A Framework for Strategic Risk Communications Within the Context of Health Canada and the PHAC's Integrated Risk Management

Risks cannot be managed without communication because, as research shows, communication is the most powerful influence on people's risk decision-making and behaviour. Increasingly, communications is being recognized as essential to enabling people and organizations, including governments, to manage risks effectively.

Certainly, this is the case today in Health Canada and the Public Health Agency of Canada (PHAC). Communication -- especially risk communications -- is seen as essential to the Department's ability to accomplish its mission: namely, helping Canadians to maintain and improve their health.

However, decades of research and experience also show that risk communications is too often ad hoc. Resulting shortfalls in communications include creating needless controversies, raising costs unnecessarily, making the risk management process more complicated, and eroding citizens' trust. Clearly, a strategic approach to risk communications that can help avoid these and other problems would provide important benefits to decision-makers and stakeholders alike.

The purpose of this Framework is to support all Health Canada and PHAC professionals involved in risk management activities in integrating effective risk communications into their work. One way it can do this is by fostering and enabling collaboration throughout the Department and the Agency. Building on successful current practices in Health Canada and the PHAC, the Framework outlines a strategic, systematic approach to risk communications within the context of integrated risk management.

The approach is intended to be flexible enough to address internal and external risk communications for all types of risk issues -- from corporate risk issues to health-specific risk issues. It is grounded in the sciences of risk analysis and risk communication, and is consistent with recent guidance from Health Canada, Treasury Board Secretariat, as well as related work in Canada and jurisdictions outside Canada, including the United States, Australia/New Zealand, and the United Kingdom.

As a Department, Health Canada addresses an exceptionally wide range of risk issues. Rather than endeavoring to anticipate all possible issues, the Framework is designed so that each Agency, Branch and Directorate in Health Canada, and the PHAC, can adapt it to the specific requirements of its roles and responsibilities for serving the highest interests of Canadians.

Note: To simplify, "Health Canada" is used throughout this document, and included the Agencies, Branches, Directorates within Health Canada, as well at the Public Health Agency of Canada.

The strategic management of risk communications, called here "strategic risk communications," is an integral part of Health Canada's risk management process. As a result, every employee of Health Canada has a role in, and responsibility for, helping ensure its effectiveness in the interest of Canadians.

The Guiding Principles of this Framework represent high standards for the practice of strategic risk communications with the goal of fostering excellence among those involved. The Guiding Principles should be applied in ways consistent with decision-makers' legal and regulatory authority. They are not intended to create any new legal obligations for risk communications.

This Framework is intended to operationalize strategic risk communications within the Health Canada's Decision-making Framework for Identifying, Strategy to Implement an Integrated Risk Management Framework at Health Canada (DMF). It also complements existing published frameworks, including the Communications Policy of the Government of Canada and the Treasury Board Secretariat Integrated Risk Management Framework.

The Framework is also linked to the Department's Corporate Risk Profile (CRP) and is intended to serve communications associated with it. The CRP is a corporate tool to identify risks and associated management challenges that could hinder the achievement of the Department's Strategic Outcomes. The Risk Profile also helps define the degree of management attention required to handle these potential risks and identifies mitigation strategies. Strategic Outcomes for the Department range from enhanced access by Canadians to quality health care services to safer products and food, and to the use of information and communication technologies to support decision-making.

The Communications Directorate is the steward of this Framework. Its role is outlined in the Appendix 2: Roles and Responsibilities. The Framework will be formally reviewed and updated as required every three years.

The Framework will also be available as a resource for strategic risk communications excellence for other Government of Canada Departments. Applied well and continuously improved, it can benefit all other Government of Canada professionals and ultimately all Canadians for many years to come.

Summary

Health Canada has developed this Strategic Risk Communications Framework to support the work of professionals throughout the Department who are responsible for formulating and implementing effective risk communications.

The Framework is anchored to Health Canada's vision and mission, and recognizes the evolving challenge of addressing public health and safety opportunities and issues important to Canadians.

The Framework emphasizes a strategic, systematic approach to formulating and implementing effective risk communications. It comprises the following: five Guiding Principles, Guidelines for Implementation, and a detailed process for strategic risk communications. All of these elements reflect current understanding in the relevant disciplines, including decision science, risk management, risk perception, and risk communications.

Professional roles and responsibilities within Health Canada related to assuring the success of strategic risk communications efforts are also described. A detailed application Handbook complements this Framework.

Importantly, the Framework is intended to be a continuously improving resource of guidance and expertise for Health Canada, which may serve as a guide for other Government of Canada Departments.

Health Canada's Vision and Mission

Health Canada is committed to improving the lives of all of Canada's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle, and effective use of the public health care system. The mission of Health Canada is to help the people of Canada maintain and improve their health.

Health Canada's Objectives

By working with others in a manner that fosters the trust of Canadians, Health Canada strives to:

• Prevent and reduce risks to individual health and the overall environment;
• Promote healthier lifestyles;
• Ensure high quality health services that are efficient and accessible;
• Integrate renewal of the health care system with longer term plans in the areas of prevention, health promotion and protection;
• Reduce health inequalities in Canadian society, and;
• Provide health information to help Canadians make informed decisions. 2.0

Objectives for this Framework

The broad objective of the Health Canada and PHAC's Strategic Risk Communications Framework is to build internal capacity for the professional practice of risk communications within the Department and Agency in order to:

• Provide support for informed decision-making and communication within Health Canada and the PHAC;
• Help stakeholders and, ultimately, all Canadians make well-informed decisions on health, environment, and safety-related topics;
• Foster Canadians' confidence in Heath Canada and the PHAC by serving as a foundation for integrated risk management within the Department and the Agency.

Strategic Risk Communications Defined

In 2000, Health Canada published its Decision-making Framework for Identifying, Assessing and Managing Health Risks (DMF) to help guide the Department's risk management efforts. In this document, "risk management" is defined as the broad collection of activities involved in addressing health and safety risks. "Risk communications" is defined as "any exchange of information concerning the existence, nature, form, severity or acceptability of health or environmental risks."

The Framework for Strategic Risk Communications incorporates that definition while advancing it in important ways.

Strategic risk communications can be defined as "a purposeful process of skillful interaction with stakeholders supported by appropriate information." It is an essential component of integrated risk management. Strategic risk communications helps decision-makers and stakeholders make well-informed decisions leading to effective risk management.

Stakeholders can be defined as any individual, group, or organization that may affect, be affected by, or perceive itself to be affected by a potential risk. Decision makers are stakeholders in the process, as are individuals and groups throughout the Department. External stakeholders can include, for example, health partners, special interest groups, and the people who bear the risk.

Strategic risk communications includes all communication content and interactions that can influence risk decisions and behaviour. Such content may be included in announcements, warnings, and guidance documents. Content may appear in verbal statements, pictures, advertisements, publications, legal briefs, labels, warning signs, or other declarations. Risk communications' content may describe risks or characterize their importance. It may also advocate actions regarding risks, hazards, and technologies, including ways to mitigate them. Interactions include everything from engaging individuals and/or groups in one-on-one or small group settings to broader and often more formal citizen engagement and consultation processes. The range of these interactions is covered in Tab 4 of the Handbook.

Effective risk communications must reflect the best available knowledge. Such knowledge should be selected for its relevance to decisions facing stakeholders and framed in terms that address their beliefs and feelings.

Guiding Principles of Strategic Risk Communications

1. Strategic risk communications is integral to integrated risk management.

• Health Canada's process for managing risk is described in Health Canada's Decision-making Framework (DMF). The interconnected activities in the DMF stress the continuing involvement of interested and affected parties, referred to as stakeholders.
• Strategic risk communications is integrated into each step of the DMF, in which it serves to enhance other risk management activities.
• Integrated Risk Management (IRM) is also important within Health Canada.^{Footnote 1} Strategic risk communications is aligned with IRM. "Integrated risk management" means incorporating risk information into the strategic priority-setting of the organization and making decisions that consider acceptable risk tolerance levels.

Integrated risk management is an organization-wide approach to managing risk at the strategic, operational, and project level. It is continuous, proactive, and systematic. It is about applying sound risk management practices and fostering a working culture that values learning, collaboration, innovation, responsible risk-taking, and continuous improvement. It represents an organized and systematic approach to determining the best course of action under uncertainty.

2. Stakeholders are the focal point.

• Those who face the greatest risk deserve the most attention, as do those most concerned with managing particular risks. Both represent stakeholders for Health Canada.
• As stated in the DMF, stakeholders -- both internal and external -- can provide valuable information, knowledge, expertise, and insights throughout the process. The views of technical experts must be focused on stakeholders' risk-related interests, priorities, and values. As a result, effective decision-making must consider stakeholders' perceptions of risks, benefits, tradeoffs, and control options. Consulting stakeholders early in the risk management process is essential to focusing it effectively.

3. Decisions are evidence-based, tapping both social and natural sciences.

• Sound scientific and technical information, combined with expert knowledge and experience are the foundation for risk management. Decisions should draw on current understanding across the full set of relevant disciplines, including the social and natural sciences, as well as business, economic, legal, and human resource management. Importantly, Health Canada decisions must also incorporate stakeholder understanding of a situation, recognizing that stakeholders' understanding on risk issues includes both how they feel about risks (experiential perspective) and what they think about them (analytical perspective).
• The usefulness of scientific evidence depends on the decision-making context of, and the outcomes that matter most to, stakeholders. The Strategic Risk Communications Process is the primary means of identifying these contexts and demonstrating that the risk management process has addressed them. (See page 2-10)

4. Risk management and risk communications processes are transparent.

• The Strategic Risk Communications Process is designed to facilitate transparency in Health Canada's risk management and risk communications process, as well as in its decision-making on risk issues.
• Strategic Risk Communications is the primary means for ensuring that Health Canada openly communicates about the risks, benefits, and risk mitigation options. It ensures that assumptions, values, methods, and plans will be clear and accessible. When facts are uncertain or unknown, Health Canada will be clear about what gaps remain and what efforts are being taken to fill them. Health Canada will also be clear about mistakes that have been made and what is being done to rectify them. When information must be kept secret, reasons for keeping it so will be clearly explained.

5. The Strategic Risk Communications Process requires continuous improvement through evaluation.

• The Strategic Risk Communications Process calls for clear, measurable objectives. Formal evaluation of the Strategic Risk Communications Process and its outcomes enables continuous improvement of risk management, promoting excellence over time as well as efficient and cost-effective procedures. Regular evaluation of both will ensure that Strategic Risk Communications remains state-of-the-science in Health Canada.

Guidelines for Preparing and Implementing Strategic Risk Communications

A large and growing body of experience and scientific literature on risk perception, risk communications, and social interaction provides considerable knowledge into sound approaches for designing strategies and communications. (See References for a listing of critical references. More detailed references are available in Tab 6 of the Handbook.) This knowledge has been used to identify a formal process for preparing and implementing strategic risk communications with five critical activities. (The Strategic Risk Communications Process is illustrated on page 2-10. What to do at each Step in the Process is described in detail in Tab 4 of the Handbook.)

The Guidelines, with key activities summarized, are described in the following order:

• Focus current understanding.
  Review and consolidate scientific knowledge and technical information about factors determining the nature and magnitude of risks of concern. Summarize this understanding explicitly from the perspective of what can be done about the risk -- so as to ensure that it is decision-relevant knowledge. Recognize that knowledge is widely distributed among stakeholders, officials, and scientists.
• Develop communications strategies sensitive to stakeholders' current thinking, goals, and choices.
  Begin the strategy development process by understanding stakeholder thinking in-depth, using appropriate, proven research methods. Develop strategies, plans, and messages based on that research, focusing on what stakeholders need to know in order to make well-informed decisions about the risk.
  
  Develop comprehensive communication plans, including focused messages, materials, and media required to reach and address stakeholders. Ensure a well-focused and coordinated effort.
  
  Prepare communications content and presentations (in the form of various materials used in various media) that are relevant, comprehensible, credible, and readily accessible. For the drafting process, clearly divide responsibility among people with three forms of expertise: (a) risk-specific subject matter, (b) communication processes, and (c) organizational issues, including legal constraints and political sensitivities. Ensure consistency with Government of Canada Communications Policy guiding principles, notably those stressing respect for diversity, accessibility, timeliness, respect for individual rights and sensitive to the needs and concerns of the public.
• Pre-test strategies, plans, and messages.
  Evaluate strategies, plans, and messages empirically to ensure that they perform as intended. Refine as required. (Methods and tools for pretesting are detailed in Tab 4 of the Handbook).
• Implement according to plan.
  Implement the plan, in order to facilitate appropriately sequenced internal and external interactions. This approach ensures consistency of message and enables evaluation of the risk communication process and outcomes.

Iterate as required throughout the implementation process, recognizing that messages and materials may need to be revised and released in various forms over more than one round of activity to achieve specific risk communications goals. Quickly address questions and issues that arise in the course of communicating in order to foster appropriate stakeholder understanding and action on the risk issue.

• Evaluate the risk communication process and outcomes.
  Measure both the effectiveness of the Strategic Risk Communications Process -- including the effectiveness of the team -- as well as the outcomes in order identify how Health Canada professionals and teams could better address future challenges and continuously improve the process.
  
  Share evaluation results with team sponsors and others to demonstrate both progress and results and to encourage discussion on the direction and substance of risk communications efforts. Share measurement results with stakeholders, when appropriate, in order to help identify risk management and risk communications opportunities, as well as ways to improve risk communications strategies.
  
  Use robust evaluation methods, with both internally and with stakeholders, to formal qualitative and quantitative research. Behavioural change measures are also possible, although it is important to recognize that peoples' failures to do what health officials recommend on a specific risk issue may reflect lack of desire or ability and not simply lack of information.

The Strategic Risk Communications Process

Decades of empirical research in risk perception and risk communications, in addition to extensive experience, suggest that the following activities encompassed in seven key steps can represent a robust process for guiding the design and implementation of effective risk communications. (Please see the Key References cited in Appendix VI.)

The process also represents a synthesis of state-of-the science approaches created by risk communication experts in several jurisdictions, including Canada, the United States and Australia/ New Zealand. It has been designed to integrate with Health Canada's Decision-making Framework (DMF).

2000 Health Canada "Decision-making Framework"

The Strategic Risk Communications Process provides step-by-step detail of the risk communications activities (depicted by the arrows) being taken to support every step in the risk management process depicted in the DMF.

The process and some key or typical activities are summarized on pages 2-10 to 2-14. Specific detail on what to do at each step, plus a full description on methods and tools that can be used, are described in Tab 4 of the Handbook. Process steps are summarized in the Guidelines for the Practice of Strategic Risk Communications noted previously.

The Process Steps Are:

1. Define the Opportunity
2. Characterize the Situation
3. Assess Stakeholder Perceptions of the Risks, Benefits and Tradeoffs
4. Assess How Stakeholders Perceive the Options
5. Develop and Pre-test Strategies, Risk Communications Plans and Messages
6. Implement Risk Communications Plans
7. Evaluate Risk Communications Effectiveness

Dialogue-based Strategic Risk Communications Process

Step 1: Define the Opportunity

The risk communication process and goals -- or outcomes -- are identified. A multi-functional project team comprising technical people and risk communicators, and possibly others, typically accomplishes this by working from an Opportunity Statement. The Opportunity Statement is developed to describe (or frame) the project scope and desired outcomes. The team can be important since effective risk communications typically require input from more than one, or a narrow set of, professional disciplines or functions.

The Strategic Risk Communications Process facilitates, or encourages, development of appropriately constituted teams within Health Canada. Disciplines represented on such teams typically include the social and natural sciences, as well as business, economic, legal, and human resource management. Team members should include professionals who can offer, as well as help integrate, vital knowledge about risk issues at hand. When warranted, team resources can include professionals from outside the Department.

One purpose of the team approach is to help ensure that the risk communications process and outcomes reflect the best blend of relevant knowledge, with members simultaneously recognizing the need to manage in a larger context of corporate risk. Better decisions can arise from this approach, thus better serving the interests of Canadians on specific issues as well as management of the Department overall.

One goal for drafting an Opportunity Statement is to build shared understanding among team members -- and with team sponsors -- about the scope of the opportunity, primary challenges, and possible strategies for addressing them. Process deliverables and communications outcomes are defined explicitly. Identifying how the process and outcomes will be measured or evaluated is also an important activity.

In this Step, team member roles and responsibilities are assigned or clarified. Potential stakeholders are identified. Documentation requirements and the documentation process are also defined. This task helps ensure transparency for risk communications and enables continuous learning and improvement.

Step 2: Characterize the Situation

Three critical activities are typically involved in this Step: a) Integrating Available Knowledge, b) Developing a Stakeholder Hypothesis and c) Preparing the Initial Framing.

If risk communications are to be authoritative, they must reflect the best available understanding of the situation. Technical experts (e.g. scientists, engineers) will have much of that knowledge, but so may dedicated practitioners and lay stakeholders. Note that stakeholders are the experts in what matters to them.

One method for integrating knowledge is through an expert model, a form of integrated assessment. These models provide a formal representation of how situations are understood, capturing the range of legitimate opinion and uncertainty. The objective here is to capture a range of views on a topic, not to force consensus. Expert models are essential management and communication development tools. Done well, they capture and integrate the broad range of critical knowledge across the system involved in risk management and risk communications on the topic. A common form of depicting the model is an influence diagram, which represents understanding in terms of variables and the relationships among them, as they relate to the outcomes of interest to stakeholders. (Please see Appendix III, page 2-19, for a definition of expert models.)

Such models provide a transparent representation, allowing stakeholders to review and contribute to the evidence, thereby ensuring balance, authoritativeness, and candor (regarding the limits to knowledge), and credibility. The knowledge summary can be detailed in a resource document, such as a "white paper." Both can be used to facilitate appropriate internal and, where advisable, external reviews with stakeholders, advisory panels, etc.

Stakeholders often include key individuals and groups who will likely be involved in, or have an important interest in, opportunities and issues associated with risk management and risk communications on the topic at hand. Specific methods and tools are used to identify who the potential stakeholders are for the topic.

Secondary research is typically conducted at this point in the process to help identify stakeholders in some detail. Such research can include media analysis reports, external trend reports, and analysis of stakeholder Web sites, position papers, etc. Experience can also guide stakeholder identification. With research results in hand, the team can prepare a hypothesis of stakeholder interests and priorities. Primary research to test this hypothesis is conducted during the next Step.

Within Health Canada, it is often important to prepare the initial framing of the risk issue. Framing is the use of language to manage the meaning of messages. Framing is what helps people make sense of a subject and judge its relevance to them. Like a photographer, a communicator puts forth messages in a "frame" that represent one interpretation of a subject over other possible interpretations. How a risk issue is framed from the outset is critical because the initial framing sets up all subsequent interpretations of it.

Based on the work done to integrate expert knowledge and conduct a preliminary assessment, the risk communicators, working with the support of the team, will determine initial framing of the risk issue. This framing is typically used to brief key internal stakeholders. But it can also serve as the foundation for "holding lines" in case media or public questions about the issue come into the Department.

This initial framing is revised and updated as new information becomes available from the team and as the stakeholder research in Steps 3 and 4 is completed.

Step 3: Assess Stakeholder Perceptions of the Risks, Benefits, and Tradeoffs

Using formal and informal research methods appropriate to the task, stakeholder needs, issues, interests, and priorities are determined. Formal research can include individual focused interviews, such as that typical in mental models research. Informal research can include semi-structured conversations with a few key stakeholders. (Please see the Appendix III, page 2-19, for a definition of mental models.)

In all research, the emphasis is on revealing and characterizing in-depth stakeholder thinking. Stakeholder interests and priorities regarding the risk issue being managed are typical focal points for research. Understanding stakeholder beliefs and the underlying rationale for beliefs, along with their values and concepts of risk, benefit, and tradeoffs are critical components of any research conducted during this Step.

To identify appropriate risk communications strategies, plans, and messages, the thinking of particular stakeholder groups can be compared to that summarized in the aggregate model developed in Step 2. This comparison will reveal critical gaps in stakeholder thinking that can be addressed through communications.

Step 4: Assess How Stakeholders Perceive the Options

In this Step, research results are used to help understand how stakeholders perceive the various risk management options being considered by the team, including the benefits and risks each entails. Understanding how stakeholders weigh the risks, benefits, and tradeoffs inherent various risk management options becomes important to the team in designing risk mitigation strategies and the communications that will enable them. It is during this Step that the alignment of the technical risk assessment and the social assessment, completed in Step 3, typically come together at a critical team meeting.

Even if the team does not change its risk mitigation strategies once it learns about stakeholder acceptability of these, it is still very advantageous to know -- and plan in advance -- if some stakeholders are likely to take exception to the planned risk mitigation option.

Reflecting what is learned through research in Step 3, the multi-functional team refines the measurable risk communication outcomes developed in Step 1 when the opportunity was framed. Outcomes are typically defined in behavioural terms; that is, what stakeholders should think, feel, and do as a result of communication.

Outcomes for broader stakeholder consultation are also defined at this point. (Some stakeholder consultation, at least at the expert level, has likely taken place to varying degrees in Steps 2 and 3.) An overarching objective is to ensure Health Canada's interests and activities can align with those of key stakeholders. It is important to describe the value that achieving key goals represents for Health Canada and stakeholders.

Step 5: Develop and Pre-test Strategies, Risk Communications Plans, and Messages

Risk communications strategies, plans, and messages are developed based on insights gained from formal and informal research into stakeholder thinking generated in Step 3. Messages are tailored to the critical decisions being addressed by stakeholders, emphasizing the information stakeholders need but do not already have, in order to make well-informed risk decisions and take appropriate action.

Written communication plans that detail messages, materials, and the appropriate media to reach and address stakeholders are prepared. One purpose of a written plan is to ensure that all essential elements have been engineered into a well-focused and coordinated effort. Another purpose is to facilitate internal review and discussion of risk management efforts. A third purpose is to demonstrate that resources are being used wisely.

In order to ensure that strategies, plans, and messages will perform as intended, all are empirically tested before deployment. Pre-testing methods include particular task-suited consultation activities, as well as formal testing research. Consultation and pre-testing can also help identify stakeholder acceptability of proposed options, plans, and actions. It can also bring to light outstanding opportunities or issues and provide insight into how to address them.

Step 6: Implement Risk Communications Plans

The risk communications plans are implemented in this Step, often by members of the team.

Risk communications materials are refined based on pre-test results in Step 5 and produced. One use of these materials is to support team members (and others) as they engage individuals and groups in dialogue as part of the broader stakeholder consultation activities. In this Step, it may be advisable to select and train additional people to conduct dialogue on the risk issue and the risk mitigation plans or options.

Strategies and communications are adapted and modified as necessary as the consultation process evolves. Materials and messages may need to be revised, upgraded, supplemented and/or released in other forms over several rounds of activity in order to achieve the team's risk communication goals. The implementation phase may also prompt new discussions or unanticipated questions. The ability to respond quickly to both can be key to furthering stakeholder understanding and action.

Step 7: Evaluate Risk Communications Effectiveness

Evaluation is consistent with the best practices in risk communications and continuous improvement.

After at least one cycle of risk communication effort is completed, the team evaluates the effectiveness of the process and the quality of outcomes for risk communications.

Formal and informal evaluations are made based on the objectives set in Step 1. A variety of measures can be made. Measurement results are used to make recommendations about improving the strategic risk communications process and specific activities within it. They may also be used to modify communications strategies and messages.