Integrated Medical Education Resources: 210328P - ETHICAL ISSUES IN EPIDEMIOLOGY

Presented prepared by Professor Omar Hasan Kasule Sr. MB ChB (MUK). MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics

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 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 research interventions carry risks and costs that must be balanced against the benefits.
The beneficiaries are not those who carry the risk

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.
Basic elements of informed consent:

A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject’s participation
A description of the procedures to be followed
Identification of any procedures that are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others that may reasonably be expected from the research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation, and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained
An explanation of who to contact for answers to questions about the research and research subjects’ rights, and who to contact in the event of a research-related injury to the subject
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

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. There are issues that must be resolved: who owns the data?

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.

CONFLICT OF INTEREST

Epidemiologists employed in academia can work relatively independently.
Epidemiologists working in government and industry are controlled by vested interests.

INFLUENCE OF INDUSTRY

Tobacco industry uses its wealth to influence research and publication
Fostering the controversy about passive smoking
Pay consultants to write letters to editors or publish biased reviews
Establish a learned society on indoor pollution
Supporting research on non-tobacco causes of lung cancer
Suppressing results of the tobacco industry’s own research
Reputable journals stopped publishing research supported by the tobacco industry
Disclosure of conflicts of interest and sources of funding

AUTHORSHIP

Doubts about the process of peer review: is it worth it? Is it worth the cost?
Gift authorship
Publication bias by reporting only favorable results
Fraudulent or manufactured data
The International Committee of Medical Journal Editors’ criteria for authorship (2015)[1] states that authorship should be based on:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
Drafting the work or revising it critically for important intellectual content; AND
Final approval of the version to be published; AND
Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
In addition to being accountable for the parts of the work he or she has done, an author should be able to identify which co-authors are responsible for specific other parts of the work. In addition, authors should have confidence in the integrity of the contributions of their co-authors.

ETHNICITY AND RACE

Ethnicity and race are constant variables in all research but are artificial constructs
Is race a biological or social category?
Ethnicity is a social construct based on language, food, religion, lifestyle and geography
Racism encourages data collection and data interpretation to favor certain races
Health conditions attributed to racial / ethnic factors and not environmental factors.

USE OF EPIDEMIOLOGIC EVIDENCE

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.

MEDIA AND EPIDEMIOLGIV 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.
Media may not understand differences among published epidemiological findings and over-blow controversies.
Epidemiological controversies are best evaluated by a careful study of the underlying evidence.

EXAMPLES OF ETHICAL 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. V
egetable-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 was thought to prevent cancer was found by Omenn at al 1996 found it causes 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).

CODE OF CONDUCT FOR EPIDEMIOLOGISTS

In 1998, the International Epidemiology Association’s European Group published a code of practice for epidemiologists that has proven durable. This stated that, among other principles:

seek the truth in good faith without doing harm or jeopardizing personal integrity;
judge their own work and ideas and those of colleagues in an impartial manner;
disclose conflicts of interest to ethical review committees;
publicly acknowledge all research sponsorship;
publish all research with scientific merit;
refuse requests to withhold findings, change or tone down the content of reports, or delay pub lication unreasonably;
ensure sponsors agree in writing that results will be published regardless of outcome and agree to the independence of the investigators;
declare sources of funding and possible conflicts of interest in publications

REFERENCES:

Concepts of Epidemiology Integrating the ideas, theories, principles, and methods of epidemiology THIRD EDITION Raj S. Bhopal, CBE, MD, DSc (hon), MPH, BSc (hon), MBChB, FFPH, FRCP(E) Oxford University Press 3^rd edition 2016