Ethical Guidelines in Pandemic Influenza: Recommendations of the Ethics Subcommittee of the Advisory Committee of the Director, Centers for Disease Control and Prevention

Because of the importance of including ethical considerationsin planning efforts for pandemic influenza, in February 2005the Centers for Disease Control and Prevention requested thatthe Ethics Subcommittee of the Advisory Committee to the Directordevelop guidance that would serve as a foundation for decisionmaking in preparing for and responding to pandemic influenza.Specifically, the ethics subcommittee was asked to make recommendationsregarding ethical considerations relevant to decision makingabout vaccine and antiviral drug distribution prioritizationand development of interventions that would limit individualfreedom and create social distancing. The ethics subcommitteeidentified a number of general ethical considerations includingidentification of clear goals for pandemic planning, responsibilityto maximize preparedness, transparency and public engagement,sound science, commitment to the global community, balancingindividual liberty and community interests, diversity in ethicaldecision making, and commitment to justice. These general ethicalconsiderations are applied to the issues of vaccine and antiviraldrug distribution and use of community mitigation interventions.

Key Words: ethics • guidelines • pandemic • influenza

The first human cases of a new and extremely severe avian influenzavirus—the H5N1 strain—were detected in Hong Kongin 1997, when 18 cases (6 of which were fatal) were reported.¹ As of March 2, 2009, 409 laboratory confirmed human casesof avian influenza A (H5N1) have been reported in 15 countries(mostly in Asia); of these cases, 256 have died.² The H5N1 virusis of great concern due to the severity of the disease it producesand the high mortality rate (approximately 60%).

Public health officials have been studying past influenza pandemicsto gain a better understanding of the potential impact of apandemic and to obtain insight into pandemic preparedness andresponse.³ The Department of Health and Human Services (HHS)has estimated that if a pandemic influenza virus with similarseverity as the 1918 Spanish flu developed in the United States,then 1.9 million Americans could die and almost 10 million couldbe hospitalized.⁴

In addition to high levels of morbidity and mortality, an influenzapandemic could be accompanied by significant social disruptionand economic impact. The number of people requiring medicalintervention could overwhelm health care facilities, the supplyof antiviral drugs may not be sufficient to address the demand,and delays and shortages in the availability of vaccines areexpected. Potential public health interventions that targetreducing the spread of the infection (eg, interventions suchas isolation of ill individuals and quarantine for exposed people)would result in disruption of usual activities and essentialservices.

Preparing for and responding to pandemic influenza raises anumber of ethical issues. Who should receive priority for limitedresources? How should decisions be made that would limit anindividual’s civil liberties? How and when will informationbe provided to the public? How will the needs of vulnerablepopulations be addressed? Increased attention has been focusedon the need for pandemic influenza plans to address these ethicalquestions.^5–11 In addition, several international andstate health organizations are developing ethical guidance forpandemic influenza.^12–15 Efforts have been made by DHHSto engage the public in a deliberative discussion about pandemicinfluenza preparedness goals and priorities. These public engagementprojects have focused on challenging ethical issues such asprioritization of the distribution of pandemic influenza vaccineand use of liberty-limiting interventions to mitigate the spreadof disease.^16,17

Because of the importance of including ethical considerationsin planning efforts for pandemic influenza, in February 2005the Centers for Disease Control and Prevention (CDC) requestedthat the Ethics Subcommittee of the Advisory Committee to theDirector develop guidance that would serve as a foundation fordecision making in preparing for and responding to pandemicinfluenza. This guidance, which follows below, was developedon behalf of the ethics subcommittee by the authors. Input onthe guidance was provided by other members of the ethics subcommittee,the CDC Advisory Committee to the Director, the CDC Public HealthEthics Committee, and other CDC staff.

Planning efforts for pandemic influenza acknowledge uncertaintyabout timing, onset, and severity of the illness and the importanceof planning for the full spectrum of possible pandemic severity.HHS guidance on community strategies for pandemic influenzamitigation introduced the concept of the Pandemic Severity Indexfor categorizing the severity of a pandemic.¹⁸ This index, basedon the case fatality ratio, assists in predicting the impactof a pandemic and serves as a tool for matching community strategyrecommendations to the severity of the pandemic. HHS’srecent guidance on allocating and targeting pandemic influenzavaccine also takes into account pandemic severity.¹⁹ Ratherthan exploring the possible range of pandemic severity, thediscussion of the ethical considerations that follows is designedfor a severe pandemic with high levels of morbidity and mortalityand significant stress on critical infrastructure. Our focuson a severe pandemic and the resulting significant impact onsocial systems led us to emphasize the importance of prioritizingactions that will maintain the functioning of society.

The guidance below identifies primary ethical considerationsand principles that may be used by those implementing pandemicinfluenza plans. The guidance does not attempt to provide specificdirectives or to assess state and local plans that have recentlybeen developed. The document emphasizes a "procedural ethics"approach. Throughout the guidance concepts such as public engagement,transparency, and fair process are emphasized. Equally importantis the establishment of oversight and appeals mechanisms toensure fairness in decision making and to revise or correctapproaches as new information becomes available. In developingthis guidance, the ethics subcommittee recognized that thereare some fundamental issues that need to be addressed to ensurethat individual rights are protected and that vulnerable populationsare not disadvantaged by pandemic preparedness efforts. Decisionsregarding allocation of scarce resources should be guided bycriteria that maximize fairness in the distribution process.Use of measures that place limitations on individual libertiesshould be implemented with care and be informed by the bestavailable scientific evidence of their effectiveness. Duringa pandemic, difficult choices will need to be made. It is theintent of the guidance that follows to provide an ethical frameworkfor guiding decision makers at all levels in preparing for andresponding to pandemic influenza. The guidance includes severalethics terms and conceptual constructs (eg, "morally relevantdistinction") that some readers may find unfamiliar. For definitionsof these terms and explanations of these constructs, the readeris referred to 2 recent publications.^20,21

ETHICAL GUIDELINES IN PANDEMIC INFLUENZA

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ETHICAL GUIDELINES IN PANDEMIC...

This document provides proposed ethical guidance for decisionmaking in preparing for and responding to pandemic influenza.The document was developed in response to a request from CDCthat the ethics subcommittee address ethical considerationsin vaccine and antiviral drug distribution prioritization andin the development of interventions that would limit individualfreedom and create social distancing. (In discourse on pandemicinfluenza, often referred to as nonpharmaceutical interventions,"social distancing" refers to methods for reducing frequencyand closeness of contact between people to decrease the riskof transmission of disease. Examples of social distancing includecancellation of public events such as concerts, sports events,or movies; closure of office buildings, schools, and other publicplaces; and restriction of access to public places such as shoppingmalls or other places where people gather.) As in many otherareas of community or public decision making, ethical issuesare frequently encountered in this decision making process.Although difficult decisions are made on a regular basis, theprocess for decision making, including the framework and reasoningthat support ethical choice, may not be clearly articulated.We are acutely aware of the need to have ethical perspectivesprovide practical assistance and to have these proposed guidelinesfully vetted by those involved in the pandemic influenza planningand response process. We offer the following document with bothcommitments in mind and attempt to articulate the boundariesand underlying ethical premises that can serve as a marker againstwhich to test implementation decisions. In using these guidelines,decision makers at all levels—federal, local, state, tribal,and so forth—should continue to exercise their best judgmentin particular situations.

General Ethical Considerations
Identification of clear overall goals for pandemic planningis essential to making difficult choices. Historically, theorganizing principle for resource (antiviral and vaccine) distributionin interpandemic years has been the minimization of seriousinfluenza-associated complications, including hospitalizationand death. Individuals most at risk for experiencing the seriousnegative health consequences of hospitalization or death ifinfected are given priority in receiving influenza vaccinations.The recommendations of 2 federal advisory committees—theAdvisory Committee on Immunization Practices (ACIP) and theNational Vaccine Advisory Committee (NVAC)—reflect thisprinciple. (The NVAC/ACIP recommendations for prioritizationof pandemic influenza vaccine are described in the HHS PandemicInfluenza Plan available at http://www.hhs.gov/pandemicflu/plan/appendixd.html.Vaccine and antiviral manufacturers, medical and public healthworkers, and people at highest risk for influenza complicationare identified as priority groups for receipt of pandemic influenzavaccine.)

However, in pandemic influenza management, a second principle—thatof preserving the functioning of society—should receivegreater priority in decision making than preventing seriouscomplications. Those individuals who are essential to the provisionof health care, public safety, and the functioning of key aspectsof society should receive priority in the distribution of vaccine,antivirals, and other scarce resources. Engagement of diversestakeholders will be essential in affirming this priority, determiningwho is considered key to the functioning of society, and establishinga distribution strategy that allows for decisions to be madewhen resources are limited. In any prioritization proposal,it must be clearly acknowledged that maintaining the functioningof society may result in a lack of resource availability tothose at high risk for severe medical complications due to preexistingmedical conditions or advanced age.

Affirming this second principle (preserving the functioningof society) raises important conceptual questions about whois valued and how particular services and functions are determinedto be key. These questions are set in important historical andsocial contexts involving individuals’ ability to attainessential positions given societal barriers and obstacles. Discussionof these questions, although important in ordinary circumstances,takes on a lower priority when confronted with the urgent demandsof preserving society.

There is a commitment to transparency throughout the pandemicinfluenza planning and response process. The reasoning behindchoices made is fully articulated (in language appropriate toparticular audiences) and the values and principles justifyingthose decisions are clearly identified and open for examination.This commitment to clarity and openness, which is based on adeep respect for all individuals and communities involved, existsin balance with the understanding that those with the authorityand responsibility of making decisions must often make decisionsin a timely manner.

Public engagement and involvement are essential to build publicwill and trust and should be evidenced throughout the planningand response process. The public is seen as a partner with otherexperts, with particular attention to vulnerable or historicallymarginalized members of society. Clear mechanisms must be createdfor public involvement in planning and for feedback throughoutthe process.

Public health officials have a responsibility to maximize preparednessto minimize the need to make allocation decisions later. (Examplesof maximizing preparedness include shortening the time for virusrecognition or vaccine production, increasing the capacity toproduce vaccines or antivirals, and increasing the suppliesof antivirals.) Proactive planning of response strategies fora pandemic, including the training of staff, is required. Thisnecessarily entails consideration of the full context in whichchoices are made. Enhancing the available range of prophylaxisand treatment options should decrease the need to focus on scarcityof resources and allocation during a pandemic. Preparednessalso includes determining and articulating what rules will governpublic health decision making in advance of the time that decisionmaking must commence. Although every specific choice or contingencycannot be foreseen, comprehensible foundational guidelines andprocedural action plans provide coherence and direction andbuild trust.

Sound guidelines should be based on the best available scientificevidence. There is no need to establish rules for the equitabledistribution of goods that will not work or to implement publichealth interventions that are ineffective. This is as equallytrue for vaccines and antivirals as it is for social distancingmeasures. Because the scientific basis for efficacy of particularinterventions continues to be studied and models projectingthe course of a pandemic are being investigated, sound scientificevidence for proposed interventions may not exist. The currentknowledge basis should serve as a foundation for ethical guidelinesand a commitment to ongoing scientific and ethical evaluationof interventions should be made.

Working with and learning from preparedness efforts globallyis essential. The United States recognizes its membership inthe global community. This recognition is not based simply onthe potential for global involvement to benefit US citizens(an "instrumental" reason), but on a deep recognition of thecommon good and our interdependence globally. Mechanisms forglobal involvement and criteria for determining the scope ofimpact of US decisions should be explicit. (The common goodrefers to the interests of a group or collective that is definedby having in common certain attributes [eg, location in a geographicallydefined community, risk for a specific disease] that createa commonality of interests. Its use in this context reflectsan understanding that, in the case of an influenza pandemic,all human beings are part of a single collective that has acommon good.)

Balancing community interests and individual liberties: Pandemicinfluenza planning, like other public and community health activities,is a cooperative and shared responsibility that balances communityand individual interests. During the course of a pandemic, thefunctioning of society may be threatened. Our moral traditionembodies an understanding that it may be ethically acceptable(or perhaps even ethically mandatory) to suspend some (but notall) ordinary moral rules in such circumstances. For example,limits on individual freedom or choice may be necessary to protectindividuals as well as entire communities during pandemic influenza.Yet, individual liberty should be restricted with great careand only when alternative approaches to realizing the goal ofweathering the pandemic are not likely to be effective. Suspensionsof ordinary moral rules should be anticipated and the conditionscalling for such suspensions should be specified.

Guiding principles in determining these restrictions includethe following:

Adopting the least restrictive practices that will allow thecommon good to be protected
Ensuring that restrictions arenecessary and proportional tothe need for protection
Attemptingto ensure that those affected by restrictions receivesupportfrom the community (eg, job security, financial supportforindividuals and their families, provision of food and othernecessities to those who are isolated or placed under quarantine,protection against stigmatization or unwarranted disclosureof private information).

Diversity in ethical decision making: Given numerous historicalexamples of abuse of individuals, particularly those who areconsidered vulnerable, in the name of the public good (eg, involuntarysterilization of the mentally retarded, the US Public HealthService syphilis study at Tuskegee, the internment of Japanese-Americansduring World War II), public health officials must adequatelyacknowledge and respond to strong currents of suspicion anddistrust of the health care system. This acknowledgement is,of course, part of a much larger health care dialog. Addressingthis distrust should be a strong and enduring commitment, andnot viewed as merely instrumental to inducing individuals tocomply with recommendations. Diverse public voices should beinvolved in determining the need for restrictions and in articulatingthe ethical justification for these restrictions.

Fair process approach: We recommend an approach to justice thatfocuses on the procedures to be followed with the hope thatgood procedures will lead to fair outcomes. Following are theelements of an ideal procedural justice approach:

Ensuring consistency in applying standards across people andtime (treating like cases alike)
Identifying decision makerswho are impartial and neutral
Ensuring that those affectedby the decisions have a voice indecision making and agree inadvance to the proposed process
Treating those affected withdignity and respect
Ensuring that decisions are adequatelyreasoned and based onaccurate information
Providing communicationsand processes that are clear, transparent,and without hiddenagendas
Including processes to revise or correct approachesto addressnew information, including a process for appealsand proceduresthat are sustainable and enforceable

The involvement of diverse voices in pandemic influenza planningand in creating a transparent procedure for decision makingis essential. In addition to engaging citizens in general, thisprocess would involve those who are primarily responsible forimplementing the pandemic influenza plans (eg, direct healthcare providers who would be asked to commit to providing careeven in the face of personal risk or the competing needs oftheir own families).

A balance between centralized, federal control and state andlocal community implementation of central guidelines must beeffectively struck (see "Ethical Guidelines Regarding SocialDistancing and Restrictions on Personal Freedom for ManagingPandemic Influenza" section for more discussion of the strongpresumption in favor of centralized decision making during apandemic). This process should be especially attentive to historicallymarginalized communities and those in which sensitivity to cultural,racial, religious, or other values must be incorporated.

Thoughtful preparation and attention to process will not provideguidance in all specific circumstances. The practice of attendingto fair process may provide support for local decision makersaddressing unanticipated questions. In addition, these decisionmakers must be authorized to use their best judgment in addressingand resolving particular issues.

Addressing Particular Ethical Issues in Pandemic Influenza Planning
Allocation of Resources
The distribution of goods should be guided by criteria specifiedwell in advance of any need to apply them. As indicated earlier,the primary goals of the distribution system should be clearlyspecified. Further distribution criteria should be evaluatedaccording to their ability to contribute to the realizationof the primary goals. These further criteria should be directedat maximizing fairness (or equity) in the distribution process.

We have concluded that a classic utilitarian approach to definingpriorities, "the greatest good for the greatest number," isnot a morally adequate platform for pandemic influenza planning.We recommend an approach to ethical justification that, likeutilitarianism, evaluates the rightness or wrongness of actionsor policies primarily by their consequences, but we furtherrecommend that planning should take into account other checks("side constraints") grounded in the ethical principles of respectfor people, nonmaleficence, and justice. For example, a classicutilitarian approach, which may accept imposing suffering onthe few for the greater benefit of all, would be tempered bysuch principles as the following:

Refraining from harming or injuring individuals and communities
Ensuring equal opportunity to access resources for those withinagreed upon priority groups
Respecting individual autonomyby, for example, employment ofthe least restrictive interventionsthat are likely to be effective

Distribution plans should further specify the following:

What scarce goods are involved in the distribution plan? Thenames of the individual vaccines or classes of goods (eg, antiviralsfor the purpose of treating or preventing influenza) shouldbe communicated publicly. It would also help to specify whatwill not be covered by the distribution plan and why (eg, drugsthat treat or prevent certain disorders or conditions that makeone more susceptible to contracting influenza). Who (or whatagency) will decide about prioritization and distribution? Amechanism for authoritative interpretations of the rules inthe case of a dispute or an appeal is needed.
Who is eligibleto be a recipient? (eg, will all individualspresent in thelocal community be eligible, regardless of visitorstatus? Willthe local community encourage travelers to returnto home communitiesto receive the scarce resource? Will exceptionsbe made? Ifso, why?)
What morally relevant criteria will be used to assignhigheror lower priorities to groups of individuals or individualswithin the determined goal (preserving the functioning of society)?For example, are certain key services more essential than others?Within the organization or group of individuals who providean essential service, are there justified criteria for determininga further order of priority (eg, those with more years of experienceor those who have dealt with crises in the past)?

Some theoretical distribution criteria that would generallynot be ethically supported in pandemic influenza planning includethe following:

To each according to purchasing power
To each according towhat he or she deserves
First come, first served. (Superficially,this may appear tobe fair but, de facto, this puts certaingroups—such asthose who are less likely to be informedor those who have inadequatetransportation—at a disadvantage.)
Criteria based on race, ethnicity, religious belief, gender,sexual orientation, or IQ, when used to make discriminationsthat are only invidious and not morally relevant

Under ordinary circumstances, the distribution criterion "toeach according to his or her social worth" is not morally acceptable.In planning for a pandemic in which the primary objective isto preserve the function of society, however, it is necessaryto identify certain individuals and groups of people as keyto the preservation of society and to accord them a high priorityfor the distribution of certain goods such as vaccines and antiviraldrugs. Identification of key individuals for this purpose mustbe recognized for what it is: It is a social worth criterionand its use is justified in these limited circumstances. Caremust be taken to avoid extension of the evaluation of socialworth to other attributes that are not morally relevant.

Among the goods that must be allocated is the time of healthcare professionals. It may be necessary to delegate the responsibilityand authority to perform procedures and interventions customarilycarried out by certain professionals to other less formallyqualified individuals. For example, physicians may need to delegateduties to nurses, physicians’ trained assistants, andother personnel (eg, retired health care professionals) whomay not be part of the customary health care team. Similarly,procedures customarily carried out by nurse practitioners andother health care professionals may also be delegated. Suchdelegations of authority and responsibility should be carefullyplanned and suitable training programs should be activated inadvance of the pandemic.

Ethical Guidelines Regarding Social Distancing and Restrictions on Personal Freedom for Managing Pandemic Influenza
In the management of a pandemic, it will often be prudent touse procedures and interventions that will limit the freedomof movement of individuals or create conditions of social distancing.In general, the proposed use of such interventions and proceduresshould be in the form of recommendations for voluntary action.Requirements for mandatory liberty-limiting and social distancinginterventions should be imposed only in cases in which voluntaryactions seem unlikely to be effective. This point notwithstanding,the remainder of this section is concerned primarily with circumstancesin which mandatory liberty-limiting and social distancing interventionsare being considered.

As noted earlier, sound guidelines should be based on the bestavailable scientific evidence. Ideally, the validity of liberty-limitingand social distancing interventions would be established ina manner similar to that used for pharmacological interventions,through carefully controlled research. In most cases this willnot be possible, however, particularly in the circumstancesof a pandemic. Indeed, in the course of a pandemic, it may benecessary to implement some interventions which have littleor no scientific support. The model we recommend is that ofevidence-informed decision making, a model that is somewhatless rigorous than evidence-based decision making but somethingthat must suffice until more satisfactory validation becomesavailable.

Liberty-limiting and social distancing interventions includethe following:

Isolation of individuals infected with or ill with influenza.
Quarantine of individuals thought to have already been exposed,including family members and others in close contact.
Closureof schools, cancellation of public events (eg, sportsevents,concerts), and closure of public venues such as shoppingmalls,restaurants, museums, and theaters, as mechanisms todecreasesocial contact that may lead to the spread of influenza.
Restrictionof access to public venues deemed more essential,such as grocerystores, public transportation, and gasolinestations.
Provisionof guidance on office practices and/or flexible workschedulingthat decreases potential for exposure.
Limit travel withinor between cities or local regions.

IS RESTRICTING PERSONAL FREEDOM IN MANAGING PANDEMIC INFLUENZA JUSTIFIED?

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IS RESTRICTING PERSONAL FREEDOM...

Implementing any of these interventions involves restrictingpersonal freedoms that are strongly held and highly valued inUS society. The ethical concept of individual autonomy, or thefreedom to make one’s own decisions, is deeply embeddedin US culture. Respect for individual autonomy is founded onthe inherent dignity and worth of the individual and the understandingof each individual’s general right to noninterference.Therefore, justification for any restrictions on individualfreedom must be carefully considered.

Legitimate restrictions on individual freedom may occur if,in exercising one’s freedom, one places others at risk.An individual does not have the right to injure another or totake someone’s property merely because she or he wishesto exercise her or his freedom. In addition, implicit in membershipin society is an obligation to abide by certain ethical andlegal constraints to enjoy the benefits of membership in thatsociety (eg, security, health care, general welfare). Theseconstraints actually provide the conditions under which personalfreedom and flourishing are possible. Thus, restrictions essentialto the common good, including the public health, of societymay be imposed on each member of society. Even so, these restrictionson personal freedom must always be carefully considered andjustified.

PROCEDURAL CONDITIONS IN RESTRICTING PERSONAL FREEDOM

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PROCEDURAL CONDITIONS IN...

We have set forth criteria for an acceptable system for allocationof resources, including some characteristics of satisfactorydistribution plans and unacceptable distribution criteria. Theseallocation considerations are equally applicable to developingguidelines regarding restrictions on personal freedom and othernonpharmaceutical interventions for managing pandemic influenza.

The process for decision making about restrictions should bewell thought out in advance. Both the decision makers and thecriteria that will be used to determine when restrictions willbe implemented should be specified. The group that specifiesthe decision makers and the criteria should be seen by all typesof stakeholders as representative or otherwise acceptable. Thegroup that is involved in implementing the policies, educatingthe public, and hearing objections should also be seen as representativeor otherwise acceptable. A reasonably diverse infrastructurethat includes voices across racial, cultural, community, provider,and recipient groups should be involved in planning, understandingthe process, and conveying the process throughout the community.In pandemic influenza, centralization of decision making maybe important in creating fair and equitable restrictions thatwill apply across communities. A process should be in placefor objections to be heard, for restrictions to be appealed,and for new procedures to be considered before implementation.

As in other areas of pandemic influenza management, transparencyabout the process is essential and communication about restrictionsshould begin early in the planning process. The public shouldbe clearly informed that restrictions on personal freedom areanticipated, that these limitations may be important to theindividual’s own protection, and that they are also necessaryto limit the spread of disease throughout the community. Communicationshould encourage individuals to partner with their communitiesand society at large in controlling influenza transmission.Information should be provided thoughtfully, balancing wheninformation should be shared with protection of privacy andpublic trust.

In pandemic influenza, there is a strong justification for centralizationof decision making. This is a departure from the customary modeof public health decision making, which occurs at the local,state, or tribal level by standards of their own choosing. Generalmaxims and criteria for restrictions on personal freedom wouldbe supported by equity and by the need to preserve the functioningof society across communities, including the tracking of disease.Local autonomy in decision making should be honored when thereis no evidence to support a belief that centralization of decisionmaking will contribute substantially to preservation of thefunctioning of society and when the easing of restrictions isproportional and reasonable in particular communities (eg, uniformduration of school closing may not be reasonable in communitieswhere the influenza wave has already ended). Local decisionmakers should be prepared to make their reasoning transparentin these situations; they must be authorized to use their bestjudgment and supported in their efforts to do so.

WHEN ARE RESTRICTIONS ON PERSONAL FREEDOM ETHICALLY JUSTIFIED?

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WHEN ARE RESTRICTIONS ON...

In enacting any measure in which personal freedom is limited,the least restrictive, effective measure should be taken. Enactmentof these measures should be based on the best available scientificevidence that:

The liberty-limiting measure will achieve its intended goal.
The limitation is proportional and no less restrictive measureis likely to be as effective. An exception to this criterionmay be justified if the less restrictive measure would be undulyburdensome (eg, either too expensive or the agency responsiblefor implementation lacks the resources or expertise to implement).
Failure to implement the measure is likely to result in graveharm to the functioning of society or to the well-being of thepublic. For example, if quarantine is enacted, then the durationof the quarantine should be clearly informed by transmissioncharacteristics and should be as short as is medically justifiable.Home quarantine should be honored when reasonable and desired,and monitoring/surveillance should be as nonintrusive as isreasonable. We should continually be asking what justifies onefurther restrictive step.

Restrictions on personal freedom should be equitably applied.It should be exceedingly clear why particular individuals orcommunities are being restricted and that the criteria thatjustify a restriction would be equally applied to any and allindividuals meeting the same criteria. Care must be taken toavoid stigmatization of individuals or groups. In addition,a process for questioning, appealing, and revising liberty-limitingmeasures should be in place and accessible when the level ofurgency during a crisis makes this realistic.

When closure of public venues is being considered, determinationmust be made of which public venues are more essential in maintainingthe functioning of society and may need to remain open withsome constraints on level of access (eg, grocery stores mayneed to remain open with some new mechanism for distributionthat safeguards both fair access and decreased potential disseminationof disease, such as maximum order amounts or a delivery service).Other examples of possible essential services are public transportationsystems and gasoline stations.

Agencies responsible for imposing restrictions such as quarantine,isolation, or other limitations must take into considerationthe fact that the affected population, their family members,and other dependents will require adequate access to food, water,and other essential services. Such agencies should attempt tosecure access to these requirements for the affected parties.Similarly, they should attempt to provide protection of therestricted individuals’ jobs and their ability to meeteconomic obligations such as mortgage or rent payments, utilitybills, and so forth. (It is beyond the scope of our mandateto specify which agencies should have decision-making authorityregarding liberty-restricting measures. We do not mean to suggestthat such agencies are responsible for the provision of necessarygoods and services. Rather, they should attempt to ensure thatsome agency stands prepared to provide such goods and services.In some cases, they may be unable to do so. This should notbe seen as an absolute barrier to implementation of the liberty-restrictingmeasure. Instead, this should be treated as a serious cost whenundergoing the obligatory cost–benefit analysis to decidewhether a liberty-restricting measure is justified.)

There should be no unwarranted invasions of privacy and themechanisms for maintaining confidentiality of private informationshould be secure. When information sharing is important to protectingthe public health, measures that safeguard personal, privateinformation should be in place and support should be given toill individuals, family members, and others potentially stigmatizedby real or potential illness.

Throughout this process, respect for individual freedom mustcontinue to be an extremely high priority. Translating thisrespect also involves serious acknowledgment of a past historyof neglect and abuse of personal freedom in multiple US healthcare programs, all with the best of public health intentions.This history is not taken lightly; the ability to restrict individualfreedom to protect the common good requires careful reflectionand examination throughout the management of an influenza pandemic.

CONCLUSIONS

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CONCLUSIONS

This document seeks to provide a framework of ethical considerationsto guide decision makers at all levels in preparing for andresponding to pandemic influenza. As such, these guidelinesare not narrowly prescriptive, but do recognize the need ofdecision makers in particular communities or regions to transformthis guidance into specific decisions. Ethical decision makingassumes that such judgments will be based on current scientificknowledge, that effectiveness of interventions is carefullyassessed, and that transparency of the process is evident. Asspecific decisions in particular communities are considered,processes should be in place for identifying which ethical issueswere addressed, how guidelines were used, how decisions affectedthe community, and what lessons can be shared with other decisionmakers. In this way, these guidelines will continue to be aninteractive, working document.

The purpose of this document is to provide ethical guidancerelating to vaccine and antiviral drug distribution prioritizationand use of liberty-limiting interventions. Although the issueof the duty of health care professionals to provide care duringa pandemic is outside the scope of this document, the ethicssubcommittee believes that this issue is of central importancein pandemic planning and response. An equally relevant issue,but also beyond the scope of this document, is the importanceof providing legal protections for health care providers who,during a declared public health emergency, may be asked to performservices outside their usual realm of responsibilities or toadminister interventions that are not yet scientifically validated.Optimal pandemic influenza preparedness will require that bothof these issues be explored further in collaboration with healthcare providers and other stakeholders.

Ethics Subcommittee Members Involved in Developing the Recommendations

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Ethics Subcommittee Members...

John Arras, University of Virginia

Georges Benjamin, American Public Health Association

Vanessa Northington Gamble, The George Washington University

Thomas Hooyman, Regis University

Bruce Jennings, Center for Humans and Nature

Mary desVignes-Kendrick, University of Texas Health ScienceCenter at Houston

Barbara Koenig, Mayo College of Medicine

Kathy Kinlaw, Emory University

Robert Levine, Yale University

Ruth Macklin, Albert Einstein College of Medicine

James Thomas, University of North Carolina

About the Authors

Ms Kinlaw is Associate Director, Center for Ethics, Emory University;Dr Barrett is Public Health Ethics Coordinator, Office of theChief Science Officer, Centers for Disease Control and Prevention;and Dr Levine is Senior Fellow, Center for Bioethics, Yale University.

Received for publication July 28, 2008; accepted April 23, 2009.

Authors’ Disclosures

The authors report no conflicts of interest.

REFERENCES

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