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. 2021 Sep 15;44(11):1193–1208. doi: 10.1007/s40264-021-01111-w

Table 3.

The International Risk Governance Council Framework [12, 13]

Risk scenario type Risk management strategy Discourse type for stakeholder engagement
Simple risk, i.e. causal links of risk and effectiveness of risk minimisation action can be established Assessment of benefit–risk evidence, and evidence-based decision on risk minimisation action Instrumental discourse of regulators/enforcement personnel, manufacturers and representatives of directly affected populations to put risk minimisation action into practice (no broad stakeholder representation necessary)
Complex risk, i.e. it is difficult to identify and quantify causal links of risk due to the multitude of potential causal agents, possibly with interactive effects, time delays between cause and effect, and intervening variables Assessment of benefit–risk evidence and its strength/gaps with transparent judgements on risk acceptability and possible actions, and decision on reasoned and proportionate risk minimisation action Epistemological discourse of experts and others from all stakeholder groups who can bring knowledge to resolve cognitive conflicts and to agree on risk characteristics, best risk estimates and reasoned risk minimisation action
Uncertain risk, i.e. it is difficult to decide on risk minimisation action due to persisting, currently unresolvable complexity Assessment of benefit–risk evidence that requires making assumptions given incompleteness of evidence, and decision on reasoned and proportionate precautionary action Reflective discourse of all major stakeholders to cope with uncertainty and collectively assess the risk, impact and acceptable, balanced trade-offs of possible actions, and to agree on reasoned precautionary action
Ambiguous risk, i.e. divergent perspectives exist on the rationale for action due to several meaningful and legitimate interpretations of accepted risk assessments Assessment of benefit–risk evidence, and conflict resolution for decision on risk minimisation or precautionary action Participative discourse of all stakeholders, including directly and indirectly affected populations in the public domain to reframe the risk issue, build tolerance, find consensus on the dimensions of ambiguity that need to be addressed in balancing trade-offs, discuss openly all issues brought up by stakeholders with respective arguments, beliefs and values, identify common values and equitable solutions and agree action satisfactory to all stakeholders (broadest and most inclusive stakeholder representation necessary)