There is no universal methodology on assessing and managing risks of potential dual-use research. However, there are a number of relevant documents on dual-use assessment, highlighted from different perspectives and frameworks, which are shown here.
Assessing and managing dual-use risks is multi-faceted and involves multiple objectives, multiple stakeholders and different management tools and mechanisms. The potential risks and possible benefits must be weighed. But how much weight do all aspects weigh? For the assessment and implementation of effective risk management measures, it is important to establish values and principles as stated in the WHO document 'Global guidance framework for the responsible use of the life sciences'. These can serve as a common language between stakeholders when social, cultural and religious beliefs and ethical values differ.
In general, an important first step in dual-use assessment is that scientists are aware that their research may involve risks. Awareness can be increased on the one hand through education and training, but on the other hand also through contact with direct colleagues or the Biorisk Management Advisor (BMA) of the organization. Researchers who are aware of possible dual-use risks are often better able to identify such risks.
Phase 1
Monitoring and identification of dual-use risks
Monitoring and identifying dual-use risks is the first phase in the assessment. The Dual-Use Quickscan can help with this, as this tool has been specifically developed for the researcher to quickly and efficiently test the research for possible risks. The tool can be used at any time during the research, from grant application to final publication of the research. The BMA can estimate for whom within the organization the Dual-Use Quick Scan is relevant. The questions in the tool are mainly intended to stimulate the thought process about possible dual-use aspects of the research and can therefore form the starting point for a conversation about the possible dual-use nature of the research. In addition, the results can also be discussed with direct colleagues with the aim of creating awareness about dual-use aspects of the research. This raises awareness more broadly within the department or research group than just about the research in question.
After completing the tool, the results can be shared with the BMA. If the results do not give reason to assume that there may be dual-use aspects to the research, then phase 2 does not need to be started. However, if the researcher or BMA is of the opinion that there may be dual-use risks, phase two can be started. The Dual-Use Quick Scan must be completed periodically for adequate monitoring and optimal awareness.
Phase 2
Dual-use risk assessment in consultation with the BMA
In this second phase, the researcher can consult with the BMA to discuss the results of the Dual-Use Quickscan in more detail. In this conversation it can be determined whether there are indeed dual-use aspects associated with the research. The purpose of the dual-use assessment carried out by the BMA is to substantiate the possible dual-use aspects of the research and whether the organization can, may and wants to conduct the research. To this end, the possible benefits of the research are compared against the risks of the research. During this consultation, a risk assessment can be carried out and it is discussed which possible risk management measures can be taken to ensure the research runs smoothly and to minimize the dual-use character. It is expected that an organization will carry out this phase for a number of studies every year.
Phase 3
Escalation of dual-use risk assessment
If no clear solution or conclusion can be found in the second phase, or if there is doubt about the possible dual-use character, or if no adequate risk assessment or risk management measures can be carried out, then the third phase can be started. In this phase, an (ad hoc) internal committee (Biorisk Management Committee, BMC, as described in ISO 35001:2019) can be formed that consists of independent researcher(s), BMA, management and possibly supplemented with other disciplines (virology, ethics, policy, communication etc). This committee, in consultation with the management, may have a mandate to make a decision about the continuation or adjustment of the research. If desired, the internal committee can receive support from the Biosecurity Bureau. This phase is expected to occur rarely and will only be for exceptional cases.