Presentation at a training
program ‘Applying the Principles of Ethics to Clinical Practice:’ held at Aramco
Dhahran April 6, 2015 by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH
(Harvard), DrPH (Harvard) Chairman of the Ethics Committee King Fahad Medical
City.
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’
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.
Benefits
vs. Risks
· Public health interventions carry risks and costs that must be balanced
against the benefits.
Informed
consent
· Freedom to participate in the study
· Freedom to abstain from participation
· Freedom to withdraw from the study at any stage.
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.
Conflict
of interest
· Epidemiologists employed in academia can work relatively independently.
· Those working in government and industry are controlled by vested
interests.
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.
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.
Case scenario 1
A community randomized study was needed to establish
whether adding multivitamin tablets to food served in public restaurants would
help reduce cardiovascular risk. Permission was obtained from the mayor of the
city since it was not possible to get consent from each individual participant.
Case scenario 2
A new vaccine against flu was found effective overseas. The
Ministry of Health wanted to test its efficacy by a randomized study. Because
of a negative media campaign, there were no volunteers for the study. The
Ministry decided to force all hospital employees above 50 years to enter the
study in the next winter season.