Ethics revised 2013

Ethical Research practiceMarch 2013

Prof G Lautenbach (Chairman, Faculty Academic Ethics Committee)

University of Johannesburg, Faculty of Education

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

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

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

Ethics and Law?

• Distinct entities

• Ethics are constrained by the law

• The law: minimal standard

• Ethical documents – Quasi legal status?

Japanese Experiments : Unit 731 “Germ Doctors” cut up a live Chinese girl

History

• 20th century

– Kingdom of Prussia – protection for vulnerable individuals by requiring consent

• 1930s

– protection extended to children in Germany until Nazi rule.

International Instruments and Guidelines

• Nuremberg Code – 1947

–Voluntary consent

–Withdrawal at any time

–Potential benefit

–Minimal harm

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.


• 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”


• Declaration of Helsinki – 1964 (expansion of the Nuremburg Code)

– updated 6 times

– 2008 revision currently in force

– currently undergoing revisions again

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


• 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

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)

How do you see the research process?

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

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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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Informed Consent

• Type of Consent?

• Qualitative Research: is the consent a once-offprocess 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)?

Informed Consent

• Quality of consent?

– Full disclosure

– Understanding and appreciation

– Voluntary consent

– Capacity

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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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• 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?

Privacy, anonymity, confidentiality and trust

2. Non-maleficence

• Avoiding harm or doing as little harm as possible

• Protection from undue harm

• Commitment to avoiding harm?

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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

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)

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

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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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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?

Vulnerable participants

• Susceptible to exploitation

• Unequal power relations

• Dependency

• Erosion of “voluntariness” component of consent

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

Ethics Committee?

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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?

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)

Research Ethics @ UJ

• FAEC Guidelines

• Ethics application form

Practical examples

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The end