Guide Principles of Risk-Based Decision Making

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Definition of Risk-based Decision Making
  1. Risk Management in Decision Making | SpringerLink
  2. Principles of Risk-Based Decision Making
  3. Risk-based decision making
  4. When to Use Risk Analysis

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Risk assessment must be conducted distinctly from other activities. Appropriate mechanisms must be in place to ensure that there is no interference with the scientific assessment of risk. Risk assessment involves determining the likelihood that a specific adverse health effect will occur in an individual or population, following exposure to a hazardous agent.

This is typically accomplished by examining physical, chemical, and biological data obtained from scientific investigations, such as those conducted in laboratories e. Risk assessment involves recognizing that a hazard exists hazard identification - is it harmful? It is important to include all relevant scientific data in the assessment of health risks. Failure to evaluate all relevant data may limit the ability of the management team to identify and analyze an appropriate range of potential risk management options, and to select the strategy that will be most effective, have the least unintended negative effects, and be undertaken at a reasonable cost.

The value of using a broad approach to risk assessment stems from the recognition that a variety of different factors or determinants may influence our health, in addition to the "physical" environment, both natural air, water, food, soil and human-built, and that health effects known and potential should be examined both directly and indirectly. It also involves considering the outcomes for specific populations in addition to risks to whole populations, including maximally exposed individuals.

It further involves considering the perspectives and knowledge of a range of interested and affected parties to the extent possible and appropriate for a given risk situation.

Risk Management in Decision Making | SpringerLink

It is important for Health Canada to acknowledge the influence of various risk factors on health, even if is ultimately decided that they are best addressed by other departments. In order to bring together all the relevant information, the risk assessment team may need to include experts from a variety of disciplines, the nature of which may vary from risk to risk.

The extent to which a broad approach can be taken during risk assessment, may be limited by existing legislation. The Link With Risk Management Risk assessment is a key part of the decision-making process, not only because it provides an estimate of the level of risk, but because it can help to identify possible options for risk management.

For example, examining information on a range of exposures and how changing the exposures would affect the level of risk, helps to identify and analyze potential risk management options and thereby contributes to policy development. While risk assessment must be conducted separately from risk management, in order to maintain scientific integrity, the two processes must be linked: risk management goals are used to focus risk assessments, while the results of risk assessment provide critical information for risk management. Identify Hazards Although hazards are identified in a preliminary way during issue identification, this is undertaken in more detail during risk assessment.

Typical activities in the identification of hazards includes:. Traditionally, hazard characterizations have focused on physical health effects, and have relied on data from toxicology and epidemiology studies and in some cases, from surveillance; more recently, emotional and mental health effects are starting to be explored. As scientific data are often incomplete or not available, estimations must often be supplemented with more qualitative approximations.

Since most exposures tend to be at low, chronic, levels, hazard characterization often requires extrapolation of data from studies involving high level of exposure i. In order to characterize hazards it may be necessary to determine a number of factors, including:. In other words, the purpose of an exposure assessment is to calculate the dose of a hazardous agent to which one or more populations or subpopulations are exposed. This activity is key to the risk assessment process because without exposure there is no risk.

Exposure assessment may include a number of the following steps. Characterizing the Exposure Pathway Before exposure can be assessed, it is necessary to characterize the exposure pathway, which describes how a hazardous agent reaches an individual or population. This involves obtaining information on: the source from which the agent originates; environmental media which carry the agent to individuals or populations of humans e.

Examples of routes of exposure include: ingestion, which includes swallowing food, water, soil, and other substances; inhalation, which includes breathing in a gas, vapour or airborne particles; skin contact, which may involve corrosion caused by skin irritants or skin penetration by agents such as ionizing and nonionizing radiation; through the intravenous, intramuscular, intraperitoneal, subcutaneous, or intradermal routes, as in the case of drugs.

The Use of Modeling For some agents, particularly those involving voluntary exposure, such as prescription drugs, exposure assessment is relatively straightforward. But for other agents, such as environmental or food contaminants, an exposure assessment is usually based on considerable uncertainties. It is often not possible to measure exposures directly; rather they must frequently be predicted, for example by using monitoring data and mathematical modelling and reconstructing historical exposure patterns.

There are two broad types of mathematical models used in exposure assessment: those that predict exposure to the agent, and those that predict the concentration of the agent.

Principles of Risk-Based Decision Making

Exposure models can be used to estimate the exposures of populations based on small numbers of representative measurements. Models that predict concentration can be combined with information on human time-activity patterns to estimate exposures. Modeling may be done on long-term and short-term exposures, both of which have limitations.

For example, in long-term exposure modeling, changes may occur in natural levels of exposure over time and in activity patterns of exposed persons; in short-term modeling, there are difficulties in modeling concentrations that vary widely over time. As with modeling, extrapolation of results can lead to uncertainties in exposure assessments.

Sometimes exposures of particular groups of individuals, such as occupational workers, are used to estimate exposures in other populations. Uncertainties may result from the extrapolation of data from high to low doses, because adverse effects observed at high doses may not be seen at lower ones. An important aspect of exposure assessment is to determine which groups in a population may be exposed, as well as which groups may be especially sensitive.

Another concern is how to deal with the effects of exposure to multiple agents, which may have similar adverse health effects. Examining Information on Risk Factors A variety of risk factors can influence the level of exposure experienced by specific subpopulations. Where appropriate, information on social, cultural, ethical, economic, and other risk factors, as well as risk perceptions, must be collected and analyzed to determine how exposure may be affected. Information that meets an acceptable level of scientific rigor is then integrated with other exposure-related information to develop more comprehensive exposure estimates.

A sound risk management decision is based on a careful analysis of the weight of scientific evidence that supports conclusions about the risks of an agent to human health. When characterizing risks, investigators determine whether exposure to a hazardous agent poses a significant risk to human health, by comparing information obtained through hazard characterization and exposure assessment. Risks are usually characterized in terms of their potency for chemicals or radiation, in terms of a dose-response relationship , pathways of exposure, and reasons for variation in response among exposed populations.

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Risk characterization often involves no additional scientific information, but requires judgement, for example, when interpreting data related to population groups with varied sensitivity and different exposures. To be truly useful, risk characterization must be accurate, balanced, and informative. This requires "getting the science right and getting the right science"[National Research Council, ].

It involves the use of reliable technical and scientific input from a range of disciplines, including biological, chemical, physical, economic, social, and behaviourial sciences; sound scientific analyses; and providing opportunities for discussion and deliberation, recognizing that this needs to be much more extensive in some situations than in others [National Research Council, ]. The success of risk characterization depends on conducting a systematic analysis that is appropriate to the issue, that carefully considers scientific uncertainties, related assumptions, and potential impacts on decisionmaking, and that responds to the health-related needs of interested and affected parties.

Success also depends on discussions or deliberations that formulate the risk issue, guide analyses, seek the meaning of analytical findings and uncertainties, and improve the ability of interested and affected parties to understand and participate effectively in the decision-making process.

National Academy Press, Washington, D. Involving Other Technical Specialists, Policy Makers, and Interested and Affected Parties Although scientists play the lead role in risk characterization, policy makers, other technical specialists, and interested and affected parties should also have opportunities for involvement.

Risk characterizations provide a key source of information for risk management decision-making, and consequently play an important role in ensuring that risk management goals are met. Policy makers and interested and affected parties can help to ensure that the characterizations have focused on the correct risk issue and have answered the health-related questions of primary concern.

Other technical specialists, particularly economists, can help to ensure that the characterizations provide the type of information that they need to perform further analyses e. The manner and extent of involvement will depend on many factors as noted in the Identify the Issue and Its Context section above [National Research Council, ]. Review the Hazard and Exposure Information This involves examining, summarizing and integrating information obtained through hazard identification, hazard characterization, and exposure assessment.

Among the factors to consider are the quality, completeness, and relevance of the information, and the nature and impact of uncertainties and other limitations related to the information and any analyses that are conducted. Generate a Quantitative Estimate of the Risk In order to produce a risk estimate, quantitative information on exposure and if available, dose , from the exposure assessment, is combined with information on the dose-response relationship obtained through hazard characterization.

The process of developing a quantitative risk estimate will differ, depending on the type of risks being considered - carcinogens and "noncarcinogens" agents that do not cause cancer or for which there are insufficient data on carcinogenic potency , microbial pathogens, etc. Consider Statistical and Biological Uncertainties and Their Impacts Risk estimates often contain a some level of uncertainty. Uncertainties may result from: the limited availability of scientific data, on for example, exposure or intake rates; long time delays between exposure and effect; the need to extrapolate data to predict the health consequences of human exposures; difficulties in determining appropriate mathematical models for extrapolation; simultaneous exposures to a variety of different agents making it difficult to determine the effects of a single agent ; and judgements made at each step of the process.

It is important to consider the nature, sources, and levels of uncertainties related to the risk estimates, and how these may impact upon the risk assessment, and to document this information. It is also important to determine whether the uncertainties are "acceptable", or whether analyses need to be repeated using better data or better techniques in an attempt to reduce the uncertainties. Both uncertainty analyses and individuals' interpretations of what uncertainties mean, can be strongly affected by the social, cultural and institutional context of a decision.

Uncertainties that result from the incompleteness and unavailability of scientific data frequently require scientists to make inferences, assumptions, and judgements in order to characterize a risk. Making judgements about risk based on scientific information is called evaluating the weight of the evidence. Risk characterizations based on scientific data, should include not only plausible conclusions about the characteristics of the risk based on available information , but also evaluations of the weight of evidence that support the conclusions, descriptions of major sources of uncertainty, and alternative views.

Uncertainties related to potential health effects, dose-response relationships, and exposure, have increasingly led to the use of a range or distribution of risk estimates rather than a single value. Single numerical estimates of risk can give the misimpression of precision, be easily misinterpreted and be misused in the absence of information which puts them into context. Using a distribution indicates the likely maximum and minimum risks for different individuals and the relative likelihood of intermediate risks between these extremes.

Generate a Qualitative Description of Uncertainty This involves preparing a summary of the uncertainties that have been noted throughout the risk assessment process, and explaining the potential impacts of the uncertainties on the risk estimates in a nontechnical manner, which is understandable to the risk management team and to interested and affected parties.

Among the general uncertainty issues to be addressed are the following:. The method for dealing with uncertainty depends on number of factors, including the nature of the agent being examined:. Identify Which Population Group s Should Be the Primary Target of Risk Management Efforts This involves determining which population or populations are at greatest risk known or potential and thus which should be the focus of risk management efforts.

Perform a Risk Comparison Risk characterizations often include some form of risk comparison , which is a way to combine frequency estimations with some estimates of the significance or severity of the health effects. Two increasingly common methods used to compare risks are risk ranking and risk prioritization. Risk ranking is useful for comparing hazards that cause a similar effect in a single medium, such as carcinogens found in drinking water.

Risk prioritization involves using specific criteria, such as the exposure levels compared to the potency to induce cancer, to determine the priority for action. Examine the Weight of Evidence This involves determining and examining the weight of the scientific evidence, in a qualitative way, order to determine whether there is support for the conclusions about risk. It may also involve: determining whether other agents might cause the same type of effects; examining the contribution that a particular agent makes, relative to those having similar types of effects in the affected population s , or subpopulation s ; determining how the risk is distributed in relation to other risks to which the affected population s , or subpopulation s are exposed; and examining the effects of risk interactions combined exposure to two or more agents or conditions, such as immune status, genetic risk factors.

Determine Whether Additional Data Must Be Collected If the data and methods used for analysis are not adequate based, for example, on scientific standards, or if no evidence exists e. Results of the analysis may reveal that additional information must be collected to properly address the issue this does not however, preclude use of a precautionary approach, involving implementation of an interim risk management strategy while further data are collected.

If peer review is required, it is necessary to identify the reviewers, and then to obtain and consider their comments. In cases where there are legislated timeframes for completion of assessments, as for Priority Substances under CEPA, it is often not possible to collect additional data or repeat analyses; in such cases it is usually indicated that better data might help to reduce uncertainty. Present the Risk Assessment to the Risk Management Team Risk assessments may be presented using a variety of methods; the choice of method may be a function of the legislative mandate.

It may be useful to provide a table indicating the estimated level of risk for the exposed population by route of exposure, as well as a full characterization of the risk, including a discussion of uncertainties, a discussion of the comparability and consistency of similar but different risks e. Risk assessment should also be made available to interested and affected parties, taking into account the need to keep some information confidential e.

The inclusion of benefit assessment and consequently the comparison of risks and benefits as part of the decision-making framework, is not intended to imply that benefits known or potential must be assessed in every situation, but rather that it should be undertaken in a consistent and systematic manner in situations where it is appropriate to do so.

In general, benefit assessment should be attempted when it is difficult or impossible for consumers to judge the benefits associated with exposure to an agent and to compare them with the associated risks. For example, it is often necessary to evaluate the benefits of a specific product e.

When to Use Risk Analysis

There are however, instances where benefit assessment is not necessary or possible, such as where the level of risk is deemed to be minimal or "de minimus", where it is not ethical to consider benefits because it might imply that a product is being endorsed, or where legislative mandate does not allow benefits to be assessed.

In cases where it is appropriate to compare risks and benefits, the comparison should be done using a societal perspective, unless dealing with a situation in which only an individual is affected e. A population or sub-population should not be placed at risk for the benefit of others. However, there is a role for other participants to play, including scientists responsible for the risk assessment, policy makers, and interested and affected parties.

Policy makers and interested and affected parties can help to ensure that assessments are focused on the benefits of most relevance, and that appropriate consideration is given to specific populations and equity issues. The manner and extent of involvement will depend on many factors as noted in the Identify the Issue and Its Context section above. Brief descriptions of these tasks as well as some related considerations are provided below.

Further information related to benefit assessment may be found in the draft Guidance Document on Socioeconomic Analysis. Collect and Assess Information on Benefits In order to assess benefits known or potential , specialists:. Identify the Type s of Benefits to be Examined The first task involved in benefit assessment is to determine what types of benefits are to be examined. These may include direct health benefits e. An important part of this determination is identifying the perspective to be used for the analysis e. Identify the Measures to Be Used Once the type s of benefits have been determined, it is necessary to identify the measures for the benefit assessment, and for reporting of the results e.

Like risks, benefits may be assessed qualitatively or quantitatively, depending on the nature of the information available. The extent to which benefits are assessed, as well as the specific considerations taken into account, vary depend upon factors such as the issue being addressed, the context in which it is being considered, and the nature and amount of information that is available. Once measures have been identified, it is necessary to select the methodology to be used e.

Collect and Analyze the Benefit Information This task involves collecting and analysing the benefit-related information. Information may be collected through various means, for example through socioeconomic analysis, or for therapeutic products, through the results of clinical trials.

One of the first things to examine once the information has been collected and analyzed, is the adequacy of the data and methods used for the analyses, as well as whether the analyses have addressed the appropriate concerns. If the data or methods are not of high quality or are not relevant, it may be necessary to conduct other studies or reanalyze the data. Another item for consideration is whether any analyses should be reviewed by third-party experts, and if so, who the third parties should be. Determine How to Deal with Uncertainty As with risk assessments, benefit assessments are frequently subject to uncertainty.

Given this, it is important to identify the nature, sources and level of uncertainty, both in terms of the benefit data themselves and in terms of the analyses that are conducted. As well, it is important to determine the potential impacts that the uncertainty will have on the benefit assessment.

Risk-based decision making

If the level of uncertainty is not acceptable, it may be repeat the analyses using better data or better techniques. Summarize the Benefit Information The final task in benefit assessment involves summarizing and integrating the information in a fair and balanced manner, similar to what is undertaken during risk characterization. The resulting benefit assessment summary should include any assumptions, uncertainties, and judgements, and should be written in a nontechnical format, suitable not only for risk managers, but for interested and affected parties. Examine Risk and Benefit Data This involves integrating, analysing, and comparing the results of the risk and benefit assessments.

Risks, benefits, and any associated costs must be evaluated in terms of the needs, issues, and concerns of interested and affected parties. In the case of therapeutic products, such as drugs, the risk-benefit profile of the agent may be compared with that of alternative therapeutic agents. When comparing risks, benefits, and costs, consideration can be given to individual versus collective risk and benefits, who benefits relative to who bears the risk as different parties may be involved , and freedom of choice versus risks and benefits to society as a whole.

As with risk assessments, benefit assessments can benefit from peer review, especially when they are complex. It is useful to summarize technical results in an easily understandable manner, to explain the methodology and criteria used, to discuss uncertainties, assumptions, and their potential impact on analyses and on decision-making. Consider a range of risk management options whenever possible. Take into account a variety of considerations when analyzing options, including the perspectives of interested and affected parties.

This step involves identifying and analysing potential options to prevent or reduce the risk of concern, and making recommendations regarding the preferred option s. A variety of options are available for risk management. Regulatory options generally rely on the government's authority to enforce compliance with legislation, and may include direct regulation, selfregulation and the issuing of permits or approvals.

Non-regulatory options include the use of advisory, economic, and technological measures, and can include taking no action when none is required to maintain the current level of health protection.

When to Use Risk Analysis

For further information, see the table that follows. A number of factors may be considered when identifying potential risk management options, including legislative authority, policies, and commitments, and how quickly the risk must be addressed. A wide range of potential options should be identified unless the nature of the risk issue or situation makes it unwise, unnecessary, or impossible to do so e.

To the extent possible and appropriate for the given situation, options should be identified in consultation with a range of interested and affected parties. This is especially important in cases of where the responsibility for managing the risk is shared, or where various parties may participate in implementation of the selected strategy. The breadth and depth of consultation should reflect factors such the nature of the issue, who the issue affects, the urgency required to resolve the issue, and the resources available.

Health Canada uses a combination of regulatory and non-regulatory approaches for risk management. Regulatory options are most frequently used, with the most common being direct regulation. Technological approaches are also sometimes used, in conjunction with legislation e. A number of factors may be considered when analysing potential risk management options. The expected effectiveness of potential options especially for different populations , and legislative, international trade, or other requirements, obligations, and limitations are key considerations, as is the feasibility of the option in terms of technological, legal, economic, and other factors.

Other considerations may include:. The nature and relative importance of the criteria used for option analysis will vary depending on the situation being addressed, and may be influenced by existing legislation.

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Some options may be eliminated quickly for various reasons. A shorter list of potential options can then be produced, and a more detailed analysis performed on this list. In general, preferred risk management options are those that provide an "acceptable" level of health protection, are most effective in reducing or preventing the risk, cost the least, create the fewest adverse unintended consequences, and are acceptable to a wide range of interested and affected parties.

In some cases, options analysis can serve to refine the goal of the risk management process. This may occur once risk managers and other interested and affected parties gain some appreciation for what is feasible, what the costs and benefits are, and what contribution reducing exposures and risks can make toward improving human health. Involving Interested and Affected Parties Interested and affected parties can play an important role in option analysis by helping to identify criteria to be used for analysis, collecting or providing required information, participating in analyses, providing a range of perspectives on the acceptability of the criteria and the results of the analysis, and helping to redefine risk management goals as required.

Some Key Considerations One key consideration when analysing options is that the same measures can affect different populations in different ways depending on a range of risk factors such as gender, age, ethnic origin, social situation, economic conditions, education, culture or personal convictions.

It may be necessary to tailor options to meet the needs of specific groups or to use different options for different groups. For example: advisory information could be provided at different reading levels, through different types of news media, and in different languages; recommended daily intakes of specific chemical contaminants in food could be different for general and sensitive populations.

A second consideration is Health Canada's difficult but necessary responsibility to balance the rights of individuals and groups with the needs and interests of society. Related to this is the importance of ensuring that societal and group rights do not unnecessarily override the rights of the individual. In principle, when the rights of an individual and society are in conflict, precedence should be given to the latter; in practice this may be a challenge to achieve.

A third consideration is the difficulty in determining what constitutes an " acceptable " level of risk. An acceptable risk is one that is so small, whose consequences are so slight or whose associated benefits perceived or real are so great, that persons or groups in society are willing to take or be subjected to that risk. The acceptability of risk, from both an individual and social perspective, is influenced by risk perception, values, judgments and other factors, such as the trade-offs people make between potential risks and benefits.

The level of trust in the person or agency responsible for managing the risk is also a factor. Although individuals may hold opinions about what is acceptable, there are often no objective measures for determining acceptability. What is acceptable to one group or individual may be unacceptable to another. Given this, attempts need to be made to determine acceptability from the perspectives of a range of interested and affected parties e. Maintaining and improving health is the primary objective. This must take precedence over all other considerations.

This step involves reviewing the results of the option analysis and making a decision about the strategy to be used to address the risk of concern. In order to determine the best approach for risk management, the risk management team must examine the results of the analyses that were conducted in the previous step, together with any related recommendations. These documents are key to the risk management process because they represent a summary and synthesis of all available information that has been considered to date. Together, they provide the foundation for selecting the risk management strategy.

Depending on the situation, the risk management strategy may consist of a simple approach involving a single risk management option, a multi-faceted approach in which a number of different options are implemented to varying degrees, or something in-between. The selection of a specific strategy frequently depends on a number of considerations, including the scope of the decision, related events or decisions occurring within the same timeframe, and other new information that becomes available.

The nature and relative importance of these considerations varies depending on the situation involved. As noted earlier, the extent to which a broad approach can be taken may be limited by existing legislation. Where choices are not limited by legislation or other factors, a combination of options is often most effective for managing risks. Use of a flexible approach can improve the efficiency and effectiveness of risk management, result in solutions that are more generally accepted and easier to implement, and may reduce the cost of implementation.

It may also encourage further research, which could provide useful information that can be used to improve the risk management process. Regulatory options still need to be implemented in certain instances and may be the only or primary part of the risk management strategy , in order to maintain current levels of health protection. However, where the cost of implementation is very high relative to the impact on health, alternatives should be considered to the extent possible.

Among the most controversial types of criteria considered during risk management decision-making are the results of socioeconomic analyses. Three common concerns are that:. Socioeconomic analysis should never be the sole or over-riding factor in making risk management decisions. The primary objective of risk management is maintaining and improving health; any socioeconomic impacts should be one of many considerations.

Economists are responsible for providing decision-makers with the best technical information available or reasonably attained, including evaluations of the weight of the evidence that supports different assumptions and conclusions. Information about costs and benefits that cannot be assigned monetary values also must be explicitly considered, along with information about risks, and social, cultural, ethical and other concerns. Peer review should play a critical role in evaluating the quality of economic analyses and the technical information underlying them.

Making a Decision with Incomplete Information An important concern in selecting a risk management strategy is how to make a decision when complete information is not available. In such cases, an attempt must be made to identify the missing information and determine its importance, and a decision made about whether to delay strategy selection until the missing information is obtained.

A lack of important information does not necessarily mean a delay in taking action, as in cases where a decision is made to use a precautionary approach and to implement an interim strategy until further data is gathered. In many cases it may suffice to consider the value of additional information in a qualitative way. In any case, the efforts and benefits of obtaining further information should be weighed against factors such as the need to address the risk quickly, the magnitude of the risk and the level of effort to address it, and the expected time, cost, and benefit of obtaining further information.

Where possible, it is useful for such decisions to be made by an expert committee of individuals who are knowledgeable about the issue and who can represent the views of key interested and affected parties.