Download Ethical and Legal Problems

Ethical and Legal Problems of
Transplantation and Transfusion.
Surrogacy. Ethical problems of
genetic engineering
technologies.
Organ
donation
• Organ donation is
the donation of
biological tissue or
an organ of the
human body, from
a living or dead
person to a living
recipient in need
of a
transplantation.
Deontological issues
• Certain groups oppose
organ donation on
religious grounds, but
most of the world's
religions support donation
as a charitable act of great
benefit to the community.
Issues surrounding patient
autonomy, living wills, and
guardianship make it
nearly impossible for
involuntary organ
donation to occur.
The use of cloning to produce organs
• The use of cloning to produce organs with an
identical genotype to the recipient has issues all its
own. Cloning is still a controversial topic, especially
considering the possibility for an entire person to be
brought into being with the express purpose of
being destroyed for organ procurement.
• While the benefit of such a cloned organ would be a
zero-percent chance of transplant rejection, the
ethical issues involved with creating and killing a
clone may outweigh these benefits.
Ethics In Xenotransplantation
• Transplantation represents a highly successful means
of treating a variety of human illnesses.
• Xenotransplantation, the transplantation of organs,
tissues or cells from one species to another, if
applied to man, would offer the possibility of a huge
supply of organs, tissues and cells for transplantation
thereby relieving the “chronic” shortage of human
donor.
• There is the need to minimize the likelihood of the
introduction of new infectious agents into the
human population via the transplant.
The Health Risk
• Risk – understood as an unwanted or
damaging future event, the actual occurrence
of which is not certain but possible – is
defined by means of two characteristics: the
level of probability and the extent of damage.
• The probability of the occurrence of a certain
damaging event in particular circumstances
can be expressed as a risk percentage or as a
statistical frequency.
Acceptability of the risk
• Probability and extent of damage – define the
acceptability of the risk, as reflected by the
risk/benefit ratio.
• Only when a risk can be concretely assessed it
is possible to apply criteria for evaluating its
acceptability.
Informed consent for xenotransplantation
• In the ethical discussion on xenotransplantation, the
subject of informed consent also deserves special
attention. Given the animal source of the organs
which will be transplanted, this issues concerns only
the recipient and, secondly, his relatives.
• At the outset the recipient should be given every
information regarding his pathology and its
prognosis, the xenotransplant operation and
subsequent therapy, and the probability of success
and the risks of rejection.
Principle of heart transplantation
Patentability and
xenotransplantation
• Research on xenotransplantation has hitherto in
large measure been carried out largely by private
pharmaceutical companies which have committed
substantial economic resources to this endeavour;
they have also been providing financing to public
institutions for the purpose of obtaining better
therapeutic results.
• It is therefore reasonable for them to expect an
economic return on the investment made; one of
the possible ways to do this is by acquiring patents.
Possibility of patenting living beings
• There is a difference between a “discovery” (which
cannot be patented) and an “invention” (which can
be patented).
• Although it is our view that the transgenic animal as
such – and all the more when they are used for
transplantation into man – should be considered
“nonpatentable”, we nonetheless believe that it is
not the purpose of present document to address
this complex question directly.
Donation after death
• The laws of different countries allow potential
donors to permit or refuse donation, or give
this choice to relatives. The frequency of
donations varies among countries.
• There are two main methods for determining
voluntary consent: "opt in" (only those who
have given explicit consent are donors) and
"opt out" (anyone who has not refused is a
donor).
Donation rates and legislation
• Register of Organ Donation and Transplantation
shows Spain, Belgium, France, and Italy — which all
have "presumed consent" laws on organ donation,
where everyone is considered a donor unless they
specify otherwise — in the top in the top five.
• In contrast the USA — which practices an "opt in"
consent law where their citizens provide express and
informed agreement to donate organs and tissues in
the event of their death — is also in the top five
ahead of many other countries that are "opt in".
Deontological issues
• From the standpoint of deontological ethics,
the primary issues surrounding the morality
of organ donation are semantical in nature.
The debate over the definitions of life, death,
human, and body is ongoing.
• For example, whether or not a brain-dead
patient ought to be kept artificially animate in
order to preserve organs for procurement is
an ongoing problem in clinical bioethics.
The use of cloning to produce organs
• The use of cloning to produce organs with an identical
genotype to the recipient has issues all its own. Cloning is still
a controversial topic, especially considering the possibility for
an entire person to be brought into being with the express
purpose of being destroyed for organ procurement.
• While the benefit of such a cloned organ would be a zeropercent chance of transplant rejection, the ethical issues
involved with creating and killing a clone may outweigh these
benefits. However, it may be possible in the future to use
cloned stem-cells to grow a new organ without creating a
new human being.
Ethical dilemmas in blood transfusion in Jehovah’s
Witnesses
• It is common knowledge that JWs do not accept blood
transfusion, even if life is threatened. This refutation is
supported in the biblical texts Genesis and Leviticus, which
recommend the faithful to abstain from meat for considering
that it has a soul, and that the assimilation of blood in the
organism by the mouth or the veins would violate Godís law.
• The JWs affirm that the human beingís soul lies in the blood
and, as such, it cannot be passed on to another person. If
that happened, the adept would disobey the commandment
of loving God with all his or her soul.
Alternative hemotherapies
• The ethical dilemmas involving healthcare to JWs can be
solved by means of alternative hemotherapies or by
transferring such a person to a CLH (Commissions for Hospital
Relations) in Brasil.
• If any of these procedures are impossible, there is an
apparent collision between the fundamental right to life and
the fundamental right to freedom of conscience and belief,
which will force the professional to decide in favor of the
prevalence of the personís dignity as the limit and base for
other rights.
The ethics of blood management
• Blood transfusion practices have evolved empirically, with few
or no research data supporting them. In the past several
decades, fuelled by fears of infection and reports of mistakes,
patients have increasingly demanded their rights to choice,
both in the components given to them as well as to refuse to
receive these therapies based on religious convictions.
• In parallel, episodic blood unavailability and growing
awareness of the need to apply evidence-based methods
have caused physicians to begin re-evaluating traditional
practices and to focus on minimizing or eliminating
unnecessary transfusions while learning and applying
methods that permit reuse of the patient's autologous blood
or rely on pharmacologic agents.
The Moral Status of
the Early Embryo
 The zygote or fertilized egg not
only contains the plan or
blueprint for a new human
being, but it has the potential
within itself to develop into that
human being. Based on these
facts, many would argue that the
zygote is a full human being from
the moment it comes into
existence. This view would
preclude any research that might
be harmful or destructive to an
embryo, unless intended to be
therapeutic for that embryo or to
improve its chances for
implantation.
Fertilization of egg
 It is possible to hold this position while acknowledging
that fertilization is a process rather than an
instantaneous event, and hence that the new human
life begins only when the process of fertilization is
completed. At least two possible candidates marking
the completion of fertilization have been suggested.
 The first is the time of syngamy, when the
chromosomes from the male and female gametes
unite to form the genotype of the embryo. Since
syngamy is not completed until about twenty-four
hours after the sperm penetrates the egg, this view
would allow some study of the early development of
the embryo.
Six- to eight-cell stage
 The embryo does not begin its life as a new human
being until the regulation of its development switches
from oocyte genes to embryonic genes. In 1988 Peter
Braude and colleagues showed that this occurs at the
six- to eight-cell stage, approximately two days after
penetration of egg by sperm.
 Arguably the embryo begins its own life distinct from
that of the oocyte at the time that its own internal
regulatory mechanism begins to function. This
interpretation would allow investigation of questions
such as why a large proportion of embryos are arrested
in their development during the earliest cell divisions
Moral status
• The human body occupies a unique and
somewhat ambiguous moral status. Although
material, and therefore a source of
temptation, the body is nevertheless
sacrosanct because it is indispensable to
human life.
• God is thought to have a divine plan for
humanity, and any attempt to subvert this
plan by tinkering with the human body is
regarded as at least prima facie wrong.
Surrogate motherhood
 Among the many applications of the new reproductive technologies
(including artificial insemination by donor—AID, in vitro
fertilization—IVF, embryo transfer, and embryofreezing) surrogate
motherhood has such far-reaching consequences that it raises a
multitude of ethical and legal questions.
 There are several reasons why a couple might choose to have a
child through a surrogate. Infertility is a common reason. With
approximately 15 to 20 per cent of all couples infertile and a
decrease in adoptable babies, many argue that surrogate
motherhood provides a unique opportunity for certain couples to
have a child biologically related to the husband. Other reasons
range from the desire to avoid passing on a genetic defect to
convenience.
Motivation
 What is the motivation for choosing to enter a
surrogate arrangement? There are several
reasons why a couple might choose to have a
child through a surrogate. Infertility is a common
reason. With approximately 15 to 20 per cent of
all couples infertile and a decrease in adoptable
babies, many argue that surrogate motherhood
provides a unique opportunity for certain couples
to have a child biologically related to the
husband.
 Other reasons range from the desire to avoid
passing on a genetic defect to convenience. Many
ethical analyses draw a sharp distinction between
these motivations.
The degree of stress
 What is the degree of stress on the couple and
especially on the surrogate mother? Can true
informed consent ever be given by the surrogate, and
can anyone predict the emotions associated with
relinquishing a child? What are the possible adverse
psychological effects on the child? What identity crisis
might ensue, and will there be a desire on the part of
the child to know his/her gestational mother?
 Will surrogate arrangements be used not only by
infertile couples but also for the sake of convenience,
or by single men or women? Should the surrogate be
paid? Would this lead to commercialization of
surrogacy and expose the surrogate mother to possible
exploitation?
Ethical considerations of the new
reproductive technologies
 The American Fertility Society issued a report,
Ethical Considerations of the New Reproductive
Technologies, setting forth the then-held ethical
position of the Society on the various new
reproductive technologies. In 1987, the
Congregation for the Doctrine of the Faith issued
the Instruction on the Respect for Human Life
and Its Origin and on the Dignity of Procreation.
 While both documents state that very similar
moral criteria were used to derive ethical
positions with respect to various reproductive
procedures, the conclusions as to the ethical
acceptability of the various procedures differ
sharply in the two documents.
Catholic statements
 While the difference in conclusion from similar
premises may be troubling to society, it can be
especially paralyzing to four groups:
 (1) those who face problems that might be solved by
one or another of the new reproductive technologies;
 (2) those who are involved in applying them;
 (3) those who are responsible for institutional policies
where such techniques may be applied; and
 (4) those who are in a position to influence public
policy in a legislative or regulatory way. Because of the
conflicting conclusions of the two documents, the
present Ethics Committee (1986-87) of The American
Fertility Society was convened and considered these
Assisted reproductive technologies in Ukraine
• Ukraine is one of a few countries in the world
where appliance of majority of assisted
reproductive technologies, especially
surrogacy, is absolutely legal. In this sphere
Ukrainian legislators have proven to be more
progressive than the main part of their
European colleagues.
The Family code of Ukraine
 Item 1. If the wife is fertilized by artificial
procreation techniques upon written consent of
her husband, the latter is registered as the father
of the child born by his wife.
 Item 2. If an ovum conceived by the spouses
(man and woman) is implanted to another
woman, the spouses shall be the parents of the
child.
 Item 3. Whenever an ovum conceived by the
husband with another woman is implanted to his
wife, the child is considered to be affiliated to the
spouses.
Basis of legislation of Ukraine about
health care
• Artificial fertilization and embryo implantation
are performed according to conditions and
order, prescribed by the Ministry of Health
Care of Ukraine, for medical grounds of
women of age, which undergoes this
procedure upon written consent of spouses,
anonymity of donor and medical secrecy.
Rules of civil registration in Ukraine
 Order of child registration is regulated by the Decree of the
Ministry of Justice of Ukraine No. 140/5 from November
18, 2003 “About amendments and additions to Rules of
civil registration in Ukraine:
 Item 2.2. In case of child birth by the woman who was
implanted by fetus, conceived by the spouses, the child is
registered upon the declaration of spouses, who gave their
consent for implantation. In this case together with the
document, confirming the fact of child birth, the woman
has to provide notarized written consent for registration
spouse as legal parents of the child. Thereby, there is a
certain note in column “For notes”: “The citizen (surname,
name, patronymic) is the mother of the child according to
medical birth certificate of 103/о-95(z0266-95) form.”
Civil Code of Ukraine
• Civil Code of Ukraine (as amended from
January 21, 2010 No. 1822-VI) regulates who
has the right to participate in assisted
reproductive programme:
• Article 281. Women or men of full age are
entitled to have been cured with assisted
reproductive technologies in accordance with
their medical indications in order, prescribed
by the law.
Approval of order manual of appliance
of assisted reproductive technologies
• Subparagraph 3 of item1. Certified medical
institutions are entitled to perform artificial
fertilization.
• Subparagraph.4 of item 1. Patients are
entitled to freely choose a medical institution
for ART treatment.
• Subparagraph 6 of item 1. ART are applied
according to medical indications upon written
free consent of patients and Statement of a
patient/patients of ART appliance.
Approval of order manual of appliance
of assisted reproductive technologies
 Subraragraph 7 of item. 1. Woman and/or man of
full age upon their medical indications are
entitled to apply to ART treatment according to
article 281 of Civil Code of Ukraine.
 Subparagraph 5.1. Donation of gametes is a
procedure, during which, according to written
voluntary consent, donors grant their germinal
cells – gametes (sperm, oocytes), or embryos for
use in infertility treatment by other persons.
 Subparagraph 5.2. Donors of gametes can not
undertake parental rights towards a future child.
Oocyte donors
•
•
•
•
Subparagraph 5.5. Oocyte donors can be:
female acquaintances and relatives;
anonymous voluntary donors;
patients of ART programmes, who according
to written voluntary consent give part of their
oocytes to recipient.
Requirements for oocyte donors
 Subparagraph 5.6. Requirements for oocyte donors:
 woman in age from 20 to 32;
 presence of a born healthy child;
 absence of negative phenotypic manifestations;
 satisfactory somatic health;
 absence of medical contra-indications for oocyte
donation;
 absence of hereditary diseases;
 absence of harmful habits: drug addiction, alcoholism,
toxic substances abuse.
List of necessary documents for oocyte donation
 Subparagraph 5.10. List of necessary documents for
oocyte donation:
 agreement with the oocyte donor, voluntary written
informed consent for participation in donation,
controlled stimulation of ovulation and oocyte
retrieval;
 statement of a written consent of husband.
 Subparagraph 7.4. A healthy woman of full age, who
gave birth to a healthy child upon her written free
consent and absence of medical contra-indications, is
entitled to perform surrogacy.
A child born by a Surrogate are foreign citizens
 Subparagraph 7.10. If parents of a child born by a
Surrogate are foreign citizens they shall inform the
address of their residence before processing of
documents and departure from country for patronage
by specialists-pediatrics and for supervision.
 Subparagraph 7.11. Registration of a child born
through ART by means of surrogacy is conducted
according to the order set by the current legislation of
Ukraine at the presence of a certificate of genetic
relationship of parents (mother or father) with a child.
Human gene transfer research
• Human gene transfer research (HGTR) involves the
deliberate transfer of genetic material (naturallyoccurring, genetically-modified, or synthetic DNA or
RNA) into human subjects.
• Clinical success has come more slowly than was first
predicted, but HGTR remains a fundamentally novel
approach to medical practice. It may one day enable
clinicians to cure genetic disorders at their source, as
well as provide oncologists with tools designed to
disable or cure specific cancers.
Clinical Successes and Setbacks
• In March 2000 Katherine A. High and Mark A.
Kay reported that subjects with hemophilia B
experienced an increase in factor IX protein
activity for at least six months after the gene
transfer.
• Yet this long awaited clinical progress has
been tempered by setbacks. In December
2002 a subject in the hemophilia-B study
developed signs of liver injury, halting the
trial.
Ornithine transcarbamylase (OTC) deficiency
• Gelsinger was affected by ornithine transcarbamylase
(OTC) deficiency. Patients with OTC deficiency lack an
enzyme needed for processing nitrogen with the result
that toxic levels of ammonia accumulate in their
bloodstreams, leading to severe mental impairment
and even death. But Gelsinger’s symptoms were
manageable so that, unlike subjects in other gene
transfer trials, he approximated a healthy volunteer.
• The viral vector used in this protocol was an
adenovirus—a virus that usually causes the common
cold. Although used in many protocols prior to
Gelsinger’s death, in his case the vector triggered a
deadly immune response.
Public Oversight of Human Gene
Transfer Research
• HGTR is overseen in the United States by two
agencies within the Department of Health and
Human Services: the NIH and the Food and
Drug Administration (FDA).
• While FDA review is “public” insofar as it
involves federal oversight, NIH review through
the Recombinant DNA Advisory Committee
(RAC) is truly a forum open to the public.
Early concerns about “genetic
engineering
• Serious debate about human gene transfer began in the
1960s, when scientists, theologians, and philosophers raised
many concerns about genetic engineering, or genetic
manipulation. Theoretical concerns evolved into real
possibilities in 1972 when scientists discovered how to
combine genetic material from different organisms.
• One of the most important outcomes of these events was the
1982 publication of Splicing Life, a report on human gene
transfer issued by the President’s Commission for the Study of
Ethical Problems in Medicine and Biomedical and Behavioral
Research. The commission argued that only transfer into
somatic tissues to prevent or treat disease could be justified.
Ethical issues in human gene transfer
research
• Early ethical and social concerns surrounding
HGTR were outlined in 1985 in the NIH’s “Points
to Consider.”
• Since then, broader public and commercial
contexts of HGTR have raised additional
concerns, especially involving subject recruitment
and economic conflicts of interest. These issues
become increasingly important as HGTR moves
toward new applications and methods.
Fundamental ethical conditions which must be respected
• 1. Concern for the well-being of genetically-modified animals
should be guaranteed;
• 2. The effects on the offspring and possible repercussions for the
environment should be considered;
• 3. Such animals should be kept under tight control and should not
be released into the general environment;
• 4. The number of animals used in experiments should be kept to a
bare minimum;
• 5. The removal of organs and/or tissues must take place during a
single surgical opera-tion;
• 6. Every experimental protocol on animals must be evaluated by a
competent ethics committee.
History of gene-transfer
• Almost 20 years since the first gene-transfer trial was carried out in
humans, the field has made significant advances towards clinical
application.
• Nevertheless, it continues to face numerous unresolved ethical
challenges — among them are the question of when to initiate human
testing, the acceptability of germline modification and whether the
technique should be applied to the enhancement of traits.
• .
Arguments in Favor of Gene Transfer Research
1) germ-line gene transfer offers a true cure, and not simply
palliative or symptomatic treatment;
2) germ-line gene transfer may be the only effective way of
addressing some genetic diseases;
3) by preventing the transmission of disease genes, the expense
and risk of somatic cell transfer for multiple generations is
avoided;
4) medicine should respond to the reproductive health needs of
prospective parents at risk for transmitting serious genetic
diseases;
5) the scientific community has a right to free inquiry, within the
bounds of acceptable human research.
Arguments Against Gene Transfer Research
1) germ-line gene transfer research would involve too much scientific
uncertainty and clinical risks, and the long term effects of such
research are unknown;
2) such gene transfer research would open the door to attempts at
altering human traits not associated with disease, which could
exacerbate problems of social discrimination;
3) as germ-line gene transfer involves research on early embryos and
effects their offspring, such research essentially creates generations of
unconsenting research subjects;
4) gene transfer is very expensive, and would never be costeffective
enough to merit high social priority; and
5) germ-line gene transfer would violate the rights of subsequent
generations to inherit a genetic endowment that has not been
intentionally modified
The difficulty of following up with patients in
long-term clinical research
• Other commentators have pointed to the
difficulty of following up with patients in longterm clinical research (III. Ledley 1993).
• Some are troubled that many gene transfer
candidates are children too young to
understand the ramifications of gene transfer
research.
Potential conflict of interest problems
• Others have pointed to potential conflict of
interest problems—pitting an individual's
reproductive liberties and privacy interests, on
the one hand.
• Against the interests of insurance companies, or
society on the other—not to bear the financial
burden of caring for a child with serious genetic
defect. Issues of justice and resource allocation
have also been raised: in a time of strain on our
health care system, can we afford such expensive
research?
Human genome project
• Progress in molecular biology has enabled us to
better understand human genetic disease, and
has helped enhance the quality of life. This has
been possible with technical developments to
detect genetic disease presymptomatically.
• Presymptomatic testing would not yield
information about the carrier status of an
individual but also about other family members.
Such information may lead to unreasonable
beliefs and could alter social relationships.
Medical Prospects
• The sequencing of the entire genome has already had a
profound impact on the wider spectrum of clinical
research, as it opens a new horizons for not only
treatment of diseases but looking at the most
fundamental causes of diseases. Already the genes for
many diseases including for example, various cancers,
Alzheimer’s disease, and polycystic kidney disease,
have been identified.
• Genomic sequencing allows rapid and accurate
diagnosis for individuals. Initially the sequencing of
human genome has led to a shift towards preventive
medicine rather than curative, because further
research is needed to develop therapies.
Scientific Prospects
• One of the ideals of science is freedom for selfunderstanding. The influence of Human Genome
Project on human self-understanding has been
heralded as revolutionary. The sequencing of the
genome will provide new clues on how we
evolved.
• It would help us to understand what it means to
be a human from different historical perspectives
of bioarchealogy, anthropology, evolution, and
human migration.
Agricultural Prospects
• Genetically-Modified Organisms (GMOs) are
already a hot topic in agriculture and livestock
breeding. GMOs are organisms with genes
modified for one or the other trait. We now have
plants that are insect resistant, disease resistant,
drought and cold resistant.
• We have farm animals that are healthier, more
productive and disease resistant. Other plants
and animals that are genetically modified include
ones that incorporate vaccines in an edible form,
or deliver hormones.