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At the end of its Ninth General Assembly, held in the Vatican from
24-26 February, the Pontifical Council for Life issued the following
Concluding Communiqué on the "Ethics of Biomedical Research. For a
Christian Vision". The Council was concerned to highlight general
ethical features that biomedicine has to take into account if it is to
serve the human person. The Council drew attention to experimentation on
human embryos (n. 9) and stated that experimentation that is not aimed
at the good of the human embryo is not morally licit. It also asked that
there be appropriate experimentation on animals before applying it to
human beings (n. 8). The Council also called for a set of international
norms that would foster sound experimentation (n. 11). The Council
called for equity in the distribution of resources between rich and poor
countries and the need to guarantee minimal means to be able to carry
out and benefit from the results of biomedical research (n. 10). Here is
a translation of the Final Communiqué of the General Assembly.
1. The Ninth General Assembly of the Pontifical Academy for Life took
place at the Vatican from 24-26 February. This year it was dedicated to
a crucial theme that has a strong social impact, "Ethics of
Biomedical Research. For a Christian Vision".
It is evident that, especially in the recent decades, biomedicine has
developed in an extraordinary way, helped by the enormous progress in
technology and computer science that have vastly extended the
possibilities for experimentation on living beings and, especially on
the human being. There have been tremendous breakthroughs, for example,
in the fields of genetics, molecular biology, as well as in
transplants and the neurological sciences.
Today more than ever, among the factors that contributed to this
development, certainly biomedical research has been instrumental in the
progress of knowledge in this sector of medicine, as the Holy Father
himself recently pointed out: "It is a recognized fact that
improvements in the medical treatment of disease primarily depend on
progress in research" (John Paul II, Address to
participants in the Ninth General Assembly of the Pontifical Academy for
Life, 24 February 2003, n. 2; ORE, 5 March
2003, p. 4).
2. In the present setting, every new discovery in biomedicine seems
destined to produce a "cascade" effect, opening up many new
prospects and possibilities for the diagnosis and treatment of numerous
pathologies that are still incurable.
Obviously, the acquisition of a growing technical possibility of
intervention on human beings, on other living beings and on the
environment, and the attainment of ever more decisive and permanent
effects, obviously demands that scientists and society as a whole assume
an ever greater responsibility in proportion to the power of
intervention. It follows that the experimental sciences, and biomedicine
itself, as "instruments" in human hands, are not complete in
themselves, but must be directed to defined ends and put in dialogue
with the world of values.
3. The primary agent of this continuous process of "ethical
orientation" is, unmistakably, the human person. Indivisible unity
of body and soul, the human being is characterized by his capacity to
choose in freedom and responsibility the goal of his own actions and the
means to achieve it. His burning desire to seek the truth, that belongs
to his nature and his specific vocation, finds an indispensable help in
the Truth itself, God, who comes to meet the needs of the human being
and reveals to him his Face through creation, and more directly, through
Revelation. Thus God favours and supports the efforts of human reason,
and enables the human being to recognize so many "seeds of
truth" present in reality, and finally, to enter into communion
with the Truth itself which He is.
In principle, therefore, there are no ethical limits to the knowledge
of the truth, that is, there are no "barriers" beyond which
the human person is forbidden to apply his cognitive energy: the Holy
Father has wisely defined the human being as "the one who seeks
the truth" (Fides et ratio, n. 28); but,
on the other hand, precise ethical limits are set out for the manner the
human being in search of the truth should act, since "what
is technically possible is not for that very reason morally
admissible" (Congregation for the Doctrine of the Faith, Donum
Vitae, n. 4). It is therefore the ethical dimension of the human
person, which he applies concretely though the judgements of his moral
conscience, that connotes the existential goodness of his life.
4. In the commitment to research and to recognize the objective truth
in every creature, a particularly important role falls to scientists in
the area of biomedicine, who are called to work for the well-being and
health of human beings, the ultimate aim of every research activity in
this field must be the integral good of man. The means it uses, must
fully respect every person's inalienable dignity as a person, his right
to life and his substantial physical integrity.
Against any false accusation or misunderstanding, let us repeat in
communion with the Pope, John Paul II, that: "The Church
respects and supports scientific research when it has a genuinely human
orientation, avoiding any form of instrumentalization or destruction of
the human being and keeping itself free from the slavery of political
and economic interests" (Address to participants in the
Ninth General Assembly of the Pontifical Academy for Life, 24
February 2003, n. 4; ORE, 5 March 2003, p. 4).
In this perspective, one must express the greatest possible gratitude
to the thousands of doctors and researchers of the whole world who,
generously and with great professionality, dedicate their energies every
day to the service of the suffering and the treatment of pathologies.
Further, the Pope recalled that: "all, believers and
non-believers, acknowledge and express sincere support for these efforts
in biomedical science that are not only designed to familiarize us with
the marvels of the human body, but also to encourage worthy standards of
health and life for the peoples of our planet" (ibid.,
n. 2).
5. For the reasons already mentioned, one can and must speak
of an "ethic of biomedical research" that, in fact, has been
increasingly developed and expressed in the last 30 years. Christian
thought too has been able to make its important contribution to this
development, bringing to the fore certain new problems in the light of
its original anthropological vision. Historically, at least two themes
can be cited as an example of the ethical attention the Christian
community pays to the world of biomedical research: the call for respect
for the person when he/she is the subject of research, especially in the
case of experimentation that is not directly therapeutic; the emphasis
on the close bond between science, society and the individual, which is
at stake in the entire process of research.
6. Thus, in elaborating an itinerary for biomedical research that
will respect the true good of the human person, it is necessary for the
synergy of the different disciplines concerned to converge through an
integrative methodology, that will take into account the complex
constitutive unity of the human being. To this end, the proposal of the
so-called "triangular method" seems to be appropriate. It is
divided into three stages: the exposition of the biomedical data; the
examination of the consequences for the human person and the discernment
of the values this factor brings to the fore; the elaboration of the
ethical norms that can guide the work of those who are involved in a
given situation, in accord with the meanings and values that were
previously identified.
7. Another theme of great importance in the context of biomedical
research is certainly that of therapeutic and non-therapeutic
experimentation, considered from the perspective of its application to
the human being, It involves many problematic aspects, both of a
scientific and ethical nature. It is indispensable, for example, to
demand a high professional standard from the researchers involved in the
experimental project, and to adopt a methodology that is rigorous in
determining and applying procedural criteria. Moreover, It is also
ethically necessary that the person conducting the experiment, with his
collaborators, maintain total personal and professional independence
with regard to possible interests (financial, ideological, political,
etc.) unrelated to the goal of the research, for the good of the
subjects involved and the genuine progress of humanity.
8. Besides, we want to reaffirm the need to do sufficient
experimentation on animals prior to the clinical experimental phase (the
application on human beings) that will enable researchers to acquire
advance knowledge of the possible harm and risks that this
experimentation could have in order to guarantee the safety of the human
subjects involved. Naturally, experimentation on animals also has to be
carried out with the observance of precise ethical norms to safeguard,
as far as possible, the well-being of the specimens used.
9. Special attention must also be paid to the treatment of human
subjects who undergo research who are especially "vulnerable"
because of their state of life, as the example of human embryos clearly
illustrates. Because of the delicate stage of their development,
possible experimentation on them in the light of current technological
advances would involve a very high—and
therefore ethically unacceptable—risk
of causing them irreversible damage and even death.
The attitude some adopt concerning the legitimacy of sacrificing the
(physical and genetic) integrity of human beings at the embryonic stage
in order to destroy them, if necessary, in order to benefit other human
individuals is likewise totally unacceptable. It is never morally licit
to do evil intentionally in order to achieve ends that are good in
themselves.
Moreover, it should be borne in mind that, although the human
individual at the embryonic stage deserves the full respect that is due
to every human person, human embryos are certainly not subjects who can
give their personal consent to experimentation that exposes them to
grave risks without the benefit of any directly therapeutic effect for
themselves. Therefore, any experimentation on the human embryo that does
not have the goal of obtaining direct benefits for his/her own health,
cannot be considered morally licit.
10. The current process of progressive globalization that involves
the whole planet and whose consequences do not always seem to be
positive, impels us to reflect on biomedical research under the heading
of its social, political and economic implications.
Given the growing limitation of the resources that are available for
the development of biomedical research, it is in fact necessary to pay
great attention to achieving a just distribution between the different
countries, taking into account the living conditions in the various
parts of the world and the emergence of the primary needs of the poorest
and most harshly tried peoples, That means that all should be guaranteed
the conditions and minimal means so that they can enjoy the benefits
deriving from research, and develop and support an endogenous capacity
for research.
11. At the legislative level, once again, we express the hope and the
recommendation that an international legislation with a unified content
can be arrived at, based on the values inscribed in the nature of the
human person. In this way, one could overcome the actual disparities
which frequently make possible the abuse and exploitation of the
individual as well as of entire peoples.
12. Finally, recognizing the enormous influence of the mass media in
the formation of public opinion and the important role they play in
inspiring in the broader public, expectations and desires that are more
or less well-founded, it appears ever more necessary that those engaged
in the sector, who choose to be concerned with the biomedical sector and
with bioethics, should be properly trained, both in the scientific and
the ethical fields, to be able to communicate the facts in simple, and
concise language without confusion or misrepresentation.
13. To conclude, the Pontifical Academy for Life, with great
enthusiasm and a deep sense of responsibility, desires to renew its
commitment and dedication to the cause of life, in sincere and
respectful collaboration with all who are involved in the field of
biomedical research, as the Pope himself said in his recent address to
the Pontifical Academy for Life: "In the area of biomedical
research, the Academy for Life can therefore be a point of
reference and enlightenment, not only for Catholic researchers,
but also for all who desire to work in this sector of biomedicine
for the true good of every human being" (ibid.,
n. 3). The Academy's principal task continues to be to make
available to the Church, to society at every level, and, especially, to
the scientific community, its own "statutory" service of study,
formation and information, in the attempt to identify
and to point out to the whole of society the values rooted in the
dignity of the human person that are indispensable if we aspire to the
true good of every person and of the whole person, with the goal of
deducing from them the ethical directives that can guide those involved
in this field in their daily endeavour.
Proposal of an Ethical Commitment for Researchers in the Biomedical
Field
Introductory note
The following "manifesto" is published as an appendix to
the Final Communiqué of the Ninth General Assembly of the Pontifical
Academy for Life. It is a concrete result of the assembly's
deliberations, whose theme this year was: "Ethics of Biomedical
Research: For a Christian Vision", offered as an open proposal
to be freely supported.
The invitation for a personal adherence is addressed to all
researchers and those involved in research in the biomedical field and
also to researchers in bioethics.
Those who wish to adhere to this "manifesto", which means
that they embrace the principles it contains, to should communicate to
the Academy by one of the following ways:
- by e-mail to: pav@acdlife.va
- by fax to: +39 06 69882014
- by post to: Pontificia Accademia per la Vita, Via della
Conciliazione, 3, 00193 Rome, Italy.
Whatever the chosen modality, it is obligatory to include one's
personal details (name, surname, address, telephone, fax, email),
profession and place of employment, academic degrees and other
qualifications.
Premise
The scientific developments of recent decades have brought about
important cultural and social transformations, modifying in a
qualitative way many aspects of human life. Indeed, the advance of
scientific progress in many sectors has given rise to great hopes of
concrete improvements for the life and future of the human person.
However, in certain sectors of scientific research problems and/or
doubts of an ethical and religious nature have arisen; they have
demonstrated unequivocally the real need for constant
dialogue/integration between the experimental sciences and the broader
human sciences and philosophy in terms of operating in a more ample
perspective so that the acquisition of greater knowledge may effectively
serve the true good of the human person.
Human life and human nature appear to be realities too complex to be
exhaustively evaluated from a single perspective; a multidisciplinary
approach therefore appears indispensable for a better understanding of
the human being in his integrity and contribute to a meaningful growth
of a science that would truly be for the human being.
Moreover, such an interdisciplinary dialogue, by re-focusing
attention on the centrality of the human person, would make the
scientists more aware of the ethical implications of their work, and,
conversely, would incite those involved in philosophical and theological
anthropology to assume toward the scientists a mission of dialogue,
collaboration and practical support, with the mutual intention of
developing cognitive and applied tools for the service of the human
community.
In this perspective, the reference to human values, and finally, to
an anthropological and ethical vision, is an indispensable premise for a
correct scientific research, that recognises the person's responsibility
to himself and to others.
In fact, without reference to ethics, science and technology can be
used either to kill or to save human lives, to manipulate or to promote,
to destroy or to build. It is therefore necessary that, through
responsible management, research be addressed toward the true common
good, a good that transcends any merely private interest, going beyond
the geographical and cultural boundaries of nations and keeping one's
vision directed toward the good of future generations.
For science to be really placed at the service of the human being, it
is necessary that it goes "beyond matter", intuiting in the
corporeal dimension of the individual the expression of a greater
spiritual good. Scientists should understand the human body as the
tangible dimension of a unitary personal reality, which is at the same
time corporeal and spiritual. The spiritual soul of the human being,
although not in itself tangible, it is always the root of his
existential and tangible reality, of his relationship with the rest of
the world, and consequently, of his specific and inalienable value.
Only such a vision can make scientific research effectively
respectful of the human person, considered in his complex
corporeal-spiritual unity, every time he/she becomes the object of
investigation, with particular reference to those events that constitute
the beginning and the end of the individual human life.
For this reason, emerges a strong need to offer to young researchers
formative programmes that put the accent not only on the scientific
preparation, but also on the acquisition of the fundamental notions of
anthropology and ethics. The expression of such programmes could, then,
crystallize in the elaboration of a true and proper Deontological
Code for researchers, to which each researcher could safely refer in
his work, and which, at the same time, would represent a sign of hope
and commitment for a truly "humanized" medicine in the new
millennium.
A first indication of the way to take, might concern the manner in
which the researchers should behave and the norms they should observe in
order to direct their research towards the objective just recalled
above. It is our desire to propose such ethical indications, to which we
firmly adhere, to all others who are involved in the world of biomedical
research; somehow, they delineate the principal features of the
researcher's "moral personality".
Commitment
- I commit myself to adhere to a methodology of research
characterized by scientific rigour and a high quality of the
information that is furnished.
- I will not take part in research projects in which I could be
subject of a conflict of interests, from the personal, professional
or economic point of view.
- I recognise that science and technology must be at the service of
the human person, fully respecting his dignity and rights.
- I recognise and respect all researches and their applications
which are based on the principle of "moral goodness" and
referring to the correct vision of the corporeal and spiritual
dimensions of the human being.
- I recognise that every human being, from the first moment of his
existence (process of fertilization) up to the moment of his natural
death, is to be guaranteed the full and unconditional respect due to
every human person by virtue of his peculiar dignity.
- I recognise, because of my duty to safeguard human life and
health, the usefulness and the obligation of a serious and
responsible experimentation on animals, carried out according to
determined ethical guidelines, before applying new diagnostic and
therapeutic methodologies to human beings. I also recognise that the
passage from the experiments with animals to the clinical
experimental stage (on man) should take place only when the
evidences resulting from the experiments with animals sufficiently
demonstrate the harmlessness or the acceptability of the possible
harms and risks that such experiments might involve.
- I recognise the legitimacy of clinical experiments on the human
being, but only under precise conditions, including, in the first
place, the safeguarding of the life and physical integrity of human
beings who are involved. Then, there is the need that the
experiments be always preceded by proper, correct and complete
information regarding the significance and developments of the same
experiments. I will treat each person who submits to an experiment
as a free and responsible subject and never as a mere means to
achieve other ends. I will never let a person be involved in an
experiment unless he/she has given his/her free and informed
consent.
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