ETHICAL AND LEGAL PROBLEMS OF TRANSPLANTATION AND TRANSFUSION

ETHICAL AND LEGAL PROBLEMS OF TRANSPLANTATION AND TRANSFUSION. SURROGACY. ETHICAL PROBLEMS OF GENETIC ENGINEERING TECHNOLOGIES

 

Bioethical problems are often discussed in legal as well as in moral contexts. Lawyers as well as ethicists are involved with such questions as abortion, euthanasia, and experimentation upon human beings. This is not surprising; the law is seriously concerned with protecting such basic rights as life, bodily integrity, and privacythe rights involved in these ethical questions.

A lot of aspects of bioethics testify that modern scientific and technical revolution must not become a barrier between a doctor and patient, regress, when after the button of device a doctor does not see individuality of patient.

Organs Transplantation in Human Beings

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. Transplantable organs and tissues are removed in a surgical procedure following a determination, based on the donor's medical and social history, of which are suitable for transplantation. Such procedures are termed allotransplantations, to distinguish them from xenotransplantation, the transfer of animal organs into human bodies.

Donation after death

As recently as the late 1960s and early 1980s, irreversible cardiopulmonary failure was the only standard for determining death for purposes of donation after cardiac death.[1] This was replaced by brain death, the irreversible loss of all function, including the brain stem, though donation after cardiac death is a resurgent source for transplantation.[1]

Legislation

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.

United States

Under the law of the United States, the regulation of organ donation is left to states within the limitations of the Uniform Determination of Death Act, the National Organ Transplant Act of 1984, and the United Network for Organ Sharing (UNOS). Each state's Uniform Anatomical Gift Act seeks to streamline the process and standardize the rules among the various states. Many states have sought to encourage the donations to be made by allowing the consent to be noted on the driver's license. Donor registries allow for a central information center for an individual's wish to be a donor.

Europe

Map showing the coverage of 3 international European organ donation associations: Balttransplant, Eurotransplant and Scandiatransplant

Within the European Union, organ donation is regulated by member states. As of 2010, 24 European countries have some form of presumed consent (opt-out) system, with the most prominent and limited opt-out systems in Spain, Austria, and Belgium yielding high donor rates.[7] In the United Kingdom organ donation is voluntary and no consent is presumed. Individuals who wish to donate their organs after death can use the Organ Donation Register, a national database.[8] The UK has recently discussed whether to switch to an opt-out system in light of the success in other countries and a severe British organ donor shortfall.[9]

Japan

See also: Organ transplantation in Japan

The rate of organ donation in Japan is significantly lower than in Western countries.[11] This is attributed to cultural reasons, some distrust of western medicine, and a controversial organ transplantation in 1968 that provoked a ban on cadaveric organ donation that would last thirty years.[11] Organ donation in Japan is regulated by a 1997 organ transplant law, which defines "brain death" and legalized organ procurement from brain dead donors.

India

Organ selling is legally banned in India. Numerous studies have documented that organ vendors have a poor quality of life (QOL) following kidney donation. Live related renal donors have a significant improvement in the QOL following renal donation using the WHO QOL BREF in a study done at the All India Institute of Medical Sciences from 2006 to 2008. The quality of life of the donor was poor when the graft was lost or the recipient died.[12]

Sri Lanka

Organ donation in Sri Lanka was ratified by the Human Tissue Transplantation Act No. 48 of 1987. Sri Lanka Eye Donation Society, a non-governmental organization established in 1961 has provided over 60,000 corneas for corneal transplantation, for patients in 57 countries. It is one of the major suppliers of human eyes to the world, with a supply of approximately 3,000 corneas per year.[13]

Donation rates and legislation

A lists of countries ordered by organ donation ranking created by the International 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". This illustrates that there are many other factors beside legislation that affect donor rates internationally, including hospital processes, public awareness, religion and culture, and road death toll rates, and goes some way to help explain why rates are so low.[original research?][citation needed]

Bioethical issues

Deontological issues

Certain groups, like the Roma (gypsies), oppose organ donation on religious grounds, but most [14] 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.

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.

Further, 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.[citation needed] While the benefit of such a cloned organ would be a zero-percent chance[citation needed] 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.

A relatively new field of transplantation has reinvigorated the debate. Xenotransplantation, or the transfer of animal (usually pig) organs into human bodies, promises to eliminate many of the ethical issues, while creating many of its own.[citation needed] While xenotransplantation promises to increase the supply of organs considerably, the threat of organ transplant rejection and the risk of xenozoonosis, coupled with general anathema to the idea, decreases the functionality of the technique. Some animal rights groups oppose the sacrifice of an animal for organ donation and have launched campaigns to ban them.

Ethics In Xenotransplantation

Transplantation represents a highly successful means of treating a variety of human illnesses. However, the number of transplants performed is limited by a shortage of human organs and tissues. 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.

However, before xenotransplantation becomes a clinical reality, there are practical challenges that must be overcome. One is rejection, the process by which the body of the transplant recipient attempts to rid itself of the transplant. Another is to ensure the correct functioning, across species barriers, of the transplant in its new host. Also, there is the need to minimize the likelihood of the introduction of new infectious agents into the human population via the transplant.

In addition there are concerns about xenotransplantation that require theological, anthropological, psychological and ethical considerations, as well as an examination of legal issues and procedural matters.

 

Bioethical issues Organs Transplantation

Further investigation and clarification is needed for a wider bioethical analysis. The ethical evaluation of the practicability of xenotransplantation, in light of the current situation as summarized in the first part of this document, requires the consideration of a whole series of factors, some of which are derived from the general moral norms valid for all transplants, and others of which are more specifically related to xenotransplantation.

The Health Risk

As previously stated, one of the fundamental ethical questions that should be examined when judging the legitimacy of xenotransplantation is that of the health risk involved in such procedures. This risk is dependent on various factors which cannot always be predicted or assessed. Before going on, therefore, it may be useful to recall some general aspects of the ethics of 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. Furthermore, the presence or absence of certain chance factors of risk can sometimes alter the probability that a certain event will take place. The extent of the damage, in contrast, is measured by the effects that the event produces. Naturally, a very probable risk is easily tolerated if the extent of damage associated with it is very small; on the contrary, a risk that causes a high level of damage, however improbable, gives rise to much greater concern and require greater caution.

HUMAN GENE TRANSFER RESEARCH

Human gene transfer research (HGTR) involves the deliberate transfer of genetic material (naturally-occurring, genetically-modied, or synthetic DNA or RNA) into human subjects.

TRANSGENESIS

As we have already observed, the possibility of working out such genetic modifications, using genes of human origin as well, is normally acceptable when done in respect for the animal and for biodiversity, and with a view to bringing significant benefits to man himself. Therefore, while recognizing the transgenesis does not compromise the overall genetic identity of the mutated animal or its species, and reaffirming mans responsibility towards the created order and towards the pursuit of improving health by means of certain types of genetic manipulation, we will now enumerate some fundamental ethical conditions which must be respected:

1. Concern for the well-being of genetically-modified animals should be guaranteed so that the effect of the transgenes expression, possible modification of the anatomical, physiological and/or behavioural aspects of the animal may be assessed, all the while limiting the levels of stress and pain, suffering and anxiety experienced by the animal;

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.

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. Special attention should be paid to making sure that the patient is informed about the real and hypothetical risks of zoonoses, in light of current data, and about the precautions to be adopted in the case of infection (in particular the possible need for quarantine, which involves avoiding physical contact with others while the risk of contagion is present). The patient must also be informed about the need to remain under medical supervision for the rest of his life, so that the necessary constant monitoring following the transplant may be carried out. In addition, adequate information on possible alternative therapies to xenotransplant therapy should not be withheld.

Deontological Issues

Pioneered by such giants as Paul Ramsey and Leon Kass, modern bioethicists disagree on the moral status of organ donation. Certain groups, like the Christian Scientists and traditional Jews, oppose organ donation on religious grounds. Issues surrounding patient autonomy, living wills, and guardianship make it nearly impossible for involuntary organ donation to occur. In issues relating to public health, it is possible that a compelling state interest overrules any patient right to autonomy.

From a philosophical standpoint, the primary issues surrounding the morality of organ donation are semantical in nature. The debate over the definition 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 harvesting is an ongoing problem in clinical bioethics.

Further, 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, more so when the clone is created with the express purpose of being destroyed for harvesting. While the benefit of such a cloned organ is a zero-percent chance of transplant rejection, the ethical issues involved with creating and killing a clone may outweigh these benefits.

A relatively new field of transplantation has reinvigorated the debate. Xenotransplantation, or the transfer of animal (usually pig) organs into human bodies promises to eliminate many of the ethical issues while creating many of its own. While xenotransplantation promises to increase supply of organs considerably, the threat of organ transplant rejection coupled with the general anathema to the somewhat alien idea decreases the functionality of the technique.

SURROGATE MOTHERHOOD

Surrogacy is an arrangement whereby a woman agrees to become pregnant for the purpose of gestating and giving birth to a child for others to raise. She may be the child's genetic mother (the more traditional form of surrogacy), or she may be implanted with someone else's fertilized egg.

Funding and Regulation of Embryo Research

The Moral Status of the Early Embryo

In contrast to China and India, most Western countries are deeply divided over ethical issues related to embryo research. Does the embryo merit full protectability from the moment of fertilization, or does it gradually attain full protectability as it moves through a series of developmental stages? If fertilization is not the point of greatest moral significance, is there some later developmental marker beyond which embryo research ought not be conducted?

Ethical problems of genetic engineering technology. Medical use of stem cells. Cloning of organs and tissues.

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. Although such issues have precedents in other medical contexts, they take on a different character in gene transfer, in part because of the scientific uncertainty and the social context of innovation.

 

Arguments in Favor of and Against Gene Transfer Research

The central argument in favor of gene transfer research is the hope that it can be used to treat desperately ill patients, or to prevent the onset of horrible illnesses. Conventional treatment for the candidate diseases for gene transfer research is limited; for patients with those diseases, gene transfer may offer the only hope. Many commentators liken somatic cell gene transfer research to other new medical technologies, and argue that we have an obligation to treat patients if we can Eric Juengst summarized the arguments for and against human germ-line gene transfer in 1991:

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.

Bioethics can be called as love of life. It is the concept. Bioethics could be viewed in descriptive, prescriptive and interactive ways. Interactive bioethics is discussion and debate between people and groups within society. Different sectors of society have been involved in the HGP, from ordinary people, patients, scientists, industry, governments, legal system, regional and international organizations, and the United Nations.

(a) Beneficence: In contemporary ethics, the principle of beneficence signifies an obligation to benefit others or to seek their good and it has been the foundation of many codes. Recalling that, the motive of the HGP is also based on the principle of beneficence to all, be it medical patients, health professionals, public institutions or private companies. Beneficence is the impetus for further research into ways of improving health and agriculture, and for protecting the environment. Beneficence supports the concept of experimentation, if it is performed to lead to possible benefits.

(b) Do no harm: Do no harm is a broad term, but it is the basis for the principles of justice and confidentiality and philanthropy. The judgement in most of the legal systems in the world follow the basic principle of do no harm. It is also seen when we address the questions of balancing between benefits and the risks in the use of technologies. Two main ethical arguments in the Human Genome Project revolve around the moral concept of justice and confidentiality that are discussed separately.

(c) Human rights: There are three philosophical schools of thoughts to define what it means to be human. The social school, the developmental school and the genetic or the scientific school. These approaches try to distinguish the human organism from human beings. Human organism is used in the genetic or the scientific sense and human being is used in what may be called its normative, ethical or moral sense. Article 1 of Universal Declaration of Human Rights endows all human beings with reason and conscience, and Article 6 gives all human beings recognition as a person. In simple terms, the human body can not be used as an experimental organism without consent. This is enshrined in codes governing medical experimentation, such as the Nuremberg Code and the Helsinki Declaration.

(d) Animal rights: Animal experimentation in biological and medical sciences has been practiced for several millennia. Ethical guidelines for research on non-human animals are based on the assertion that animals are sentient, have conscious experiences, and feel pain and suffering, especially the vertebrate animals. The defenders argue that medical breakthrough come from animal experimentation. Usually the benefits of discoveries to humans generally overweigh the suffering of animals. The statistics of the use of animals can be misleading because the degree of harm varies widely.

Nevertheless, we can not ignore the moral status of animals. The boundaries of the moral obligations are not limited to the members of our own species. Though humans are considered superior in many respects such as self-awareness, rational decision-making, ability to communicate and think, and others, animals cannot be regarded as means of achieving our goals. We do not perform experiments on a severely disabled human either mentally or physically as our means to understand the disease. Macer argues in Bioethics is Love of Life, that the ethical limits of animal use intrinsic ethical factors like pain, self-awareness, future planning, value of being alive and individual love of life. Also extrinsic factors including human necessity or desire, human sensitivity to animal suffering, fertility in humans, other animals disapproval and religious status of animals, are important.

(e) Authority: Many people raised doubts about who should be involved in the sequencing of the genome and who should do the work. The project required a multi-disciplinary approach involving medical experts, biologists, bioethicists, information specialists, computer experts and many others for data banking and analysis. The multidisciplinary authorisation of the Genome Project has on one hand rewarded it with speeding the process, on the other hand it aroused conflict between different groups because of the inherent interests of their respective fields.

(f) Autonomy: The concept of autonomy in bioethics gives each individual the recognition of the human capacity for self-determinism and being different in spite of sharing same DNA which is regarded as a common heritage. This is also true in the choices we make.

Personal choices are expressed in law as rights. With the advent of new technologies we have the ethical challenge of respecting people as equals, allowing them to exercise their personal values and decisions. Freedom of expression is parallel to autonomy, but it is debatable that it should not encroach the territory of others.

(g) Ownership: The competition for the genome sequencing between the publically funded Genome Project and the worlds leading private company Celera Genomics is well known. The fear behind this is the unwarranted risk of data ownership. Since it is agreed that all human beings share the same genome, from the ethical perspective, the sequenced data should be owned by all human beings, as it is emphasized in UNESCOs Universal Declaration of Human Genome and Human Rights.

(h) Justice: The other side of the possibility for transforming medicine is who will actually benefit? Will everyone have access to such revolutionized health care? There is a fear that it might widen the gap between rich and poor. In the developing world, the Human Genome sequencing may not be the first choice for better treatment, where millions of people do not even have access to basic medical treatment. The poor tropical countries could be more interested in deciphering the genomes of disease causing bacteria, viruses or parasites that could provide new target of drugs vaccines or antibiotics. Even in rich countries, not all will benefit equally. It is agreed that it will be extremely difficult and in some cases impossible to provide best treatment to all in need, but a rational and balanced approach is needed so that the people in developing world have their share of benefits from these advancements.

(i) Confidentiality and privacy: It will not be surprising if in the next few years we all will be able to get our individual genomes sequenced. Already distinctive genetic information can be obtained from a simple test. Despite sharing a common genome each individual is distinct in both physical and behavioural characteristics which are determined to some extent by our genes. Those are very personal and confidential to all of us.

The privacy of the genetic information is reinforced not only because of the presumed prospects for the use of such information beyond medical reasons, for instance, discrimination of the genetic underclass at different levels, but also to retain the trust with people and respect for persons autonomy. However, there are exceptions considered by some if it will avoid physical harm to someone, for example.

(j) Responsibility: The responsibility of use or the misuse of the genetic information is an individual decision, but what is useful for one may not be useful for others. The definition of misuse is also debatable. So the responsibility of the misuse of genetic information cannot be put on the people involved in genetic research, though private companies may be exceptions depending on the use. If genetic discrimination occurs, it will be the fault of social values rather than of the technology.

(k) Scientists and social duty: Scientific freedom to research what scientists desire is included in the fundamental human rights under the UN Declaration of Human Rights, and in the UNESCO Charter. Researchers and scientists have a basic right to experimentation, scientific research and to explore new things. Scientific research and experimentation may not always give the positive, correct or accurate results. Many people regard the HGP as an extension from the desire to know ourselves. Inarguably there are benefits for public good already from the genome projects. But there always lies the danger of misusing scientific freedom. The scientific community has to bear the moral responsibility for using very powerful knowledge, as agreed in the UNESCO Declaration on the Human Genome and Human Rights.

(l) Consequences: The consequences of the HGP are affirmative only when used in a proper way, for the well being of all of humanity. The tremendous potential of the technology is unquestionable. It gives hope and choices for the future. It depends on the action and the motive behind the use of genetic sequencing and further use of the gained genetic information. We have to use the precautionary principle approach, which says we need to be very careful to avoid harm.

HUMAN CLONING

To understand the cloning debate (and to distinguish cloning from genetic engineering, which many opponents fail to do) we need to understand:

(a) Reproductive cloning: creating a new organism from a single cell of an adult. The genes (but not the far less-important mitochondrial DNA) of the offspring are identical to the parent.

(b) Therapeutic cloning: creating embryos to supply embryonic stem cells as a source of spare parts to treat disease.

(c) Genetic engineering: changing genes in cells that will be transmitted to all offspring, was recently used to make pigs that many supply compatible transplant organs for people.

Uses of Reproductive Cloning

What uses might there be, or what reasons might someone have, for producing a human being through cloning? What follows is a survey of a number of possible uses of this procedure, some of which are obviously more problematic than others. The ethical issues that have been or might be raised regarding the possible uses of reproductive cloning will then be discussed. One of the probable primary uses, if cloning does become a reality, is for the treatment of fertility problems. For example, if the male or husband is sterile, or does not produce sperm, DNA from one of his cells could be inserted into a de-nucleated egg from the female or wife who would also bear the child. Both would then be contributing to the make up and birth of the child. Many have pointed out that there is a strong desire among people who want a child to have one that is biologically related to them. These parents also may wish to avoid the confusion that can result from the use of donor eggs or sperm. If the woman is infertile, another womans egg could be used along with the DNA of the infertile woman or her husband or partner. Cloning might also be used to avoid genetic diseases.

Another possible use would be in the fertilization of a woman who wants to have children to whom she is related biologically, but who does not have a partner and does not wish to use donor sperm. The woman might be one who is single and who has not found a suitable partner, or who is divorced and still wants to have children. A cell from her body could be used. In this case the child would be a clone of the woman herself. Or in the case of a lesbian couple, a cell from the body of the other partner could be used. In this case both would have contributed to the make up of the child.

Someone might want to produce a child who is a clone of a much-loved spouse or child who has died. As noted below, while this would not bring back the loved one or duplicate them exactly, there would be some similarities and thus in a way the ability to keep some part of the person alive. One might even want to achieve a certain kind of immortality by cloning oneself. This would be similar in some way to living on through our children and their children.

Cloning could also be used to help ill family members. There have been cases in which parents have conceived a child in the hope that he or she could be a donor match for a sibling who had some serious disorder. A child who was the clone of such a sibling could also be a blood or bone marrow donor for the sibling. Although no one is suggesting that clones would be produced simply as the source of organs, some organ donation might not be objectionable. Finally, cloned human beings could provide us with further information about the relationship between nature and nurture. A disabled person might want to show or see what he would have been like but for the disability, or someone might simply be curious to see how a clone of himself might grow to adulthood.

Ethical Objections and Arguments

Ethics judges or evaluates human choices and actions or policies as being, for example, good or bad, right or wrong, and just or unjust. Ethical or moral judgments (the terms being used synonymously here) require reasons that justify them. Many people have raised various ethical objections regarding human cloning. The arguments and the reasons given for them are summarized here as well as the responses of critics of the arguments. However, since what is presented is only a summary, it is not possible to give a full analysis of the kind of reasons that they exemplify and why these might or might not be well-grounded in generally-accepted values or in ethical theory.

It should also be noted at the outset that ethical evaluation is independent of social policy and law. Not everything that is morally bad or wrong ought to be illegal. It takes a separate set of reasons to conclude that because some instances of human cloning might be morally wrong that they should then also be illegal. Nevertheless many of our policies and laws do have ethical bases. First the ethical arguments will be treated and then nally some social policy issues related to them. Some suggestions regarding the relationship between these two domains will also be provided.