ETHICAL ISSUES IN EPIDEMIOLOGY

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ETHICAL ISSUES IN EPIDEMIOLOGY  

• Introduction to Epidemiology Sharon Cooper,
  Ph.D.

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Background Ethics in Epidemiology

•  
• Epidemiology vs. experimental biology
• Epidemiology addresses complex and often
  controversial problems
• Value of studying human species--strengths and
  limitations (may be without direct personal
  benefit)
• Must meet ethical standards of respect for human
  beings
• Must have willing participation, avoid harm to
  body and mind, have respect for social values
• Balance between model for public health
  (protecting public welfare) vs. model for
  medicine (protect welfare of individual)
• Ethical evaluation (obligatory conduct) is not
  synonymous with legal evaluation (permissible
  conduct)

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Ethical Principles as Basis of Ethical
GuidelinesIn Epidemiology

•  
• Respect for autonomy--(respect for
  decision-making capacities of autonomous persons)
• Non-malificience--(do not cause harm)
•  
• Beneficence-- (provide benefits and balance
  benefits against risks)
•  
• Justice--(fairness in distribution of benefits
  and risks)
•  
• Obligatory unless conflict with another moral
  principle
•  

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Ethical Guidelines for Epidemiologists(Beauchamp
et al., 1991)

•  
• I.    Obligations to the subjects of research
• To protect their welfare
• To obtain their informed consent
• To protect their privacy
• To maintain confidential information 
• II.    Obligations to society
• To avoid conflicts of interest
• To avoid partiality
• To widen the scope of epidemiology
• To pursue responsibilities with due diligence
• To maintain public confidence
•            

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Protection of Human Subjects(Beauchamp et al.,
1991)

• No absolute right to scientific knowledge
• Consent procedures are adequate for procuring
  consent from each individual subject 
• The privacy of subjects and the confidentiality
  of information have been adequately protected 
• Risks to subjects have been minimized and have
  been shown to be justifiable by reference to
  anticipated benefits of the research 
• Subjects who might be especially vulnerable to
  influence or to harm have been protected by
  additional measures
• The selection of subjects is fair and the
  research does not place an undue burden on a
  particular class of subjects
•  Plans have been included for the communication
  of study results
•  
•  

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Privacy and Confidentiality

•  
• Important and growing concern--personal concern
  vs. societal impact
• Large impact on epidemiologic research 
• Ethical principle of autonomy and non-malificence
  (do no harm)
• Use of medical records
• To ascertain cases either for case-control or
  cohort study
• To validate participant responses or vital
  statistics data

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Privacy and Confidentiality Cont.

• Many documented breaches of confidentiality
  of medical
• records but not epidemiologic research 
• CPHS, IRBs help guard privacy and
  confidentiality
• Informed consent
• Securely store data
• Study identifiers (not personal)
• Provide results in aggregate
• Examples where impacted epidemiology--Social
  Security
• Administration, Medical Records, Death
  Certificates

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Interpreting Findings

• Issues of causation
• Inconsistency in results
•  
• Media release and interpretation before
  scientific discussion
•  
• Publication bias (media and scientific) against
  negative results
•  

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Should Epidemiologists be Advocates in Public
Policy-Making?

• Numerous examples of use of epidemiology in
  public policy (e.g., John Snow, Simmelweis,
  immunization programs, seat belt legislation,
  public smoking bans)
• Unresolved controversy on epidemiologists' roles
• Epidemiologists have obligation to advocate
• Policy-making and science do not mix (i.e.,
  produce scientific results to be used for
  advocacy)
• Epidemiologists may participate, but as private
  citizens

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Conflict of Interest

• Most researchers--academic, industry, or
  government 
• Should we assume all researchers are biased?
  (i.e., human)
• Funding source--academic--usually outside funding
  with peer review usually industry and government
  research--internally funded
• Publication of results
• Peer-reviewed journal
• Media release
• Disclosure of financial interests
• Disclosure of results (university policies on
  publication)
•  Media perceptions--power

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Other Issues

• Choice of research questions--agency policies
  stimulate and limit choice of questions open to
  researchers 
• Clinical trial--ethical to withhold treatment
  from one group?
• Issues of screening (e.g, treatment options,
  labeling, confidentiality of results)
• Issues of intellectual property (e.g., student
  thesis, authorship)

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References

• Beauchamp TL, Childress JF. Principles of
  Biomedical Ethics. New York Oxford University
  Press, 1994.
•  Beauchamp TL, Cook RR, Fayerweather WE, Raabe
  GK, Thar WE, Cowles SR, Spivey GH. Ethical
  Guidelines for Epidemiologists. J Clin Epidemiol
  1991 44(S1)515S-169S.
•  Coughlin SS (ed). Ethics in Epidemiology and
  Clinical Research. Annotated Readings. Newton,
  Massachusetts Epidemiology Resources, Inc.,
  1994
•  Coughlin SS, Beauchamp TL (eds). Ethics and
  Epidemiology. New York Oxford University
  Press, 1996.
•  Gordis L. Epidemiology. Chapter 19. Ethical
  and Professional Issues in Epidemiology.
  Philadelphia W.B. Saunders and Co., 1996.
•  Levy BS, Wegman DH. Occupational Health.
  Recognizing and Preventing Work-Related Disease.
  Third Edition. New York Little, Brown and Co.,
  1995.

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Issues in Research with Migrant Farmworkers
(complex but intuitive)

• Language issues
• Compensation
• Authorization status
• Legal language of medical referral in informed
  consent

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My Learning Curve (counterintuitive)

• There are times it is not appropriate to share
  results.
• There are certain circumstances where children
  can provide informed consent.
• Passive consent may be preferred.
• There is no automatic right in academics to
  obtain scientific knowledge
• The scope of human subject considerations in
  grant proposal submissions is large.