Ethics in an epidemic: ethical considerations in preparedness planning for pandemic influenza.

Introduction

In the event of an influenza pandemic, a host of difficult decisions will have to be made, including stark choices about allocation of limited resources such as antivirals, the imposition of restrictive measures such as quarantines, the level of risk that health care workers should be expected to face while caring for the sick, and the use of travel restrictions and other measures to contain the spread of disease. These decisions will affect population survival rates and impact fundamental individual rights and freedoms. (1)

The World Health Organization has recommended that every country develop and maintain an up-to-date national influenza preparedness plan. (2) Further, to assist with preparation and planning, the WHO has developed a checklist of essential and desirable elements of national preparedness plans. (3) The checklist specifically includes discussion of legal and ethical issues. (4)

The purpose of this paper is to present an overview of a more detailed report produced by the Pandemic Influenza Working Group at the University of Toronto Joint Centre for Bioethics [JCB]. The full report, Stand On Guard For Thee: Ethical Considerations in Preparedness Planning for Pandemic Influenza, is freely available on the Internet. (5) An elaboration of the methodology used for developing the report's ethical framework is presented elsewhere. (6)

Background

Government leaders and health care officials in many parts of the world are developing pandemic plans. However, there has been precious little public discussion and debate about the planning process. The values underlying pandemic plans must be made public. Decision-makers should discuss the values with people who could be affected, ranging from health care workers, who will find themselves on the front lines, to hospital administrators who will make decisions about the allocation of limited resources, to the public at large, who will be affected in many ways. This discussion should take place in advance of a health crisis, not when patients are lining up at emergency wards.

Openly discussing the choices and confirming that they are based on ethical values that are shared by members of a society brings important benefits. If ethical values are clearly built into pandemic plans in an open and transparent manner, and with buy-in from multiple sectors of society, the plans carry greater trust, authority, and legitimacy. (7) Advance discussions of such issues can help address fears of the unknown. People will be more likely to cooperate, and accept difficult decisions made by their leaders for the common good.

The need for a clearly understood and widely accepted ethics approach to dealing with serious communicable disease outbreaks was underscored during the outbreak of severe acute respiratory syndrome [SARS] in early 2003. SARS showed the universal vulnerability of humans to communicable diseases, and the need for coordinated and cooperative responses across national borders. It also found that health care systems had generally not prepared themselves to deal with the hard ethical choices that rapidly arose. (8)

Research in the aftermath of SARS found that as the crisis became more severe and restrictions were imposed, there were concerns over access to care, the allocation of medicines, the availability of safety equipment, and the sharing of vital information. (9) Debate arose as to whose values should prevail during a public health emergency.

Leaders in governments and health care systems had not previously developed an ethical framework or held prior consultations to deal with the suite of ethical issues forced on them by SARS. Decision makers had to balance individual freedoms against the common good, fear for personal safety against the duty to treat the sick, and economic losses against the need to contain the spread of a deadly disease. Information and conditions changed constantly and decisions had to be rapid. The transparency of those decisions was not ideal owing to limitations of time. The lesson learned, therefore, was the necessity to establish an ethical framework in advance, and to do so in a transparent manner with public input.

SARS gave the world an advance warning of the need for ethical frameworks for decision-making during other communicable disease outbreaks, such as a flu pandemic. Research has identified critical issues and ethical principles that can be applied to pandemic planning. While much of the research was done in Canada, the lessons are generally applicable around the world.

The Pandemic Influenza Working Group at the University of Toronto has developed a comprehensive ethical guide or framework for planning for and dealing with major communicable disease outbreaks, such as SARS or pandemic influenza. The guide was developed with expertise from clinical, organizational, and public health ethics and has been validated and vetted by health care officials through a series of consultations and deliberations. Indeed, the framework has been successfully integrated into pandemic plans in both Canada and the U.S. and has informed a World Health Organization consultation on ethical issues in pandemic planning. (10)

An Ethical Guide for Pandemic Planning

Research on the SARS experience indicated that people are more likely to accept such decisions if the decision-making processes are reasonable, open and transparent, inclusive, responsive and accountable, and if reciprocal obligations are respected. (11) Although these principles can sometimes be difficult to implement during a crisis, SARS showed there are costs from not having an agreed-upon ethical framework, including loss of trust, low morale, fear and misinformation. SARS taught the world that if ethical frameworks had been more widely used to guide decision-making, this would have increased trust and solidarity within and between health care organizations.

Based on the SARS experience, the JCB Pandemic Influenza Working Group assembled an ethical guide for planning and decision-making that can be used both in advance of and during an influenza pandemic. The guide is composed of 15 ethical values--10 substantive values and five procedural values--that should be seen as a package of interdependent values that are important in any democratic society.

Recommendations

We strongly encourage all levels of governments and the health care sector to assess their pandemic preparedness plans against the ethical framework and recommendations presented in the Stand On Guard For Thee report. We further encourage that all pandemic plans incorporate a significant and comprehensive public engagement process.

In the U.S., the Keystone Center for Science and Public Policy has undertaken formal efforts to engage citizens in the process of pandemic planning. The Public Engagement Pilot Project on Pandemic Influenza [PEPPPI] was initiated in July 2005 to discuss and rank goals for a pandemic influenza vaccination program and to pilot test a new model for engaging citizens on vaccine-related policy decisions. (12) To help inform decision-makers and public policy officials, various stakeholder groups--including citizens-at-large from all regions of the country--have been invited to participate in prioritization exercises.

More recently, in New Zealand, the National Ethics Advisory Committee has adapted the Stand on Guard For Thee framework in the preparation of its draft statement of ethical values. The working paper was then publicly released as a discussion document for input and feedback by citizens and stakeholder groups. (13) The feedback received through this process will be used to produce a final statement of ethical values for inclusion in the national Influenza Pandemic Action Plan.

Key Ethical Issues

An influenza pandemic will bring with it myriad ethical issues. Based on the experience of SARS, the Working Group identified four key ethical issues that are likely to arise. Drawing from the 15-point ethical framework, the applicable ethical values for each issue have been identified and recommendations for dealing with each have been developed. The recommendations are particularly addressed to governments and decision-making bodies, mainly in the health care sector.

Readers are referred to the full Stand On Guard For Thee report for case scenarios, a listing of key values, and targeted recommendations for each of the four key issues. These are:

* health workers' duty to provide care during a communicable disease outbreak;

* restricting liberty in the interest of public health by measures such as quarantine;

* priority setting, including the allocation of scarce resources, such as vaccines and antiviral medicines;

* and global governance implications, such as travel advisories.

We recognize that these may not be the only ethical challenges that will arise in an influenza pandemic--the issue of research ethics in the context of a public health emergency is another--but they are critically important issues that the Working Group has identified. Planners and decision-makers need to be vigilant for other ethical challenges that will need to be managed.

Next Steps

The ethical framework presented in the Stand On Guard For Thee report is by no means complete or finalized. Rather, it is best regarded as work in progress. Despite extensive dissemination and uptake of this framework, there remain gaps in understanding certain facets of it. The framework itself was derived by expert consensus and reflection. How the values identified are ultimately justified or justifiable has not yet been completely explored from the perspective of normative theory.

It is also unknown the extent to which the proposed values identified in the framework are endorsed by the Canadian public. The framework has undergone extensive vetting within the health care sector: it has been vetted by hospital staff and administrators, government officials in public health and long term care, the hospital voluntary sector, and even international government health agencies. (14)

Although we have solicited and incorporated feedback on the framework widely in the health sector, we have yet to test how the ethical framework resonates with the Canadian public. We view this as an essential step in the process of normatively justifying the framework. For ultimately, if the framework does not reflect the interests and values of the Canadian public, its utility to the policy makers and pandemic planners who seek to protect the interests and well-being of that same public will be diminished. This is because the framework will lack the moral legitimacy that is derived from having consulted with the public. (15)

If an influenza pandemic strikes, it will undoubtedly cause widespread hardship. The degree of hardship will, in large measure, be determined by our response. And we will be much better able to respond if we have prepared in all possible ways, including having reached a general agreement on an ethical approach. In the aftermath of a pandemic, history will judge today's leaders on how well they prepared for and acted during the crisis and whether citizens were treated in an ethical manner.

Ross E.G. Upshur, Director, Joint Centre for Bioethics; Karen Faith, Director of the Clinical Ethics Centre at Sunnybrook & Women's College Health Sciences Centre; Jennifer L. Gibson, Research Associate with the Canadian Priority Setting Research Network (CPSRN) and the Clinical Ethics Group, Joint Centre for Bioethics; Alison K. Thompson, Joint Centre for Bioethics; C. Shawn Tracy, Joint Centre for Bioethics; Kumanan Wilson, Departments of Medicine and Health Policy Management and Evaluation, University of Toronto, and Peter A. Singer, Co-Director of the Canadian Program in Genomics and Global Health, Joint Centre for Bioethics, University of Toronto, Toronto, Ontario.

1. C.S. Tracy, R.E. Upshur & A.S. Daar, "Avian influenza and pandemics" (2005) 352:18 New England Journal of Medicine 1928.

2. World Health Organization, Responding to the avian influenza pandemic threat: recommended strategic actions (Geneva: World Health Organization, 2005), online: WHO <www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_05_8-EN.pdf>.

3. World Health Organization, WHO checklist for influenza pandemic preparedness planning (Geneva: WHO, 2005), online: World Health Organization <http://www.who.int/csr/resources/publications/influenza/FluCheck6web.pdf>.

4. Ibid. at 5-7.

5. Ross E. Upshur et al., Stand on guard for thee: ethical considerations in preparedness planning for pandemic influenza (Toronto: University of Toronto Joint Centre for Bioethics, 2005), online: Joint Centre for Bioethics <www.utoronto.ca/jcb>.

6. Alison K. Thompson et al., "Pandemic influenza preparedness: an ethical framework to guide decision-making" (2006) 7 BMC Medical Ethics 12.

7. Ross E. Upshur, "Enhancing the legitimacy of public health response in pandemic influenza planning: lessons from SARS." (2005) 78:5 Yale Journal of Biology and Medicine 335.

8. Ontario, The Sars Commission, The SARS Commission Final Report: Spring of Fear (2006) (Honourable Mr. Justice Archie Campbell, Commissioner), online: The SARS Commission <http://www.sarscommission.ca/report/index.html>; National Advisory Committee on SARS and Public Health, Learning from SARS: renewal of public health in Canada (Ottawa: Health Canada, 2003), online: Public Health Agency of Canada 

9. Leslie A. Nickell et al., "Psychosocial effects of SARS on hospital staff: survey of a large tertiary care institution"(2004) 170:5 CMAJ 793.

10. World Health Organization, Addressing ethical issues in pandemic influenza planning (Geneva: World Health Organization, 2006), online: WHO <http://www.who.int/ethics/influenza_project/en/index.html>.

11. Singer et al., supra note 8.

12. Keystone Center for Science and Public Policy, Citizen voices on pandemic flu choices: a report of the public engagement pilot project on pandemic influenza (December 2005), online: The Keystone Center <http://www.keystone.org/spp/health-pandemic.html>.

13. National Ethics Advisory Committee, Ethical values for planning for and responding to a pandemic in New Zealand: a statement for discussion (Wellington, New Zealand: Ministry of Health, 2006), online: National Ethics Advisory Committee <http://www.newhealth.govt.nz/neac/publications/ethical-values-for-pandemic-planning-and-response.htm>.

14. Supra note 6.

15. Supra note 7.

Table 1. Ten substantive values to guide ethical decision-making in a
pandemic

Substantive value              Description

Individual liberty             In a public health crisis, restrictions
                               to individual liberty may be necessary to
                               protect the public from serious harm.
                               Restrictions to individual liberty
                               should:
                               * be proportional, necessary, and
                               relevant;
                               * employ the least restrictive means; and
                               * be applied equitably.
Protection of the public from  To protect the public from harm, health
  harm                         care organizations and public health
                               authorities may be required to take
                               actions that impinge on individual
                               liberty. Decision makers should:
                               * weigh the imperative for compliance;
                               * provide reasons for public health
                               measures to encourage compliance; and
                               * establish mechanisms to review
                               decisions.
Proportionality                Proportionality requires that
                               restrictions to individual liberty and
                               measures taken to protect the public from
                               harm should not exceed what is necessary
                               to address the actual level of risk to or
                               critical needs of the community.
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 public from serious
                               harm.
Duty to provide care           Inherent to all codes of ethics for
                               health care professionals is the duty to
                               provide care and to respond to suffering.
                               Health care providers will have to weigh
                               demands of their professional roles
                               against other competing obligations to
                               their own health, and to family and
                               friends. Moreover, health care workers
                               will face significant challenges related
                               to resource allocation, scope of
                               practice, professional liability, and
                               workplace conditions.
Reciprocity                    Reciprocity requires that society support
                               those who face a disproportionate burden
                               in protecting the public good, and take
                               steps to minimize burdens as much as
                               possible. Measures to protect the public
                               good are likely to impose a
                               disproportionate burden on health care
                               workers, patients, and their families.
Equity                         All patients have an equal claim to
                               receive the health care they need under
                               normal conditions. During a pandemic,
                               difficult decisions will need to be made
                               about which health services to maintain
                               and which to defer. Depending on the
                               severity of the health crisis, this could
                               curtail not only elective surgeries, but
                               could also limit the provision of
                               emergency or necessary services.
Trust                          Trust is an essential component of the
                               relationships among clinicians and
                               patients, staff and their organizations,
                               the public and health care providers or
                               organizations, and among organizations
                               within a health system. Decision makers
                               will be confronted with the challenge of
                               maintaining stakeholder trust while
                               simultaneously implementing various
                               control measures during an evolving
                               health crisis. Trust is enhanced by
                               upholding such process values as
                               transparency.
Solidarity                     As the world learned from SARS, a
                               pandemic influenza outbreak will require
                               a new vision of global solidarity and a
                               vision of solidarity among nations. A
                               pandemic can challenge conventional
                               ideas of national sovereignty, security
                               or territoriality. It also requires
                               solidarity within and among health care
                               institutions. It calls for collaborative
                               approaches that set aside traditional
                               values of self-interest or territoriality
                               among health care professionals,
                               services, or institutions.
Stewardship                    Those entrusted with governance roles
                               should be guided by the notion of
                               stewardship. Inherent in stewardship are
                               the notions of trust, ethical behaviour,
                               and good decision-making. This implies
                               that decisions regarding resources are
                               intended to achieve the best patient
                               health and public health outcomes given
                               the unique circumstances of the influenza
                               crisis.

Table 2. Five procedural values to guide ethical decision-making in a
pandemic

Procedural value      Description

Reasonable            Decisions should be based on reasons (i.e.,
                      evidence, principles, and values) that
                      stakeholders can agree are relevant to meeting
                      health needs in a pandemic influenza crisis. The
                      decisions should be made by people who are
                      credible and accountable.
Open and transparent  The process by which decisions arc made must be
                      open to scrutiny, and the basis upon which
                      decisions are made should be publicly accessible.
Inclusive             Decisions should be made explicitly with
                      stakeholder views in mind, and there should be
                      opportunities to engage stakeholders in the
                      decision-making process.
Responsive            There should be opportunities to revisit and
                      revise decisions as new information emerges
                      throughout the crisis. There should be mechanisms
                      to address disputes and complaints.
Accountable           There should be mechanisms in place to ensure that
                      decision makers are answerable for their actions
                      and inactions. Defense of actions and inactions
                      should be grounded in the 14 other ethical values
                      proposed above.