Press Release 03/2014

German Ethics Council issues opinion on biosecurity

How shall we deal appropriately with research that aims to contribute to medical progress or other important goals of society, when the results might also be misused by bioterrorists or other criminals? In its opinion on this question, "Biosecurity – freedom and responsibility of research", the German Ethics Council presented today five recommendations to the Federal Government and the public. They range from implementing educational programmes on biosecurity and the development of a national biosecurity code of conduct for responsible research to proposals concerning binding regulations and international initiatives.

Some research results obtained in the life sciences can be used not only for the benefit of individuals and society as a whole, but also misused with intent to cause harm. In 2012, two studies in which the transferability of avian influenza viruses between mammals was artificially increased through experiment initiated an ongoing international debate about life science research that is open to misuse and how to deal with the issues involved.

Research such as this is referred to as Dual Use Research of Concern (DURC), defined as work that can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to cause damage to public health and safety, the environment or to other important legal interests.

At the instigation of the Federal Government, the Ethics Council examined as to whether the existing legal frameworks and codes of conduct in the sciences and in the private sector are sufficient to minimize the potential for misuse of DURC. It has come to the conclusion that, although many regulative instruments already exist, further measures for raising levels of awareness and promoting responsible attitudes as well as legal regulations are needed for a comprehensive risk containment strategy.

Specifically, the Ethics Council advocates firstly heightening the scientific community's awareness of the danger of misuse, secondly the establishment of a national biosecurity code of conduct to deal responsibly with research that may be open to misuse, and thirdly making funding of DURC contingent on approval by a new DURC Commission.

The Ethics Council's fourth recommendation involves suggestions for legally binding regulations. This includes the legal definition of DURC, the appointment of a DURC Commission, the obligation to obtain the advice of this Commission before conducting relevant research and the establishment of a procedure for evaluating the DURC consultation procedure.

The advice to be provided by the DURC Commission is to address in particular the question as to whether the prospective benefits are sufficient to justify taking any risks involved. Further, the Commission should issue recommendations for measures designed to reduce risks, for monitoring, for planned research collaborations and for the dissemination and publication of results from DURC.

Some Council members recommend extending the consultation process to include an approval procedure to be conducted by a federal agency.

In its fifth recommendation, the Ethics Council calls upon the scientific community and the Federal Government to promote the development of biosecurity codes of conduct for responsible research both within the EU and at a global level.

The Opinion can be accessed online here.