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210112P - EPIDEMIOLOGY: ETHICAL ISSUES IN RESEARCH

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Presented at an online Nursing Diploma Program held at King Fahad Medical City on 12th January 2021 by Dr Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics.

 

1.0 ETHICAL APPROVAL

  • A study involving humans must get approval from a recognized body in our case the Institutional Review Board (IRB).
  • For approval, the study must be scientifically valid. It is unethical to waste resources (time and money) on a study that will give invalid conclusions.
  • In 1992 the Council for International Organizations of the Medical Sciences published ‘Guidelines for Ethical Review of Epidemiological Studies’


2.0 INDIVIDUAL vs. COMMUNITY RIGHTS

  • There is sometimes a conflict between the requirement to protect the rights of the individual and protection of the community.
  • Restrictions may have to be made on an individual in the public interest.


3.0 BENEFITS vs. RISKS

  • Public health interventions carry risks and costs that must be balanced against the benefits.


4.0 INFORMED CONSENT

  • Study subjects must be free to participate in the study, abstain from participation, or elect to withdraw from the study at any stage.


5.0 PRIVACY AND CONFIDENTIALITY

  • Data collected in an epidemiological study should not be released to any third party without consent of the subject.
  • Epidemiological data can be subpoenaed by a court of law when public interest takes precedence over individual rights.
  • Data is reported in the aggregate without any personal identifiers.
  • Access to data is limited during all stages: collection, management, and analysis
  • Data ownership: who owns the data? The participant, the researcher, the institution?


6.0 INCIDENTAL FINDINGS

  • An epidemiologic study may uncover previously unrecognized disease.
  • Pre-symptomatic disorders that do not require immediate medical attention cause no ethical problems.
  • Disorders that require intervention create an ethical problem because the epidemiologist is required to breach confidentiality in the process of making sure that the patient gets the necessary care and that innocent persons will not be exposed to infectious disease.


7.0 CONFLICT OF INTEREST

  • Epidemiologists employed in academia can work relatively independently. Those working in government and industry are controlled by vested interests.
  • Sponsors of research may force researchers to suppress some information

8.0 STUDY INTERPRETATION and COMMUNICATION- MISLEADING ROLE OF THE MEDIA

  • Risk reports that are not yet confirmed can be picked up by the media. It is difficult to keep epidemiological findings secret.
  • Media have a tendency to sensationalize issues that complicates later intelligent debates.
  • Media may not understand differences among published epidemiological findings and over-blow controversies.
  • These controversies are best evaluated by a careful study of the underlying evidence.


9.0 EXAMPLES OF CONTROVERSIS IN EPIDEMIOLOGY

  • MacMahon et al 1981 found that coffee causes pancreatic cancer whereas Feinstein et al. 1981 found that coffee did not cause cancer.
  • Barefoot et al. 1983 found that type A personality was associated with heart disease but Shekelle at al. 1987 found that it was not.
  • Vegetable-derived margarine had been thought to be good for the heart but Willet and Asherio 1994 found that it was bad for the heart.
  • Falck et al 1992 found that pesticides caused breast cancer whereas Krieger et al 1994 found that they did not.
  • Steinberg et al 1991 found that estrogen replacement therapy causes breast cancer whereas Kaufmann et al 1984 found that it did not.
  • Beta carotene thought to prevent cancer was found by Omenn at al 1996 to cause cancer.
  • Miller at al 1989 found oral contraceptives to cause cancer but the Cancer and Steroid Hormone Study Group of 1986 found that it did not (page 330 Ross C Brownson and Diana B Petiti: Applied Epidemiology: Theory to Practice. OUP New York and Oxford 1998).


10.0 EPIDEMIOLOGICAL FINDINGS AFFECT/EFFECT POLICY and LEGAL RULINGS

  • Epidemiologists must know how to communicate risk to the public.
  • It is an ethical obligation to report research findings to subjects so that they may take measures to lessen risk.
  • Epidemiological evidence is different from legal evidence but fate sometimes determines that the two meet in a court of law.
  • Epidemiological evidence may not be accepted in a court of law because it has few certainties; it is all probabilistic.
  • Epidemiological evidence is concerned with populations whereas legal evidence pertains to individuals.