HSBH1007 Lecture Notes - Lecture 5: De-Identification, National Health And Medical Research Council, Primum Non Nocere
22 Aug 2018
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Ethics in Research: Lecture 6
What are Ethics in Research?
• Honesty
• Objectivity – not just doing something b/c of
money
• Integrity
• Carefulness
• Openness
• Respect for intellectual property
• Confidentiality
• Responsible publication
Unethical Research:
• Enrolling people in research without their written content
• Not giving participants full information about the research
• Enrolling your family members in your research (conflict of interest)
• Enrolling a person because you think they ‘should’ be enrolled
• Withholding information – intervention could be harmful (“above do no harm”)
• Using a disadvantaged/minority group (orphans, poor, illiterate, disability)
• Not including some subjects in research (racial discrimination)
• Offering money for research
• Examples:
o Stanford Prison Experiment – created mental instability
o Polio in 20th C – test vaccines on mentally ill patients (marginalized group)
• Ethics & Drugs:
o Usually test on animals first
o Don’t do human testing until done animal testing
Unethical Conduct:
• Publishing same paper in 2 different journals without telling editors
• Not informing a collaborator of your intent to file a patent in order to make sure you are the
sole inventor
• Using an inappropriate statistical technique to enhance the significance of your research
• Bypassing the peer review process & announcing your results through a press conference
w/o giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other
people in the field or relevant prior work
• Stretching the truth on a grant application to convince reviewers your project will make a
significant contribution to the field
• Failing to keep good research records or failing to maintain research data for a reasonable
period of time
• Promising a student a better grade for sexual favours
• Responsible mentoring
• Respect for colleagues
• Social responsibility
• Non-discrimination
• Competence
• Legality
• Animal care
• Human subjects protection
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• Making significant deviations from research protocol approved by your institutions Animal
Care & Use Committee or Institutional Review Board for Human Subjects Research w/o
telling the committee or board
• Not reporting adverse events in a human research experiment
• Wasting animals in research
• Sabotaging someone’s work
• Rigging an experiment so you know how it will turn out
• Deliberately overestimating clinical significance of a new drug to obtain economic benefit
• People must be in a condition to give informed consent
Examples of Unethical Conduct in Experimental Research:
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Role of Legislation:
• Keeping the researchers honest:
o National Medical Health & Research Council (NHMRC)
o Aboriginal Health & Medical Research Council
o Ethics Review Board (HERC or AERC)
o Research Office
o Therapeutic Goods Administration (TGA) – AUS [makes ethical decisions about PBS]
o Federal Drug Administration (FDA) – USA
o Drug Regulatory Office (Pharmaceuticals)
HREC or IRB:
• Human Research Ethics Committee (HREC) or Institutional Review Board (IRB) have
responsibility of reviewing every application for research in a given institution
• HREC is an ethics committee
• What risks could happen?
• W/ animals = tend to do many procedures on the SAME animals
• USYD has 3 Ethics Review Boards:
o Clinical research
o Humanities research
o Animal research (AREC)
The University of Sydney Page 11
Examples of unethical conduct in experimental
research
Worldwide examples:
Nazis during WWII – Josef Mengele tested genetic effects and
Used twins to test the effects of a range of substances
Prisoners were coerced into participating; they did not willingly volunteer
and there was never informed consent. Typically, the experiments
resulted in death, disfigurement or permanent disability, and as such can
be considered as examples of medical torture.
In Australia :
the Chelmsford Deep Sleep Therapy Cases
Subjects were given deep sleep therapy to ‘cure’ a
range of ailments including depression and stress.
Many died – none were fully aware of what the
treatment involved and most were in no condition to
give informed consent
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