Eubios Journal of Asian andInternational Bioethics
EJAIB Vol. 26 (5) September 2016www.eubios.info
ISSN 1173-2571 (Print) ISSN 2350-3106 (Online)
Official Journal of the Asian Bioethics Association (ABA)

Copyright ©2016 Eubios Ethics Institute(All rights reserved, for commercial reproductions).

Contents

page
World Bioethics Day - Darryl Macer
161
Cross Cultural Perspectives on Dignity, Bioethics,
and Human Rights: A Reflection on World Bioethics
Day
162- Irina Pollard
EJAIB & I
164
- Atsushi Asai
Seven Sexual Revolutions in History: Destination Successful Failure
165- Jayapaul Azariah
Japanese Bioethical Challenges Concerning Self- 175
Management Support For Patients With Chronic
Conditions: An Analysis of Quality of Life & Autonomy- Aya Enzo, Taketoshi Okita, Atsushi Asai
Can the Principle of Procreative Beneficence Justify
the Non-Medical Use of Preimplantation Genetic
Diagnosis?
180- Biplab Kumar Halder
Deliberative Democracy for a Gene Editing Policy 185- Ann Boyd
Editorial Board
190
Guiding Bioethical Principles through Issues ofColonisation
191- Chuckie Calsado
The Regulatory Regime for the Use of Embryos in
Research: Braithwaite’s Theory of Responsive
Regulation
200- Dr Patrick Foong
ABA Renewal and EJAIB Subscription
207-8
Editorial address, and all correspondence to:Prof. Darryl Macer, Ph.D., Hon.D.
Provost, American University of Sovereign Nations(AUSN), Arizona, USA
Email: darryl@eubios.info
http://www.eubios.info
Registered address of EJAIB: P.O. Box 16 329,
Hornby, Christchurch 8441, New ZealandWorld Bioethics Day 2016 Issue
This issue includes 8 papers in a celebration ofdiversity and global bioethics. There is a mixture ofphilosophical analysis, classroom teaching strategies
and student surveys, policy analysis, historicalcommentary, and cross-disciplinary analysis ofbioethics issues from various countries. Promotion ofa good-life (Eubios) for all beings is a critical element
for healthy bioethics discourse, that we share with thespirit of World Bioethics Day which this issuecelebrates thanks to the suggestion of Irina Pollard.
This issues is published and the editorial is written on
the 19 October and AUSN also celebrated with anactive debate and dialogue from Asia, America,
Europe and Africa.
The Asian Bioethics Association (ABA) and local
hosts, the Indonesian National Bioethics Commission
and UGM in Jogyakarta, Indonesia, will soon hold
ABC17 (14-17 November 2016) to continue this
discussion and education of bioethics. AUSN and
Eubios Ethics Institute are also co-organizing withothers a number of Bioethics Conferences trainings in
the coming 7 weeks all around Asia and the Pacific,
so please join physically or by skype.
- Darryl Macer

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

Cross Cultural Perspectives
on Dignity, Bioethics, andHuman Rights: A Reflection
on World Bioethics Day- Irina Pollard, Ph.D.
Department of Biological Sciences, Faculty of Science &Engineering, Macquarie University, Sydney, Australia, NSW
2109, Australia
Email: irina.pollard@mq.edu.au
Head of the Australian Unit of the UNESCO Chair in
Bioethics,
Vice-President for the Pacific, Asian Bioethics Association(ABA)

Part 1: Introductory Background
The term bioethics prompts us to think ‘biology’ and‘ethics’ emphasizing the importance of science and its
applications as they relate to our modern
technologically-based societies. Decisions about the
responsible use (or misuse) of science’s capabilities
embrace a diversity of matters such as theenvironment, human health, society and international
policy – all challenging population growth, economic
activity and conflict resolution including warfare.
Clearly, contemporary science and its possible
technological applications occur within the contexts ofsocieties which may have generated differing
philosophies, beliefs and ethical values structures.
Therefore, to resolve differing perspectives on adiversity of significant issues and to develop global
principles underpinning sustainable and worldwide
decision making, we need to cover contemporary
attention as characterized in, for example,
anthropology, sociology, biology, medicine, religion,
psychology, philosophy, environmental science andeconomics. Since ethical values cannot be separated
from biological facts we are increasingly in need of asustainable international ethic involving the survival of
the total ecosystem.
In the above context, the UNESCO Chair in Bioethics(Haifa) has announced a World Bioethics Day to bethcelebrated globally for the first time on the 19
October, 2016. The theme of this year’s celebration is‘Human Rights and Human Dignity’ (article 3 of the
Universal Declaration of Bioethics and Human rights).
The present in human history may indeed be the mostappropriate time to enforce a complete rethink ofeverything in order to build a functional futureinterlocking new and sustainable models of existence.
The indiscriminate use, abuse and misunderstandingof science’s valuable technological developments are,beyond doubt, a matter of ethical concern andcollective responsibility. Biological education, whileconsistent with new knowledge, ought also to be
relevant to real-life experiences within sociocultural
1and ethical contexts. Bioscience ethics provides a
1

Irina Pollard, Bioscience Ethics, Cambridge University
Press 2009.

source of information that bridges the gap between
applied science and applied ethics. An allencompassing interpretation of bioethics, theknowledge of which would promote both humansurvival and improvement of the human condition is inneed of urgent review.
Reworking the Future for Following Generations
It is reasonable to postulate that for the huntergatherer a deepening understanding of the wisdomand beauty of Nature may have played the central rolein the evolution of ethical thought. It may be useful toremind ourselves that ‘aesthetics’ has its root in the
Greek word ‘aisthetes’ meaning ‘one who perceives’,
illustrating the wisdom of integrating science, ethics
and art with Nature. Holistic ethics (also sometime
called ecocentric ethics where the entire ecosphere isconsidered) was practised in ancient traditions and has
survived in several forms as, for example, theDreamtime of the Australian Aboriginal people.
Recorded history gave us more insight into our recent
evolution.
Much is made of the Sumerians of Mesopotamia (theancient country between the Tigris and Euphrates
2
rivers, now Iraq) who, in about 3000 BCE , left behinda vast legacy of ‘firsts’ inscribed on clay tablets incuneiform script. Theirs was the first recorded example
of a palace-driven urban society co-operative withgovernment. The Sumerian legacy also included anearly record of ethical thought. The ethical concept had
to do with restoring justice and freedom to the citizens
of Lagash, a Sumerian city-state. But humancivilization had been developing for several millennia
before the written record began, so that the evolutionof premonitions of human ethical thought on topics
such as truth, justice, freedom, mercy and compassion
began long before their written record. Relationships
between Nature, science, medicine and ethics
continued to occupy our ancestors till the present day
reinforcing the fact that ethics and morality are natural
phenomena that evolved from an evolutionary scheme
shaping social behaviour maintained by deeplyinterlocking brain processes. Now, more than everbefore, the time has come when our accumulated
intellectual knowledge and extraordinary expertise isasserting Homo sapience to advance a value-based
ethics in modern terms. The following summarizes how
my University has responded to this need.
Education – History’s Newest Revolution
There is an increasing employer demand for theiremployees to be equipped with the knowledge andskills they need to be responsible global citizens.
Macquarie University has responded to this need bymeans of its Global Leadership Program (GLP).
Macquarie’s Global Leadership Program offers
students the opportunity to undertake a challenging
extra-curricular program designed to build leadershipability,internationalawareness,cross-cultural
2

BCE – Before the Common Era. The reader is also
welcome to substitute the equivalency BC.

Eubios Journal of Asian and International Bioethics 26 (September 2016)
understanding and professional skills. The GLP is thefirst program of its kind in Australia in which over 2,800
undergraduate, postgraduate and study abroad /exchange students are actively enrolled. The GLP
project convenors understanding of ‘Global’ embraces
the following:" Cultural literacy and cross-cultural competence.
" Global perspectives and outlooks.
" Global issues including legal, political,
economic, social, cultural and ethical.
" Human dignity and human rights.
" Diversity & multiculturalism.
" Indigenous culture and rights.
" Environment and sustainability.
" Global citizenship including ethical behaviourand social responsibility.
Apart from the requirements as listed above there isalso a persistent and targeted call to cover theprevailing shortages of publicly accessible programs
that challenge the knowledge gap between newly
acquired technological information and bioethicalarbitration. Dr Irina Pollard is the invited convenor of
the project designed to cover the bioscience ethicalsubdivision of Macquarie’s GLP program. The
following reveals her basic contributions to ethics
education and reflect on similarity as interrelated topossible contributions as recently identified for Worldth
Bioethics Day to be celebrated for the first time on 19
October 2016.
The ethics Colloquium reflects upon the heritability of
ethics and its socio-biological implications andinvestigates lifestyle and reproductive health, fertility
and the assisted reproductive technologies (ART). The
colloquium also considers the evolution of the humanbrain and socio-ethical impacts on political rights,
international conflict and peace initiatives. Throughethical playoffs, role plays and international casestudies students are invited to explore the ethicaldilemmas arising from the intersection of science,
culture and technology.
Part 2: Bioscience Ethics – International
Perspectives on Human Reproductive Biology
Technologies, all by-products of science, haveredefined how we live, work, fight, relax andcommunicate with one another. Bioscience ethics is an
unencumbered secular discipline that facilitates free
and accurate information transfer from applied science
to applied bioethics. Since the 1990s, bioscience
ethics has become an internationally recognizeddiscipline interfacing science and bioethics withinprofessional perspectives such as medical, legal,
bioengineering and economics (http://www.biosciencebioethics.org/ ). In the final analysis, bioscience ethics
is a transdisciplinary subject whose dimensions arereflected in the emerging frontiers of science andethics that enhance biological understanding andpromote adaptive harmony with changing technology.
Flexible open-ended engagement by whatever meansare potent forces for building bridges that generate
positive change globally.

163

Colloquium Outline
Part 1 is on maintaining health and wellbeing; theheritability of ethics; change from conception to death;sociobiological implications.
Part 2: reproductive health; lifestyle and environment;
assisted reproduction and epigenetics.
Part 3: the evolution of the human brain; automatic
survival functions; transgenerational effects of stress;
the ecology of violence and warfare; conclude with
science ethics education i.e., biological rights andpolitical rights continuum; risk management – theprecautionary principle.
Delivery Mode
The Colloquium is modelled as interactive workshopsthat encourage students to discuss, debate, analyseand critically engage with the topic. Convenors areencouraged to create an open forum where students
feel comfortable asking questions, contributing theirperspectives and participating in group activities. The
following group activities are included to encourage
participation:•
Key discussion questions.
•
Debates•Role plays•
Simulations•
Small group activities - for example a real or
hypothetical case study that students consider frommultiple viewpoints.
•
Facilitated self-reflection.
•
Framingtheworkshopaccordingtoquestions/interest students have about the topic.
Student Learning Objective and Outcomes" Able to critically analyse across disciplines,
cultures and diverse environments.
" Able to communicate ideas and be a force forpositive social change.
" Able to pay attention and learn from others.
" Able to produce coherent, logical and ethicallysound arguments.
" Able to work independently and cooperatively.
" Able to extract key bioethical issues from thescientific literature, presentations andgroup
communications.
" Acquire a wide-ranging understanding of major
ethical issues posed by particularassisted
reproductive technological advances and theirapplications.
In summary
It is expected that the above objectives andoutcomes will increase biological knowledge which, inturn, will strengthen ethical interest across divergent
cultures and environments.
Examples of Possible GLP Topics for Discussion" Earth – our common home – is increasingly being
destroyed thanks to human activity.
" People most affected from climate change will bethose living in the Asia-Pacific region

164

Eubios Journal of Asian and International Bioethics 26 (September 2016)" From anthropocentrism to biocentrism.
" The early days of Artificial Reproductive
Technology (ART) was an ethical nightmare.
" What is the role of doctors and healthcare
providers in safeguarding the unborn child's health?
" What are the rights of a fetus?
" The patient was a married woman whose
husband was infertile. Without seeking consent ofeither husband or wife, the doctor inseminated her withthe sperm of one of his medical students.
" Interdependence; cycling of resources;
adaptation; succession and justice are the driving
determinants of psychosocial health.
" Bioscience ethics is dedicated to fostering
public awareness and understanding of bioethicalissues and to exploring solutions to bioethicalchallenges.
" Group reflection on how the colloquium content
is useful / relevant to becoming a Global Citizen.
Reflect on a picture: http://www.9to5hdwallpapers.com/wpcontent/uploads/2012/03/cute-little-baby-hd-wallpaper.jpg

EJAIB & I
- Atsushi Asai, MD., Ph.D.
- Department of Medical Ethics,
Tohoku University Graduate School of Medicine
2-1 Seiryo, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.
Email: aasai@med.tohoku.ac.jp

In this Letter to the Editor, I would like to commend
the Eubios Journal of Asian and International Bioethics(EJAIB) for the characteristics of their journal
publications that are not found in other journals. In
submitting many manuscripts to the EJAIB over the
past two decades, I have come to appreciate thedistinct and invaluable policies of this journal
concerning paper acceptance and publication.
Between 1995 and 2016, the EJAIB has kindly
published as many as 25 papers and 8 case studies
that I solely or jointly wrote. In addition, one paper was
also included in one of the books published by the
Eubios Ethics Institute. This means that I havepublished roughly a third of all my academic papers in
English in the EJAIB.
The themes of these papers are quite diverse andinclude topics such as the ideal forms of medical ethics
education, problems concerning informed consent inJapan, descriptive studies of ethical dilemmas inclinical settings, medical futility as an essential
concept, appropriate medical care for patients in apersistent vegetative state, unknowability about facts
and the need for humility, cultural issues in selfdetermination and proposals of new ethical principles,
implications of the UNESCO Declaration of Bioethics
and Human Rights, arguments on the validity of
secular ethical positions relative to religious
perspectives, pros and cons of capital punishment anddifficulties in making definite conclusions, an ethicalanalysis of commercial films concerning Hansen’sdisease and capital punishment, the impossibility ofdeath with dignity in present-day Japan, confidentiality
and the duty to warn others when caring for a patientwith HIV, proposal of medical ethics education using
the Analects, issues concerning how to deal with anincompetent patient’s refusal of medical treatment,
disagreement among family members about lifesustaining treatments, compulsory interventions forpsychiatric patients, urgent unproven interventions forpediatric patients, a patient’s ability to pay healthcare
costs, and assisted reproductive technology and its
resulting changes in family dynamics.
I have come to acknowledge fully that the EJAIB asa journal is quite broad-minded, truly global, andprogressive. Moreover, its policies are highly
distinctive. For example, the EJAIB was the first of
many bioethics journals to begin publishing online foropen access—an exceptional feat at the time. The
EJAIB has accepted papers pertaining to diverse
themes in the field of bioethics and has not excluded
papers that other journals are likely to judge as
inappropriate, such as my paper on capital
punishment. Papers on a wide array of topics are
accepted, and not just those written about trendy
topics of that particular era. Another laudable policy isthat the journal does not stick to mere formalities andhas not gotten caught up in the so-called academic
customs, as exemplified by my case study on urgent
unproven interventions on pediatric patient publishedin the EJAIB, which was written in a very
unconventional manner.
In addition, authors can state honestly and without
hesitation that “I do not know” or “We have noconclusions thus far” in the Conclusions section of apaper. Other journals would not allow this ambiguity or
admittance that conclusions simply cannot be drawn
on some issues in the real world. An example of thiswould be our recent paper about somatic support ofbrain-dead pregnant women and childbirth, whichconcluded that conclusions could not be made on
many issues. The EJAIB also allows authors to
express rather controversial positions, both freely andfrankly. For example, my coauthors and I were able topublish a paper concerning an incompetent patient’s
refusal of life-saving treatment, allowing us to express
the opinion that sometimes an incompetent patient’s
refusal should still be respected, for the reasons ofemotional capacity rather than rationality.
Finally, the EJAIB is very generous and helpful to
non-English speaking authors, and does not reject amanuscript solely because of less-than-perfect English
expressions. Other journals sometimes require
multiple rounds of English proof-reading, even if thefirst version was appropriately proofread byprofessional native English speakers. As a Japanese
author who constantly struggles with English, I greatly
appreciate the editors’ tolerance of linguistic issues,
and would go so far as to say that this encourages andpromotes the global or international perspectives of thejournal.
Thank you, Darryl. I hope to continue sending mymanuscripts to the EJAIB.

Eubios Journal of Asian and International Bioethics 26 (September 2016)

Seven Sexual Revolutionsin History: Destination Successful Failure- Jayapaul Azariah, Ph.D.
Former Professor and Head, Department of Zoology,
University of Madras, India
Past President, Asian Bioethics Association (ABA)
Email: jazariah1@hotmail.com

Introduction
Necessity is laid upon humanity to step back and to
trace the origin of sexual revolutions and its
proliferation down the memory lane in human history.
This is a survival need. As the sexual revolution
proliferates the population level also dips. Further the
total fertility rate (TFR) of human population is
declining. Will human sex revolution enhance thechances of human survival as a population or
endanger it?
The present study is divided in to three parts: (i) sex
revolution in the very ancient historical past (ii) in thevery recent past and (iii) in the near future. In order totrace sex revolution to the very ancient past it isneeded to identify a non-religious and trustworthy
ancient text. Such a text has been identified. The
present trends in sex revolution have been traced byanalysing the published results of sociological surveys
among American society. The future trends have beenassessed by making predictions based on the recent
advances in stem cell assisted reproductive
technology. The study also focuses on the question:“Are morals, men, sex, and God necessary for humansurvival as a species?” Of these four issues two issues- morality and sexuality - are considered as marks of
Humans for further consideration.
The Origin of Sexuality
For any scientist who wants to trace the origin ofhuman sexuality and sex revolution it is an impossible
task since there is no cultural fossil to documents it.
Alternately one has to turn to ancient recorded texts(now known as scriptures), either to Vedic or to The
Book of Genesis.
Affirmative consent that the Book of Genesis (Gen.)is a universally valid non-religious reliable document isfound in the works of Dr. S. Radhakrishnan who was aprofound Hindu proponent and a world renowned
philosopher. Servapalli Dr. S. Radhakrishnan was
also the past President of India. His understanding of
the opening chapters of Genesis is quite remarkable.
He claimed that that the early chapters are a common
heritage to all humanity. He wrote correctly “The
Jewish Bible does not begin with the Jews. It starts
with the story of Adam, which in Hebrew means ‘man’,adomi. The book of Genesis says: ‘This is the book of
the generations of man’. It does not speak of theLevite, the priest, or the Jews but of men. The childrenof earth are viewed as one family. They have one
ancestor who is the father of all” (Radhakrishnan, 1968165

p. 36). Judaism and other world religions including
Christianity were not practised at this stage in history!
Hence the Book of Genesis is a reliable non religious
document.
Fertility – Common To All Humans
The Book of Genesis contains the very first fertility
blessing on humankind. And God blessed them (maleand female), and God said unto them, “Be fruitful, andmultiply, and replenish the earth, and subdue it” (Gen.
1: 28). Fertility is the ability to reproduce i.e. to “befruitful, and multiply, and replenish”. This is a threefold
unconditional blessing which is effective to all
humanity regardless of religion. It is very hard to makeit inoperative. It works seamlessly well in a God centricsociety. In human beings this blessing operates
through sexual reproduction since human beings aresexual beings. Therefore sex occupies and plays adominant role
Fecundity
Fecundity is the number of eggs a female canproduce in a reproductive season. Some fishes have
two reproductive seasons per year while others haveone. A very big fish can produce millions and millionsof eggs. Since the process of fertilization is externalmany of the eggs and young ones will be eaten bylarger predators.
In the case of human beings
fertilization is internal and a single fertile egg is
produced per monthly cycle throughout the year. Dogs
can have sexual intercourse only during the
reproductive season, one season per year. But humanbeings can have sex throughout the year but not
throughout the life time. There is precisely defined“childbearing years” for a human female.
Total Fertility Rate
The term “Total Fertility Rate” refers to the number ofchildren a woman can deliver in her married life time.
Total fertility rate (TFR) is the average number ofchildren that is likely to be born per a given woman ofa country when all women live up to the end of theirchildbearing years and bore children according to agiven fertility rate at each age. TFR is therefore a
direct measure of the degree of fertility of a woman. It
differs from the crude birth rate which refers to births
per woman. TFR is a critical factor in ensuring thestability of a human population.
A country must ensure that a woman should givebirth to at least two or three children to keep the
population above the critical replacement level: one
child to replace the death of a person and one to keep
the status quo and the third to keep the level well
above the critical replacement level. Humantechnology can interfere and affect the threefold fertility
blessing: by the production of condoms andcontraceptive devices to arrest the process of “befruitful”; to legalize abortion to arrest the ability to“multiply”; and to introduce socially and culturally
detrimental norms and practices that will adversely
affect the TFR.

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

Factors Affecting TFRThere are many factors that affect TFR. They fallunder social cultural legal and political frame work.
These factors are: sexual revolution; abortion, after
birth abortion; use of condoms/contraceptives; samesex marriages and legalizing them; cohabitation andlive-in-relationship,cryopreservationofsperm;
childfree life by choice after marriage; single mothersby choice; eating genetically modified food and eating
fruits cultivated with methyl iodide which is a
reproductive endocrine disrupter. Let us take sexual
revolutions and its associated factors for further
discussion.
The Very Ancient Sexual Revolution
In ancient historical past there were two great andpowerful political rulers: the Pharaoh the king of Egypt(Gen. 12) and Abimelek the king of Gerar (Gen. 20).
The culture of these two neighbouring countries has
relevance for the present study. These two kingspracticed a culture of treating ALL beautiful but
unmarried women as their own property. If the very
beautiful woman is married then they make the woman
unmarried by killing the husband. There were no
dignity of human life and the rights of a woman. This
was their national policy of unlawful rule of their law.
Two issues arise from the unethical practice. (i) Is
sexual revolution linked with a notion of not nurturing
the “fear of God”? (ii) Was there a sexual revolution inthese monarchical regimes?
Fear of God and sexual revolution
Abraham had a fateful encounter with both Pharaoh
the king of Egypt (Gen. 12) and Abimelek the king ofGerar. His life was in very great danger because of hisvery beautiful wife and because of the practice ofkilling the husband to release the beautiful lady.
Abraham found that there was absolutely no fear of
God in the kingdom of Gerar/in their eyes (Gen. 20:
11). That indeed sex ethics and fear of God areinversely related is strongly supported by sociologicalstsurveys conducted during the present 21 century.
Secondly it is indeed sex revolution to deprive therights and dignity of womanhood to consider the
woman as a mere property to be acquired.
The Very First, Second & the Third sexual
revolutions
There were three sexual revolutions in the Genesis
account. The first sexual revolution occurred in the lineof brutal Cain, the son of Eve and Lamech who was
the head of the family of inventers (Gen. 4). Lamech
took two wives and murdered those who opposed his
new ethics. He very boldly broke the century oldcultural tradition of considering marriage as the union
between one man and one woman. His new culture
became widely accepted practice that Abraham’s
father married two wives. This is the impact of the very
first sexual revolution. Even Abraham and King David
were victims of the first sexual revolution.

2ndSexual Revolution
The second sexual revolution is that of high sex
culture practiced in the kingdoms of Egypt and Gararnd(Gen. 12 to 20). Details of the 2 sex revolution havebeen given in an earlier section.
rd

3 Sexual Revolution
In the ancient past there were two kingdoms - Sodomand Gomorrah (Gen 14: 8). The third sexual revolution
took place in these kingdoms where the citizens
practiced MSM – i.e. men having sex with men (Gen.
18 -19). What about the women? The men of thesetwo kingdoms had legal sanctions to practice ‘gayism’.
Hence the kingdoms can be termed as termed as“Gaydoms”. There may have been many other typesof legal freedom including religious freedom but not forthe practice of heterosexual autonomy. The cost andconsequences of adopting a culture of MSM wereimmense. There was a very serious environmental
destruction and these two kingdoms were totally wipedout (Azariah, 2015 a).
Fourth sexual revolution (1920)
There were additional three sexual revolutions sincethe 1920s (Huber, 2015). The year 1920 marked theinitiation of the fourth “sexual revolution.” Party songs
carried the message of sexual permissiveness of the
flapper generation. There were pop songs with lines
like: “Too Many Parties, Too Many Pals” and “She isn’t
like her mother, and yet she might have been, If it
hadn’t been for petting parties, cigarettes and gin”
This indicated the beginnings of sexual pulse of theday. Even though the carefree lifestyle of the 1920s
ushered in a conservative backlash against habits thatwere deemed harmful to the family and society all the
expectations about sex were reserved for marriage
alone (Huber, 2015).
The seed of fourth “sexual revolution.” took time for
germination but for an unknown zoology professor atIndiana University who wrote, in 1948, on the topic
of “Sexual Behaviour and the Human Male”. His
tickling report put an end to the conventional
understanding of sex (Huber, 2015). Alfred Kinsey
followed the above argument and concluded that “mostmen and women are not monogamous, that humans
are sexual (and sexually responsive) from birth, that 10
percent of men are homosexual, that bestiality is fairly
common behaviour and that “celibacy, delayed
marriage and asceticism” are “cultural perversions.”
Huber (2015) commented on the sexual climate of thatday by pointing out the view of Kinsey’s colleague Paul
Gebhard: “It didn’t much matter what you did sexually
as long as it didn’t hurt anyone else and it made you
and your partner happy.” Although the Kinsey reportbecame a bestseller traditional conservatives held theview that sex belonged within marriage. Thus Kinsey’sviews began to work to erode cultural expectations
surrounding sex. Thus the floodgates for the 2nd sex
revolution were slowly opened.

Eubios Journal of Asian and International Bioethics 26 (September 2016)
Fifth Sexual Revolution and the Growth of Sex
Education
The year 1960 marked the birth of the fifth “sexual
revolution”. The birth of full-fledged pornography in1970 led to the remark that the year 1970 was thegolden year of pornography and 1970s accelerated
the acceptability of premarital sex as morally ‘right’.
The availability of the contraceptive Pill and abortion tocover the obvious effects of sex offered men andwomen sexual freedom without the consequences ofconception. But there were breaches in other areas ofmoral domain. Births outside of legal marriage weredoubled between 1960 and 1970. The incidence of
Sexually Transmitted Infectious Diseases in young
adults was increased by 165 percent between 1967
and 1971(Huber 2015). Thus it opened the floodgatesfor sex education.
Sixth Sexual Revolution
The sixth sexual revolution began to take roots in1980s. It relates to marked changes in sexual
orientation and the redefinition of marriage. In the pastmillennium, traditional marriage was defined as theunion between a male and a female, The American
DOMA (Defence of Marriage Act) endorsed it. This
union is child centric producing biological parents.
When the number of gay and lesbians increased they
were not covered by DOMA. The word “marriage”
needed to be redefined as the union between two
persons or people regardless of sex. It should be
noted that the partners in gays and lesbians
relationship are indeed human persons and hence
their partnership includes shades of human rights
issues. Nevertheless it should be emphasized that thissame sex union in essentially a child-adoption-centric(foster children) relationship and incapable ofproducing biological parents. In the case of lesbians afrozen sperm or a male sperm donor is necessary(Azariah, 2015 b).
It all started as (i) same sex relationship (1980s)
which was upgraded as (ii) same sex marriage (2015).
Currently attempts are being made to achieve (iii)same sex reproduction by deriving a sperm and fertile
human egg from the stem cells (2030?). Derivation ofa woman’s egg appears to be a very strong limiting
factor. Necessity will arise in a later day when and if
stem cell technology overcomes this obstacle of not
being able to derive a fertile human egg from one’s
own stem cell to re-redefine the word “marriage”.
Seventh Sex Revolution
The seventh sex revolution is yet to be born. But thefoundations have been laid so as to cater to the needsof same sex reproduction. A new film "The Baby
Formula" imagines two lesbians conceiving (Same-sex
reproduction) with sperm derived from each other's
stem cells – and the science may not be far-fetched.
This new film was directed by Ms. Alison Reid withlesbian actors Megan Fahlenbock and actor Angela
Vint.
The current and immediate issues are redefinition of
marriage, marriage equality and legalizing of same sex

167

marriage. Now the conversation which runs like “myhusband she has gone to work” and “my wife he iscooking…” will be history. But in future what will be
the problem(s)? It is hard to predict. Tomorrow’s issue
3
will be “Will women one day father children?”Cumulative impact of Sexual Revolutions
Laumann et al (1994) reported on the number of sex
partners of American males and females have hadsince the age of 18. Their report revealed that “3% of
men have had zero sexual partners since the age of18, 20% have had 1 partner, 21% have had 2-4
partners, 23% have had 5-10 partners, 16% have had
11-20 partners, and 17% have had 21 or morepartners.” There was a significant variation in thenumber of sex partners between males and females in
the age group of 30-44 years. Mosher et al (2005)
reported that males had on an average of 6-8 female
sexual partners in their lifetime whereas females had 4male sexual partners in their lifetime. The data
represents a normal distribution curve. Similarly data
are available for females. “3% of women have had
zero sexual partners since the age of 18, 31% have
had 1 partner, 36% have had 2-4 partners, 20% have
had 5-10 partners, 6% have had 11-20 partners, and
3% have had 21 or more partners. 20% of American
men and 31% of American women have had one sex
partner in their lifetime”.
Two inferences can be made out of the above data:(i) men and women were not satisfied with their(married?) sex partners and (ii) they sought sexualpleasures outside of their marriage which means thatthey cheated on their spouses.
1980s Health Impacts - AIDS Crisis
Beginning with 1980s the world was led into a deadly
AIDS crisis. Sex education in the schools was animminent need of the hour. Organizations likeSexuality Information and Education Council of theUnited States (SIECUS) developed sex curricula inteacher-training programs which did not emphasise thedebarring premarital sex and promiscuity in teens andyoung adults. A paradigm shift in sex prevailed inacademic teaching advocating that it is normal forschoolchildren to do experimentations in sex. Basedon the Alfred Kinsey’s report a new sex revolution was
introduced under a brand new name of ‘safe sex’
which heavily rested on the use of condoms.
Injection Drug Users and HIV
HIV infection is generally associated with sociocultural factors such as homosexual behaviour andInjection Drug Users (IDUs). The town Austin, Indiana
is a socially conservative, largely rural region just northof the Kentucky border. But they are IDUs and use
needles over 300 times. A drug addict, a 45-year-old
woman tested positive for HIV, one of nearly 150
cases in a small population of 4,200 people. Feargripped her when she learned the unforgiving
3This issue was in news media like The Globe and The Mail
- 19.06.09.

168

Eubios Journal of Asian and International Bioethics 26 (September 2016)

consequences of HIV infection. She is stigmatised tostart antiretroviral therapy because she does not want
to be spotted entering the clinic on Main Street(Goodnough, 2015). There was a severe outbreak of
HIV and hepatitis due to a surge in heroin use in states
including Indiana, Kentucky and West Virginia (Hulse,2015).
Condom-centric culture
Strong emphasis was placed on the avoidance ofconception and the prevention of AIDS. In sex
education students were taught sexual risk avoidance(SRA) rather than sexual abstinence and moderationin sexual activities in teens. Condom-centric – riskreduction programs exploded and the age of first sex
experience was lowered to 16-17 years of age. With
the advent of new found high culture of sex without
restrictions teens began to spend more time with sex
and less time with their academic studies. A young girlcame home and told her mother “we were taught what
not to do; where not to do; when not to do; and how
not to do!” Such a “progressive” free sex culture camewith a heavy price tag in terms of human fertility loss
and adverse impacts on the reproductive health of thewoman.
Use of condoms/contraceptives
Data collected by the General Social Survey of
American population provide interesting revelation in
the pattern of sexual activity in USA. StephensDavidowitz, (2015) found an interesting contradiction
between the heterosexual men aged 18 and above
and heterosexual woman on the performance of sex
acts and the usage of condoms. Men confessed thatthey do on an average of 63 sex acts per year, 23
percent of them used a condom which may reveal that
more than 1.6 billion heterosexual condom usage per
year. On the other hand heterosexual women say they
are engaged in an average 55 sex acts per year, using
a condom in 16 percent of them which adds up to
about 1.1 billion heterosexual condom users per year.
There is a slip in the data and Stephens-Davidowitz(2015) asks the question “Who is telling the truth, menor women? Neither”. In USA, moreover, just about 600
million condoms are sold every year. It is predictedthat the condom market may reach well over 700
million.
What about India? An internet search yielded no dataon the number of condoms and contraceptives soldper year. Nevertheless a rough estimate can be made.
In a city like Chennai there are 100,000 sex-workers
who are expected to entertain at least threecustomers per day. All of them practice safe sex anduse condoms. This works out to 300,000 sex acts perday. The rest can be calculated. It seems certain thatsex is one single dominant act humans do.
Sexual revolutions ushered in the necessity tointroduce sex education in educational systems andthe free distribution of condoms. But condoms
sometimes fail to prevent conception. Unwanted
pregnancies are eliminated. Liberal views in familyplanning favour abortion. Therefore abortion clinics

were opened which polarized the society into twogroups: the pro-life activist and the pro-choice groups.
In USA, from 1973 to 2015, there were about 57.5
million (m) abortions and in China 336 m due to one
child policy. In India, female foeticide amounts to 24 m
or more. These figures dwarf the number killed during
World War 1. In WW1 about 1.5 m Armenians were
killed. Hitler killed 17 m and Joseph Stalin killed 23 m
only. These killings affect TFR adversely.
Sex Revolution Cultural Pollutant
Ms. Mary Eberstadt has published a ground-breaking
book entitled “Adam and Eve After the Pill: Paradoxesof the Sexual Revolution” (March, 2012) on thewidespread discontent with regard to the newly foundsexual freedom. She brings to light that both secularand religious leaders are of the opinion that “the sexual
revolution is one of the most important milestones inhuman history. Perhaps nothing has changed life forso many, so fast, as the severing of sex andprocreation. But what has been the result?” Eberstadt,
in her book, “makes a strong case that contraception
is the technological engine of negative changes in theway men and women have come to live their sexuality
and their relationships in general” (Migeon, 2015).
r & k-factors
The book, “The Population Bomb” authored by
Paul Ehrlich induced an unfounded technological fearin the minds of politicians that uncontrolled population
explosion will result in the imbalance between natural
resource availability and per capita utilization. In the
study of population growth two factors are important:the r – factor and the k-factor. The r – factor refers to
the “reproductive potential” of a young growing
population which is birth (b) minus death (d) or (b – d)
= r and the k-factor which represents a stable
population that has reached a stability with the carrying
capacity of the environment wherein (b – d) = 0. It is amature stable population. The carrying capacity is alimiting factor in animal population. Strangely humanpopulation growth does not follow these limiting
factors. Human population growth is a density
independent growth. Human populations multiply inspite of limiting factors. The most important limiting
factor is the reproductive health of the woman and herfunctioning womb.
Contraceptive Chemical pollution
The chemical pollution that adversely affects
reproductive health of a woman is the widespread useof hormonal contraceptives. Ms. Grigg-Spall is theauthor of the book “Sweetening the Pill”. She
documents negative impacts of hormonal disruptive
contraceptives. In adults the “symptoms ranged fromsignificant increase in breast size and severe pain,
mouth ulcers, loss of sex drive, significant increase inappetite leading to weight gain, monthly bouts ofthrush, depression, fits of rage, fatigue, suicidal
thoughts and loss of focus and motivation.” In teenage
young adults the “reproductive systems are shut down
before they are fully developed.”Eubios Journal of Asian and International Bioethics 26 (September 2016)
These hormonal contraceptives suppress ovulationand menstruation.
Evidences are mounting that
hormonal contraceptives are directly linked to thereproductive health disorders of women. Moreover, thehabit of morning a pill causes every woman to“experience, over time, impaired physical and mental
health”. Besides there is other “extensive, direct effects
brought on by various formulations: dehydration of thebody, vitamin deficiency, suppression of the adrenal
glands, and reduction of testosterone. These
disruptions can result in increased allergies, lowenergy, poor sleeping patterns, increased bloodpressure and stress, higher risk of heart attack, andlow libido” (Migeon, 2015).
On the other hand fertility awareness based methods(FABMs) are preferable since they relieve women of
the pollution to her body. A personal testimony of
Grigg-Spall makes a woman a fertile woman: “In the
few months I took off the pill I felt lighter. A rush of
positive emotions let me feel happiness, excitement
and enthusiasm”.
Landmark Years
The following years –1920, 1960 and 1980s are theimportant years that changed the course of human sex
in histpry. In the 1970s and 1980s, Paul Ehrlich’s book,
The Population Bomb, successfully galvanized thegeneral fear that population growth meant doom forour planet. It triggered international campaigns andpolicies aimed at controlling birth rates worldwide. But,
while trying to save the earth with implementation of
now disproven population policies and theories, wehave endangered one key species: humans;
specifically, women.
Women’s health has been put at risk by thewidespread use of contraceptives and, for many
women their own reproductive ecosystem has fallen
apart to uncoordinated pieces and even become
hostile to motherhood. Two contemporary authors,
Holly Grigg-Spall and Mary Eberstadt are fromradically opposed viewpoints on ethics and politics, Buteach put forward their case effectively that hormonal
contraceptives have much to do with theendangerment of women and her reproductive health.
Eberstadt, in her book Adam and Eve after the Pill,
made a strong case that contraception is thetechnological engine of negative changes in the way
men and women have come to live their sexuality andtheir relationships in general. She has described “thesocial evidence we have witnessed in the past 50
years of broad use of these methods: an increase in
pre-marital sex and cohabitation, of extra-marital
affairs, of divorce, and a general acceptance of sexual
behaviours previously considered harmful to society”.
She added that “modern contraception may even be
the central fact of our time: it is hard to think of any
other whose demographic, social, behavioural, andpersonal fallout has been as profound.”The relationship between a woman and her
spouse/partner, which until now was a primary basefor a stable “reproductive-ecosystem,” is not goingwell. While, according to Eberstadt, there is ample

169

evidence that “married, monogamous people are most
likely to be happy,” fewer find themselves in thatsituation. The number of divorced or separated women
has gone from about 6 percent in 1950 to 15 percent
today, and of never married from 17 percent to 29
percent. This trend comes at a high price for women,
who end up raising children on their own and having tofend for themselves on one income.
Single mothers by choice
A penetrating question was raised by Hampikian(2012) “Men, Who Needs Them?” or does mankind
really need men to produce babies? The answer is a“No” for the following reasons.
(i) For procreation women are essential and are self
sufficient; while men are not.
(ii)
“If a woman wants to have a baby without aman, she just needs to secure sperm (fresh or frozen)
from a donor (living or dead). The only technology the
self-impregnating woman needs is a straw or turkey
baster, and the basic technique hasn’t changed muchsince Talmudic scholars debated the religious
implications of insemination without sex in the fifth
century. If all the men on earth died tonight, thespecies could continue on frozen sperm. If the women
disappear, it’s extinction”.
(iii) Cloning totally eliminates both sex (inter course)
and the importance of man in procreations. (iv) Human
sperms can be ‘created’ from the stem cells while thehuman egg cell cannot be manufactured. More
importantly nothing can be done without a woman’s(human) womb. Finally due to some selective
catastrophe if all the men are eliminated from on earth
then human race can continue by self impregnation bya woman with frozen sperms but if the womb of awoman disappears then it is nothing but extinction of apowerful and intelligent species.
Fatherless broken Homes
New data were published by the Family ResearchCouncil (FRC). The Index of Belonging and Rejection
released by them “revealed a dismaying statistic about
the state of American families: 55 percent of 15-to-17year-olds in America do not live in intact families” (Ford2014). It is statistically sad to note that “more than
40% of all children are born out of wedlock and one inthree children live in single-parent homes. If Americans
are concerned about the next generation, it’s time tostrengthen marriage.” The ill effects of a unstablesociety built on a foundation of declining strength of a
traditional marriage was reiterated by the American
President when he said “We know the statistics—that
children who grow up without a father are five times
more likely to live in poverty and commit crime; ninetimes more likely to drop out of schools and twenty
times more likely to end up in prison. They are more
likely to have behavioural problems, or run away from
home, or become teenage parents themselves. And
the foundations of our community are weaker becauseof it” (Ford, 2014). It is a common knowledge thatmarried parents in an intact family have a edifying
influence on the lives of children from low-income

Eubios Journal of Asian and International Bioethics 26 (September 2016)

170

households since stable marriages in intact families
reduced childhood poverty by 82%. The researchstudy clearly showed that “children who live in singleparent homes— or communities where the majority ofhomes are headed by single parents— have asignificant disadvantage in moving up the income
scale.”nd

Morals – 2 Mark of Humanity
Human beings are moral and spiritual beings too.
Human morality is the moral- spiritual framework thatsustains the human ability to distinguish the ‘right’ from(and) the ‘wrong’ as well as the good from the evil. The
origin of morality is not an easy topic for discussion.
Those who are spiritually minded will link it with thecreation of humankind in the image of God since God
is the moral person. Unlike the believers in God the‘non-believers’ may find it difficult to ascertain that
morality is an evolutionary by-product since there is nointermediary cultural fossil in all the plant and animal
kingdoms to support the worldview of evolutionary
biology that there are transitional animal fossils which
are ethical in nature. It does not mean then that a nonbeliever or a secularist or a rationalist or an
evolutionist is immoral. No one can say that an
evolutionist can’t be a morally upright person. With orwithout God a person can be morally a good person.
An atheist can say that God is not necessary in his/herlife to lead a morally good life. But the ground truth
paints a different story. Barna Research Group
conducted a survey on the attitude of both spirituallyminded persons (Christians & Other Faiths) and on
non believers (Agnostics & Atheists) towards theacceptance of seven moral issues as ‘morally
acceptable behaviours’.
Surprisingly the nonbelievers (Agnostics & Atheists) were readily accepted
these seven moral issues (like abortion, cohabitation
without marriage and nudity) as ‘morally acceptablebehaviours’. Details are discussed below.
Moral Development
There are just two streams of thought on moral
development: (i) the secular (rationalist /evolutionist
and non-believers) and (ii) the religious (Hindu,
Christian and Islam). A person’s moral development islinked with country of birth, religious faith of theparents or partners and upbringing of the child. In achild’s bodily development stages sex hormones playa significant role in the sexual awakening of a child.
The internet has brought the various contours ofhuman sexuality at the moral door steps of adeveloping mind. Pornography is one such contours ofhuman sexuality – a corrupted form of sex. In thedeveloped and Christian influenced western nations achild, as early as nine years of age, is exposed to suchcorrupted sex by a simple press of a button of a handset. Therefore in this study an attempt has been madeto trace the changes in the perception of sex ethics
from a moral viewpoint. This has been done by
studying human-sex-history of the recent past. Usefuland large amount of data are available on the publicdomain. The present study has used these survey

statistical data which have been recently published on
the mindset of Christians, other faith groups, agnostics
and atheists towards human sex and sexuality in USA.
Happiness Gap: Between Pornography andReligious Mindset
Do people with religious mindset view pornography?
Yes! They do! The Austin Institute for “The Study ofFamily and Culture” carried out a study on
pornography and religious affiliations. The study
respondents were Christians belonging to mainline
churches of Protestants and Catholics with 4 to 5
subsets in them. The survey assessed the percent ofrespondents who viewed pornographic materials a
week before the survey (Patterson and Prince, 2012).
The research team published the results withgraphical representation. Following is a summary of
their results. Percentage values are given inparenthesis. The results showed that American men inboth the study groups view pornography more than
women. American Christianity is steadily losing its
moral grounds. According to this study pornography
has come to stay deeply rooted in American soil. The
data are summarized below.
Evangelical Protestants
Men (29%) Women (4%)
Pentecostals
Men (21%) Women (2%)
Fundamental Protestants Men (37%) Women (1%)
Mainline Protestants
Men (33%) Women (2%)
Liberal Protestants
Men (46%) Women (8%)
Traditional Catholics
Men (21%) Women (3%)
Moderate Catholics
Men (26%) Women (6%)
Liberal Catholics
Men (35%) Women (2%)
Other Catholics
Men(26%) Women (18%)
Latter Day Saints / Mormons Men (14%) Women (3%)
Other Christians
Men (24%) Women (9 %)Church attendance and Pornography
The study was extended to those who attend Church
service on Sundays – (i) those who attend weekly
Church service regularly (ii) those who attend Church
occasionally and (iii) those who never attend a Church
service at all any time (Patterson and Prince, 2012).
The percentage data on viewers of pornography inthese three categories of people are summarized
below.
(i) Attend Church weekly Men (26%) Woman (6%)(ii) Attend occasionallyMen (38%) Woman (9%)(iii) Never attend Church Men (53%) Woman (12%)
The data showed an inverse relationship. Those who
attend weekly Church service on Sundays view lesspornographic materials than those who never attend
Church.
A Moral Decay
The Barna Research Group Ltd USA conducted, in
October 2003, a telephone interview survey with anationwide random sample of 1024 adults using its
Barna Research Group telephone interviewing facility
in Ventura, CA. The maximum margin of sampling
error associated with the aggregate sample was ±3
percentage points at the 95% confidence level. Adults
in the 48 continental States were covered and it tookEubios Journal of Asian and International Bioethics 26 (September 2016)
necessary precaution to ensure a fair distribution of
respondents with respect to the geographic dispersionof the U.S. adult population. Multiple call-backs wereused to increase the probability of including a reliable
distribution of adults.
Secondly the respondents were both believers in
God and non-believers. There were three arms in thesurvey: (i) Christians (ii) Other faith groups and (iii)
Agnostics & atheists. The survey addressed sevenmoral issues listed below.
Barna Research Survey Results
Table 1: Percentage of Adults Who Consider A
Behavior To Be “Morally Acceptable”
MORAL
ISSUES

1.
2
3
4
5
6
7

All
Adults

61%
60%
59%
45%
42%
38%
36%

Evangelicals

27%
12%
15%
4%
7%
5%
7%

Born
Again

45%
49%
49%
33%
35%
28%
29%

Other
Faith

69%
70%
71%
45%
47%
49%
46%

Atheist/Agnostic

75%
87%
78%
71%
69%
70%
68%

Table Credit: Barna Research Group Ltd.
Seven cardinal moral behaviours chosen for survey
1. Gambling
2. Co-habitation without marriage
3. Enjoying sexual thoughts/fantasies about someone
4. Having an abortion
5. Having a sexual relationship with someone of the
opposite sex to whom you are not married
6. Looking at pictures of nudity or explicit sexual behaviour
7. Using profanity

Faith can retard moral decay
The results of the above study have a significant
bearing on the moral development in both groups of a
population: (i) society as a whole and (ii) on theindividual person as well. The following threeconclusions can be drawn from the above critical database: (i) all the three arms of the study are prone towander into areas where angels afraid to step into (ii)even though Protestants and Catholic Christians were
impacted they were not totally deprived of theirmorality and (iii) people with agnostic and atheistic
worldviews are those who can very easily accept all
the seven issues that were posed in the Barna
research study as morally acceptable acts. The
Evangelical Christians scored the lowest while theagnostics and the atheistic scored the highest in all theseven moral issues. It only shows that the faith or theworldview a person holds matters in these
representations of moral development.
All round moral decay
The Christian Post (2003) also reported the results ofBarna Research Group Ltd November 12, 2003
survey: “a majority of Americans believed that each of
three activities were “morally acceptable.” Those
included gambling (61%), co-habitation (60%), andsexual fantasies (59%). Nearly half of the adult
population felt that two other behaviours were morally
acceptable: having an abortion (45%) and having a171

sexual relationship with someone of the opposite sex
other than their spouse (42%). About one-third of the
population gave the stamp of approval to pornography(38%), profanity (36%), drunkenness (35%) andhomosexual sex (30%). The activity that garnered theleast support was using non-prescription drugs (17%).”
The Future of Morality
Brooks (2010) reported “Study after study finds that
Americans are not hierarchical. American children areraised to challenge their parents. American underlings
are relatively free to challenge their bosses. In thiscountry you’re less likely to have to submit to authority.
… Americans are now in a depressed state of mind.
As China and India rise, nearly two thirds of Americans
believe their nation is in decline”. The fear of moral
decline leads to a condition in which morality continues
to decay” (Christian Post 2003, Patterson, et al 2012).
The Barna Research Group Ltd survey results were
published in November 2003. Twelve years haveelapsed and hence it is desirable to get a fresh look
into the moral climate of the present and the emerging
global society. If the emerging society has a majority ofgay community then a new global bioethics may haveto be developed for the new global gayism. The phrase“slippery slope” means that a course of action
undertaken to correct one error leads to further
dangerous disastrous unsolvable situations. In the longrun, will the society trip into amoral abyss since further
morality decay has been predicted?
Cardinal moral behaviour numbers 4 - 7 (Table 1)
Moral items 4, 5, & 6 are concerned with sexual
morality. It is very interesting to note that only a verysmall percentage of evangelicals i.e. 4 to 7 % alone
had considered that these four behaviours are morally
acceptable and the majority of Evangelicals consider
that these actions are definitely immoral. Why? It isbecause of their unmistakeable belief that the entire
Bible, including Genesis narrative account of creation(Genesis 1 – 11), is the revealed, inspired, infallible
and inerrant Word of God. They generally “walk theirtalk”. Their doctrinal teaching is contained in thefollowing sexual morality statements: (i) No sex act
before marriage (ii) Nothing outside marriage and (iii)
No deviant sexual orientation other than the sociallyaccepted tradition of male – female union in marriage.
But some do give way to their basic instinct (4-7%)
which only proves the rule.
Naked Truth is Tragic Truth
Does Genesis 1-11 prohibit pornography? There isno direct answer to this question since this word does
not occur in Genesis 1-11. The word pornography
does not occur because the practice was not inexistence. But the naked truth is that this passage
does record the action taken by Adam and Eve tocover their nakedness. There was an inner urge inthem NOT to remain naked. If the word “nakedness” isthe equivalent of the word “nudity” and sincepornography mainly deals with the uncovering of ahuman body then Genesis 1-11 does indicate that it isEubios Journal of Asian and International Bioethics 26 (September 2016)

172

natural for a human being to remain body covered.
Adam and Eve both switched fig leaves to cover theirnude condition. But the creator God provided a betterand durable instrument of skin to cover their
nakedness. If pornography is morally unacceptablethen to regulate the pornographic culture both humanregulatory actions plus God’s spiritual provisions arenecessary. The tragic truth is that post-modern
people’s culture and technological culture have broken
these two regulatory norms. The naked and the tragic
truth is that pornography has come to stay.
Global Perspective - TFR
2012
Ranking1
280Country

TFR

Niger
Uganda
India

7.52
6.65
2.58

2014
Ranking
1
5
81

TFR
6.89
5.97
2.51

121
USA
2.06
123
2.01
137
UK
1.91
140
1.09
155
Netherlands
1.78
156
1.78
202
Japan
1.39
208
1.40
203
Greece
1.39
207
1.41
219
Taiwan
1.16
222
1.11
220
Hong Kong
1.09
221
1.17
221
Macau
0.92
223
0.93
222
Singapore
0.78
224
0.80
Note: source data for a few countries are taken from “TheWorld FactBook” : Total Fertility Rate (TFR) CIA, USA.

Data were provided for a total of 222 countries in2012 and for a total of 224 countries in 2014. In boththe assessment years Singapore ranks the lowest TFR
of 0.78 and 0.80 respectively. Some 50 years ago
Singapore was a third world island nation. But now
Singapore is one of the costliest cities of the world tolive in. In 2015 its school educational system is
Number One in global ranking. But with the lowest
TFR Singapore is not doing well. In a few years time
there will not be enough native born Singaporeans to
run the country. In two years time the country could
raise 0.02 of TFR (from 0.78 to 0.80). How long will ittake to reach the required and desired level of 2.00
and above TFR?
Chief Damage - Fertility Loss - A Case Study
Rich data on TFR and spiritual health of New
Zealand are available.

The above TFR graph can be dissected into thefollowing four segments:
Phase 1 Segment 1
Phase 2 Segment 2
Phase 3 Segment 3
Phase 4 Segment 4

1921 to 1935 = fall1935 to 1960 = rise1960 to 1978 = deep fall1978 to 2015 =point of no return

Chief Points to Consider(i) Among the sexual revolutions the land-markthyears are the following: the 4 revolution was startedtharound 1920 and the 5 one was started around 1960.
That there were two peaks with downward tripping
points in the NZ TFR curve at 1920 and also at 1960 it
is very tempting to come to a conclusion that theseththdownward trips are due to the 4 and the 5 sex
revolutions. But such a conclusion is not valid since it
is not supported by ground truth. There is no
documentary evidence to reach the above conclusion.
nd(ii) A chief point to consider is the fact that the 2
deep fall which reached the replacement level around1978-80 failed to recover even after 35 years. Againth
1980s coincides with 6 sex revolution. It is a wellknown biological fact that same sex marriages are notchild centring and can’t produce biological parents –the father and the mother.
(iii) The chief factor(s) that enabled the fallen TFR
curve to recover in the previous two cases – prior to1920 and at 1935 – may be identified and that rightrecovery note may be struck again!
Stage I
Segments 1 & 2 constitute Stage I. It comprises of afall and a subsequent rise. Troughton (2007) in his
Ph.D thesis entitled “Jesus in New Zealand 1900 1940” outlines the socio and political and religious
reasons which could be used to explain the fall andrise of TFR. His thesis revealed that in early days, NZ
Christianity was influenced by the doctrines of both
English and American evangelicals. But under the
influence of Liberation Theology it tried to reinterpret
Christianity in a social context (p 128) and hencesocial Christianity and moral campaigning were thefocal points. There is no indication that the first sexual
revolution of the Western world (1920) had any
bearing on the declining TFR. There were three sex
revolutions 1920, 1960 & 1980s. But the social factor
that brought down TFR was alcoholism which broke
the cohesiveness of Christian homes. In 1928 NZ
voted on the issue of National Prohibition and secured
only 294,453 (40.2%) votes which was less than thevote for National Continuance 374,502 or 51.1%).....(p145). The upward trend of TFR did “lay in the
combination of social activism and evangelical faith.
Jesus was exemplary but also the source ofregenerative life” due to the work of activist like
Kagawa (p 176).
Stage II
Segments 3 & 4 constitute Stage II with a second
deep fall and a subsequent flattening of the curve.
There was no recovery. There was a deep spiritualthslide. NZ became the 13 country to legalise same sex
marriage by a parliamentary vote of 77 to 44 (April 17,2013). Just 77 parliamentarians decided for the entire
NZ and changed the definition of marriage. Strangelyndthe 2nd point of decline coincides with the 2 year of
second sex revolution i.e 1960. The slide was deepand steady because the year 1970 was the goldenyear of pornography. There appears to be noEubios Journal of Asian and International Bioethics 26 (September 2016)
documentation on such relationship. Hence the blame
was put on women’s empowerment and her higher
educational and earning capacity.
The New Zealand Herald published an article with acatchy title “Money in the bank, fewer buns in oven:
Why women are having fewer babies?” “Babies aregoing out of fashion again as Kiwi women increasingly
put work and study ahead of childbearing”. Better
education – with a five year Ph.D programme on hand
women who are living in rich residential areas and withhigher incomes are those who are likely to have lesser
number of children (Collins, 2015). Fertility rates were
now lowest where women were better educated, had
higher incomes and were more likely to be in paid
work. It may be added that the two sex revolutions
may be the causal detrimental factor the low TFR. The
death of TFR coupled with inner moral and spiritual
decay will affect the security of a population under theheavy burden of detrimental socio cultural revolutions.
Synergistic effect of a national declining TFR and a
decaying morality is hard to rejuvenate spiritually for it
takes a sustained production of high quality of humanresource which is not there.
Suggested Remedy“With Germany about to tip over the edge into
population decline, and many countries already facing
steep decline, there is little doubt that we need tosupport and encourage families with young
children. Is encouraging more flexible work options forparents one way to do this? Even people who havemore than enough money tend to work long hours,
often also “catching up” on the weekend. It’s pretty
clear that long outside work hours and children don’t
go well together - the work of the home isimportant. Are people choosing long hours; or are thepart-time and flexible options simply not there”(Roberts, 2015)? All solutions end up with a question
mark!
Incomplete Conclusions
There are more questions than answers. The
conclusions will remain incomplete till remedial
measures are found. The human marriage andparenting are being redefined. More and more
fatherless homes and broken homes are being
created. Will human society be stable? Our ‘one home’
mother earth is being over stressed to yield her natural
resources to sustain the ever growing humanpopulation. Will the planet earth withstand the resource
exploitation? Will the human species survive with thecontinued decline in human total fertility rate? With theonslaught of present and the future sex revolutions will
the human society be led to the final destination –successful failure to close the “happiness gap”.
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Needle Exchanges. New York Times May 16, 2015
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The Social Organization of Sexuality: Sexual Practices in
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Migeon, G., 2015 Save the earth, one woman at a time.
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years of age, United States, 2002. Advance data from vitaland health statistics; no 362. Hyattsville, MD: National
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Patterson, R and Prince, J., 2012 Pornography, Religion andthe Happiness Gap:
Does Pornography impact theactively Religious Differently? Journal for the ScientificStudy of Religion 51: (1) 79-89.
http://relationshipsinamerica.com/relationships-and-sex/howmuch-pornography-are-americans-consuming.
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174

Eubios Journal of Asian and International Bioethics 26 (September 2016)

Japanese Bioethical
Challenges Concerning
Self-Management Support
For Patients With Chronic
Conditions: An Analysis of
Quality of Life & Autonomy- Aya Enzo (Corresponding Author)- Taketoshi Okita- Atsushi Asai
Department of Medical Ethics, Tohoku University Graduate
School of Medicine
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Email: enzo@med.tohoku.ac.jp

Abstract
Prevention and control of chronic conditions areglobal healthcare challenges. Patient self-management
has been deemed essential for treating chronic
conditions and improving the quality of patient life.
However, the current Japanese system for supporting
patient self-management of chronic conditions hasreceived little ethical assessment. The first aim of thisarticle is to provide an ethical analysis of current
Japanese support for self-management of chronic
conditions with reference to international discussions
concerning self-management, developed mainly inwestern societies such as Europe, the United States.
The second aim is to clarify the challenges faced by
Japanese biomedical ethics
concerning selfmanagement support by focusing on the ethicalconcepts of quality of life and autonomy. This article
identifies the following two challenges: [1] dispelling
conceptual confusion concerning basic ethicalconcepts such as quality of life and autonomy, and [2]exploring the conceptual relationship between these
ethical concepts, as they relate to providing support forchronically ill patients. By addressing these challenges
and constructing a theoretical basis for radical change
in support mechanisms, bioethics in Japan could
contribute to efforts to construct a comprehensive
support system for patients with chronic conditions,which organize variety kinds of supports, such as
medical professional supports, supports from patient’s
groups, local community supports, familial supports,
support in patients’ workplace, and supports forpatients’ family members as well.
Keywords: Chronic conditions; Self-management;
Autonomy; Empowerment; Quality of life; Japan
Introduction
The Japanese healthcare system has given thenation the world’s longest life expectancy, withcomparatively little expenditure (Hashimoto et al. 2011,
pp. 1174-82, Japanese Ministry of Health, Labour andWelfare 2013, pp. 115-119, trans version p. 9, p. 32).
Nevertheless, prevention and control of chronic
conditions remain challenging with current Japanesepolicies, as they do globally (Ikeda et al. 2011, pp.
1100-1103). Major chronic conditions, such as
diabetes
mellitus,
hypertension,
cancers,
cardiovasculardiseases,andcerebrovasculardiseases, remain the leading causes of morbidity andmortality in Japan, consuming 30% of total national
healthcare expenditure.
Since 2000, the Ministry of Health, Labour andWelfare has been engaged in the “National Health
Promotion Movement in the 21st Century (Healthy
Japan 21),” as a health promotion measure forcitizens. This movement categorizes the four main
chronic conditions—cancer, cardiovascular disease,diabetes, and chronic obstructive pulmonary disease(COPD)—as “lifestyle-related diseases.”
The primary aim of this program is as follows: “Topromote people’s health comprehensively through adecrease in premature death, the extension of theperiod during which people can live without suffering
dementia or being bed-ridden (healthy life span), andso forth, in order to realize a society where all thenationals can live a healthy and happy life” (Japanese
Ministry of Health, Labour and Welfare 1999, part 2
chap. 6 sec. 4)
To this end, the second phase of the movement was
launched in 2013, with five basic national goals
including the prevention of the onset and progressionof the four main chronic conditions. For example, in thecase of diabetes, specific goals include “reducing thenumber of patients” and “increasing the number ofvisits for continuing treatment against diabetes.”
If the Japanese government is seriously committed tothese goals, the development of national programs forpatient self-management must be achieved, because
patient self-management is essential for successfultreatment of chronic conditions and improvement ofpatient quality of life (QOL). As used herein, the term
“patient self-management” refers to actions thatpatients take to manage chronic health conditions.
Patient self-management extends beyond daily
routines such as taking medicine, checking bloodpressure or glucose levels, and monitoring symptoms.
It also includes managing emotions, setting goals,
working with health professionals, arranging schedules
to accommodate treatment regimens, and developing
social networks 1). Internationally, patient selfmanagement has come to be regarded as essential for
successful treatment of chronic conditions andimprovement of patient QOL as individual well-being.
There exist numerous efforts that seek to improve thequality of self-management support for patients withchronic conditions in the West, primarily in Europe andAustralasia (Bodenheimer et al., 2002; Meetoo andGopaul 2005; Aujoulat et al., 2007; Greenhalgh 2009).
In Healthy Japan 21, however, there are no
programs aimed specifically at supporting patient selfmanagement. In addition to this political negligence,
Japan’s bioethicists have paid insufficient attention to
the social mechanisms that support self-managementof chronic conditions, such as information giving, basic
skills training, skill-building workshops, and counsellingfor problem solving. This article aims to provide anEubios Journal of Asian and International Bioethics 26 (September 2016)
ethical analysis of the current Japanese selfmanagement support system for patients with chronic
conditions and to clarify challenges in Japanese
biomedical ethics concerning self-management
support. Section 1 reviews the status of support
mechanisms in Japan. Section 2 attempts to analyze
this system. Section 3 identifies two bioethicalchallenges in Japan. Overall, this study argues that thetheoretical basis of bioethics in Japan must be
harnessed to create radical change in support
mechanisms.
Current Japanese Support for Self-Management ofChronic Conditions
In Japan, patients who self-manage chronic
conditions are supported almost exclusively in
professional medical settings such as clinics,
hospitals, or medical centers. There are, however, nostandardized national mechanisms for supporting selfmanagement. Support by medical professionals is
generally provided along with treatment, andcategorized as “patient education” or “instruction.” Forexample, many hospitals and clinics provide classes
for diabetic patients. Specialists who assist patientswith self-management are given designations such as“Certified Diabetes Educator” (Nihon To-nyobyo
Gakkai 2012, pp. 3-6). Similarly, an accreditation
system established in 2015 designates specialists who
assist patients with high blood pressure as “educators”(Nihon Ko-ketsuatsu Gakkai 2015).
However, the previous two decades have broughtsignificant changes in methodological concepts ofpatient education or instruction in Japan. The old styleof education juxtaposed the role of professionals andpatients. It regarded medical professionals as
instructors who set goals for patients and informed
them about their treatment regimens. Patients were
expected to follow their instructions without questions
or resistance. This perspective assumed that patients
who did not follow their instructions lacked discipline orunderstanding of their conditions, and that theyneeded re-education (Yamaguchi 2008, pp. 2-3,
Katsuyama and Akutagawa 2012, pp. 699-707). In
contrast, the new style of patient education does notdelineate professionals as providers of instruction andpatients as its passive recipients. Rather, patients are
regarded as active learners who make decisions, alter
behaviors, and integrate self-management of chronic
conditions into their lives. Medical professionals are
partners who assist in setting and implementing goals,
as well as, when necessary, identifying problems,
reviewing plans, and redesigning them (Yamaguchi
2008, pp. 2-5, Ishii 2011, pp. 33-39, Nihon To-nyobyo
Gakkai 2012, pp. 2-12).
This methodological change in Japan has beenclearly influenced by ethical arguments regarding theconcept of patient autonomy and such related
conceptsas“patient
adherence,”“patient
empowerment,” and “executional autonomy,” whichhave been developed mainly in western societies(Funnell and Anderson 2004, pp. 123-4, Holm 2005,
pp. 159-64, Williamson 2014, pp. 5-6, Naik et al.,175

2009, p. 24). In short, autonomy is becoming morepervasive in the new style of patient education in
Japan. For example, a guidebook from the Japan
Diabetes Society refers to “patient empowerment” inthe following manner: “Collaborative relationships
between patients and medical professionals are
essential for the treatment of diabetes. In such
relationships, medical professionals do not control
patients, but patients control their own diabetic care.
That is, “empowerment” means that patients are given
both the ability to participate in their care as an active
agent of diabetic care and to control their care andhealth-related behavior” (Nihon To-nyobyo Gakkai
2012, pp. 9-10).
The ability to both participate in and control their careis indispensable for patients to acquire or recovercontrol of their lives, i.e., to become or remainautonomous. Autonomy in the context of Japanesepatients’
self-management
entails
self-control,
responsibility, and independence. Many characteristics
of patients with “lifestyle-related diseases” would
certainly match the image of autonomous individuals.
In Japan, symptom-free individuals with lifestylerelated diseases, such as diabetes, metabolic
syndrome (visceral fat syndrome), or hypertension,
who do not require medical support may subjectively
be classified as “patients” at routine health checkups.
This classification is a result of uniform diagnostic
criteria for these diseases, which aim for early
detection and prevention. Therefore, there are many
patients in Japan who remain active in their lives andhave high capacity to control their own lives. In thisrespect, the concept of autonomy has significant
implications for ethical analysis of self-management
support in Japan.
As shown above, in Japan self-management support
for chronically ill patients has been exclusively
provided within medical settings, and we can find themethodological changes in these medicalized
supports. These changes has been influenced by
ethical arguments over patient autonomy. Yet, when
considering patient autonomy seriously, are themethodologicalchangesinJapaneseselfmanagement support sufficient to empower patients or
respect their autonomy? How can other ethical criteria(e.g., patient QOL) be considered in assessing thecurrent Japanesesupport system
for selfmanagement? In the next section, in order to identify
the challenges faced by Japanese biomedical ethics,
we will analyze the current Japanese support systemwith consideration of two ethical criteria: autonomy and
QOL.
Ethical Analysis of the Current Japanese Support
System: Autonomy and Quality of LifeFirst, the concept of improved patient QOL is one of
the basic ethical criteria for assessing selfmanagement support systems. The improvement orpreservation of patient QOL is usually regarded as abasic goal of support for chronic conditions in Japan,
as well as in many countries, although without clear
definition given to this concept. For example, improved

176

Eubios Journal of Asian and International Bioethics 26 (September 2016)

QOL is one of the established goals in Japan’snational cancer control strategy (Japanese Ministry of
Health, Labour and Welfare 2013, trans version chap.
2). According to a guidebook from the Japan Diabetes
Society, “preservation of quality of patients’ life throughsuccessful control of blood glucose level, body weight,
blood pressure, and serum lipid” is one of the mostbasic goals of treatment for diabetes (Nihon Tonyobyo
Gakkai, 2012, p. 24).
If our society or government is seriously committed to
the goal of improved QOL, it is clear that the current
medicalized support system is insufficient. This isbecause not only disease itself, but also theimplementation of patient self-management andtreatment, can adversely affect patient QOL. Selfmanagement process affect all aspects of patient life,
such as life style and work style. For example, patient
self-management of chronic conditions requires
patients to alter lifelong behavioral patterns and often
to accommodate typical daily schedules, including
household task and job. Self-management practices
can limit patients’ interactions with coworkers, friends,
and family members by limiting the content of theirmeals, and sometimes affecting their identities or selfconceptions. Furthermore, self-management may
require patients to reassess their pre-illness lives andreconstruct their life plans. The contribution of medical
support to improved patient QOL is actually quite
limited. For example, patients whose treatment
involves radical changes in diet might be taught theimportance of a proper diet, which foods are
nourishing, and how to count calories. This type of
instruction might not teach patients how to incorporatea dietary regimen into complex daily life, including
family or job responsibilities. Instruction on such topics
is indispensable for patients to implement selfmanagement in their lives without diminishing their
QOL.
If a society is committed to the goal of improving
patient QOL, it is necessary to construct anappropriately comprehensive support system thatencompasses the wide range of challenges thatpatients will face in implementing self-management ona daily basis. Proposals to construct comprehensive
support systems are gaining support internationally. In
2002, for example, the World Health Organization(WHO) developed its Innovative Care for Chronic
Conditions (ICCC) Framework, “a comprehensive
framework for updating healthcare to meet the needsof chronic conditions” (WHO 2002, p. 1). The ICCC
and its prototypical Chronic Care Model (CCM) aretaking effect worldwide (Wagner et al. 2001, Nuño etal. 2012, pp. 55-64). In contrast, the primarycontributors to improved patient QOL in Japan havebeen informal ones, such as family or local community,
rather than healthcare professionals (Hiroi 2013, pp.
17-30). As the proportion of single-person households
is growing (from 7.6% in 1990 to 13.1% in 2010;
Statistics Bureau 2010, chap. 1, p. 7), the role ofinformal communities in this effort is now rapidly
declining. Yet, our society has no substitutes for the
traditional informal communities.

Second, from the point of autonomy, themethodologicalchangesinJapaneseselfmanagement support can be welcomed for theiremphasis on patient perspective. However, even the
new style of patient education provides incomplete
support for patient autonomy. In the new style ofpatient education, as in the old style, it is presupposedthat patients are self-sufficient at implementing goals
without assistance outside of that received in ahealthcare setting. Within this system, if patients fail tovisit a doctor regularly or to implement their own goals,
regardless of the reason, patient attitudes tend to be
regarded as something to be corrected within a
medical setting. Many factors that affect successful
self-management, however, are beyond the control ofindividual patients in the absence of assistance fromother people. For example, it is often necessary forpatients to rearrange their life or work schedules toincorporate dietary or exercise regimens. If patientsare to adhere to dietary regimens or visit their doctors
regularly, they require some help or cooperation not
only from healthcare professionals but also from family
members and colleagues. Patient self-management
should not be considered an individual management
issue. In order for patients to establish or regain
control over their lives, it is necessary that theirautonomy be taken into consideration both in clinicaldecision-making
andin
implementing
selfmanagement
practices.
Incorporating
patient
autonomy into self-management implementation
involves some intervention or support from externalsources, as well as from healthcare professionals.
Internationally, ideas regarding patient autonomy
have been expressed through discussions of theconcepts of “patient empowerment,” or “executive
autonomy” (Naue 2008, pp. 315-24, Lanoix 2013, p.
691, Williamson 2014, pp. 11-12, Van Geelen 2014, p.
22) 2). According to Lanoix, the concept of the patient
as a person embedded in a support network of
informal caregivers is essential for long-term illnesses.
Efforts to construct systematic support for chronic
patients to regain control of their lives have spread in
Europe and the United States (Meetoo and Gopaul
2005, pp. 28-29, Aujoulat et al., 2007, pp. 13-20). For
example, the United Kingdom (UK) nationwide Expert
Patients Programme was launched in 2001. This
program is based on “developing the confidence andmotivation of the patient to use their own skills,
information and professional services to take effective
control over life with a chronic condition” (Department
of Health 2001, p. 22). Similar programs are underway
in Australasia, Europe, and the United States, althoughdata regarding their effectiveness are poor
(Greenhalgh 2009, p. 630).
In contrast, patient autonomy in Japan is still
perceived as patient self-determination in clinicalsettings. In the context of Japanese discussions
regarding support for chronic patient self-management,
patients are usually portrayed as being self-sufficient
agents who implement self-management goals without
assistance. The term “lifestyle disease” can be taken
to reflect such an impression of patients. The

Eubios Journal of Asian and International Bioethics 26 (September 2016)
implication of this term is that the diseases in question
exclusively result from individual patients’ lifestyles(which consist of their choices), commonly leading to
the assumption that patients can choose to change
their lifestyles, thereby completely preventing these
diseases. If the discussion about support forchronically ill patients relies on these assumptions, thefact that patients require some support in implementing
goals will remain neglected and the need to constructsystematic support systems for chronically ill patientsto establish or regain control over their lives will not beadequately recognized.
Bioethical Challenges in JapanAs discussed in the previous section, selfmanagement support for chronically ill patients has
thus far been exclusively provided within medical
settings, and at the state level there remains little
policy regarding self-management support of patientswith chronic conditions as laid out in Healthy Japan 21.
Though some efforts to improve quality of support
through methodological change are observable at the
medical level, even the improved versions of support
are insufficient in providing for improved patient QOL,
and incomplete regarding patient autonomy.
In order to properly address these defects in thecurrent Japanese self-management support system,
interdisciplinary efforts must be made to construct aframework for society-wide self-management support
systems. Japanese bioethics could have an important
contribution to make to this end. The remainder of thisarticle addresses two challenges faced by bioethics in
our country.
The first bioethical challenge is to explore theappropriate interpretation of, or dispel conceptual
confusion about, two basic ethical concepts. Though
the concept of QOL is prevailing in the context ofhealthcare for chronic conditions in Japan,
interpretations of it are confusing. For example,
according to a textbook for clinicians, “QOL includes
subjective concepts. Then we cannot assess quality ofa patient’s life objectively” (Editorial committee of amanual for clinician 2008, p. 61). In contrast,
guidelines for the management of hypertension say,“since assessment of QOL of a patient withhypertension involves a wide range of assessment,such as assessment of comfortable feeling, physicalsymptoms, sexual functions, labor effectiveness,emotional states, cognitive functions, satisfaction forwhole life, social activities, it is necessary to assess allof them objectively and comprehensively as far as
possible” (Committee for establishment of guidelines
for treatment of high blood pressure in Nihon Koketsuatsu Gakkai, 2014, p. 36).”
In some instances, QOL is regarded as a subjective
concept, while in others it is regarded as objective. As
discussed previously by one of the authors of thisarticle, we can reconcile these seemingly contradictoryinterpretations with a consistent conception of QOL byanalyzing shared value systems in our country
concerning “good human life.” Under this conception,
QOL can be interpreted in the following ways: 1) it can177

be accurately evaluated through communication
betweenpatients
andmedicalprofessionals(objective), but the relative importance of each factor
involved in QOL depends on the individual patient’s
manner of thinking (subjective); 2) it is possible toestablish general standards for QOL evaluation basedon shared value judgments of what constitutes a goodlife (objective), but effective evaluation depends oneach individual patient’s condition (subjective). By
providing a consistent conception of QOL, bioethics inJapan could clarify the limitations of medicalized
support systems, and provide a theoretical basis forconstruction of a national level support system that
addressed the wide range of challenges that patients
will
face
in
implementing
self-management
independently.
The concept of autonomy is required to explore aninterpretation that is suitable within the Japanesesocial context. As noted in the previous section, newinterpretations of autonomy, such as executive
autonomy, have been developed in the context ofpatient self-management, while in Japan, autonomy isstill perceived as patient self-determination in clinicalsettings. Although these new interpretations might gain
support in Japanese culture, in which mutual
assistance between families or local communities has
been traditionally regarded as important, there remainsome questions to be answered. Based on these newinterpretations, some paternalistic interventions which
frustrate patients’ present autonomy might besuggested in the name of the preservation of future
patient autonomy. Yet, are such interventions
permissible? If they are permissible, how can we
discriminate between permissible and impermissible
paternalism? In order to explore support system
configurations that purport to assist patients inestablishing or regaining control over their lives, theappropriate interpretation of autonomy must be
explored by clarifying these questions.
The second significant challenge for bioethics inJapan is to clarify the conceptual relationship between
basic concepts. For example, the concepts ofautonomy and QOL are perceived to be implicitly
consistent with each other. Respecting a patient’s
autonomy is assumed to improve their QOL and viceversa. However, the relationship between these twoconcepts is not so simple. These concepts differ innature, with the concept of QOL being categorized asconsequentialist, and respect for autonomy as a nonconsequentialist or deontological concept. Moreover,the demands of each concept may sometimes beconflicting. For example, it is easily imaginable that apatient knowingly prefers other activities to managing
his disease, which is expected to degrade quality of hislife in the long run. In this case, intervention on behalfof improved QOL might frustrate him as anautonomous decision-maker.
In Japan, as noted earlier, the uniform diagnostic
criteria for some lifestyle-related diseases aredesigned for early detection and prevention of disease,hence, there could be many individuals who areclassified as “patients” even in the absence of178

Eubios Journal of Asian and International Bioethics 26 (September 2016)

symptoms during routine health checkups. Similarly,
one of specific targets for primary prevention ofdiabetes in Healthy Japan 21 is “increasing thenumber of patients who continue their diabetes
treatments.” Policies of this type for chronic conditions
are usually justified in light of individual patients’improved QOL, as well as social cost-benefit
calculations. Under this rather paternalistic policy inJapan, some patients who are diagnosed at very earlystages, and who lack any symptoms, might knowingly
prefer other activities, such as working or studying, tomanaging their diseases. Moreover, there might bepeople who resist even being categorized as “patients”
in the absence of any symptoms or health-related
anxiety. In the case of such individuals, should theirchoice to reject any intervention for QOL be respected
as autonomous choice? If not, for what reason? And
what kind of support mechanism is ethically best forJapanese society?
By exploring the conceptual relationships or ethicalpriorities of QOL and autonomy, bioethics in Japan
could help establish an ethically appropriate support
system configuration.
Conclusion
Japanese ethical discussions about support forchronic patients are still at an early stage ofdevelopment. It would be beneficial to begin these
discussions by exploring the challenges faced by
Japanese bioethics. This article identifies the following
two challenges: [1] dispelling conceptual confusion
concerning basic ethical concepts such as QOL andautonomy, and [2] exploring the conceptual
relationship between these ethical concepts, as they
relate to providing support for chronically ill patients.
By addressing these challenges and constructing atheoretical basis for radical change in support
mechanisms, bioethics in Japan could contribute toefforts to construct a comprehensive support systemfor patients with chronic conditions. Such acomprehensive system would integrate a variety of
support mechanisms, including medical services forpatients with chronic conditions, and support for otherpeople who live with these patients.
Notes1) Greenhalgh and other authors define “selfmanagement” on the basis of biomedical views of
one’s self. These narrower definitions restrict patientmanagement of chronic conditions to such activities as
taking prescribed medications. More comprehensive
considerations, such as dealing with emotions andsetting goals, would be categorized not as selfmanagement but as “coping with illness.” The broader
definition employed here is more common, notably in
the UK’s Expert Patients Programme.
2) Other theoretical discussions of self-management
and chronic conditions replace autonomy with otherconcepts. For example, Willems argues that agency
rather than autonomy is needed to self-manage
chronic diseases (Willems 2000, p. 24).

Acknowlegements
This work was supported by JSPS KAKENHI, Grant
Number 15H01861 and 16K16681

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Can the Principle ofProcreative Beneficence
Justify the Non-Medical Useof Preimplantation Genetic
Diagnosis?
- Biplab Kumar Halder
Memorial University of Newfoundland, Canada
Email: bkh517@mun.ca

Abstract
The Principle of Procreative Beneficence formulatedby Julian Savulescu and Guy Kahane states that theparents have a moral obligation to select the best
possible child, when selection is possible, by means of
the genetic screening of the embryos. Savulescu not
only advocates the genetic screening in order to avoid
the disease markers but also advocates for selecting
the non-disease genetic traits of an embryo whichmight contribute to the child’s better future, e.g. theintelligence of the child or selecting a particular sex. In
the paper, I put forward the question whether
preimplantation genetic diagnosis is justified in thecase of selecting the non-disease genetic markers. I
explore the fundamental assumptions of the Principleof Procreative Beneficence as well as its moral
foundation in order to understand Savulescu’s claim. I
argue against the pro-selection view of Julian
Savulescu exploring the basic assumptions and moral
foundation of the Principle of Procreative Beneficence.
The Principle of Procreative Beneficence presumes
that the non-medical and medical use ofPreimplantation Genetic Diagnosis are mutually
inclusive in the question of a moral obligation for theparents. However, I identify that this is not the case if
we consider the possible consequences ofPreimplantation Genetic Diagnosis to the potential lifeof the child; the non-medical and medical use ofPreimplantation Genetic Diagnosis are mutually
exclusive in terms of their implication on a child. The
Principle of Procreative Beneficence also presumes adegree of parental obligation in the concept of‘significant moral reason’ in the case of employing
Preimplantation Genetic Diagnosis which is morally
problematic. Finally, I argue that the moral foundationof the Principle of Procreative Beneficence is based onthe ‘common moral intuition’ which is not an authentic
source of moral truth; hence, the Principle of180

Eubios Journal of Asian and International Bioethics 26 (September 2016)

Procreative Beneficence cannot justify the non-medical
use of Preimplantation Genetic Diagnosis.
When I was just a little girl
I asked my mother, “What will I be?
Will I be pretty; Will I be rich?”
Here’s what she said to me“Que sera, sera
Whatever will be, will be
The future’s not ours to see
Que sera, sera
What will be, will be”[A popular song in the movie The Man Who Knew Too
Much (1956)]
Introduction
A pronatal view of procreation seldom requires
ethical justification. We take it for granted that we havean obligation to procreate. We presume an intrinsic
blameworthiness for not procreating (Benatar, 2006;
Overall, 2012). An extreme version of prenatalism not
only advocates the obligation to procreate, but also
extends the domain of obligation for parents to ensure
the best possible life of the child. The Principle ofProcreative Beneficence (PB) is one such extreme
pronatal view in reproductive ethics. Julian Savulescu
formulated the principle in his paper “Procreative
Beneficence: Why we Should Select the BestChildren”. Further development of the principle wasdone in another paper titled “The Moral Obligation toCreate Children with the Best Chance of the Best Life”
in collaboration with Guy Kahane (Savulescu &Kahane, 2009). The principle states that the parents
have a moral obligation to select the best possible
child, when selection is possible, by means of thegenetic screening of the embryos. Preimplantation
Genetic Diagnosis (PGD) is a reproductive technologythat makes it possible to discover the medical and nonmedical genetic traits of embryos. By medical traits itmeans the possible risk of some genetic disorders or
chromosomal abnormalities such as Down Syndrome
and Cystic Fibrosis, whereas non-medical traits meansome non-disease traits such as intelligence, sex, or
perfect pitch. PB justifies employing PGD not only for
medical reasons, but also for non-medical reasons. It
is less controversial to employ PGD in order todetermine chromosomal abnormalities or other genetic
diseases. Moral controversy arises when PGD isemployed in order to select the preferred sex or certain
genetic traits such as the intelligence of a child. The
pro-selection view is divided on the issue of whether
parents have a moral obligation to select the child withthe best life or the child with a life worth living. Julian
Savulescu claims that his formulation of PB is distinct
from some other versions of PB (e.g. ‘the prevention ofharm’ view or ‘the obligation to ensure a minimallydecent life for the child’ view) and that it makes astronger claim that parents have a moral obligation to
select their child with the best chance of the best life.
In fact, his proposed version of PB claims for a“significant moral reason” for the parents to ensure thebest possible life of the child. The central inquiry of thepaper is to find out whether non-medical use of PGD
can be justified by PB proposed by Julian Savulescu.
To explore the issue, I put forward the question, can
PB make such a strong claim that the parents have amoral obligation to select the best possible child byemploying PGD? In other words, can non-medical useof PGD be justified, in terms of its claimed obligation,
by PB? I argue against the pro-selection view of Julian
Savulescu exploring the basic assumptions and moral
justification of PB. PB presumes that the non-medical
and medical use of PGD are mutually inclusive in thequestion of a moral obligation for the parents.
However, I identify that this is not the case if we
consider the possible consequences of PGD to thepotential life of a child; the non-medical and medical
use of PGD are mutually exclusive in terms of theirimplication on a child. PB also presumes a degree ofparental obligation in the concept of ‘significant moral
reason’ in the case of employing PGD which is morally
problematic. Finally, I argue that the moral foundationof PB is based on the ‘common moral intuition’ which
is not an authentic source of moral truth; hence, PB is
not justified, with its morally problematic assumptions,
to claim a moral obligation for the prospective parents
regarding the non-medical use of PGD.
How Preimplantation Genetic Diagnosis Works
In Vitro Fertilization (IVF) is one of the Assisted
Reproductive Technologies (ARTs) that has given thehope to the couples who have been unsuccessful toprocreate for number of reasons. Generally, there isprenatal testing (the test for the fetus) available forcouples who are at high risk of transmitting genetic
diseases to their offspring. If the fetus is diagnosed
with any sort of genetic abnormality, then the options
are either termination of the pregnancy or giving birth
to a child with a genetic disease. PGD is comparatively
a new technology that detects the genetic conditions ofembryos before implanting it into the uterus. A single
cell from the embryo is taken by biopsy to detect thegenetic abnormalities. Therefore, PGD has brought up
alternative options for the couples who have known
genetically transmittable disease. In IVF process, thegoal of employing PGD is to diagnose for the specificgenetic conditions for the embryos, not the fetus,
before the pregnancy. Couples can choose an
unaffected embryo after mutation analysis in the caseof PGD which liberate them from the anxiety of a
possible pregnancy termination and start a pregnancy
with the knowledge of the genetic condition of theiroffspring (Fiorentino et al., 2006, p 670).
Currently, the technology is used mostly to detect thegenetic abnormalities. However, in near future, there isa possibility to detect some non-diseases genetic traitsof the embryos as well by this technology such as theintelligence or height of the child. One of the popular
non-disease uses of PGD at present in the westerncountries is ‘sex selection’. Couples may select the sexof their potential child from the available embryos.
There are existing laws in different jurisdictions
restricting the sex selection only to ‘family balancing’;Eubios Journal of Asian and International Bioethics 26 (September 2016)
for example, a couple may opt for a baby girl if they
already have two or more baby boys in the family.
The Foundation and Formulation of the Principleof Procreative Beneficence
The advancement of reproductive technology has
made us rethink the parental moral obligation.
Savulescu’s attempt is to formulate a guidance
principle for the prospective parents. He formulates the
Principle of Procreative Beneficence and claims thatthe parents have a moral obligation to act inaccordance with the principle. The principle says,
If couples (or single reproducers) have decided tohave a child, and selection is possible, then they havea significant moral reason to select the child, of thepossible children they could have, whose life can be
expected, in light of the relevant available information,
to go best or at least not worse than any of the others.
(Savulescu & Kahane, 2009, p. 274).
Savulescu’s principle conceives an underlying
argument in it. Let us examine Savulescu’s argumentin the principle:
Premise 1: Parents have an obligation to care about
the potential for wellbeing of their future children
Premise 2: Some specific genetic traits make our life
‘most advantageous’Premise 3: It is possible, by means of PGD, to selectsome specific genetic traits which can make the life ofa child ‘most advantageous’
Conclusion: Parents have a moral obligation to selectthose genetic traits in order to ensure the mostadvantageous life of their child.
The first premise of the argument discusses parental
obligation to secure the wellbeing of their futurechildren. Savulescu appeals to our common sense
morality in order to justify parental obligation. Usually
parents do care about the wellbeing of their children.
We save money in order to provide the best care to
our children; we select our partner with certain genetic
attributes and desire our children to bear those
attributes so that they can be benefited; we take timeto prepare ourselves financially and materially so that
we can provide the best environment to our children.
According to Savulescu, common sense moral intuition
says that it is morally wrong if parents do not concern
themselves with their children’s future life.
The second premise entails that some certain
genetic traits of human beings contribute to making thelife advantageous. For example, intelligence is such a
trait by virtue of which someone can be successful inlife. Or, a specific gender may serve as anadvantageous condition for a child. The third premisesays that it is possible now to select the genetic traitsof embryos by means of PGD. Previously people had
to depend on nature to have the desired genetic traits.
The conclusion infers that the parents have an
obligation to select the best possible child so that he or
she can lead the most advantageous life. If we look at
the argument carefully, we see that the obligation
inferred in the first premise has been extended toanother degree in the conclusion. In the first premise, ittalks about parental obligation in general. Whereas,181

the conclusion extends the general obligation to a
specific category i.e. obligation to select the bestembryo. The meaning of general obligation implies
that parents should be concerned about the future of
their child. On the other hand, a specific category ofobligation implies that if genetic selection creates a
better future for their child, the parents should opt for it.
What is the justification of this jump from theassumption of a general obligation to an obligation to aparticular action? I shall discuss this problem later on.
Let us now analyze some of the significant propertiesof the principle. ‘Significant moral reason’, ‘relevant
available information’, and ‘best life’ are the threeimportant properties of the principle. Savulescu argues
that with the relevant available information, the parents
have a moral obligation to select the best embryo forthe sake of the best possible life of their child. By‘relevant available information’ Savulescu means thegenetic information of embryos. There are bothdisease and non-disease genetic information available
in the process of PGD. The PGD clinics are permitted
to offer tests for about 250 genetic conditions or the
genetic conditions licensed by the respective
jurisdictions. Prospective parents can opt for any
number of those tests of genetic conditions and havethe genetic information of the embryos. However, theprinciple rests on some basic assumptions which, I
argue, are problematic in nature.
Some Morally Problematic Assumptions of the
Principle of Procreative BeneficenceFirstly, Savulescu presumes a degree of obligation in
the formulation of PB. By ‘significant moral reason’,Savulescu means that the prospective parents have an
obligation towards their potential child. However, hedoes not mean that the parents have an absolute
moral obligation to ensure the best life of the child.
Rather, he uses the phrase ‘significant moral reason’to express a flexible concept of obligation. There are
criticisms of such a flexible account of obligation in
Savulescu’s paper. Robert Sparrow writes,
Savulescu confuses reasons with obligations andmoves between the claims that parents have somereason to want the best for their children and the moreradical claim that they are morally obligated to attempt
to produce the best child possible. (Sparrow, 2007).
Can there be a flexible concept of obligation?
Savulescu argues that there is an obligation for
procreative parents to ensure the best life for theirchild, but the obligation can be ignored in some
exceptional cases. For example, there is no obligation
to select the preferred embryo if the mother is exposed
to any health risk due to the selection. Savulescu uses
the term ‘obligation’ in the title of his paper; however,
he replaces the term with ‘significant moral reason’ in
his formulation of PB. This replacement, in my opinion,
implies a degree of moral obligation. This is evident in
his claim for a non-absolute moral obligation. But thequestion comes whether we can claim a degree ofobligation. Can we have the concept of ‘less obligation’or ‘more obligation’ in the realm of morality? Can we
say that we have less obligation to select the best

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

embryo if the selection procedure involves a possibilityof harm to the mother, otherwise we have moreobligation? Clearly not, either we do have an obligation
to do certain actions or we do not. There is no middle
ground between them.
Secondly,
Savulescu
presumesthemutualinclusiveness of the medical and non-medical use of
PGD in formulating PB. The problem of thisassumption becomes clearer if we envisage theimplication of the medical and non-medical use of PGD
in the construction of the best possible life. In
Savulescu’s view, there are some genetic traits which
can contribute to the formation of a healthy,
successful, and happy life. If a couple avoids some
genetic conditions such as Cystic Fibrosis or Down
Syndrome, then it would help the child to have a better
life in future without those diseases. Similarly, if a
couple chooses some genetic conditions such as
intelligence or height, then the child have a betterchance to lead a better life than leading a life without
those traits. Both cases contribute to the possibility ofleading a good life according to Savulescu. But, dothey have a similar implication? Are they mutually
inclusive in terms of determining the parental
obligation? Let us consider the current available
diagnosis for the genetic conditions to determine
genetic abnormalities and their implication to theconstruction of a good life. There is scientific evidence
that some genetic traits cause some specific diseases.
Currently it is approved in the UK to test for 250
geneticconditions(HumanFertilisation
andEmbryology Authority, n.d.). If parents want to avoid
any specific genetic condition, then they can test it
during PGD. However, there are scientific evidences toprove the correlation between the type of gene andpossible diseases. This is empirically tested that the
choices made by the parents in case of the selection ofgenes to avoid some certain diseases has a necessary
relation to the chances of leading a better life. For
example, there are identifiable genetic markers whichcause immediate diseases like Down syndrome and
Tay-Sachs. PGD can also identify certain genetic
markers which might develop certain diseases like
Alzheimer, Huntington disease, Hemophilia A and B,
and Breast cancer in later life. That means, theavoidance of certain genetic traits contributes directly
to the construction of a better life comparing a life withthe diseases stated above.
Now, is it the same for the selection of non-disease
genetic markers? More specifically, does the selectionof certain sex, e.g. male, contribute to the constructionof the best possible life of a child? In the disease case
we have empirical and scientific evidence to thepossibility of leading a better life for a child; whereas,
there is no empirical evidence but a hypotheticalassumption by a moral intuition to find the correlation
between non-diseases genetic selection and thepossibility of leading a good life. Therefore, theselection of non-disease genes is not equivalent to the
avoidance of certain disease traits in the case of
employing PGD. Savulescu argues for the same moral
obligation for both selecting non-disease traits andavoiding disease traits in order to have the best
possible life of the child. Selection of non-disease traits
and avoidance of disease traits are mutually inclusive
in Savulescu’s view which is morally problematic.
Now, how does this mutual exclusiveness of the
choice of disease traits and non-disease traits make adifference to the parental obligation? I discuss thequestion whether parental choices of genetic selection
have a necessary relation to the chances of the
wellbeing of their children. It seems, when we read
Savulescu, that selecting genetic traits of the embryos
is directly connected to the wellbeing of the potential
child. But, a critical examination reveals that therelation is not necessary, but is rather contingent.
Genetic selection has very little to do to the formationof future life. We shape our life by everyday activities
and thoughts. Our life is not the legacy of our genetic
blueprint. Even complex symbolic information cannot
be contained in the genes which are passed on fromparents to offspring. Developmental psychology
provides us proof of how we attain skills, a sense ofidentity, and the ability to form an empathetic
relationship with others through environmental
influences. The new research in the area of cognitive
science and developmental psychology shows thatgenes are not the blueprint of complex mental imagery
and processes, but rather they function as the initialcatalysts of developmental process (Knox, 2004).
Therefore, someone’s success in life has nothing to dowith his or her genetic inheritance. Even if we select‘smart genes’ during PGD, that does not guarantee asuccessful life of the child. With an overarching view ofgenetic inheritance, PB ignores the human capacity ofinnovation.
Clearly, disease and non-disease selection of genes
have
different
meritsanddifferent
ethicalconsiderations. Savulescu claims the same ethicalconsiderations for both cases. Intelligence, certain sex,
skin color, or height might work as a part of theconstituents of the best life, but that does not meanthat the best possible life is not possible without them.
An intelligent person might end up miserable in his or
her life. Recent studies in neuroscience andpsychology have found a correlation between
intelligence and anxiety. “Gifted children are prone todisharmonious development, which may result in thedevelopment of personality disorder, obsessional
behavior, and anxiety disorder” (Coplan et al., 2011).
Sometimes, the higher IQ might cause greater
psychological fragility of a person.
In my opinion, it is morally obligatory to avoid passing
on some specific genes if it may cause possible
diseases; whereas it is not morally obligatory but
morally permissible to select the non-disease traits ofembryos so that the child has a possibility of leading agood life because of those genetic traits. Therefore,
the selection of non-disease traits and avoidance ofdisease traits in PGD are mutually exclusive in termsof determining the obligation for the parents.

Eubios Journal of Asian and International Bioethics 26 (September 2016)
The Moral Foundation of the Principle ofProcreative Beneficence
It is customary for the ethicists to formulate a moral
principle and judge human actions on the basis of thatprinciple. Usually the principles are justified by moral
reasoning with a solid and reliable moral foundation.
Savulescu’s attempt is no exception. He formulates PB
in order to judge the morality of certain procreativedecision of the prospective parents. But, what is themoral justification of Savulescu’s principle? He tries toavoid the complex philosophical justification of his
principle, but rather he justifies his principle by thecommon moral intuition. He argues that people havegeneral intuition about the concept of a good life. We
also ought to do the best possible things for ourchildren to ensure the best life. For example, we savemoney before bringing our child into this world. Or, forexample, a sensible couple would wait some time ifthere is any health risk to procreate in a certain period.
I completely agree with this common moral intuition.
But can PB be justified by the common moral intuition?
Hypothetically, we can easily think of counterexample
of Savulescu’s argument. For example, everybody
wants the best life of their child but people would
disagree about the means to achieve the ‘best life’.
One would not take bribe in order to ensure the best
life of his/her child. The question comes, can we relyon such a principle which is based on just common
moral intuition or should we look for a stronger
principle in order to claim an obligation? ImmanuelKant in his Groundwork of the Metaphysics of Morals
states some conditions of moral law should it claim an
obligation. He says, “Everyone must admit that a law, if
it is to be valid morally, i.e., as the ground of an
obligation, has to carry absolute necessity with it; thatthe command ‘You ought not to lie’ is valid not merely
for human beings, as though other rational beings did
not have to heed it; and likewise all the other genuinely
moral laws; hence that the ground of obligation here is
to be sought not in the nature of the human being or
the circumstances of the world in which he is placed,
but a priori solely in concepts of pure reason, and thatevery other precept grounded on principles of mereexperience, and even a precept that is universal in acertain aspect, insofar as it is supported in the smallest
part on empirical grounds, perhaps only as to its
motive, can be called a practical rule, but never amoral law.” (Kant, 2002, p 24).
I do not claim that all moral principle should havesuch an ambitious plan, rather I claim that a principle
must have a proper justification in order to claim an
obligation. The counterexample proves that common
moral intuition itself is not an authentic source of moral
truth. Common moral intuition needs to have a higher
rational justification. Moreover, in traditional logic anappeal to intuition is considered as an informal logicalfallacy.
Common moral intuition in the case of disability:
Julian Savulescu applies PB in the case of disability toshow that PB can contribute in the debate of whether aparent can bring a deaf child in this world intentionallyfor the sake of the wellbeing of the child. However,183

common moral intuition can also be misleading in thecase of disability. Usually, non-disable people thinkthat the quality of life of the people living with disability
is extremely low. But, disable people themselves rate
their quality of life higher than the assessment of theoutside observers (Albrecht, 1999). This proves that acommon moral intuition does not hold for thefoundation of a moral principle.
Some Possible Objections
It might be said that Savulescu’s principle claims a
prima-facie obligation for prospective parents rather
than a final obligation. A prima-facie obligation in thiscase means that the parents have an obligation to theirchild with some conditions. For example, PB does notclaim an obligation for parents if employing PGD mightcause any health risk to the mother. However, in myopinion, even if PB claims a prima-facie obligation forparents, we need to be cautious to frame it. Since, if
someone does not fulfil an obligation, he or she issubject to a moral blameworthiness. Can we blame acouple if they do not select a non-diseases genetic traitof their child respecting the child’s right to an open
future? A further analysis will be needed in order todetermine the conditions of the prima-facie obligation.
For example, in the case of PGD, we need todetermine the circumstances where parents have nomoral obligation to select the non-disease genetic
traits of their child. It seems that Savulescu is reluctant
to generate a discussion of the general conditions of
the prima-facie obligation for prospective parents.
Rather, he emphasizes more on the parental obligation
than the discussion of the circumstances where an
obligation can be suspended. Therefore, claiming a
prima-facie obligation will go in vein without adiscussion of its conditions.
An objection can be raised that still we generally
know that some genetic traits are good for people.
Usually, intelligent people are successful in their life.
But, there is no evidence that tells us that intelligent
people always lead a good life. Perhaps, we
mistakenly place all the credit to intelligence or someother genetic traits when we evaluate a successful life.
Moreover, success has very little to do with a good life.
Some people’s genius and intelligence havecontributed to the society in a great manner, but theirlives were not good at all. A BBC documentary titled“Dangerous Knowledge” has explored how four brilliant
mathematicians – George Cantor, Ludwig Boltzmann,
Kurt Gödel, and Alan Turing – became insane for their
genius and committed suicide after their breakthroughdiscovery (Malone, 2007). These counterexamples
prove that it is at least questionable to take it for
granted that some genetic traits are necessarily
relevant to the concept of a good life.
Another objection might be raised in that if we aremorally justified in employing PGD to identify thepossible genetic diseases, then we are also justified to
select specific genetic traits of the embryos.
Proponents of this view often ignore the distinction
between medical and non-medical use of PGD in
terms of parental obligation which I discussed earlier.

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

Conclusion
Parental obligation to select non-disease traits ofembryo is not justified if we critically investigate theconstituents of a good life. The concept of ‘good life’ or‘most advantageous life’ is too broad to be affected bya single event like selecting a non-disease genetic
trait. We encounter billions of events in our whole life
and a specific genetic trait has very little to do toinfluence the eventful life of a person. Someone mightlead a good life because of his or her ability to manage
emotion perfectly, someone might lead a good life
without any contemplation and philosophical insightabout the world around us. Think of the people whohave the motto of ‘eat, drink, and be merry’; aren’t theyleading a good life? Selecting a single genetic trait
cannot change the whole course of life to make it goodor bad. Rather, our everyday choices shape our lifeand create our future as well. Some people lead agood life simply by virtue of their luck, not intelligence.
In my opinion, selecting the embryos with certain
genetic traits is not obligatory for the parents if we
critically analyze the concept of moral obligation. There
are at least two conditions of obligation, as we
generally understand it. First of all, in order to hold amoral obligation, we must presume that there is
freedom of choice, though there are huge debates as
to whether freewill is a must to assume moral
responsibility. We do not enter into the debate here,
rather it is presumed, for the sake of the argument,that freedom of will is necessary for moral
responsibility. In other words, we are responsible forsuch actions in which we have control over, or wehave the ability to do otherwise. Secondly, our choices
or actions must have a necessary relation to thechances. We do not hold any responsibility if our
choices do not have a necessary relation to thechances. For example, Peter Singer argues in thecontext of the moral obligation of rich countries to help
the poor countries. According to his view, the richpeople cannot be blamed as murderer if they do notchoose to help them. Because they are not actively
involved to the death of those poor people (Singer,2011). Surely, we do not hold responsibility for dying
children in poor countries because of hunger or
malnutrition. If I prefer buying a car to giving charity to
Oxfam, I cannot be accused of murdering children inpoor countries. Why don’t I bear any obligation fordeath of the children in poor countries? Because, my
choice of buying a car does not have a necessary
relation to the chance of children’s death in poor
countries. Similarly, choosing a non-disease genetic
trait does not have a necessary relation to the chanceof children’s future good life.
What kind of obligation do the parents have to theirchildren, negative obligation or positive obligation, or
both? Julian Savulescu, in his formulation of PB,
presumes both negative and positive obligation ofparents towards the children. The question can beformulated in terms of absolute duty and limited duty.
Do parents have an absolute duty towards theirchildren, or a limited duty? An absolute duty will concur
them to ensure the best suitable condition for thechildren, no matter what happens to the parents. A
limited duty will keep some space for the parents tothink of the means by which children’s best life will beensured. If we have the ability to prevent harm and if it
does not cost much to us and if we do not prevent it,then it is immoral. This means, we only have anegative obligation towards others. Savulescu refuses
the Prevention of Harm View on the ground of common
moral intuition, although, he does not offer any
additional justification for the positive obligation ofparents toward their child. A possible objection in thisregard is from a feminist perspective of ethics. For
example, the ethics of care advocates a special kind of
obligation towards the people we are related to. The
parents have a special obligation to their children, andthe children have a special obligation towards theirparents. But, one thing should be noted that the ethics
of care does not imply an unlimited obligation forparents. PB is too demanding for the prospective
parents. It demands the parents to act out of altruism.
Parental responsibility becomes a burden in the caseof genetic selection of non-disease traits. Suppose, if
something goes wrong in the genetic selection
process, the parents will be responsible for all of thesufferings of their child because of their choice. Thus,
PB ascribes a huge burden towards parents. PB does
not clarify why parents should take such a
responsibility. Ethics of care would not recommend
parents to act altruistically as well.
Different ethical considerations are required for
disease and non-disease genetic selection of PGD.
Parents have moral obligation to protect their childfrom possible disease, and they should reject theembryos on the basis of available genetic informationin the process of PGD. However, parents are notmorally obligated to select the non-disease genetic
traits. Non-disease traits are contingently related to thewellbeing of the child. The principle of Procreative
Beneficence does not capture this contingent relationof selection and consequence. Hence, its claimed
moral obligation for parents is flawed. Consequently,
non-medical use of Preimplantation Genetic Diagnosis
cannot be justified by the Principle of Procreative
Beneficence.
Bibliography
1. Albrecht, G. L., & Devlieger, P. J. (1999). The disability
paradox: High quality of life against all odds. Social
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2. Benatar, D. (2006). Better never to have been: The
harm of coming into existence. Oxford: Clarendon Press.
3. Coplan, J. D., Hodulik, S., Mathew, S. J., Mao, X., Hof,
P. R., Gorman, J. M., & Shungu, D. C. (2012). The
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250 cycles of Preimplantation Genetic Diagnosis for single
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doi:10.1093/humrep/dei382
5. Hillier, F. S., & Lieberman, G. J. (2001). Introduction tooperations research. New York: McGraw-Hill.

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6. PGD - Pre-implantation genetic diagnosis (PGD) Genetic testing. (n.d.). Retrieved May 13, 2016, fromhttp://www.hfea.gov.uk/preimplantation-geneticdiagnosis.html
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Groundwork for the metaphysics of morals. New Haven:
Yale University Press.
8. Knox, J. (2004). From archetypes to reflective function.
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9. D. M. (Director). (2007). Dangerous knowledge [Motion
picture on DVD]. UK: BBC [UK].
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11. Savulescu, J., & Kahane, G. (2009). The Moral
Obligation To Create Children With The Best Chance Of
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12. Singer, P. (1999). The Singer Solution To World
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13. Singer, P. (2011). Practical ethics. New York:
Cambridge university press.
14. Sparrow, R. (2007). Procreative Beneficence,
Obligation, and Eugenics. Life Sciences Society and
Policy, 3(3), 43.

Deliberative Democracy for
a Gene Editing Policy- Ann Boyd, Ph.D.
Professor of Biology, Hood College, 401 Rosemont Ave.
Frederick, MD, 21701, USA
Email: boyda@hood.edu

Introduction
How human beings know what is right and good, oreven recognize an ethical problem is central to the
ethics enterprise. Scientifically friendly logic anddeductive reasoning follow a systematic course ofreasoning, hypothetically from defining the problem toposing an answer. Such a process often fails to
integrate deliberation, cultural values, and empiricalknowledge into dialogical rationality. A case study is amini-narrative in which a character represents others
who may face a similar moral dilemma. A case study is
not merely a laboratory of the mind – a think problem
to be analyzed to find a solution. Science students
may complain that bioethics is more conceptual thanpractical and are surprised to discover that deductive
reasoning is not critical thinking. Knowledge is situatedand contextual. Policy formation in the use of
biotechnological innovations may represent a scientificsolution to a problem, but policies affect many people
in a variety of circumstances in particular and often
profound ways. Deliberative democracy is central to
the success or failure of informed debates about
emerging possibilities rendered by scientific discovery.
For example, within the past decade scientists
discovered that bacteria can defend against viral
infection by recording a segment of the viral DNA in
the bacterial genome, creating a DNA memory bank.

185

These sequences were named “clustered regularlyinterspaced short palindromic repeats (CRISPR).
Subsequently, the combination of an RNA directedendonuclease system CRISPR-Cas uses RNA totarget a specific sequence and the Cas enzyme todegrade the DNA within the target zone which is thenrepaired. The potential was recognized as a way toedit DNA, to correct mutations and restore normal
genetic sequences. Is the ordinary, average,
reasonable citizen sufficiently informed to enter intomeaningful dialogue about a policy governing gene
editing? Deliberative democracy would advocate for an
open, informed, debate in the process of establishing a
policy for gene editing.
Direct-to-consumer testing
Research suggests that scientific literacy in general
has a limited influence on perceptions. Generally,
individuals within the U.S. have a positive perspective
about science, claiming that science improves andprolongs life. Genetic testing and screening havebeen in place for decades with a physician’s referral.
Beginning in 2002 when Myriad Genetics marketed agenetic test for GRAC to detect a type of early onset
breast cancer, an evolution of print, television, internet
advertising make direct to consumer genetic testingreadily available without a doctor’s referral. Companies
emerged including 23andMe, Navigenics, deCode
Genetics and DNA Direct. A person can buy apaternity test kit for $150 to determine if a child is his
genetic progeny (Sandroff, 2010).
The Food and Drug Administration (FDA) expressed
concern in 2010 that tests done by different companies
may use different targets and report divergent
interpretations. The Food and Drug Administrationsuspended genetic testing to review the status of thetesting kits as to whether they are subject to FDA
regulation. In 2011, NIH announced that a registry ofgenetic tests for more than 1,600 clinical conditions
would be established. NIH could help by providing
links between the medical community, consumers andgenetic testing companies (Edwards and Huang,2014).
After review the results were made public:“FDA believes that in many circumstances it is notnecessary for consumers to go through a licensed
physician to have direct access to their personal
genetic information” (FDA, 2015).
Genetic testing for some genetic diseases isstraightforward and specific. Others fish for information
among a dense number of possibilities for complex
diseases where multiple pathways may be involved.
The only requirement is the ability to pay. Anyone witha computer can search the internet for a genetic trait ordisease. Whether the explanations are understandableis an open question. Whether individuals consult theirpersonal physician about their concerns is unknown. It
remains to be empirically confirmed if genetic testingleads to better patient outcomes.
Segue into Personalized Medicine
The emerging field of personalized medicine is a
product of whole genome sequencing (WGS). It

186

Eubios Journal of Asian and International Bioethics 26 (September 2016)claims to offer a best treatment option for any
individual based on genotypic data taking into
consideration such as how a drug will be metabolized,
how long it lasts in the system, and how efficiently it issecreted. Tumors with particular types of mutations
may reveal a specific therapeutic target such an
enzyme or surface receptor. To define and hone thefield, NIH has launched a research project on
personalized medicine that expects to enroll a million
people, over a ten year period at the cost of one billion
dollars (Yurkiewicz, 2010, Kaiser, 2015)
Whole Genome Sequencing is becoming more
affordable (relatively speaking as it currently costs
between one and five thousand US dollars). It is
curious who will elect to have their own or a futurechild’s genome entirely sequenced. What would be thebenefit and what are the risks? Certainly WGS may
reveal non-health as well as health related information.
Susceptibility to a host of complex diseases can betallied. Using filters, cardiac profiles can be culled fromgenes associated with cancer. Presymptomatic
diagnosis of late onset diseases such as Alzheimer’sand Huntington’s raise questions about when a person
might want to know, have the right or need to know?
As more information accumulates, it should become
more precise to separate the informative genetic tags
from the rest of the data. WGS presents choices thatappeal to autonomy-principled individuals, however,
the wider social implications are often ignored until
some insurance company or national healthcare
provider makes it a condition of paying for genetic
testing, screening, or in vitro fertilization (IVF) assisted
reproduction (Dondorp, and deWert, 2013). Policy
thus far has taken a cautionary approach but voices ofstrong advocacy are increasingly strong in the public
square.
Assisted reproductionMore than five million babies have been born throughassisted reproduction since the birth of Louise Brown.
More recently mitochondria replacement therapy
allows a donor’s mitochondria to be placed in themother’s egg to eliminate metabolic diseases
derivatives of mitochondrial genes. Since the genes in
the mitochondria are not part of the chromosomes or
nuclear DNA, the technique does not count as germline therapy. While the child to be born from suchmanipulation does not consent to MRT, one might still
think the future child argument germane to policy
formation. John Harris points out that at the time of
MRT no child exists (Harris, 2016). Consideration of
the future interest of the child drives the debate fromthe individual autonomous choice to a larger social
deliberation.
Evolution of gene therapy
Gene therapy has a mixed and disappointing history.
Excitement over potential correction of a gene(adenosine deaminase ADA) to correct severe
combined immunodeficiency disease (SCIDS, often
called crib death) revealed that inserting a correct
gene into the bone marrow of children would repair

and allow the immune system to regain function. Thiswas exciting news. Five children in France received
the treatment, but several years later; these children
developed leukemia because the insertion site of the“correct” gene interfered with other normal genes(Check, 2002). Still scientists persist in trying todevise ways to intervene based on a sense of duty tohelp future generations live fee of life limiting traits. Asof 2013, clinical gene therapy protocols were being
conducted in the U.S., Europe, China for cystic
fibrosis, hemophilia B, Fanconi’s anemia, Familial
hypercholesterolemia, ADA deficiency and for three
types of cancer but all of these studies are somatic celltherapies: none are germ line (Sanjukta, 2013). In
some cases the genes delivered therapeutically are
not stable, some of the vectors have proven toxic orallergenic, and insertion of the gene into a functionalsite of another gene can be harmful. Where earlierdelivery systems failed, new hope has been ignited by
the discovery of CRISPR (clustered regularlyinterspaced short palindromic repeats).
CRISPR Mediated Gene Editing
It began with a modest discovery that bacteria could
fight off viruses based on keeping track of infecting
DNA within the bacterial genome, a type of repetitive
DNA memory bank. An RNA directed endonucleasesystem, CRISPR-Cas uses RNA to provide sequencespecificity and the Cas protein to degrade the targeted
nucleic acid which is repaired by a repair mechanism(Jinek et al., 2012, Mali et al., 2013, Hsu et al., 2014).
Jennifer Doudna of the University of California,
Berkeley and Emmanuelle Charpentier now at Max
Planck Institute for Infection Biology in Berlin, reported
that CRISPR could cut specifically targeted sequencesof DNA.
Feng Zhang of the Broad Institute in
Cambridge Massachusetts, examined more than 600
Cas9 enzymes from hundreds of bacteria in search ofa smaller version that would fit into a small viralgenome and found Cas9 in Staphylococcus aureus(Zhang, 2015).
In April 2015 a report was published by scientists at
Sun-Yat-sen University in China on the use of CRISPR
to edit a gene associated with beta-thalassemia inhuman embryos which were not intended for gestation(Liang et al., 2015). The article describes the team’s
effort to modify (edit) the human beta-globin gene in 86
embryos donated from IVF clinic. The results sound anote of caution. Of 71 surviving embryos, 54 had theedited changes in the right gene, however additional
unintended mutations were found in other genes
meaning that the specificity needs improvement. The
data suggested that the technique has potential toremove mutations that cause genetic diseases and to
replace the mistaken coding sequence with the correctfunctional one. While there were problems withefficiency and accuracy, the excitement this report
generated was informative and the authors concluded
that the system is not ready for clinical use.

Eubios Journal of Asian and International Bioethics 26 (September 2016)
Policy Evolution
The American Association for the Advancement of
Science on its web site invites the public to vote on themost significant scientific discovery reported in a single
year. The results were: Pluto got 35% of the vote,
CRISPR 20%, Lymphatic system located in the central
nervous system 15% and Ebola vaccine 10%. The
reclassification of Pluto got more publicity perhaps
than the discovery of CRISPR but the Ebola outbreak
was heavily covered in the media. It is unclear if thesignificance scientifically as judged by persons who
voted in the survey was based on understanding thescience involved or on the recognition of an event
heavily publicized. CRISPR is the latest in a series of“breakthrough discoveries” that raises hopes of editing
human embryos in order to erase harmful mutations,improve the quality and quantity of human life andhealth. All technologies as they emerge need to beshown to be safe and effective in laboratory
experiments (Harris, 2016).
Francis Collins, Director of the National Institutes of
Health (NIH) released a statement on funding ofresearch saying that none of the national researchfunds could be used to edit human embryos (April 29,2015). The White House Office of Science andTechnology Policy issued a Note on Genome Editingon May 26, 2015. The US House Committee on
Science, Space, and Technology’s Subcommittee on
Research and Technology held its first congressional
hearing on genetically engineered human DNA in June
2015. The International Bioethics Committee of
UNESCO updated their report on the Human Genome
recommending a ‘moratorium on genome editing of thehuman germline” in Oct 2015. This flurry of responses
indicates several things. First there was already inplace a prohibition from UNESCO and the Council ofEurope and the European Union which viewed
germline modification as unethical and an abuse ofhuman rights. The US federal research budget
prohibited research involving creation or destruction ofhuman embryos as well as germ line modifications.
The US FY2016 budget withheld funding for humanembryo editing research (Reardon, 2015).
Relatively small percentages of the population seek
reproductive assistance. Given the limited use, even if
the ability to genetically test, select, alter the embryos
were approved, it is unlikely that the human gene pool
would be radically altered. There is a risk that a
subpopulation of people would become genetically rich
(Powell, 2015). Genetic injustice challenges us toachieve greater justice. Policies ought to represent
the rational, dialogical, common good of thecommunity (Smith, 2013)
Framing the Debate
There is no such thing as an unframed message.
Framing refers to the idea that how information ispresented has an impact on how the public receives
the message. The importance of framing for science
communication has been documented (Scheufele,
2013; Nisbet, et al., 2003). Framing of a scientificdiscovery or communication intends to make the187

message understandable. The challenge is to frame
the message so that the most dialogic communication
follows to shape public policy. Research shows that
there is a lifecycle of frames in public discourse,“starting with initial excitement about the promise ofsocial progress and the economic potential of newtechnologies, then shifting to concerns about scientificuncertainties, risks and moral concerns, into framing
the technology in terms of the societal controversies
surrounding it” (Scheufele, 2014 p 13589).
Public attitudes toward issues such as climatechange are not uniformly based on a comprehensive
understanding of the science involved. Research has
shown that public opinion often relies on the easiest
retrievable context to form a judgment. When
genetically modified food was called “frankenfood” it
had a negative impact. When “climate change” wascalled “global warming”’ people experiencing a severe
winter storm, laughed. What influence does CRISPR
being a “breakthrough of the year” have on thedebate? Knowledge does not always translate into
positive attitudes about a scientific discovery. It is
hoped that complex scientific information can betranslated in ways average citizens can understandinviting a deliberate process to shaping policy.
Is “editing” the most neutral term? Metaphors operateconsciously and subconsciously in complex ways.
Does it have a metaphorical influence on thediscussion of germ line therapy? Policy formation
should reflect a deliberative dialogue with knowledge
about the technology, how it works, how it could be
used, what is unknown, about potential negative as
well as positive consequences, and the broader impact
such technology could have on the whole humanfamily.
Meaghan O’Keefe et al. (2015) examined articles in
the public media mentioning CRISPR and found thatthe most common metaphor for the genome was “text”
and the idea of “editing the text” was used toemphasize what can be done to “correct genes.” Inthese analogous and metaphorical explanations there
was no mention of risk. “We need metaphors for
CRISPR that indicate the technology’s uncertainties
and unknowns, and that convey its current value tobasic research and potential clinical and public healthbenefits….Metaphors should accurately represent how
the technology actually works and can be used, should
avoid reductionist effects, and should allow forunderstanding of bioethical implications” (O’Keefe, etal., 2015).
Student survey
Interested to know what various level students know
about CRISPR and what they think the ethical public
policy should be, I engaged students in four classes ina survey. The classes included a freshman honors
class (AIDS and Ethics, Honors 102), an upper division
undergraduate honors/philosophy course (Global
Issues in Public Health, HN/PHIL 316), Biology Senior
Seminar (Bio 470) and a first year graduate course in
Molecular Genetics (BMS 524). The questions andresulting responses are presented in Table 1.

Table 1 Survey on Gene Editing
Age:
Gender:Religious preference:

BMS 524*
22-45 (29)
50% female
Christian 45%
Muslim 18%
JewishNone36%

Bio 470 *21-26 (23)
90% female
20%

HNPL316*
17-33 (26)
66% female
50%

H102*
18-19 (18.5)
73% female
47%
14%

80%

36%

53%

50%

54%
7%
23%
15%

38%
15%
15%
31%

Political affiliation:
Democrats
Republican
Independent
None

30%
10%
20%
40%

10%
40%

1. Which of the following requires retrieval of sperm and eggs to achieve fertilization?
a) In vitro fertilization
82
80
85
62
b) Cloning
7c) Sexual intercourse
18
10
7
37
d) None of the above10
2. Louise Brown was first human birth usinga) IVF72
90
10087b) sexual reproductionc) cloning
181012d) none of the above9
3. Preimplantation genetic diagnosis involves embryoa) selection
27732b) DNA analysis
63
20
20
30
c) IVF23d) all the above
9
80
70
30
4. A sheep named Dolly was the cloned animal that brought ethical debate about the possibility of human cloning.
a) True
100
100
100
100
b) False
5. Objections to human cloning includea) right to genetic identityb) synthetic and unnatural
1812c) unanticipated harmd) all of the above
82
100
100
87
6. Natural reproduction produces identical twins 3 out of every 1000 birthsa) True
34808580b) False
63
20
15
12
7. MRT is a process of replacing genetic mother’s mitochondria with mitochondria from another female donor.
a) True
81807686b) False
18
20
23
13
8. Mitochondrial genes have no influence on identity conferring featuresa) True
45503120b) False
54
50
69
80
9. The UK but not the US has a regulatory oversight group for human reproductive issuesa) True
60606960b) False
40
40
31
40
10. Harms occur through natural procreation with normal genetic lotterya) True
72909196b) False
271081211. Post conception actions by a mother can cause serious defectsa) True
90
100
92
100
b) False
108
12. Consent is a process of informed choicea) True
90
100
100
100
b) False
10
13. Deciding to use MRT should be considered based on the child’sa) right to consent
18
20
14
14
b) open futurec) best interest
72
80
86
86
d) none of the above10
14. CRISPR editing of embryos is opposed asa) unsafe
3610b) playing God
10
7
6
18
c) unnatural
10806d) all of the above
54
92
87

Eubios Journal of Asian and International Bioethics 26 (September 2016)189

BMS 524*
Bio 470 *HNPL316*H102*
15. Embryo editing is intended to correct mutations so that a child born will not have a genetic diseasea) True
81
100
92
94
b) False
187
6
16. Gene editing is still in research phasea) True
90906988b) False
10
10
30
12
17. Gene editing research is banned for all research funded by FY2016 US budgeta) True
3640
4666b) False
64
60
53
33
18. If you were aware of a genetic risk of a disease that limits human life and causes suffering would you:a) use IVF to select an embryo without the genetic risk
50
33
25
23
b) use gene editing if available 8163123c) accept whatever child produced by natural procreation
16
11
6
17
d) adopt a child
23
38
37
35
19. Have you read about and formed opinions about gene editing?
a) Yes
63
60
42
18
b) No
36
40
58
81
20. Do you support research and human use of gene editing in human embryos?
a) Yes
72
70
53
68
b) No
18
15
25
c) don’t know
9
30
30
6
•
•
•
•

BMS 524 is a graduate course in molecular genetics within the Biomedical Science M.S. program
Bio470 is the senior seminar for biology majors
HNPL316 is an honors course for undergraduates: global issues in public healthH102 is a freshman honors seminar, AIDS and Ethics.

Interestingly 80% of students know what is involved
in using in vitro fertilization, that Dolly was the firstcloned animal, and that harms do occur throughnatural procreation. Only 50% understand thatmitochondrial genes do not confer features on the
future child in the same manner as the nuclear
genome, and 80% think MRT should be considered in
the “best interest of the future child.” Most, 80%,recognize object to human cloning on the basis of theright to genetic identity, using synthetic and unnatural
means, and/or unanticipated harm.
Regarding CRISPR and the promise of gene editing,the results were more varied. Asked why some would
oppose gene editing, 10-36% said it was unsafe, 618% said it is “playing God”. That gene editing wasperceived to be unnatural varied widely from 6 to
80%.. The majority (80-100%) think gene editing
intends to correct mutations to relieve the burden ofgenetic disease but 69-90% recognize that thetechnique is still in the research phase and not readyfor clinical practice. Fewer (36-66%) knew that genetic
editing in human embryos was excluded from the U.S.
FY2016 budget. Personal opinion varied about what
they would do personally if faced with risk of passing a
genetic disease to a child. Most interesting was the
response to whether they had read about gene editing
which increased with educational attainment as one
might expect. The majority of students admitted they
supported research on gene editing in humanembryos. The suggestion is that whether they
understand the details and science behind gene
editing, they think research should continue because it
MIGHT prove useful. This is where the scientificpotential should influence political policy formation.
This is a very limited sample and is a snapshot of

people with an interest in science, so no conclusions
should be drawn about how they represent the
population at large.
Conclusions
UNESCO Universal Declaration on the Human
Genome and Human Rights stressed the duties ofmutual assistance among nations, to the “common
welfare of humankind” (UNESCO, 1998). The sharedcontent of the human genome points to a unity among
human beings and is factually and symbolically theheritage of humanity. If the market economy
harnesses the applications of genetic information forcommercial gain, the common heritage of humankind
risks becoming a divisive factor instead of a tool topromote wellbeing (Cahill, 2001). The daily news
raises questions related to emerging technology, thecost of health care, whether the research agenda
actually promotes better quality of life. Technology
evolves, equipment is expensive, professionals doing
research are highly skilled and what is discovered
today may not become part of a standard medical
practice for generations (Boyd, pp121-128). Public
policy generated from deliberative democracy isdifficult in a polarized political climate. Daniel Callahanobserved the difficulty in 2005 and it is even more
intense today: “If you are a conservative and speak
freely, the liberals will go after you – and not simply torefute your ideas, but to signal to the world that you area moral threat to medical progress, unprejudiced
reason, and the great struggle for human freedom. If
you are a liberal, and speak freely, the conservatives
will go after you, sometimes implying but usually
saying outright that you are a menace to the sanctity oflife, human dignity, and the deepest of Western values.

190

Eubios Journal of Asian and International Bioethics 26 (September 2016). . If bioethics is to retain its vitality and be taken
seriously, it will have to find a way to extricate itself
from the culture wars” (Callahan, 2005). Healthy
dialectic invites difference, helps us examine issues,and concepts in ways that value the tension as ameans of advancing knowledge and understanding.
Technology by design and intent is for the use ofpeople. It is the choices people make in how to use
technology that bears the greater moral accountability(Boyd, J. and Boyd, A., 2014). The balance of good
(helpful) vs evil (harmful) will influence individual
choice to use or not use this technology, but only if thetechnology is available to choose. Certainly there islittle to no pressure to make gene editing mandatory,
but to allow available when proven safe and effective
through more research.
References
Boyd, Ann, 2016. Science and Ethics in Dialogue: EthicalResearch Conduct and Genetic Information Application, pp
121-128, IN Colloquium Series on the Genetic Basis of
Human Disease #7, Morgan & Claypool Life Sciences,(Ed)
MichaelDean,
DOI:
10.4199/C00138ED1V01Y201509GBD007.
Boyd, Jeremy and Ann Boyd, 2014. “Thinking andTechnology,” EJAIB 24: 114-116.
Cahill, Lisa S. 2001. “Genetics, Commodification and Social
Justice in the Globalization Era,” Kennedy Inst of Ethics J
11 no 3 pp 221-238. DOI: 10.1353/ken.2001.0020.
Callahan, Daniel, 2005. “Bioethics and the Culture Wars,”
Cambridge Qtly Healthcare Ethics 14 pp 424-431. DOI:
10.1017/S09631801050577.
Edwards, Kule T. and Caroline J. Huang, 2014. “Bridging
the Consumer-Medical Divide: How to Regulate Direct-toConsumer Genetic Testing,” Hastings Ctr Rept 44, no 3 pp
17-19. DOI: 10.1002/hast.310.
Yurkiewicz, Shara 2010. “The prospects for personalized
medicine,” Hastings Ctr Rept 40 pp 14-16.
Kaiser, Jocelyn 2015 “NIH plots million-person megastudy,”
Science347(6224)
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Eubios Journal of Asian and International Bioethics 26 (September 2016)

191

Abstract
Current bioethical principles fall short on addressing
the ethical and/or moral permissibility of bioethicalpractices such as biomedical procedures, clinicalresearch, social science research and other practicesof the same nature. Bioethical principles of autonomy,
justice, informed consent, beneficence and nonmaleficence and others are pseudo-justification of
ethical codes that allow ethical permissibility of suchpractices through the limit-situation imposed by agentsof power and knowledge. The vertical nature of power
and knowledge predisposes other agents such as low
socioeconomic status (SES) patients/subjects to otherforms of ethically and morally impermissible practices
that these current guideline fail to acknowledge andanswer. The issue of colonisation, with implication on
this power and knowledge hierarchy, gives light to theoppressive nature of the different bioethical practices.
The understanding and acknowledgment of theexistence of the oppressive nature of these practices
may lead to more genuine relationship between thewielder of power and knowledge (doctor-researcher)and of the vulnerable agent (low SES patient/subject).
This research shows the importance of the applicationof other philosophical theories such as postcolonial
theory and critical theory in the development of a moresocially aware agent, and how the current principles
anchored on Western philosophies adhere to reactive
formulation and implementation of these principles.
Keywords:
EthicalPrinciples,
Colonisation,
Oppression, Critical Theory, Postcolonial Theory

or moral between agents of power through false
relationship because of hierarchical nature of power
and knowledge (Foucault 1972-1977).
Nevertheless, the reactionary shortcomings of theformulation of ethical guidelines on these infamous
cases opened the discussion on the existence ofdifferent vulnerable groups that are dominated or
subjugated in terms of the hierarchical nature of thepower structure of the medical process, agents andinstitutions. This paper focuses on low socioeconomic
status (SES) charity patients as a vulnerable group in
medical research and clinical trials, where theirenrolment in charity care predisposes them to possible
oppressive nature of the practice. Furthermore, theiragency as an oppressed group is no less different in
the agency qualified to Indigenous People, as such,
oppression as a result of a colonizing system should
be further examined as a guiding ethical principle inthe conduct of biomedical practice, clinical research,social science research and other such practices.
Colonisation will be forwarded in the current
discussion of the current ethical guidelines used inclinical research, as its exclusion serves as a gap inthe ethical conduct of biomedical and clinical research
practices. The application of biocolonisation in the
conduct of bioethical research involving Indigenous
People (IP) should serve as a guide in the inclusion ofcolonisation, as an ethical value, in the conduct of
research involving vulnerable groups. This paper
shows that other vulnerable groups such as low SES
charity care patients/subjects are not fundamentallydifferent from other forms of colonisation that IPs
experience especially in the context of bioethicalresearch. As an overarching theme, low SES groups
are prone to some form of colonisation in the conductof research, which the other ethical values cannot
respond to, as colonisation is beyond their ethical or
moral scope. Lastly, the paper does not aim todiscredit the other ethical values currently used in the
ethical guidelines but to highlight the need to include
colonisation in the guidelines in order to fully realize
the conduct of ethical research.

Introduction
The current ethical guidelines that pervades
biomedical practice, clinical research, social science
research, and other such practices are at mostreactive to cases of exploitation and unethical research
conduct (Emanuel, Wendler & Grady 2000). It is areaction to infamous cases such as the Nazi andJapanese medical experiments, which resulted in the
primacy of autonomy and informed consent in the
conduct of clinical research and other unethicalpractices which resulted in the formulation of thecurrent ethical guidelines. Common to these cases areindividual’s agency as participants rather than subjects
to the practices. Moreover, the general acceptance ofthe existence of these unethical practices lends itself
to ethical scrutiny, and as such subjecting it to ethicalreview and under ethical guidelines. However, thesebioethical principles tend to fail when they follow
pseudo-justifications of what makes a practice ethicalThe Health Care System, Vulnerability andColonisation
The current climate of health care system and how
the implication of its implementation around the world
inherently carries with it the issue of vertical power
relation, where, the institution together with the healthworkers carry with them a hierarchical nature of powerover their patients (Foucault, 1972-1977). The current
ethical guidelines on ethical medical practice, clinicalresearch and other practices of the same nature fails
to address this, thus, they fall short in the ethicalconduct of these practices if this is not acknowledge
and put into practice.
Different countries practice health systems compliant
with the Declaration to the Right to the highest
standard of health (WHO 2013a). The healthcare
system a country implements is a product of its“unique conditions, history, politics and national
character, which are in constant reform” (Tanner 2008:

Guiding BioethicalPrinciples through Issues ofColonisation- Chuckie Calsado,
Bioethics teacher, Philippine Science High School - Main
Campus, Philippines
Email: chuckiecalsado@gmail.com

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6). This does not necessarily mean universal accessacross social classes as the rate in which those who
belong in the poorest income quartile seek services
drops by eight percent in private hospitals and a dropof 26% in public hospital if hospital bill increase by apercent (Tan 2001). This shows that the poor are at a
disadvantage in accessing healthcare, a climate ofvulnerability to those who seek charity care such as
those belonging to low SES. Socioeconomic status
variables (income, education, race, etc.) could serve
as indicators of health outcomes, and with increasingsocioeconomic disparity (UN 2013) and health carecost (Drechsler & Jutting 2005), there is an inevitability
for individuals in low SES groups to access health carethrough free or subsidised care such as charity care.
SES have been shown to have implication on themeasurement, access and administration of healthcare quality and outcomes (Asch, Kerr, Kessey,
Adams, Setodji, Malik, & McGlynn 2006; Fiscella 2004)
such as in caring for patients under low SES group byphysicians and other health care workers (Bernbeim,Ross, Krumbolz, & Bradley 2008). Personal andfinancial strains have negative effects on the attitudesof physician concerning low SES patients such as in
the acknowledgment and exercise of autonomy andother ethical guidelines in the conduct of medical
procedures.
Given the above examples, vulnerable andmarginalized groups carry the highest burden when it
comes to issues related to the attainment of standard
health care. Those who are at a financial disadvantage
due to the financial burden of a health care insurance
submit themselves to other forms and ways ofacquiring health care through uncompensated care.
Low SES groups usually disproportionately represent
those who access charity care, as these groups belong
to the low-income uninsured population (DeLia 2007).
This has led to cases where these groups are
subjected to different clinical research practices, which
can be a side effect of their enrolment in charity care.
A US survey shows that teaching hospitals andmedical school faculty practice groups are the major
health care providers of charity care (AAMC 2013).
Together with providing charity care to the uninsured,these institutions maintain their core mission of
medical education, biomedical research and innovative
patient care. For instance, various medical schools
integrate clinical research in their curriculum(Laskowitz, Drucker, Parsonnet, Cross, & Gesundhet.
2010), which provides a high percentage (40%) ofcharity care in 2007 (AAMC 2013). Patient/subject’s
socioeconomic status expose them to be dominated or
subjugated under authorities such as doctors,
researchers and medical students who have researchinterest in them as an available controlled ormanipulated research group, and sometimes areforced to show deference to show gratitude throughunwilling participation to clinical research procedure as
an implication of the health care they received throughcharity care. These considerations should inform
ethical guiding principles in dealing with patient/subject
in low SES group as they exhibit multiple vulnerabilities

as shown by Kipnis’ taxonomy of biomedical
vulnerability (Kipnis 2001).
“The sensitive understanding of vulnerability—themany precariousnesses that afflict the humancondition—exposes a certain universality in these
themes even while grounding a broader case forkindness and sensitivity. None of us is without somecognitive limitation. Everyone is subject to juridic
authority, not all of which is wisely benevolent.
Socialization itself entails patterns of deference. All ofus face an eventual and too real prospect of medical
exigency. And no one is immune from extreme needand the harms that can flow from deficits in thesystems we count on to provide us with essential
services and protections. Nor are researchers the only
ones who need to learn how to engage the vulnerablewith sensitivity and honor. The topic surely has animportance extending beyond the boundaries ofresearch ethics” (Kipnis 2001: 10).
The arguments above substantiate how individuals in
low SES are vulnerable agents in bioemedical
practices, specifically in health care and other forms ofresearch. Freire (2006) further argues that current
ethical guidelines are a function of a neoliberal system,
in which he explains,“We need to say no to the neoliberal fatalism that weare witnessing at the end of this century, informed by
the ethics of the market, an ethics in which a minority
makes most profits against the lives of the majority. In
other words, those who cannot compete, die. This is aperverse ethics that, in fact, lacks ethics” (Freire, 2006:
25-26).
Socioeconomic status, together with age, political,
ethnic background or gender, should not prevent an
individual or a group from the right to health, afundamental component of human rights and a life ofdignity (WHO 2013a). But with a neoliberal slant,
where autonomy, benevolence, non-maleficence,
informed consent and justice are mechanisms toprovide legitimacy to current practices, it fails to
become a guideline on genuine ethical practice. These
ethical principles are reactionary at best and limitedin
addressing
current
hierarchicalpower
imbalance
betweenpatient
andmedicalpractitioner at its worst. Power imbalance, or thehierarchical nature of power should be addressed
especially as it exists between a patient andhealthcare practitioner or researcher. In colonisation,
domination is a central theme that has implication in
the control by individuals or groups of other individual’sor group’s territory or behavior (Horvath 1972).
Colonisation is not ahistorical, as domination exists
across time in the subjugation, oppression andexploitation by an agent over another agent.
Colonisation could be equated to exploitation in termsof economic variables (Marxist-Leninist conception ofcolonialism) or as a culture-change process(anthropology) (Horvath 1972). Colonisation consistsof repeated and more or less successful attempts ofthe core (coloniser) to create a periphery (colonised)
and impose political control in order to exploit thecolonised economically (Sanderson 2005). ThroughEubios Journal of Asian and International Bioethics 26 (September 2016)
the process of generalization, there exists a case ofoversimplification of colonialism in which J. E. Spencer
commented, “this becomes quite clearly a case of theWest trying to impose a simple universal definition of
morality in aggression upon all the practicers thereof”(Spencer in Horvath 1972: 54). Beyond the resource
and territorial conquest concept of colonisation, othercolonial theorists defined colonisation in terms of
oppression, the oppressed as subhuman agents,
otherness, colonizing gaze, power imbalance, theprimitive vs the scientific or the modern and labor
theory to name a few (Freire 2006; Nandy 1983;
Fanon 1986; Hooks 1992).
Freire (2006) ‘consistently argued that a thoroughunderstanding of oppression (in light of colonisation)must always take a detour through some form of classanalysis’ (p. 13). This class analysis will allow us tofurther understand the ethical permissibility of clinicalresearch not only through the hegemonic universal
definition of morality by the West but also through thelens of the oppressed. This is evident in the classstratification, which exists between the clinicalresearcher and the research subject, where hierarchyof knowledge, power and wealth exists.
Colonisation as a bioethical principle (biocolonialism)is specifically applied on the temporally extended
power imbalance between Western and “indigenous”
cultures and contemporary practices of culturalimperialism (Whitt 2009). Within the context of
biocolonialism is the commodification of knowledge
and of genetic resources, which is at odds with therespect, and other ethical values, which indigenous
communities rightfully have (Whitt 2009). The OCAP
principles or “Ownership, Control, Access andPossession” is embedded in the ethical guidelines ofvalues applied on research involving indigenous
people (Burgess & Tansey 2009). Colonisation in
Indigenous People such as the First Nations ofCanada are characterized by “colonially-createdcultural disruptions that compound the effects ofdispossession to create near total psychological,
physical and financial dependency on the state” (Alfred
2009: 42). Colonisation is a result of cumulative andongoing effects of dependency which results in social
suffering, unresolved psychophysical harms ofhistorical trauma and cultural dislocation, which limit
their individual and collective autonomy (Alfred 2009).
The specificity of the values being applied to research
involving indigenous people, considered as ahistorically colonised and oppressed group, should
support the application of these same principles onother colonised or oppressed groups.
As shown in the previous sections, low SES groups
are prone to physical, psychological and financial
dependence in the access of health care; thisdependency is akin to the dependency that IPs
experience. The context of dependency should not be
mistaken as the dependency seen between a child anda parent, the mentally-handicapped and theircaregivers, and other such types of dependency. Thisdependency is rooted in the ongoing process ofcolonisation, which SES groups experience as a result

193

of unresolved historical, political, economic andsociocultural
domination.
Accordingly,as
psychological, physical and financial dependency of
IPs is considered as the determining factor in the
inclusion of colonisation as an ethical value in
research, as low SES groups exhibit these samecharacteristics, colonisation should then be considered
as an ethical value in the conduct of bioemedical andclinical research practices involving low SES groups.
The acceptance and recognition of the ethicalimplication of colonisation should not only apply to a
specific group such as IPs, rather, to groups who arehistorically oppressed or colonised. In which
individuals of low SES belong to. Their history of
oppression results in their low SES and creates acontinuing reality of domination and oppression.
The ethical guidelines as limit-situations
Ethical research guidelines are a function of the
medical or experimental controversies of the time inwhich they were formulated in order to prevent future
scandals to occur or ever happening (Emanuel andothers 2000). Ethical justifications of these ethicalguidelines are based on historical and ethical reasons,which supported the different ethical values. The cruxof this strategy is that it allows further scrutiny of acertain ethical issue at hand but neglects to accountfor other underlying or related ethical issues. The given
ethical requirements are subject to this problem, inwhich ethical requirements in the conduct of clinicalresearch such as informed consent and favorable riskbenefit ratio is a product of a code of ethics such as
the Nuremberg Code (Emanuel and others 2000).
Code of Ethics are prone to pseudo-justifications, as
moral values such as maximizing happiness do not
inform us what to do or what action or type of action to
be taken (Muresan 2015). Relevant ethical issues
might have been taken into account but the ethicalvalue of non-exploitation is not enough to draw upon
the context of colonisation, which exists in developing
countries.
A further review of the current ethical guidelines
shows that they were developed in response to
medical/research problems or scandals. They are
incomplete and only respond to the current concerns
and therefore lack a systematic ethical framework.
Patients/subjects in low SES as a subpopulation, havea unique characteristic, which makes them vulnerable
to certain clinical research beyond these ethicalguidelines. The ethical context of colonisation, which isapplied on the conduct of research (social, clinical orscientific) on Indigenous people; consideration forfurther protection of low SES charity carepatient/subject should be explored.
The history of colonisation, which brought about
injustices and oppression, seen in IPs is mirrored by
the experiences of low SES charity care
subject/participant. A further review of the ethicalguidelines shows a lack of an ethical requirement,
which touches on the issue of colonisation of theresearch subjects. If colonisation is acknowledged in
the conduct of research on IPs, then why is it non-

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existent on other vulnerable groups which exhibit thesame vulnerabilities as IPs do? This might be reflectiveof the lack of acknowledgement on the issues ofcolonisation, as it is an ongoing process or the mere
dismissal of the core population to its existence andimplication, it lacks the sensational nature of the otherbiomedical scandals which precipitated the formulationof the current ethical guidelines. Some of these ethicalrequirements act as procedural requirements such as
independent review and informed consent to ensure
certain values are achieved. Lastly, there is an issue of“who watches the watchmen” in the proceduralapplication of these ethical guidelines as “experts”
such as educated and trained investigators, IRBs,
statisticians, ethicists and lay people are the ones whoweigh the ethical permissibility of a certain research.
They bring with them, in their expertise, a colonisinggaze (Hooks 1992) against their research subject,which the other ethical guidelines fail to recognize.
Domination, subjugation, and hierarchical nature of
power and knowledge are not addressed by these
ethical guidelines, which is characteristic ofcolonisation.
Research Subject as Currency in the Research
Process“The oppressed have been destroyed precisely
because their situation has reduced them to things. In
order to regain their humanity they must cease to bethings and fight as men and women” (Freire 2006).
Informed consent ensures the primacy of autonomyof the individual as opposed to the utilitarian calculusof the greatest good for the greatest number. But
Beauchamp (2006) clarifies the influence of theutilitarian calculus in the clinical research setting
independent of autonomy: ‘[…] the National
Commission was very concerned throughout its workthat it had become too easy in the biomedical world touse utilitarian justifications of research.” This is
illustrated in a utilitarian value, in which a moral
calculus “grounded in business ethics, are used inapplying cost-benefit calculations to public healthpolicies such in the case of clinical researches”(Sharav 2013). The ethical values supporting some ofthe ethical guidelines set up by Emanuel and others(2000), shows the primacy of this utilitarian calculationon the risk-benefit ratio and resource allocation. A
societal viewpoint has taken priority, even if informed
consent and autonomy has been the focus of thedifferent declarations as resources and researches areincorporated in utilitarian calculation of cost and benefit
ratio. But this societal viewpoint should not in any way
viewed through the lens of Freire’s critical theory
where social awareness takes primacy. It is repletewith utilitarian policies that have determined which
individuals or subpopulation (especially vulnerable
groups) will bear the burden of clinical research forsocietal benefits. The human interaction component ofclinical research has been broken down to procedural
and institutional bureaucratic practices, which
separates the researchers from the subject/patient intosub-human components of the whole process. Whenclinical research participants are considered to bevariables and mere test subjects to a certain study,
they are deemed as non-humans or subhumans to thecolonizing gaze of the researcher (coloniser) (Nandy
1983; Hooks 1992).
Veatch (1989) contends that the ethical guidelines
we follow should be viewed skeptically, as these
ethical principles such as justice, autonomy,
beneficence, and other ethical values are not as
conclusive as they seem to be and the guidelines weapply could be less protective than they appear. More
importantly, these ethical values are grounded inWestern ethical values, in which, other populations
might not be completely protected. Even if ethicalprinciples such as autonomy seems to have taken
primacy in the ethical guidelines, Western medical
science has moved and is still moving towardutilitarianism and this process has occurred in tandemwith a gradual devaluation of life (Rifkin in Ethics inembryo 1987). Thus, the Western valuation ofconsequentialist and non-consequentialist ethicalprinciples should be addressed and reviewed to better
cater to the needs of other populations (Olivier 1995).
The importance of considering how ethicalprocedures should be embedded and governed by awider network of procedural and cultural norms
should be further discussed (Liddell and Richards2009). These cultural norms are beyond the scope ofautonomy, beneficence, non-maleficence, justice,
resource allocation, non-exploitation and conflict ofinterest, which govern the currently widely used ethicalguidelines. There is still a room for debate on thecontext of colonisation, which is being applied in the
conduct of scientific research involving indigenous
people (Burgess and Tansey 2009). In a utilitariancalculation of cost and benefit ratio, vulnerable groups
such as low SES charity care patient/subject will carrymost of the burden due to their history of oppression.
In terms of education, health care, accessed toresources and facilities, power imbalance, their historyof colonisation prevents them from complete
realization of their rights and freedom. The current
ethical guidelines or principles have become a limit
situation, where practices can be legitimated within thehallowed confines of the current principles even if
these practices can be unethical under the lens ofcolonisation.
On Colonisation and Ethical Research
As discussed earlier, the implementation of ethicalguidelines, such as informed consent, can act as alegitimising or procedural activity provided by personsof authority (doctors/investigators) of power oversubordinates (patient/subject). This is supported by thestudy of Ahmad, Krupat, Asma, Fatima, Attique, andMahmood (2014), which shows the attitude of
medical students toward their patients as more highly
doctor-centered than patient-centered. The attitude“Doctors Know Best” is transferred from a teacherdoctor to the medical students where patient autonomy
and confidentiality is not given importance as the focus

Eubios Journal of Asian and International Bioethics 26 (September 2016)of the medical curriculum is disease treatment rather
than doctor-patient partnership, which transfers thecontrol of patient health to the doctors (Ahmad andothers 2014). Knowledge and attitude of medical
students toward clinical research is currently lacking(Wazaify, Nabulsi, Al-Khateeb and Silverman 2012).
Imbalance of power through the curriculum can be as
detrimental as lack of knowledge by medical students
in the context of autonomy, ethical research guidelines
and other related concepts, which can result to
uninformed agents of power.
Medical students and teachers, a group which most
likely practice clinical research, show that they areunable to answer clinical trial methodology and ethicalrequirements of the process (Dhodi, Thakkar, Billa,
Khobragade, Sinha, and Patel 2013) as the very
curriculum engenders would-be medical practitioners
and clinical researchers to have a vertical doctorpatient attitude. This creates a power structure which
is not bidirectional, neutral, and non-hierarchical.
When power imbalance between agents of powerarises, there is a possibility of existence of hierarchy ofpower and the subjugation of knowledge (Foucault
1972-1977). There is a totalitarian theory, which exists
in the application of these ethical guidelines, where
subjugated knowledge exists. Foucault argues that
subjugated knowledge exists as “1) historical contents
that have been buried and disguised in a functionalist
coherence or formal systemization and 2) disqualified
as inadequate to their task or insufficiently elaborated:
naive knowledge, located low down on the hierarchy,
beneath the required level of cognition or scientificity”(Foucault 1972-1977: 81-82). This is reflective ofNandy’s (1983) contextualisation of colonisation inwhich he characterizes the colonisers as the scientificand/or the modern and the colonised as the primitive.
The colonisers view that it is their responsibility andduty to modernize the primitive (colonised) throughtheir more advanced knowledge.
In the clinical research setting, the researchers
impose their more “advanced” knowledge over the
rudimentary knowledge of the patient/subject. Given
the context of the medical curriculum, and how thiscurriculum shapes medical practitioners and clinicalresearchers, it is contradictory to the primacy ofautonomy which ethical guidelines consider having
precedence over doctor/investigator paternalism. Thishas great implication on low SES charity carepatient/subject as a group: they do not hold much
power and their knowledge, beliefs, and values are
subjugated in the context of a clinical research orpractice. This power imbalance is not discussed ingreat detail in the ethical principles of the current
ethical guidelines on biomedical practice and research.
The book “Black Looks- Race and Representation”,
argues that “the commodification of difference
promotes paradigms of consumption wherein whateverdifference the Other inhabits is eradicated, via
exchange, by a consumer cannibalism that not only
displaces the Other but denies the significance of that
Other'shistory
throughaprocessofdecontextualisation“(Hooks
1992:
31).

195

Commodification should not be viewed here in thestrict sense where there is an exchange of goods
through economies of exchange, but vulnerable
groups as the currency of the consumption process.
Decontextualisation of the history of low SES charity
care patient/subject lends itself to abuse, as
understanding of their current status quo is not clear toauthorities of power (doctor-researcher). Medical
practitioners who might be involved in a clinicalresearch practice, such as nurses, have negative
attitudes toward the poor due to their misplacedcharacter judgment of this group (Sandhurst n.d.). The
attitude of physicians toward group with low
socioeconomic status shows “that health care
professionals have some ambivalent feelings orattitudes toward caring for the poor and as a result it isquestionable of how those attitudes affect healthoutcomes” (Sandhurst n.d: 19). This exhibits the“colonizing gaze” towards the “others” which medical
practitioners harbour toward low SES group. Below is
an excerpt of an interview, how a coloniser’s gaze candim a medical practitioner’s understanding of thereality of a low SES research participant,‘I thought people (pause) if poor people wanted tomake a difference, they could (pause) they just would
have to go to school and do it and I just felt like maybe
they were being lazy and that’s all it was—just a caseof laziness. I just thought that they maybe just needed
to take a little bit more responsibility of their getting a
job or, you know, doing stuff like that because where
I’m from, everybody (pause) if you wanted a job you
just went to the mall or you just went, you know, to thestore and you got a job; but we had cars to get us tothose jobs, you know, we had parents who could pick
us up and take us there [.……] Well, if I have to get ajob, couldn’t the poor people get a job?’ (Sandhurst n.
d., p. 40).
By understanding the context of the coloniser’s gazeand the issue of otherness, which different agents ofpower enforce and assume, an ethical guideline might
be crafted which will best suit this group. As Freire(2006) argues, it is through reflection and action, which
we will be able to advance the current situation of
those who are being oppressed such as low SES
charity care patient/subject. Theory without action is as
lacking as action not founded in theory, as ourreflection (theory) will be our guide to appropriate
actions. As shown in the above passage, by having a
biased understanding of the poor, decision making,attitudes and treatment of investigators creates acolonizing value. By being labeled as poor or of low
SES, the current debate has altered one's place andparticipation in contemporary politics (Hooks 1992), in
this case the participation of low SES charity carepatient/subject to bioethical practices.
When membership to a group engenders someone
to be commodified as a currency or resource for
consumption, groups or individuals become analternative playground for dominant groups to affirm
their power (Hooks 1992). In this case, can a low SES
charity care patient/subject really exercise autonomy
when they are under a subjugating environment and196

Eubios Journal of Asian and International Bioethics 26 (September 2016)

authority? There is a perceived notion of autonomy, as
social injustices have not been addressed, autonomy
acts as a banner post which does not address aninjustice. The relationship or the focus ofcommunication has slanted towards the treatment of
the disease rather than viewing the patient as a humanbeing. It seems the person is seen only as a vessel ofrights and freedoms, not as an agent beyond theserights and freedoms. This is reflective of the otherness
andcolonisation
which
medicalpractitioners
inadvertently impose on their patient/subject.
The utilitarian calculus on ethical guidelines further
affirms the colonising context of subhuman treatmentof the colonised. There is a perceived duty imposed oncolonised groups, where resources allocated to them,
it is their duty to repay this by entering in a contract tohelp in the pursuit of generalizable knowledge such as
in clinical researches. But the history of oppression
and colonisation, further subjugates them into thesecontracts, as such they should not be viewed asahistorical agents rather as a product of ongoing
injustices. Utilitarianism as embedded in the context ofcolonization legitimizes oppression as a necessary
step to progress, remedy to feudalism and as adoctrine of progress (Nandy 1983). Nandy (1983)
further argued that colonisation is a “political economy,
which ensures a one-way flow of benefits, the subjects
being the perpetual losers in a zero-sum game and therulers the beneficiaries” (p. 31). Its utilitarian context
promotes real material game and abhors the false
claim of losses in social relations and psychologicalstates (Nandy 1983). Thus, to ethically respond tovulnerable group, they should not be viewed as anahistorical group, rather, a subpopulation which
inherently and historically brings with them a culture of
oppression. Mircea Eliade (in Nandy 1983: 58) argue
that,“While a modern man, though regarding himself
as the result of the course of universal history, does
not feel obliged to know the whole of it, the man of thearchaic societies is not only obliged to remember
mythical history but also to re-enact a large part of it
periodically. It is here that we find the greatest
difference between the man of the archaic societies
and modern man: the irreversibility of events, which isthe characteristic trait of History for the latter, is not afact to the former.”
Colonisers are viewed as a modernising, dominantgroup, who bring with them the concept of progress
while the colonised are primitive and need to be
educated and have second-rate social consciousness(Nandy 1983). This is not only true to the arguments of
Nandy in the context of British India but also true forvulnerable groups such as low SES charity carepatients/subjects, due to their history of oppression
and colonisation are viewed as a primitive group whichneeds to be answerable to the modern man (doctorresearcher). Some will argue that this is not far fromthe truth as these low SES charity carepatients/subjects have low level of literacy, lower
achievement, behavioral problems, dropping out ofschool, financial problems, health problems, negative
psychological effect (Davis-Kean 1999); all indicators

created and formulated by the colonisers to legitimise
their colonizing gaze. Yes, this is viewing the patientsfrom a deficit perspective, which focuses on their
weaknesses borne out of a subjugating anddominating character.
th
On the 9 Annual Meeting of the Report of the Global
Forum on Bioethics in Research the concept ofcolonisation has been discussed in terms of the ethics
of using Indigenous Groups as clinical research
participants (Global Forum on Bioethics in Research2008). This encompasses anthropological, sociologicaland biomedical researches where IPs are target
groups of research. In one of the plenary session,
Moana Jackson tried to frame the concept of ethicalresearch in the unethical construct of colonisation(2008). As colonisation is an ongoing process, where
research occurs in a colonising structure, it isparamountthat
researchers,
IRBs,
research
institutions should act in non-colonising or decolonising
ways. Jackson (2008) further argues, “that science is
not pure, it is a product of enlightenment andcolonisation and it is therefore unhelpful to separate
the notion of scientific method from that history,
specifically in the way it relates to Indigenous People”(p. 12). Debra Harry (2008) argues further that “current
laws and policies privilege scientific, academic, andcorporate interests, resulting in the misappropriation
and alienation of the collective heritage of Indigenous
Peoples” (p. 13). This shows that the laws, policies,
and institutions that should protect the interest ofminorities or the “colonised”, serve the interest ofscientific, academic and corporate interests.
Biomedical guidelines, even with strict adherence toethical values such as autonomy, respect, justice, etc.,
are used in the justification and self-preservation of theinstitution and the investigators. Ethical guidelines
serve to legitimize institutional requirements instead ofprotecting the interests of colonised groups. Harryfurther argues on the ongoing concept of
biocolonialism, which subjugates colonised groups
such as IPs, which is rooted in “neopositivist
assumption of value neutrality and in a practice ofvalue bifurcation, which together enable it to deflect
ethical and political critique,” (Whitt 2009: 1). As aresult of this practice, it expedites a culture ofknowledge subjugation resulting in a legitimisingrationale for biocolonial practice, which clinicalresearch practices have assumed. Harry (2008)
proposed a systemic change on research practice,such as clinical research, by viewing colonised groups
as rights holders rather than stakeholders. A reflection
on the difference of these terms prevents colonising
nature of the research process and agents. She further
argues that equitable partnerships on research, where
existence of power is bidirectional, to promote respect,
protect sovereignty, appropriate methodologies, isbased on trust, respect and transparency (Harry 2008).
The ethical guidelines, with its ethical values, act asa limit-situation for both the researcher-medical
practitioner and low SES charity care patient/subject to
act within the confines of a given research. Freire(2006) argues that these limit-situations should not act

Eubios Journal of Asian and International Bioethics 26 (September 2016)as a barrier of hopelessness, rather as a barrier to be
overcome. The legitimacy and how these ethicalguidelines are seen as an institutional requirement
should be debated, as they promote the existence of
oppression and domination of research subjects. As
informed
consent
becomesaninstitutional
requirement, more than a protective measure tosafeguard research subjects, and the utilitarian natureof these ethical guidelines still exists, it supports thedehumanizing acts of the oppressor (research agents)
towards
theoppressed(subjects).
Thisdehumanization is a result of prior situation of
subjugation, which subjects the research subjects tothe oppressive nature of the research practice. Fanon(1986) and Nandy (1983) qualified this dehumanizationor subhumanization to the context of the primitive andthe modernizing/scientific agent.
As a scientific agent or modernizing agent, it is theresearcher, which has control over the primitive or thecolonised. This is seen in situations in which uponcompletion of the informed consent, perceived or real
oppression is not accounted for in vulnerable groups
such as SECR charity care patients/subjects. There isno acknowledgment of the existing oppression,
whether willful or not, this extends the continuing
process of domination and oppression of this group.
The research subjects become the currency of theresearch agents in their conviction to transform objectsof their purchasing power. The research becomes theact of purchasing, while the research subject becomesthe currency and the research results become theprofit. Freire (2006) further argues that, “We need to
say no to the neoliberal fatalism that we are witnessing
at the end of this century, informed by the ethics of themarket, an ethics in which a minority makes mostprofits against the lives of the majority. In other words,
those who cannot compete, die. This is a perverse
ethics that, in fact, lacks ethics [……] I do not accept. .
. history as determinism. I embrace history as
possibility [where] we can demystify the evil in thisperverse fatalism that characterizes the neoliberaldiscourse in the end of this century.”
The research subject feels inferior to the researcher
as he views the researcher to be the only one who
knows things and runs things, here exists dominationand subjugation. As the researcher and ethics
committee choose the terms of engagement, throughthe approved research protocol, they become theactors and authors of the process and the researchsubjects as the objects (Freire 2006). These result in
an illusion of acting through the action of theresearchers by the research subject, where autonomy
exists, it is only a perceived autonomy, as researchsubjects become mere objects of utility. Difference isthe currency of production, in which this difference isoften invented for the interest of social control forcommodity innovation (Fanon 1986). Hence, we canassume that research is an innovative commodificationof the oppressed.

197

Conclusion‘There is nothing noble in being superior to yourfellow man; true nobility is being superior to yourformer self.’-Ernest Hemingway
The acknowledgment of the existence of colonisation
towards IPs and the lack of it towards other groups isthematic of the primitive-scientific/modern man
relationship of colonisation. As IPs remain in theirprimitive state, they are viewed as prone to the ethicalissues which colonisation brings in the conduct of
research. As the other vulnerable groups have been“modernized” and “progressed” from their primitive
state, there is a mistaken belief that they are not prone
to the ethical issues involving colonisation as anexisting phenomenon. Kipnis addresses these types ofissues in his statement, “fair entitlements of researchsubjects who are disadvantaged socioeconomicallyand in other forms should be considered to prevent
tolerating unfair arrangements in the context of clinicalresearch that we would not find acceptable elsewhere”(p. 10).
We should reflect on the argument of Freire on thesupremacy of Western thought and philosophy, whichpervades in the different aspects of our society. He
states, “I can go on with examples to point out how
academics who argue for clarity of language not only
seldom object to language that obfuscates reality, but
often use the same language as part of the general
acceptance that the "standard" discourse is given andshould remain unproblematic. Although theseacademics accept the dominant standard discourse,
they aggressively object to any discourse that both
fractures the dominant language and bares the veiled
reality in order to name it. Thus, a discourse thatnames it becomes, in their view, imprecise andunclear, and wholesale euphemisms such as"disadvantaged,""disenfranchised,""educationalmortality," "theater of operation," "collateral damage,"and "ethnic cleansing" remain unchallenged since they
are part of the dominant social construction of images
that are treated as unproblematic and clear”’ (Freire,2006 in p. 22).
After five decades of the development of his theory of
oppression and colonisation, his arguments are stillthematic of the current status quo. We cannot be
ambivalent towards this philosophical theory, as it
addresses legitimate bioethical issues involving
biomedical and research subjects. A paradigm shift
should be used in order to address issues such ascolonisation, which has been a continuing ethicaldebate, in the application of the ethical guidelines on
research.
As it might seem like it addresses the bioethicalissues on any research, we have to always question
institutional guidelines on how they address andresolve inherent bioethical issues. We need to always
challenge the status quo, as the status quo might not
represent the most ethical reality we strive to build in
our society. By looking at the bioethical issue ofcolonisation, it lends itself to alternative discussion ofbioethical permissibility of other medical procedures
such as surrogacy, clinical trials in underdeveloped

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

countries, and other colonised groups. We have to
move beyond the coloniser’s gaze in the legitimizationof the procedural nature of the ethical guidelines toresearch, which does not address the bioethical issueof colonisation and the other dimensions it brings with
it. Recognition of colonization, with an implication on
oppression and hierarchy of knowledge and power
among agents, as an ethical guideline might lead togenuine partnership among medical practitioners,
researchers and patient-participants.
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Eubios Journal of Asian and International Bioethics 26 (September 2016)

The Regulatory Regime for
the Use of Embryos in
Research: Braithwaite’s
Theory of Responsive
Regulation- Dr Patrick Foong
Swinburne Law School, Swinburne University, Cnr Wakefield
and William Streets, Hawthorn, Victoria 3122, Australia
Email: pckfoong@gmail.com

Abstract
The controversies of human embryonic stem cellresearch is a compelling point to posit the argumentthat it should be stringently regulated. This paper
explores the theory of responsive regulation byProfessor John Braithwaite. It examines the applicationof his theory to the design of Australia’s regulatorymodel in the regulation of research involving humanembryos which may serve as a model for other nations
to adopt. The paper also discusses the concept of
tripartism, an aspect of the responsive regulatory
theory, as a possible solution to the potential problem
of regulatory capture/ corruption.
Introduction
While biomedical applications of stem cell researchpromise significant benefits, human embryonic stem
cell (HESC) research raises serious ethical issues
since the harvesting of stem cells from an embryo
involves its destruction. The controversy of this type of
research is a compelling point to argue that it should
be strictly regulated. Currently, there are debates inmany nations, including some Asian countries, on the1legalisation and the regulation of HESC research.
This paper explores the theory of responsive
regulation by Professor John Braithwaite, or what is
termed as ‘smart regulation’. It examines theapplication of his regulatory theory to the design ofAustralia’s regulatory regime in the regulation ofresearch involving embryos. It also discusses theconcept of tripartism, an aspect of the responsive
regulatory theory, as a possible solution to the serious
potential problem of regulatory capture/ corruption. A
face-to-face interview was conducted with Braithwaite
to seek his views and the application of his general2
regulatory theory in the context of stem cell regulation.
1

For instance, in Malaysia, somatic cell nuclear transfer(SCNT) research may be permitted in the future. In
Singapore, the research is legal and there are existing
safeguards to prevent exploitation of women. But thesesafeguards are not as comprehensive as the Australianstringent regulation.
2
Braithwaite has conducted several empirical researchstudies in this area, including the regulation of nursing
homes and business. The interview was held on 19
October 2009 in his office at Australian National University(ANU).

Embryonic stem cells are obtained from excess in
vitro
fertilisation(IVF)/
assisted
reproductive
technology (ART) embryos and cloned embryos
created through somatic cell nuclear transfer (SCNT)/
therapeutic cloning which shares the technology as thecreation of Dolly, the sheep. A critical constraint is thatphysicians are limited by a lack of organ donors. In
comparison to adult stem cells, embryonic stem cells
are much easier to identify, isolate, maintain and growin the laboratory. They are also more versatile thanadult stem cells. As pluripotent cells, they have thecapacity to form each cell type in the body to create
skin, bones, organs and other body parts that patientswith injuries or illnesses in need of transplants mightneed to receive. Embryonic stem cells have uniqueproperties; they are unspecialised and able to divide
as well as renew themselves for long periods. Thesecells will permit the growth of required tissue when it isneeded.
There are scientists who regard HESC research as
the epitome of stem cell research. In 2013, Shoukhrat
Mitalipov and his team at the Oregon Health & Science
University and the Oregon National Primate ResearchCenter accomplished a scientific first by creatingembryonic stem cells from cloned human embryos
through SCNT research using cells from infants. In
2014, researchers at the Research Institute for Stem
Cell Research at CHA Health Systems in Los Angeles
had produced stem cells using SCNT, from adults,
bringing them closer to developing patient-specificlines of cells.
The Importance of Regulating EthicallyControversial Research
The first question to ask is whether it is necessary to
regulate HESC research. It might be argued that it ispreferable to adopt a minimum regulation or to leave
the research as completely unregulated. In general,scientists may prefer free and uninhibited research.
There are respectable individuals who argue infavour of adopting the regulation. Francis Fukuyama
asserts that it is crucial to regulate biotechnology(Fukuyama, 2002). He is concerned that unregulated
biotechnology poses an insidious threat to society’s
3
way of life and compromises human dignity. He statesthat ‘the people in Brave New World may be healthy
and happy, but they have ceased to be human beings.
They no longer struggle, aspire, love, feel pain, makedifficult choices, have families or do any of the things
that we traditionally associate with being human. They
no longer have the characteristics that give us humandignity’ (Fukuyama, 2002). He explains that there is agrave concern that, ultimately, biotechnology may
cause society to lose its humanity, which is an
essential quality that has underpinned its sense of whothey are (Fukuyama, 2002). Roger Brownsword also

3

Fukuyama explained that on one extreme of thecontinuum is nuclear technology which is extremely
dangerous and on the other extreme is information
technology (IT) which is relatively benign. Biotechnology
lies in between the two extremes.

Eubios Journal of Asian and International Bioethics 26 (September 2016)
supports the need for regulation, stating, ‘no regulationis hardly a serious option and there is surely little virtue
in leaving eugenics to the play of subjective preference
and the market ... if we accept the deeper implicationsof a liberal eugenics, such an abdication of regulatory
responsibility is likely to have highly corrosive
consequences ... the dilemmas associated with theregulation of human genetics must be confronted’
4(Brownsword, 2004).
Michael Kirby makes a strong case for adopting a
regulation, especially for controversial research (Kirby,
52008). He refers to reproductive cloning where heasserts that for the law to be silent about the activity is
to provide a green light to conduct experiments in thetechnology He states that nothing then would restrain
the scientists except for their ethics, their religious
beliefs, the availability of research funding andinstitutional ethics clearance requirements. Without
regulation to prohibit or regulate an activity, scientists
may choose to conduct controversial experiments
because of interest and or curiosity. Kirby says that
regulatory inaction is a decision; he warns that theabsence of regulation can be interpreted to mean thatthe society has made a decision to allow thetechnological advances to arise without impediment.
He asserts that while ‘proponents of technologicalinnovation have often favoured containment of law anda libertarian approach to the development oftechnology, yet most lawyers recognise that there arelimits’ (Kirby, 2008). Kirby is also concerned that
overregulation might be worse than no regulation at all
as it may impose burdensome constraints onscientists. He stresses that ‘limits must be clearly
expressed and upheld in an effective way’ (Kirby,2008).
The regulation of scientific research is not a new
6
subject. In biotechnology, there are countries which
are enacting regulatory instruments to regulate
controversial areas of research. In Australia, the Gene
Technology Act 2000 (Cth) was passed to regulate
research on genetically modified organisms (GMOs),
the objective is to protect the health and safety ofpeople and also to protect the environment. In
Australia, the decision has already been taken to passlegislation to regulate research involving humanembryos primarily because law promotes certainty andclarifies what is permitted for stem cell scientists. To
quote a report (Human Cloning: Scientific, Ethical and4

5
6

Roger Brownsword (Kings College London) is abioethicist and a leading scholar on issues of technology,
ethics and law.
Michael Kirby is a retired High Court judge.
Biotechnology is described as using living things,
including plants and animals, to create products or toperform tasks for human beings. Over time,
biotechnology has formed the basis of learning abouthuman diseases and the development of medical
treatments. It has led the way to a new era in health carewith the development of improved methods for detecting,preventing and treating diseases. These include thedevelopment of new diagnostic and therapeutic tools,
DNA profiling, cloning and stem cells.

201

Regulatory Aspects of Human Cloning and Stem Cell
Research/ Andrews Report): ‘We owe it to thescientists to try and clarify, through legislation, thosecircumstances in which procedures may be acceptable
7… and those cases in which a line may be drawn …’
Accordingly, enacting laws to regulate HESC research
will provide higher likelihood of clear boundaries,
scope and protections to stem cell scientists. It also
ensures transparency and accountability.
Achieving Regulatory Effectiveness
It is interesting to note that Brownsword recommends
the application of Braithwaite’s responsive regulatory8
theory to achieve regulatory effectiveness. He asserts
that, “There is no point in reinventing the wheel ... We
do have some general regulatory intelligence. It is notas though observers of the regulatory process havedetected no recurring patterns (relatively speaking) inregulatory failure and regulatory success ... we cancarry forward the principal insights of smart regulatory
theory, namely that traditional criminal law
interventions cannot be counted on to control in theway that regulators intend, that regulators have at theirdisposal a range of instruments that might be deployed
to channel and control conduct and that regulators
would do well to seek out the particular combination of
instruments that most effectively promote their
particular regulatory purposes. While these insights
are valuable in steering regulators away frominterventions that are likely to be futile or evencounterproductive, we are ... short of a comprehensive
and reliable regulatory jurisprudence (with settled
precedents) pointing to the particular combinations of
instruments that are appropriate for particular cases”(Brownsword , 2008).
Brownsword identified the primary challenges ofregulating innovative technologies and one of them
was the problem of attaining regulatory effectiveness(Brownsword, 2008). In regulating new technologies, it
is essential that regulators bear in mind the difficulties
that they may encounter. He warns that unless thesechallenges are adequately addressed, the regulatoryenvironment is defective, ‘as opposed to a regulatoryenvironmentthat
supports
thedevelopment,
application and exploitation of technologies that willcontribute to such an overarching purpose, anenvironment properly geared for risk management andbenefit sharing’ (Brownsword & Somsen, 2009).
Accordingly, to establish an effective regulatory
framework for emerging technologies, the regulators
must first recognise the difficulties likely to be faced
and then attempt to design and sustain a regulatoryenvironment that is effective.

7

8

See 57-58 of Andrews Report where the committee
reported that they agreed with Professor Donald
Chalmers’ view to introduce legislation.
There was also an interview conducted with Brownword
held on 18 November 2009 in his office in the law faculty,
Kings College London.

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

Regulators achieve regulatory effectiveness when
their intervention works and is fit for purpose i.e., itneeds ‘to be beyond reproach ... a regulatoryintervention must be backed by legitimate regulatory
purposes, and the regulatory means employed must
be both morally clean and effective’ (Brownsword,2008) or else the regulatory environment is deficient.

pyramid, the licence to do business is revoked and thebusiness will cease.

9

The Responsive Regulatory Theory
An effective regulatory framework for HESC researchshould be responsive. The theory of responsive
regulation was conceptualised by Professor Ian Ayres
and Professor John Braithwaite in 1992 (Ayres &Braithwaite, 1992). This theory proposes that
‘regulators should be responsive to the conduct of[regulatees] [before] deciding whether a more or lessinterventionist response is needed’ (Braithwaite, 2008).
The first response to proscribed behaviour is todetermine how effectively individuals or corporations
self-regulate before deciding whether to escalate
intervention. Giving primacy to less invasive responses
10
facilitates this approach and ‘attempts to solve thepuzzle of when to punish and when to persuade.’
The most distinctive part of the responsive regulationis the Braithwaite’s regulatory pyramid (see Figure 1)
with every increment step increasingly demanding in
its sanctions. The pyramid illustrates the idea that lesspunitive measures should be the reaction of the first
instance. At the lowest rung of the pyramid, selfcompliance is encouraged. The broad foundation of
the pyramid represents most of the cases which aredealt with informally, restorative dialogue-based
approach. They are not punitive responses; they arebased on persuasion and self-regulation. The
narrowing towards the top of the pyramid illustrates theincreasingly fewer cases handled by progressively
more formal means.
Moving up the pyramid, the regulations are becoming
more demanding in their sanctions. The inexorability ofescalation to punitive responses is the key toinfluencing human behaviour. Regulators will be able
to move up and down the pyramid to access theappropriate level of regulation necessary.
Beginning at the base of the pyramid, attempts are
made to encourage compliance with the law by
persuasion. If this does not materialise, the next step is
to issue a warning; if this does not lead to compliance,
civil monetary penalties are imposed. If this fails,
criminal prosecution ensues and penalties such as fine
will be imposed, if this fails, the licence to operate issuspended and this fails, arriving at the apex of the9This section relies on John Braithwaite, Regulatory
Capitalism, Edward Edgar Publishing, 2008, 88-139.
10
Braithwaite explains that what motivated him and Ayres toformulate this theory is due to the frustration with the ‘see
sawing’ in policy making between two groups of people;
on one hand, a group who argues that business people
only understand the bottom line and therefore must be
punished for lawbreaking and on the other hand, a group
who claims that business people are responsible people
who can be persuaded to comply with the law.

Figure 1: An example of Braithwaite’s enforcement
pyramid in the context of a businessAccording to responsive regulatory theory, a ‘spectreof punishment [is] threatening in the background but
never threatened in the foreground’ (Braithwaite,2008). The theory claims that if persuasion is to work,
stiffer forms of consequences must loom as a real andlikely threat. The primary issue is that the peak of theenforcement pyramid creates downward pressure thatcauses most of the action to occur at the bottom of the
pyramid, that is, in the realms of persuasion and selfregulation (Braithwaite, 1990-1991). The existence of
the ability to get as tough as is necessary can bring
into existence a culture that is voluntaristic and lesslitigious. Braithwaite asserts that if the top of the
pyramid is removed, there would be fewer prospects ofself-regulation and persuasion as an alternative topunishment. The greater the heights of punitiveness towhich a regulatory agency can escalate, the greater its
ability to push regulation down to the bottom of theenforcement pyramid. A truncated pyramid with atruncated range of escalations will exert lessdownward pressure to keep regulation at its base thana taller pyramid whereas a tall enforcement pyramid
can be used to apply considerable pressure from theheights of its peak to promote voluntary compliance.
Braithwaite refers to the regulatory agencies as ‘the
Benign Big Guns that walk softly while carrying very
big sticks’ (Braithwaite, 1990-1991); while regulators
indeed have powers, they seldom use the power ofcriminal prosecution. Compliance with the law is
optimised by regulation that is both robust andforgiving. Forgiveness is advocated for its importancein building commitment to comply in future andpunishment is about deterrence. As Braithwaite states,‘Paradoxically, the bigger and the more various are thesticks, the more regulators will achieve success by
speaking softly’.
It is noted that the theory of responsive regulation
might not be appropriate in some regulatory arenas.
Ayres and Braithwaite explain that the theory is ‘not aclearly defined program or a set of prescriptions
concerning the best way to regulate’ and therefore, thetheory should not be mechanically applied as theappropriate strategy to be adopted would ‘depend on
the context, regulatory culture and history’Eubios Journal of Asian and International Bioethics 26 (September 2016)(Braithwaite, 1992). It is acknowledged that the theoryof responsive regulation is an approach designed indeveloped countries. Also, it is recognised that alimitation that the developing world faces is the lack of
capacities necessary to make responsive regulation
work effectively compared to wealthy societies.
However, Braithwaite argues, “Responsive regulation
deals with the fact that no government can enforce
laws. It is useful for thinking about regulation indeveloping countries with weak enforcement abilities”(Braithwaite, 2006). The theory of responsive
regulation is relevant and applies in developed anddeveloping economies.
Australia’s Regulatory Scheme on Research
Involving Human Embryos and the Application of
the Responsive Regulatory Theory
An essential characteristic of Australia’s regulatory
regime over HESC research is its stringent statutory
licensing scheme. The Research Involving Human
Embryos Act 2002 (RIHE Act 2002) establishes anational licensing system where scientists must be
licensed for each research project that involves theuse of a human embryo. The aim of the Act is to allow
research on embryos but only in limited circumstances.
Its main feature is the licensing regime for the use of‘excess’ assisted reproductive technology (ART)embryos and SCNT embryos as well. The Act createssome offences relating to the utilization of the humanembryos without a licence. It is an offence to use anembryo that is not an excess ART embryo or SCNT
embryo (Section 11) and to breach a licence condition(Section 12). The seriousness with which thelegislature regards these offences is reflected in the
penalties with a maximum of five years’ imprisonment.
The Act establishes the Embryo Research Licensing
Committee (Section 13) whose primary job is tolicense the use of excess ART embryos and SCNT
embryos in research (Section 20). There are twostages to the issue of a licence. Section 21(3) RIHE
Act 2002 states that the licensing committee must notissue the licence unless it is satisfied with the fulfilmentof various conditions, one of which is that the applicant
must have obtained approval for the project by the
Human Research Ethics Committee, in accordancewith and acting in compliance with the National
Statement on Ethical Conduct in Human Research(2007) (National Statement 2007). Secondly, section
21(4) RIHE Act 2002 provides that in deciding where
to issue the licence, the licensing committee is directed
to consider various matters including ‘any relevant
guidelines ... published by the CEO of the National
Health and Medical Research Council (NHMRC) ...’and‘HREC’s[research
ethicscommittee’s]
assessment of the application ...’. The NHMRC
guidelines accompany the legislation which lay down
the steps that researchers should comply. While theseguidelines are not legally enforceable, failure to follow
them is likely to lead to non-issuance of a licence toconduct the research. The licensing committee will notissue a licence to a scientist who intends to embark
SCNT research unless his/ her research proposed in203

the application is evaluated and approved by aresearch ethics committee. This committee will makesure that the researcher has acted in accordance andcompliance with the National Statement 2007. The
research ethics committee’s approval of the application
is a pre-requisite for the issuing of a licence.
The key features and operations of the Embryo
Research Licensing Committee of the National Healthand Medical Research Council (NHMRC) (LC) include
the committee’s membership, duties, powers,
operations including the issue of licence, theimposition of licence conditions, variation/ suspension/
revocation of licence and monitoring compliance,
reviews and appeals by applicant for licences,offences under the Act, transparency and cost
recovery mechanism. This is the major role thisregulatory authority has performed in the effective
regulation of research involving human embryos inAustralia since 2003 and this continued after the
Amendment Act 2006 was passed. There is general
support for the necessity of the oversight of embryoand stem cell research. The LC fulfils a valuable role inthis process based on submissions in the Lockhart
review. These favourable submissions influenced
Recommendations 34, 35 and 38, which provided forthe continuity of the LC as the regulatory body in thisarea of enforcement.
Pyramid design is described as a creative anddeliberative activity (Braithwaite, 2006). ‘Regulators
who think responsively tend to create different types ofpyramids for various sorts of situations (Braithwaite,2006). The pyramid of regulatory strategies is
illustrated in Figure 2 below.

Figure 2: A pyramid of regulatory strategies toregulate HESC research
At the bottom of the pyramid is education. Throughthis strategy, awareness is created among stem cellscientists about the importance of observing highethical standards while embarking HESC research aswell as the results of non-compliance with the law. The
Australian regulatory framework incorporates thiscritical aspect; it is based on the concept of‘cooperative compliance’ where licence holders areencouraged to cooperate with the NHMRC to comply

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

with the legislation. In addition to education, theemphasis is also placed on communication;collectively, these will create and promote awarenessof the responsibilities of both licence-holders andinspectors. A key mechanism for raising awareness isthrough information exchange visits, which were
provided to researchers, human research ethics
committee members and other groups. Also,
information is provided through seminars, workshops,
websites and publications. These activities may deterscientists from breaching the law.
On the next level of the pyramid is the professional
Code of Practice/ industry self-regulation, the objective
being to give guidance and support a well as advice toscientists. Professional bodies and institutions should
be encouraged to adopt industry self-regulation as it
sets industry standards for compliance. However, thispaper notes that a reservation of the model of selfregulation is that it may be seen as a licence for selfinterested regulatory activity, that is, the industry may
act in ways that suit its interests and sets regulatory
standards as long as it is happy to comply with thosecriteria.
Higher up on the pyramid is the Guidelines scheme,
also known as soft law, created by government
11
agencies. Guidelines are particularly useful in theregulation of new technologies. They are flexible andmay be amended as needed. Changes can be done
gradually, focusing on areas that arise as fresh
12
discoveries are made. Finally, at the apex of the
pyramid is a statutory licensing scheme whererestrictive research on embryos is allowed by statuteand criminal offences apply where the activity is
13
pursued without a valid licence.
The regulatory architects in Australia use
Braithwaite’s theory of regulation. Its regulatory design
illustrates the various rungs of the pyramid ofregulatory instruments incorporating a mix of different
strategies namely, education, guidelines and strict
statutory licensing system. Smart regulation explores
many avenues. The evolving responsive Australian
regulatory regime, incorporating a combination of thestatutory licensing scheme, adherence to NHMRC
guidelines and education promoting awareness of
responsibilities, backed by monitoring and inspection
system for facilitating monitoring compliance with thelegislation,achieves
regulatory
effectiveness.
Education visits to research centres by the LC createawareness among researchers of their responsibilities
under the Acts. The strict criteria that the LC must
adhere to in issuing licenses, only where it is satisfied
that the proposed activity has been considered andapproved by an HREC acting in compliance with the11

For instance, NHMRC guidelines in Australia.
Countries that have adopted national guidelines schemeas their regulatory model include USA, Japan, India,
China, Spain and Malaysia.
13
Nations which have statutory licensing scheme include
UK, Sweden, New Zealand, Canada, Finland, Greece,
Israel, the Netherlands, Singapore, South Korea, theAmerican states of California and New Jersey.
12

14

NHMRC’s National Statement. The LC must also
have regard to relevant guidelines issued by the15
NHMRC.
To date, there has been no finding of noncompliance by Australian stem cell scientists andhence, there have been no prosecutions. This point
illustrates the success of the Australian regulatory
system governing research involving human embryos
and thus, it is a model that other nations may consider
emulating.
The Strengths-Based Pyramid
It is also useful to explore Braithwaite’s second
pyramid which is the ‘strengths-based pyramid’ as
illustrated in figure 3. It is a pyramid of responses toboth individuals and organisations. This pyramid of
support promotes a virtue whereas the pyramid ofregulatory
strategies
restrains
vice.
It
has
characteristics of the provisions of incentives insteadof the imposition of punishments. As it progresses
upwards, it moves to targeting progressively bigger
rewards on progressively smaller target groups.
Beginning at the bottom, strategies are minimallyinterventionist and minimally costly, yet they have therelevance to the broadest community (Braithwaite,2008).

Figure 3: A possible approach to a Braithwaite’spyramid of strengths–based pyramid to motivate
conduct
The responsive regulatory theory suggests that
‘regulators should operate with a cooperative default
approach’ (Brownsword, 2008) and try to attain winwin relationships with the regulatees. They will perform‘well to respond to non-compliance in a way thatleaves room for escalating sanctions, for flexibility, andfor sensitivity to the nature and character of particularregulatees’ (Brownsword, 2008).
With the strengths-based pyramid model (Figure 3),
scientists are motivated to be compliant withregulations. At the bottom of the pyramid, througheducation, researchers are informed and motivated to
conduct research while observing high ethicalstandards. On the next level is receiving a praise andnot everyone is singled out for special praise. This isfollowed by winning prize/ research grant and again
14

Research Involving Human Embryos Act 2002 (Cth) ,s21(3)(c).
15
Ibid s21(4)(c).

Eubios Journal of Asian and International Bioethics 26 (September 2016)
not every scientist will get the award. The next rung is‘escalated’ prize/ award and few will obtain, forinstance, a $1m grant. At the apex of the pyramid,
even fewer will receive an award such as the Nobel
prize or being conferred knighthood or being named asthe ‘Person of The Year’ and getting a cash prize.
It is noted that both pyramids are complementary. A
regulatory system, which includes both regulatory andstrengths-based pyramids, is effective as it has a
combination of instruments that promote the regulatory
purposes with a spectre of punishment in the
background. Thus, they have the effect of controllingthe conduct of scientists. As Braithwaite states, it is16
paramount to adopt a mix of support and sanctions.
Regulatory Capture and Tripartism
Brownsword has expressed his concern that
regulatory agencies may be ‘captured’/ bribed by somepowerful and influential regulatees (Brownsword,2008). Regulatory policy that fosters cooperation
between the regulator and the regulatee could evenencourage corruption. This is especially true whererelationships between the parties are ongoing andencounters are repeatedly made by the same
regulator. Corrupt dealings then become more
tempting to both sides.
A method to achieve regulatory effectiveness is toassign inspectors to monitor the licensees’ compliancewith the law. Brownsword agrees that the inspectorate
system might meet regulatory effectivenessa as it is anatural feature of a regulatory regime. Having set thestandard, the regulators then have to monitor and an
inspection is what they do. Then the question iswhether this will guarantee compliance to which the17answer is no. He cautions that an inspection system
is no guarantee of conformity concerning some18
hypothetical scenarios. Where the regulatory regime
requires the inspector to provide notice before the dayof the examination, as opposed to making random
visits, this announcement will enable preparations to
be carried out before the audit is conducted. Also,
where regulators face limited resources, the frequency
of inspections could be reduced. Where regularinspections are conducted, a cosy relationshipbetween the inspector and the researcher might evendevelop and the inspector is captured by the regulatee.
If it is not completely transparent and unaccountable,
the regulatory authority is prone to be captured by its
licensees from whom the body derives its funds. Whilethese scenarios suggest that monitoring compliance byinspectors
does
notguarantee
regulatory
effectiveness, it is nevertheless a natural feature andsignificant to include such monitoring as part of the
package of the regulatory system.
Braithwaite explains that any system could becorrupted but some are harder to corrupt than others.
He refers to examples where there are opportunities
for corruption and says, ‘Elections could be fixed. You
16

In an interview with Braithwaite.
In an interview with Brownsword.
18
Ibid.
17

205

can corrupt the electoral officer and get him to countthe votes wrongly’ and he also gives the example of
the grant of an Oscar academy award where every
member of the academy gets a vote as to who shall19
win the Oscar, so there’s the possibility of corruption.
As a possible solution to the severe risk of regulatory
capture/ corruption, Braithwaite advocates the conceptof tripartism, a process involving a third player in theregulatory process, for example, public interest groups(Ayres & Braithwaite, 1992). It encourages theparticipation of these groups by giving them access tothe information available to the regulator, a seat at thenegotiating table with the regulatory agency andregulate, and the authority to sue or prosecute. As
Braithwaite explains, “Solutions to the problems of
capture and corruption - limiting discretion, multiple
industry rather than single industry, agency jurisdiction
and rotating personnel- inhibit the evolution ofcooperation” (Ayres & Braithwaite, 1992).
As an illustration of the concept of tripartism,
Braithwaite refers to the example of the issue of a
grant. He explains, “When you have a licensing boardthat gives grant, the committee does it rather than abureaucracy and you have representatives. Tripartism,that is what most countries do. The government givesout research grants to universities but people who
make recommendations to government are people
who are experts from industry, from universities, fromthe government and they sit down as a committee tomake a collective decision. It’s much harder to bribe acommittee than it is to an individual bureaucrat. If it’s abureaucracy giving out a grant, then all you have to do
is to bribe the head of bureaucracy ... So you just haveto corrupt one person but if it’s a committee withpeople from outside the bureaucracy that are giving
out the grants, then you can still bribe the committee
but it’s hard. One member of the committee isn’t open
to being bribed and blows the whistle on all the others.
He/ she might it morally offensive to take a bribe. And
those who take a bribe fear that they may be introuble. So the committee are protected against bribery
just like juries in criminal cases. Juries are good
institutions and one of them is that it’s always easier tobribe a single judge than to bribe the whole jury. The
judges are repeat players so they build a relationshipand use that. If you’re an organised crime group, youbuild that relationship with the judge. You can bribethat one judge on multiple occasions. The organised
crime group makes that investment with the judge.
Whereas with juries, this is the only case that they sit
on with their whole lives and the investment in buildingthat relationship does not bring much return. So it’sharder to bribe a committee. The solution connectswith tripartism that is having the third or fourth party
20
involved in the process”.
19
20

In an interview with Braithwaite.
In the interview with Braithwaite, he referred to Indonesia‘sindependent Corruption Eradication Commission/ Komisi
Pemberantasan Korupsi (KPK) which he thinks was
effective in controlling corruption in the country in the
period 2005 -2008 and he also made brief reference ofthe success of the Hong Kong model.

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Eubios Journal of Asian and International Bioethics 26 (September 2016)

In Australia, the composition of its NHMRC Licensing
Committee comprises professionals from a diverse
background. The selection of the committee prescribedin the legislation reflects this. It requires that board
members be drawn from a range of areas of expertise
which include expertise in research ethics, publichealth research, biotechnology law, embryology,
consumer issues relating to assisted reproductive
technology, consumer health issues related todisability and disease and regulation of assisted
reproductive technology. Thus, tripartism is aneffective solution to the potential problem of regulatory
capture/ corruption and it is, therefore, important tohave multi-players in the field.
Conclusion
It is critical that the regulation is based upon goodscience as opposed to basing judgments ‘upon
assumptions, religious dogma, intuitive beliefs or21
popular opinion’ (Kirby, 2008).
Braithwaite’s
responsive regulatory theory is useful and influential in
the design of an effective regulatory framework toregulate HESC research. With such tight regulation
over controversial research, this has the effect ofallaying public concerns and restoring confidence.
Regulatory effectiveness could be attained whenregulators apply Braithwaite’s theory, which suggests a
mix of different regulatory strategies. With the pyramidof strategies, the emotional economy of shame and thestrengths-based pyramid, emotional economy of pride,
there is a range of instruments that inflict punishments
as well as provide incentives. These devices are
employed to channel/ control the conduct of scientists
involved in the field of HESC research. They will
promote the regulatory purposes and the framework
has a spectre of punishment in the background. A
regulatory architecture that comprises a collective mixof regulatory instruments leads to regulatory
effectiveness, as argued by Brownsword.
Accordingly, in nations which are contemplating
regulating the controversial HESC research, the designof the regulatory framework based on Braithwaite’s
responsive regulatory model, comprising the twopyramids, is recommended for adoption. They could
consider the various specific provisions of theAustralian regulatory framework on cloning and stem
cell research and its strict regulatory regime is an
excellent model for other countries to emulate.
References
Allan, Sonia. (2010) ‘Regulatory Design Strategies andEnforcement Approaches for Research Involving Human
Embryos and Cloning in Australia and the United
Kingdom- Time for a Change’, Sydney Law Review, Vol.
32, No. 617 pp.617-644.
Ayres, Ian & Braithwaite, John. (1992) Responsive
Regulation, Oxford: Oxford University Press.

21

Kirby explains that countries that have been mostsuccessful in responding to HIV/ AIDS are those thathave observed this important point.

Braithwaite, John. (1990-1991) ‘Convergence in Model ofRegulatory Strategy’, Current Issues Criminal Justice Vol2, pp. 59-65.
Braithwaite, John. (2006) ‘Responsive Regulation andDeveloping Economies’ World Development Vol 43,
pp.884-898.
Braithwaite,John.
(2008)
Regulatory
Capitalism,
Cheltenham, Edward Edgar Publishing.
Brownsword, Roger. (2004) ‘Regulating Human Genetics:
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Vol 12, pp.14-39.
Brownsword, Roger. (2008) Rights, Regulation andTechnological Revolution Oxford, Oxford University Press.
Brownsword, Roger and Somsen, Han (2009), ‘Law,
Innovation and Technology: Before We Fast Forward - A
Forum for Debate’ Law, Innovation and Technology Vol 1,
pp 3-73.
Devaney, Sarah. (2013) Stem Cell Research and theCollaborative
Regulationof
Innovation.
London:Routledge.
Fukuyama, Francis. (2002) Our Posthuman Future New
York, Picador.
Human Cloning: Scientific, Ethical and Regulatory Aspects of
Human Cloning and Stem Cell Research (2002).
Kirby, Michael. (2008) ‘New Frontier’ in Roger Brownsword &Karen Yeung (eds), Regulating Technologies Oxford, Hart
Publishing.
Mascini, Peter. (2013), ‘Why was the Enforcement Pyramidso Influential? And what price was paid?’ Regulation &Governance, Vol 7, pp 48–60.
Ross, John. (2015) ‘One Step Back, 10 steps forward forStem Cells’, The Australian.

American
UniversityofSovereign Nations celebrates

http://www.ausn.info

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Shaping Genes: Ethics, Law and Science of Using Genetic Technology in Medicine and Agriculture
by Darryl Macer, Oct. 1990, 421pp.
NZ$50
Equitable Patent Protection in the Developing World
by William Lesser, May 1991, 150pp.
NZ$40
Attitudes to Genetic Engineering: Japanese and International Comparisons (Bilingual)by Darryl Macer, May 1992 330pp.
NZ$40
Human Genome Research & Society
Eds: Norio Fujiki & Darryl R.J. Macer July 1992
ISBN 0-908897-03-0 (English), 230pp. ISBN 0-908897-04-9 (Japanese), 240pp.
NZ$40
Intractable Neurological Disorders, Human Genome Research and Society Eds: N. Fujiki & D. Macer
Feb. 1994 ISBN 0-908897-06-5 (English), 320pp. ISBN 0-908897-07-3 (Japanese), 340pp.
NZ$40
Bioethics for the People by the People by Darryl Macer,... May 1994 ISBN 0-908897-05-7, 460pp.
NZ$50
Bioethics in High Schools in Australia, Japan and New Zealand,
by D.Macer, Y.Asada, M.Tsuzuki, S.Akiyama, & N.Y.Macer March 1996, ISBN 0-908897-08-1, 200pp.(A4) NZ$50
Protection of the Human Genome and Scientific Responsibility (English and Japanese Bilingual)
Editors: Michio Okamoto, Norio Fujiki & D.R.J. Macer, April 1996, ISBN 0-908897-09-X, 210pp.
NZ$40
Bioethics in India Eds: Jayapaul Azariah, Hilda Azariah & Darryl R.J. Macer
June 1998 ISBN 0-908897-10-3, (includes 115 papers) 403 pp. (Printed in India)
NZ$60
Bioethics is Love of Life: An alternative textbook
by Darryl Macer, July 1998 ISBN 0-908897-13-8, 152pp.
NZ$40
Bioethics in Asia Eds: Norio Fujiki & Darryl R.J. Macer,(includes 118 papers from Nov.1997 conferences, ABC’97 Kobe and Fukui Satellite)
June 1998 ISBN 0-908897-12-X, 478 pp. October 1999 ISBN 0-908897-14-6 (Japanese), 320pp.
NZ$50
Ethical Challenges as we approach the end of the Human Genome Project
Editor: Darryl Macer, April 2000 ISBN 0-908897-15-4, 124pp.
NZ$40
Bioethics Education in Japanese High Schools (in Japanese only)
Editor: Darryl MacerApril 2000 ISBN 0-908897-16-2, 112pp.
NZ$40
st
Bioethics and the Impact of Human Genome Research in the 21 Century
Eds: Norio Fujiki, Masakatsu Sudo, & D.R.J. Macer March 2001 (English and Japanese bilingual, 350pp). NZ$50
st
Bioethics in Asia in the 21 Century
Eds: Song Sang-yong, Koo Young-Mo & Darryl R.J. Macer
August 2003 ISBN 0-908897-19-7, 450pp.
NZ$50
Challenges for Bioethics from Asia Ed: Darryl R.J. Macer November 2004 ISBN 0-908897-22-7 656 pp. NZ$70
A Cross Cultural Introduction to Bioethics, Editor: Darryl Macer 2006, 300pp. (A4)
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