Integrated Medical Education Resources: 220118P - EPIDEMIOLOGY: ETHICAL AND PROFESSIONAL ISSUES

Presentation at a KFMC Nursing Diploma Program Epidemiology: Ethics in Research Held at King Fahad Medical City, Riyadh on 18 January 2022. By Professor Omar Hasan Kasule Sr. Mb Chb (Muk). MPH (Harvard), DrPh (Harvard) Professor of Epidemiology and Bioethics

MEDICAL ETHICS FRAMEWORK

Autonomy = respect for individual rights
Beneficence = Do good
Non-maleficence = do not harm

ETHICAL ISSUES IN EPIDEMIOLOGY

Review and approval of the research proposal by IRB.
Respect participant's right to autonomy: Respect participant autonomy by obtaining 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.
Respect participant rights to protection and welfare: Protecting the welfare of the participant by minimizing risk and establishing the right balance between individual and societal benefit. Protecting the privacy and confidentiality of participants.
Balance risks vs benefits: Public health interventions carry risks and costs that must be balanced against the benefits.

PROFESSIONAL ISSUES IN EPIDEMIOLOGY

Interpret and communicate study findings to the public (for self-protection) and policymakers.
Avoid conflict of interest (COI)
Follow the Code of conduct for epidemiologists

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 1991 the Council for International Organizations of the Medical Sciences published ‘International Guidelines for Ethical Review of Epidemiological Studies’^[1]: consent, maximize benefit, minimize harm, confidentiality, and conflict of interest.

PARTICIPANT RIGHTS 1: INVESTIGATOR'S OBLIGATION TO STUDY SUBJECTS^[2]

Informed consent and after full disclosure
Protecting privacy and confidentiality. Access to data.
Balance of individual rights vs societal benefit
Communicating results of the study

PARTICIPANT RIGHTS 2: ETHICAL GUIDELINES FOR EPIDEMIOLOGISTS^[3]

Minimizing risk and protecting the welfare of research subjects
Obtaining informed consent
Ethical review of proposals
Maintain public trust
Meeting obligations to communities

PARTICIPANT RIGHTS 3: INDIVIDUAL vs. COMMUNITY RIGHTS

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

PARTICIPANT RIGHTS 4: PRIVACY AND CONFIDENTIALITY

Data collected in an epidemiological study should not be released to any third party without the 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?

PARTICIPANT RIGHTS 5: INCIDENTAL FINDINGS

An epidemiologic study may uncover previously unrecognized diseases.
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 diseases.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION-1: Misleading Role of The Media

Media have a tendency to sensationalize issues that complicates later intelligent debates.
Media may not understand the differences between published epidemiological findings and over-blow controversies.
Risk reports that are not yet confirmed can be picked up by the media. It is difficult to keep epidemiological findings secret.
Interpretation of RR, OR, and AR may not be true because of random errors (measured by the p-value), bias (systematic errors such as selection bias or information bias), and confounders. Fallacies of numerical reasoning.
Biological vs statistical significance.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 2: Examples of Controversies in Epidemiology

Epidemiological controversies are best evaluated by a careful study of the underlying evidence and not be debated in the media.
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 et al. 1987 found that it was not.
had been thought to be good for the heart but Willet and Vegetable-derived margarine Asherio 1994 found that it was bad for the heart.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 2: Examples of Controversies in Epidemiology, con’t.

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 et al 1996 to cause cancer.
Miller et 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).

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 3: 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.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 3: Epidemiological Findings Affect/Effect Policy and Legal Rulings con’t.

Epidemiological evidence is concerned with populations whereas legal evidence pertains to individuals.
Lung cancer patients sue tobacco companies for the causation of cancer. The judgment depends on establishing a causal relationship between tobacco and lung cancer. The counter-argument is that smoking is not the only cause of lung cancer.
Criteria of causation: time sequence, the strength of the association, specificity of the association, biological plausibility, consistency, dose–effect relationship, and decrease of risk with the termination of exposure.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 4 Ethnicity and Race^[4]

Race and ethnicity are used uniformly as confounding factors in most studies
Race and ethnicity are not discrete but are continuous variables
Racism in attributing disease risk to race with some races being better
Race and genetics are artificial social-political constructs. Differences among races and ethnicities are minor/superficial and do not relate to disease risk. Analysis of the genome has destroyed the concept of race.
Social and environmental factors underlie disease

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 5: Fallacies In Epidemiology^[5]

The fallacy of weight of evidence = a lot of weak evidence does not become strong evidence
The fallacy of repeated citation = what is cited a lot need not be true
The fallacy of authority based on individuals or books
The fallacy of simple solution = parsimonious does not mean right
The fallacy of risk = RR or OR may not be accurate for causality

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN STUDY INTERPRETATION and COMMUNICATION - 5: Fallacies In Epidemiology^[5] con’t.

The fallacy of inappropriate extrapolation, if too much or exposure is risky, is moderately safer?
Fallacy of significance tests = p value not always true
Fallacy of obsfuscation = use of complex language
Fallacy of covert bias

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN CONFLICT OF INTEREST - 1^[6]

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.
Conflict of interest.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITY IN CONFLICT ON INTERESTS: 2: How The Tobacco Industry Interfered with Epidemiology^[7]

Fostering controversy about the effects of passive smoking
Paid consultants who write articles for academic journals
Publishing biased review articles
Research on non-tobacco causes of lung Cancer
Hiding Results of Research on Tobacco

EPIDEMIOLOGISTS PROFESSIONAL RESPONSIBILITY IN CONFLICT OF INTEREST 3: Manipulation of Authorship

Pressure to publish to win grants, promotions, and appointments. Many seek authorship they do not deserve.
The International Committee of Medical Journal Editors criteria for authorship (2015) are^[8]:
substantial contribution to the conception or design of the work or the acquisition, analysis, or interpretation of data for the work
drafting the work or revising it critically for important intellectual content
final approval of the version to be published
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.

EPIDEMIOLOGIST PROFESSIONAL RESPONSIBILITIES: CODE OF CONDUCT FOR EPIDEMIOLOGISTS^[9]

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 publication unreasonably;
Ensure sponsors agree in writing that results will be published regardless of the outcome and agree to the independence of the investigators;
Declare sources of funding and possible conflicts of interests in publications.

REFERENCE:

https://cioms.ch/wp-content/uploads/2017/01/1991_INTERNATIONAL_GUIDELINES.pdf
David Selentano et al. Cordis Epidemiology 6th edition ElSevier Philadelphia 2019
Jones Bartlett. Epidemiology 101 2nd edition LEARNING Massachusetts 2018 by Robert H Friis p. 184
Raj Bhopal. Concepts of Epidemiology integrating the ideas, theories, principles, and methods of epidemiology, 3rd edition. Oxford University Press. 2016. p. 408.
Raj Bhopal. Concepts of Epidemiology integrating the ideas, theories, principles, and methods of epidemiology, 3rd edition. Oxford University Press. 2016, p. 414
David Selentano et al. Cordis Epidemiology 6th edition ElSevier Philadelphia 2019 page 402
Barnes and Bero 1998 quoted by in Concepts of Epidemiology integrating the ideas, theories, principles, and methods of epidemiology Raj Bhopal Oxford University Press 2016. p. 405-406.
Raj Bhopal. Concepts of Epidemiology integrating the ideas, theories, principles, and methods of epidemiology, 3rd edition. Oxford University Press. 2016, p. 40
Published by the International Epidemiology Association's European Group in 1998 updated in 2007