Do ethics make a difference?

Roger Watson

Professor of Nursing

University of Hull

12 April 2015

What are ethics?

• Ethics are what you do when nobody is looking

Without ethics

• Your guess is as good as mine

• Expediency rules

• People become objects

• Dishonesty becomes common practice

• Extremism takes over

Where do ethics apply?

• Patient care decisions

• Research involving patients

• Research not involving patients

• Reporting research results

Patient care

• Issues:– Information giving– Information sharing– End-of-life decisions– Prioritisation of resources

Information giving

• What is wrong with me?

• Am I dying?

• Will I get better?

• How long will I live?

Information sharing

• Should a family know a diagnosis before the patient?

• Does a family member or any significant other have a right to know what it wrong with a patient?

• Should patient information be available for research?

End-of-life decisions

• Should life be extended at any cost?

– To the individual?– To society?

• Is euthanasia acceptable?

• Who knows best?

Prioritisation of resources

• To whom should scarce medical resources be available?

• Whose life is more important: e.g mother or unborn child?

• Should we invest in prevention or cure?

Ethical requirements in research

• Necessary to ensure that harm to participants is minimised

Ethical frameworks

• Deontological

– Based on rules

• Utilitarian

– The end justifies the means

• Personal

– What you think is right

Ethical framework

• A commonly used framework is that of Beauchamp & Childress:

– respect for autonomy– non-maleficence– beneficence– justice

Respect for autonomy:

• respecting the decision-making capacities of autonomous persons

• enabling individuals to make reasoned informed choices.

Beneficence

• this considers the balancing of benefits of treatment against the risks and costs

• the healthcare professional should act in a way that benefits the patient

Non maleficence

• avoiding the causation of harm

• the healthcare professional should not harm the patient. All treatment involves some harm, even if minimal, but the harm should not be disproportionate to the benefits of treatment.

Justice

• distributing benefits, risks and costs fairly

• the notion that patients in similar positions should be treated in a similar manner.

Ethics specific to research

Respect for autonomy

• Informed consent (1)

– Information• Full information about what participation means must

be provided to the participants

• Information must be:

– For a wide reading ability

– Written in non-technical language

– Explain risks and benefits

Ethics specific to research

Respect for autonomy

• Informed consent (2)

– Consent• People must give their consent prior to participation

• Consent should be signed

• People should be able to withdraw without prejudice to their treatment

• Special considerations

– Incentives

– People unable to give consent

Ethics specific to research

Beneficence

• The outcome – by intention – of the research should have the potential to do good (general)

Ethics specific to research

Non maleficence

• The outcome – by intention – of the research should have the potential to do no harm (general)

• If the research is harming the participant then there must be a mechanism to detect and withdraw the participant (specific)

Ethics specific to research

Justice

• Research should not only be designed for the ‘normal’ demographics in terms of:

– Age– Ability– Social status– Ethnicity

Governance of research

Mechanisms must be in place to:

• Training and certification of those involved in research

• Monitor compliance with ethical requirements

• Check record keeping of:

– Consent– Recruitment– Reporting of adverse events consequences– Follow up of participants

Reporting research

Avoiding fraud:

• Fabrication:

– Invention of data or cases

• Falsification:

– Wilful distortion of data• Ignoring outliers?

• Not admitting that some data are missing.

• Post hoc analyses that are not admitted?

• Not including data on side effects in a clinical trial

Ethical Issues in Publication1. Duplicate Publication

2. Authorship and Order

3. Scientific Misconduct (including plagiarism)

4. Conflict of interest

Duplicators and plagiarisers

• 62,312 Medline citations (sample)

• 0.04% with no shared author but content highly similar = plagiarism

• 1.35% with shared authors and highly similar content = duplication

• Therefore, possibly 3500 plagiarised and 117,500 duplicate papers

(Mounir Errami et al 2008)

Duplicate Publication

• Not republishing the same findings

• Not submitting the same manuscript to two or more journals at once

• Not dividing one research project into many little papers (“salami slicing”)

Authorship• Who can be an author?

• Authorship order

• Issues and problems with authorship

Authorship

• International Committee of Medical Journal Editors (ICMJE) at http://www.icmje.org/ states authorship is based on:

• 1) substantial contributions to the conception and design of a paper, or acquisition of data or analysis and interpretation of data, and,

• 2) drafting the article or revising it critically for important intellectual content and final approval of the version to be published.

Plagiarism

• Plagiarism ranges from the unreferenced use of others’ published and unpublished ideas, including research grant applications to submission under “new” authorship of a complete paper, sometimes in a different language.

• It may occur at any stage of planning, research, writing, or publication: it applies to print and electronic versions.

What is Conflict of Interest?

• Conflict of interest

– a set of conditions in which professional judgement concerning a primary interest (such as the validity of a research study) tends to be unduly influenced by a secondary interest (such as financial gain).

– ....or may give that impression

Committee on Publication Ethics (COPE)

• Founded in 1997 as a response to growing anxiety about the integrity of authors submitting studies to medical journals.

• Founded by British Medical Journal & Lancet editors

Do ethics make a difference?

email: r.watson@hull.ac.uk

@rwatson1955