BRUSSELS, Belgium — The European Union is introducing a new level of control into its $5 billion-a-year research program — an ethical assessment, which will especially impact biotechnology and life sciences research.

Right now the EU is preparing its so-called fifth research framework program, which is scheduled to fund R&D from 1998 to 2002 as soon as it is approved. But a committee of experts has come up with a new requirement covering the ethical aspects of the program, even before any research gets under way.

"It is for the European Commission [the EU's rule-making and rule-enforcing body] to submit the research projects that it finances to certain requirements and to an ethical evaluation."

The committee is the group of advisers on the ethical implications of biotechnology — independent experts nominated to offer guidance to the commission on tricky life science issues.

It says in its opinion, "Research into bioethics and the social sciences is necessary both for an understanding of the ethical implications of research into biotechnology and genetics and for the ethical assessment of this research. Thus, bioethics research and research ethics are complementary."

It goes on to speak of various "levels of assessment," initially covering a project's implementation (including, for "particularly sensitive" subjects, assessment by independent panels of experts), and then the declared aims of the project and the envisaged applications of the results, in which "the precautionary principle must be respected."

The opinion goes on to a "third level" of ethical assessment, where it admits that it "is up against the complexity and unforeseeability of all the possible uses and consequences of the results of research." This is all the more difficult, it says, "in that it is bound up with conceptions of the future of society in general. This ethical assessment is therefore more a subject for public debate and for national and community sociopolitical bodies."

There are other desiderata set out in the group's opinion.

It wants research ethics to oblige researchers to abide by a code of conduct "entailing rigor and intellectual probity both with regard to defining and conducting research projects and in relation to the presentation and interpretation of the results of research (including when these results are negative and even where there are commercial pressures on research)." And "in order to be conducted competently, an ethical assessment of research needs to be supported by research in bioethics."

This type of research and, more widely, social sciences research should continue to be encouraged at the community level, says the group. The analysis of ethical questions on controversial and publicly debated research issues should be encouraged even on practices such as gene germline therapy — which is in any case excluded from funding under the EU research program, under an earlier EU decision. And the group urges "strengthened" studies at the EU level on the interactions between research and development and society (such as dialogue among the scientific community, the public and the media, it suggests).

It says the European Commission should set up a regularly updated information system concerning all the ethical and legal data related to life sciences at both national and international levels, and should ensure that links are established with national ethics committees and similar national bodies in the member states.

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