Ethical and Professional Issues in Epidemiology

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Ethical and Professional Issues in Epidemiology

• Public Health 2610
• November 18, 2002
• Lowell E. Sever

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• We are all responsible for all.
• - Dostoevsky -

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Outline of Points to be Considered

• Ethical issues in epidemiology
• Ethics and ethical principles
• Ethical obligations to research subjects
• Ethics of randomized controlled trials
• Professional issues in epidemiology
• Data ownership and sharing
• Public health and bioterrorism CDC, anthrax and
  smallpox

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Ethics and Epidemiology

• There is almost no step in the research process
  in epidemiology in which ethical issues do not
  exist.

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Ethics and Epidemiology

• Ethics for epidemiologists involves an interplay
  between the model of public health (supporting
  the public good) and the model of medicine
  (supporting the good of the individual).

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Ethics

• In its descriptive sense, the term ethics can be
  used to refer to the set of rules, principles,
  values and ideals of a particular group of people
  (morals).
• In its analytic sense, the term ethics can be
  used to refer to the systematic study of moral
  concepts and theories (moral philosophy).

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Ethical PrinciplesThe Georgetown Mantra

• Respect for autonomy - Protection of the ability
  of persons to act as autonomous agents
• Non-maleficence - Protection of persons from harm
• Beneficence - Provision of benefits or assistance
• Justice - Giving each person their due

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Core Values, Duties and Virtues

• Core values underlie the mission and purpose of
  epidemiology and are more restricted than general
  ethical principles.
• Duties (obligations) pertain to various parties
  such as research participants, society, sponsors,
  employers and professional colleagues.
• Virtues are character traits (motivational
  factors) that dispose us to act in ways that
  achieve good things. Virtuous traits include such
  things as humility, fidelity, justice, patience,
  industry and veracity.

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The New Public Health

• The new public health a new morality?
• Epidemiology governing by numbers
• The healthycitizen
• Risk discourse and the environment
• The healthy city
• The duty to participate

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Epidemiology governing by numbers

• The emergence of epidemiology
• The construction of epidemiological facts
• Quantification and epidemiological truths
• Contested knowledges
• Epidemiology and risk discourse
• Self and other in epidemiological discourses

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Integration of Public Health Ethical Problems
into Public Health and Bioethics

• In programs designed to promote health and
  prevent disease and injury (e.g. what is the
  responsibility of individuals to live healthy
  lives?)
• In methods used to reduce or eliminate risk (e.g.
  what level or degree of risk is socially
  acceptable?)

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Integration of Public Health Ethical Problems
into Public Health and Bioethics

• In epidemiological research (e.g. is the need for
  informed consent in the biomedical model of
  research the appropriate model to use for public
  health research?)
• In the topic area of socioeconomic disparities
  (e.g. to what extent should the field take a
  public stand on important policy issues?)

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IRB Protocol Review Questions - I

• Does the protocol have scientific value?
• Does the protocol have scientific validity?
• Does the study have a valid scientific design and
  yet pose an inappropriate risk for subjects?
• Are risks to subjects minimized?

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IRB Protocol Review Questions - II

• Are the risks to subjects reasonable in relation
  to anticipated benefits, if any, to subjects and
  the importance of the knowledge that may
  reasonably be expected to result?
• Is the selection of subjects equitable?
• Are additional safeguards in place for subjects
  likely to be vulnerable to coercion or undue
  influence?

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IRB Protocol Review Questions - III

• Will informed consent be obtained from research
  subjects or their legally authorized
  representatives?
• Is there adequate provision for monitoring the
  data collected to ensure the safety of subjects?
• Are there adequate provisions to protect the
  privacy of subjects and to maintain the
  confidentiality of data?

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Privacy

• Refers to freedom of the person to choose for
  himself or herself the time and circumstances
  under which and, most importantly, the extent to
  which, his or her attitudes, beliefs, behavior,
  and opinions are to be shared with or withheld
  from others.

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Confidentiality

• Refers to managing private information when a
  subject shares private information (confides in)
  an investigator, the investigator is expected to
  refrain from sharing this information with others
  without the subjects authorization or some other
  justification.

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Ethics of Randomized Controlled Trials

• In order for randomized controlled trials to be
  ethical, there must be genuine uncertainty about
  the comparative therapeutic merits of each
  treatment arm, i.e., a state of equipoise must
  exist.
• A data monitoring committee is commonly employed
  to periodically review the evidence emerging from
  a clinical trial and to stop the trial when there
  is decisive evidence in favor of one treatment.

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Ethics of Randomized Controlled Trials

• Often require the balancing of potential benefits
  to individual patients with those that may be
  gained by future patients or society as a whole.
  
• Tension may exist between the physicians
  responsibility to act in the best interest of
  each individual patient and the societal need to
  acquire new knowledge by randomizing patients
  according to a standard protocol.

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Ethics Guidelines for Epidemiologists(The
American College of Epidemiology)

• The professional role of epidemiologists
• Minimizing risks and protecting the welfare of
  research participants
• Providing benefits
• Ensuring a equitable distribution of risks and
  benefits
• Protecting confidentiality and privacy
• Obtaining the informed consent of participants
• Submitting proposed studies for ethical review

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Ethics Guidelines for Epidemiologists(The
American College of Epidemiology)

• Maintaining public trust
• Avoiding conflicting interests and partiality
• Communicating ethical requirements to colleagues,
  employers, and sponsors and confronting
  unacceptable conduct
• Obligations to communities
• Reporting results
• Public health advocacy
• Respecting cultural diversity

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Public Health, Epidemiology Bioterrorism
Betsy Foxman

• Public health infrastructure, disease detection
  and intervention strategies, have been remarkably
  effective in preventing all of us from becoming
  ill from many of the diseases of just a
  generation ago measles, polio, and smallpox.
  Unfortunately, these successes have made public
  health an easy target for cuts in government
  spending.

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Public Health, Epidemiology Bioterrorism
Betsy Foxman

• Disease surveillance and outbreak investigation
  and containment are a cornerstone of public
  health. Establishing public health
  infrastructure will not only protect us from the
  current threats but prepare us for future events.
  Stockpiling cipro and smallpox vaccine will not
  help if god forbid we face chemical attacks
  or something else currently unthinkable.

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Public Health, Epidemiology Bioterrorism
Betsy Foxman

• As we face the growing possibility of a
  recession with an administration that believes
  tax cuts are the way to stimulate the economy,
  our state and local agencies will be increasingly
  be forced to make very hard choices. If public
  health agencies chose to put most resources into
  counter bioterrorism activities other public
  health activities will suffer, such as their
  fight against HIV/AIDS and other sexually
  transmitted diseases, infant mortality and
  vaccine preventable infections.

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Public Health, Epidemiology Bioterrorism
Betsy Foxman

• A well trained and well equipped public health
  workforce is essential to protecting everyones
  health and to ensuring that we have a
  knowledgeable resource to give us both the good
  and bad news about threats to our health.