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Abstract

Various successes in regenerative medicine by therapeutic cloning have given rise to expectations that treatments will soon be developed for incurable diseases. But using embryonic stem cells for this purpose raises many ethical dilemmas including those about the beginning of human life. Arguments concerning stem cell research and therapeutic cloning in different countries are influenced by both the religious and bioethical traditions which dominate in these cultures. This article examines how these traditions have influenced stem cell research in Iran through an account of scientific advances and the development of regulations on embryonic stem cell research in Iran.
Indian Journal of Medical Ethics Vol V No 4 October-December 2008
[ 181 ]
Abstract
Various successes in regenerative medicine by therapeutic cloning
have given rise to expectations that treatments will soon be
developed for incurable diseases. But using embryonic stem cells
for this purpose raises many ethical dilemmas including those
about the beginning of human life. Arguments concerning stem
cell research and therapeutic cloning in different countries are
influenced by both the religious and bioethical traditions which
dominate in these cultures. This article examines how these
traditions have influenced stem cell research in Iran through an
account of scientific advances and the development of regulations
on embryonic stem cell research in Iran.
Introduction
Ethics, religion and culture intersect at one of the most divisive
scientific issues: embryonic stem cell (ESC) technology.
Reports published in November 1998 by US scientists regarding
their success in isolating and cultivating ESC lines (1, 2), caused
an intense debate on the ethical, social and legal implications
of human ESC research in many countries, one that continues
today. Recent debates have focused on “therapeutic cloning”
which holds out the promise of life-changing treatments and
possible cures for many degenerative diseases, including
Alzheimer’s, Parkinson’s, diabetes, and cardiomyopathies (3).
Proponents and opponents of therapeutic cloning argue about
the best and worst case scenarios and the ethical, religious and
cultural implications of this scientific breakthrough. Some call
it the beginning of the end, and others hail its potential for
saving lives. However, different communities have expressed
different opinions at the national and international levels.
For reaching international consensus on the ESC debate, it is
necessary to understand specific national arguments (4) and
the perspectives of different cultures and traditions regarding
ESC technology. It is the intention of this paper to provide
an overview of ESC research in Iran, which has assumed a
leadership role in this area in the Middle East, to outline the
ethical arguments that are central to this debate, and to identify
the ethical reasoning underlying the approval of ESC research
in Iran.
The development of ESC research in Iran
Iran has a long history of scientific achievement. Prior to the
advent of Islam, it was a leader in mathematics and astronomy.
However, like the rest of the Middle East, its scientific power
CoMMent
Embryonic stem cell research in Iran: status and ethics
MANSOOREH SANIEI1, RAYMOND DE VRIES2
1Erasmus Mundus Master of Bioethics Fellow, Departmento di Filosofia, Universita Degli Studi di Padova, Piazza Capitaniato 3, 35100 Padova, ITALY
email: saniee50@yahoo.com 2 Bioethics Program, University of Michigan, School of Medicine, 300 North Ingalls Street, Rm 7C27 Ann Arbor, MI 48109-0429 USA
e-mail: saniee50@yahoo.com
declined as Europe entered the Renaissance period in the early
1300s. Over the next several hundred years, Iran developed
slowly and was unable to reach its full potential scientifically
(5). It is now starting to invest heavily in science, and major
developments are occurring in ESC research with the full
support of the government.
In 2002, Iran’s supreme leader, Ayatollah Khamenei, publicly
supported human embryo research and congratulated the
scientists who had produced the stem cells. Iran’s clerics and
political leaders have also actively promoted science and
technology in an attempt to enhance the country’s global
status (6). According to Iran’s Shi`ite religious authorities
(the Grand Ayatollahs), stem cell research and therapeutic
applications are permissible only in the pre-ensoulment
stages of foetal development (7). Due to these positive
decrees (religious opinion about whether or not an action is
permissible) on the use of ESCs for research and therapeutic
purposes, Iran is one of the first Muslim countries to produce
ESCs (8).
The Royan Institute, one of the leading institutes for stem cell
research in Iran, has expanded its work in investigating the
potential for ESCs to differentiate into various cell types, such
as cardiomyocytes, __cells and neural cells (9). At the same time
other research institutes are involved in regenerative medicine.
These include the Iranian Molecular Medicine Network (with 34
research institutes and centres as members), the Iran Polymer
and Petrochemical Institute, and Shaheed Beheshti University
of Medical Sciences (10, 11). The main goal of this research is
to understand human cell specialisation and developmental
biology and to create specialised cells to treat a wide range of
diseases and conditions (12).
In 2003, the Royan Institute reported the establishment of Iran’s
first human ESC line named Royan H1 (“royan” in Persian means
“embryo”) from a blastocyst (9). With this achievement, Iran
became the 10th country in the world capable of producing,
cultivating and freezing human ESCs (13). Since 2004, scientists
at the Royan Institute have established five human ESC lines,
named Royan H2 to Royan H6. Royan H2, H5 and H6 had the
normal (46,XX and 46,XY) karyotypes and Royan H3 and H4
had the triploid (69,XXY) karyotypes which can differentiate in
vitro to a variety of cell types (12). This achievement, although
not a breakthrough on its own, has enabled scientists to pursue
many avenues of research in generating therapeutic cells from
these cells (5). For example, recent activities have centred on
Indian Journal of Medical Ethics Vol V No 4 October-December 2008
[ 182 ]
differentiating human ESCs into endocrine pancreatic-like cells,
hepatocyte-like cells, and so on (14, 15, 16).
In the last few years, other fields of stem cell technology
have also progressed in Iran, such as bone marrow stem
cell transplantation in the hematopoietic disorders, for
chronic myelogenous leukaemia and thalassaemia major
(17, 18), multiple sclerosis (19), advanced liver cirrhosis,
myocardial infarction (20, 21), and peripheral blood stem cell
transplantation for thalassaemia major (22). They are the results
of activities in, and collaboration between, research centres
where the stem cells were prepared and clinical centres where
the patients were selected, treated, and followed.
The rapid progress in stem cell technology forced the
government to put in place appropriate ethical and scientific
supervision of stem cell research and therapeutic applications
to make sure that these advances are used responsibly, fairly
and humanely. In 2005, the Ministry of Health and Tehran
University of Medical Sciences jointly developed a set of
guidelines regarding research on gametes and embryos which
permitted the use of human embryos for stem cell research and
therapy under certain circumstances (7, 23, 24). According to
these guidelines, National and Regional Ethical Committees in
universities and research centres should supervise ESC research
and therapeutic cloning adhering to these guidelines as well as
the Ethical Guidelines for Genetic Research (7). The principles
behind the Ethical Guidelines for Gamete and Embryo Research
are given in brief below:
1. Respect for human dignity and human rights
2. Voluntary and informed participation in research which will
not affect the patient’s treatment
3. Respect for privacy and confidentiality
4. Equitable distribution of benefits and harms, especially in
research, includes clinical treatment
5. Minimisation of risk for the embryo or the future child and
maximisation of benefit for individuals and society
6. Prohibition of the production of hybrids using humans and
animals
7. Prohibition of eugenics
8. Prohibition of the production of human embryos for
research purposes
9. Use of only surplus IVF embryos, below 14 days, for research
which includes destruction of the embryo
10. Responsible persons for the embryo are the donor, her
partner and recipients
11. All information regarding research and clinical cares of the
embryo is available to responsible persons.
However, Iran’s approach is currently based on guidelines, not
parliamentary legislation (24) and the guidelines are still open
for public examination and debate.
Ethical arguments
Most scientists believe that stem cell research will lead to
stem cell-based therapies only if scientists can derive new ESC
lines. ESCs are needed since their ability to live indefinitely in
tissue culture and the wide range of cell types to which they
give rise make them unique. Therefore, the most important
ethical problem regarding the source and use of ESCs is the
moral status of the human embryos which are used to derive
stem cell lines. This moral problem brings into tension two
fundamental moral principles that we highly value: the duty
to respect the value of human life and the duty to prevent or
alleviate suffering (25). Now, the question is: shall we destroy
one life to save another one or should we ignore the potential
of life-saving treatments out of respect for the potential life
of the embryo? For the protection of human life and dignity,
we should first determine when life begins and the foetus is
considered a person.
Scientists’ point of view
Scientists, respecting scientific evidence and ethical reasoning,
have argued for using human ESCs for treatment, saying that
the risks outweighed the benefits. They have stated that, first,
ESCs gave hope of treatment or cure for many diseases. Second,
the embryos they would work on would be at a very early stage
of development. Third, ethics bodies already allow research
on embryos up to 14 days for the improvement of IVF (26).
Finally, ESC research provides a new tool for basic science, with
broad potential applications in genetics and developmental
biology (27). From this viewpoint, early embryos have little
moral significance. Therefore, there is not sufficient reason
not to proceed with treating embryos as a research resource.
Some ethicists have presented a utilitarian argument, that if
the products of ESC research might potentially treat diseases
such as Alzheimer’s, or prevent the birth of disabled children,
the decision weighed more heavily in favour of proceeding
than not proceeding (28). Of course, this is not a strong ethical
argument in itself.
Opponents are concerned about the “slippery slope” of this
debate, which is that devaluation of human embryos at
the very beginning of their life would encourage a policy
of sacrificing the vulnerable for the benefit of others. The
instrumental use of embryos may increase society’s toleration
for the loss of life and also make it easier for society to accede
to currently more controversial practices involving the ending
of life. This, in turn, could put persons with disabilities and the
aged at risk (29). According to this argument, even if we do not
regard research on embryos as wrong, it may still open the way
to dehumanising practices such as embryo farms, “reproductive
cloning”, “designer babies”, the use of foetuses for spare parts,
and the commodification of human life (30, 31).
This is a powerful critique - that research on embryos could
lead to completely objectifying and commodifying human
life. In addition, the religious critique questions when human
life begins - at conception, at 14 days, at viability, or at the
development of consciousness (32). The debate on research
involving human embryos, abortion and IVF existed from the
late 1970s, but human ESC research introduced subtle but
Indian Journal of Medical Ethics Vol V No 4 October-December 2008
[ 183 ]
important changes into this ongoing debate. However, ethics,
religion and culture rightly or wrongly feel threatened by new
knowledge and new technology.
Islamic point of view
In Iran embryo research is influenced by the religious belief
that full human life with its attendant rights begins only after
the “ensoulment” of the foetus (33). Islam is unique among
world religions in that the embryological development of
humans has been extensively discussed and described in the
divine scripture, the Qur`an, and commented on in detail by
Prophet Mohammad and the Imams, exemplary teachers
who are descendents of the Prophet (34). Ensoulment is
generally believed by Muslim scholars to take place at 120
days after conception [although a minority belief indicates
ensoulment takes place 40 days after conception (35).]
However, a majority of the Shi`ite and some Sunni jurists have
exercised caution in making such a distinction[MSOffice1]
because they regard the embryo in the pre-ensoulment stages
as alive and its eradication as a sin. Based on theological and
ethical considerations derived from the Qur`anic passages
that describe the embryonic journey to personhood
developmentally, and the rulings that treat ensoulment and
personhood as occurring over time almost synonymously,
it is correct to suggest that Shi`ite and a majority of Sunni
jurists will have little problem in endorsing ethically regulated
research on stem cells that promises potential therapeutic
value (36, 37).
As mentioned earlier, although Iran currently has no
comprehensive legal framework for research on human
embryos, there are guidelines, namely the Ethical Guidelines
for Gamete and Embryo Research. Article 12 of the guidelines
stresses that generating human embryos for research purposes
is forbidden. Moreover, these guidelines have been provided
for the use of human embryos below 14 days that were created
through IVF techniques, but which are not used in assisted
reproduction treatments (23). It seems that Iran sees human
dignity violated by the generation of embryos exclusively for
research, as the notion of human dignity implies that human
life has intrinsic value independent of the approval and aims
of others. However, those ethical concerns with regard to
intentions and the mode of generating human embryos for
research purposes do not apply to supernumerary embryos.
In 2006, Mohammad Abdur Rab, World Health Organisation
representative in the Eastern Mediterranean, published a paper
that called upon Islamic countries to arrive at a consensus
regarding ESC research. He also pointed out that in 2005, 24
Islamic countries had supported the United Nations Declaration
on Human Cloning prohibiting all forms of human cloning,
while the remaining Muslim countries had abstained or voted
against the declaration (38). This suggests that there are other
issues beyond the influence of religion or science, that permits
new knowledge to be accepted in one country and rejected in
another though both may have the same religious background
and scientific interests.
Although both science and religion are key factors, the full
range of cultural perspectives across countries also drives
legislative decisions on ESC research and human cloning.
Indeed, religion and scientific progress alone cannot define the
debate; other salient issues need to be considered, including
cultural traditions regarding respect for human life, human
dignity, and human rights; attitudes toward regulation of
science; perceptions of the medical and economic values
of therapeutic cloning and balance between individual and
corporate identity (39).
In ancient Persian medicine, health was valued highly, and an
appropriate lifestyle to maintain good health was advocated.
In fact, the maintenance of health and the healing of illness
were two central goals in health and medicine. Ancient Persian
culture valued the accumulation of knowledge and emphasised
the importance of helping others, especially the weak. After
Islam, Persian culture was inspired by Islamic teaching as well
(40). Iran is the only Islamic Republic whose legal system is
founded solely on Shi’ite Islamic law or shari’a, which also
allows democratic representation. Islamic law has historically
been flexible and sensitive to public needs and socio-cultural
realities. The differences in rulings of Shi`ite scholars stem
from the Hadith (the Prophet’s sayings) and are based mainly
on the reliability of the narrators of a particular Hadith, and
its conformity to the verses of the Qur’an to other similar
traditions (32). Moreover, there are two principles invoked by
scholars that have aided this flexibility: Istislah (consideration
of the public good) and Istihsan (seeking an equitable and just
solution), when the logical outcome of a ruling based on shari’a
principles is harsh or impractical in application (32, 41). When
faced with a health crisis on a large scale, scholars can invoke
Istislah and Istihsan in their rulings on medical and health
affairs, rather than considering the question in an isolated or
theoretical sense as was done in the past (32) or even in the
present in some countries.
Conclusion
At the global level, the number of countries that advocate
therapeutic cloning and human ESC research while remaining
opposed to reproductive cloning, is growing. Some countries,
even in the Islamic world, are at the threshold of cutting-edge
research in this area. Indeed, at the cutting-edge field of human
ESC research, Iranian scientists work with broad government
approval and government funding on the potent cells from
early-stage embryos that researchers believe hold the promise
of curing many diseases. Experts provide the inputs of scientific
progress, religious traditions, individual value systems and
concepts of humanity and life in order to reach a responsible
decision. The flexibility of Islamic scholars in Iran has been
promising for scientists in the country. However, while Iran has
dealt with the debates regarding ESC research and the moral
status of the embryo as regards IVF and abortion, it still needs
to get to the roots of the stem cell controversy.
Acknowledgements: This paper is the result of research
performed as part of the educational programme Erasmus
Indian Journal of Medical Ethics Vol V No 4 October-December 2008
[ 184 ]
Mundus Master of Bioethics. We would like to thank Dr Pascal
Borry (Leuven, Belgium), Professor Wim Dekkers, Dr Bert Gordijn
(Nijmegen, The Netherlands) and Professor Corrado Viafora
(Padova, Italy) for helpful suggestions and encouraging support.
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... Over the past few decades, there has been rapid growth in ARTs, stem cell research, and cloning in Iran. For example, Iran was the first Muslim country to create a human embryonic stem cell line (2003) and among the top 10 countries that produced, cultured, and freezed human embryonic stem cells (Aramesh and Dabbagh 2007;Larijani and Zahedi 2004;Saniei 2013;Saniei and De Vries 2008). In addition, new legislations and formal guidelines on assisted reproduction, stem cell research, cloning, contraception, and therapeutic abortion have been passed and announced. ...
... Saniei is another scholar who has published about the Shiite perspectives on the ARTs and the early human embryo, in English (Saniei 2010(Saniei , 2013Saniei and De Vries 2008). In addition to a descriptive picture of the historical developments in this field over the past decades, Saniei provides the results of a qualitative study that shows the importance of the flexibility of Shiite scholars in permitting stem cell research in Iran for the rapid growth of this field in this country (Saniei 2013). ...
... Moreover, mostly influenced by the guideline developed in the Western world, the Iranian National Guideline for Research on Human Gamete and Embryo requires researchers to perform research only on surplus embryos remaining after infertility treatment and forbids producing human embryos just for research purposes (Aramesh and Dabbagh 2007;Larijani and Zahedi 2004). Limiting the use of pre-implantation embryos for research purposes to the surplus embryos remaining from therapeutic IVF procedures is also compatible with the Islamic idea of respect for human life that partially extends to its earliest stages (Fadel 2012;Saniei and De Vries 2008). ...
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Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems, designing and establishing convenient collaborative educational courses at different levels.
... The literature primarily highlights the pivotal role of one person in this regard: Professor Bagher Larijani, one of the former chancellors of TUMS who also founded the Medical Ethics Research Center (MEHRC) in Iran [41]. It is argued that the reason why Professor Larijani was able to successfully lead discussions surrounding medical and biomedical research ethics -which is a potentially sensitive issue in most countries [35,47] -is that not only he is a prominent medical practitioner and leading researcher in Iran but also he came from a highly religious and politically influential family [41].His father was a religious authority and his brothers have always held important decision-making positions in the Islamic Republic of Iran [41]. Therefore, Larijani could use the confidence that Iranian authorities had in him as an opportunity [41] and he played a crucial role in (i) promoting the activities of MEHRC both among the policy-makers in the health system and among the Islamic scholars; and consequently, (ii) developing medical research ethics guidelines in Iran [40]. ...
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