violation of
Screening for disease has the potential to benefit some, but also justice as far as healthcare resources are concerned (47).
the possibility of causing harm to some. Physicians inviting the
Equally difficult are situations where clinical colleagues
public for screening tests should communicate the benefits as
request unwarranted investigations, possibly due to a lack of
well as the risks of the procedures. Similarly, the annual health
understanding of the complexity of the test and its attendant
check – with a substantial laboratory component – needs a
merits and demerits, or as a part of defensive medicine
judicious approach. Recent evidence suggests that the routine
(48). While this is a difficult problem, attempts must be
health check makes little difference to mortality from cancer
made to communicate with and educate the clinician. Over
and cardiovascular disease (43, 44). Yet, doing away entirely
investigating one patient may result in another patient being
with all health checks would be erroneous. The selective use of
under investigated (3).
clinically indicated investigations, rather than uniform panels of
tests for all may be the most appropriate step. We end with an oath for pathologists, based partly on an earlier
oath, that one of us had co-authored (49).
Non-maleficence and overdiagnosis
Unexpected ethical issues have also surfaced recently. The A pathologist’s oath
easy availability of ultrasound has led to a marked increase in
I promise to use my knowledge of medicine and of
diagnosis of small thyroid nodules with the result that there
pathology to diagnose the patient’s condition, using my
has been a veritable “epidemic” of papillary carcinoma of the
training and whatever means I have in the laboratory. I
thyroid. How many are incidentalomas which would have been
shall, however, not perform unwarranted tests.
asymptomatic, and ideally should have never been detected?
Schnadig (45) advises that the concept of overdiagnosis must Because one’s life is one’s most valuable possession, and
be included in pathology education as well as to the public because a patient has chosen to trust me with his or her
and that limits must be set, by consensus with the physicians life, I shall respect that trust and shall be grateful to the
concerned, for screening by ultrasound and fine needle patient for putting his or her trust in me. Because trust is a
aspiration as well as mutation analysis. two way affair, I would also expect the patient to trust me
as I endeavour to care and heal.
Similarly, genetic testing also often yields unexpected findings
and raises challenging ethical issues pertaining to autonomy I​​ shall follow the laws of the land. Where guidelines are in
and consent (46). direct conflict with my personal beliefs, I shall guide the
patient appropriately, even if it means referring the patient
Other issues to another physician.
Over investigation also leads to unnecessary expenditure for
I shall respect the patient’s right to confidentiality and
the patient or for the institution. Wastage of resources is an
autonomy, and shall not discuss his or her condition with
ethical issue and must be addressed by pathologists (3).

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 Indian Journal of Medical Ethics Online First Published January 7, 2020

anyone unrelated to his treatment protocol, without his indicated, I shall recommend that the patient seek an
permission. expert opinion on the case. Depending on the specific
circumstances, I shall help the patient get a second
I​ shall always endeavour to prevent any kind of harm,
opinion.
whether physical or mental or financial and thus practise
non-maleficence. I​​ shall not venture into areas that I am not qualified
to practise. However, given my basic background as a
The patient’s welfare takes priority and I shall, thus, practise
physician, I shall endeavour to offer my opinion, when
the Hippocratic ideal of Primum non nocere.
needed, on matters beyond pathology.
I​ shall be scrupulously honest in my dealings with my
colleagues. I know that some colleagues can be difficult Because medicine consists of life-long learning, I expect
to get along with; conversely, it is possible that, at least to be in a position where I will benefit from the learning
on occasion, I may be unreasonable. Either way, I shall of others. Similarly, I hope to be able to learn from the vast
never let my personal likes and dislikes come in the way of experience of my colleagues. 
patient management. I​​ believe that research is an important component of
I shall remain true to my chosen profession of medicine my role as a physician-pathologist. I shall attempt to
and pathology in particular. I shall not demean myself investigate and find the answers to questions that are of
by offering cuts or kickbacks to anyone. I shall also not importance, without wasting resources or putting patient
accept commissions or freebies or company junkets or safety in jeopardy. I shall concentrate on diseases of local,
other arrangements that might compromise my opinion regional and national importance.
of people or companies of any kind, which could bias my I shall use the most appropriate journal to spread the fruit
objective thinking and clinical practice. of my research. I shall not fall prey to predatory journals by
I understand that these are my personal beliefs and may either publishing in them or by refereeing their articles.
not be shared, in full, by every colleague or organisation I​​ shall not manipulate data or plagiarise or indulge in
that I may be associated with. Thus, I shall attempt to other unethical publication practices. I shall do my best to
balance the best interests of all parties involved, with encourage my younger colleagues and friends, including
patient safety and care being the prime consideration. those from other departments; this, I shall do, by allowing
I​​ shall keep up with the advances in medical literature and them to make the effort and earn first author position,
try my best to use the knowledge in a dispassionate and where feasible. Because I believe in the circle of life, I would
scientific manner. I shall evaluate carefully, all new tests expect them to do the same subsequently with their
before accepting them as reliable and useful. Thus, I shall younger colleagues.
not blindly recommend “routine” health checks.
I take this oath voluntarily, not because it is mandatory
I shall attempt to spread relevant medical knowledge to or fashionable or politically correct, but because I truly
the community in whatever manner possible, either by believe in it.
writing in the lay press or at lectures.
Conflict of interest: None declared.
I shall try my best to work in as scientific and ethical a
Acknowledgements: None.
manner as possible. I shall take care not to waste precious
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