Eubios Journal of Asian andInternational Bioethics
EJAIB Vol. 25 (4) July 2015
www.eubios.info ISSN 1173-2571
Official Journal of the Asian Bioethics Association (ABA)

Copyright ©2015 Eubios Ethics Institute(All rights reserved, for commercial reproductions).

Contents

page

Editorial: Public Heath and Society
97- Darryl Macer
Ethical Concerns Surrounding MERS Outbreak in Korea 98- Bang-Ook Jun
Santhara between Law and Morality: India’s Dilemma
about a Jain Practice100- Norman K. Swazo
The ethical aspects of halal certification of medical
devices in Malaysia
104- Nur Farhani Zarmani, Mohd Anuar Ramli, Shaikh Mohd
Saifuddeen Shaikh Mohd Salleh
Nurturing medical ethics and professionalism throughlife experience: ‘A day in a doctor’s life’
109- Nor Azwany Yaacob, Siti Rahmah Hashim Isa
Merican, Wan Nazirah Wan Yusuf
Should an Incapacitated Patient’s Refusal of Treatment
Be Respected? Discussion of a Hypothetical Case112
- Hiroko Ishimoto, Sakiko Masaki, Atsushi Asai
A Qualitative Study of the Attitudes of Three SelectedGroups in Malaysia on ethical implications of
Pre-implantation Genetic Diagnosis (PGD)
119- Angelina Patrick Olesen, Siti Nurani Mohd Nor,
Latifah Amin
Ethics status of clinical research and trials in developing
countries
124- Yuanyuan Liu
ABA Renewal and EJAIB Subscription
128

Editorial address, and all correspondence to:Prof. Darryl Macer, Ph.D., Hon.D.
Provost, American University of Sovereign Nations(AUSN), Scottsdale, Arizona, USA
Email: dmacer@au-sn.com
darryl@eubios.info
http://www.au-sn.com
http://www.eubios.info
Registered address of EJAIB: P.O. Box 16 329,
Hornby, Christchurch 8441, New Zealand

DO NOT MISS:
Bioethical Challenges and Responses to the
New Glocal Knowledge Economy: 16th Asian
Bioethics Conference (ABC16)
3-8 November 2015, Quezon City, Philippines
See ABA website for draft agenda and details!

Editorial: Public Health and Society
This issue starts with a paper highlighting some of the
ethical concerns surrounding the 2015 MERS outbreak in
Korea by the former President of the Korean Bioethics
Association, Prof. Bang-Ook Jun. There are a number ofrecommendations, including transparency between the publicand government in identifying hospitals where cases arebeing treated, and enhanced and equitable protection for
health care workers. Although that outbreak has ended, there
are ongoing cases in Saudi Arabia and Jordan with concernsthat the increased pilgrimage of persons in September will
challenge public health practices.
The next paper examines the Indian court case involving a
religious practice of Santhara by Jain’s and its similarities inthe eyes of a Court to suicide which is currently not “legal”.
Norman K. Swazo explores these links, and we note that
there is ongoing legal attention being paid to this distinction.
It has some implications for cultural practices that arise in
several cultures and in meditative practices that were seen
also in the Samurai tradition, and other places. It is surely partof an evolution in the way that we treat end of life. A paper
arguing that an Incapacitated Patient has a right to Refusal ofTreatment by Hiroko Ishimoto, Sakiko Masaki, Atsushi Asai,
examines a hypothetical case from ethical principles.
Three papers from Malaysia are descriptive in methods andinclude a study on the halal certification of medical devices in
Malaysia by Nur Farhani Zarmani e al. A nurturing model of
ethics and medicinal education at USM is presented byanalyzing student diaries as they accompanied practitioners
by Nor Azwany Yaacob et al. Angelina Patrick Olesen, Siti
Nurani Mohd Nor and Latifah Amin present a Qualitative
Study of the Attitudes of Three Selected Groups in Malaysia
on ethical implications of Pre-implantation Genetic Diagnosis(PGD), finding generally positive religious and medical
attitudes to the practice, and supporting informed consent byparents. Yuanyuan Liu explores through some Chinese cases
challenges in researchers use of ethics committees andappropriate informed consent forms.
We look forward to publishing more papers soon, and willth
be including some from the forthcoming 16 Asian Bioethics
Conference, to be held 3-8 November in Manila. EJAIB has
signed an agreement with EBSCO to include EJAIB papers in
the EBSCO journals service, although all the contents areavailable on the web through browser searches, this may
increase the visibility of the papers through another platform.
- Darryl Macer

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

Ethical Concerns
Surrounding MERS
Outbreak in Korea- Bang-Ook Jun, Ph.D.
President, Gangneung-Wonju National University, Korea
Email: bojun@gwnu.ac.kr

Middle East respiratory syndrome (MERS) is ahighly lethal respiratory disease caused by a1
coronavirus (MERS-CoV). Since the first case of
MERS-CoV in Korea was confirmed at 20 May 2015,
the numbers of cases seems to have dropped after 17
June 2015. Thirty five patients died and 186 patients
have been confirmed, while 16,668 unconfirmed
patients were quarantined (as of 10 July 2015), though
the introduction of MERS-CoV was started by a single
traveler. The Korean outbreak is the largest outside theArabian Peninsula.
Many authors pointed out several reasons tocontribute to this unexpectedly large and complex
2
spread of MERS-CoV in Korea. First, MERS is
comparatively new disease. With the exact mode oftransmission and source of MERS coronavirus still
unknown, the development of treatment, let alone
vaccines, remain a long way off, making prevention all
3
the more important.
And the relative lack of
preparation for such a novel disease resulted in the4
rapid transmission in healthcare settings and beyond.
Second, MERS-CoV is difficult to diagnose
particularly in the early stage of infection. The index
5patient did not report his recent travel history. This low
index of suspicion caused a delay in the initial
6
diagnosis, and the important reason for the spread of
the virus may be relative unpreparedness for7
prevention and limited epidemiological expertise.
Third, the conditions and customs of Korean
hospitals made the matters worse. Emergency rooms
are often crowded and have not adequate isolation andventilation facilities, and patients on wards often use
the family members and non-hospital caregivers to
1

A Zumla, D S Hui, S. Perlman. 2015. www.thelancet.com
M H Hyun, Y Park. 2015. Re: Why the panic? South Korea's
MERS response questioned. British Medical Journal BMJ
www.bmj.com/content/350/bmj.h3403/rr
3
2015. MERS-the latest threat to global health security.
www.thelancet.com The Lancet 385:2324 Published online 13
June 2015.
4
C Thomas. 2015. MER-CoV: Where are we now? Annals
Academy of Medicine 44:155-156.
5
World Health Organization. Middle East Respiratory
Syndrome(MERS)
inthe
Republicof
Korea.
http://www.who.int/csr/disease/coronavirus_infections/situation-assessment/update-15-06-2015/en/ Published online 15
June 2015.
6
M H Hyun and Y Park. 2015. Re: Why the panic? South
Korea's
MERS
response
questioned.
www.bmj.com/content/350/bmj.h3403/rr
7
A Jack. 2015. Why the panic? South Korea's MERS
response questioned. British Medical Journal BMJ
2015;350;h3403 Published online 24 June 2015.
2

8

provide basic care. The habit of doctor shopping,
visiting multiple hospitals seeking care, also facilitated9
the spread of MERS-CoV.
Other reasons with some ethical concerns
contributed this outbreak. The government did notdisclose hospital names, so the further transmission of
the MER-CoV was unavoidable. The hospital did notsupply sufficient protective gear to protect thehealthcare workers and increasing numbers were
infected as a result of poor infection control
10measures. Also they even discriminated between
regular workers and part-time workers in protection of
infection. Lastly, the self-quarantined MER-CoV carriers
behaved in out-of-control manner.
Governmental Secrecy over MERS-CoV Information
There has also been concern that government
secrecy triggered panic and led to unnecessary
11
disruption. The Korean government refused to identify
the hospital where the patients visited or were being
treated. However, this refusal fueled the rumors: People
could not know whether they had been exposed.
Patients who should be treated got fear of going to any
medical facilities. All the reported cases during the earlyphase of outbreak were among the medical staff,
patients or visitors at several hospitals. The secrecy did
not curtail but raised the risk of disease as shown by
the Korean case. The first line of an endemic defense
must be full and complete transparency between the12public, government agencies and nations.
The opposition party accused the government thatthe refusal to disclose the name of hospitals thattreated MERS patients eventually lead to containment
failure of the MERS-CoV. The government mightapparently fear the announcement would hurt the13
profits of the hospitals.
The Korean government also tried to downplay
concerns about the disease. Worrying negative
economic effects, President Park and othergovernmental leaders urged the public and the8

A Jack. 2015. Why the panic? South Korea's MERS
response questioned. British Medical Journal BMJ
2015;350;h3403 Published online 24 June 2015.
9
World Health Organization. Middle East Respiratory
Syndrome(MERS)
inthe
Republicof
Korea.
http://www.who.int/csr/disease/coronavirus_infections/situation-assessment/update-15-06-2015/en/ Published online 15
June 2015.
10
A Zumla, D S Hui. 2014. Infection control and MERS-CoV
inhealth-care
workers.
Lancet383:1869-1871.
www.thelancet.com Published online 31 May 2014.
11
A Jack. 2015. Why the panic? South Korea's MERS
response questioned. British Medical Journal 350:h3403.
Published online 24 June 2015.
12
Whensecrecy
kills.
http://www.taipeitimes.com/
News/editorials/archives/2015/06/06/2003620020 Published
online 6 June 2015 MailOnline. 6 June 2015.
13
NPAD accuses government of favoritism to Samsung
hospital.
http://www.koreaherald.com/view.php?ud=20150619000970
Published online 19 June 2015

Eubios Journal of Asian and International Bioethics 25 (July 2015)14

business community to return to normal.
Theauthorities tried to persuade society that MERS is justanother seasonal flu, and simple hygiene such as handwashing may effectively prevent this disease. As theextent of human-to-human transmission was unclear,this attitude could mislead people. As theconsequences of infection seem to be severe, people
should be more prepared to prevent the transmission
15
according to the precautionary principle.
Hospital Negligence
The most important thing to manage a viral
respiratory infection is the containment of the index
patient and probable carriers inside the hospital. In
case of the close contact, it was recommended by the
U.S. Centers of Disease Control, that the medical staffs,
patients and visitors wear a surgical mask, gown andgloves on entering the emergency room and wards.
The second edition of the Korean MERS manual, usedby 24 May 2015, neglected the above guidelines.
Medical staffs staying in the same treatment facilities
for symptoms of respiratory infection, or visitors within 1
meter of the patients were only considered as close
contacts, and probable carriers without this range wereomitted from the quarantine list. In addition to contact
precaution, airborne precautions should be applied toreduce contamination in the hospital setting. Medical
facilities should apply proper room ventilation rate andthe suspected patients should be contained in thisproper ventilated room. In fact, Samsung Medical
Center has sufficient mechanical ventilation rooms anda separated infirmaries, but it did not contain patients inwell-equipped emergency rooms.
As of 26 June 2015, totally 39 medical staff were
infected by MERS-CoV. Eight doctors, 15 nurses and
16 workers were included. This high infection ratio
indicates a failure of sufficient protective measures forhealth care workers. The protective gear of Samsung
Medical Center staffs had apparently been insufficient.
The Ministry of Health and Welfare reinforced theprotection measures afterward. While the government
recommended Samsung Medical Center to provide Dlevel protective gear for medical staff, it provided
protective equipment called VRE - which leaves the16neck and ankles exposed - until 17 June 2015.
Another ethical issue that workers in the medical
facilities were not treated equally is arising. In earlyoutbreak, hospital orderlies were not provided withmasks nor protective clothing. The ninety second

14

J Kim, J-M Park. Moody's say MER poses risk to South
Koreaneconomy,signs
outbreakslowing.http://www.dailymail.co.uk/wires/reuters/article3129149/Moodys-says-MERS-poses-risk-S-Korean-economysigns-outbreak-slowing.html Published online. 18 June 2015.
15
J W Choi, K H Kim, Y M Cho, S H\ Kim. 2015. Current
epidemiological situation of Middle East respiratory syndrome
coronavirus clusters and implications for public healthresponse in South Korea. Journal of Korean Medical
Association 58: 482-497.
16
Anothersamsung
doctorcontracts
MERS.
http://www.koreaherald.com/view.php?ud=20150626000879

99

patient, security officer emergency room of Samsung
17
Medical Center was not wearing N95 mask, had beenin contact for about ten minutes with the Sixth patient
aged 71, dead and confirmed with MERS-CoV
18
infection. After the infection, the Ministry of Labor
recommended the hospital to supply masks foroutsourced workers.
Also the hospital was accused of a poor probablepatients' listing. After close contact with the fourteenthpatient, an ambulance worker came into contact withpatients and medical staffs for nine days who were
having MERS symptom. The hospital omitted theworker from the quarantine list only because he was a19
non-regular worker.
Patient (Carrier) Irresponsibility
Some people did not show willingness to follow thequarantine procedure and in some instance thehospitals did not gave clear directions for quarantine.
For instance, the son of the third patient, after close
contact with his father, then took a flight to Hong Kongto China via Hong Kong despite the onset of symptoms.
He was later in isolation with confirmed MERS in
Huizhou, Guangdong province, and high-risk close
contacts were under surveillance. His trip widened theinternational pool of people who have to be tracked for20
possible exposure to the disease.
Even a Korean doctor couple, after treating a MERS
21
patient, defied self-quarantine and visited Philippines.
The governmental secrecy, Hospital negligence, andprobable patients' irresponsibility altogether increased
the risk of transmission of the MERS-CoV and those
eventually lead to harm to others. The principle ofnonmaleficence designates that one should not act inways to cause harm to others. Particularly, one should
avoid harm or even the risk of causing harm. This
principle can be violated with or without intention. Even
if someone doesn't intend harm to a patient or otherperson through unnecessary risk, he/she cannot avoid
violating this principle. Though the government,
hospitals and probable patients in quarantine did notintend harm to other persons, they unknowingly
subjected people to unneeded risk and they were22
supposed to violate this principle.
17

Ministry of Labor recommend "The hospitals must supply
masks
for
subcontracted
workers."
http://news.khan.co.kr/kh_news/khan_art_view.html?artid=20
1506121546561&code=940702 Published online. 12 June2015.
18
http://koreatechblog.com/weather/mers-virus-outbreak/
19
MERS-stricken
Samsung
hospital
faces
crisis.
http://www.koreaherald.com/view.php?ud=20150616001120
Published online 6 June 2015.
20
2015. MERS-the latest threat to global health security.
www.thelancet.com The Lancet 385:2324 Published online 13
June 2015.
21
L. Abella. South Korean doctors defy MERS self-quarantine,
visit Philippines. http://kickerdaily.com/south-korean-doctorsdefy-mers-self-quarantine-visit-philippines/ Posted on 9 June2015.
22
http://rhchp.regis.edu/hce/ethicsataglance/
Nonmaleficence/Nonmaleficence.pdf

100

Eubios Journal of Asian and International Bioethics 25 (July 2015)

Research Ethics
The other minor ethical issue of the research ethics
can be raised. Recent MERS outbreak in Korea
probably put pressure on epidemiologists to accelerate
paper publication as fast as they can. Three rapid
communications were published in the same copy of
23
Eurosurveillance,
a medical journal published by
ECDC and one regular paper was published in Korean
24
Journal of Medical Association already. The race topublish could lead them to ignore research ethics, as
25
we have seen before. Two investigators of Gyeonggi
Infectious
DiseaseControl
CenterEpidermic
Intelligence Service asked the journal Eurosurveillace
to retract the epidemiological paper on the South
Korean MERS-CoV cases because investigators of
Gyeonggi infectious disease control center used thedata on 37 MERS-CoV cases at St. Mary Hospital in
Pyeongtaek without proper permission of the centerand they added names of two complainants who were26
not informed about the content of that paper. So thejournal Eurosurveillance published a note of concern on
27
the improper authorship and data use.
Experimental Treatment
Besides these ethical concerns, there can be
another ethical issue using unproven treatment directly
to the patients. At Samsung Medical Center, two MERS
patients were injected with blood plasma from fully
28
recovered patients.
The plasma therapy was
conducted on two MERS patients after obtaining their29
consent to improve the emergency condition where no30
other treatment was available. The clinical basis of
23

Avian
Flu
Diary.
http://afludiary.blogspot.kr/
2015/06/eurosurveillance-three-mers-rapid.html
24
J W Choi, K H Kim, Y M Cho, S H Kim. 2015. Current
epidemiological situation of Middle East respiratory syndrome
coronavirus clusters and implications for public healthresponse in South Korea. Journal of Korean Medical
Association 58: 482-497.
25
K Kupferschmidt. Research team clash over too-similar
MERS
papers.
http://news.sciencemag.org/asiapacific/
2014/06/research-teams-clash-over-too-similar-mers-papers
Posted online 10 June 2014.
26
Epidemiology investigators and medical doctors struggling
over MERS paper published in an international journal.
Chosun Ilbo. Published online 3 July 2015 (in Korean).
27
H Y Park, E J Lee, Y W Ryu, Y Kim, H Lee, S J Yi. 2015.
Epidemiological investigation of MERS-CoV spread in asingle hospital in South Korea, May to June 2015.
Eurosurveillance
2015:20(25):pii=21169.
http://www.
eurosurveillance.org/Viewarticle.aspx?Articleid=21169.
28
South Korea Tried Old Weapon to Fight MERS. The WallStreet Journal Published online 17 June 2015.
29
South Korea conducts experimental plasma therapy on
MERS patients. http://www.reuters.com/article/2015/06/16/ushealth-mers-southkorea-deaths-idUSKBN0OV2XU20150616
Published online 16 June 2015.
30
South Korean begins experimental MERS plasma trial
considerseconomic
stimulus.
http://www.washingtonpost.com/news/to-yourhealth/wp/2015/06/16/south-korean-officials-go-on-offensiveagainst-mers-plasma-trial-begins-stimulus-considered/Published online 16 June 2015

injecting blood plasma on MERS patient is weak,though it was previously used on patients infected by
31
SARS and Ebola. A phase 2 clinical trial of serum
containing antibodies from MERS survivors is being
32
planned. Though this convalescent plasma therapy issuggested as the emergency measure for MERS-CoV
33
infected patients, it could raise several questions; how
can we analyze danger against safety of that therapy,
in what patients' condition can we apply plasma
injection therapy, or can we prepare additionalguidelines to conduct plasma injection?
Conclusion
The
KoreanMERS-CoV
outbreakwas
extraordinarily large and complex due to theunpreparedness for this comparatively new disease.
MERS outbreak in Korea not only raised the concern
over endemic disease but also called attention toseveral ethical issues such as governmental secrecy,
hospitals' negligence, patients' irresponsibility, andresearchers' misconduct. The former three altogether
were supposed to violate the principle of nonmaleficence, and that eventually caused illness andeven death to patients. In addition to the proper
prevention and treatment measure, we must raisesome ethical sensitivity to cope with the risks of thisdeadly pandemic disease.

Santhara between Law and
Morality: India’s Dilemma
about a Jain Practice- Norman K. Swazo, Ph.D., M.H.S.A.
Director, Office of Undergraduate Studies, Office of the Vice
Chancellor; Professor of Philosophy, Department of History
and Philosophy, SHSS; Professor of Public Health,
Department of Public Health, SHLS, North South University
Office: ADM 622, Bashundhara R/A, Plot #15, Block B, Dhaka
1229, Bangladesh
Email:norman.swazo@northsouth.edu

The Legal Issue
In the year 2006, Mr. Nikhil Soni filed a D.B. Civil
Writ Petition (No. 7414), a matter of public interest
litigation (Nikhil Soni v. Union of India & ors.), filed withreference to Article 226 of the Constitution of India.
(High Court, 2015)
At issue is the practice of“santhara” (also called “sallekhana”) performed bymembers of the “Shvetambara group” in the Jain
31

Y Cheng, R Wong, Y O Y Soo, W S Wong, C K Lee, M H L
Ng, K C Wong, C B Leung, G Cheng. 2005. Use ofconvalescent plasma therapy in SARS patients in Hong Kong.
European Journal Clinical Microbiology & Infectious Disease
24: 44-46.
32
Too many unknown stymie response to MERS.
www.thelancet.com Vol 386:15 Published online 4 July 2015.
33
Anti-MERS-CoVconvalescentplasmatherapyhttps://clinicaltrials.gov/ct2/show/NCT02190799?term=MERS&rank=4

Eubios Journal of Asian and International Bioethics 25 (July 2015)
religion, santhara a matter of “giving up the body,”
involving “a fast unto death,” commenced after taking avow. The Court recognized the respondent definition of‘santhara’ with reference to Jain scriptures, as an action
undertaken “to weaken the strength of the body andpassion for putting an end to the bodily existence
without consciously coveting death by fasting” (italics
added). There are conditions for undertaking this vow,i.e., “one is faced with an unavoidable natural calamity,
severe drought, old age or an incurable disease,” with astrong recommendation that the matter be discussed“thoroughly and frankly” with a religious preceptor(guru).
There is a difference between petitioner andrespondents on the question whether Jains believe
santhara to be a means to moksha (denied in argumentfrom respondent). The Court acknowledged that,“Jainism believes in rebirth and so the consequences of
our Karmas are dependent upon own good and bad
thoughts, words, and deeds.” The goal of santhara isintentionally to “purge the soul from karmas” and to“attain salvation in the least possible number of birthand death cycles.” Jainist “metaphysics” understands
the body to be one’s “non-soul” (ajiva), related to thesoul (jiva), an individual to direct his/her life so as to be
emancipated from this entanglement (a goal called“atma darshan”). Jainism assumes an individual to bemaster of his/her own destiny, in which case it follows
as a matter of his/her own rational decision that s/he“follow the best method of leaving the body.” Theargument here involves a conditional proposition: If and“when the body does not cooperate to help in living
meaningfully any more, [then] the person should
resolve for Santhara.”
Petitioner in this case claimed that the practice of
santhara is a matter of religious thought but should betreated as an action both “illegal and punishable under
the law of the land” because (1) a religious practice,
however voluntary, “cannot be allowed to violate theright to life of an individual,” and (2) the practice of
santhara “amounts to ‘suicide’ [defined here as“intentional killing of oneself”], which is a criminal
offence” and punishable as such under the penal code.
‘Intention’ here involves an individual’s understanding
and anticipation of “the probable consequences of what
he is about to do.” The Constitution of India recognizes
a right to freedom of religion (Article 25) as afundamental right, even as Article 21 of the Constitution
recognizes a citizen’s entitlement “to freedom of
conscience and the right freely to profess, practice andpropagate religion.” However, the claim from petitioner
is that the right to life has precedence, in which casethe entitlement to religious belief and associatedpractice is limited thereby.
The State government adopted a “protectionist”
position on grounds of the fundamental right to freedomof religion and objected, inter alia, that petitioner failed
to substantiate his claims in a way that is required for
public interest litigation. It is granted that, only by“interests of public order, morality and health” may theright to religious freedom be limited as a matter of101

public law.
The Court noted the claim of one
respondent that at issue here is a contraposition of
Hindu (majority) and Jain (minority in religion andcultural community) religious beliefs and practices,hence “private ends” represented in bad faith as amatter of public interest and the public good.
Respondent furthermore cited court judgment(Smt.Gyan vs. State of Punjab, JT 1996(3), SC 339),
according to which an individual who is terminally ill anddying may claim a right to die with dignity “as a part ofright to live with dignity.”
The court in the cited case opined that such cases
do not involve “extinguishing life” but instead“accelerating conclusion of the process of natural death
which has already commenced.” However, this is not tobe confused with voluntary active euthanasia as
understood in European and American contexts of thedebate about assisted dying. There is some claim herethat the Jainist practice of santhara may be the sameas passive euthanasia as understood in the Europeanand American contexts, insofar as withdrawal of life
support is permissible in cases of terminal illness. The
analogy is that santhara is the equivalent of withdrawalof life support. Under the Jain metaphysics, death is aprocess involving exchange of body, in which case,respondent argues, an individual may claim “a moral
right to terminate his life.”
In its decision issued on 10 August 2015, the High
Court of Judicature for Rajasthan, India, expressed its
supervening question: “whether the practice ofSanthara/Sallekhana practised by the Shbetambarasgroup of Jain religion is an essential tenet of the Jain
religion,” in which case, if the answer is in theaffirmative, then the practice is “protected by the right toreligion under Article 25 of the Constitution of India.”
The Court cited Gian Kaur vs. State of Punjab, which
held that, “The right to life does not include the right todie. The right to human dignity does not include theright to terminate natural life…” Further, whatever
American and European conceptual and practicaldistinctions made between active and passive
euthanasia, the Court reminds that the Supreme Courtof India has “held that both euthanasia and assisted
suicide are not lawful in India,” the latter permissible
only through a legislative act that is for the time being
wanting. In this sense, then, the analogical reasoning
to permit the practice of santhara is not equivalent tothat which authorizes passive euthanasia. Currently,
the law of India does not criminalize refusal of lifesaving treatment.
Notably, the Supreme Court of India has
acknowledged the legal difficulty of dealing with thequestion of permission to die when an individual wishes
to discontinue life support. A procedure specified by
the Supreme Court must be followed. The procedureincludes review of the case by a medical committeethat includes a psychiatrist, a neurologist, and aphysician, with the Court then having authority to issue
its decision, “keeping in view the best interest of thepatient.” The implication here, then, is that under thelaw established hereby even a Jainist seeking to102

Eubios Journal of Asian and International Bioethics 25 (July 2015)

perform santhara must petition the Court and accept
the judgment rendered as to permissibility of death.
That said, the Court concedes that the “antiquity of Jain
religion and Santhara is unquestionably proven by its
mention in the ancient scriptures.”
The Court
concedes, furthermore, that Jain religion is “equally
modern and rational in its philosophy and approach.”
However, at issue in the Court’s judgment is whether
the practice of santhara is “an essential religious
practice”—“without which the following of the Jain
religion is not permissible.” The Court concluded that it
does not find the requisite evidence to allow this claim;
nor have respondents established the matter at issue
with the requisite evidence: “It is not an essential part ofthe philosophy and approach of the Jain religion, nor
has been practiced frequently to give up the body forsalvation of the soul.” The Court’s judgment is starkly
clear: “We are unable to accept the submission that thepractice of ‘Santhara’ or ‘Sallekhana’ as a religious
practice is an essential part of the Jain religion, to be
saved by Article 25 or Article 26 or Article 29 of theConstitution of India.”
The dire consequence of the Court’s judgment isthat the petitioner’s writ is accepted, that any form ofsanthara practiced by the Jainist community ispunishable under the Indian penal code, that the Stateauthorities are now directed to “stop and abolish thepractice of ‘Santhara’ and ‘Sallekhana’ in the Jain
religion in any form.”
The Moral Issue
The decision taken by the Indian court does notprejudge the outcomes of debates in India about either
euthanasia in general or physician-assisted suicide.
These debates remain inconclusive. Accordingly, theCourt recognizes the right of the legislature to settle thematter through an appropriate legislative act of thatbody. However, the decision of the Court, the ongoinglack of consensus among the Indian public, and thelack of legislative initiative do not eliminate the moral
and philosophical issues here. Law and morality
remain inextricably bound in any democraticallyconstituted government; and so, this is the case with
India. At the moment, because the matter under review
appealed to a question of constitutional law, the Court
could not but settle the issue in the way it did. But, one
can consider the moral question at hand differently;
because the “rationality” associated with the question atissue can be engaged in way other than that of positivelaw.
Those who adhere to, or otherwise find good reason
to tolerate, religious beliefs such as those held in the
Jain religion yet have moral standing to speak to thequestion at issue in light of prospective legislation. The
Court has not settled the normative question, since thisinvolves one or another moral account separate fromthe legal account. Hence, one may ask here what
constitutes a reasonable moral rationality to bejuxtaposed—and even contraposed—to the legal
rationality that grounds the Court’s approach to thepractice of santhara.

The above point about rationality issues from anengagement of the epistemological problem ofdivergent rationalities and divergent concepts of justiceabout which the prominent moral philosopher Alasdair
MacIntyre reminds us in any number of his works. In
his The Tasks of Philosophy, MacIntyre (2006)
contributes a chapter entitled, “The ends of life, theends of philosophical writing.” There, MacIntyre
reminds that, “A text or set of texts may on the one
hand engage those who read and discuss it, so thatthey become inhabitants of its conceptual world andformulate their questions only in its terms, so that, as it
were, their world becomes text and their inquiries are
no longer about the ends of life, even when these are
the subject matter of the texts in question, but only
about
the-ends-of-life-as-conceived-within-thisparticular-textual-universe.” [p. 127] Thus, this is what
has happened with those who are recipients of the
Court’s decision. The basic philosophical question
concerns what may or may not be done with respect tothe ends of life, but this basic question is now
marginalized by the dominance of the legal texts,
despite a review of religious and scholarly texts thatspeak to the issue of Jainist metaphysics and religious
practices. This is an important consideration, as amatter for philosophical interrogation, because, as
MacIntyre clarifies, it is not only the text or texts that areat issue, but the fact that the text is “read through layersof interpretation.”
There is a hermeneutic obligation presented here—viz., to avoid becoming “imprisoned within a textual
world,” when the life-world with its questions about theends of life remains central and pressing to thephilosophical and moral inquiry. Anyone seriously
engaging the Court’s decision must move beyond thattext and its rationality to consider what the Jainist
practitioner finds paramount about the ends of life,
including here the end that presents itself
metaphysically and physiologically as death through an
act of santhara.
The point is not to contest
metaphysical claims from the point of view of somestandard of truth (correspondence, coherence,
pragmatic, etc.), but to acknowledge that the questions
at issue have rival answers that are lodged in one or
another rational commitment. This includes the moral
philosophy or moral theology that is at play in thedisputation about meaning, about ends, and about thecorrect (morally permissible) means to achievement of
those ends.
It matters, for example, that in the case in India, thepetitioner is a practicing lawyer, in which case his
prejudice (taken here positively, not negatively) is oneof law, not that of morality per se. This petitioner
interprets santhara as an act of suicide, in which case,he finds this a criminal act, insofar as it is an allowanceand transgression of the right to life protected by theConstitution of India. This is, once again, a legal
interpretation. There is no philosophical or moral
assessment involved, even as the petitioner is nothimself a member of the Jain religious community. The
Court recognized the rationality of the Jain

Eubios Journal of Asian and International Bioethics 25 (July 2015)
metaphysical system, despite the Court’s conclusion
about santhara. Those concerned with “the ends oflife” have reasonable epistemological interest in theveracity of Jainist metaphysics and in the moral valueof santhara within this metaphysics. That said, it must
be remembered that the Jainist is concerned with theends of life and the means to fulfillment of those ends,
having some guidance from the Jainist metaphysics,
surely. But, s/he is not concerned with this as a matterof law or legal rationality at all. This concern with theends of life is what is salient and “urgent,” not the
Court’s legal reasoning or decision as such.
We must remember that the Jainist who takes a vowof santhara does so—as MacIntyre would say—under
the influence of whatever cultural ethos s/he inhabits.
For him/her, santhara as a rite of the Jain religion has
its own immediacy of meaning, without the need forsustained philosophical or moral interrogation. Hereone can ask what it means for a Jainist to live “anexemplary life” that then ends with the practice of
santhara, as a matter of personal conviction andexamination with his/her guru, which is itself
intermediate (according to Jainist metaphysics) to a
subsequent rebirth, soul (jiva) joined in rebirth to a new
body. The legal approach to the practice of santhara
does not engage this question; nor does the Court’s
legal assessment engage this question even whenconcerned to evaluate the variety of texts at its disposal
to decide whether santhara is an essential part of Jain
religion. It is in this sense that the justice that is to berealized in this matter, for the individual as Jainist perse, is more than what is stipulated by the Court in its
interpretation of what is and is not constitutionallyprotected.
For the Jain who undertakes the practice of
santhara, the underlying question is not “what does itmean to be a law-abiding citizen of India?” (an answer
to this question then being an account of what it means
to be a “good citizen”) but, rather, “what does it mean totake a vow of santhara?” (an answer to this question
then being an account of what it means to be a “goodman”). These two questions are contraposed such as
to disclose the contemporary sociopolitical problem ofIndia’s movement to democratic modernity, while
having a pluralist culture that includes a diverse
religious ethos, the latter having its antiquity and,
thereby, the authority of traditions of belief and practicelong established. Jainist metaphysics has its own
rationality, and with this rationality there is a concept ofjustice installed, such that, given the goal of atma
darshan, the Court’s decision amounts to an interdictionthat sets aside the propriety of this goal and the Jainist
concept of justice. Both as a matter of principle andpractice, the Court’s decision transgresses this Jainist
concept of justice that issues from the goal of atma
darshan as a guiding principle within the Jainist religion.
Hence, one can ask as does MacIntyre in his otherprominent work on this philosophical type question:
Whose justice? Which rationality? (MacIntyre, 1988)
Here we find the hermeneutic dilemma of “rival
justices” and “competing rationalities” that MacIntyre

103characterized and engaged: the dilemma that issues
from “considering the intimidating range of questions
about what justice requires and permits, to whichalternative and incompatible answers are offered bycontending individuals and groups within contemporarysocieties.” (MacIntyre 1988,1) India has its own “sceneof radical conflict,” its own “quarrel” between antiquity
and modernity, to resolve, if it can, without deferring
automatically to the authority of its Constitution and to
the interpretations of the courts. Citizens of India, noless than others outside of India, are called upon, as
MacIntyre puts it, “to confront the question: How ought
we to decide among the claims of rival andincompatible accounts of justice competing for ourmoral, social, and political allegiance?” (MacIntyre,
1988, 2) The positions advanced by both petitioner andrespondents in the High Court are party to this more
fundamental question, although neither has undertaken
this question per se so as to provide a meaningful
answer to guide either public deliberation, public policy,
or public law, much less moral resolution amongcontesting communities.
The fact is that the legal interpretive framework that
informs the Court’s analysis does not offer a way out of
the hermeneutic dilemma so long as it will merely
privilege its own legal rationality and its own
constitutional concept of justice. Similarly, merely
privileging the practical rationality that belongs to the
Jain religion likewise does not offer a way out of thehermeneutic dilemma. The petitioner sought legal relief
and thus legal resolution.
The Jain’s practicepresupposes a religious resolution.
Each hasinterpretive prejudices installed in the rationality eachprivileges, and these are unavoidably incompatible,
with attempted resolution of problems of justice alreadyincommensurable therefore. MacIntyre observes, as apoint of instruction to us: “And so when disagreements
between contending views are sufficiently fundamental,
as they are in the case of those disagreements about
practical rationality in which the nature of justice is atstake, those disagreements will extend even to theanswers to the question of how to proceed in order toresolve those same disagreements.” (MacIntyre, 1988,
4)
At issue here is an account of rationality and an
account of justice, thus justification of beliefs andjustification of practices both at issue under conditionsof contested rationality, cultural pluralism, and theinstallation of modernity yet in quarrel with the antiquity
of one or another religious ethos. This is a scene ofradical conflict that is not unique to India. Yet, thegovernment of India and the citizens of India cannot but
move forward with the requisite diversity of deliberationand disputation recognized for what it is, so as then to
engage the answer to the fundamental question about
the ends of life that the Jain practice of santhara hasbrought to the fore as a matter of rationality and justice.
While the Court’s decision follows from what is and is
not justiciable within the purview of the applicablejurisprudence, outside that framework there is ample
reason to find the practice of santhara as indeed

104

Eubios Journal of Asian and International Bioethics 25 (July 2015)

essential to Jain religion, thereby to find this practicemorally permissible when voluntary and according tocustomarydeliberative
vow
justifiedbythemetaphysical rationality that governs Jainist religious
beliefs and practices.

This paper will discuss the ethical aspects ofdeveloping halal medical devices for the needs ofMuslims in Malaysia and other Islamic nations.
Keywords: halal, certification, medical devices,
Malaysia, stakeholder

References

Introduction
Issue on halal authenticity is one of the major
concerns for Muslims today. In Islam, an importantfactor for Muslim consumers is whether a product ishalal (lawful) or haram (unlawful) (Ramin Jorfi et al.,2012). Malaysia is heading towards becoming a main
player in the world Halal market.
Demands for products with halal certification are
escalating, in line with the growth of population (Ahmad
Nizam Abdullah, 2006). Extensive literature often
debate on the determination of halal authentication ofhalal food product, cosmetics and pharmaceuticals(Mohammad Aizat Jamaludin et al., 2011). However, up
to the best knowledge of the authors, there is still no
specific study on halal medical devices. Hence, there isa religious need to provide medical devices that are
certified halal in order to cater to the needs of Muslim
consumers who make up 64.3% of the Malaysian
population.
The total value of Malaysia medical device export
was RM 15.35 billion (USD 4.76 billion) in 2013
representing a 7% increase over RM 14.35 billion
recorded in 2012 (AMMI, 2014). In the medical device
industry, there are a number of stakeholders who needto have their voices heard throughout the process.
Each stakeholder has diverse and unique needs
relating to the medical device, the needs of one may
highly affect the needs of another, and the relationships
between stakeholders may be tenuous (de Ana,
Umstead, Phillips, & Conner, 2013).
This study however, differs from the other as theaim is to identify two distinct types of stakeholders
involve in developing halal certification of medical
devices in Malaysia; either direct stakeholder or indirect
stakeholder. This paper demonstrates how thesestakeholder attributes differ for two distinct categories
of stakeholders. This study would be useful for all
players in this industry as the findings would help todevelop strategies to promote halal certification of
medical devices in Malaysia.

High Court of Judicature for Rajasthan at Jaipur Bench,
Jaipur, “Court Order in Nikhil Soni v. Union of India &ors.,” Ref. D.B. Civil Writ Petition No. 7414/2006, 10
August 2015.
MacIntyre, Alasdair, 2006. The Task of Philosophy, Selected
Essays, Volume 1. Cambridge: Cambridge University
Press. pp.125-142.
MacIntyre, Alasdair, 1988. Whose Justice? Which
Rationality? Notre Dame: University of Notre Dame
Press.

The ethical aspects of halal
certification of medical
devices in Malaysia
1

2- Nur Farhani Zarmani , Mohd Anuar Ramli , Shaikh Mohd
3
Saifuddeen Shaikh Mohd Salleh1
Master Candidate, Department of Fiqh & Usul, Academy ofIslamic Studies, University of Malaya, Kuala Lumpur
3
Lecturer, Department of Fiqh & Usul, Academy of Islamic
Studies, University of Malaya, Kuala Lumpur, Malaysia
2Consultant Expert, Programme of Applied Sciences with
Islamic Studies, Academy of Islamic Studies, University of
Malaya, Kuala Lumpur, Malaysia
E-mail: farhani40@ymail.com

Abstract
The medical devices industry is one of the fastest
growing sectors of healthcare industry with a large
market, a wide variety of products and growing
applications. In Malaysia, this industry is a major
contributor to the economy and government initiatives
support its growth to position Malaysia as a medical
device manufacturing hub in the Asia-Pacific region.
There are more than 180 manufacturers of medical
devices in Malaysia involved in the production ofsophisticated devices such as orthopedic products,
surgical instruments and dialysis machines. Local
companies are moving towards complying withinternationally recognized quality standards such as
ISO 13485 as an attempt to penetrate the global
market. However, there is a religious need to provide
medical devices that are certified halal in order to caterto the needs of Muslim consumers who make up 64.3%
of the Malaysian population. It is an advantage that
Malaysia halal certification industry is well-developed
and recognized as a model all around the world.
Malaysia shows a strong industrial manufacturingpotential for a wide range of halal products. The
availability of supporting industries thus provides
Malaysia with the ideal conditions to develop into a
medical device hub in Asia as well as to establish a
global acceptance model for halal medical devices.

Methodology
The framework proposed in this study is based on
two types of data collection; interviews and electronic
references. Preliminary interviews were conducted to
the local sutures manufacturer. It took about an hour
covering semi-structured questions. The manufacturer
was asked about the process of catgut production inorder to determine the halal-built-in through the
production chain and also the procedure to comply theinternational standard as well as the shariah.
Interview was also conducted to the Medical Device
Authority (MDA) in order to have the details on acts andstandards related to medical devices to follow as a

Eubios Journal of Asian and International Bioethics 25 (July 2015)
guideline to start the halal certification for the medical
devices in the market.
Discussion
Malaysian is fully committed to strengthening theHalal industry and achieving the vision of making
Malaysia a global Halal hub. Halal is part of Shariah
principle and is mentioned in The Holy Quran. Shariah
is the code of conduct for the Muslims to follow andapply in every activity (Ab Talib & Mohd Johan, 2012).
The definition of halal is permitted, permissible andlawful. Haram (non-halal) is the opposite of halal, whichmeans forbidden and unlawful in the context of Islamic
law. In present, halal aspect has become a concern inthe production and application of various products. For
examplemeat
products,
cosmetics
products,
pharmaceuticals products, services such as banking
and finance and tourism. Unfortunately, halal
certification for medical devices has not being
discussed intensely in the literature.
Fromastrategic
perspective,
stakeholder
management urges corporation to consider the impactof their action and decision making on the various
stakeholders. Stakeholder management, with its
underlying business ethics component, focuses on thefair treatment, by the “firm”, of its various group of
stakeholders: especially of suture manufacturers,
doctors, and patients. However, beside these primary
stakeholders, there are also important indirect
stakeholder such as civil society and pressure groups
who defend the interest of specific stakeholder groups.
There are also regulators such as law, official
institutions and control organisations; and finally thepress and other media. The stakeholder approach also
has to focus on the need for corporations to inform
transparently and through dialogue, especially in its
approach to pressure groups.
According to Freeman et al., (2004), stakeholder
theory has primarily focuses on corporate responsibility
towards a firm’s stakeholders. The literatures suggest
many classification of stakeholders using various
criteria (Vasi & King, 2012). Most classicalcategorisation, based on priority, refer to primaryversus secondary stakeholders (Donaldson, et al.,1995) or normative versus derivative stakeholders(Phillips, 2003).
Stakeholders are those groups or individuals withwhom
theorganizationinteractsorhasinterdependencies and any individual or group who canaffect or is affected by the actions, decisions, policies,
practices or goals of the organization. Primary
stakeholders are those who have a formal, official, or
contractual relationship, and all others are classified as
secondary stakeholders (Gibson, 2000). Primary
stakeholders enjoy a direct and contractually
determined relationship with the organization whereas
secondary stakeholders are at the boundaries of theorganization who may be affected on by its actions butlack any contractual connection (Fassin, 2012). The
secondary stakeholders are capable of influencing
whether the operation is effective (Gibson, 2000). The

105

implication is that a stakeholder is any individual orgroup with power to be a threat or benefit. Secondary
stakeholders include nongovernmental organizations(NGOs), civil society groups, activist groups, outsiders
or social movements (G. A. de Bakker & den Hond,2008).
Normative stakeholders are those stakeholders towhom the organization has a moral obligation (Phillips,
2003). However, derivatives stakeholders are thosestakeholders to whom the organization has no direct
moral obligation as stakeholders. These groups cover
the competitors, activist, terrorist and the media(Phillips, 2003). They can affect the organization evenwith no legitimate relationship with it.
According to the perspective of promoting halal
certification for medical device in Malaysia, this attempt
involve ethics responsibility. Ethically, this duty should
be a concern to large groups of stakeholders. In orderto promote halal medical devices, there is a need tobuild a platform for a discussion between both direct
and indirect stakeholders for halal medical device
standardization (Idamazura, 2014).
Primary stakeholders who should directly be
involved in the application of halal medical devices are
the manufacturers (local or international), doctors,
nurses, and patients. Basically, the manufacturers are
responsible to ensure that medical devices
manufactured meet or exceed the required standards ofsafety and performance (Norshakira Ramli, 2014).
The major users of medical devices include thedoctors and nurses who employ the medical device
only for the intended indications. They also ensure theproper use of medical devices by being a competentuser (having appropriate qualification, training andexperience). Besides that, doctors and nurses areencouraged to share experience gained with medical
devices with others (users, distributors andmanufacturers) by reporting any incidents to acoordinating centre from which warnings can be issued(Norshakira Ramli, 2014). The users also need toensure proper maintenance of medical devices during
active use and safe disposal of obsolete medical
devices (Medical Device Authority (MDA), 2013).
Patients and healthcare providers embody theengagement of religion with modern medicine on a daily
basis. Patients’ salient health beliefs and health carechoices are often informed by religious values andunderstandings. Religion also influences the practicepatterns of healthcare professionals in both visible andunconscious ways (Curlin, 2008).
However, the secondary stakeholders cover the
responsibility carried by the policy maker, which is the
Medical Device Authority (MDA), Department of Islamic
Development Malaysia (JAKIM), consumer association,and researchers. MDA serves to address issues ofhealth and safety of people associated with the medical
devices (Jabatan Perdana Menteri, 2012). Generally,
MDA is responsible in establishing and implementing
policies and regulations to control medical devices toensure safe and effective medical devices sold or madeavailable in the country (Nor Idamazura, 2014).

106

Eubios Journal of Asian and International Bioethics 25 (July 2015)

JAKIM is the authority responsible for Halalcertification in Malaysia. There is a high potential inpromoting halal medical devices in Malaysia since
Malaysia’s Halal certification issued by JAKIM is
globally recognised for its stringent criteria and isregarded as having a strong industrial and commercial
set up to produce and market Halal products as well as
having strong relationships with the major trading
nations of the world, and strong government support(Badruldin et al., 2012). The process of awarding Halalcertificates involves not only an official site inspection of
production plants but also the examination on the Halal
status of raw materials (Badruldin et al., 2012). In orderfor us to promote halal certification of medical devices
in Malaysia, this attempt has to take into account theneeds of its various stakeholders and balance theirdivergent interest (Frooman, 1999).
Acknowledgements
The authors would like to express their appreciation to
Postgraduate Research Fund (PPP) of the University of
Malaya for the financial support of this study (grant No.
PG033-2013B) and University of Technology MARA forsponsorship.

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Ahmad Nizam Abdullah. (2006). Perception and Awarness
among Food Manufacturers and Marketers on Halal Food in
the Klang Valley. Universiti Putra Malaysia.
Badruldin, B., Mohamed, Z., Sharifuddin, J., Rezai, G.,
Abdullah, A. M., Latif, I. A., & Mohayidin, M. G. (2012).
Clients’ perception towards JAKIM service quality in<IT>Halal</IT> certification. Journal of Islamic Marketing.
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Curlin, F. A. (2008). Commentary: A case for studying therelationship between religion and the practice of medicine.
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P. (2013). Value driven innovation in medical device design: aprocess for balancing stakeholder voices. Annals ofBiomedical
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Donaldson, T., Preston, L. E., & Preston, L. E. E. E.
(1995). Theory the Stakeholder of the Concepts , Evidence ,Corporation : and Implications. Management, 20, 65–91.
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Fassin, Y. (2012). Stakeholder Management, Reciprocity
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& D. M. H. (2011). Realisasi Pandangan Fuqaha Tentang
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Revisiting Peter Singer’sControversial Argument in
Animal Liberation- Christopher Ryan Maboloc, MA, MA Applied Ethics
Ateneo de Davao University, Davao City, Philippines
Email: ryanmaboloc75@yahoo.com

In this paper, I will question Peter Singer’s positionon the moral equality of all species. In order to highlight
how mistaken he is, I will apply this issue in the use ofanimals in medical research. Lastly, I will offer a softer
position compared to Singer that advances animal wellbeing without Singer’s prejudice against the othermembers of the human species.
Human Dignity and Moral Equality
According to Peter Singer, the idea that humanbeings and only human beings possess an inviolable
value is unfair. He writes in Animal Liberation: “Thebelief that human life and only human life is sacrosanct
is a form of speciesism…The only thing that
distinguishes the infant from the animal, in the eyes of
those who claim it has a right to life, is that biologically,34
it is a member of the species Homo sapiens.”
34

Peter Singer, “Animal Liberation,” in Daniel Bonevac, ed.,Moral Issues Today (Boston: McGraw-Hill, 2002), 86.

Eubios Journal of Asian and International Bioethics 25 (July 2015)
Speciesism is a violation of the basic principle ofequality. The reason is that it unduly favors humananimals in terms of the right to life. Non-humananimals, which are unable to defend themselves in arational way, are thereby put in a familiar disadvantage
because they cannot speak for themselves. In thisregard, the idea that those non-human animals are lessthan human puts the former at the lower end of theladder of evolution. Since non-human animals are notendowed with intrinsic moral worth, it makes using
them or manipulating them inside the research lab,
morally acceptable.
What is Singer’s position regarding the above? Let
us revisit Singer’s controversial argument in Animal
Liberation. He says: “The life of every human being issacred. Yet people who would say this about the infant
do not object to the killing of nonhuman animals. How
can they justify their different judgments? Adult
chimpanzees, dogs, pigs, and many other species far
surpass the brain-damaged infant in their ability torelate to others, act independently, be self-aware, andany other capacity that could reasonably be said to givevalue to life.”
There is no mistake in Singer’s assertion that weshould be sensitive to animal welfare and that theyshould be accorded at least the equality of treatment.
But Singer here compounds the notion of equality interms of moral status and equality in terms oftreatment. What is morally objectionable in his position
above is that he gives more moral worth to non-humananimals like a chimpanzee than that of a braindamaged child or infant. Singer (p.81) complains:“There are many obvious ways in which men andwomen resemble each other closely, while humans andanimals differ greatly. So it might be said, men andwomen are similar beings and should have similar
rights, while humans and nonhuman animals aredifferent and should not have equal rights.”
The position that animals are of greater value thanbrain-damaged infants because some non-humananimals like chimpanzees have higher thinking skills
than these infants is morally problematic because it
seems to suggest that moral worth proceeds only frommental functionality. Singer’s above argument suffersfrom two dangerous flaws. First, it identifies the dignity
or moral worth of the human person with that of ahuman person’s functional mental capacities. Second,Singer wrongly assumes that the higher “thinking”
capacity of nonhuman animals gives them a moral
status equivalent to that of a human person.
The dignity or moral worth of any man or woman
does not proceed from his or her mental skills or
capacities. Our dignity comes from our intrinsic value
as persons. Singer opines that the idea of personhood
35
can be misleading. This happens, he argues, when it
is taken to mean interchangeably as “human being.”
For him, a person is an agent or one who plays a role inlife. As such, he argues that a brain-damaged child fails

such a criterion. But I protest that the functioning of ourbrain has nothing to do with our moral worth. While abrain-damaged child has less autonomy in terms ofmaking judgments or somehow, none at all, due to aphysiological condition, nothing about it diminishes hisor her value as a human being.
Singer may argue that brain-damaged children areincapable of reciprocating or of choosing a future forthemselves, and so they have less interaction say
compared to active dogs, but the fact of the matter
however is that such a situation actually motivatesfamily members and others human beings to be morecompassionate about their children. The incapacitatedinfant in this regard is not excluded from that
community of beings although he or she cannot
physically move. Beyond the notion of utility, ourhumanity does not come from our usefulness in thisworld. Of course, objects matter because of theirfunctions. But humans are not objects. We are humans
because of the fundamental uniqueness of each andevery single human life. This uniqueness does notcome from our mental capacity. Rather, it emanatesfrom the unique way as to how each human life is lived
and shared with others.
While it is true that the brain-damaged child may not
be able to perform the tasks that a “bright” monkey can,but in the same manner, a “bright” monkey also cannot
also render the deep joy of parenthood, for instance, inthe basic recognition that there is a human life out therethat is a value in itself, because, however difficult thecondition, your child’s life is irreplaceable. While it is not
objectionable that we should minimize the pain andsuffering of non-human animals, assessing the issue
from the point of view of moral equality, to say the least,
is morally problematic.
The use of Non-human Animals in Medical researchNow, Singer’s position with respect to moral equality
becomes all the more a matter of moral concern when it
is applied in the case of using non-human animals for
medical research. It is a matter of fact that every
modern advance in medicine, every new drug, newoperation, new therapy of any kind, must sooner orlater be tried on a living being for the first time.
Prohibiting the use of non-human animals in any
experiment for biomedical research, according to Carl
Cohen, or sharply restricting it, must result either in theblockage of much valuable research or in thereplacement of animal subjects with human subjects.
There are very serious consequences, “unacceptable tomost reasonable persons,” Cohen argues, “of not using36
animals in research.”
The use of non-human animals in medical research,says Cohen, are justified since animals have no moral
or political rights. For Cohen, to have a right means tomake a claim. It is a claim that one party may exercise
against another. You have the right to demand from
36

35

rd

Peter Singer, Practical Ethics, 3
Cambridge University Press, 2011), 74

edition, (New York:107

Carl Cohen, “The case for the use of animals in biomedical
research,” in Daniel Bonevac, ed., Moral Issues Today(Boston: McGraw-Hill, 2002), 98.

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

your government, as an example, the just and equitable
distribution of welfare benefits. Furthermore, thecontent of any claim should be fully understood by eachparty. Non-human animals are incapable ofunderstanding any moral claim.
For Cohen, the lack of rational capacity restricts
non-human animals from making any plausible legal
claim against another. Whatever rights may be, Cohen(p.94) suggests, they are necessarily human; theirpossessors are persons, human persons. Humanbeings have that unique capacity for moral judgment.
For Cohen, humans are possessors of reason; nonhuman animals are not. Humans are autonomous moral
subjects; animals are not. For this reason, for Cohen,
animals cannot have legal rights. Cohen adds:“Humans have such moral capacities. They are in thissense self-legislative, are members of communities,
governed by moral rules, and do possess rights.
37
Animals do not have such moral capacities.”
The above means that humans do have moral
obligations on others. Since human beings are capableof moral reflection, they can assess or evaluate theconsequences of their moral judgments. As such,human beings can distinguish between right and wrong,
between good and evil. Non-human animals, however,following Cohen, lack these attributes. For this reason,
non-human animals cannot be conferred the same
moral status as humans. William Baxter offers a strict
anthropocentric position in this case: “The point is this:questions of ought are unique to the human mind andworld, they are meaningless as applied to nonhuman38
animals.”
So if medical research aims at promoting the greater
welfare of human beings, and granting that there is no
greater value than human life, then the use of nonhuman animals in medical research is acceptable. If
non-human animals are not utilized in biomedical
research, then we may not be able to undertake
biomedical studies that can potentially save thousandsof lives later. While computer simulations may beconsidered as a matter of replacement or while lines ofstem cells offer some significant advance in the field ofbiomedical research, the argument still stands that froma utilitarian point of view, the utilization of non-humananimals in the meantime have actually contributed to
the greater good and very survival of the humanspecies.
While we have to be considerate of the fact that
non-human animals indeed do suffer in the course of
medical experiments, the moral good or value of
medical research cannot be substituted for a concern
on whether or not a rat, rabbit, or a dog feels pain.
Singer’s argument on the moral equality of all animals
is misplaced because he tries to elevate the status of
non-human animals by being prejudiced against
members of the human species who are disadvantagedby physical situations that are not of their own

choosing. Singer is simply mistaken in equating themoral worth of non-human animals with that of a humanbeing.
The Principle of Non-harm and the Case for Animal
RightsTom Regan proposes a softer position with respect
to animal rights and well-being. For instance, Regan
puts into question the issue in terms of theunacceptability of the system in which we treat animals.
Regan notes: “Factory farming, they say, is wrong. It
violates animal rights. But traditional animal agricultureis all right. Toxicity tests of cosmetics on animals violate
their rights, but important medical research, cancer
research, for example, does not. The clubbing of baby
seals is abhorrent, but not the harvesting of adult39
seals.”For Regan, the fundamental wrong is the systemthat allows us to view animals as our resources, here
for us, to be eaten or surgically manipulated, or
exploited for sport or money. This strictly “means to anend” argument counters the moral justification thatseeks to advance the use of non-human animals for thewell-being of the human species.
But it can be argued that our common
understanding is that people have no direct duties toanimals. We think that we can do animals no wrong.
For instance, if someone will kill your goat, someone
has done something wrong to you, but not to your goat.
Killing your animal henceforth means violating yourrights over your goat which you as the owner areentitled to.
Thus, Regan says that it seems that “as for animals,
since they cannot understand contracts, they cannot
sign contracts and since they cannot sign, they have no40
rights”. The right to life then implies the direct duty not
to harm any human life. In the case of animals, our duty
is to the owners; to animals there is only an indirect
obligation. While the obligation is indirect, Regan
proposes that non-human animals should not be used
as mere instruments.
Based on the foregoing, it seems to me that the idea
proceeds from the fact that using animals harms them.
So the moral argument herein should be the principle ofnon-harm. Let me explain the principle of non-harm. In
both Singer and Regan, while moral capacity is absent
on the part of non-human animals, such does not entitle
human beings to harm the latter. Singer’s problem
however is that he is questioning the use of non-humananimals by comparing and equating their moral status
to that of a brain-damaged child. He even suggests thatsacrificing the unique life of that child should not alarm
any of our moral or cultural sensibilities. By proposing
infanticide, he seems to say that it is acceptable toharm a defenseless infant. Therefore, he is saying that
it is sometimes moral to kill a human being if that
39

37

Ibid. 95
38
William Baxter, “People or penguins,” in Daniel Bonevac,ed., Moral Issues Today (Boston: McGraw-Hill, 2002), 130.

Tom Regan, “The case for animal rights,” in Daniel
Bonevac, ed., Moral Issues Today (Boston: McGraw-Hill,
2002), 89.
40
Ibid. 90

Eubios Journal of Asian and International Bioethics 25 (July 2015)
human being does not or cannot reciprocate in thesame manner as an active dog. He commits more harm
too by saying that it is more immoral to kill a dog.
But can we not promote the idea of advancing andprotecting the well-being of non-human animals without
making comparisons? Dogs and other household pets
have been known to develop bonds of friendship withchildren, including children with special needs. We canalso say that policies may be developed in order toprotect non-human animals from abuses. These
policies do not in any way prejudice the relationshipbetween humans and non-human animals alike.
In rectifying Singer, what is morally tenable is tomaintain that it is unjust and morally wrong to kill any
human being because each and every human being isa person. Unarguably, this position does not prevent
one from also saying that it is also unjust or morally
objectionable to kill non-human animals. The principleof non-harm applies in both instances.
References
William Baxter. “People or penguins.” In Daniel Bonevac, ed.,Moral Issues Today (Boston: McGraw-Hill, 2002).
Carl Cohen. “The case for the use of animals in biomedical
research.” In Daniel Bonevac, ed., Moral Issues Today(Boston: McGraw-Hill, 2002).
Peter Singer. “Animal Liberation.” In Daniel Bonevac, ed.,Moral Issues Today (Boston: McGraw-Hill, 2002).
Peter Singer. Practical Ethics. (New York: Cambridge
University Press, 2011),
Tom Regan, “The case for animal rights.” In Daniel Bonevac,ed., Moral Issues Today (Boston: McGraw-Hill, 2002).

Nurturing medical ethics
and professionalism
through life experience:‘A day in a doctor’s life’- Nor Azwany Yaacob, Siti Rahmah Hashim Isa Merican, Wan
Nazirah Wan Yusuf
Students Personal and Professional Development Program,
School of Medical Sciences, Health Campus, Universiti Sains
Malaysia, 16150 Kubang Kerian, Kelantan, Malaysia
Email: Nor Azwany Yaacob: azwanyusm@gmail.com

Abstract
The teaching and learning on medical ethics andprofessionalism had been discussed as a process
beyond the boundaries of lecture halls. It is acomponent in medical education that should not be
focused on theory alone but more on inculcating it as awork culture in future career of a graduates. In
Universiti Sains Malaysia (USM), the basic theory andprinciples had been well scheduled as part of thecurriculum activities, but additional non-lecture activities
were also arranged to emphasize the application of it.
‘A day in a doctor’s life’ program is a program where agroup of year 1 medical students were assigned to a

109

volunteered medical lecturer. They will follow all thelecturer’s clinical duty such as ward round, clinic,
operations and patient education session. This paper
describes the qualitative findings from the students’reflection diaries. The students wrote about theirobservation on how the doctors communicate differently
in different situation and with different type of patient,
how they realize that doctor may not cure always but
the doctors’ act give the comfort that the patients’ needand how they realize that a doctor’s job must be carriedout with caring, determination and dedication that will
overcome all the challenges in medical profession.
These observations were more meaningful for them inpursuing their medical profession dream.
Keywords: Professionalism, Ethics, Education
Introduction
Medical ethics teaching had always beenemphasized in our Medical Degree curricular. The
teaching is spread continually throughout the five year
study period. There are always debates on whether
professionalism and ethics can be taught, who is thebest person to teach, how best to teach and how toassess the learning outcome. We believe that we cannurture the professional behavior by blending the theory
with application of it in real life event by making our
future professional aware of the ethical culture in thisfield of medicine. Prober and Heath (2012) proposed
way of changes in teaching our future doctors such as
simulation and case based exercises. These activities
do not replaced lectures but enable teachers to actuallyteach rather than giving speeches.
These
multidimensional methods will allow lecturers to perform
other role of teachers, i.e. role model and learningfacilitators (Harden and Crosby, 2000).
The year one Medical degree program in Universiti
Sains Malaysia (USM) begins with bioethics and social
health block. Lectures on professionalism, principles of
medical ethics, good communication skills are among
the lectures scheduled. Apart from these academic
activities, The Students Personal and Professional
Development Program had arranged a program called
Hospital attachment: A day in doctor’s life. This
program aimed to give the first exposure to the newstudents on routine work of a doctor, the variability oftasks and the importance of professional behavior in
medical practice.
Methodology
This paper described the reflection by the year 1
medical students from three academic sessions from2011 to 2014 who were involved in the hospital
attachment. Students are divided into small groups often and assigned to a clinical lecturer who volunteered
to participate. The students will follow all activities thatthe lecturer was involved in from morning to evening
and even night calls. Clinical departments involved areinternal
medicine,
pediatric,
generalsurgery,
otorhinolaryngology,
ophthalmology,
orthopedic,
neuroscience, plastic and reconstructive surgery,obstetrics and gynecology and emergency medicine.

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

The students were asked to observe and later reporttheir observations in a group reflective diary. They are
asked to describe what they had observed and what
they had learned from the observation. Thirty eightreflective diaries were reviewed for the underlying
themes by three coordinators.
Findings
Four themes were found from the content analysis.
These are professional behavior; empathy, caring andhumanity; teamwork and communication skill. The
physician professional behavior that had been
observed is the adherence to ethical and moral
standard, accountability and commitment (Table 1).

mental model on teamwork blended with mutual trust(Table 3).
Table 2: Humanistic values observed by students
Humanistic
Students’ reflection [Examples]valuesHonesty &integrity

Their concern towards their patientsshow how strongly sincere andcommitted they are towards what they
do for a living.

Table 1: Physician professional behavior observed
Professional
Students’ reflection
Behavior[Examples]
Adhering to highethical & moral
standards

Exercisingaccountability foroneself and forcolleagues

Demonstrating acontinuingcommitment toexcellence

Dr R reminded us to treat every
patient equally regardless of status,
race and religion “everyone has theright to receive a treatment, no one
should be discriminated”
Although the staffs were busy, they
still put on the sweetest andwelcoming smile. Dr I stressed thatsometimes we have to work withpeople from other departments so it
is crucial for us to build a good
rapport with them

I was amazed with their (doctors andstaffs) knowledge and the way they treat
their patients. They show respect, loveand commitment at the same time

Caring &compassion

The patient is a type 2 diabetes patient
who had undergone a left leg
amputation. She doesn’t want to gettreatment and gave up her life. Dr A was
so understanding and calm. Poor she
couldn’t even move her legs. We give
her motivation to move on.

Dr N told us -’we can only try ourbest to save people, but whether the
person can survive, it is not in ourcontrol’
It is not as easy as ABC to indicate
the real disease. From time to time a
doctor had to recall and update theirknowledge. For us, it is really cool!

Dealing with highlevel of complexity
and uncertainties

The doctors and the health careteam work very hard to approach the
problem faced by every patients,
with efficient communication,
discussion of diagnosis anddevelopment of thoroughly thoughtmanagement plans

Humanistic values are well observed by thestudents who reflected the observation of honesty,
integrity, empathy, and caring (Table 2).
The students also reported observations ofteamwork in the daily work of a doctor. They observed
how doctors work together between specialists andother health care personnel in making decision for thebest care of the patient. They also noted a shared

Dr S treats patient friendly. The old
medical record was reviewed eventhough it is thick as the Guyton book
Dr R was really patience and nice to herpatients and even though I’ve met
unfriendly doctors before this, her
attitude completely changed myperspective and I made myself apromise that I would treat my patients
just the same way when I become adoctor in future
Dr A showed us to an old man withprostate cancer. It a sad case and at theend we felt empathy towards the old
man and his family

I learned a lot – punctuality,
dedication, patience and emotionallystrongThey portray love and passion inwhat they do, which is an example ofproving that they have a career, nota job

Exhibiting acommitment toscholarship andadvancing the field

Finally we realized the reality of being adoctor – full of tiredness, irregular
working hours and continuous learning
but when you do your job properly andsincerely you will get all the satisfaction

Altruism &empathy

There was a man being catheterized as
he had difficulties going to thebathroom. “ouch!” I flinched at thethought of experiencing it myself. Guessthat’s what they call empathy, no?
We noticed the elderly woman in the
bed looking rather more ill than theothers. A woman in her twenties was at
the bedside, tears gleaming in her eyes.
Further at the foot of the bed, a young
man was having serious discussion witha doctor. Dr Y whispered to us that theold woman had a terminal illness andwas in critical stage. But despite all thatwas going around her, the elderly
woman exudes strength and couragethat seems to infect us all.

Eubios Journal of Asian and International Bioethics 25 (July 2015)
Table 3: Teamwork skill and attitude observed by
students
Teamwork skill andStudents’ reflection
attitude[Examples]

Adaptability

Team/collective orientation

Shared mental models

Mutual trust

I had the opportunity toobserve how the specialists
discussed and exchange
views in trying to diagnose apatient. It needs not only
wide knowledge andexperience but also needcooperation andcompensatory behavior withrespect to each other“Doctors’ don’t work alone”– work hand in hand withnurses and other personnel
We learned that anorganized environment andteamwork is strongly
required – every teammember had to play theirrole well to ensure task isdone wellIn order to solve the patientscases, doctors need tocooperate with each otheras a team and discuss
among themselves to figureout the best solution andmedication for the patients.
It showed us the importanceof teamwork andcooperation amongcolleagues

Students also observed the doctors and teammembers communicate with patients and the caregivers. They observed from the process of developing
rapport, gathering and sharing information to establish
a shared understanding between the physician and thepatients on the management (Table 4).
Discussion
Good professionals not only learn during thestudents years in classroom but continue to learn when
they start working through years of experience inmanaging patients and following examples from themore experience ones. It took years of life experience
to mould a physician into a professional; a doctor who
does not only have knowledge and skill but who will
behave professionally. A physician behavior such as
adherence to ethical and moral values, humanistic
values, accountability, and commitment defines medical
professionalism(WalshandAbelson,2008).
Humanistic values include honesty and integrity, caring
and compassion, altruism and empathy, respect
towards others and trustworthiness are values to learn
through life experience rather than just theory
supplementation.
Health care workers perform interdependence tasks
in achieving the common goal for the best care ofpatients. They have to work together even though they
may not undergo the training together (Baker et al,1112005). Students communicate with each other and with
their teachers on medical problem, but they have tolearn how to communicate the medical knowledge andinformation to their main client which are the patient
and the care givers. These include the essential ofcommunication tasks, i.e. building the doctor-patient
relationship, opening discussion, gathering information,
understanding patients’ perspective, share information,
reach agreement on problem and plans and provide
closure (Kalamozoo consencus, 2001). Team work andcommunication skills needs more than just theory.
Other mode of teaching such as problem basedlearning and formal curriculum have the limitation ofgiving the practical part of this. It was observed in thisprogram that students are able to observe andabsorbed the values. Thus, we teachers have toprovide the life experience and be the role model to ourstudents. These observations were more meaningful forthem in pursuing their medical profession dream.
Table 4: Elements of communication observed by thestudents
Elements ofStudents’ reflection [Examples]
communication

Developing
rapportGather, share
information

Establishingsharedunderstanding

Provide closure

Conversation may begins with a simple“how are you?” to make patient feel atease.
It’s funny to see the doctor interact withthe granny; she really is good at
winning his heart so that it is easier totreat him later.
I was so excited to see Dr R
communication skill to persuade thepatient to cooperate for the physicalexamination
The patient asks many questions andthe doctor answer them all. That’s how
to get a cooperation from a patient, by
responding to them and praise for thegood attitude they showed
We watched how she (the doctor)
communicated with the patient and her
subordinates and how she handled thepatient. It is not easy to communicate
with a patient especially if we don’t
understand what they said as it could
lead to misunderstanding. So we learn
here that we need to understand andclarify what the patients are saying to
avoid misunderstanding
We observed how Dr I communicated,gave conscience information on the
medications to his patients. He
patiently explained the procedures
which started with greetings and self
introduction.

References
Charles G. Prober and Chip Heath. Lecture Halls without
Lectures — A Proposal for Medical Education. N Engl J
Med 366;18; 2012 pp 1657-9
Harden R M and Crosby J R AMEE Medical Education
Guide No 20. The good teacher is more than a lecturer –112

Eubios Journal of Asian and International Bioethics 25 (July 2015)

The twelve role of a teacher (2000).Medical Teacher
22(4): 334-347.
Colin Walsh and Herbert T. Abelson.
MedicalProfessionalism: Crossing a generational divide
Perspectives in Biology and Medicine, volume 51,
number 4 (autumn 2008):554–64
David P. Baker, Eduardo Salas, Heidi King, James Battles
and Paul Barach. The Role of Teamwork in theProfessional Education of Physicians: Current Status andAssessment and Recommendations. Joint Commission
Journal on Quality and Patient Safety. April 2005, vol 31
No. 4
Essential Elements of Communication in Medical
Encounters: The Kalamazoo Consensus Statement.
Participants in the Bayer–Fetzer Conference on
Physician–Patient Communication in Medical Education
Acad. Med. 2001; 76:390–393.

Should an Incapacitated
Patient’s Refusal ofTreatment Be Respected?
Discussion of a HypotheticalCase- Hiroko Ishimoto
Gastroenterology and Hepatology, Kumamoto University
Hospital, 1-1-1 Honjyo, Kumamoto, 860-8556, Japan
Email: heaven272005@yahoo.co.jp- Sakiko Masaki,
Department of Bioethics, Kumamoto University Graduate
School of Life Science, Kumamoto University, 1-1-1 Honjyo,
Kumamoto, 860-8556, Japan
Email: sakikomaki@hotmail.co.jp- Atsushi Asai,
Department of Medical Ethics, Tohoku University Graduate
School of Medicine, 2-1 Seiryo, Aoba-ku, Sendai, 980-8575,
Japan
Email: aasai@med.tohoku.ac.jp

Abstract
In the present super-aging society, issues
concerning what treatment should be given forincapacitated patients have become more important
than ever before. This paper discusses whether or not
an incapacitated patient’s refusal of treatment should
be respected. The authors present a complete
hypothetical scenario involving a 75-year-old
moderately demented man suffering from malignant
lymphoma.
Of primary importance are the respect for patientdignity and the protection of human rights. Acts suchas coercion, disregard, restriction, and surveillancecan be unethical in many situations. The effectivenessof chemotherapy for malignant lymphoma and its
adverse outcomes could offset each other, leaving no
net benefits for the patient. The patient is vulnerable
and this very vulnerability requires the utmost
protection and care. However, protection must be
sensitive and comprehensive and the protection of hislife at the expense of many other valuable factors is
not justifiable. Coercing unwanted treatment would be
intrusion, not protection, because of the physical andpsychological suffering. When the refusal is explicit,
consistent, and stable enough, it should to be viewed
as true and current desire.
Due to moderate dementia, the patient has lost his
rational capacity, but his emotional capacity remains. If
the remaining portion of his personality is rooted in his
feelings, these feelings should be respected as muchas possible. Those involved in the care of the patients
who refuse treatment should not force them toundergo it simply on the grounds that it may be an
established standard in their own country. What must
be asked first is whether or not forced treatment would
promotethepatient’s
subjective
well-being.
Additionally, treatment decisions should not be
distorted due to the selfishness or discriminatory
feelings of those involved in his care.
In situations in which patients lack decisionmaking capacities, overriding the patients’ refusals oftreatment should be regarded as an exception, rather
than a standard course of action. Even in patients whoare incapacitated, treatment refusal could stem fromthe feelings of the individual. Their subjective wellbeing would not be improved through close
observation, restraint, denial, and coercion, thepurpose of which they does not understand.
Keywords: Refusal of treatment; decision-making
capacity; incapacitated patient; forced interventions;emotional capacity
1. Introduction
In the present aging society, both the number andpercentage of patients who lack decision-making
capacity have been increasing. Issues concerning
what medical care should be given and how
healthcare decisions should be made for such patients
have become more apparent than ever before. This
paper discusses whether or not an incapacitatedpatient’s refusal of treatment should be respected, i.e.,a commonly encountered ethical dilemma surrounding
elderly patients with moderate dementia (1). Previous
case studies in the field of biomedical ethics involving
refusal of care by incapacitated patients and theirarguments have focused on various difficult issues,
such as the difficulty of assessing patient decisionmaking capacity, disagreements over the treatment
plan by concerned individuals, judgments regardingwhether or not physicians should use legally-endorsed
or forced interventions, the shortcomings of surrogate
decisions, the challenge of managing current
preferences expressed by incapacitated patients, andthe moral responsibilities imposed on physicians (2,3). However, to the best of our knowledge, little
discussion and arguments have been established onwhether or not an incapacitated patient’s refusal oftreatment should be respected, with the exception ofissues pertaining to compulsory treatments forpsychiatric patients who are dangerous to themselves
and/or others.

Eubios Journal of Asian and International Bioethics 25 (July 2015)
In this paper we present a complete hypotheticalscenario (Table 1), discuss major factors that may
significantly impact the response to an incapacitatedpatient’s refusal of treatment, and present relevant
questions by referring to the scenario. The authors
then address and answer the aforementioned
questions and argue that medical interventions should
not be imposed upon the patient in the discussed
scenario, and that forced treatments should be
regarded as exceptions, rather than a standard courseof action. The authors also examine selfishness anddiscriminatory feelings among those involved indecision-making for incapacitated patients.
Table 1. Hypothetical Scenario for Discussion
Mr. A is a 75-year-old man who had retired from acareer with a pharmaceutical company. He had
developed hypertension 30 years earlier, undergone asurgical procedure for stomach cancer 20 years
earlier, and had an acute myocardial infarction withcoronary intensive care 10 years earlier. He wasdiagnosed with progressive Alzheimer’s disease when
he was 75 years old. He currently has moderate stage
dementia.
Mr. A was brought to the hospital by his family due
to his poor physical condition. Medical interview andphysical examination findings revealed significant
weight loss, systemic lymphadenopathy, and fever. He
suffered from dehydration and poor nutritional status.
Diagnostic tests confirmed the presence of malignant
lymphoma, and Mr. A was immediately admitted to thehospital. On admission, he seemed to recognize that
he was in a hospital room, but he did not understandhis medical conditions or the reason that he had been
admitted. This lack of understanding, secondary todementia, caused his remarks and behaviors tofrequently seem inconsistent and unrealistic.
The attending physician explained treatment
options for malignant lymphoma to Mr. A’s family, but
not to Mr. A himself. The physician informed his family
that chemotherapy for Mr. A’s condition would likely beeffective, and would improve his clinical symptoms
andprognosis.
Alternatively,
however,thechemotherapy could cause him to develop acute heart
failure and/or renal failure due to the tumor
destruction. After discussing the treatment options withthe family members, the physician visited Mr. A’s roomand said to him, “Let’s fix your disease.”
Every time the treatment for his condition was
discussed, Mr. A consistently and repeatedly told his
family and physician, “I want to go home without
treatment.” However, his family wanted him to undergo
chemotherapy because they hoped that Mr. A would
survive as long as possible. Mr. A had not written any
advance directives concerning medical treatments andhis family members were not aware of his previous
wishes on this matter.

113

Table 2: Important Questions Regarding the Caseof Mr. A
1. May restraints and close observation be used tocarry out chemotherapy?
2. Is it fair for Mr. A if he is treated in the same way as
patients whose decision-making capacity can improveor be restored?
3. Is it justifiable to change current attitudes toward anincapacitated patient’s refusal of treatment based on
the presence of advance directives, or knowledge ofthe patient’s previous wishes regarding medical
interventions?
4. Is it appropriate for a patient’s family and physician tochoose a course of action on behalf of the patient when
medical uncertainty regarding outcomes is significant?
5. Do the culture and times in which a patient lives
justify different courses of treatment for identicalconditions?
6. Is a patient obligated to undergo chemotherapy
against his own wishes on behalf of the family’sinterests?
2. Potential Factors Affecting the Response to an
Incapacitated Patient’s Refusal of Treatment
Several questions related to factors affecting the
response to an incapacitated patient’s refusal oftreatment are in Table 2. In the following sections, theauthors use the scenario of Mr. A to discuss several
factors that may impact the way that medical
professionals and patient families make decisions forincapacitated patients who refuse treatment.
2-1. Necessity of Restraints and Surveillance (close
observation)
Mr. A may pull out his intravenous (IV) line
because he does not want to stay in the hospital orreceive medical treatment. His 30-year experience,
which includes surgery and coronary intensive care,might negatively impact his preference for inpatientcare to some degree. He may simply forget that he isreceiving IV medications due to his moderatedementia, and may make sudden movements in his
hospital bed. It is likely that hand mittens, sensors
surrounding his bed, and/or a surveillance camera will
be used to prevent Mr. A’s IV line from coming out or
being withdrawn. Hand mittens are a form of physicalrestraint, and surveillance cameras and sensors are
methods of close observation. Chemical restraints,
such as sedation, could be used if he showed extreme
resistance to treatment. A whole body physicalrestraint may even be employed if he attempted toleave the hospital against medical advice. Mr. A may
experience serious psychological trauma, as well as
deep distrust of and anger against both medical
professionals and his family. Patients with dementia,
such as Mr. A, cannot understand the reasons why
medical professionals detain or restrain them. They
could be forced to undergo unwanted medical
treatment, which causes discomfort and suffering, anddue to the inability to recognize either its purpose orsignificance, their suffering might be intensified. Given

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

these serious concerns, is it appropriate to use
restraints and close observation to implement
treatments for a patient with dementia?
2-2. Possibility of Recovery from an Incapacitated
State
Attitudes toward treatment refusal by incapacitatedpatients are likely to change depending on thepossibility of patients recovering their decision-making
capacity. Whether a patient’s lack of such capacity ispermanent or temporary is a crucial factor that affects
the decision to override or accept the patient’s refusalof treatment. Here, decisional capacity refers to thespecific acts of comprehending, evaluating, andchoosing among realistic options (4). Appreciating thenature of one’s own medical situation and theconsequences of giving or refusing consent, rather
than merely understanding them, is crucial (5). The
authors assume that medical professionals and patientfamily members are likely to force incapacitatedpatients to receive recommended interventions despite
the patient’s refusal if the patient’s decision-making
capacity is expected to recover. For example, it islikely that a severely depressed patient who attemptedsuicide and refused a psychiatry consultation would beforced to undergo treatment for depression. Similarly,
forced interventions such as IV hydration may be used
in a patient with transient intensive care unit (ICU)
delirium who refuses treatment and oral fluids. This
reflects the current convention of providing treatment
to help patients avoid further self-harm, and to recover
their decision-making capacity, i.e., autonomy. In suchcases, the patient will regain decision-making capacity
and, in many cases, this coercion is later perceived as
beneficial by the patient. The patient would likely
appreciate this forced treatment when cognitive
function is restored (6), and may even thank thephysician for compulsory treatment later on. This,
however, is not Mr. A’s scenario.
Mr. A’s decision-making capacity will deteriorate
progressively and never improve, i.e., he will never beautonomous again. Due to the progressive nature ofhis moderate stage dementia, he will not understandthe meaning of his treatment, including chemotherapy
and other necessary measures, and will not appreciate
those who forced him to undergo chemotherapy. The
authors argue that significant ethical differences exist
between patients with curable depression or
temporary confusion versus patients with Alzheimer’s
disease like Mr. A, concerning the achievable goals ofcompulsive treatment. Therefore, the authors question
whether justice can be achieved if Mr. A is treated in
the same way as patients whose decision-making
capacity is likely to improve or be restored. It is also
argued that justice requires equals to be treatedequally and unequals to be treated unequally in
relation to morally relevant inequalities (7). The
possibility of recovery from an incapacitated state is a
morally relevant inequality.

2-3. Presence of Advance Directives
For the sake of argument, consider the scenario in
which an incapacitated, bedridden patient with asevere cerebral infarction suffers from aspiration
pneumonia. The patient adamantly refuses IV
antibiotic therapy saying, “No more needles, I have
had enough and am fed up with it.” Unlike Mr. A, thepatient has advance directives, which were preparedin an appropriate manner through advance careplanning (8). His directives indicate that he does notwant any life-saving interventions (including bloodtransfusions, antibiotics, hemodialysis, vasopressors,or any other intensive treatments) in the event that hebecomes bedridden and loses decision-making
capacity, and if there is no chance of improving his
underlying disease. In this case, some medical
professionals would accept his refusal based on thewishes expressed in valid advance directives, which
are regarded as important factors in planning apatient’s care (9). Others might disregard both hisadvance directives and refusal given the high efficacy
and low burden of IV antibiotic therapy.
In Mr. A’s scenario, however, there are no
advance directives and no one knows what his wishes
would have been regarding aggressive treatment ofhematologic malignancy prior to his loss of decisionmaking capacity. The authors believe that Mr. A’sexpressed refusal against chemotherapy would be
respected in the same way as that of the above case if
his advance directives indicated that he wishes toforego aggressive life-saving or life-prolonging
treatments in the event that he loses decisional
capacity. However, in Mr. A’s case, advancedirectives, which can justify forgoing or withdrawing
life-sustaining treatments for seriously ill patients, aremissing.
An incapacitated patient with advance directives
expressing treatment refusal, who is currently refusing
the same treatment, would be considered to be
expressing the fundamental values of his character.
However, the refusal of treatment by Mr. A, who has
no advance directives, could be considered the resultof irrationality, confusion, or disorientation due tomoderate dementia, although no reports exist on how
treatment refusal by an incapacitated dementia patient
has actually been dealt with in clinical settings.
Healthcare professionals confronted by such refusal
may consider themselves in a deadlock, and the
predominant course of action is unclear.
It cannot be denied that Mr. A’s negative feelingsand dim yet unpleasant memories of past inpatientcare have driven him to refuse further treatments.
Despite having not prepared written advancedirectives, he may have decided not to have any
aggressive medical interventions in the case of future
dementia. No one knows. It would be consideredunjustifiable for an incapacitated patient’s refusal to beignored if the patient clearly refused treatments andhad advance directives that were consistent with therefusal. On the other hand, is it ethically wrong toregard the current wishes of treatment refusal asEubios Journal of Asian and International Bioethics 25 (July 2015)
stronger evidence to justify forgoing intervention thanadvance directives written in the past, even if, like Mr.
A, the patient lacks decision-making capacity? The
authenticity and implications of a moderately
demented patient’s refusal should be carefully
deliberated because the patient lacks decisional
capacity. It is also necessary to contemplate whatmakes the patient refuse medical care and how
strongly the current refusal should be considered in
the treatment decision.
2-4. Magnitude of Uncertainty
Medical uncertainty refers to the uncertainty ofwhether the goals of a medical intervention would beachievable. Reliable data concerning success rates
may exist, but statistics cannot foretell what will
happen to an individual patient. The magnitude of
medical uncertainty varies depending on the clinicalsituation of the patient. In the current case,chemotherapy may alleviate Mr. A’s symptoms andimprove his prognosis. Conversely, side effects ofchemotherapy including vomiting, infection, and loss of
hair, and possible subsequent complications including
acute heart failure and/or renal failure due to tumor
destruction, could aggravate his condition or
potentially even be fatal. In such situations, medical
decision-making is a gamble. A capable patient would
decide upon a course of treatment by considering all
possible risks and benefits, with an understanding thatthe outcome of any decision is uncertain. However,
due to his dementia, Mr. A is neither able tounderstand the risks and benefits of his treatment
options, nor choose which intervention he deems mostdesirable.
In situations in which a moderately demented
patient like Mr. A clearly refuses a course of treatmentthat involves medical uncertainty and significant
consequences, are his healthcare providers and family
members justified in making treatment decisions forhim, against his wishes? The legitimacy of imposing
potentially life-saving chemotherapy with possible
lethal complications based on decisions by others
must be addressed. It is also necessary to balance
beneficence and non-maleficence in the care of amoderately demented patient who still retains theability to feel (i.e., is sentient) and express his or her
wishes.
2-5. Standard Course of Action in the Present Setting
Mr. A has voiced his refusal to undergo
chemotherapy, stating “I would like to go home without
treatment.” However, the standard course of action for
elderly patients with malignant lymphoma in thesociety in which Mr. A lives is to undergo
chemotherapy. Hence, it is very unlikely that his
refusal would be accepted without resistance fromthose involved with his care. This is because, within
Mr. A’s society, most people assume that he would
want to undergo chemotherapy for his lymphoma if hewere capable of rational decision-making. It is
common for families and healthcare professionals to115

insist that a patient with lymphoma undergo
chemotherapy, regardless of patient refusal in thissociety. In fact, regardless of society, it would likely bevery difficult for those concerned to accept refusal by apatient with or without decisional capacity if a rational
patient would agree to undergo the treatment.
In contrast, within societies in which the standard
course of action for elderly patients with hematologic
malignancies does not include invasive or aggressive
treatments, Mr. A’s wish “to go home without
treatment” would be perceived as natural andreasonable. It is very likely that aggressive treatment,such as chemotherapy, is not recommended, andhence the refusal itself may never occur in the firstplace. In Mr. A’s case, he is likely to be admitted due
to his temporary poor condition, but would bedischarged once stabilized without further treatment
recommendations. Therefore, whether or not thepatient’s wish to not undergo chemotherapy isregarded as treatment refusal depends on the medical
standards in a particular setting. Such standards,
which affect patients purely by chance, may determine
whether or not patient refusals are accepted.
Even in identical medical situations, social
acceptance of patient refusals may differ based on thetime and place where a patient happens to live. In asense, social standards at a particular place and time
determine the priority of values, and whether or not apatient’s treatment refusal is deemed perverse ispurely a matter of chance. The decisive power andintentions of family members also differ depending on
the time and place in which they exist. The authors
question whether it is ethically justifiable or acceptable
for a patient’s refusal to be treated differently based
merely on the place, time, and culture the patient
happens to be born in.
In present day Japan, for example, no legal
regulations concerning the termination of medical
intervention exist, and healthcare professionals are
uncertain about which actions or inactions are
forbidden. For example, no legally enforceable
advance directives exist. Also, when death is not
imminent, the right to refuse life-saving treatment is
not usually considered. In such situations, when thefamily’s opinion differs from that of the patient, patient
intent may not be given priority. “The Principle ofHarmony (Wa no Seishin)” overshadows respect forautonomy in most human interactions, including
clinical ones. Those who are too physically, mentally,or socially weak to express and maintain their wishes
are the most damaged by inappropriate medical
intervention imposed on them by others, in particular,
one’s own family (10, 11).
Medical interventions for incapacitated patients
may continue as psychological assistance for families
in Japan. Family members may want to avoid feelingsof regret such as ‘We have left this or that undone’
after the patient’s death, and this regret tends to steer
family members away from less aggressiveinterventions and a “natural course of dying.” (12) In
these circumstances, medical intervention presents a116

Eubios Journal of Asian and International Bioethics 25 (July 2015)

purpose for the family to pursue. When interventions
or “doing something” becomes the goal itself, rather
than a successful outcome for the patient,extraordinary measures never become useless or
futile since the alleviation of regret becomes anunconscious benefit for the family. There appears to
be an intervention principle involved where doing
something is better than nothing, regardless ofconsequences. However, doing something harmful orburdensome to a patient to ease familial regret is aserious abuse of medical interventions, regardless ofthe family’s psychological needs (10).
Culture can be regarded as a set of distinctive
spiritual, material, intellectual, and emotional featuresof society or a social group and it encompasses, inaddition to art and literature, lifestyle, ways of living
together, value systems, traditions, and beliefs (13).
The authors argue that respect for cultural diversity isimportant in the clinical setting, but the value of cultural
diversity should not be accepted without questioning
when it potentially conflicts with other values such as
dignity, liberty, and subjective well-being. Although themeaning of human dignity is ambiguous and various
definitions exist, the authors define human dignity as“humanness,” “being free,” “not feeling miserable orhumiliated,” and “living without losing human pride”(14).
2-6. Family Wishes
What values are protected by overriding anincapacitated patient’s treatment refusal? If a pregnant
woman refuses to treat a medical condition that isharmful to her fetus, forcing her to undergo treatment
would protect the life of the fetus, which is highly
desirable. If a patient with a highly infectious, deadly
disease refused isolation treatment, compulsory
treatment would save the lives of others and protect
community members. Compulsory inpatient care forpsychiatric patients who are a danger to themselves orothers also has apparent benefits. If a patient refuses
antibiotic therapy for an easily treatable disease thatposes a risk of serious or persistent medical
conditions, forced treatment may be used to preventthe resulting burden on the patient’s family and society(3).
It can be argued that forced interventions that
override refusal of treatment by incapacitated patientsare justifiable when direct or indirect harm may occur
to other members of society. In other words, common
good and third party benefits are prioritized overindividual preferences or benefits. In such cases, theincapacitated patient is considered to have a moral
obligation to receive unwanted treatments. However,in the case of Mr. A, is it justifiable to force treatment
despite his clear refusal? The treatment may save his
life, and thus fulfill his family’s wishes that he survive
as long as possible. The authors agree that family
satisfaction is important. However, can it be claimed,
without reservation, that Mr. A has a moral duty toendure unwanted chemotherapy for the sake of his
family? The authors argue that prioritizing anincapacitated patient’s desire over the wishes of thefamily is a crucial issue that needs to be addressed inreal world clinical settings.
3. Selfishness and Discriminatory Feelings
A number of the factors mentioned in the previous
section may impact the decisions and actions of those
involved in the care of an incapacitated moderately
demented patient, such as Mr. A, who refuses
treatment. The course of action and decisions made insuch situations may change depending on how thequestions presented in the previous section (Table 2)
are answered. The authors posit that selfishness, selfinterest, and discriminatory feelings of those involvedin the care of incapacitated patients are likely tonegatively influence the decisions made regarding therefusal of treatment by such patients.
It can be argued that decision-making by thepatient’s family may not be purely patient-centered.
There is always the possibility that family member selfinterests may distort perceptions of, and judgments
regarding, what is best for the patient. Such interests
include Mr. A’s pension benefits, which the family willcontinue to receive as long as he lives; the financial
burden of treating and caring for him; or life insurance
policies that he may possess. Family relationships
may also affect the attitudes of family members. All
these issues could lead to biases among family
members, and could sway consideration in their favor,
even if it is against the best interest of Mr. A. The
judgment of benefit is based on value, and both theunderstanding and perception of what is valuable arelikely to change according to personal experiences orbackgrounds. Thus, Mr. A’s values are not necessarily
the same as those of his family members.
It is also necessary to pay close attention to thediscriminatory feelings that family members or
healthcare
professionals
may
have
towardincapacitated patients, such as those with dementia. It
has been reported that such patients suffer fromdiscrimination in healthcare settings (15-18). The
authors ask whether possible discriminatory feelings
among those involved in the care of incapacitatedpatients may result in an underestimation of expressed
preferences, suffering, pain, agony, or anger in suchpatients. The authors also present the concern that thefamily members and healthcare professionals incharge of Mr. A’s care may immediately deem histreatment refusal as not deserving of serious
consideration due to his moderate dementia. There isapprehension among some who consider anincapacitated patient’s afflictions to be milder thanthose of capable patients, or who believe patients’emotions to be superficial. The lack of consideration
for Mr. A’s treatment refusal by those involved in his
care could result in forced interventions.
The reality of this situation is that it is impossible
to know the inner experiences of an incapacitatedpatient. Nevertheless, Mr. A could feel as if he wasignored, treated unfairly, or pushed even if he hasmoderate dementia. His experience would likely beEubios Journal of Asian and International Bioethics 25 (July 2015)
even worse if he had to be physically restrained.
These experiences and situations would be extremely
unpleasant as long as an individual is conscious andsentient, regardless of the level of incapacity or age.
4. Ethically Justifiable Decision-Making for
Treatment Refusal by Incapacitated Patients
It goes without saying that judgments regarding
Mr. A’s chemotherapy or other relevant issues should
not be distorted due to the self-interests or
discriminatory feelings of those involved in his care.
Serious efforts must be made to ensure that conscious
self-control is employed to prevent biased judgments.
In the following discussion, the authors suggest an
ethical course of action for Mr. A’s medical treatment
by answering the questions presented in Table 2.
Of primary importance are respect for patientdignity (i.e., “humanness,” “being free,” “not feelingmiserable or humiliated,” or “living without losing
human pride” (14)) and the protection of human rights(e.g., respect for human dignity and privacy,
prohibition of degrading treatment, right to liberty, andnon-discrimination). Acts such as coercion, disregard,
restriction, suppression, surveillance, and deception
are in principle unethical and unacceptable. Perceived
violations of human rights may occur in everyday life
or in a clinical setting. Medical interventions and carethat involve such behaviors should be permitted only
in exceptional situations in which sufficient reasons to
do so exist.
Is Mr. A’s situation exceptional enough to justify
ignoring his refusal and imposing compulsory
interventions? The authors do not believe so. Mr. A
does not pose a danger to himself or others. The
possibility
existsthattheeffectivenessofchemotherapy and the harm resulting from its side
effects or complications would offset each other,leaving no net benefits. Nothing is certain andchemotherapy for Mr. A can be called “bet.” He cannot
understand that his treatment is a bet or appreciatethat he has joined in on the bet. Patients withdecisional capacity provide their informed consent withan understanding of the uncertainties of diagnosis andtreatment outcomes (19). This, however, is not thecase with Mr. A. Is it inappropriate for a patient’s family
and physician to choose a course of action on behalfof the patient when medical uncertainty regarding
outcomes is significant?
Additionally, dementia is a major condition that willcontinue to worsen even if his malignant lymphoma
improves. The authors argue that Mr. A’s case does
not involve an exceptional situation that would justify
forced intervention and disregard of his wishes.
Because Mr. A cannot appreciate the benefit ofchemotherapy, he would likely regard many of its
effects as futile, and aggressive interventions would
not be justifiable to him.
It can be argued that coerced treatments such as
physical restraints could only be justifiable when it isnonintrusive, safe, non-experimental (3). Physicalrestraints might be acceptable only if no alternatives

117

exist, and there is a serious danger to the patient orothers and if it were used in the least restrictive
manner possible and for short duration (20). On theother hand, Mr. A cannot naturally appreciate thenecessity of physical restraints and it would incite fear
and anger. Moreover, in Mr. A’s case, the restraints
would not be for a short duration, and he would likely
suffer for a long period. Mr. A is not a threat to others,
and outpatient palliative care exists as an alternative.
Physical restraints, which undoubtedly deprive an
individual of freedom, would disregard his dignity in an
extreme manner. Thus, the authors argue that both
physical and chemical restraints should not be used
on Mr. A.
A claim could be made that Mr. A is vulnerable
due to his old age and lack of decision-making
capacity, and that this very vulnerability requires theutmost protection and care. The authors would argue,
however, that protection must be both sensitive andcomprehensive, and that the protection of his life at
the expense of many other valuable factors is notjustifiable. Forcing Mr. A to undergo unwanted
treatment would be intrusion, not protection, becauseof the physical and psychological suffering it would
cause. If Mr. A was temporarily vulnerable due to apassing and curable condition, then forced intervention
could ensure the protection of his future autonomy. Insuch a situation, forced treatment may be justified
because he could later appreciate such paternalistic
interventions. The reality of this case, however, is that
Mr. A is permanently incapacitated and he will never
be able to understand the good intentions of otherpeople. The possibility of a patient recovering his or
her autonomy is highly relevant for decision-making insituations involving an incapacitated patient who
refuses treatment. The authors argue that justicerequires Mr. A to be treated differently from atransiently incapacitated individual, i.e., it is unfair for
him to be treated in the same manner as patients
whose decision-making capacity can improve or berestored.
The fact that Mr. A refuses treatment, as well as
his basic aversion toward chemotherapy, should beemphasized the most in this discussion. As describedin the current case, Mr. A’s refusal is explicit,
consistent, and stable enough to be viewed as histrue, current desire. Due to his dementia, Mr. A has
lost his rational capacity, but his emotional capacity
remains. The authors argue that if the remaining
portion of his personality is rooted in his feelings, thenthese feelings should be respected to the extent
possible, provided that they are judged to be true andhis own. If Mr. A wants to go home and not receive
treatment, this desire should be respected. Those incharge of Mr. A’s treatment should attempt toempathetically imagine his feelings and, even if he did
not write advance directives or previously express his
wishes to refuse aggressive treatment, to respect what
he currently wants as a matter of principle. The
authors argue that, in Mr. A’s scenario, regardless of

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

the availability of advance directives, his feelings andstatements against treatment should be respected.
It is important to remember that the
aforementioned impure elements may impact
judgments made regarding the best interests of thepatient. The management of treatment refusal by anincapacitatedpatient
could
vary
significantly
depending on the culture, nation, institution, or time atwhich it occurs due to diverse value systems (13).
Different approaches may be employed in identical
medical situations. For instance, in elderly patientswith malignant lymphoma, both aggressive treatment
with chemotherapy and non-treatment may be
indicated for good reasons. It can be argued that those
involved in the care of incapacitated patients who
refuse treatment should not force them to undergo it
simply on the grounds that chemotherapy may be an
established standard in their own country. What must
be asked first is whether or not forced treatment would
benefit the patient’s subjective well-being. The
determination of an incapacitated patient’s bestinterests where no clues except current refusal exists
is difficult. However, it is unlikely that subjective wellbeing, dignity, and liberty would be protected throughthe imposition of something unwanted, particularly inpatients with longstanding decision-making incapacity.
Thus, medical care based on cultural value systems
that deprive an individual of dignity, liberty, and privacy
should be prohibited. It also goes without saying thatthe primary target of medical care is the patient, notthe patient’s family. The family’s interest should not beprioritized over that of the patient. Mr. A does not havea moral duty to receive chemotherapy to satisfy thedesires of his family, and adequately scheduled
palliative care would not cause any harm to his family.
If forced chemotherapy was initiated without Mr.
A’s consent in a single case, aggressive treatment
could become the established course of action, andother interventions aimed at curing the malignant
lymphoma may continue to follow. It is very likely that
if Mr. A’s refusal of treatment and wish to return home
is initially ignored, it will continue to be disregarded inevery subsequent step. Mr. A would then be in asituation with no option of turning back. The authors
argue that Mr. A may never lead a happy life if forced
chemotherapy and ongoing medical interventions
continued.
Finally, those who overrule an incapacitatedpatient’s refusal of treatment should be responsible forany consequences of the forced interventions. To
force unwanted treatment is to take on permanent andserious responsibilities. Mr. A’s sense of well-being
depends largely on the experience of comfortableemotions. Could those involved in Mr. A’s carealleviate his feelings of distrust, unpleasantness, andconfusion in any manner except by giving sedatives or
waiting for his emotions to dissipate? The authors do
not believe so. It is unclear what Mr. A will require in
the future to enjoy a high quality of life. However, theauthors cannot imagine that his subjective well-being
would improve through close observation, restraints,

denial, and coercion, the purposes of which he does
not understand. A better option for Mr. A would be inhome palliative care. Inpatient care, in and of itself,
can worsen the symptoms of dementia and aging,
resulting in confusion and anxiety, leading to further
harm.
5. Conclusions
In conclusion, even in situations involving patients
who lack decision-making capacities, overriding thepatient’s refusal of treatment should be regarded as an
exception, rather than a standard course of action,
especially when the refusal is explicit, consistent, andstable. Even in patients who are irreversibly
incapacitated, treatment refusal could stem from thepatient’s feelings. Due to his dementia, Mr. A has lost
his rational capacity, but his emotional capacity
remains. The authors argue that clear and persistent
refusal should be regarded as an expression of Mr. A’semotional capacity maintained in his current
personality and be viewed as his true and current
desire. It would be inappropriate for his family and/or
physician to choose a course of action on his behalf.
His refusal, which is rooted in his feelings, should be
respected. Mr. A cannot appreciate the nature andmeaning of medical treatments for his malignancy andthey would only cause suffering and agony. Patientsshould be treated with respect and courtesy, andmedical procedures should be avoided unless there
are good therapeutic reasons to pursue them (21). A
reason that one cannot understand or appreciate isnever a good one.

References
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Dictionary of Medical Ethics, BMJ Publishing group,
1997, London
8 Lois Snyder, JD, for the American College ofPhysicians Ethics, Professionalism, and Human
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9 Tom L. Beauchamp, James F. Childress. Principles
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Press, Oxford, 2009, p186-7.
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Toshinori Tanida. Death with dignity is impossible incontemporary Japan. Eubios Journal of Asian andInternational Bioethics 2012;22:49-53.
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Contemporary issues concerning informed consent
in Japan based on a review of court decisions andcharacteristics of Japanese culture. BMC Medical
Ethics 2014, 15:8
12 Kouzo Ishutobi. Heionshi no susume, Kodansha,
Tokyo, 2010.
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Ethics of Science and Technology. Bioethics Core
Curriculum. Section 1: Syllabus Ethics Education
Programme, UNESCO, 2008, Paris, 50-52
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Medical Friend Sha, Tokyo, 2004, p185-190,
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Icon Books, London, 103-7.,
18 Harry Lesser Ageism in Encyclopedia of Applied
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19 Legare F, et al. Core competencies for shareddecision making training programs: insights from aninternational, interdisciplinary working group J
Contin Educ Health Prof. 2013 ; 33(4): 267–273.
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London, p.100.

A Qualitative Study of the
Attitudes of Three SelectedGroups in Malaysia on
ethical implications of Preimplantation Genetic
Diagnosis (PGD)- Angelina Patrick Olesen Dr. (PhD in Bioethics)
Pusat Citra Universiti, Universiti Kebangsaan Malaysia,
43600 Bangi, Selangor, Malaysia (corresponding author)
Email: olesen.angelina@ukm.edu.my- Siti Nurani Mohd Nor, Assoc Prof Dr
Section for Co-curricular courses, External Faculty Electives &TITAS (SKET), University of Malaya, 50603 Kuala Lumpur- Latifah Amin, Assoc Prof. Dr.
Pusat Citra UKM, Universiti Kebangsaan Malaysia, 43600
Bangi, Selangor, Malaysia
Email: nilam@ukm.my

119

Abstract
The introduction of PGD in the clinical setting is adouble-edged sword. This technology has great
potential to prevent illness and diseases in novel ways,
but at the same time it brings about clinical, ethical andsocial dilemmas. The aim of this study was toinvestigate and explore the attitudes of the participants
regarding ethical issues arising from the use of PGD;
including questions on the moral status of the embryo,playing God, optimizing quality of life for future children
and the freedom of choice. In-depth interviews using an
open ended, semi-structured questionnaire wereconducted with 21 selected participants. The responses
to these questions were then analysed qualitatively
using thematic analysis. Participants from within the
medical fraternity unanimously used their vast medical
knowledge in reproductive medicine to explain theirperceptions on PGD. Whereby, for religious scholars,
responses on each theme are constantly related to thepossible consequences of PGD toward the unborn
embryos, resulting in a variety of responses because
opinions on the moral status of embryos differ from one
religion to another. Finally, a group of potential PGD
users clearly displayed their responses on the themes
either from the perspective of religious beliefs or past
reproductive histories, which explained the diversity ofviews on the ethical issues discussed. Their
perceptions on the themes described their rather
unique approach to the issues that are based on
several reasons, which emphasize their commitment totheir profession, patients, children or future children,and religion.
Keywords:
pre-implantation
genetic
diagnosis,
Malaysia, ethical implications, qualitative study,
thematic analysis
Introduction
William (2007) describes PGD as a new
reproductive technology that provides parents withchoices that are unavailable previously. It enables
parents to select embryos based on their genetic
characteristics before implanting the selected embryos
into the mother’s womb thus, prevent illnesses anddiseases. PGD however, brings about clinical, ethicaland social issues. While there is no doubt regarding theclinical usefulness of PGD for inherited disorders, there
is still doubtfulness on its reproductive outcome, whichbecomes one of the major clinical issues regarding
PGD (Kuliev, 2008). This may be due to the clinical andtechnical factors involved in PGD, which potentially may
affect the viability of embryos and the selection processof euploid embryos for transfer. Kuliev (2008) addedthat due to the limitations of FISH (Fluorescence In Situ
Hybridization) technique to test for only a part of the
genome also raised some clinical issues related toreproductive outcome of PGD.
According to Shenfield et al (2003), the increasing
numbers of PGD have led to three overriding concerns
about medical inappropriateness, ethical acceptability
and, adequacy of regulatory oversight. Medical
inappropriateness questions whether medical reasons

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

alone are enough for individuals to demand for PGD or
for physicians to provide PGD. Ethical acceptability
looks on how well accepted are the ethical issues thatarise from the use of PGD such as moral status of theembryos or issues of discriminations. And lastly,
adequacy of regulatory oversight asks whether thegovernment or medical community has done enoughmonitoring and supervision together with any existing
guidelines on the use of PGD. Cumulatively, there are
5187 clinical pregnancies that gave rise to 4140
deliveries and 5135 newborns [singleton; 3182, twin;
921, triple; 37] (Harper et al. 2012).
Despite being a new technology, the first case of
PGD in Malaysia was reported in 2004 (Abdul Rahman,Z. 2006). With little coverage regarding the case, it is
not known how members of the public react to such
medical intervention. Therefore, it is relevant andimportant to conduct this study in Malaysia in order tofind out how participants feel about PGD, and ethicaland clinical issues of PGD, and identifying the factors
behind their perceptions of PGD.
Materials and Methods
Twenty-one participants were voluntary participantsin this study. Eight of participants were medical experts,
whose work involves contact with women or couples
undergoing or who plan to undergo PGD and fertility
treatment. Seven were potential PGD users, wheremost of them had personal experiences with genetic
diseases, which could be a factor influencing theirdecision-making regarding PGD. The remaining six
were representatives from three different religiousorganizations where, their views and opinions could
potentially influence the views of members of theirgroups of their congregations regarding PGD.
In-depth
interview,using
semi-structured
questionnaires, were adopted for this study. The aim
was to encourage participants to articulate theiropinions on PGD using their own terms. For this study,
three different sets of open-ended, semi-structure
questionnaires for three selected groups of participant
were designed based on ethical and clinical issues
posed by PGD such as limitation of testing technique in
PGD, reproductive outcome of using PGD, moral statusof embryos, discrimination issues, safety issues andparental reproductive rights. There is a need to havedifferent set of questionnaires for each selected group
because some of the question asked would be more
toward medical knowledge, which would not beappropriate to be asking to participant that has no
medical background. On the other hand, some questionthat was meant to explore participant personal
experience raising and living with genetic disease
would not be appropriate for medical personal where
researcher focus more on their medical knowledge andexperience using PGD. The design of thequestionnaires was guided by a previous review of theliterature on PGD and they were consecutively pilot
tested.
Interviews lasted between 40 and 90 minutes.
Interviews were taped-recorded, and handwritten notes

were also taken during, or at the end of, each interview.
All of the interviews were transcribed and the data wasthematically analyzed to determine common patterns or
issues highlighted by the participants. The categories
were refined in the course of reading and re-reading
and continuously checking the data for counterexamples and alternatives. With each re-reading, newinsights occurred and it became possible to makeassociations and connections between different
aspects of the data. Key words and phrases werenoted, and as themes emerged and connections weremade in a cynical progression, they were re-grouped ina process similar to that utilized by other researchers(Redshaw et al. 2007). No new themes emerged during
the final interviews, indicating that data saturation had
been achieved. Quotations are used to illustrate thethemes generated by the analysis, to support theinterpretations made and to demonstrate the metaphorsthat appear to be operating in this context (Henwood
and Pidgeon, 1992). It is important to note that theopinions expressed by the participants involved in thisstudy cannot be generalized to the entire Malaysian
population.
Results
Moral status of embryo
Participants’ views on moral status of embryo areambiguous. Embryo’s status could be classified as justan accumulation of cells, a living human or non-living
human. For one participant: ‘It’s depends on ones
definition of when does life begin. Some people mightview that discarding of embryo during PGD as an act ofabortion and some might not’. (P7)
Discussion on the theme among potential PGD
users showed a rather interesting finding. They either
discussed moral status of embryo based on thepracticality of the technology, which view destruction ofembryos during PGD is part of the process therefore;
do not place embryo status higher: ‘Actually the ‘issue’
regarding embryo’s moral status has not crossed mymind. For me, embryo is embryo. I do not think it asanything else. The destruction of embryo happens
during the process because it is part of the procedure’.
(P10)
Or based their discussion on religious values,
where, the view of religious ruling body on embryo
status ranked higher than their own view on embryo
moral status. ‘I would prefer to know what does thereligious ruling body said about moral status of embryo
before I actually make any decision regarding embryo’s
status’. (P11)
Religious scholars’ views differ according to theirreligious teaching regarding the moral status ofembryos: ‘The process of conception itself is a processof which already has a moving direction or development
towards personhood. Therefore, it should be allowed to
grow and develop naturally. It should be allowed to
grow to its potential as human regardless of how it willturn out to be. It is not appropriate to destroy the livesof these embryos just because they might be disabled.
Who are we destroying what God has created’. (P16)

Eubios Journal of Asian and International Bioethics 25 (July 2015)
Contrary to the above statement, two other religious
scholars with different religious backgrounds statedotherwise: ‘In Islam, life is considered as sacred andshould be respected. However, embryo is considered
as living human only after 120 days of conception inwhich, in this period the spirit is breathed into it. So you
can see embryo that is use in PGD is not considered aslife yet because it is only a few days old.’(P20)‘If the decision to use PGD can end up withhappiness for both the couple and having a healthy
child fulfills their desire, then it is fine. There is no
reason to prevent them from using PGD. After all,
Buddhism emphasizes on personal happiness andfulfillment, and also the need to relief others from
suffering’. (P21)
Taking Over the Work of God‘I do not see it as trying to play God nor do I thinkthat parents who choose to go for PGD are trying toplay God. It is an individual choice. In fact for me, thatis an act of courage. Parent is willing to go through an
expensive, invasive and risky procedure such as PGD,
knowing there is still a small chance that it might fail. I
mean, what kinds of parent will you be when you knowthat you are able to do something to save your childand yet you do nothing about it’. (P1)
In this evocative description, it encapsulates how
parents are willing to try anything in order to make surethat their children are free from disease, particularly,
life-threatening genetic diseases. For some parents, thetrajectory they followed was more of an obstacle race inwhich they were beset by unexpected hurdles anduncertainty of how their children life will be when the
diagnosis was positive for genetic disorder. Therefore,
PGD seem to offer them the best solution to their
medical needs. However, for other participants, dealing
with the uncertainty and unexpected hurdles in raisingchildren afflicted with genetic disorder, reflect thestrength of motherhood and beauty of life itself. At thesame time, these participants mentioned that theirstrong faith in the Creator, motivates them to persevere
and perform the duty in raising their sick children withjoy and thanksgiving as they are able to spend timewith their children although it might be shortened by thegenetic disease. Based on these explanations, they
thus, viewed parents who tried to change the naturalprocess of human procreation via medical intervention
as trying to take over the work of God: ‘Sometimes,
although our children are sick, they always manage to
give us joy and happiness despite the struggle we haveto go through by taking care of them. I am talking basedon my own personal experience of raising my son who
is also a Thalassemia patient’. (P11)
Living with genetic disease could change people’s
perception on PGD because they tend to understandwhat others, who are in the same medical situation like
them, are going through. They described that having tolive with genetic disease your whole life makes you lookat certain issues differently as compare to being bornand remain healthy your whole life: ‘You can view it astrying to meddling with natural procreation process but

121

it depends on the individuals as well because they havetheir own reasons to do so. And due to my own
circumstances, I tend to understand why and I do notwant to pass judgment on those who use it’. (P13)
The emphasis for most potential PGD users was on
the ability to freely choose whether to use PGD or notwithout being judge as good or bad parents because
reason to use the technology are varied based on their
medical needs: ‘I also do not want to judge parent who
use PGD. Personally for me, these couples just want to
do the best they can for their child. As for myself, I
won’t totally reject the idea of using PGD but at thesame time, I am not saying that I will use it’. (P14)
Religious scholars’ views on this theme are varied
widely due to their different religious practices andbeliefs. Trying to change children based on the parent’s
desire is like rejecting God’s gift and plan in our life:‘How can you not say that it is not trying to take over
the work of God when clearly for me they have theability to select and discard embryos? If they are nottrying to play God, then no need to indulge in suchtechnology and just accept the child as it comes’.(P18)
On the contrary, another religious scholar has adifferent opinion: ‘If it is done for social reasons, it isforbidden in Islam because it does not have anynecessity. The act of choosing indicates that we are notpleased with what God has given to us. But if it is doneto avoid any disease, it is not trying to taking over
God’s work but rather our efforts to ensure that ourgeneration is fit enough and will not spread any genetic
disease’. (P20)
In many accounts, the impact of religious teaching
and beliefs on staunch believers could be very
profound, particularly when it comes to interventions
that possibly change the course of human procreation:‘I believe that everything happen for a reason. I accept
it as God’s plan in my life and if that is the case, I trustthat he will provide me with the strength to go throughit.’(P12)
In this, they were aware of the expectation andjudgments that can be made about their wish notwanting to use PGD although knowing it can help theirchildren lead a healthier life. For them: ‘Healthy or not,as a mother, I will love and accept him/her
unconditionally.’(P11 & P12)
Optimizing Quality of Lives
In describing how PGD could change their life, someparticipants viewed it as a way to optimizing the qualityof life for their future children, particularly for parents
who already have one or more children afflicted withgenetic disorder, and planning to have more children in
the future. PGD could avoid the transmission of
inheritable genetic disorders to their future children.
These participants regarded such desires as a parent’s
main responsibility in term of making sure that theirchildren are born healthy, thus do not see the decision
to use PGD to optimize the lives of their children as anegative desire: ‘Some genetic diseases are very rare
and treatments are sometimes very expensive oraccess to medication is very limited. That is why in122

Eubios Journal of Asian and International Bioethics 25 (July 2015)

certain situation, PGD might be the best solution forthese parents who wish to avoid the said predicaments
thus, avoiding the need to deal with the after care andtreatment of the child’. (P6)
Some responses to the topic on optimization ofquality of life via PGD are negative because the thoughtthat PGD enables parent to pre-select their future childreflected that it might or could lead to genetic
enhancement of children for other reason than medical
purposes, leading to “the slippery slope” argument.
However, for some participants, the negative
perception on PGD, particularly, the notion that PGD
can be used for genetic enhancement, arises due to thelack of knowledge on PGD:
‘PGD can give parents the perfect child, in term of theirhealth but it does have its limitation. Don’t misinterpret
PGD as having the ability to produce a ‘disease freechild’. Yes, PGD can eliminate certain types of genetic
diseases but parents have to know what kind of
disease to be eliminated. PGD can only work for those
who know about their genetic combination and history
because it is not a genetic screening but genetic
diagnoses’.(P2)
For other participants who are not in favor of using
PGD to pre-select their future children’s genetic
makeup, feel that by doing so, they do not accept theirchildren as who they are: ‘If I focus on getting theperfect child, how would my son feels about it since hehas genetic disability? I might be sending him amessage that he is not good enough just because he is
sick’. (P11)
Extremely high costs of using PGD were expressedby these participants who think that PGD can only caterto certain groups of people who can afford to pay forthe service. Fortunately for them, the needs ofThalassemia patients are well taken care of nowadays,
as compare to the previous year where knowledge
about it and resources was very limited: ‘Nowadays,
you can do blood transfusion in any government
hospital and medication are also charged at a veryminimal price, even free for those who really can’t
afford it.’(P11). P11 added, ‘Well, my Thalassemia
child might not be cured and have to live with thecondition all his life but at least it is possible for them tolive a meaningful life with these help we received’ as
we can’t afford PGD’.
Inequity in access to PGD and other new
reproductive genetic technologies (NRGTs) is acommon concern in most countries that provide thesefacilities due to the high cost involved (Redshaw et al.
2007). On the other hand, when asked about how they
feel about using PGD to provide the optimal lifestyle totheir future children, some participants described thedecision by parent to use PGD is part of their parental
responsibility and effort to find cure for their children:‘For me, PGD is a medical tool used to eliminate
genetic disease, thus provide parents like me with theperfect child that we long for….we just want to give thebest to our child and try to provide optimal lifestyle forthem’. (P10)The narrative these participants provided showed
how some parents are prepared to do almost anything
to have a healthy baby. Their commitment anddetermination in finding medical alternative indicate
their different way of showing their love to their child,
which is in contrast to some, where accepting theirchildren as who they are seen as their unconditional
love toward their child. However, parents’ desire to use
PGD to conceive the perfect child, received criticisms
from Christian scholars in this study. These religious
conservatives claimed that parental aspiration for theperfect child, can lead to the new era of eugenic.
According to Abraham (2012), religious conservative
claimed that parents’ desire to have the ‘perfect child’ isto avoid the task of taking care for children with special
needs, which come with possible burdens and troubles.
PGD will no longer be a technology to eradicate genetic
diseases but instead, becoming a technology to createchildren whose future depends on their social featuresand genetic combination, which are purposely design toprovide them with that extra edge compare to the restof the peers: ‘There are some people who have genetic
disease, which restricted their movement and limiting
their daily activities, or people with disability that makethem dependent on others but still enjoy their life. In
fact, I do not see anything low about their quality of life’.
(P18)
Rights to decide on reproductive choices
The vast majority of participants supported thenotion that parents should be given the freedom tomake their own decision regarding their own
reproductive choices: ‘I feel that it is wrong not tosuggest or even inform parents regarding PGD whenas physician you know that it provide them with thealternative that they desperately need. How they will
decide on it is up to them’. (P2)Some physicians feel that it is the right of the parent
to decide what is best for their child, especially when
the child is still or will be under their care. Although
there was also an awareness that some parents might
request to use PGD for trivial reasons such as forsusceptible condition, they still strongly believe that the
final decision whether to use PGD or not is solely
belong to the parent: ‘Even in the case of susceptible
conditions or sibling donors, I do think that it is the rightof the parents to choose whether to go for PGD. As
long as there is no harm inflicted toward the child, thenI think it should be good enough to allow them to use
PGD’. (P4)
Having personal experiences living or caring forindividuals with genetic disorder, potential PGD users inthis study firmly believe that final reproductive decision
should be the right of the respective parents. This isbecause, they understand what these parents are going
through and they believe they need some space tothink about their decision without getting any pressure
from third parties: ‘We do not walk in their shoes so wehave no idea what they go through every single day.
We can have sympathy on them but we’re not the oneEubios Journal of Asian and International Bioethics 25 (July 2015)
who has to carry the burden. So, why not let them be
the one who make the call’. (P9)For these participants, they are applying their own
struggle and hardship having to raise children withgenetic disabilities or, living with genetic disabilities
themselves, to support their argument that parents
should make the decision on PGD. However, increasing
rights of parents regarding reproductive decision, at thesame time, has increased concerns that it might lead to
unforeseen
consequences.
Christianscholarsmentioned their concern on the effects of increased
reproductive rights of parents might have on the society
at large. They fears that the increase of reproductive
rights might lead to what they describes as the ‘slippery
slope’ of PGD. For instance, using PGD for nonmedical sex selection raises arguments and concerns
on issues related to the potential for inherent gender
discrimination, inappropriate control over non-essential
characteristics of children as well as inappropriate andpotentially unfair use of limited medical resources forsex selection rather than for more genuine, and urgent
medical needs (Hersberger and Pierce, 2011). But
contradictory to this idea, the Islamic scholars involvedin this study viewed PGD as a stepping stone inmedical field that can help parents who are in greatneed of it. Although having no qualms allowing Muslim
parents to use PGD, they however, do not think thatparent has the total rights to decide: ‘Before theydecide to use PGD, they first need to make sure that
their reason to use the technology, comply with thereligious ruling on the matter. And it is also restricted toapplications within legal marriage frames according toIslam’. (P20)
Discussion
One of the most frequently discussed or debatedethical issues of PGD are concerning the moral statusof embryo (Robertson, 2003). Participants’ discussions
on the moral status of embryo displayed diversity
including that the embryo is not a living human thus,
requires limited status quo but nevertheless, still needs
to be respected or, the embryo is considered as a living
human, and must not be destroyed and/or, embryo is aliving human until certain period of time. Scientifically,
the definition of moral status of embryo is verystraightforward, which defines the embryo as anaccumulation of cells that does not carry any moral
status, thus it has limited rights compared with normal
humans (Ehrich et al., 2008). However, for those whoare religiously affiliated, embryos are either defined ashaving a soul or not, which explained the participants’
acceptance or rejection on the use of PGD.
Due to its capability to enable parents to pre-selecttheir children’s genetic makeup, parent who decided touse PGD may be accused of trying to play God. Most of
the time, this term is used in a negative way whereby
trying to ‘play God’ is associated with humans trying tointerfere with the natural process of human procreation(Jones, 2004). It is interesting to discover that both
hostility and rationality towards the procedure are both
displayed in this study. For those who work in the123

medical scene, the acceptance toward PGD is basedon medical evidence on the positive effect of PGD on
their patients. However, for potential users and religious
scholars, they either accept or reject the notion that an
attempt to use PGD is an attempt to take over the workof God or trying to play God.
Participants who reject this notion are normallythose who themselves live with genetic disease or are
raising children with a genetic disease. Parents orindividuals who are in the same situation generally
show more empathy and compassion toward others
who are in the same situation (Doolin & Motion, 2010).
These parents have no control over the underlying
genes of their condition and it is not their choice to deal
with such tragic disease (Jones, 2004). One of theunderlying factors that influenced and motivates theirneed to search for medical alternatives such as PGD, isthe notion of human suffering. This is consistent with aprevious study done among women who had, have orare susceptible to breast cancer; those who favour theuse of PGD associated the notion of avoiding sufferingin their child as one of the reason for their choice(Quinn et al. 2009). For participants that view PGD as
humans trying to play God, the influence of religion isstated as one of the reason for their perception. Thisfinding and decision is not something new because
according to Watt (2004), some parents are willing to
let nature take it course and leave the health of their
future offspring to chance rather than making the choice
to use PGD.
One of the disadvantages of PGD is the high costs
involved in using it and this could probably be one of
the main hindrances for anyone who wants to use PGD.
However, high cost of the aftercare of children born withgenetic disabilities particularly, genetic disease that arevery rare and treatment is scarce, can also motivate
parents to use PGD. This in fact, a significant finding inthis study because high costs involved in the after careof disabled children has not been associated withparent’s motivation to request for PGD. The cost of
taking care of a child with genetic disabilities might in
the long run exceed the price of going through PGD,
thus some parents might feel that it is a small price to
pay in order to have a healthy child.
Recognising parent’s rights to make final decision
regarding their reproductive choices, almost all
participants in this study, are strong advocates ofparent’s
reproductive
decisions.
All
medicalprofessionals generally identify reproductive rights as acore value during counselling with their prospective
patients before using the treatment (Bisecker, 2010).
These views are shared by all potential PGD users inthis study, despite their difference views on otherissues related to the use of PGD. For potential PGD
users, their support for parent’s reproductive rights isnormally associated with their own personal
experiences with genetic disorder. When individuals
use their own experiences to justify their perception of
PGD, it changes the way they look at the technology.
Previous study showed that personal experiences andreproductive history are more important determinants of

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

eventual PGD use than the mode of inheritance or the
expected clinical impact of the disorder (Van Rij et al.
2011). Personal experiences and reproductive history
are also found to be a reason why some parents
believe that they know what is best for themselves andtheir future children, thus influencing their own
reproductive decisions (Hershberger and Pierce, 2010).
Another significant finding in this study is the link
between participant’s personal experience with genetic
disorders and their belief about the appropriateness of
individual decision -making on PGD. This is notably an
important finding because frequently presentations on
personal experience with genetic disorder are generally
associated with their own decision-making or motive to
use PGD but not as a contributing factors to support theappropriateness of individual decision-making on PGD
for others. However, it is worth to acknowledge that
despite participants support for individual decisionmaking, there are few participants who believe that the
final reproductive decision should not be the sole rightof the prospective parents. These views are based onparticipants’ religious perspective where absolute
freedom is non-existent in their religious teaching.
Humans do not have the right to determine when achild will be born, who the parents will be, which gender
the child will be or when a child will dies as these are all
God’s prerogatives (Tang, 2008).
Conclusion
Based on the findings, this study showed that there
are three factors that dominate and influence theperception of participants during the discussion;
medical and clinical knowledge, religious beliefs andpersonal experiences with genetic disorders. These
factors shaped their perceptions on PGD, thus
influence their decision on using PGD. The
maintenance of religious beliefs and a strong sense ofrespect to rich Asian cultures is a strong influence toreproductive choices in Malaysia. However, in contrast
to this statement, this study showed that some potential
PGD users not only place religious beliefs as part of thefactor that influence their decision making on
reproductive choices but also the practicality of thetechnology as well as their previous personal
experiences with genetic disorder.
Acknowledgment
The results of this study come from the research project,“Ethical Implications of Pre-implantation Genetic Diagnosis(PGD): A qualitative study on three selected groups in
Malaysia’. We thank all participants in this study for their timeand efforts to make time for the interviews session.

Conflict of Interest
The authors have no conflict of interest

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Eubios Journal of Asian and International Bioethics 25 (July 2015)

Ethics status of clinicalresearch and trials indeveloping countries- Yuanyuan Liu
Marist College, 3399 North Road, Poughkeepsie,
NY 12601, USA
Email: kittyliu1991@aliyun.com

Abstract
With the development of economic globalization,
more and more clinical research and trials shift fromdeveloped countries to developing countries. The
globalization of clinical trials also brings some ethicaland scientific concerns. This paper discussed someethical problems of clinical trials in the developing
countries including 1) "golden rice" event in China; 2)
Informed consent in clinical trials in developing
countries; 3) Ethical consciousness in clinical researchand trials in developing countries. The essay suggeststhat the level of medical ethics in developing countries
is lower than that in developed countries. How can we
improve the ethical consciousness of clinicalresearchers and subjects and how can we protect
patient rights are important problems faced bydeveloping countries.
Key words: Clinical trial; informed consent; Ethicalconsciousness; developing countries
In the past clinical research and trials weretraditionally conducted in developed countries such as
U.S and Western Europe. In recent years there is atendency to transfer these to developing countries. With
the development of economic globalization, there is a
close link between developed and developing countries
in aspects of economy, trade, science and so on.
Therefore, clinical research and trial also have a shift
from developed countries to developing countries.
Glickman et al (2009) published an essay entitled“Ethical and Scientific Implications of the Globalizationof Clinical Research” which discussed “recent trends inand underlying reasons for the globalization of clinicalresearch, highlight important scientific and ethicalconcerns, and propose steps for the harmonization ofinternational clinical research”. [1] The authors
indicated that the number of countries serving as trialsites outside the United States doubled in 10 years,
whereas the proportion of trials conducted in the UnitedStates and Western Europe decreased. For example,
from 1995 to 2005, trials conducted in Africa wereincreased from 5.0% to 8.7%; trials conducted in
Eastern Europe and Russia were increased from 2.5%
to 5.2%. In contract, trials conducted in United States
were decreased from 53.8% to 42.6%; trials conductedin Western Europe were decreased from 40% to 36.5%[1].
What causes this dramatic shift? The main reason
that clinical trials transfer to developing countries is thatthe cost is cheap in developing countries. For example,“a first-rate academic medical center in India charges

125

approximately USD1,500 to 2,000 per case report, lessthan one tenth the cost at a second-tier center in the
United States”[1]. In addition, the low wages of doctors
and nurses in developing country also make the humancost reduced. The great number of potential research
participants in developing countries also is a great
attraction to drug companies.
The globalization of clinical trials also brings someethical and scientific concerns, for example, the choiceof the participants, the transparency of clinical trial
results in developing countries, the regulatory oversightof clinical trials, training and experience of clinicalinvestigators, institutional review board quality andefficiency and so on. This paper will discuss someethical problems of clinical trials in the developing
countries including 1) "golden rice" event in China; 2)
Informed consent of clinical trial in developing
countries; 3) Ethical consciousness in clinical researchand trial in developing countries.
"Golden rice" event in China
In 2012, a research paper published in the American
Journal of Clinical Nutrition caused a great disturbancein Chinese society and aroused widespread concerns
The title of this thesis is “β-Carotene in Golden Rice isas good as β-carotene in oil at providing vitamin A tochildren”. In this paper, author said they conducted a
trial of transgenic food "golden rice" (GR) in Hunan
province of China. [2] The subjects were 72 healthy
children, divided into three groups. Among them, 24
children were fed with genetically modified food "goldenrice". The researchers examined the content of vitamin
A in the serum of children. The results show that “Theβ-carotene in GR is as effective as pure β-carotene in
oil and better than that in spinach at providing vitamin A
to children.”[2] Therefore, “GR may be as useful as asource of preformed vitamin A from vitamin A capsules,
eggs, or milk to overcome VAD in rice-consuming
populations.” [2].
This paper has aroused strong repercussions in
China. Many people believe that it is irresponsible
behavior to use Chinese children as subjects oftransgenic rice. The public appealed to the government
to examine the legitimacy of this research. China
Center for Disease Control and Prevention (CDC) andother agencies soon released an investigation report.
The report says that this transgenic trial is in violation of
relevant regulations, research ethics and scientificintegrity. The related responsible persons in China
were dismissed from their posts.
The main researchers are staff from Tufts University
in United States. The investigation of Tufts University
showed that although the "golden rice" research data
are correct and they also do not find the health andsafety risks, but the study itself does not completely
follow the rules of the university ethics review
committee and the United States Federal regulations[3]. The survey finds that there is not enough evidence
to prove that the project was evaluated and approvedby the relevant departments of China. Therefore, there
are flaws in the process of obtaining informed consent,

126

Eubios Journal of Asian and International Bioethics 25 (July 2015)

including the lack of a clear explanation to transgenic
attributes of "golden rice". The researchers made somechanges to the research process and the changes did
not obtain the approval of the ethics review committee.
According to the results of investigation, Tufts
University took corrective measures. The person in
charge of the project shall not engage in human studies
within two years. He needs once again to accept
training on human research related rules andregulations. In addition, the university ethics review
committee also revised the rules and procedures.
Ethics review committee will carry out more detailed
audits of future research outside the United States [3].
Actually, golden rice is a good product. There is no
problem in this clinical research if viewed only from thescientific point of view, but, there was a deficiency of
ethics in this incident. First of all, the effectiveness of
informed consent: Informed consent is an importantguarantee to protect subjects in human trials. According
to guidelines specifically designed to protect children as
research subjects, “for children to become participants,
permission must be obtained from parents or
guardians, and children must give their ‘assent’”. [4]The content of the informed consent should be in fullcompliance with ethical standards and should enable
the subjects family fully understand the risks andbenefits. The ethics committee should examine thecontent of informed consent, and supervise the processof informed consent. However, the survey results
showed that the signed informed consent was just avery simple notice. There is no introduction about realtest information, just saying that it is nutritious meals.
There was not any information about transgenic rice in
the informed consent [5]. The test site is in themountains of Hunan province. The local residents'
educational level is not high. It is difficult for them tounderstand the information provided by researchers.
Thus it is also difficult for them in the balance of risks
and benefits. In this case, an effective informed consent
is especially important.
Secondly, timeliness of ethical review: The ethicalreview should have the effectiveness. If the research
project exceeds formulary review period, it should resubmitted the ethical review application. Upon giving
approval, the project can continue. In this case, theproject went through the ethical review in Zhejiang
Province in 2003. When the test was carried out, it was
beyond the valid period. The project should be
reviewed again, but the researchers did not submit theapplication for review again. In this process, thesupervision function of the ethics committee has also
become a mere formality [6].
The “Golden Rice” incident exposed problems in thedesign of relevant laws and regulationsTherefore, thetransparency of ethical review should be increased
including the whole process of supervision on informed
consent. "Golden rice" event is not a simple technicalproblem, but the contradictions caused by lack of ethics.
We should examine and resolve these issues of ethics
to guarantee the healthy orderly development oftransgenic technology. It is also necessary to introduce

the accountability mechanism into the ethical andpublish the whole supervision process.
Informed consent of clinical trials in developing
countries
Informed consent is essential in clinical researchand trials. Informed consent means that researchsubjects must make a voluntary choice about
participation, based on sufficient knowledge andcomprehension about the research design, the risks
and benefits, and their rights as participants. Informedmeans to let subjects understand relevant information,
including information disclosure and information
understanding. Consent of the subjects should bevoluntary, including capacity to consent and freeconsent. But the quality of informed consent of clinicalresearch participants is different between developing
countries and developed countries. Mandave et al(2012) reviewed and compared available data on thequality of informed consent from research in bothdeveloping and developed countries. Their review
shows that the quality of informed consent depends on
the type and amount of information disclosed, adequate
comprehension of trial information, and a voluntarydecision to enroll [7]. Their data suggest that “(1)comprehension of study information varies among trial
participants in both developed and developing countries,
and comprehension of randomization and placebo
controlled
designsisgenerally
lower
than
comprehension of other aspects of a trial; (2) research
participants report different sources of pressure to enrol,
and those in developing countries are less likely thanthose in developed countries to say they can refuse orwithdraw from participation, and more likely to worry
about the consequences of refusal or withdrawal.”[7]Generally speaking, the quality of informed consent
of clinical research participants in developing countries
is worse than that in developed countries. The
participants in developing countries have more difficulty
to understand information about trial design,
randomization and placebo controls because theseconcepts are unfamiliar to them. Participants indeveloping countries felt they could not refuse orwithdraw from the trial. Possible explanations may bedeference to authority, cultural norms, or a fear of not
being able to access needed care.
Hill et al investigated informed consent in Ghana. In
a placebo controlled vitamin A supplementation trial,
they explored whether subjects understand the trial andwhether they know that not all the capsules provided in
the trial are the same. The data suggest that most
women in the trial knew that they were taking part inresearch but that their interpretations of the trial varied.
Many women believed they were receiving an active
and beneficial medication. Only 13% knew that not all
the trial capsules were the same. [8] The complex
language and lengthy consent forms may be the reason
for this result  especially in populations with poor
education. For example, despite extensive training andprovision of fieldwork manuals, 17% of the fieldworkers

Eubios Journal of Asian and International Bioethics 25 (July 2015)
did not understand the concept of placebo and thoughtthat all the trial capsules were the same [8].
Similarly, other developing countries also have asimilar situation. For example, in Gambia only 10% ofparticipants understood the placebo-controlled designin a vaccine trial; in Uganda only 19% of mothers knewthat not all of the treatments in a malaria trial were thesame; In Haiti only 20% of participants passed anassessment of their trial knowledge, which included
whether they knew the purpose of the study, the risks
and benefits of participation and that participation was
voluntary; In Bangladesh only 48% of respondents
knew they were free to withdraw after giving consent. In
South Africa only 28% of participants knew the study’saim, 21% of participants understood randomization and
19% understood placebo [8].
Generally speaking, subjects in developing countries
have low trial knowledge. The main reason is the lackof education. So informed consent should be simple
and easy to understand in these countries. When theparticipants cannot understand the informed consent,
an accurate and unbiased translation should be
provided. When trial participants are from rural or social
vulnerable groups, informed consent in the design
process should seek help from the local community or
non-government departments. For example, in the caseof Ghana discussed above, “the consent procedure
consisted of gaining community consent from traditional
leaders at the district and village level, followed byvillage level community meetings, where senior project
staff introduced the aims and methods of the trial andanswered questions. In urban areas, community
meetings were replaced by radio broadcasts, asmeetings often have low attendance in such settings.”[8] Therefore, in informed consent process, we should
consider the background of potential subjects, the local
resources and cultural and educational level ofsubjects. In order to protect trial participants’ right of
informed consent, they have a right to be told what they
are getting into so that they can decide whether theywant to go through with it or not.
China is also a developing country. It is also one of
the world's fastest growing countries. All medical rules
and regulations in China are in continuous
improvement. Ma et al investigated the current informed
consent in clinical research in China. The investigation
objects are from Beijing Jishuitan Hospital, one of thelargest hospital in Beijing, China. They carried out aquestionnaire survey in 1691 patients, and analyzed
the data according to sex, age and educational level.
The results showed that 85% of the patients agreed toprovide blood samples and operation specimens for
medical research and signed the informed consent;
15% of the patients did not agree to provide blood
samples and operation specimens for medical researchand did not sign the informed consent. [8]The author analyzed the reason of informed consent
or not consent. Among 1619 voluntarily signed theinformed consent, 78% of the people think that thepatient should respect the opinion of the doctor, 13% of
the people think that donated samples were no harm to127

the body, 8.5% of the people think that they should
support the medical scientific research work. [9] These
data suggest that the doctor' authoritative is recognized
be the vast majority of the patients but relative lack of
medical scientific research cognition. Among 281 who
did not sign the informed consent, the main reasons arethat the patients mistrusted doctors’ decisions or they
could not understand the content of informed consent
The results indicated that doctors play a leading rolein process of informed consent. Thus, the doctor's good
moral consciousness and the moral behavior are an
important prerequisite and condition of scientificresearch activities carried out smoothly.
In addition, there are individual differences among
patients in cultural, knowledge and professional
backgrounds. Even if the doctors try to explain scientificconcepts, informed consent is also very difficult to let
the patient fully understand. Among 1619 patients who
signed the informed consent, those who fully
understand the content of informed consent only
accounted for 23% [9]. This result may be related to thethree reasons. Firstly, most patients are no medical
background knowledge. They do not understand therelationship between the biological information
resources and development of medicine. The lack of
medical knowledge is difficult to make up for in a
relatively short time. Secondly, most of the patients can
not accurately understand and accept the information
because of their lower educational levels. Thirdly, in theprocess of signing the informed consent, some doctors’language is simple and blunt, the lack of humane care,lack of communication skills, so that make patients withexcessive tension and anxiety, are more prone tomisunderstanding.To sum up, in clinical research andexperiments, informed consent is an important part.
The doctor in the informed consent process plays aleading role. So, the doctor should popularize medical
knowledge to patients in the daily work. The doctor
should be fully informed patients with patiently
explanation and good communication. Thus the patient
can correctly exercise the right of informed consent,
reduce misunderstanding and actively participate in
medical research.
Ethical consciousness in clinical research and trial
in developing countries
The clinical research thesis is one of the main formsof clinical research results. There are more ethicalproblems existing in developing countries than those indeveloped countries. Meng et al. investigated the statusof current ethics development in scientific literatures
published in the Chinese Journal of Epidemiology [10].
They reviewed published papers from 2006 to 2010 toassess the medical ethical issues among the original
papers focusing on human trials. The results showedthat 29% of papers announced of “informed consent by
the subjects”, and the proportion with “having had
approvals from the ethic committee” announced is only
7% [10]. The papers that said that they “had approvals
from the ethic committee” are far less than the papers
that reported they had “informed consent by the128

Eubios Journal of Asian and International Bioethics 25 (July 2015)

subjects”. This phenomenon indicates that although theauthors have certain medical ethics consciousness,they still need to improve and standardize the ethicalbehavior in the process of biomedical research.
The authors also compared the changes in informed
consent and ethical review in five years. The proportionof the papers announced of “informed consent by the
subjects” is increased from 21.3% in 2006 to 40.6% in
2010. The proportion of the papers announcing thatthey “had approvals from the ethic committee” isincreased from 3.2% in 2006 to 10.3% in 2010. [10] In
general, there is an upward trend year by year. Thischange shows that the ethical consciousness ofscientific research personnel is gradually formed.
In order to understand the problems in ethics in
China, Meng et al also compared the differences
between China and America in the areas of
epidemiological areas [11]. They reviewed papers
published in the Chinese Journal of Epidemiology andin the American Journal of Epidemiology from January
2006 to December 2010 and compared the ethicalissues involved in the papers that focusing on humantrials. The results indicated that the papers marked"informed consent by the subjects" were 29% and 38%
respectively in China and United States. The papers
marked “having had approvals from the ethic
committees” were 7% and 63% respectively in China
and United States. Among the studies in the Chinese
Journal of Epidemiology, the proportion of ‘informed
consent’ and ethical review was lower than the
proportion in the American Journal of Epidemiology.
Especially, there is larger difference in the ethicalreview [11]. These results indicate that there is a big
gap between China and United States on the
consciousness of informed consent and ethical review.
The authors also compared the changes of informed
consent and ethical review in five years between China
and United States. The proportion of the papers
announcing “informed consent by the subjects”
increased from 21% in 2006 to 41% in 2010 and from
38% in 2006 to 41% in 2010 respectively in the Journalof China and United States [11]. These changes
indicate that there is an increasing ethics
consciousness through five years both in China andAmerica. China's increase is more obvious.
The above comparison shows that in China, ethicalconsciousness in clinical research and trial is weak. In
the clinical research papers, the ratio of mentioning
informed consent and ethical review is not high. So I
think that we should strengthen the publicity of medical
ethics, and show the function of ethics review
committees and normative ethics programs. Firstly, we
should standardize the procedures of informed consent.
Prior to applying for ethics review, clinical investigators
must receive voluntary written informed consent. If a
researcher is unable to obtain written informed consent,
they should obtain verbal informed consent, and submit
the certification materials. For subjects without ability,
unable to make their own decisions, written informed
consent from the guardian or agent must be obtained.
Secondly, the ethics committee review function should

be strengthened. The ethics committee of scientificresearch institutions should strengthen the supervisionand management functions. The ethical review should
be carried out during the whole process of clinicalresearch project to ensure that the project complies
with ethical principles. Thirdly, when clinical research
papers publish in academic journals, the status of
informed consent and ethical review should be declaredin the paper.
Conclusions
With the development of economic globalization,
more and more clinical research and trials shift fromdeveloped countries to developing countries. For theseclinical research and trials, the large population size ofdeveloping countries means that substantial numbersof individuals affected by rare diseases may be found,
therefore, it is easy to find all kinds of disease subjects.
In addition, the low cost in developing countries also is
one of the reasons attracting clinical researchers fromdeveloped countries. But the globalization of clinical
trials also brings some ethical and scientific concerns.
This paper at first described an ethical violation event in
China - "golden rice" event. Then the status of informed
consent of clinical trial in developing countries wasintroduced. At last, the ethical consciousness in clinicalresearch and trial in developing countries was
discussed.
In a word, the level of medical ethics in developing
countries is lower than that in developed countries. We
should improve the ethical consciousness of clinicalresearchers and subjects and how we protect patient
rights.
References
1. Glickman SW, McHutchison JG, Peterson ED, et al.
Ethical and scientific implications of the globalization ofclinical research. N Engl J Med. 2009, 360: 816-23.
2. Tang G, Hu Y, Yin SA, et al. β-Carotene in Golden Rice isas good as β-carotene in oil at providing vitamin A tochildren. Am J Clin Nutr. 2012, 96: 658-664
3. http://news.xinhuanet.com/2013-09/18/c_117425514.htm(accessed March 17, 2015)th4.
MunsonR.
MaristCollege
Edition(9
Edition). Intervention and Reflection: Basic Issues in
Bioethics. Cengage Learning, OH. Page 17
5. Tian X, Yuan H, Ouyang D. Introspection of “Golden Rice”
incident. Chinese Medical Ethics. 2013, 26: 17-20
6. Tian H, Zhai XM. How to treat geneticall modified crops
correctly - reflection on the “Golden Rice” trial. Chinese
Medical Ethics. 2013, 26: 14-16
7. Mandave A, Pace C, Campbell B, et al. The quality of
informed consent: mapping the landscape. A review of
empirical data from developing and developed countries.
J Med Ethics. 2012, 38: 356-365
8. Hill Z, Tawiah-Aqyemanq C, Oder-Danso S et al. Informed
consent in Ghana: what do participants really
understand? J Med Ethics 2008, 34: 48-53
9. Ma Y, Xin B, Wang N et al. The Investigation Study for
Understanding of Informed Consent on Individual Sample
Collection in Medical Research. Medicine and Philosophy
2012, 33: 28-30
10. Meng R, Zhai Y, Chen S, et al. Investigation on Current
Condition of Medical Ethics Consciousness and its
Enlightenment in Epidemiological Research. Chinese
Medical Ethics 2012, 25: 828-829
11. Meng R, Zhai Y, Chen S, et al. Differences on ethicalconsciousness issues between the Chinese Journal of
Epidemiology and the American Journal of Epidemiology.
Chinese Medical Ethics 2012, 33: 106-110.

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