Code of Conduct: Working with Highly Pathogenic Microorganismsand Toxins

German Research Foundation (DFG) Senate Commission on Genetic Research
13 March 2013

In recent years there has been rapid development in research in the field of infections, immunity and pathogenicity factors. The use of highly pathogenic microorganisms in research
has yielded important scientific findings. The function of bacterial toxins, the entry andspread of highly pathogenic viruses in host cells and the relationship between cellular andhumoral immunity and highly pathogenic microbes are all examples of areas of research thatoffer important potential for both basic research and the development of new diagnostic
methods, treatments and vaccines.
However, the use of highly pathogenic microorganisms and toxins comes with the risk that
research findings could be used to develop biological weapons. This is referred to as the'dual use problem', and it is not limited to research involving highly pathogenic microorganisms and toxins. Examples of findings which are affected by this problem can also be foundin other fields, such as materials science, computer science and even the social sciences.
There exists a consensus that public safety should be considered the highest priority. However, we must also consider the benefits to human health that can be achieved through research with pathogenic organisms, as well as freedom of research and freedom of publication.

The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has discussed the dual use problem on many occasions in its statutory bodies. The DFG wants toprovide researchers with a code of conduct which addresses the problems of working withhighly pathogenic microorganisms and toxins and responds to the specific situation in Germany. The DFG has therefore drawn up the following recommendations for researchers
working with highly pathogenic microorganisms and toxins:

1.

The DFG agrees with the decision of the National Research Council of the National
Academies in the USA, which believes the following experiments to be particularly relevant to the dual use problem:•Efforts to increase the virulence of pathogenic microorganisms or to convert apathogenic microbes into pathogenic microbes•Experiments to induce resistance to effective antibiotics and antiviral substances

DFG Senate Commission on Genetic Research
Code of Conduct: Working with Highly Pathogenic Microorganisms and Toxins
13 March 2013

DFG

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Experiments to increase the transmissibility of pathogens•

Experiments to modify the host spectrum and stability of pathogens•

Efforts to avoid methods of diagnosis and detection•

Efforts to disclose the ineffectiveness of vaccines•

Experiments to make biological agents or toxins more suitable for use as weapons(weaponisation)

2.

The DFG believes it is necessary to carry out research work with pathogenic microorganisms and toxins. This is the only way in which we can develop strategies to combat
dangerous pathogens and protect the population against infections. In addition, many
findings in basic research have been the result of work involving highly pathogenic microorganisms and toxins. The DFG therefore believes that as few restrictions as possible should be imposed on research involving pathogenic microorganisms.

3.

However, the DFG also promotes a responsible approach to work of this type. It expects
researchers to evaluate their experiments at the planning stage and before starting workwith regard to a potential dual use problem and to document this evaluation process in
the laboratory records. This applies to the experiments themselves and to planned publications.

4.

The DFG will continue to fund research which addresses problems relating to highly
pathogenic microorganisms and toxins. However, principal investigators should address
an existing or potential dual use problem in their proposals. Reviewers are requested toassess the information provided by applicants and make a recommendation to the review boards.

5.

In the case of proposals where the dual use problem is applicable, the review boards
will - if necessary following preparation in an ad hoc working group - carefully examine
the proposals and, if appropriate, make suggestions as to how the proposed work
should be carried out. If necessary the responsible Senate Commission and/or the Senate may be involved in the process.

6.

The DFG does not believe that preventing the publication of sensitive findings is aneffective way of minimising misuse. It believes that researchers must be allowed to continue publishing data relating to highly pathogenic microorganisms and toxins in peerreviewed journals. The publication of research data is a central requirement for scholarlyself-evaluation. Only known dangers can be countered. The specific publication guidelines of the journals in question should always be observed.
DFG Senate Commission on Genetic Research
Code of Conduct: Working with Highly Pathogenic Microorganisms and Toxins
13 March 2013

DFG

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The DFG believes it is necessary to continue funding international cooperation, academic exchanges and the sharing of data, materials and methods in relation to research on pathogenic microorganisms and toxins. The appropriate national and international laws and guidelines must of course be observed.

8.

The DFG suggests that universities and non-university institutions should regularly
hold seminars and other events for students, doctoral researchers and postdoctoral
researchers on the subject of working with highly pathogenic microorganisms andtoxins. The annual briefings required by the Genetic Engineering Act also provide an
opportunity to raise awareness of the dual use problem. Research Training Groups,
graduate schools, Collaborative Research Centres, research centres and clusters ofexcellence in relevant disciplines also provide suitable opportunities.

9.

The DFG advocates the continued development of best practice in connection withhighly pathogenic microorganisms and toxins and the ongoing adaptation of the scientific framework. Findings should be shared with other organisations within Germany and abroad, for example the Medical Research Council (MRC) and the Wellcome Trust in the UK and the American Society for Microbiology (ASM). Relevant
specialist associations and scientific academies could also make important contributions to this process.

DFG Senate Commission on Genetic Research
Code of Conduct: Working with Highly Pathogenic Microorganisms and Toxins
13 March 2013

DFG