1. Principles of human ethics & research
MEDI6302
Session 5
Principles of human ethics & research
Sydney
Broome
Fremantle

2. Ethics
The concepts of right & wrong, justice & injustice, virtue & vice, good & bad, and the activities to which these concepts apply
(NHMRC 2015).
© Eric J. Visser 2017 UNDA. All rights reserved

3. What is human research?
Research on people, their data or tissues (NHMRC 2015)
Observations
Surveys, interviews
Testing
Tissues analysis
Data-bases
© Eric J. Visser 2017 UNDA. All rights reserved

4. Human research? ALL human research requires ethics approval
Human vs animal research ethics approval
Special groups (children, cognitive impairment, unconscious)
Aboriginal research (cultural)
Tissues (embryos)
© Eric J. Visser 2017 UNDA. All rights reserved

5. Ethics approval Ensures research conforms to ethical values, such as:
Merit (worth doing well, benefits)
Integrity (honesty, transparency, accountability)
Beneficence (do good, risk vs benefits)
Respect & autonomy (for subjects)
Justice (fairness)
Professionalism (best practice)
© Eric J. Visser 2017 UNDA. All rights reserved

6. Integrity
Honesty & probity as qualities of character & behaviour (NHMRC 2015)
Transparency, accountability, best-practice
How is integrity assessed?
Self
Peers
Ethics committee
Audit & oversight
Subjects’ feedback
© Eric J. Visser 2017 UNDA. All rights reserved

7. Doing the right thing ‘Do unto others’ test
Would you let your mother be in the trial?
Subjects rights always comes first
Autonomy respected
Informed consent
Consider fellow researchers, funders
Consider ‘the greater good’
© Eric J. Visser 2017 UNDA. All rights reserved

8. Doing the wrong thing Academic fraud 10% of publications?
Publish or perish
Profile & employment
Psychological issues
Financial, criminal
Conflicts of interest
NHMRC 2015
© Eric J. Visser 2017 UNDA. All rights reserved

9. © Eric J. Visser 2017 UNDA. All rights reserved

10. © Eric J. Visser 2017 UNDA. All rights reserved

11. Risk vs benefit Duty of care
Non-maleficence (primum non nocere) (do no harm)
Safety
‘Do unto others’ test
Rights of subject always comes first
Risk management
Ethics committee
High, low, negligible risk
Insurance, legal
NHMRC 2015
© Eric J. Visser 2017 UNDA. All rights reserved

12. Subject vs researcher relationship
Beneficence (doing good unto others)
Ethics & professionalism
Duty of care
Informed consent
Conflicts of interest
Inducements, payments
Power imbalance
Privacy
© Eric J. Visser 2017 UNDA. All rights reserved

13. Informed consent Autonomy of subject Information Risk vs benefits
NHMRC 2015
Autonomy of subject
Information
Risk vs benefits
Integrity
Transparency
Conflicts of interest
Professionalism
© Eric J. Visser 2017 UNDA. All rights reserved

14. Consequences Risks vs benefits Benefits
-personal (intellectual, professional, financial)
-societal (scientific, therapeutic, economic)
Impacts on future research
-guides or stimulates further research
-meta-analysis
-networking, cooperative projects
-builds research experience (will be more efficient in future)
© Eric J. Visser 2017 UNDA. All rights reserved

15. Impacts Scientific Clinical Patient Population Special groups
Health care policy
Financial & economic
© Eric J. Visser 2017 UNDA. All rights reserved

16. Impacts Publications (thesis) Presentations Publicity (media)
Intellectual property (patents)
Financial, business, economic
Professional (development)
Personal (family, work)
Nobel prize?
© Eric J. Visser 2017 UNDA. All rights reserved

17. Make an impacts list Impacts Benefits (+) Risks (-) Key findings
Scientific
Research
Clinical
Subject
Societal
Financial, economic
Personal, family
Professional
© Eric J. Visser 2017 UNDA. All rights reserved

18. End
© Eric J. Visser 2017 UNDA. All rights reserved