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120507P - ETHICAL ISSUES IN PUBLIC HEALTH RESEARCH

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Paper written by Professor Omar Hasan Kasule Sr.


1.0 ETHICAL APPROVAL
·      A study involving humans must get approval from a recognized body.
·      For approval the study must fulfill certain criteria.
·      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
·      Freedom to participate in the study
·      Freedom to abstain from participation
·      Freedom 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.
·      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.
·      Ownership: who owns the data?
·      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.

6.0 CONFLICT OF INTEREST
·      Epidemiologists employed in academia can work relatively independently.
·      Those working in government and industry are controlled by vested interests.

7.0 STUDY INTERPRETATION and COMMUNICATION: CONTROVERSIAL FINDINGS
·      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. They may not understand differences among published epidemiological findings and over-blow controversies.
·      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.

8.0 STUDY INTERPRETATION and COMMUNICATION: PUBLIC POLICY
·      Study findings affect policy.
·      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.