Medical Research Ethics
•
Dr Andrew Papanikitas, NIHR Academic Clinical Lecturer in
General Practice, Department of Primary Care Health
Sciences, andrew.papanikitas@phc.ox.ac.uk
March 16, 2016
Ground Rules for applied ethics discussion

Chatham House Rule
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Please respect each other, we are talking about right and
wrong, good and bad, professional and unprofessional
 This does not mean that you need to agree with each-other
Medical Research Ethics
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Introductions
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Research - A particularly worthy activity, why?
What kinds of medical research might be relevant to
our discussion?
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Medical Ethics is defined by Research
Collins Medical Dictionary (2005: 392)
… medical ethics is concerned with the many questions and dilemmas
that have arisen in consequence of medical advances –questions
such as the rightness of prolonging life by extraordinary means,
choices in allocating limited resources, decisions about organ
transplantation, the propriety of psychosurgery, how far research on
fetuses is justified, how trials of new drugs should be conducted,
whether the diagnosis of genetic defects in embryos is always justified
and how far genetic engineering may ethically proceed.
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A long tradition of inhumanity?
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Herophilus (335-280 BC) and Erasistratus
(304–250 BC) may have vivisected Egyptian
Prisoners in Alexandria
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1916 Chemical tests on 25,000 servicemen at
Porton Down
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Tuskegee study in Alabama from 1932 to 1972
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Nazi Germany – experiments in concentration
camps
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March 16, 2016
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The Nuremberg Tribunals

Harmful/lethal experiments
conducted on captive human
subjects
German doctors involved
argued:
 Others had conducted
harmful research on humans
 The interests of the state in a
time of war
 There were no universally
agreed standards for human
research
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Some Background
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1949 Nuremberg Code: 1) consent 2) justification 3)design 4)
avoiding harm 5) qualified scientists 6) end experiment if
causing harm or consent withdrawn
 National Research Act Public Law of 1974 (IRBs)
 1964…2008 WMA Declaration of Helsinki revised
 1968 Informal RECs in the UK
 1984 and 1990 Principal guidelines covering research in UK
issued by the Royal College of Physicians require ethical
review prior to being carried out.
 1991 Statutory Provisions for LRECs and MRECs
 2009 IRAS
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Broad principles (do any relate to the
philosophical ideas which you have already
covered?
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Equipoise
A clear purpose
Principle of Benefit/least harm
Consent
Confidentiality
Justice
Other issues
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Double standards? Clinical Case

Dr A sees patient B in the outpatient department. B is suffering
from depression of a type likely to be helped by
antidepressants. There are several slightly different
antidepressants available. Dr A advises B to take a particular
antidepressant (Drug X). However he says nothing about the
other antidepressants that may be prescribed
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March 16, 2016
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Double Standards? Research case

An RCT is underway to compare two antidepressants, drug X and
drug Y. Although Dr A tends to prescribe drug X, on reflection he
does not think there is good evidence to prefer X to Y. It could be
important to establish their relative effectiveness. Dr A therefore
agrees to ask suitable patients whether they would be prepared to
take part in the trial . Dr A sees patient B in the outpatient
department. In order to conform to the REC’s standards, Dr A must
obtain valid consent for B to enter the trial. He must inform B about
the trial and its purpose. He must also inform B about both drugs
and tell B that a random process will be used to choose which will
be prescribed.
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Double Standard
For:
 2 masters?
 Patients view the two situations differently
 Informed consent is needed in research to maintain trust in doctors
Against
 Doctors should always be acting in patients best interests
 The second 2 points are empirical – they could be wrong?
SO... Should everyday medical ethics adhere to the standards of
research ethics
Chalmers I and Lindley R I, Double standards on informed consent to
treatment. In Doyal L, Tobias J (Eds) Informed consent in medical
research, BMJ Books, London, 2001: 266-276
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Should research ethics be the standard for
clinical ethics?
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Based on patient autonomy and informed consent
Has framed the model of clinical ethics anyway
Research is the basis of the tools used by clinical medicine
Informed consent involves consensual understanding of a
spectrum of clinical interventions
 Necessary as clinical interventions are increasingly
complicated

Kagarise and Sheldon, 2000
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March 16, 2016
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Consider

A US governor proposes to a patient on death row that he will
commute his sentence if and only if he takes part in a medical
experiment
Feinberg J. Harm to self: the moral limits of the criminal law. Oxford: Oxford University Press,
1986.
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The point? Vulnerable groups (do any relate to the
philosophical ideas which you have already
covered?)
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Children
Incapacitous adults
People who are not at liberty
People in developing countries
The human foetus
Animals
Are there any other vulnerable groups
YOU!
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Different kinds of research – different
principles?
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Qualitative research
Observational research
Database use
Biobank use
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Is there anyone in the group who has experience of these and
others?
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Group discussion: Publication Ethics
What are the ways that published work can be criticised on ethical
grounds?
 Fraud
 Gift or Ghost authorship
 Plagiarism (and self plagiarism)
 Multiple submission
 Conflicts of interest
 Any others?
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In Summary

Research ethics is largely based on simple principles: Clear
rationale, Appropriate design, Consent, Harm minimization but
also fairness.
 These principles apply to any research involving humans (and
animals)
 The principles form the basis of preparation for ethical review
by a REC
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Some Further Reading

Slowther A, Boynton P, Shaw S, Research governance: ethical
issues, JRSM, 2006; 99: 65-72
 Wilson S, Draper H and Ives J, Ethical issues regarding
recruitment to research studies within the primary care
consultation, Family Practice, 2008; 25: 56-461
 Hope T, Savulescu J, and Hendrick J, Research, Chapter 14,
pages 217-234 in Medical Ethics and Law: the core curriculum
(2nd Edn), Elsevier 2008
 Kagarise MJ, Sheldon GF, Translational ethics: a perspective
for the new millennium, Arch Surg, 2000; 135 (1):39-45
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