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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.