HMCS Max Bernays Pre-Deployment Brief (May 2024).pptx
Ethics revised 2013
1. Ethical Research practice
March 2013
Prof G Lautenbach
(Chairman, Faculty Academic Ethics Committee)
University of Johannesburg, Faculty of Education
2.
3. History
• Prior to 19th century
– Research into disease done by individuals, shared
with peers
– e.g. Edward Jenner – 20 years…vaccination with
cowpox as inoculation against smallpox
– Baron Larrey – surgeon general in Napoleons
army… treatment on the field of battle
• 19th Century
– William Beaumont, US Army surgeon – consent to
participate in research
4. What is ethics?
• A critical reflection of morality with it’s intent
to safeguard human dignity and to promote
justice, equality, truth, and trust
• 2 fundamental objectives:
– Know how to act in a given situation
– Provide strong reasons for doing so
5. Research Ethics?
• A means of ensuring that vulnerable people
are protected from exploitation and other
forms of harm
• Evolving language
– From passive subject to active participant
6. Ethics and Law?
• Distinct entities
• Ethics are constrained by the law
• The law: minimal standard
• Ethical documents – Quasi legal status?
8. History
• 20th century
– Kingdom of Prussia – protection for vulnerable
individuals by requiring consent
• 1930s
– protection extended to children in Germany until
Nazi rule.
9. International Instruments and
Guidelines
• Nuremberg Code – 1947
–Voluntary consent
–Withdrawal at any time
–Potential benefit
–Minimal harm
10. Why the Nuremberg Code?
• “In the workroom next to the dissecting room, fourteen Gypsy twins
were waiting and crying bitterly. Dr Mengele didn’t say a word to
us, and prepared a 10cc and a 5cc syringe. From a box he took
Evipal and from another box he took chloroform, and put these on
the operating table. After that the first twin was brought in … a 14
year old girl. Dr Mengele ordered me to undress the child and put
her head on the dissecting table. Then he injected the Evipal into her
right arm intravenously. After the child had fallen asleep, he felt for
the left ventricle of the heart and injected 10cc of chloroform … .
After 1 little twitch the child was dead … in this manner all 14 were
killed.”
Mengele then removed the eyes from the dead twins and shipped
them off to Berlin for further study.
11. International Instruments and
Guidelines
• Universal Declaration of Human Rights –
1948:
“No one shall be subject to torture or to cruel,
inhuman or degrading treatment or punishment.
In particular, no one shall be subjected without
his free consent to medical or scientific
experimentation”
12. International Instruments and
Guidelines
• Declaration of Helsinki – 1964 (expansion of
the Nuremburg Code)
– updated 6 times
– 2008 revision currently in force
– currently undergoing revisions
again
13. H.K. Beecher, 1966
• PUBLICATION - Ethics and clinical research
(1966)
• Proposed committees to examine proposed
research for protection of participants
• Basis of modern day research
ethics committee system
14. International Instruments and
Guidelines
• Council of International Organisation of
Medical Scientists (CIOMS)- 1993 ; 2002 (currently
undergoing revisions)
• International Conference on Harmonisation
(ICH) Good Clinical Practice Guidelines – 1995;
2002
• Singapore Statement on Research Integrity -
2010
15. South African Instruments &
Guidelines
• Bill of Rights of the Constitution of South Africa
• National Health Act (No.61 of 2003)
• Guidelines for Good Practice in the Conduct of Clinical Trials
with Human Participants in South Africa – 2006 (2nd ed)
• Ethics in Health Research: Principles, Structures &
Processes – 2004 (undergoing revisions)
• Ethical and Legal Guidelines for Biotechnology Research in
SA (DST) - 2006
• Health Professions Council of South Africa Ethical
Guidelines (HPCSA)
17. 1. Respect for Autonomy
• Respect for persons (deeper than respect for
autonomy)
• Respect for individual choice & decision
making by participants
• Self determination
• Respect for human rights
• Dignity of human participants (including privacy)
• Forms the basis for informed consent &
confidentiality
18. Informed Consent
• Has permission been granted from relevant
authorities? (Department of Education, school district, school,
headmaster)
• Has the research project been fully explained to the
participants?
• Have participants been informed/requested/ given
consent regarding monitoring devices (video, digital
recorders etc.) and have they fully understood
• Have participants been informed that they may
discontinue their participation (right to withdraw; principle of
voluntariness)
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19. Informed Consent
• Type of Consent?
• Qualitative Research: is the consent a once-off
process or sought continuously at specific points
throughout data collection and analysis?
• How will consent be obtained with minors?
• How is their assent (agreement) obtained?
• From whom is proxy (substitute) consent obtained?
• Signed letter of consent included (addendum)?
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20. Informed Consent
• Quality of consent?
– Full disclosure
– Understanding and appreciation
– Voluntary consent
– Capacity
21. Privacy, anonymity, confidentiality and
trust
• The principle of privacy - confidentiality and
anonymity of human participants must be
protected at all times
• How were participants offered confidentiality
and anonymity for their
involvement in the
research? (think of group
data; electronic media and
anonymity)
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22. Privacy, anonymity, confidentiality and
trust
• Will participants receive feedback on the
research process?
• Will they be allowed to comment on
transcripts, data analysis, data discussion and
interpretation? (member checking, audit trail,
‘methodological auditing’)
• What happens to the data after the inquiry?
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23. 2. Non-maleficence
• Avoiding harm or doing as little harm as
possible
• Protection from undue harm
• Commitment to avoiding harm?
24. Safety in participation: no harm
• Purpose of ethical review:
– To ensure that human participants participate in
research freely and without unreasonable risk
– Where there is some degree of risk,
the process of ethical review has to
ensure that the potential benefits
outweigh the risk
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25. 3. Beneficence
• Doing good for others
• Promoting others’ interests and well-being
• Act in best interest of participants
• Reduce risks to a minimum
• Maximizing potential benefits
• Differs from benevolence (wishing good for
others)
26. 4. Justice
• Obligation to treat persons in accordance with
what is right & proper
• Will participants be treated fairly and impartially?
– Procedural
• Fair allocation of resources
– Distributive
• Are benefits and burdens fairly distributed?
• Does research “take away” from essential services e.g.
teaching time, health care etc.
– Corrective
• Correcting wrongs through compensation
27. Issues around experience, competence
and qualifications
• Research competence?
(HIV/AIDS; vulnerable / Sensitive inquiries)
• Research proposal approved
by supervisor & HOD prior to
submission to the Ethics Committee?
• Has the methodology section been adequately
discussed to ensure rigorous and ethical
research?
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28. Issues around participation
• Has the selection process of participants been
properly described?
• In what way has the issue of voluntary
participation been dealt with?
• Who will be participating in the investigation
in terms of race, gender, age range,
institutional association and other special
criteria?
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29. Vulnerable participants
• Susceptible to exploitation
• Unequal power relations
• Dependency
• Erosion of “voluntariness” component of
consent
30. Research Misconduct
• Misappropriation (intellectual property or contribution
– Plagiarism
– Use of confidential information
• Corrupt scientific record
• Compromise integrity of the scientific record
• Interference (damage research)
• Misrepresentation
32. Ethical review
intended to protect the researcher as well as
the participating human participants
Participants treated as authentic
“respondents” in the research endeavour and
not simply as “objects” to be studied?
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33. Research Ethics Committees (REC)
• “Institutional Review Boards” IRBs (USA)
• National Health Act 61 of 2003
– Compulsory prior approval of health research by a REC
– Review and approval of research by a SA REC is
necessary even when reviewed by REC or IRB outside
SA
– Research is conducted in accordance with the SA
constitution (the only one that entrenches informed consent to
participate in medical research)