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Seller Comments: Shiny and new! Expect delivery in weeks. Seller Comments: All books are new and come with a 21 day return guarantee. Availability: On-Demand. Thus, in application, the principles have to be specified and — in case of conflict — balanced see below: methodological approach.
A coherentist model of justification has several advantages: despite unresolved foundational issues, it allows us to find consensus on the level of prima facie binding mid-level principles, since they build on our everyday moral convictions and are compatible with various ethical justifications. At the same time, it makes moral controversies more transparent, since they can be analyzed as conflicts between principles with different weights. Identifying precisely the type of ethical conflict is often the first step toward a solution.
Based on the coherentist model of justification, we have developed a normative foundation for PHE that contains five substantive ethical criteria see Substantive Normative Criteria and seven procedural conditions see Procedural Conditions for a Fair Decision Process. Table 1 presents the substantive normative criteria that should guide ethical analysis in PH based on a coherence approach of justification see above.
They are linked to the specific characteristics of the field of PH, thereby taking into account that PH focuses on populations rather than individuals, works preventively rather than curatively, and usually requires action at the population rather than the individual level 1. Many ethical principles and considerations relevant for PH have already been elaborated over the last several years [cf. They are justified by more basic ethical principles including maximizing health benefits, preventing harm, respecting autonomy, or promoting justice.
The order of the criteria is determined by the sequence of their application. First of all, the benefit of the intervention has to be established.
Without an expected benefit, the intervention should not be implemented and there is no need to apply the other criteria. After assessing expected benefits and potential harms of the intervention, implications on individual autonomy, distributive justice, and efficiency can be evaluated.
It is important to realize that this set of criteria constitutes only the starting point of any ethical analysis. Before applying the criteria, evaluators have to assess whether all criteria are relevant to the PH intervention or policy decision, whether further criteria have to be taken into consideration and whether the criteria require further specification for the application domain.
Table 1. Substantive normative criteria for ethical analysis in public health. An ethical evaluation of a PH intervention must start with assessing its expected benefit.
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This requires defining the goals of the intervention with the range of expected effects. These can be surrogate endpoints, e. The magnitude and likelihood of the effect should be quantified e. In addition, the validity of the available evidence is relevant. Are the underlying studies randomized-controlled trials or retrospective cohort studies? How adequately have the studies been implemented and published [e. Besides internal validity the credibility of the results for the study sample , the external validity of the demonstrated effect is also relevant. The external validity concerns the credibility of the results outside of the study sample and thus indicates how generalizable the results are.
The intervention-specific, health-related benefit should be higher than the potential benefits of alternative interventions, thereby providing an additional benefit for the target population. An expected benefit can seem plausible even if the underlying evidence is not of the highest desirable internal and external validity. In this case, it is necessary to explicitly state the reasons for the lack of suitable data and the arguments why it nevertheless seems appropriate to implement the intervention.
This transparency is a necessary prerequisite for dealing appropriately with the frequently uncertain demonstration of benefits in the field of PH 16 , The necessity to review alternative PH interventions to achieve the same goal is not just an imperative of instrumental rationality and the principle of benefit maximization, but also allows us to identify any alternatives that might be ethically less problematic — e.
Oftentimes, beneficial PH interventions are associated with social and health risks and burdens e. For this reason, it is important to assess not only potential benefits but also potential harms. Potential harm should be assessed for those directly and indirectly affected and be compared with the expected benefit for the target population to determine the net-benefit.
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Analogous to the expected benefit, the magnitude, likelihood, and scientific validity of the potential harm need to be assessed [cf. It is one of the central goals of the ethical assessment to recommend suitable measures for reducing the — often unavoidable — risk of harm for the individual as much as possible.
In summary, i the practical relevance of the different endpoints e. The controversy among experts on the benefits and harms of mammography screening exemplifies how differently these three aspects can be assessed in a single intervention 19 and how these differences affect PH decision making. The ethical principle respect for autonomy is relevant to PHE in two ways. First, PH interventions can and should if possible improve the health literacy and competence of the target population 20 — For this purpose, it is necessary to provide, among other things, high-quality information about the type of intervention and its potential benefits and harm, adapted to the needs of people with different knowledge, capabilities and ways of accessing information 23 , Second, in light of the usually unavoidable burdens and risks, individuals should generally be able to decide themselves about their participation in a certain PH program after being sufficiently informed informed consent.
If individual informed consent to participation is not possible e. If certain PH goals can only be achieved effectively by influencing or even restricting individual freedom of choice e. In particular, it has to be demonstrated that the PH goal cannot be achieved with a less restrictive or less manipulative intervention As a general rule, restrictions should be minimized 9.
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For example, before legally mandating a PH intervention, there should be an attempt to achieve sufficient participation by non-coercive incentives. The fact that a less restrictive intervention might forfeit a potential health benefit for the population is not per se an argument for more restrictive interventions. The expected health benefit rather has to be balanced against the potential social harm restriction of freedom, protection of privacy, or stigmatization. Public health interventions often have an impact on the distribution of health outcomes and therefore the opportunities that citizens are offered in a society For reasons of equity , therefore, all people who might benefit should have equal access to a given PH intervention.
Both financial and non-financial barriers to access have to be taken into account.
In addition, the distribution of potential benefits and harm has to be examined. PH interventions should contribute to reducing existing health inequalities. For example, interventions can be tailored to the needs of health-disadvantaged groups while avoiding possible negative social consequences like stigmatization. When PH interventions accept a potential harm for certain subgroups to achieve a significant expected benefit for another subgroup, strategies to compensate for these risks have to be considered for the sake of compensatory justice.
For example, people placed under quarantine need to be given appropriate psychological support and their captivity should be alleviated as well as possible beyond the regular standard of care in hospitals. Another example concerns health professionals exposed to an increased risk of infection by their patient contact during a pandemic e.
In the light of limited public resources, the efficiency of a PH intervention has to be assessed. This requires determining the incremental cost—benefit ratio, i. The type of benefit and harm entering into the net-benefit of the PH interventions has to be explicitly defined. As with the potential benefit and harm, the internal and external validity of the efficiency assessment have to be evaluated. Determining the incremental cost—benefit ratio presupposes reviewing the alternative if any strategies to achieve the same PH goals.
Since PH interventions have an impact on the well-being and autonomy of individuals and often require collective efforts, they should be implemented by a legitimate decision-making authority within a fair process. Even reasonable and fair-minded people often come to different conclusions in the face of complex moral deliberations.
Among other things, this is due to the fact that many evaluations — e. How can we make legitimate decisions under these conditions of moral controversy? We suggest adding consistency, participation, and managing conflicts of interest 28 — 30 , so that any ethical analysis of PH interventions has to assess how far the seven conditions for a fair decision process described in Table 2 are met. Further conceptual research is necessary to develop quality criteria for the practical implementation of the seven conditions e.
Further empirical research is necessary to evaluate the feasibility as well as the intended and unintended effects of the seven conditions The results may help to determine more specific guidelines on the adequate implementation of the seven procedural conditions in the practice of PH 32 — After having laid out substantive ethical criteria and conditions for a fair decision process, we now present a step-by-step methodological approach that shall guide the ethical evaluation of a given PH intervention in the different phases of its development, implementation, and evaluation.
Any ethical analysis must start with a thorough characterization of the PH intervention, the context in which it will be applied, and possible alternative interventions to achieve the PH goal that might minimize potential negative impact on PH, individual autonomy, equity, or efficiency. After describing the PH intervention, the normative basis of the evaluation needs a critical review: do the normative criteria cf.
Table 1 require further specification or even supplementation for the PH intervention? The practical relevance of each principle should be clarified, starting with a concrete statement of the content and scope of the principle for the PH intervention at hand. Different policy makers or evaluators may arrive at different specifications with potentially different results in the analysis. While this cannot be eliminated completely, using this explicit framework at least requires the evaluators to explicitly define and justify the specifications so that the underlying sources of disagreement become transparent — and thereby open to revision.
In practice, the five normative criteria Table 1 are often given unequal consideration. For example, an investigation might focus more on balancing expected benefits criterion 1 with the restrictions of autonomy criterion 3 , while neglecting equity implications criterion 4. Similarly, many criticisms of national pandemic plans make some effort to apply criteria 1—3 but do not explicitly consider criteria 4—6 37 , In the third step, each of the specified normative criteria is used to evaluate the PH intervention.
The evaluators must ask, for example: what are the expected benefits of the intervention? A step-by-step assessment can reveal currently unresolved controversies and identify the need for further conceptual or empirical studies. The fourth step requires compiling each assessment from the previous step into an overall evaluation of the PH intervention. This involves identifying conflicts between the criteria and balancing the conflicting ethical obligations. Balancing requires finding convincing reasons why one criterion or the other should prevail.
Being explicit about the reasons that determine the relative weights of the conflicting criteria creates transparency and allows a revision of the balancing by challenging the underlying reasons. For example, there might be good reasons to doubt the validity of the information considered in a particular case or competing information might be available.
The balancing of conflicting ethical obligations shall be illustrated by two examples:. Example 1: in considering a quarantine of a tuberculosis patient, we have to balance respect for autonomy criterion 3 and protecting others from the risk of a transmitted tuberculosis infection here: criterion 1. The severity and high likelihood of the anticipated harm to others could be a good reason to assign more weight to protecting others than to the freedom of the infected patient.
To balance the conflicting criteria, we have to assess the relative weight of the arguments 40 : the benefit for the target population — 5 prevented deaths per residents in one study 41 — seems to be rather large compared to the burdens and risks for the HCP due to the influenza vaccination and the restriction of freedom of choice. However, the available studies could not prove a significant effect on the primary outcome, i.
The latter example points to another important ethical consideration in the synthesis: before implementing a PH intervention that involves a conflict between the normative criteria, it is important to carefully look for alternative strategies to achieve the PH goal that are ethically less challenging. For example, if a PH intervention is particularly effective but requires a significant restriction of individual autonomy, it should be investigated whether a less restrictive intervention could lead to satisfactory results, perhaps at the price of a somewhat reduced effectiveness.
In most cases, the overall ethical evaluation will not result in a clear-cut rejection or endorsement of the PH intervention, but rather in a stronger or weaker recommendation, for example, to implement or — in the cases of a negative evaluation — forgo the intervention see Table 3. Rather, it will identify various aspects and conflicts that have to be considered from an ethical perspective. And if mandatory vaccination policies are considered, the HCP should be involved in the decision-making process cf.
Methodological approach for putting PHE into practice. After successful implementation, any PH program should be followed-up and monitored in regular intervals to assess 1 whether the ethical evaluation was adequate, 2 whether there are new ethical issues arising, and 3 whether the recommendations are followed and whether they are effective in assuring an ethically appropriate execution of the PH program. Or: mandatory vaccination policies should be evaluated whether they really have an additional benefit on the mortality and morbidity of elderly long-term care residents compared to voluntary programs.
Another example for the demand of monitoring the follow up and the effects of ethical recommendations is the following: there is a broad consent that mammography screening becomes more ethical if participants are adequately informed about potential benefits and harms of the screening procedure itself. The ethical analysis, however, should not stop with the recommendation to inform adequately but should be bound to the necessity of quality assessments with respect to the information process and its results 24 , We have developed the framework primarily to provide practical guidance.
The transparent, systematic approach will enable those who implement a PH intervention and those affected by it i. The results of the evaluation can then be the basis for political decisions on several levels in the health care system and society about the implementation of PH interventions. While it is not the primary goal of the framework to provide guidance for these political processes, some of the ethical requirements will also apply: especially, the conditions of a fair decision process cf.
Table 2 should also be met in the political sphere of decision making — which currently is often not the case. Whether the presented framework will be able to achieve its goals has to be determined by practical application: are all necessary normative considerations concerning substantive justification and procedural fairness included in the framework?
Does the methodological approach provide a useful tool for evaluators of PH practice? Applying the framework to further examples of PH interventions will shed more light on its strengths and weaknesses. The framework itself requires critical monitoring by scholars and practitioners in the field of PH. There is an increasing need for assessing the ethical implications of PH practice. While several approaches have been published over the last decade, none of them give a complete account of both the normative foundation and the methodological approach.
Based on a coherentist model of justification, we set out here a systematic framework for ethical analysis in PH that includes 1 an explicit normative foundation with five substantial criteria and seven procedural conditions and 2 a six-step methodological approach for applying the normative considerations to concrete PH interventions. Rather, normative questions about the effectiveness, benefits, or harms of a PH intervention can only be answered by reference to the evidence from empirical studies. In this respect, the framework strives for evidence-based PHE. They all read and approved the final manuscript and agree to be accountable to all aspects of the work.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Dawson A. Resetting the parameters. Public health as the foundation for public health ethics. In: Dawson A, editor. Public Health Ethics.
Ethics in Public Health and Health Policy
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