Ethics and International Public Health: Examples from the Control and Research on Infectious Diseases

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Ethics and International Public Health Examples
from the Control and Research on Infectious
Diseases

• Richard A. Cash, MD, MPH
• Harvard School of Public Health
• 22 March 2007

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Ethical issues in public health related to
infectious disease control and research

• What are the rights of the individual vs those of
  the community?
• Does the community share a common good and if so
  who defines it?
• Who bears the burden of prevention?
• What does the public deserve in terms of health
  care? Can the market provide this?
• If the control of infectious diseases is a global
  public good, what and individual, community, or
  nations responsibilities to global health?
• What standard of care should be followed in
  research and what is owed to the community?

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Chinas response to SARS

• Denial
• Public and international mistrust of government
• Admission of problem (April 2003), five months
  after first reports
• Mayor of Beijing Minister of Health fired
• Quarantine of exposed persons
• Migrant workers flee Beijing
• Airport testing (fever, cough)
• Individual rights limited

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Strategies for limiting spread

• Rapid identification of cases
• Isolation of suspect/probable cases
• Quarantine post-contact
• Screening of travelers from epidemic areas
• No travel within 10 days of contact
• Increasing public awareness

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Isolation

• Separates ill from healthy and restricts movement
  to stop spread of illness
• Focused delivery of specialized health care in
  homes, hospitals, or health care facilities
• Standard procedure in hospitals for patients with
  TB and certain other infectious diseases
• Voluntary in most cases, but government has
  authority to compel isolation

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Quarantine

• Applies to the exposed who may be infected but
  not yet ill
• Intended to stop the spread of illness
• Cities, provinces/states, and nations can declare
  and enforce quarantine
• Authority may vary widely from country to country
  and region to region
• In the US the CDC also empowered to detain,
  medically examine, or release individuals
  suspected of being infected

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Smallpox
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Smallpox eradication in Bangladesh and India
coercion or good public health?

• 1971-72 Smallpox spreads from Bengali refugee
  camps in India to Bangladesh countryside
• Strategy one case in a village means that all
  are immunized
• Refusal not an option
• Forced immunization, isolation and quarantine
• Bangladesh and India become smallpox free in 1975

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HIV/AIDS in Cuba

• In the early 1980s the island nation screened
  population, with a particular emphasis on those
  returning from sub-Saharan Africa
• HIV isolated from larger in communities (eg
  leper colonies), allowed family contact but no
  conjugal rights, and given treatment
• Communities opened up in 1990s
• Cuba has the lowest prevalence of HIV/AIDS in the
  Americas

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Reasons for refusal to be treated, isolated,
quarantined, or vaccinated

• Distrust of authorities
• Social/political protest
• Religious convictions
• Superstitions
• Lack of reliable information
• Stigmatization

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Isolation and quarantine (I)A human rights
perspective

• What system is in place to make a decision?
• Are there laws that allow for redress and
  challenge?
• Is there transparency and accountability in terms
  of how decisions are made?

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Isolation and quarantine (II)

• Is the public health evidence being reviewed? Is
  the decision evidence-based?
• Is there a valid public health objective?
• Is the action necessary to reach this objective?

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In what other areas might these principles with
respect to public health practice and research in
infectious diseases?

• Surveillance
• Research
• Increased research between developed and
  developing countries in drug testing and
  surveillance

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WHO definition of surveillance
Surveillance is the ongoing systematic
collection, collation, analysis and
interpretation of data and the dissemination of
information to those who need to know in order
that action may be taken
Source WHO-CSR
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Does surveillance differ from research?

• Public sector function
• Directly linked to public health policy and
  strategies
• Meant to impact the population from which the
  data are being collected (not necessarily the
  individuals)
• Not usually intended to be generalizable
• Systems already exist in countries that have
  traditionally collected and used data without
  focus on the individual

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• "Surveillance is not research. Public health
  surveillance is essentially descriptive in
  nature. It describes the occurrence of injury or
  disease and its determinants in a population. It
  also leads to public health action.."
• Source World Bank Group, Public health
  surveillance toolkit, http//survtoolkit.worldban
  k.org (2002) accessed 12 November 2003.

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• "It is inappropriate to regard ethical
  oversight strictly as an impediment. In the
  context of public health surveillance, it can
  serve as a means of avoiding inadvertent breaches
  in confidentiality and stigma it can help to
  ensure that the public understands that
  surveillance will occur and what purposes it
  serves it can protect politically sensitive
  surveillance efforts. There is, after all, an
  ethical mandate to undertake surveillance that
  enhances the well-being of populations."
• Source Fairchild AL and Bayer R. Ethics
  and conduct of public health surveillance, 2004
  Science, 303 631-2.

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Potential ethical dilemmas (I)

• 1. Individual good versus population good
• Data/specimens may not benefit individual
• Need for response versus observation
• 2. Procedures that have risk (e.g. blood or CSF
  collection)
• Not generally practiced (ie driven by
  surveillance activities).
• 3. Cross-over or primary versus secondary intent
• Primary intent data used for public health
• Secondary intent data/specimens used to answer
  research question

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Potential ethical dilemmas (II)

• 4. Adding "research" to routine surveillance
• -Routine surveillance may also have nested
  research activities
• 5. Field testing new surveillance methods for
  generalizability
• 6. Confidentiality versus need for personal
  identifiers
• 7. Epidemiologic investigation of surveillance
  events
• Is informed consent needed?
• Ethical issues around contact tracing

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Potential ethical dilemmas (III)

• 8. Ownership of data and specimens
• 9. Overburdening a surveillance system (and
  staff), particularly at peripheral levels
• Data could be obtained more efficiently
• Collecting data on a condition for which there is
  no public intervention or no intention to
  intervene
• Collecting data on a condition of questionable
  importance
• Poor management causing undue reporting burden
• Collecting data that are never used

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Issues for discussion

• What criteria should be used to decide whether
  surveillance needs ethical review?
• Who should review the criteria?
• Can the ethical principles used for research
  (respect for persons, beneficence, justice) be
  applied to surveillance?
• Practically, how does one apply ethical
  principles to surveillance?
• One size may not fit all
• Should benefit/risk analysis (beneficence) be at
  the center of the discussion?

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Principles of ethical research

• Scientific validity
• Fair selection of study population
• Favorable risk-benefit ratio
• Independent review
• Informed consent
• Social value
• Respect for participants and communities
• Collaborative partnerships
• Emmanual et. al

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Ethical issues in HIV/AIDS research

• Informed consent
• Obligations to the community
• Standards of care
• Confidentiality and privacy (case)
• Testing of drugs and vaccines

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Obligations to the community

• Confidentiality
• Long term care use the tested products or what
  is available and sustainable?
• Availability of products tested?
• Licensing
• Surveillance
• Maintenance of treatment and diagnostic
  facilities
• Training and technology transfer

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Standard of care

• Should it be the ideal ie provide best proven
  therapy in the world? or--
• Minimum highest level of health care attainable
  and sustainable in the host country?
• Should the criteria be that which is attainable
  and sustainable (ICMR)?
• Should the package of care be decided following
  dialogue between host and sponsor?

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Standard of care

• Factors to consider in determining level of care
• Level of care in sponsoring country
• Minimal and highest level of care in host country
• Availability of health workers and ability to
  provide care
• Duration and sustainability of care

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Confidentiality

• Information may be stigmatizing but what about
  other stigmatizing diseases?
• Who will have access to data?
• How will data be protected?
• How will results be disseminated?
• How will populations be identified? Do
  communities have rights?
• Is there a responsibility for partner
  notification?

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Summary and recommendations

• Ethical issues arise in many areas of public
  health including defining the problem, program
  implementation and evaluation, and research
• Setting standards must develop from a dialogue of
  all concerned
• Context important in arriving at solutions to
  ethical dilemmas
• Ethical guidelines should be continuously
  reviewed as the situation is constantly changing