Position statement on bioterrorism and biomedical research

Introduction

1. The mission of the Wellcome Trust (the 'Trust') is to foster and promote research with the aim of improving human and animal health.

2. In furthering its charitable mission, the Trust funds a significant body of basic and clinical research in the fields of infection and immunity, pathogen and host genetics, and tropical medicine, both in the UK and at centres of excellence in developing countries. Such research is essential in order to improve our understanding of the pathology of infectious diseases of humans and animals. This knowledge will enable the development of improved diagnostics, vaccines, therapeutics and other control strategies to alleviate the suffering and the social and economic burden that such diseases cause throughout the world.

3. The Trust is aware, however, that in light of global events, biomedical research that involves the use of potentially harmful pathogens and toxins has come under increased scrutiny, and that there are heightened concerns that the misuse of this research could increase the potential threat of bioterrorist attacks.

Balancing benefit and risk

4. The Trust recognises that there are particular concerns regarding research that could directly result in, or enable the future development of, pathogens and toxins which could potentially serve as bioweapons. A committee convened by the US National Academy of Sciences recently identified seven classes of experiment to illustrate the types of endeavour that would require careful review by informed experts1. The experiments this committee specified are those that would:

demonstrate how to render a vaccine ineffective
confer resistance to therapeutically useful antibiotics or antiviral agents
enhance the virulence of a pathogen, or render a non-pathogen virulent
increase transmissibility of a pathogen
alter the host range of a pathogen
enable the evasion of diagnostic and detection modalities
enable the weaponisation of a biological agent or toxin.

5. The Trust considers that in order to address these legitimate concerns, it is important that appropriate processes exist at institutional, national and international levels for the review and oversight of research that could result in such outcomes.

6. The Trust would emphasise, however, that further research involving harmful biological pathogens and toxins will be crucial in the fight to combat the diseases that these agents cause and to improve our ability to respond to bioterrorist attacks. In most cases the risks associated with such research will be minor in comparison with the potential benefits. The Trust considers that the creation and dissemination of scientific knowledge is a definite and tangible public good, which would need to be set against risks that may sometimes be hypothetical and hard to quantify.

7. The Trust believes, therefore, that regulatory processes must not unduly restrict this essential research. Any additional regulatory requirements that may be introduced should apply only to those research projects where there is tangible cause for concern. The Trust expects that this will represent a very small proportion of the many research projects undertaken in academic research laboratories that involve the use of pathogens and toxins.

Wellcome Trust funding decisions

8. To ensure that the research the Trust funds is in line with its mission and is of the highest scientific quality, all Trust-funded research is independently peer reviewed by experts. Reviewers are required to consider whether the proposed methodology is appropriate for achieving the stated objective and they may raise any ethical or safety concerns that they have regarding a particular application. The Trust will develop specific guidance for reviewers and applicants on the issues addressed in this statement.

9. The Trust would emphasise, however, that it will often be extremely difficult at the grant application stage to identify projects which could generate results that might theoretically be misused, and assess accurately the extent of any such risk.

10. As a condition of grant support, institutions in receipt of Wellcome Trust funds are responsible for ensuring that they comply fully with the requirements of all regulatory authorities for the storage, use and transfer of harmful biological materials, and any additional provisions to safeguard security that may be specified by such authorities. Institutions also accept full responsibility for the management, monitoring and control of all research work funded by grants, and for ensuring that permanent and temporary staff and students employed to undertake such work receive training appropriate to their duties.

11. The Wellcome Trust Sanger Institute ensures that it meets the requirements of all regulatory authorities, and that any ethical implications are considered through appropriate mechanisms in developing its research programme. With regard to its work on pathogen genomics, the Sanger Institute has robust mechanisms in place to ensure compliance with relevant regulatory instruments for safe use, security and transfer of the agents and genetic materials derived from them.

12. The Trust has established a Standing Advisory Group on Ethics (SAGE) to consider and advise the Trust on any major ethical issues associated with applications for funding that cannot be addressed through the standard procedures of local ethical review, and the Home Office Inspectorate (for animal experiments) or Research Ethics Committee (in the case of studies involving human subjects).

13. If a situation arose where concerns had been raised that an application had a serious risk of misuse associated with it, and such concerns could not be resolved through these mechanisms, then the Trust would not fund that application. The Trust would anticipate, however, that such circumstances would be extremely rare.

Dissemination of research

14. The Trust considers that it is essential to the progress of biomedical research and its ultimate application to healthcare that researchers the world over have access to research findings so that they can verify, build upon and apply this knowledge. In the vast majority of cases, the interests of the international research community, and ultimately the public, will best be served when the results of research are disseminated through publication in peer-reviewed journals.

15. The Trust would be concerned by the introduction of any limits on publication which threatened the principle of open communication in science. It endorses fully the view stated by the National Academy of Sciences Committee that the dissemination of research results in the context of scientific publication should be based on the voluntary self-governance of the scientific community, and not be subject to formal regulation by governments.

16. The pre-publication release of fundamental genomic information into public domain resources, including data pertaining to pathogenic organisms, has been of enormous benefit to the research community. It is the Trust's view that the benefits of sharing such data greatly outweigh any potential risk of misuse. The Trust will continue to support pathogen genomics projects at the Sanger Institute and elsewhere that generate data on infectious disease agents and make this information freely available to all.

International collaboration and training

17. The Trust would likewise be concerned by the introduction of processes that could unreasonably restrict the ability of talented scientists from overseas to work and train in UK laboratories, or inhibit the ability of scientists in the UK to collaborate with scientists overseas. In considering the introduction of any changes to existing regulatory processes, the Trust would urge the UK Government to consider the immense contribution made by these individuals to the UK science base and the crucial importance of international collaboration to the scientific enterprise.

Promoting research best practice and ensuring public trust

18. It is the Trust's view that a system based upon self-governance by the scientific community will ultimately provide the most effective means of managing risks of misuse, the assessment of which will often require expert scientific judgement. The Trust considers that the community should take active steps to further develop mechanisms of self-governance, and that through doing so it can ensure that responsibly conducted research is not unnecessarily obstructed.

19. Discussions on such mechanisms will need to involve scientists from relevant disciplines and representatives of professional societies, funding agencies, regulatory bodies and other key stakeholders. The Trust intends to participate actively in these discussions, and will explore how it can work to stimulate this process. In taking these discussions forward it will be important for the scientific community to maintain an active dialogue with governments and security services to ensure that their requirements and concerns are addressed.

20. In order to promote best practice in the conduct of research and maintain public trust, the Trust considers that the international scientific community must take proactive steps to ensure that its members are aware of potential risks and concerns relating to terrorist misuse of research, and of the regulatory and ethical responsibilities that they hold.

21. The Trust considers that the development of a 'code of conduct' for scientists could play an important role in this regard. The Trust intends to engage with the UK Government and other scientific organisations in further discussions on this issue.

22. It is essential that the international scientific community engages effectively with society in addressing these risks. The Trust is committed to fostering public engagement on the issues raised by advances in biomedical science, and will consider how it can work in partnership with other organisations to engage the public on the issues addressed in this statement.

23. The Trust considers that the risks associated with the potential misuse of scientific research for terrorist purposes must ultimately be addressed internationally, and that efforts to raise awareness and develop best practice among the research community will need to be implemented globally in order to be effective. The further development of processes to build international consensus on these issues will therefore be crucial.

1See: 'Biotechnology Research in an Age of Terrorism' (The National Academies Press, October 2003).