Some risk issues involve contextual factors that need to be understood and addressed before making a decision. Such factors may include social, legal or ethical concerns specific to the issue. If you identify significant contextual factors when preparing the Issue Characterisation Checklist, you can conduct an assessment to gauge their possible impact on the decision. Records of previous decisions and discussions may be a helpful source of information. A contextual assessment may also require the involvement of subject-matter experts.

Actions

• Conduct the required reviews (see below). This involves gathering relevant information and assessing how it might shape risk management decisions. In your analysis:
• Social concern and risk perception review:
  This review considers the level of awareness and concern about an issue in society, which is often reflected in the amount and type of media coverage of the issue. Understanding these
  concerns can help shape the risk communication strategy.
  Questions to consider:
  • Does the situation involve a lot of media coverage, high-profile people, or controversy?
  • Is the hazard unfamiliar? Is transmission unclear? Are the effects potentially serious?
  • Is the risk perceived as involuntary? Is the perceived risk higher than the actual risk?
  • Is the situation linked to a previous controversy?
  • Is there a perception that the blood operation has contributed to the risk?
  • Is there a history of poor relationships with stakeholders and the public?
• Ethics review:
  This review explores ethical issues of significant concern to specific groups or the general public. questions to consider:
  • Does the situation involve an ethical issue?
  • Has the ethical issue affected public policy in the recent past?
  • How might the issue affect the public perception of the risk?
  • Is the risk perceived as unfair?
  • Does the risk outweigh the benefits?
  • Are the risks and benefits distributed unfairly within society?
  • Does an excess risk fall to specific groups?
  • Does the issue involve vulnerable groups?
  • Has there been a lack of consent or access to information?
• Other reviews if needed (e.g., legal issues, jurisdictional differences)
  • For example, the ramifications of a blood safety decision by blood operators in another jurisdiction or legal consequences associated with a risk management option.
  • A contextual assessment should be conducted at a level of detail appropriate to the nature and significance of the issue. The output is a written description and analysis of
    relevant factors.
• Prepare a brief written summary of the contextual assessment.