Managing risks of research misuse

As funders, BBSRC, the MRC and the Wellcome Trust strive to support research of the highest scientific and ethical quality that will advance knowledge and its application to deliver benefit to the public. We recognise, however, that there is a risk that the results of some types of research which are funded in line with this objective, could also potentially be misused to cause great harm (for example, to develop biological weapons). In this statement, we set out a shared approach to managing these types of risks, and describe how we think the broader research community should play their part.

We have agreed a common joint project [PDF 229KB] statement on managing risks that the outputs – in terms of the knowledge, products and/or technologies – resulting from the research we support could be misused for harmful purposes. While our position is restricted to the life sciences, we believe the principles and approach set out could be readily applied to other research disciplines.

Research which poses significant risks of this type has been referred to as ‘dual use research of concern’. In our position statement, we adopt the US government’s definition of this term, which is “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products and technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material or national security”.

Our joint statement covers issues such as:

• balancing benefit and risk
• dissemination of research
• international collaboration and training
• promoting good research practice
• ensuring public trust.

While such risks must be considered and managed in an appropriate manner, our view is that responsibly conducted research – including that involving potentially harmful biological agents – must not be unduly restricted. Indeed, such research will be absolutely vital in the fight to combat disease and address other major societal challenges.

We believe that a system based primarily upon self-governance by the scientific community, but drawing on the inputs of other key stakeholders, will ultimately provide the most effective means of managing risks of misuse. We suggest that the community, of which we as funders are part, 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. Crucially, this process must be underpinned by an active ongoing dialogue between researchers and other key stakeholders, including Governments and security services.

BBSRC, the MRC and the Wellcome Trust each 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, and in consultation with our research communities, we have implemented five key provisions in our grant application processes and funding requirements to help ensure that risks of misuse associated with research proposals are identified and assessed during the grant funding process, where it is possible to do so.

These five steps are:

• inclusion of a question on application forms requiring applicants to consider short and medium-term risks of misuse associated with their proposal
• explicit mention of risks of misuse in guidance to external experts who peer review grant applications 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 guidelines on good practice in research to include specific reference to risks of misuse.
• a requirement to notify funders, and other relevant authorities, of any change in the status of a dual use risk or any new risks that may emerge during the course of a funded research project that were not anticipated in the original application.

These actions are intended to heighten awareness, and are a means of helping to identify possible risks of misuse at an early stage. Ultimately what matters most is people's motives, and an awareness of the possible motives of research users. The changes we have implemented in our processes will not be sufficient on their own to prevent misuse by somebody with the primary intent to do harm, nor will they identify new risks that arise as the research progresses. Other processes within the research environment are therefore also important. These include effective research governance at the local (institutional) level, appropriate levels of caution in making appointments, provision of appropriate training and education, and compliance with existing biosafety and biosecurity regulations.