L Huober, C Buccelli
L Huober, C Buccelli. Ethics Committees in Europe: The Future. The Internet Journal of Law, Healthcare and Ethics. 2006 Volume 4 Number 2.
Although in past Europe, has been a whole of nations with different ethical, philosophical, historical and religious bases, that have often brought to completely divergent decisions in ethical field, today appears as a new and homogeneous political and economic reality.
The faster and faster scientific and technological progress has given birth to serious ethical questions, that we needs to keep in mind when we appraise the biomedical, scientific and technological progress, and the new EU itself to found have to give valid answers to such question.
On January 27 and 28th 2005 , the Conference “Research Ethics Committees in Europe: Facing the future together” was held in Bruxelles.(1)
The main purpose of such a lecture was the intent to start a debate in order to define the methods, to analyze the role of ethics, of science, and to open a dialogue among Member States of the European Union on the future initiatives and actions of the sector.
The Conference held in Bruxelles was born as an attempt to give further indications for the definitive and complete application to the national regulations of scientific research of the directive 2001/20/CE (2) of the European Parliament and of the device of the European Council of April 4 2001 concerning the reapproaching of the legislative, regulation and administrative dispositions of Members States related to the application of the good clinical practice in the execution of the clinical experimentation of medicine to human use.
In all the 25 countries that compose the EU various national systems of Ethical Committees, have come to estabilish working to different levels.(3,4,5,6)
Also in the other European countries, not involved yet in the European Union, bodies of ethical revision of the activity of scientific research have a risen, and in any case they belong to the ERA, the European (scientific) Research Area.
The main problem faced in the lecture of Bruxelles was that the Committees, even if diffused in the whole continent in more or less homogeneous way, all worked following different rules.
The aim, therefore, was to have applied, in a homogeneous way, the European Guide lines, these lines have been elaborated with the goal to establish a greater degree of scientific effectiveness and procedural responsibility in the activity of the Ethics Committees in Europe.
It has been proposed to create a round table to start a debate through which the EC can develop specific procedures to develop their functions inside the research.
The international meeting “Facing the Future”, has also been proposed as moment of closing of the Sixth Framework program of the European Union.
The Sixth Framework Program is the most important tool of realization, of incentive for the innovation and the improvement in the practical use of the results of the research through their transformation in commercial technologies to be used in the whole Union, also in the new Members States.
Since June 16th 2004, the European Commission has adopted a communication:”Science and technology: key elements for the future of Europe”, to guarantee to the EU a role of first-rate in the research and in the technological development.
Such Communication suggested the doubling of the endowment destined to the European research; this endowment was raised to 10 million of Euros for the period 2007-2013, that is the years of duration of the following Seventh Framework Program.
The Sixth Framework Program - the last of a series of community actions aimed to finance the research –has smoothed the way to research and innovation, trying to gather the lost activities constituting a strong structure of support.
Such structure is denominated ESR, European Space of Research, a base for gathering and intensifying made by EU efforts to support the research coordinating them with the National and International measures.
The purpose of the ESR is to drive and to optimize the activities of research and to address Europe toward a policy of innovation, guaranteeing in such way the economic and competitive future of the Union.
Besides the 6FP 2002-2006, has assembled on the research of high quality, to improve and to integrate the science and the research in Europe.
In detail the principal themes are:
Sciences of the life, genomics and byotecnologies for the health
Technologies for the society of the information
Nanotecnologies for nanosciences, multifunctional materials founded on the knowledge, new devices and processes of production
Aeronautics and Space
Safety and food quality
Sustainable development, global change and ecosystems
Citizens and governance in the society of the knowledge
A 6FP important characteristic is the creation of new tools of financing - the nets of excellence and the integrated projects - to constitute a critical mass of competences and resources so that to achieve more ambitious objectives of research.
During the Lecture placed in Bruxelles, it has been realized that the efficiency and the transparency of a system of revision and ethical control, depends on a clear framelaw, able to control the situation in a uniform way.
The French system, with the creation of a framelaw comprehensive of all the matters connected to the research and the Ethical Committees it is a positive example to hold in consideration.
The concept of “self-esteem” exasperated in France, is, sometimes, a positive concept, and it should be also considered in the countries where the Committees operate, partly on the base of regional norms, partly on the professional normative and finally on the base of a feared scientific self-control.(7)
Such differences have not been eliminated, as they hoped, from the knowledgment receipt of the European directives on the regulationes of good clinical practice, so that the Union, has “tolerated” the persistence of a pluralism of systems of Ethical Committees, of different operational systems of research, of discordant evaluations in the importance that the same activity of search covers in the various states.(8)
Traced the frame of the Ethical Committees in Europe, the Lecture proposes to point out a line to follow, to give a starting point for the conception of a “unique system” regulating the activity of research and the functions of the Ethical Committees in the whole European Continent.
The European Council has so taken the decision to create a “European Space of Research” coordinated in all his functions (essential aspect in the context of a study of the formalities of government of Europe).(9)
A unique and coordinated system, in fact, would strengthen the assignment of monitoring of the same research.
Using the words of an Australian researcher, K. Jamrozik:
“It would be better that the Ethical Committees spent less time to review the protocols and much more time to follow the course of the research.” (10)
As to say that it is necessary to favour the transformations of the society and the progressive change of the rules.
But will the revolution of the Ethical Committees realize, and with which resources?
In the last years, there has been no document, guidelines, directive and national normative, that concern the activity of search, that has not exalted the role of the Ethical Committees as public guarantors of the ethicality of the searches: “Why then should hesitate to ask or rather, to pretend, that economic and political investments correspond to this exaltation, as they are necessary to give the Committees, at least in the future, the necessary material conditions to acquit to their assignments?”