ETHICS OF BIOMEDICAL RESEARCH IN A CHRISTIAN VISION
PROCEEDINGS OF THE NINTH ASSEMBLY OF THE PONTIFICAL ACADEMY FOR LIFE
Vatican City, 24-26 February 2003
Edited by :
JUAN DE DIOS VIAL CORREA
ELIO SGRECCIA
LIBRERIA EDITRICE VATICANA
2004
Presentation(Prof. JUAN DE DIOS VIAL CORREA and H.E. Msgr ELIO SGRECCIA)
Discourse of the Holy FatherJOHN PAUL II
INTRODUCTORY REPORTS
H.E. Msgr. JAVIER LOZANO BARRAGÁN,New paradigm: roots and proposals
Prof. VINCENZO CAPPELLETTI,Biomedicine in the twentieth century
STATEMENTS IN THE ROUND TABLE
""The Contemporary Frontiers of Biomedical Research at the Service of Man""
Prof. MÓNICA LÓPEZ BARAHONA,Some recent advances in molecular biology with a direct impact on human life
Prof. ANGELO VESCOVI,Neural stem cells: functional stability, plasticity and therapeutic potential
Prof. IGNAZIO MARINO,Ethics of biomedical research: for a christian approach
Prof. ANTONIO BATTRO,New frontiers in neuroeducation
SUBJECTS REPORTS
Prof. ADRIANO BOMPIANI,Experimental research in the field of biomedicine. Spheres, methods, validity criteria for research projects
Prof. GONZALO HERRANZ,Some Christians contributions to the ethics of biomedical research: a historical perspective
Prof. ADRIANO PESSINA,The relation between biomedical research, anthropology and ethical philosophy. Notes for a methodological reflection
Prof. ROBERT SPAEMANN,Ars longa, vita brevis
Prof. WILLIAM MAY,Human dignity and biomedical research: the respective positions of the subject of research and the researcher
Prof. DANIEL SERRÃO,Ethics of experimental research in humans: principles and guidelines
Prof. EUGENE DIAMOND,Conflicts of interest in medical ethics
Rev. Prof. ROBERTO COLOMBO,The vulnerable subjects of biomedical research: the case of the human embryo
Prof. ANTONIO SPAGNOLO,Ethics research committees (ERCs): operational procedures and quality of the ethical review
Prof. JUAN DE DIOS VIAL CORREA,Ethics of animal experimentation
Prof. ADRIANA LORETI-BEGHE’,International regulations and biomedical research: contemporary advances and future prospects
Prof. PIERMARCO AROLDI,The involvement of the general public in biomedical research: the role of the mass-media
H.E. Msgr. ELIO SGRECCIA,Policy in biomedical research: values and priorities
APPENDIX: FINAL DOCUMENTS
Final Communiqué
Proposal of an Ethical Commitment for Researchers in the Biomedical Field
JUAN DE DIOS VIAL CORREA,
ELIO SGRECCIA
PRESENTATION
The theme of the most recent annual Assembly of the Pontifical Academy for life: “Ethics of Biomedical Research. A Christian View” (Vatican City, 24-26 February 2003) was characterized by the sheer scale of the questions examined and the actuality of many of the problems posed.
The ethics of research concern, in particular, the whole process that the planned investigation entails: the project’s objectives; the way it is funded; the ethics of experimentation, which involves many problems in turn (risks, consent, method of enrolling patients, validity of the investigative programme, objectivity of the controls, dissemination of the results); the technological or clinical implications of the phase of application; the allocation of financial resources; the justification for any patents; and the manufacture and sale of related drugs or therapeutic aids. Even experimentation on laboratory animals is not devoid of ethical problems, which are now being taken into consideration with greater awareness.
Some particularly delicate questions concern not only the process of research as such, but the object or subject of the experimentation: the embryo, the foetus, the woman at the age of fertility, the problems deriving from assisted procreation, cloning, the use of stem cells, or those relating to experimentation on primitive populations. These are problems that have already invested the judicial sphere and remain controversial and hotly debated also in the international assemblies.
Another new phenomenon of recent times is the ever greater incidence that economic and financial problems have on the development of research as a whole, including biomedical research. Innovative scientific research, and the capacity to export its results and products, are proportioned to a country’s level of economic development. Biomedical research is not exempt from this reality: the economically more developed countries are those that have more advanced programmes of scientific research and a higher level of medical assistance.
The work of the important conference, whose results are being presented here, preceded as usual by preparation within a task force of experts, touched on a large part of these issues, without ignoring the cultural context in which they are placed, current trends in research and the most advanced frontiers in which research in the biological, neurological, medical and surgical research is now being conducted. Specific issues such as those of research on the human embryo, experimentation on animals, and on stem cells, were accompanied by, and examined in the light of, specifically bioethical, philosophic, socio-political and legislative themes.
But there is a further feature that adds to the significance of the assembly and the value of the volume that contains its Proceedings: at the end of the meeting, apart from the Conclusions that sum up the various issues examined and ethical guidelines enunciated, an “Appeal to Researchers” was also issued. It calls on researchers to add their signature to a demanding ethical pledge against which future research could be evaluated and dialogue pursued. There has already been a significant response to this appeal, also on the part of whole institutes.
This appeal echoes that of the Holy Father, included in his address to the participants: “I therefore renew a heartfelt appeal that scientific and biomedical research, by avoiding any temptation to manipulate the human person, may dedicate itself with commitment to exploring ways and resources for the support of human life, the cure of diseases and the solution of the ever new problems in the biomedical field” (L’Osservatore Romano, Monday-Tuesday, 24/25 February 2003).
This volume, therefore, marks a point of specific connotation of the Christian values in the field of biomedical research. But it also reflects the course followed by the Pontifical Academy for Life, which, as the Holy Father said in the same address, “should represent in the field of biomedical research a point of reference and illumination not only for Catholic researchers, but also for all those who wish to operate in this sector of biomedicine for the true good of every human being” (ibid.). That is an invitation the Pontifical Academy for Life cannot ignore. It has the responsibility to accept it with humility and spirit of service.
John Paul II
Addressto the Members of the Pontifical Academy For Life
February, 24th 2003
Dear Members of the Pontifical Academy for Life,
1.The celebration of your Assembly gives me the joyful opportunity to greet you and to offer my appreciation for the intense dedication which the Academy for Life shows for the study of new problems, particularly in the field of bioethics.
I would like to say a special "thank you" to your President, Prof. Juan de Dios Vial Correa, for his kind words of greeting and to your Vice-President, Bishop Elio Sgreccia, who is zealous and energetic in his dedication to the task entrusted to him. I warmly greet the members of the Board of Governors and the speakers for this significant meeting.
2.In the work of your Assembly, with a detailed programme offering complementary reflections, you have wished to address the topic of biomedical research from the perspective of reason illumined by faith. This perspective does not restrict the field of observation, but rather extends it, since the light of Revelation comes to the aid of reason to offer a fuller understanding of what is intrinsic to human dignity. Is it not the human being, as scientist, who promotes research? Often the human being is the subject on whom the experiments are carried out. In every case, the results of biomedical research are at the service of the human being.
It is a recognized fact that improvements in the medical treatment of disease primarily depend on progress in research. In this way above all, medicine has been able to make a decisive contribution in wiping out lethal epidemics and in treating serious illness successfully, notably improving in many parts of the developed world, the duration and quality of life.
We must 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.
3.Furthermore, the Catholic Church wishes to express gratitude to so many scientists who are dedicated to biomedical research. In fact, the Magisterium has frequently asked their help for solutions to sensitive moral and social problems and from them has received convincing and effective collaboration. Here I especially wish to mention Pope Paul VI's invitation to researchers and scientists in his Encyclical Humanae vitae, to make a contribution "to the welfare of marriage and the family" by seeking "to explain more thoroughly the various conditions favouring a proper regulation of births" (n. 24). I make my own his invitation, stressing its permanent application, which is made even more timely by the pressing need to find "natural" solutions for the problems of conjugal infertility.
In the Encyclical Evangelium vitae, I myself appealed to Catholic intellectuals to be active in the leading centres where culture is formed so as to introduce into society, in a concrete way, a new culture of life (cf. n. 98). With this in mind, I founded your Academy for Life, "to study and to provide information and training about the principal problems of law and biomedicine pertaining to the promotion and protection of life, especially in the direct relationship they have with Christian morality and the directives of the Church's Magisterium" (Apostolic Letter given Motu proprio, Vitae mysterium, 11 February 1994, n. 4; ORE, 9 March 1994, p. 3). 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.
4.I therefore renew my heartfelt appeal so that scientific and biomedical research, resist every temptation to human manipulation, dedicate itself firmly to exploring ways and means to sustain human life, to treat disease and to solve the new problems that arise in the biomedical domain. The Church respects and supports scientific research when it has a genuinely humanist orientation, avoiding any form of instrumentalization or destruction of the human being and keeping itself free from the slavery of political and economic interests. In presenting the moral orientations dictated by natural reason, the Church is convinced that she offers a precious service to scientific research, doing her utmost for the true good of the human person. In this perspective, she recalls that, not only the aims, but also the methods and means of research must always respect the dignity of every human being, at every stage of his development and in every phase of experimentation.
Today perhaps more than in other ages, given the enormous developments of the experimental biotechnologies that deal with the human being, scientists must be aware of the insuperable limits that the protection of the life, the integrity and dignity of every human being impose upon their research. I have often returned to this subject because I am convinced, with regard to certain results and claims of experimentation on human beings, that no one can remain silent, and especially not the Church, whose present silence would in the future be condemned by history and even by the devotees of science themselves.
5.I would like to address a special word of encouragement to Catholic scientists so that they may make a competent and professional contribution in the sectors where help is more urgently needed for the solution to problems that affect human life and health.
I especially direct my appeal to the institutes and universities endowed with the title of "Catholic", that they endeavour to measure up to the high standard of the spiritual values that presided over their beginnings. We need a true and just movement of thought, and a new culture of a high ethical character and of unexceptional scientific value to promote a genuinely human and effectively free progress in research.
6.One last observation is necessary: there is an increasingly urgent need to fill the very serious and unacceptable gap that separates the developing world from the developed in terms of the capacity to develop biomedical research for the benefit of health-care assistance and to assist peoples afflicted by chronic poverty and dire epidemics. I think especially of the tragedy of AIDS, which is very serious in many African countries. It is essential to realize that to leave these peoples without the resources of science and culture means to condemn them to poverty, financial exploitation and the lack of health care structures, and also to commit an injustice and fuel a long term threat for the globalized world. To value endogenous human resources means to guarantee the balance of health care and, in short, to contribute to the peace of the whole world. Thus the relevant moral dimension of biomedical scientific research necessarily opens to the dimension of justice and international solidarity.
7.I hope that the Pontifical Academy for Life, that begins its 10th year, will take this message to heart and will ensure that it reaches all researchers, believers and non-believers, and contribute in this way to the mission of the Church in the new millennium.
To support this special service, that is dear to my heart and necessary for humanity today and tomorrow, I invoke upon you and upon your work the constant help of God and the protection of Mary, Seat of Wisdom. As a pledge of heavenly light, I gladly impart to you, to your family members and colleagues, my Apostolic Blessing.
(original version, in Italian, published in "L’Osservatore Romano", Lunedì-Martedì 24/25 Febbraio 2003, p. 5)
JAVIER LOZANO BARRAGÁN
NEW PARADIGM: ROOTS AND PROPOSALS
Attending to United Nations meetings, and seeing the different positions of the Governments in the World about the principles and values according to which one must build the Bioethics, I tried to find an ethical system from which one can logically understand those official issues. Between several settlements I find finally the right material to construct the synthesis. This system is called the New Paradigm, that now I will expose synthetically in the first part of my talk. Once individualizing the system, I thought it was necessary to go to his roots. Some of them I will present in the second part, and in the third part I will make some evaluation and positive proposals.
THE NEW PARADIGM [1]
It is strange that in the matter of Ethics the norms will have a compilation into a Paradigm that in its own concept for many is only a hypothesis and properly not required to be truth. And it is still more strange that one can configure norms not according to the truth; but the fact is that we have now this Paradigm and it is taken as supreme law for many Departments of Health in the World, and guides the behaviour of many Bioethics Committees. I synthesize it in 12 points:
The authors
Within the United Nations, the World Health Organisation and UNESCO, were requested to accept this Paradigm in particular by three NGOs: "The Women's Environment and Development Organisation", "The Earth Council Green peace" and "The International Planned Parenthood Federation". They have adopted a series of principles within the context of what is called 'new ethics' or 'global ethics'. Some of their significant points are as follows:
The global development
Today's world, as it is, cannot go on; after the Cold War we are faced with unsustainable ecological situations, we are going towards a total degradation of the planet because of pollution caused by toxic refuse of every kind, as well as radioactive waste. All of this brings us a constant malaise that continue cannot go on. We need to work for the everyone's well-being and prosperity. We need to achieve global prosperity and well-being.
The sustainable development
Such global prosperity and well-being is possible only with global development and not with that kind of development which has been achieved so far. This is because such development can no longer be sustained. We should achieve SUSTAINABLE development, that is to say development that will no longer damage the planet, where, indeed, through harmonious development, there will be prosperity and well-being for everyone, a prosperity and well-being that centres around the person.
The quality of life
Global prosperity and well-being with sustainable development is the aim of the new global ethics. It is that convergence towards which the new paradigm is directed. This global prosperity and well-being is what constitutes that goal known as QUALITY OF LIFE, which is defined 'as the perception of the individual of his position in life, in the context of the culture and the system of values in which he finds himself, in relation to his goals, expectations, standards and interest'. This is a concept of life of vast range that embraces in a complex way the physical health of the person, his psychological state, his personal beliefs, his social relations and his ability to relate to the relevant data of his environment (WHOQOL).