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UK Research Sponsors address concerns about misuse of biomedical research

The UK’s three leading bioscience research funding agencies have recently (8 September 2005), published a joint policy statement on reducing the risk of the research they fund being misused for harmful purposes by terrorists or others.

The Medical Research Council (MRC), the Wellcome Trust and the Biotechnology and Biological Sciences Research Council (BBSRC), issued the statement in light of public concerns that bioscience research could be misused in the development of bioweapons.
Their statement builds on existing policies and processes that the MRC, Wellcome Trust and BBSRC already have in place to ensure that the research they support meets the highest ethical and scientific standards.

Working in unison, the MRC, Wellcome Trust and BBSRC conducted a consultation exercise with members of the funding and advisory committees across the three organisations. This examined how existing procedures might be strengthened to heighten awareness amongst the scientific community and identify and assess risks of misuse at the initial grant application stage.

The consultation has led to a series of common changes to each organisation’s policy statements, guidance and procedures. These will include changes to funding application forms, the development of clear guidance for funding committees and modifications of organisational guidelines on good practice in research.

Colin Blakemore, Chief Executive of the Medical Research Council said:

The medical research community recognises that there are concerns about possible harmful uses of civil research. These additional safeguards in our assessment processes will draw such issues more clearly to the attention of applicants for MRC funding and encourage them to address any areas for potential misuse of their research at the earliest possible stage. Of course, such measures on their own will not prevent the efforts of a determined terrorist, but this is a positive step by the research community to raise awareness and reduce the risks.”

Dr Mark Walport, Director of the Wellcome Trust said:

We understand that many people are alarmed by the threat of bioterrorism. But we need to balance these fears with sensible and practical measures that will help us manage such risks while ensuring that the benefits of research are realised. We hope the policies we have adopted both reassure the public and encourage the scientific community to remain vigilant to the risks of misuse. There are many deadly infectious agents and it is vital for public health that the scientific community can pursue legitimate research to understand and treat these diseases.”

Professor Julia Goodfellow, Chief Executive of the Biotechnology and Biological Sciences Research Council (BBSRC) said:

Advances in fundamental bioscience research have the potential to be misused in bioterrorism. This risk is not new, nor is it restricted to high-tech areas of science or those directly related to human health. Adopting this common policy with the other two major funders of bioscience research will heighten awareness amongst the whole of the biological science community.”

Joint BBSRC, MRC and Wellcome Trust policy statement

The BBSRC, the MRC and the Wellcome Trust have each issued position statements on bioterrorism and biomedical research. These cover issues such as: balancing benefit and risk; funding decisions; dissemination of research; international collaboration and training; and promoting research best practice and ensuring public trust. The position statements are available on the organisations’websites.

The position statements propose that a system based upon self-governance by the scientific community will ultimately provide the most effective means of managing risks of misuse. They suggest that the community should take active steps to further develop mechanisms of self-governance, and that through doing so the community can ensure that responsibly conducted research is not unnecessarily obstructed.

The BBSRC, the MRC and the Wellcome Trust already have rigorous processes in place for ensuring that the research we support is of the highest scientific quality and conforms to all relevant ethical and regulatory requirements. In light of concerns over research misuse,we have been working in partnership to examine how these existing procedures could be strengthened to help ensure that risks of misuse associated with research projects are identified and assessed at the grant application stage, where it is possible to do so.

The MRC has consulted members of funding and advisory committees across the three organisations, on the basis of a discussion document. The outcome of this has led the BBSRC, the MRC and the Wellcome Trust have agreed to change their policy statements, guidance and procedures in four areas:

  • _ Introduction of a question on application forms asking applicants to consider risks of misuse associated with their proposal;
  • _ Explicit mention of risks of misuse in guidance to referees as an issue to consider;
  • _ Development of clear guidance for funding committees on this issue and the process for assessing cases where concerns have been raised;
  • _ Modification of organisational guidelines on good practice in research to include specific reference to risks of misuse.

The misuse of research for terrorist purposes may be only one of a number of possible ways in which the outcomes of research could conceivably result in harm. Therefore, these changes refer to all kinds of research misuse. They have been introduced to heighten awareness, and as a means of identifying possible risks of misuse at an early stage. Ultimately what matters most is people’s motives. The changes to the processes of the funding bodies will not be sufficient on their own to prevent misuse by somebody with that primary intent. Other processes within the research environment are also important; these include effective research governance at the local (institutional) level, appropriate levels of caution in making appointments, and compliance with existing health and safety regulations.

 


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