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There are a lot of magisterial documents which develop clearly the position of the Church, namely “Instruction on Respect for Human Life in its Origin and on the Dignity of Procreation – Donum Vitae, published in 1987, and the Encyclical Letter Evangelium Vitae, 1995, of the Pope John Paul II.
In an address to the Ninth General Assembly of the Pontifical Academy for Life, de Pope called on everyone to speak out against the destructive research on human embryos “I am convinced that no one, much less the Church, is allowed to be silent in the face of certain result or pretexts of experimentation on man”, he said.

The Academy, meeting to discuss biomedical research was told of “the growing urgency to find natural solutions to the problem of conjugal infertility.
"I renew my heartfelt appeal," John Paul II stated, "that scientific and biomedical research, while avoiding every temptation to manipulate man, be faithfully dedicated to exploring ways and resources to support human life, the cure of illnesses and solutions to the ever new problems in the biomedical field." He emphasized that "the Church respects and supports scientific research when it pursues an authentically humanistic orientation, fleeing from every form of exploitation or destruction of the human being and keeping itself free from the slavery of political and economic interests. "The Pope stressed that "not only the goals, buy also the methods and means of research must always be respectful of the dignity of every human being, at whatever stage of their development and in every phase of experimentation”.
At this meeting of the Academy, in February, 2003, Roberto Colombo, a Priest and a Scientist, Prof. of the Catholic University of the Sacred Heart in Milan presented an excellent paper entitled – The most vulnerable subjects of Biomedical Research – The case of human embryo, which develops the catholic thinking on this subject.

After a discussion on the vulnerability of the  subject which enter in a biomedical research, enumerating the different risks and harms, namely dignitary harms as a consequence of attempts on human rights, during the recruitment operative or follow-up phase of a research protocol, Prof. Colombo presents in depth the case of the human embryo as a most vulnerably subject. I will present and comment his text.
The question of the human embryo's vulnerability in biomedical research arises from the evident condition of weakness that characterizes embryonic life, with special reference to the in vitro human embryo. The distinctive precariousness in the condition of the human embryo developing outside the mother's womb cannot be denied. Notwithstanding the efforts to improve them, culture's media and conditions are far from ideal when compared with the natural tubal and uterine environment, and in vitro embryonic development is exposed to a series of risks including delayed growth, infection, blastomeres' fragmentation, partial cavitation, abnormal distribution of cells between the inner cell mass and the trophoblast, alteration of the zona pellucida, and delayed hatching. Furthermore, cryopreservation in liquid nitrogen - a procedure carried out if the embryo is not transferred to the uterus within day 5 or 6 of culture - is not a safe condition for the storage of embryos.

Depending on the stage of embryo's development, the techniques employed and the length of cryopreservation, a number of embryos are irreversibly injured or exposed to death. On the whole, the in vitro human embryo is totally dependent on the laboratory's artificial environment and the care of biologists and technicians. Any instrument out of order, altered culture medium or failure to obey precautionary rules (such as those concerning sterility) can have dramatic consequences on the embryo's life and integrity. Although in utero embryonic development is not free from risks, in vitro circumstances are characterized by an unusual exposure to several injuries and, accordingly, the human embryo in vitro is a highly vulnerable subject.

Besides risks that are common to any in vitro fertilization (IVF) and embryo culture (EC) and transfer (ET) procedure, research protocols add further exposure of embryos to dangerous conditions. Some experiments require per se the destruction of the developing embryo. This is the case of research on pluripotent embryonic stem cells (ESC), obtained by removing the inner cell mass (20-30 cells) of the blastocyst at 5-6 days after fertilization and culturing the obtained cells in the presence of certain growth factors. Other kinds of experiments are less invasive. Among them are the studies of cell cycle, gene expression (mRNA and protein synthesis) and metabolism in the cleaving, morula and blastocyst stage embryos. To perform these investigations, embryonic cells are either removed or injected with tracing substances and analyzed by microscopic, immunochemical or molecular techniques. Embryos that survive these experiments are not allowed to develop and to be transferred to the uterus. Last, research on new techniques of microassisted IVF and of agamic reproduction (cloning), as well as pre-implantation genetic diagnosis, while aimed at generating normally developing embryos, are affected by a number of failures, i.e. embryonic malformations and deaths. «Experimentation on embryos and foetuses always involves risk, and indeed in most cases it involves the certain expectation of harm to their physical integrity or even their death».Donum Vitae

However, physical harms are by no means the sole type of injury a human embryo can suffer while being generated and developed outside the mother's womb, and, even more, subjected to experimental research. The human embryo's dignity as a human individual (subject), i.e. the son or the daughter of a woman and a man endowed with their own dignity and value, is threatened because other persons exercise undisputed dominion over the life and the integrity of the developing embryo. No matter how important the scientific and clinical data obtained or how noble and humanitarian the intention of an experimental study, it cannot reduce the human embryo to an "object" or "instrument". «The use of human embryos and fetuses as an object of experimentation constitutes a crime against their dignity as human beings who have a right to the same respect owed to a child once born, just as to every person»,as stated in Evangelium Vitae.

In the second place and in the context where we use the term "vulnerability", it reminds us that some researcher has, knowingly or negligently, taken unfair advantage of the human embryo's weakness, carrying out experiments on an incompetent or "voiceless" subject. The reasons why the embryo is very susceptible to be exploited in an unethical biomedical investigation allow us to point again to the high vulnerability of this research subject. Although free and informed consent is not the only ethical principle to justify research on human subjects, the absence of the capacity to deliberate about and decide whether or not to participate in an experimental study is considered to be a clear indicator of vulnerability. Cognitive vulnerability, in the presence of a more than "minimal risk" to the subjects, would suffice to proscribe proxy consent in a non-therapeutic experimental setting. This is true for the human embryo as well. «No objective, even though noble in itself, such as a foreseeable advantage to science, to other human beings or to society, can in any way justify experimentation on living human embryos or foetuses, whether viable or not, either inside or outside the mother's womb. The informed consent ordinarily required for clinical experimentation on adults cannot be granted by the parents, who may not freely dispose of the physical integrity or life of the unborn child»Donum Vitae.

In utero human embryos are under the formal authority of their parents (or the mother alone) if competent, while the in vitro embryo may be subject to either the legal parents or other persons, such as physicians, investigators or judges (embryos left over from IVF-ET cycles or generated for experimental purposes only). Because of this subordination, human embryos are juridically vulnerable: they are liable to the authority of others who may have an interest conflicting with or neglecting the best interest of the research subject. This distinctive vulnerability calls into question the validity of the consent. «This is especially a concern when those in authority are also those who are conducting, commissioning, or somehow benefiting from the research».

The human embryo as a candidate subject of biomedical research is also vulnerable in an indirect way, i.e. via the vulnerability of the person(s) that is required to give the proxy consent. The embryo's mother can be juridically vulnerable herself, as in the case of a girl under the authority of her parents or subject to a custodian. Parents may be affected by deferential vulnerability, e.g. under a powerful social and cultural pressure. They may mask an inner reticence not to consent or find it hard to turn down a request from their physician.
The more insidious and dangerous way in which the human embryo becomes a highly vulnerable in the context of experimental research results from the denial of its subjectivity. If it is not recognized as a subject of research - as every human being involved in biomedical research is - there are no compelling reasons for treating the human embryo according to the same criteria of respect and protection which should be adopted regarding all human individuals to whom is commonly attributed the moral and legal status of a person. "Respect" and "protection" can be granted to non-subjects as well: even objects can themselves be worthy of some kind of respect and protection. In the context of biomedical research, "biological objects" (such as animals and human organs, tissues, and cells) have a certain value. However, their value and therefore their protection is instrumental to an end. The human being is always an end in himself and is worthy of protection "for his own sake".

Ljubljana, 29 de Setembro a 1 de Outubro/2003



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