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Pandemic influenza preparedness: an ethical framework to guide decision-making

Pandemic influenza preparedness: an ethical framework to guide decision-making Background: Planning for the next pandemic influenza outbreak is underway in hospitals across the world. The global SARS experience has taught us that ethical frameworks to guide decision- making may help to reduce collateral damage and increase trust and solidarity within and between health care organisations. Good pandemic planning requires reflection on values because science alone cannot tell us how to prepare for a public health crisis. Discussion: In this paper, we present an ethical framework for pandemic influenza planning. The ethical framework was developed with expertise from clinical, organisational and public health ethics and validated through a stakeholder engagement process. The ethical framework includes both substantive and procedural elements for ethical pandemic influenza planning. The incorporation of ethics into pandemic planning can be helped by senior hospital administrators sponsoring its use, by having stakeholders vet the framework, and by designing or identifying decision review processes. We discuss the merits and limits of an applied ethical framework for hospital decision-making, as well as the robustness of the framework. Summary: The need for reflection on the ethical issues raised by the spectre of a pandemic influenza outbreak is great. Our efforts to address the normative aspects of pandemic planning in hospitals have generated interest from other hospitals and from the governmental sector. The framework will require re-evaluation and refinement and we hope that this paper will generate feedback on how to make it even more robust. nity is identifying scientific research priorities and needs Background As the world prepares for the emergence of a pandemic related to the anticipated pandemic [1-5]. There is also a strain of influenza, trans-national, national and local need to examine the ethical issues that arise from plan- organisations and agencies are designing plans to manage ning for a public health crisis of this magnitude. Who community outbreaks. In addition, the medical commu- should get the limited supply of antivirals? Are health care Page 1 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 workers duty-bound to care for the ill in a pandemic when Kotalik argues that as "every discourse about health care they may have competing familial obligations? Who will has not only a scientific but also a moral dimension, [pan- be prioritized for scarce ventilated hospital beds? When demic influenza] plans also presuppose certain ethical should hospitals cancel elective surgeries or restrict hospi- values, principles, norms, interests and preferences" [10]. tal visitation? To date, the bioethics community has been It is important to make these presuppositions explicit, slow to respond to public health issues in general [6,7], because, as the SARS experience in Toronto taught health and pandemic influenza planning in particular [8,9]. In care organisations, the costs of not addressing the ethical this paper we discuss the need for ethics in pandemic concerns are severe: loss of public trust, low hospital staff influenza planning and discuss the ethical framework we morale, confusion about roles and responsibilities, stig- developed to guide pandemic planning in hospitals. matization of vulnerable communities, and misinforma- tion [12-14]. Another key insight from SARS that we In the only article we could find that has an in-depth anal- overlook at our peril was that in times of crisis, "where ysis of the ethics of pandemic planning, Kotalik offers an guidance is incomplete, consequences uncertain, and ethical analysis of the pandemic plans of three countries. information constantly changing, where hour-by-hour His arguments are primarily about the ethics of pandemic decisions involve life and death, fairness is more important, planning efforts, as opposed to the ethics in pandemic rather than less [emphasis added]" [14]. As we shall argue, planning. For example, he argues persuasively that it is fairness considerations are both procedurally and sub- problematic that all three countries' plans accept particu- stantively important: there is a need for fair decision-mak- lar conditions of resource scarcity as planning assump- ing processes, as well as equitable distributions of scarce tions [10]. While Kotalik has raised important issues human and material resources. about the ethics of pandemic planning in his article, our ethical framework focuses specifically on providing guid- Take the example of triaging ventilated beds in an ICU. In ance to decision-makers about ethical issues in pandemic theory, decision-makers rely on scientific evidence to planning. This includes providing guidance on how to determine how best to maximise benefit in the allocation design an ethical process for decision-making, and pro- of ventilated beds, but science cannot tell us whether or viding guiding ethical values for the consideration of sub- not the initial decision to maximise benefit is just. Because stantive issues. the notion of maximising benefit is derived from a reflec- tion on values, ethical analysis is required to determine The framework here proposed is an example of practical why a utilitarian approach to triage though maximisation ethics that attempts to provide decision-makers with an of benefit is preferable to the assignment of ventilated introduction to and articulation of generally accepted eth- beds on a different basis, for example that of greatest need. ical principles or values. The significance of this ethical Even if the utilitarian maximisation of benefit is thought framework is a) in the unique collaborative approach to be ethically sound, how to implement a system based taken to its development that involved ethicists with dif- on this criterion is not ethically straightforward, and ferent areas of expertise and a variety of health care stake- requires ethical reflection about what counts as good holders, and b) that it fills an important need in pandemic stewardship, and about the moral obligation to demon- planning for an ethical framework to guide decision-mak- strate transparency, accountability, fairness and trustwor- ing that has been unmet in most pandemic planning proc- thiness in the allocation of scarce resources. esses world wide. The importance of ethics to pandemic planning is in the The importance of ethics in pandemic planning "the application of value judgements to science" [15], One of the characteristics of a public health crisis is that especially as they are embedded in planning assumptions, health needs overwhelm available human and material and within the practice of medicine itself. For example, resources. Difficult decisions must be made about how, while ethics might have little to contribute to understand- where and to whom resources should be allocated. Medi- ing the mechanism of influenza virus transmission, it can cal science provides valuable information to help make make a significant contribution to debates such as what these decisions. However, science alone is insufficient. levels of harm the public are prepared to accept, how the Now consider that resource allocation decisions are just burdens of negative outcomes should be distributed one kind of decision decision-makers face in preparing across the population and whether or not more resources for, and getting through an influenza pandemic [9]. As a should be invested in stockpiling antiviral medications. few scholars have begun to point out, pandemic planning needs to take ethical considerations seriously, and not The use of ethical frameworks to guide decision-making allow the urgency of logistical and scientific needs to side- may help to mitigate some of the unintended and una- line a discussion of ethical considerations [10,11]. voidable collateral damage from an influenza pandemic. As Kotalik argues, the incorporation of ethics into pan- Page 2 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 demic plans can help to make them "instruments for Our working group was formed in response to the pan- building mutual trust and solidarity at such time that will demic planning initiative that took place at S & W in early likely present a major challenge to our societies" [10]. 2005. The hospital's Clinical Ethics Centre was invited to Using ethical frameworks to help guide decisions can offer provide ethics support in this planning initiative. It soon greater assurance that the values instantiated within them, became apparent that the scope of the issues went beyond such as accountability, transparency and trust, will be the purview of clinical ethics to include organisational carefully thought about in decision-making and when and public health ethics. Expertise in organisational and reviewing decisions with stakeholders. public health ethics was quickly procured through the University of Toronto Joint Centre for Bioethics which is Discussion a partnership between the University and sixteen affiliated Development of the ethical framework healthcare organizations that includes S & W among its One of the key lessons from the Toronto SARS experience partners. S&W was subsequently de-amalgamated into was that health care institutions and their staff could ben- Sunnybrook Health Sciences Centre and Women's Col- efit from the development of ethical frameworks for deci- lege Hospital, thus the ethical framework is currently sion-making [12]. The intention of this section is not to being implemented at Sunnybrook HSC. systematically derivate from normative theory the values and principles in the framework. This paper has a more As the framework took shape, we were invited to join the narrow focus – it is an example of applied/practical ethics MOHLTC planning efforts. We began to work with the that attempts to introduce and articulate values that are Vaccine and Antiviral working group at the MOHLTC, and already commonly accepted. It is not our intention to we adapted our work to meet the related but distinct chal- comprehensively defend the values in the framework, but lenges facing government. While our work with the rather to show from which areas of scholarship they were MOHLTC began with the Vaccine and Antiviral working drawn, articulate their relevance to pandemic planning, group, the ethical framework we developed for the and to demonstrate their discursive legitimacy through a MOHLTC was eventually included in the Ontario Health process of stakeholder engagement and vetting. To our Pandemic Influenza Plan [16] not as an annex to the section knowledge, no other pandemic planning process has on vaccines and antivirals as we had originally antici- attempted to a) develop an ethical framework to guide pated, but as an ethical framework for the plan as a whole. pandemic influenza planning and b) assess an ethical framework's robustness and resonance in the community Review of clinical ethics and public health ethics literature of its intended users. Thus, the significance of the proce- Expertise in clinical ethics was important to the develop- dural elements of the development of the framework is ment of this framework because of the knowledge, skills not to be minimized, nor are the insights we have gleaned and experience clinical ethicists need to address dilemmas from implementing the framework in health care organi- or challenges found in the daily clinical arena. An obvious sations and in a governmental setting. challenge was how to integrate expertise in public health ethics into a framework designed to guide decision-mak- Building on key lessons from SARS [12-14] and the "emer- ing in clinical health care settings. A related challenge was gency ethics" literature and drawing on our expertise in to thoughtfully integrate generally accepted principles clinical, organisational, and public health ethics, we iden- and values from clinical ethics with those in public health tified key ethical processes and values that are relevant for ethics. In order to meet this challenge, the authors turned health care organisations. These values were presented to not only to the respective ethics literature, but also to the and vetted by a variety of health care stakeholders. Thus, SARS experiences of Toronto hospitals and health care this framework is the product of an iterative and inclusive providers. A review of the SARS literature, and that of pub- process. lic health ethics more generally, guided the integration of the public health and the clinical ethics perspectives Formation of a working group [6,9,10,12-14,17-19]. The Toronto experience with SARS In Ontario the need for guidance on the ethical issues per- demonstrated that organisations faced unique ethical taining to an influenza pandemic has been widely challenges when dealing with a public health crisis, and acknowledged. As word of our work on an ethical frame- much of the ethics literature identified a need for greater work for Sunnybrook and Women's College Health Sci- forethought in how organisations can foster ethical deci- ence Centre (S & W) became known, we were invited to sion-making in times of crisis [12-14]. We reasoned that join other hospitals' pandemic planning efforts. There was the legitimacy of this framework would be enhanced by also broader sectoral interest in ethics, and we were including insights from the analysis of a recent public invited to join the Ontario Ministry of Health and Long health crisis like SARS. Term Care's (MOHLTC) efforts to design a pandemic plan. Page 3 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Lessons from emergency ethics esses is based upon the "accountability for reasonable- Not surprisingly, the literature on clinical ethics has little ness" model developed by Daniels & Sabin [26] and to say about disaster preparedness and how to make deci- adapted by Gibson, Martin & Singer [27]. This model pro- sions about such things as triage under extraordinary cir- vides a useful means of identifying the key elements of cumstances. The ethics literature on bioterrorism and ethical decision-making processes. An extensive literature battle-field triage informed our thinking and called our has developed around Daniels' and Sabin's accountability attention to important issues such as the duty to care, rec- for reasonableness framework. The Daniels and Sabin iprocity, equity and good stewardship [20-25]. The impor- framework has broad applicability across institutional set- tance of having ethically robust criteria and policies tings and priority setting situations [28-35]. Because the developed in advance of a pandemic influenza outbreak is Daniels and Sabin framework applies deliberative theo- underscored in this literature, for "critical decisions like ries of democratic justice to the specific problem of health these should not be made on an individual case-by-case care priority setting, and because it is unique in this basis" and "physicians should never be placed in a posi- regard, we felt it promoted the kind of deliberative tion of individually deciding to deny treatment to patients approach to pandemic planning that this ethical frame- without the guidance of policy or protocol" [22]. Robust work is intended to support. Table 1 outlines the charac- disaster preparedness requires practising preventive eth- teristics of an ethical decision-making process. ics. Stakeholders will be more able to accept difficult deci- sions during a pandemic influenza crisis if the decision- Stakeholder vetting making process has, and is perceived to have, ethical legit- The ethical framework was vetted through S & W's Pan- imacy. demic Planning Committee, the Joint Centre for Bioeth- ics' Clinical Ethics Group (comprised of the affiliated Ethical values health care organizations' clinical ethicists), the MOHLTC The second part of the framework identifies ten key ethical Vaccine and Antiviral Working Group, and the MOHLTC values that should inform the pandemic influenza plan- pandemic planning committee. Through this process, we ning process and decision-making during an outbreak. refined the framework and we are grateful to these groups These values are intended to provide guidance, and it is for their valuable insights. important to consider that more than one value may be relevant to a situation. Indeed, the hallmark of a challeng- The ethical framework ing ethical decision is that one or more value(s) are in ten- The ethical framework is intended to inform decision- sion and that there is no clear answer about which one to making, not replace it. It is intended to encourage reflec- privilege in making the decision. When values are in ten- tion on important values, discussion and review of ethical sion with one another, the importance of having ethical concerns arising from a public health crisis. It is intended decision-making processes is reinforced (see above.) also as a means to improve accountability for decision- making and may require revision as feedback and circum- The values identified in our ethical framework were based stances require. initially on previous research findings on ethics and SARS at the University of Toronto Joint Centre for Bioethics The framework is divided into two distinct parts, and (JCB). This work was funded by a Canadian Institutes of begins with the premise that planning decisions for a pan- Health Research grant in 2004 through 2006 and has led demic influenza outbreak ought to be 1) guided by ethical to several key publications on the ethical dimensions of decision-making processes and 2) informed by ethical val- SARS [14,36-39]. In particular, Singer et. al., in their sem- ues. Ethical processes can help to improve accountability inal British Medical Journal article begin to identify key and it is hoped that, to the extent that it is possible for eth- ethical values that were of relevance during the SARS epi- ical processes to produce ethical outcomes, the substan- demic in Toronto. These values were then further articu- tive ethical quality of decisions will be enhanced. lated by our working group and adapted for the pandemic Recognising, however, that ethical processes do not guar- influenza planning context. Through a discursive process antee ethical outcomes, we have identified ten key ethical of stakeholder consultation with public health specialists, values to guide decision-making that address the substan- ministry officials, S & W's pandemic influenza committee, tive ethical dimensions of decision-making in this con- and the Clinical Ethics Group at the JCB, we augmented text. the values to include two new values (stewardship and trust [40,41]) and refined the definitions of each value in Ethical processes light of the anticipated demands of a pandemic influenza In planning for and throughout a pandemic influenza cri- crisis compared to a hospital-based epidemic such as sis, difficult decisions will be made that are fraught with SARS. The substantive values identified and articulated in ethical challenges. Our framework around ethical proc- the framework are not intended to be an exhaustive set, Page 4 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Table 1: Ethical processes (Listed in alphabetical order). Adapted from Daniels, N. Accountability for reasonabless. BMJ 2000, 321:1300–1301. Value Description Accountability There should be mechanisms in place to ensure that ethical decision-making is sustained throughout the crisis. Inclusiveness Decisions should be made explicitly with stakeholder views in mind and there should be opportunities for stakeholders to be engaged in the decision-making process. For example, decision-making related to staff deployment should include the input of affected staff. Openness & Transparency Decisions should be publicly defensible. This means that the process by which decisions were made must be open to scrutiny and the basis upon which decisions are made should be publicly accessible to affected stakeholders. For example, there should be a communication plan developed in advance to ensure that information can be effectively disseminated to affected stakeholders and that stakeholders know where to go for needed information. Reasonableness Decisions should be based on reasons (i.e., evidence, principles, values) that stakeholders can agree are relevant to meeting health needs in a pandemic influenza crisis and they should be made by people who are credible and accountable. For example, decision-makers should provide a rationale for prioritising particular groups for anti- viral medication and for limiting access to elective surgeries and other services. Responsiveness There should be opportunities to revisit and revise decisions as new information emerges throughout the crisis as well as mechanisms to address disputes and complaints. For example, if elective surgeries are cancelled or postponed, there should a formal mechanism for stakeholders to voice any concerns they may have with the decision. and they may underdetermine how best to achieve the the ethical framework can be used to identify key ethical overall goals of pandemic planning, which generally aspects of decision-making. include the minimization of morbidity, mortality, and societal disruption. Nevertheless, this is not to say that Let us take the issue of targeting and prioritizing popula- that a procedural engagement about the overall goals of a tions for vaccine and antivirals to illustrate how the values pandemic response would not benefit from using the eth- in the ethical framework can help guide decision-making. ical framework to guide and shape debate. A description The values of solidarity and protecting the public from of the values that should guide decision-making can be harm would require that priorities be set to maximize the found in Table 2. capacity to help society ensure that the ill are cared for during a pandemic. Furthermore proportionality would Included in the framework are "hot button" ethical issues require that decision-makers consider who within the that we identified through our work with Toronto hospi- community are most vulnerable to the contagion as well tals and the MOHLTC. These issues were as follows: as who are most likely to benefit from immunization. A well-informed public conversant with the values in the a) Targeting and prioritizing populations for vaccines and ethical framework and aware of the expertise that antivirals informed the ranking of priorities for immunisation would be consistent with value of trust and the principle b) Intensive Care Unit and hospital bed assignment of transparency. c) Duty to care Lastly, while knowing how to use the framework to inform decision-making is vital, there is more to ensuring d) Human resources allocation and staffing that the framework will be used or useful. e) Visiting restrictions Lessons for implementing an ethical framework We have identified three necessary, if not exhaustive ele- f) Communications and how reviews of decisions will be ments to the successful integration of ethics into hospital handled pandemic planning processes. These elements are 1) sponsorship of the ethical framework by senior hospital These "hot button" issues are not intended to be exhaus- administration; 2) vetting of the framework by key stake- tive, but rather they serve to illustrate how the values in holders and; 3) decision review processes. Page 5 of 11 (page number not for citation purposes) Table 2: Ethical values to guide decision-making (Listed in alphabetical order) Value Description Example Duty to Provide Care The duty to provide care and to respond to suffering is inherent to all health care professionals' codes of ethics. In an influenza Health care workers who are at increased risk pandemic, demands on health care providers and the institutions in which they work will overwhelm resources. Health care because they are caring for patients with providers will have to weigh demands from their professional role with other competing obligations to their own health, to influenza must weigh familial obligations, and family and friends. Health care workers will face significant challenges related to resource allocation, scope of practice, obligations to self with their professional duty professional liability, and workplace conditions. to care. In addition, they may also have to Decision makers should: comply with vaccination or antiviral regimens • Work collaboratively with stakeholders and professional colleges in advance of an influenza pandemic to establish practice for prophylaxis which may conflict with their guidelines individual liberty. • Work collaboratively to develop fair and accountable processes to resolve disputes • Provide supports to ease this moral burden of those with the duty to care • Develop means through which institutions will handle appeals or complaints, especially with regards to work exemptions, or the vaccination/prophylaxis of staff Equity The principle of equity holds that, all things being equal, all patients have an equal claim to receive needed health care. During In allocating scarce resources, the value of influenza pandemic, however, tough decisions will need to be made about which health services to maintain and which to defer equity could guide in developing fair criteria for because of extraordinary circumstances. allocation while consideration is given also to Measures taken to contain the spread of a deadly disease will inevitably cause considerable collateral damage. In an influenza compensation for those who will not meet pandemic, this will extend beyond the cessation of elective surgeries and may limit the provision of emergent or necessary inclusion criteria yet are entitled to receive services. care. Decision-makers must strive to: • Preserve as much equity as possible between the interests of patients [afflicted with the influenza] and those who need urgent treatment for other diseases • Ensure procedural fairness in decision-making Individual Liberty Individual liberty is a value enshrined in health care practice under the principle of respect for autonomy. Under usual Social distancing strategies that employ visitor circumstances, health care providers balance respect for individual autonomy with a duty to protect individual patients from restrictions in hospitals must be necessary for harm. In a public health crisis, however, restrictions to individual liberty may be necessary to protect the public from serious the protection of the public and must be harm. Patients, staff, and members of the public may all be affected by such restrictions. proportionate to the threat being allayed. Restrictions to individual liberty should: • Be proportional to the risk of public harm • Be necessary and relevant to protecting the public good • Employ the least restrictive means necessary to achieve public health goals • Be applied without discrimination Privacy Individuals have a right to privacy in health care. In a public health crisis, it may be necessary to override this right to protect the The need to conduct contact tracing of public from serious harm. A proportionate response to the need for private information requires that it be released only if there possibly infected people might require that are no less intrusive means to protect public health. particular groups or even individuals are Decision makers should: identified publicly. The need to do so must be • Disclose only private information that is relevant to achieve legitimate and necessary public health goals weighed against the potential harm of exposing • Release private information only if there are no less intrusive means to protect public health communities and individuals to stigmatization. • Determine whether the good that is intended is significant enough to justify the potential harm that can come from suspending privacy rights, (e.g. the harm from stigmatization of individuals or particular communities) • Provide public education to correct misconceptions about disease transmission and to offset misattribution of blame to particular communities Proportionality Proportionality requires that restrictions to individual liberty and measures taken to protect the public from harm should not The decision to close an emergency room must exceed what is necessary to address the actual level of risk to, or critical need of, the community. consider if the potential harm in keeping the Decision makers should: emergency room open is significant enough to • Use least restrictive or coercive measures in limiting or restricting liberties or entitlements warrant its closure. • Use more coercive measures only in circumstances where less restrictive measures have failed to achieve appropriate public health ends. BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Page 6 of 11 (page number not for citation purposes) Table 2: Ethical values to guide decision-making (Listed in alphabetical order) (Continued) Protection of the A foundational principle of public health ethics is the obligation to protect the public from serious harm. This principle requires When making the decision to quarantine Public from Harm that citizens comply with imposed restrictions in order to ensure public wellbeing or safety. To protect the public from harm, individuals, protection of the public from harm hospitals may be required to restrict public access to service areas (e.g. restricted visiting hours), to limit availability of some must be weighed against individual liberty. services (e.g. elective surgeries), or to impose infectious control practices (e.g. masks or quarantine). Note that while the ethical value of individual When making decisions designed to protect the public from harm, decision makers should: liberty is often in tension with the protection of • Weigh the medical and moral imperative for compliance the public from harm, it is also in individuals' • Ensure stakeholders are made aware of the medical and moral reasons for public health measures interests to minimize harm to others. • Ensure stakeholders are aware of the benefits of compliance & the consequences of non-compliance • Establish mechanisms to review these decisions as the public health situation changes and to address stakeholders concerns or complaints Reciprocity Reciprocity requires that society supports those who face a disproportionate burden in protecting the public good and takes The provision of antiviral medication and/or steps to minimise their impact as far as possible. In an influenza pandemic, measures to protect the public good are likely to vaccination to hospital staff for prophylaxis is impose a disproportionate burden on health care workers, patients, and their families. Health care workers may face expanded one way hospitals can ensure the safety of their duties, increased workplace risks, physical and emotional stress, isolation from peers and family, and in some cases, infection workers who may be exposed to greater than leading to hospitalization or even death. Similarly, quarantined individuals or families of ill patients may experience significant usual risks in discharging their duty to care. social, economic, and emotional burdens. Decision-makers and institutions are responsible for: • Easing the burdens of health care workers, patients, and patient's families in their hospitals and in coordination with other health care organizations • Ensuring the safety of their workers, especially when redeploying staff in areas beyond the usual scope of practice Solidarity SARS heightened the global awareness of the interdependence of health systems and the need for solidarity across systemic and Territoriality between hospital departments institutional boundaries in stemming a serious contagious disease. An influenza pandemic will not only require global solidarity, it and between health care institutions needs to will require a vision of solidarity within and between health care institutions. be overcome with good communication and Solidarity requires: sense of common purpose in order to provide • Good, open and honest communication equitable care across jurisdictions • Open collaboration, in a spirit of common purpose, within and between health care institutions • Sharing public health information • Coordinating health care delivery, transfer of patients, and deployment of human and material resources Stewardship In our society, both institutions and individuals will be entrusted with governance over scarce resources, such as vaccines, A hospital's decision to stock-pile antiviral antivirals, ventilators, hospital beds and even health care workers. During a pandemic influenza outbreak, difficult decisions about medication must consider whether this is an how to allocate material and human resources will have to be made, and there will be collateral damage as a result of these effective way of protecting staff from infection, allocation decisions. Those entrusted with governance roles should be guided by the notion of stewardship. Inherent in where the money for stockpiling will come stewardship are the notions of trust, ethical behaviour, and good decision-making. from, and whether that money could be put to Decision makers have a responsibility to: better use elsewhere. • Avoid and/or reduce collateral damage that may result from resource allocation decisions • Maximize benefits when allocating resources • Protect and develop resources where possible • Consider good outcomes (i.e. benefits to the public good) and equity (i.e., fair distribution of benefits & burdens) Trust Trust is an essential component in the relationships between clinician and patient, between staff and the organization, between Early engagement with stakeholders may go the public and health care providers, and between organizations within a health system. In a public health crisis, stakeholders may some distance to justify stakeholder confidence perceive public health measures as a betrayal of trust (e.g. when access to needed care is denied) or as abandonment at a time of in decision-makers' trustworthiness. In part, greatest need. Decision-makers will be confronted with the challenge of maintaining stakeholders' trust while at the same time the value of trust is respected and promoted by stemming an influenza pandemic through various control measures. It takes time to build trust. following the ethical processes outlined above. Decision-makers should: • Take steps to build trust with stakeholders before the crisis hits not while it is in full swing • Ensure decision making processes are ethical and transparent to those affected stakeholders BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Page 7 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Sponsorship by senior administrators instantiated in the framework resonate with the stake- Whether or not an ethical framework is used to inform holder community. decision-making in a health care institution depends to a large extent on people in senior positions of an organisa- It has been our experience that the values in the frame- tion seeing its relevance to the decision-making process. work did resonate with the pandemic planners with In part, this is dependant on how robust the framework is, whom we have shared this ethical framework. The prima- but it also requires the willingness to frame (at least some) rily pragmatic justification for the selection of the values pandemic planning issues as normative in nature. in the framework means that the framework is provisional so it ought to be subject to revision in light of compelling Some may argue that the values in the framework are too argument, empirical evidence and further stakeholder stringent or impractical to implement under crisis condi- feedback. It is important to note, however, that the itera- tions, especially those found in the Ethical Processes part tive and inclusive process through which the values in the of the framework (see Table 1). Certainly, crisis condi- framework were deliberated amongst the various stake- tions may place constraints on the extent to which each holder groups lends them a form of discursive ethical principle can be acted upon. However, efforts should be legitimacy and helps to justify their inclusion in the ethi- made to put them into action to the fullest extent possible cal framework. We intend that the framework invite fur- under the circumstances and in our experience this is only ther dialogue about its legitimacy and its adequacy. We possible with the support of senior administrators. will return to this issue in the final section of this paper. The senior administration at S & W (many of whom were Ideally, the vetting process would include people who can part of the Pandemic Planning Committee) had previous represent the interests of patients, families and volunteers experience with the accountability for reasonableness who are part of the hospital's constituency. Although framework for decision-making, and thus their pandemic patient relations, human resources and occupational influenza planning committee was already familiar with health representatives from S & W provided guidance and the Ethical Processes part of the framework, and they were feedback in the development of the framework, direct receptive to the idea of being guided by an ethical frame- input from patients and family representatives was not work. Senior administrators may also have been receptive obtained. One limitation of our framework is that is has to the ethical framework because, as they learned from yet to be vetted by these important stakeholders. SARS, organisations that did not have decision-making processes that honoured the values for ethical process dur- The importance of solidarity to the management of a pub- ing SARS have been dealing with a legacy of collateral lic health crisis would also suggest that the public and damage to staff and patients in the form of distrust and other health care organisations be considered stakehold- low morale [12]. For these reasons, the senior administra- ers in hospital pandemic planning. While it may not be tors at S & W played an important role in vetting the ethi- pragmatic for hospitals to undertake broad public consul- cal framework. Ensuring that institutional "sponsors" are tation and vetting processes for their pandemic plans in in favour of adopting an ethical framework is important general, and their ethical frameworks in particular, soli- for gaining widespread support for using an ethical frame- darity and equity suggest that these broader stakeholder work in decision-making, and for ensuring that the ethical interests are relevant to pandemic planning. Conse- framework does not become something that looks good quently, opportunities for broader ethical dialogue about but remains unused. pandemic planning need to be encouraged. Vetting of the ethical framework by key stakeholders Decision review processes In order to obtain support for, or "buy in" to an ethical In order to ensure that the support of key stakeholders is framework, it is important that key stakeholders in an maintained through an outbreak, there need to be effec- institution vet the framework. This requires careful con- tive communication mechanisms in place. An important sideration of who the key stakeholders are in an institu- aspect of responsive decision-making processes is ensur- tion. Not only should this include those with ing that there are formal opportunities to revisit and revise responsibility for decision-making, but also those who decisions as new information emerges. As part of our eth- will be affected by decisions taken. For the vetting process ical framework, we formulated a template for decision is not just intended to create "buy in" but also to decrease review processes, (adapted from, Gibson, JL: Formal deci- the likelihood that interests and issues that are (morally) sion review process template. Unpublished; 2003) that aids relevant to pandemic planning will be neglected or over- organisations in identifying existing and establishing new looked, thereby enhancing the moral legitimacy of the mechanisms that can be used for the formal reviews of values in the framework. In addition, a process of stake- decisions. We believe decision review mechanisms are an holder vetting increases the likelihood that the values essential part of ethical decision-making in a public Page 8 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 health crisis, and are one way to put the values in the eth- the product of applied ethical analysis, and should be ical framework in to action. evaluated in light of this, one of its strengths is that it can also redress what Callahan and Jennings would character- Formal mechanisms for reviewing decisions are needed in ize as "critical" ethics problem of power disparities within order to capture feedback from stakeholders on key deci- institutions. sions, and to resolve disputes and challenges. These proc- esses are important for ensuring that decisions are the best Conclusion possible under the circumstances given changing informa- Cultural limitations and future directions tion and for engaging stakeholders constructively around Within pluralistic societies, there are many different ethi- the difficult decisions that must be made. Given the cal perspectives that exist simultaneously on issues about unpredictable nature of public health emergencies and global, public and individual health. An ethical frame- the difficulty this poses for those in charge of planning work to guide decision-making is robust to the extent that and decision-making, it is reasonable to assume that deci- it reflects the values and beliefs of the decision-makers sions will be revised throughout the pandemic influenza who refer to it and the values and beliefs of those affected crisis. Disputes or challenges may arise from the restric- by the decisions being taken. Our framework relied heav- tions or requirements imposed on staff, patients and fam- ily on the Toronto experience with SARS to surface and ilies during a pandemic influenza outbreak. Thus, examine the ethical values that are important for a public decision review processes are essential. Again, while some health crisis. An influenza pandemic is likely to present us may argue that this is too stringent a measure for a time of with particular ethical challenges that are different from crisis, we argue that reviews of decisions will be taking SARS due to the predicted severity of the contagion and its place regardless (most likely in an ad hoc manner), and spread to the community. It would therefore be important that to formalize this process is to increase its fairness and not to uncritically adopt such a framework but rather to moral legitimacy. Indeed, there may be existing mecha- use it as a basis for continued reflection and re-evaluation nisms which can handle these kinds of reviews. to ensure its relevance and responsiveness during the unfolding health crisis. It is also important to consider the Scope of the ethical framework extent to which an ethical framework is reflective of the It is important to distinguish between different types of community in which it is to be used. Lessons from SARS ethical analyses in order to explain the approach that was as it was experienced in China would likely surface some taken to the development of the ethical framework dis- different ethical values, or emphasise different aspects of cussed herein. Callahan and Jennings draw a useful dis- our framework. As Callahan and Jennings have argued: tinction between applied ethics and critical ethics [7]. Our ethical framework is an example of applied ethics because We submit that a rich discourse on ethics and public the framework identifies and relies on "general principles health cannot be advanced without relating it to the back- that can be applied to real-world examples of professional ground values of the general society, and the particular conduct or decision-making"[7] and because it is communities, in which it will be carried out.[7] "designed to give professionals guidance and to give cli- ents and the general public standards to use in assessing Indeed, as previously maintained, there are many issues professional conduct" [42]. While there is certainly a need related to pandemic influenza planning – particularly for critical ethical analysis that pays attention to problems those raised by a critical ethical analysis – that require that are the "result of institutional arrangements and pre- broad public debate. While these kinds of issues require vailing structures of cultural attitudes and social power" public debate that takes place at the societal level, ethical [7], one would not expect a ethical framework designed to pandemic planning requires that organisations and agen- guide clinical decision-making to explicitly address these cies foster internal dialogue about the values instantiated kinds of issues. in an ethical framework. For it is imperative that the val- ues outlined in a framework resonate with the members This is not to say that this ethical framework cannot of an organisation, and the community it serves. The pro- address the kinds of issues that a critical ethical analysis cedural aspects of the framework provide a means to might address. For example, the framework promotes val- ensuring that the values of the community are reflected in ues and processes that seek to redress the power dispari- decision-making through the procedural principles of ties within institutions. The section of the framework that inclusiveness and responsiveness. deals with ethical processes in particular is a challenge to how institutional decisions are typically made. For exam- It is important, too, to recognise that values are not static, ple, the value of "inclusiveness" as a process principle is and that circumstances will evolve rapidly during a pan- essential for redressing power differences amongst key demic influenza outbreak. Ethical frameworks will also stakeholders [27]. Thus, while the ethical framework is require re-evaluation and revision. The challenge will be Page 9 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 to continue to recognise the importance of moral reflec- Competing interests tion under circumstances that are not conducive to it and The author(s) declare that they have no competing inter- to encourage a process of re-evaluation that strives to ests. assess whether resulting decisions are consistent with those values the framework is intended to promote. For Authors' contributions this reason, it is imperative to start the ethical dialogue in AT, KF, JG and RU contributed equally to the develop- advance, and to find ways to encourage consideration of ment of the ethical framework. AT drafted this manuscript ethical issues at all stages of decision-making. We hope and KF, JC and RU contributed equally to the revision of that this paper will go some way towards advancing this the manuscript. All authors read and approved the final objective, and that this paper stimulates discussion of the manuscript. ethical issues and values that pervade pandemic planning. Acknowledgements We should like to thank the Pandemic Influenza Planning Committee at We believe that this framework is unique in its blending Sunnybrook and Women's College Health Sciences Centre, the Clinical of clinical, public health, and organizational ethics. One Ethics Group at the University of Toronto Joint Centre for Bioethics, and of its strengths is that it draws on lessons from the recent the Vaccine and Antivirals Working Group of the Ontario Ministry of public health crisis of SARS in Toronto, and it is to some Health and Long Term Care. This framework was vetted through these extent empirically grounded. Another strength is that it is groups and was bettered from their feedback. Ross Upshur is supported by the product of an inclusive process of development that the Canada Research Chair in Primary Care Research. We also thank our included stakeholder vetting. It is also unique in its three peer reviewers, Angela Bate, Ezekiel Emanuel and Akria Akabayashi attempt to provide guidance to decision-makers facing a for their helpful insights and comments. public health crisis. We hope that the framework's accept- References ance by hospitals and the provincial government in 1. Stohr K: Avian influenza and pandemics: research needs and Ontario signals a change in the way that decisions are opportunities. N Engl J Med 2005, 352:405-407. taken by institutions that are charged with making deci- 2. Osterholm MT: Preparing for the next pandemic. N Engl J Med sions that have life and death consequences for the public. 2005, 352:1839-1842. 3. Tam T, Sciberras J, Mullington B, King A: Fortune favours the pre- pared mind: a national perspective on pandemic prepared- Summary ness. Can J Public Health 2005, 96:406-408. 4. Reichert TA: Preparing for the next influenza pandemic. The  Good pandemic planning requires reflection on values Pediatric Infectious Disease Journal 2005, 24:S228-S231. because scientific information alone cannot drive deci- 5. Wong S, Yuen K: Avian influenza virus infections in humans. sion-making. Chest 2006, 129:156-168. 6. Beauchamp E, Steinbock B: New Ethics for the Public's Health. New York, Oxford University Press; 1999.  The development of an ethical framework for hospital 7. Callahan D, Jennings B: Ethics and public health: forging a strong relationship. American Journal of Public Health 2002, 92:169-176. pandemic planning calls for expertise in clinical, organisa- 8. Kotalik J: Preparing for an influenza pandemic: ethical issues. tional and public health ethics. Bioethics 2005, 19:422-431. 9. Zoloth L, Zoloth S: Don't be chicken: bioethics and avian flu. The American Journal of Bioethics 2006, 6:5-8.  Stakeholder engagement is essential for the ethical 10. Kotalik J: Addressing issues and questions relating to pan- framework to be relevant and legitimate. demic influenza planning: final report and recommenda- tions. , Health Canada; 2003. 11. Tracy SC, Upshur R, Daar A: Avian influenza and pandemics. N  The ethical framework contains procedural and substan- Engl J Med 2005, 352:1928. tive ethical values to guide decision-making. 12. Berstein M, Hawryluck L: Challenging beliefs and ethical con- cepts: the collateral damage of SARS. Critical Care 2003, 7:269-271.  Three key elements of integration of ethics in to pan- 13. Singer P, Benatar S, Berstein M, Daar A, Dickens B, MacRae S, Upshur demic planning are 1) sponsorship from senior hospital R, Wright L, Zlotnick Shaul R: Ethics and SARS: lessons from Toronto. BMJ 2003, 327:1342-1344. administration; 2) vetting by stakeholders and; 3) deci- 14. Bell J, Hyland S, DePelligrin T, Upshur R, Berstein M, Martin D: SARS sion review processes. and hosptial priority setting: a qualitative case study and evaluation. BMC Health Services Research 2004, 4:. 15. Perhac R: Comparative risk assessment: where does the pub-  An ethical framework is robust to the extent that pan- lic fit in? Science, Technology and Human Values 1998, 23:221-241. demic influenza planning decisions are seen to be ethi- 16. MOHLTC: Ontario Health Pandemic Influenza Plan. Toronto, ; 2005. cally legitimate by those affected by them. 17. Upshur R: Principles for the justification of public health inter- vention. Can J Public Health 2002, 93:101-103.  In order to increase the robustness of pandemic plan- 18. Gostin LO: Public health, ethics, and human rights: a tribute to the late Johnathan Mann. J Law Med Ethics 2001, 29:121-130. ning in general, timely public debate about the ethical 19. O'Neill O: Public Health or Clinical Ethics: Thinking beyond issues is essential. Borders. Ethics & International Affairs 2002, 16:. 20. Wynia MK, Gostin LO: Ethical challenges in preparing for bio- terrorism: barriers within the health care system. Am J Public Health 2004, 97(7):1096-1102. Page 10 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 21. Iserson K, Pesik N: Ethical resources distribution after biologi- cal, chemical or radiological terrorism. Cambridge Quarterly of Healthcare Ethics 2003, 12:455-465. 22. Pesik N, Keim M, Iserson K: Terrorism and the ethics of emer- gency medical care. Annals of Emergency Medicine 2001, 37:642-646. 23. Veatch R: Disaster prepardeness and triage: justice and the common good. Mt Sinai J Med 2005, 72(4):236-241. 24. Kipnis K: Overwhelming casualties: medical ethics in a time of terror. Accountability in Research 2003, 10:57-68. 25. Marer S, Sutjita M, Rajagopalan S: Bioterrorism, bioethics and the emergency physician. Topics in Emergency Medicine 2004, 26:44-48. 26. Daniels N: Accountability for reasonableness. BMJ 2000, 321:1300-1301. 27. Gibson J, Martin D, Singer P: Priority setting in hospitals: fair- ness, inclusiveness and the problem of institutional power differences. Social Science and Medicine 2005, 61:2355-2362. 28. Ham C: Tragic choices in health care: lessons from the Child B case. British Medical Journal 1999, 319:1258-1261. 29. Norheim OF: Procedures for priority setting and mechanisms of appeal in the Norwegian health care system: ; Amster- dam. ; 2000. 30. Daniels N, Sabin J: Setting limits fairly: can we learn to share scarce resources? Oxford, Oxford University Press; 2002. 31. Martin DK, Giacomini M, Singer P: Fairness, accountability for reasonableness and the views of priority setting decision- makers. Health Policy 2002, 61:279-290. 32. Martin DK, Shulman K, Santiago-Sorrell P, Singer P: Priority setting and hospital strategic planning: a qualitative case study. Jour- nal of Health Services Research and Policy 2003, 8:59-68. 33. Gibson J, Martin DK, Singer P: Setting priorities in health care organisations: criteria, processes, and parameters of suc- cess. BMC Health Services Research 2004, 4:. 34. Gibson J, Martin DK, Singer P: Priority setting in hospitals: fair- ness, inclusiveness, and the problem of institutional power differences. Social Science and Medecine 2005, 61:2355-2362. 35. Mitton C, Donaldson C: Health care priority setting: principles, practice and challenges. Cost Eff Resour Alloc 2004, 2(1):3. 36. Nickell LA, Crighton EJ, Tracy CS, Al-Enazy H, Bolaji Y, Hanjrah S, Hussain A, Makhlouf S, Upshur R: Psychosocial effects of SARS on hospital staff: survey of a large tertiary care institution. Canadian Medical Association Journal 2004, 170:793-798. 37. Ruderman C, Tracy CS, Bensimon CM, Bernstein M, Hawryluck L, Zlotnick Shaul R, Upshur REG: On pandemics and the duty to care: whose duty? who cares? BMC Medical Ethics 2006, 7:. 38. Singer P, Benatar S, Bernstein M, Daar A, Dickens B, MacRae S, Upshur R, Wright L, Zlotnick Shaul R: Ethics and SARS: lessons from Toronto. British Medical Journal 2003, 327:1342-1344. 39. Wilson K, McDougall C, Upshur R, Joint Centre for Bioethics SARS Global Health Ethics Research Group: The new International Health Regulations and the federalism dilemma. PLoS Med 2006, 3(1):e1. 40. Saltman RB, Feroussier-Davis O: The concept of stewardship in health policy. Bulletin of the World Health Organization 2000, 78:. 41. Goold SD: Trust and the ethics of health care institutions. The Hastings Centre Report 2001, 31:26-33. 42. Jennings B: Frameworks for ethics in public health. Acta Bioeth- ica 2003, 9:165-176. Publish with Bio Med Central and every Pre-publication history scientist can read your work free of charge The pre-publication history for this paper can be accessed "BioMed Central will be the most significant development for here: disseminating the results of biomedical researc h in our lifetime." 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Pandemic influenza preparedness: an ethical framework to guide decision-making

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Springer Journals
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Copyright © 2006 by Thompson et al; licensee BioMed Central Ltd.
Subject
Philosophy; Ethics; Philosophy of Medicine; Theory of Medicine/Bioethics
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1472-6939
DOI
10.1186/1472-6939-7-12
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17144926
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Abstract

Background: Planning for the next pandemic influenza outbreak is underway in hospitals across the world. The global SARS experience has taught us that ethical frameworks to guide decision- making may help to reduce collateral damage and increase trust and solidarity within and between health care organisations. Good pandemic planning requires reflection on values because science alone cannot tell us how to prepare for a public health crisis. Discussion: In this paper, we present an ethical framework for pandemic influenza planning. The ethical framework was developed with expertise from clinical, organisational and public health ethics and validated through a stakeholder engagement process. The ethical framework includes both substantive and procedural elements for ethical pandemic influenza planning. The incorporation of ethics into pandemic planning can be helped by senior hospital administrators sponsoring its use, by having stakeholders vet the framework, and by designing or identifying decision review processes. We discuss the merits and limits of an applied ethical framework for hospital decision-making, as well as the robustness of the framework. Summary: The need for reflection on the ethical issues raised by the spectre of a pandemic influenza outbreak is great. Our efforts to address the normative aspects of pandemic planning in hospitals have generated interest from other hospitals and from the governmental sector. The framework will require re-evaluation and refinement and we hope that this paper will generate feedback on how to make it even more robust. nity is identifying scientific research priorities and needs Background As the world prepares for the emergence of a pandemic related to the anticipated pandemic [1-5]. There is also a strain of influenza, trans-national, national and local need to examine the ethical issues that arise from plan- organisations and agencies are designing plans to manage ning for a public health crisis of this magnitude. Who community outbreaks. In addition, the medical commu- should get the limited supply of antivirals? Are health care Page 1 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 workers duty-bound to care for the ill in a pandemic when Kotalik argues that as "every discourse about health care they may have competing familial obligations? Who will has not only a scientific but also a moral dimension, [pan- be prioritized for scarce ventilated hospital beds? When demic influenza] plans also presuppose certain ethical should hospitals cancel elective surgeries or restrict hospi- values, principles, norms, interests and preferences" [10]. tal visitation? To date, the bioethics community has been It is important to make these presuppositions explicit, slow to respond to public health issues in general [6,7], because, as the SARS experience in Toronto taught health and pandemic influenza planning in particular [8,9]. In care organisations, the costs of not addressing the ethical this paper we discuss the need for ethics in pandemic concerns are severe: loss of public trust, low hospital staff influenza planning and discuss the ethical framework we morale, confusion about roles and responsibilities, stig- developed to guide pandemic planning in hospitals. matization of vulnerable communities, and misinforma- tion [12-14]. Another key insight from SARS that we In the only article we could find that has an in-depth anal- overlook at our peril was that in times of crisis, "where ysis of the ethics of pandemic planning, Kotalik offers an guidance is incomplete, consequences uncertain, and ethical analysis of the pandemic plans of three countries. information constantly changing, where hour-by-hour His arguments are primarily about the ethics of pandemic decisions involve life and death, fairness is more important, planning efforts, as opposed to the ethics in pandemic rather than less [emphasis added]" [14]. As we shall argue, planning. For example, he argues persuasively that it is fairness considerations are both procedurally and sub- problematic that all three countries' plans accept particu- stantively important: there is a need for fair decision-mak- lar conditions of resource scarcity as planning assump- ing processes, as well as equitable distributions of scarce tions [10]. While Kotalik has raised important issues human and material resources. about the ethics of pandemic planning in his article, our ethical framework focuses specifically on providing guid- Take the example of triaging ventilated beds in an ICU. In ance to decision-makers about ethical issues in pandemic theory, decision-makers rely on scientific evidence to planning. This includes providing guidance on how to determine how best to maximise benefit in the allocation design an ethical process for decision-making, and pro- of ventilated beds, but science cannot tell us whether or viding guiding ethical values for the consideration of sub- not the initial decision to maximise benefit is just. Because stantive issues. the notion of maximising benefit is derived from a reflec- tion on values, ethical analysis is required to determine The framework here proposed is an example of practical why a utilitarian approach to triage though maximisation ethics that attempts to provide decision-makers with an of benefit is preferable to the assignment of ventilated introduction to and articulation of generally accepted eth- beds on a different basis, for example that of greatest need. ical principles or values. The significance of this ethical Even if the utilitarian maximisation of benefit is thought framework is a) in the unique collaborative approach to be ethically sound, how to implement a system based taken to its development that involved ethicists with dif- on this criterion is not ethically straightforward, and ferent areas of expertise and a variety of health care stake- requires ethical reflection about what counts as good holders, and b) that it fills an important need in pandemic stewardship, and about the moral obligation to demon- planning for an ethical framework to guide decision-mak- strate transparency, accountability, fairness and trustwor- ing that has been unmet in most pandemic planning proc- thiness in the allocation of scarce resources. esses world wide. The importance of ethics to pandemic planning is in the The importance of ethics in pandemic planning "the application of value judgements to science" [15], One of the characteristics of a public health crisis is that especially as they are embedded in planning assumptions, health needs overwhelm available human and material and within the practice of medicine itself. For example, resources. Difficult decisions must be made about how, while ethics might have little to contribute to understand- where and to whom resources should be allocated. Medi- ing the mechanism of influenza virus transmission, it can cal science provides valuable information to help make make a significant contribution to debates such as what these decisions. However, science alone is insufficient. levels of harm the public are prepared to accept, how the Now consider that resource allocation decisions are just burdens of negative outcomes should be distributed one kind of decision decision-makers face in preparing across the population and whether or not more resources for, and getting through an influenza pandemic [9]. As a should be invested in stockpiling antiviral medications. few scholars have begun to point out, pandemic planning needs to take ethical considerations seriously, and not The use of ethical frameworks to guide decision-making allow the urgency of logistical and scientific needs to side- may help to mitigate some of the unintended and una- line a discussion of ethical considerations [10,11]. voidable collateral damage from an influenza pandemic. As Kotalik argues, the incorporation of ethics into pan- Page 2 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 demic plans can help to make them "instruments for Our working group was formed in response to the pan- building mutual trust and solidarity at such time that will demic planning initiative that took place at S & W in early likely present a major challenge to our societies" [10]. 2005. The hospital's Clinical Ethics Centre was invited to Using ethical frameworks to help guide decisions can offer provide ethics support in this planning initiative. It soon greater assurance that the values instantiated within them, became apparent that the scope of the issues went beyond such as accountability, transparency and trust, will be the purview of clinical ethics to include organisational carefully thought about in decision-making and when and public health ethics. Expertise in organisational and reviewing decisions with stakeholders. public health ethics was quickly procured through the University of Toronto Joint Centre for Bioethics which is Discussion a partnership between the University and sixteen affiliated Development of the ethical framework healthcare organizations that includes S & W among its One of the key lessons from the Toronto SARS experience partners. S&W was subsequently de-amalgamated into was that health care institutions and their staff could ben- Sunnybrook Health Sciences Centre and Women's Col- efit from the development of ethical frameworks for deci- lege Hospital, thus the ethical framework is currently sion-making [12]. The intention of this section is not to being implemented at Sunnybrook HSC. systematically derivate from normative theory the values and principles in the framework. This paper has a more As the framework took shape, we were invited to join the narrow focus – it is an example of applied/practical ethics MOHLTC planning efforts. We began to work with the that attempts to introduce and articulate values that are Vaccine and Antiviral working group at the MOHLTC, and already commonly accepted. It is not our intention to we adapted our work to meet the related but distinct chal- comprehensively defend the values in the framework, but lenges facing government. While our work with the rather to show from which areas of scholarship they were MOHLTC began with the Vaccine and Antiviral working drawn, articulate their relevance to pandemic planning, group, the ethical framework we developed for the and to demonstrate their discursive legitimacy through a MOHLTC was eventually included in the Ontario Health process of stakeholder engagement and vetting. To our Pandemic Influenza Plan [16] not as an annex to the section knowledge, no other pandemic planning process has on vaccines and antivirals as we had originally antici- attempted to a) develop an ethical framework to guide pated, but as an ethical framework for the plan as a whole. pandemic influenza planning and b) assess an ethical framework's robustness and resonance in the community Review of clinical ethics and public health ethics literature of its intended users. Thus, the significance of the proce- Expertise in clinical ethics was important to the develop- dural elements of the development of the framework is ment of this framework because of the knowledge, skills not to be minimized, nor are the insights we have gleaned and experience clinical ethicists need to address dilemmas from implementing the framework in health care organi- or challenges found in the daily clinical arena. An obvious sations and in a governmental setting. challenge was how to integrate expertise in public health ethics into a framework designed to guide decision-mak- Building on key lessons from SARS [12-14] and the "emer- ing in clinical health care settings. A related challenge was gency ethics" literature and drawing on our expertise in to thoughtfully integrate generally accepted principles clinical, organisational, and public health ethics, we iden- and values from clinical ethics with those in public health tified key ethical processes and values that are relevant for ethics. In order to meet this challenge, the authors turned health care organisations. These values were presented to not only to the respective ethics literature, but also to the and vetted by a variety of health care stakeholders. Thus, SARS experiences of Toronto hospitals and health care this framework is the product of an iterative and inclusive providers. A review of the SARS literature, and that of pub- process. lic health ethics more generally, guided the integration of the public health and the clinical ethics perspectives Formation of a working group [6,9,10,12-14,17-19]. The Toronto experience with SARS In Ontario the need for guidance on the ethical issues per- demonstrated that organisations faced unique ethical taining to an influenza pandemic has been widely challenges when dealing with a public health crisis, and acknowledged. As word of our work on an ethical frame- much of the ethics literature identified a need for greater work for Sunnybrook and Women's College Health Sci- forethought in how organisations can foster ethical deci- ence Centre (S & W) became known, we were invited to sion-making in times of crisis [12-14]. We reasoned that join other hospitals' pandemic planning efforts. There was the legitimacy of this framework would be enhanced by also broader sectoral interest in ethics, and we were including insights from the analysis of a recent public invited to join the Ontario Ministry of Health and Long health crisis like SARS. Term Care's (MOHLTC) efforts to design a pandemic plan. Page 3 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Lessons from emergency ethics esses is based upon the "accountability for reasonable- Not surprisingly, the literature on clinical ethics has little ness" model developed by Daniels & Sabin [26] and to say about disaster preparedness and how to make deci- adapted by Gibson, Martin & Singer [27]. This model pro- sions about such things as triage under extraordinary cir- vides a useful means of identifying the key elements of cumstances. The ethics literature on bioterrorism and ethical decision-making processes. An extensive literature battle-field triage informed our thinking and called our has developed around Daniels' and Sabin's accountability attention to important issues such as the duty to care, rec- for reasonableness framework. The Daniels and Sabin iprocity, equity and good stewardship [20-25]. The impor- framework has broad applicability across institutional set- tance of having ethically robust criteria and policies tings and priority setting situations [28-35]. Because the developed in advance of a pandemic influenza outbreak is Daniels and Sabin framework applies deliberative theo- underscored in this literature, for "critical decisions like ries of democratic justice to the specific problem of health these should not be made on an individual case-by-case care priority setting, and because it is unique in this basis" and "physicians should never be placed in a posi- regard, we felt it promoted the kind of deliberative tion of individually deciding to deny treatment to patients approach to pandemic planning that this ethical frame- without the guidance of policy or protocol" [22]. Robust work is intended to support. Table 1 outlines the charac- disaster preparedness requires practising preventive eth- teristics of an ethical decision-making process. ics. Stakeholders will be more able to accept difficult deci- sions during a pandemic influenza crisis if the decision- Stakeholder vetting making process has, and is perceived to have, ethical legit- The ethical framework was vetted through S & W's Pan- imacy. demic Planning Committee, the Joint Centre for Bioeth- ics' Clinical Ethics Group (comprised of the affiliated Ethical values health care organizations' clinical ethicists), the MOHLTC The second part of the framework identifies ten key ethical Vaccine and Antiviral Working Group, and the MOHLTC values that should inform the pandemic influenza plan- pandemic planning committee. Through this process, we ning process and decision-making during an outbreak. refined the framework and we are grateful to these groups These values are intended to provide guidance, and it is for their valuable insights. important to consider that more than one value may be relevant to a situation. Indeed, the hallmark of a challeng- The ethical framework ing ethical decision is that one or more value(s) are in ten- The ethical framework is intended to inform decision- sion and that there is no clear answer about which one to making, not replace it. It is intended to encourage reflec- privilege in making the decision. When values are in ten- tion on important values, discussion and review of ethical sion with one another, the importance of having ethical concerns arising from a public health crisis. It is intended decision-making processes is reinforced (see above.) also as a means to improve accountability for decision- making and may require revision as feedback and circum- The values identified in our ethical framework were based stances require. initially on previous research findings on ethics and SARS at the University of Toronto Joint Centre for Bioethics The framework is divided into two distinct parts, and (JCB). This work was funded by a Canadian Institutes of begins with the premise that planning decisions for a pan- Health Research grant in 2004 through 2006 and has led demic influenza outbreak ought to be 1) guided by ethical to several key publications on the ethical dimensions of decision-making processes and 2) informed by ethical val- SARS [14,36-39]. In particular, Singer et. al., in their sem- ues. Ethical processes can help to improve accountability inal British Medical Journal article begin to identify key and it is hoped that, to the extent that it is possible for eth- ethical values that were of relevance during the SARS epi- ical processes to produce ethical outcomes, the substan- demic in Toronto. These values were then further articu- tive ethical quality of decisions will be enhanced. lated by our working group and adapted for the pandemic Recognising, however, that ethical processes do not guar- influenza planning context. Through a discursive process antee ethical outcomes, we have identified ten key ethical of stakeholder consultation with public health specialists, values to guide decision-making that address the substan- ministry officials, S & W's pandemic influenza committee, tive ethical dimensions of decision-making in this con- and the Clinical Ethics Group at the JCB, we augmented text. the values to include two new values (stewardship and trust [40,41]) and refined the definitions of each value in Ethical processes light of the anticipated demands of a pandemic influenza In planning for and throughout a pandemic influenza cri- crisis compared to a hospital-based epidemic such as sis, difficult decisions will be made that are fraught with SARS. The substantive values identified and articulated in ethical challenges. Our framework around ethical proc- the framework are not intended to be an exhaustive set, Page 4 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Table 1: Ethical processes (Listed in alphabetical order). Adapted from Daniels, N. Accountability for reasonabless. BMJ 2000, 321:1300–1301. Value Description Accountability There should be mechanisms in place to ensure that ethical decision-making is sustained throughout the crisis. Inclusiveness Decisions should be made explicitly with stakeholder views in mind and there should be opportunities for stakeholders to be engaged in the decision-making process. For example, decision-making related to staff deployment should include the input of affected staff. Openness & Transparency Decisions should be publicly defensible. This means that the process by which decisions were made must be open to scrutiny and the basis upon which decisions are made should be publicly accessible to affected stakeholders. For example, there should be a communication plan developed in advance to ensure that information can be effectively disseminated to affected stakeholders and that stakeholders know where to go for needed information. Reasonableness Decisions should be based on reasons (i.e., evidence, principles, values) that stakeholders can agree are relevant to meeting health needs in a pandemic influenza crisis and they should be made by people who are credible and accountable. For example, decision-makers should provide a rationale for prioritising particular groups for anti- viral medication and for limiting access to elective surgeries and other services. Responsiveness There should be opportunities to revisit and revise decisions as new information emerges throughout the crisis as well as mechanisms to address disputes and complaints. For example, if elective surgeries are cancelled or postponed, there should a formal mechanism for stakeholders to voice any concerns they may have with the decision. and they may underdetermine how best to achieve the the ethical framework can be used to identify key ethical overall goals of pandemic planning, which generally aspects of decision-making. include the minimization of morbidity, mortality, and societal disruption. Nevertheless, this is not to say that Let us take the issue of targeting and prioritizing popula- that a procedural engagement about the overall goals of a tions for vaccine and antivirals to illustrate how the values pandemic response would not benefit from using the eth- in the ethical framework can help guide decision-making. ical framework to guide and shape debate. A description The values of solidarity and protecting the public from of the values that should guide decision-making can be harm would require that priorities be set to maximize the found in Table 2. capacity to help society ensure that the ill are cared for during a pandemic. Furthermore proportionality would Included in the framework are "hot button" ethical issues require that decision-makers consider who within the that we identified through our work with Toronto hospi- community are most vulnerable to the contagion as well tals and the MOHLTC. These issues were as follows: as who are most likely to benefit from immunization. A well-informed public conversant with the values in the a) Targeting and prioritizing populations for vaccines and ethical framework and aware of the expertise that antivirals informed the ranking of priorities for immunisation would be consistent with value of trust and the principle b) Intensive Care Unit and hospital bed assignment of transparency. c) Duty to care Lastly, while knowing how to use the framework to inform decision-making is vital, there is more to ensuring d) Human resources allocation and staffing that the framework will be used or useful. e) Visiting restrictions Lessons for implementing an ethical framework We have identified three necessary, if not exhaustive ele- f) Communications and how reviews of decisions will be ments to the successful integration of ethics into hospital handled pandemic planning processes. These elements are 1) sponsorship of the ethical framework by senior hospital These "hot button" issues are not intended to be exhaus- administration; 2) vetting of the framework by key stake- tive, but rather they serve to illustrate how the values in holders and; 3) decision review processes. Page 5 of 11 (page number not for citation purposes) Table 2: Ethical values to guide decision-making (Listed in alphabetical order) Value Description Example Duty to Provide Care The duty to provide care and to respond to suffering is inherent to all health care professionals' codes of ethics. In an influenza Health care workers who are at increased risk pandemic, demands on health care providers and the institutions in which they work will overwhelm resources. Health care because they are caring for patients with providers will have to weigh demands from their professional role with other competing obligations to their own health, to influenza must weigh familial obligations, and family and friends. Health care workers will face significant challenges related to resource allocation, scope of practice, obligations to self with their professional duty professional liability, and workplace conditions. to care. In addition, they may also have to Decision makers should: comply with vaccination or antiviral regimens • Work collaboratively with stakeholders and professional colleges in advance of an influenza pandemic to establish practice for prophylaxis which may conflict with their guidelines individual liberty. • Work collaboratively to develop fair and accountable processes to resolve disputes • Provide supports to ease this moral burden of those with the duty to care • Develop means through which institutions will handle appeals or complaints, especially with regards to work exemptions, or the vaccination/prophylaxis of staff Equity The principle of equity holds that, all things being equal, all patients have an equal claim to receive needed health care. During In allocating scarce resources, the value of influenza pandemic, however, tough decisions will need to be made about which health services to maintain and which to defer equity could guide in developing fair criteria for because of extraordinary circumstances. allocation while consideration is given also to Measures taken to contain the spread of a deadly disease will inevitably cause considerable collateral damage. In an influenza compensation for those who will not meet pandemic, this will extend beyond the cessation of elective surgeries and may limit the provision of emergent or necessary inclusion criteria yet are entitled to receive services. care. Decision-makers must strive to: • Preserve as much equity as possible between the interests of patients [afflicted with the influenza] and those who need urgent treatment for other diseases • Ensure procedural fairness in decision-making Individual Liberty Individual liberty is a value enshrined in health care practice under the principle of respect for autonomy. Under usual Social distancing strategies that employ visitor circumstances, health care providers balance respect for individual autonomy with a duty to protect individual patients from restrictions in hospitals must be necessary for harm. In a public health crisis, however, restrictions to individual liberty may be necessary to protect the public from serious the protection of the public and must be harm. Patients, staff, and members of the public may all be affected by such restrictions. proportionate to the threat being allayed. Restrictions to individual liberty should: • Be proportional to the risk of public harm • Be necessary and relevant to protecting the public good • Employ the least restrictive means necessary to achieve public health goals • Be applied without discrimination Privacy Individuals have a right to privacy in health care. In a public health crisis, it may be necessary to override this right to protect the The need to conduct contact tracing of public from serious harm. A proportionate response to the need for private information requires that it be released only if there possibly infected people might require that are no less intrusive means to protect public health. particular groups or even individuals are Decision makers should: identified publicly. The need to do so must be • Disclose only private information that is relevant to achieve legitimate and necessary public health goals weighed against the potential harm of exposing • Release private information only if there are no less intrusive means to protect public health communities and individuals to stigmatization. • Determine whether the good that is intended is significant enough to justify the potential harm that can come from suspending privacy rights, (e.g. the harm from stigmatization of individuals or particular communities) • Provide public education to correct misconceptions about disease transmission and to offset misattribution of blame to particular communities Proportionality Proportionality requires that restrictions to individual liberty and measures taken to protect the public from harm should not The decision to close an emergency room must exceed what is necessary to address the actual level of risk to, or critical need of, the community. consider if the potential harm in keeping the Decision makers should: emergency room open is significant enough to • Use least restrictive or coercive measures in limiting or restricting liberties or entitlements warrant its closure. • Use more coercive measures only in circumstances where less restrictive measures have failed to achieve appropriate public health ends. BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Page 6 of 11 (page number not for citation purposes) Table 2: Ethical values to guide decision-making (Listed in alphabetical order) (Continued) Protection of the A foundational principle of public health ethics is the obligation to protect the public from serious harm. This principle requires When making the decision to quarantine Public from Harm that citizens comply with imposed restrictions in order to ensure public wellbeing or safety. To protect the public from harm, individuals, protection of the public from harm hospitals may be required to restrict public access to service areas (e.g. restricted visiting hours), to limit availability of some must be weighed against individual liberty. services (e.g. elective surgeries), or to impose infectious control practices (e.g. masks or quarantine). Note that while the ethical value of individual When making decisions designed to protect the public from harm, decision makers should: liberty is often in tension with the protection of • Weigh the medical and moral imperative for compliance the public from harm, it is also in individuals' • Ensure stakeholders are made aware of the medical and moral reasons for public health measures interests to minimize harm to others. • Ensure stakeholders are aware of the benefits of compliance & the consequences of non-compliance • Establish mechanisms to review these decisions as the public health situation changes and to address stakeholders concerns or complaints Reciprocity Reciprocity requires that society supports those who face a disproportionate burden in protecting the public good and takes The provision of antiviral medication and/or steps to minimise their impact as far as possible. In an influenza pandemic, measures to protect the public good are likely to vaccination to hospital staff for prophylaxis is impose a disproportionate burden on health care workers, patients, and their families. Health care workers may face expanded one way hospitals can ensure the safety of their duties, increased workplace risks, physical and emotional stress, isolation from peers and family, and in some cases, infection workers who may be exposed to greater than leading to hospitalization or even death. Similarly, quarantined individuals or families of ill patients may experience significant usual risks in discharging their duty to care. social, economic, and emotional burdens. Decision-makers and institutions are responsible for: • Easing the burdens of health care workers, patients, and patient's families in their hospitals and in coordination with other health care organizations • Ensuring the safety of their workers, especially when redeploying staff in areas beyond the usual scope of practice Solidarity SARS heightened the global awareness of the interdependence of health systems and the need for solidarity across systemic and Territoriality between hospital departments institutional boundaries in stemming a serious contagious disease. An influenza pandemic will not only require global solidarity, it and between health care institutions needs to will require a vision of solidarity within and between health care institutions. be overcome with good communication and Solidarity requires: sense of common purpose in order to provide • Good, open and honest communication equitable care across jurisdictions • Open collaboration, in a spirit of common purpose, within and between health care institutions • Sharing public health information • Coordinating health care delivery, transfer of patients, and deployment of human and material resources Stewardship In our society, both institutions and individuals will be entrusted with governance over scarce resources, such as vaccines, A hospital's decision to stock-pile antiviral antivirals, ventilators, hospital beds and even health care workers. During a pandemic influenza outbreak, difficult decisions about medication must consider whether this is an how to allocate material and human resources will have to be made, and there will be collateral damage as a result of these effective way of protecting staff from infection, allocation decisions. Those entrusted with governance roles should be guided by the notion of stewardship. Inherent in where the money for stockpiling will come stewardship are the notions of trust, ethical behaviour, and good decision-making. from, and whether that money could be put to Decision makers have a responsibility to: better use elsewhere. • Avoid and/or reduce collateral damage that may result from resource allocation decisions • Maximize benefits when allocating resources • Protect and develop resources where possible • Consider good outcomes (i.e. benefits to the public good) and equity (i.e., fair distribution of benefits & burdens) Trust Trust is an essential component in the relationships between clinician and patient, between staff and the organization, between Early engagement with stakeholders may go the public and health care providers, and between organizations within a health system. In a public health crisis, stakeholders may some distance to justify stakeholder confidence perceive public health measures as a betrayal of trust (e.g. when access to needed care is denied) or as abandonment at a time of in decision-makers' trustworthiness. In part, greatest need. Decision-makers will be confronted with the challenge of maintaining stakeholders' trust while at the same time the value of trust is respected and promoted by stemming an influenza pandemic through various control measures. It takes time to build trust. following the ethical processes outlined above. Decision-makers should: • Take steps to build trust with stakeholders before the crisis hits not while it is in full swing • Ensure decision making processes are ethical and transparent to those affected stakeholders BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Page 7 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 Sponsorship by senior administrators instantiated in the framework resonate with the stake- Whether or not an ethical framework is used to inform holder community. decision-making in a health care institution depends to a large extent on people in senior positions of an organisa- It has been our experience that the values in the frame- tion seeing its relevance to the decision-making process. work did resonate with the pandemic planners with In part, this is dependant on how robust the framework is, whom we have shared this ethical framework. The prima- but it also requires the willingness to frame (at least some) rily pragmatic justification for the selection of the values pandemic planning issues as normative in nature. in the framework means that the framework is provisional so it ought to be subject to revision in light of compelling Some may argue that the values in the framework are too argument, empirical evidence and further stakeholder stringent or impractical to implement under crisis condi- feedback. It is important to note, however, that the itera- tions, especially those found in the Ethical Processes part tive and inclusive process through which the values in the of the framework (see Table 1). Certainly, crisis condi- framework were deliberated amongst the various stake- tions may place constraints on the extent to which each holder groups lends them a form of discursive ethical principle can be acted upon. However, efforts should be legitimacy and helps to justify their inclusion in the ethi- made to put them into action to the fullest extent possible cal framework. We intend that the framework invite fur- under the circumstances and in our experience this is only ther dialogue about its legitimacy and its adequacy. We possible with the support of senior administrators. will return to this issue in the final section of this paper. The senior administration at S & W (many of whom were Ideally, the vetting process would include people who can part of the Pandemic Planning Committee) had previous represent the interests of patients, families and volunteers experience with the accountability for reasonableness who are part of the hospital's constituency. Although framework for decision-making, and thus their pandemic patient relations, human resources and occupational influenza planning committee was already familiar with health representatives from S & W provided guidance and the Ethical Processes part of the framework, and they were feedback in the development of the framework, direct receptive to the idea of being guided by an ethical frame- input from patients and family representatives was not work. Senior administrators may also have been receptive obtained. One limitation of our framework is that is has to the ethical framework because, as they learned from yet to be vetted by these important stakeholders. SARS, organisations that did not have decision-making processes that honoured the values for ethical process dur- The importance of solidarity to the management of a pub- ing SARS have been dealing with a legacy of collateral lic health crisis would also suggest that the public and damage to staff and patients in the form of distrust and other health care organisations be considered stakehold- low morale [12]. For these reasons, the senior administra- ers in hospital pandemic planning. While it may not be tors at S & W played an important role in vetting the ethi- pragmatic for hospitals to undertake broad public consul- cal framework. Ensuring that institutional "sponsors" are tation and vetting processes for their pandemic plans in in favour of adopting an ethical framework is important general, and their ethical frameworks in particular, soli- for gaining widespread support for using an ethical frame- darity and equity suggest that these broader stakeholder work in decision-making, and for ensuring that the ethical interests are relevant to pandemic planning. Conse- framework does not become something that looks good quently, opportunities for broader ethical dialogue about but remains unused. pandemic planning need to be encouraged. Vetting of the ethical framework by key stakeholders Decision review processes In order to obtain support for, or "buy in" to an ethical In order to ensure that the support of key stakeholders is framework, it is important that key stakeholders in an maintained through an outbreak, there need to be effec- institution vet the framework. This requires careful con- tive communication mechanisms in place. An important sideration of who the key stakeholders are in an institu- aspect of responsive decision-making processes is ensur- tion. Not only should this include those with ing that there are formal opportunities to revisit and revise responsibility for decision-making, but also those who decisions as new information emerges. As part of our eth- will be affected by decisions taken. For the vetting process ical framework, we formulated a template for decision is not just intended to create "buy in" but also to decrease review processes, (adapted from, Gibson, JL: Formal deci- the likelihood that interests and issues that are (morally) sion review process template. Unpublished; 2003) that aids relevant to pandemic planning will be neglected or over- organisations in identifying existing and establishing new looked, thereby enhancing the moral legitimacy of the mechanisms that can be used for the formal reviews of values in the framework. In addition, a process of stake- decisions. We believe decision review mechanisms are an holder vetting increases the likelihood that the values essential part of ethical decision-making in a public Page 8 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 health crisis, and are one way to put the values in the eth- the product of applied ethical analysis, and should be ical framework in to action. evaluated in light of this, one of its strengths is that it can also redress what Callahan and Jennings would character- Formal mechanisms for reviewing decisions are needed in ize as "critical" ethics problem of power disparities within order to capture feedback from stakeholders on key deci- institutions. sions, and to resolve disputes and challenges. These proc- esses are important for ensuring that decisions are the best Conclusion possible under the circumstances given changing informa- Cultural limitations and future directions tion and for engaging stakeholders constructively around Within pluralistic societies, there are many different ethi- the difficult decisions that must be made. Given the cal perspectives that exist simultaneously on issues about unpredictable nature of public health emergencies and global, public and individual health. An ethical frame- the difficulty this poses for those in charge of planning work to guide decision-making is robust to the extent that and decision-making, it is reasonable to assume that deci- it reflects the values and beliefs of the decision-makers sions will be revised throughout the pandemic influenza who refer to it and the values and beliefs of those affected crisis. Disputes or challenges may arise from the restric- by the decisions being taken. Our framework relied heav- tions or requirements imposed on staff, patients and fam- ily on the Toronto experience with SARS to surface and ilies during a pandemic influenza outbreak. Thus, examine the ethical values that are important for a public decision review processes are essential. Again, while some health crisis. An influenza pandemic is likely to present us may argue that this is too stringent a measure for a time of with particular ethical challenges that are different from crisis, we argue that reviews of decisions will be taking SARS due to the predicted severity of the contagion and its place regardless (most likely in an ad hoc manner), and spread to the community. It would therefore be important that to formalize this process is to increase its fairness and not to uncritically adopt such a framework but rather to moral legitimacy. Indeed, there may be existing mecha- use it as a basis for continued reflection and re-evaluation nisms which can handle these kinds of reviews. to ensure its relevance and responsiveness during the unfolding health crisis. It is also important to consider the Scope of the ethical framework extent to which an ethical framework is reflective of the It is important to distinguish between different types of community in which it is to be used. Lessons from SARS ethical analyses in order to explain the approach that was as it was experienced in China would likely surface some taken to the development of the ethical framework dis- different ethical values, or emphasise different aspects of cussed herein. Callahan and Jennings draw a useful dis- our framework. As Callahan and Jennings have argued: tinction between applied ethics and critical ethics [7]. Our ethical framework is an example of applied ethics because We submit that a rich discourse on ethics and public the framework identifies and relies on "general principles health cannot be advanced without relating it to the back- that can be applied to real-world examples of professional ground values of the general society, and the particular conduct or decision-making"[7] and because it is communities, in which it will be carried out.[7] "designed to give professionals guidance and to give cli- ents and the general public standards to use in assessing Indeed, as previously maintained, there are many issues professional conduct" [42]. While there is certainly a need related to pandemic influenza planning – particularly for critical ethical analysis that pays attention to problems those raised by a critical ethical analysis – that require that are the "result of institutional arrangements and pre- broad public debate. While these kinds of issues require vailing structures of cultural attitudes and social power" public debate that takes place at the societal level, ethical [7], one would not expect a ethical framework designed to pandemic planning requires that organisations and agen- guide clinical decision-making to explicitly address these cies foster internal dialogue about the values instantiated kinds of issues. in an ethical framework. For it is imperative that the val- ues outlined in a framework resonate with the members This is not to say that this ethical framework cannot of an organisation, and the community it serves. The pro- address the kinds of issues that a critical ethical analysis cedural aspects of the framework provide a means to might address. For example, the framework promotes val- ensuring that the values of the community are reflected in ues and processes that seek to redress the power dispari- decision-making through the procedural principles of ties within institutions. The section of the framework that inclusiveness and responsiveness. deals with ethical processes in particular is a challenge to how institutional decisions are typically made. For exam- It is important, too, to recognise that values are not static, ple, the value of "inclusiveness" as a process principle is and that circumstances will evolve rapidly during a pan- essential for redressing power differences amongst key demic influenza outbreak. Ethical frameworks will also stakeholders [27]. Thus, while the ethical framework is require re-evaluation and revision. The challenge will be Page 9 of 11 (page number not for citation purposes) BMC Medical Ethics 2006, 7:12 http://www.biomedcentral.com/1472-6939/7/12 to continue to recognise the importance of moral reflec- Competing interests tion under circumstances that are not conducive to it and The author(s) declare that they have no competing inter- to encourage a process of re-evaluation that strives to ests. assess whether resulting decisions are consistent with those values the framework is intended to promote. For Authors' contributions this reason, it is imperative to start the ethical dialogue in AT, KF, JG and RU contributed equally to the develop- advance, and to find ways to encourage consideration of ment of the ethical framework. AT drafted this manuscript ethical issues at all stages of decision-making. We hope and KF, JC and RU contributed equally to the revision of that this paper will go some way towards advancing this the manuscript. All authors read and approved the final objective, and that this paper stimulates discussion of the manuscript. ethical issues and values that pervade pandemic planning. Acknowledgements We should like to thank the Pandemic Influenza Planning Committee at We believe that this framework is unique in its blending Sunnybrook and Women's College Health Sciences Centre, the Clinical of clinical, public health, and organizational ethics. One Ethics Group at the University of Toronto Joint Centre for Bioethics, and of its strengths is that it draws on lessons from the recent the Vaccine and Antivirals Working Group of the Ontario Ministry of public health crisis of SARS in Toronto, and it is to some Health and Long Term Care. This framework was vetted through these extent empirically grounded. Another strength is that it is groups and was bettered from their feedback. Ross Upshur is supported by the product of an inclusive process of development that the Canada Research Chair in Primary Care Research. We also thank our included stakeholder vetting. It is also unique in its three peer reviewers, Angela Bate, Ezekiel Emanuel and Akria Akabayashi attempt to provide guidance to decision-makers facing a for their helpful insights and comments. public health crisis. We hope that the framework's accept- References ance by hospitals and the provincial government in 1. Stohr K: Avian influenza and pandemics: research needs and Ontario signals a change in the way that decisions are opportunities. N Engl J Med 2005, 352:405-407. taken by institutions that are charged with making deci- 2. Osterholm MT: Preparing for the next pandemic. N Engl J Med sions that have life and death consequences for the public. 2005, 352:1839-1842. 3. 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Goold SD: Trust and the ethics of health care institutions. The Hastings Centre Report 2001, 31:26-33. 42. Jennings B: Frameworks for ethics in public health. Acta Bioeth- ica 2003, 9:165-176. Publish with Bio Med Central and every Pre-publication history scientist can read your work free of charge The pre-publication history for this paper can be accessed "BioMed Central will be the most significant development for here: disseminating the results of biomedical researc h in our lifetime." Sir Paul Nurse, Cancer Research UK http://www.biomedcentral.com/1472-6939/7/12/prepub Your research papers will be: available free of charge to the entire biomedical community peer reviewed and published immediately upon acceptance cited in PubMed and archived on PubMed Central yours — you keep the copyright BioMedcentral Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 11 of 11 (page number not for citation purposes)

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