The ethics and etiquette of epidemiological research

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Epidemiology is the study of how often diseases occur in different groups of people and why. Information from such research is used to plan and evaluate strategies to prevent, as well as guide the management, of individual patients.¹

In theory, research should be driven only by a desire to establish the truth. However, in the real world, other factors often interfere with this aspiration and can result in conflicts of interest. Research has to be funded, carried out and ultimately published, whilst researchers seek to promote their reputations and careers. Research is, therefore, often conducted amidst many competing agendas.²

The public also has a right to know about hazards to health and to be equipped to make evidence-based choices concerning treatment and prevention. This is not possible without research. Doing no research is often unacceptable from an ethical perspective, where there is clinical uncertainty. The quality of research should also be optimised; poor research may lead to wrong decisions which may have a profound negative impact on patient health.³ Equally it is unethical to undertake research that would involve withholding a treatment that has been previously proven to be clinically effective.

Ethical constraints must be balanced against opportunities to expand knowledge and improve care for patients. Over the last 50 years, there have been a number of guidelines published, which aim to improve the ethical standards of epidemiological research. This section draws on several papers that are all available online and referenced below. The reader is encouraged to read them in full for more information^3,5. Other documents in this section also include information about the ethics of individual study designs.

The roots of epidemiological ethics

The ethics of epidemiology and public health have emerged from several sources, including:³

Bioethics - a field of inquiry that originally explored problems faced in the practice of medicine and biomedical research, and now also covers clinical practice, regulatory policy, research practice, and cultural and social concerns
Philosophical ethics – theories and concepts drawn from the writings of Aristotle, Kant, Mill, Rawls, etc
The experiences of public health practitioners around the ethical problems that underlie professional practice, such as advocacy, conflicts of interest, and scientific misconduct.

The Declaration of Helsinki⁴ was developed by the World Medical Association as a set of ethical principles to ‘provide guidance to physicians and other participants in medical research involving human subjects.’ Although it is not legally binding, it has become widely accepted as the cornerstone of human research ethics. The first version was adopted in 1964 and has been amended seven times since, most recently in 2013.

It includes principles on:

Safeguarding research subjects
Informed consent
Minimising risk
Adhering to an approved research plan/protocol.

Informed consent

Informed consent is a process by which the risks, benefits, and expectations of a research project are disclosed to a participant in order for them to make an informed decision about whether to participate. Broadly, this requires competence, autonomy (voluntary and lacking coercion), and consent, as well as full comprehension of the risks, burdens, and benefits.⁴

Specifically, informed consent includes three key components:²

Information - there should be adequate disclosure of information regarding risks, burdens and benefits, enabling the patient or subject to make an informed choice.
Understanding - the individual should have the ability to understand what he or she is told and to make a reasoned choice based on that information (capacity).
Voluntariness - there should be a voluntary decision or agreement on the part of a capable person.

Where informed consent has been obtained, it must be clearly documented.

Research participants have the right to refuse to take part in a study. Informed consent should be given freely, without external pressure and without unreasonable inducements. There should always be an assessment of what incentives, if any, may be offered to potential respondents for participating in the study. Whilst some reimbursements such as travel costs may be reasonable, paying participants to take part may not be.

For some epidemiological studies, particularly case-control studies and historical cohort studies, non-disclosure of the full aims of the study may be permissible, because full disclosure of the study hypothesis could bias the investigation.³

Do no harm³

One of the most basic ethical principles of medicine and epidemiology is the moral obligation to cause no harm to participants (non-malfeasance), whether physical or psychological. Although the risk in an epidemiological investigation is usually minimal, most people who take part gain no personal benefit.

Epidemiologists often use personal data, so privacy must be respected. Data should only be stored with personal identifiers if absolutely necessary, and identifiable information should never be stored on computers outside research establishments. Files containing personal identifiers (name, security numbers, addresses, telephone numbers, etc) should be stored in locked cabinets.

Conflicts of interest

A conflict of interest is a situation in which a researcher has, or appears to have, a private or personal interest, for example a financial investment, sufficient to influence the objective exercise of their professional judgement.²

Researchers must disclose actual, apparent or potential conflicts of interest to their colleagues, the ethics committee and subsequently to a journal publishing their work. All sponsorship of research should also be publicly acknowledged.

Publications

Research results should be published in an appropriate journal without undue delay. As a general rule, research findings should be subject to independent peer review prior to publication or submission to the media. The non-publication of research with “negative” findings (results which fail to reject a study’s null hypothesis) is also seen as unethical.

Scientific misconduct

Any large-scale study provides ample opportunity for the data to be manipulated. Scientific misconduct is defined as any deviation from an interpretation not reached in good faith and without the aim of objectivity. External pressures to publish and to obtain research funding are strong risk factors for scientific misconduct. Recent examples indicate that epidemiological research is not immune to the most severe form of misconduct – the fabrication of data.²

References

Coggon D, Barker D, Rose G. Epidemiology for the uninitiated (5th ed.), BMJ Publishing Group 2003
Good Epidemiological Practice: IEA Guidelines for Proper Conduct in Epidemiologic Research
(http://ieaweb.org/good-epidemiological-practice-gep/ - Accessed 8/04/17)
Weed D, McKeown R. Ethics in epidemiology and public health I. Technical terms. J Epidemiol Community Health 2001; 55:855–857
Full text of the Declaration of Helsinki: (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ - Accessed 8/04/17)
Weed D, McKeown R. Ethics in epidemiology and public health II. Applied terms. J Epidemiol Community Health 2002; 56:739-741