What is ethics? What is Research?

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ETHICS DEFINED
 A discipline dealing with what is proper course of action for man
(Aristotle, cit in Mckeon,1941)

 A branch of philosophy that looks at what is good and what is bad

 A system of obligation that we have towards others

 Also known as moral philosophy, involves, systematising,

defending, and recommending concepts of right and wrong
behaviour (www.iep.utm.edu/ethics)

 A study of principles guiding the good of the individual within the

context of social interactions and the community

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ETHICS DEFINED
Meta Ethics: “is a branch of analytic
philosophy that explores the status,
foundations, and scope of moral values,
properties, and words” Source:
https://www.princeton.edu/~achaney/tmve/wiki100
k/docs/Meta-ethics.html

Normative Ethics: addresses the

ETHICS AS A question of ‘What ought to be done?’
THEORETICAL Normative Ethical theorists (Socrates,
ENTERPRISE Kant, Stuart, Bentham) seek to provide
action guides and codes.

Applied Ethics: domain specific

ethics (Business, biomedical; APA,
engineering, etc.)

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 ETHICS EVOLUTION

Kant (1724-1804)
Aristotle
(384-322 BC) Siddhartha rightness of an action is
Socrates Gautama (563-
– proposed a determined by the
(469-399) 480 BC)
theory of character of the principle
virtue that a person chooses to
act upon

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 ETHICS EVOLUTION

Bentham (1781) –
Principle of utility –
diapproves or Martin Luther Fanon (1925-
approves of every Mahatma Ghandi King 1961) African
action according to (1869 – 1948) Nelson Mandela philosophy,
tendency to augment (1918-2013) humaneness
or diminish
happiness

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 Generalisability of findings: the
extent to which the sample used in the
research project reflects the broader
population of interest

Univesality and
Scientific Rigour
objectivity (explicit
(truth is accepted if there
Key rules and systematic
is sufficient evidence to
procedures)
support claims made Features of - Research should be
through the research
process. Such claims
Scientific designed in a manner
Research that allows any
have to withstand the
competent researcher
scrutiny of repeated
to conduct a similar
testing)
study and generate the
same findings

Originality of research work: original

ideas backed with appropriate evidence in a
clear, logical and convincing argument that
illustrates critical and analytical thinking.

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Research Ethics
therefore are:

1. A code of guidelines on how to conduct

scientific research in a morally acceptable way.

2. Principles and standards that help researchers

to uphold the value and standards of knowledge
construction.

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© P Msweli 2020
 ETHICAL CONSIDERATIONS IN THE
RESEARCH PROCESS

1. Conceptualisation and design of the study

(scientific merit, identify risks and ways to
mitigate the risks)
Ethical
considerations 2. When participants are recruited (the process
of informed consent, right to privacy)
come into play at
six stages of 3. During the intervention or measurement
procedure to which participants are subjected
research (management of risk)
4. In the release of results obtained
5. (protection of confidentiality and
anonimity)
6. After the release of results (ensure that
participants and communities involved in
the research benefit)

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ANOTHER WAY OF LOOKING AT RESEARCH
ETHICS IS BY LOOKING AT UNETHICAL
RESEARCH CONDUCT
 Deception (issues of full disclosure)
•
Withholding information about the aim of the study
•
Misleading participants about the risks inherent in participating in
the study
 Plagiarism
 Conducting research that does not have a scientific base (ill-
formed problem statement)
 Lack of objectivity and integrity in the design and conduct of
research
•
Not identifying the methodological constraints of the study that
determine the validity of the findings
• Misinterpretation of results
• Not providing details of theories and methods that might be relevant
in the interpretation of research findings
 Fabrication or falsification of data
 Not following the appropriate ascription of authorship to a
publication

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© P Msweli 2020
ANOTHER WAY OF LOOKING AT RESEARCH
ETHICS IS BY LOOKING AT UNETHICAL
RESEARCH CONDUCT
 Not respecting the right to privacy
 Not respecting the right to anonymity and confidentiality
 Not respecting rights of vulnerable groups
• Children
• Mentally handicapped individuals
• The aged
• Prisoners
• Illiterate
• Those with low social status

 Not having due consideration for the environment

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FUNDAMENTALLY RESEARCH ETHICS ARE:
 a way of conducting the research enterprise
such that the three fundamental principles of
research (respect, beneficence and justice) are
upheld.
 Ethical research must conform with the national
and international accords and prescripts.

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Justice: researchers should Respect
not place one group of people at
Respect for research participants
risk solely for the benefit
(informed consent)
another.
Respect for sponsors of research
Risks and benefits
should be distributed in Respect for communities where
an equitable manner participants come from
when recruiting
participancts Respect for knowledge and
academic community
PRINCIPLES OF
RESEARCH
ETHICS
Benefits must be weighed against potential
risk that a person might have by participating

Research should only be justified if its

Beneficence: the researcher is conduct and result will be of benefit to
responsible for the mental, physical the participants
and social wellbeing of the
participant throughout the How the community will benefit should

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participation
© P Msweli 2014 in the study.
be clear from the research protocol
 DIFFERENCE BETWEEN CLINICAL AND SOCIAL
SCIENCE RESEARCH
Clinical Research Social Science Research
Definition A research study intended to test A systematic recording and
safety, quality, effectiveness of analysis of data that
new and/or existing or old may lead to generaliseable,
medicines, medical devices principles and
and/or treatment options, using theories resulting in prediction and
human participants (SA – GCP possibly management of
Guidelines, 2006) behaviour and events in society.
Research Invasive and non-invasive Review of literature, review of data,
activities procedures that may include interviews, focus groups,
surgical untervention, removal of observatations, administration of
body tissues/ fluids, survey instruments, or tests etc.
administration of chemical
substances, observation,
administration of questions etc.
Phases Four phases More or less eight phases
or steps (depending on research questions
followed and design of the study)

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 PHASES OF RESEARCH: CLINICAL VS SOCIAL
CLINICAL TRIALS SOCIAL RESEARCH
PHASE I: A new drug, vaccine or PHASE 1: Problem identification
medical device is tested in a small group PHASE2: Problem definition
of healthy persons for the very first time.
The aim is to determine the general
safety, the correct dosage and negative PHASE 3: Development of a theoretical
effects. framework

PHASE II: Clinical trials the new drug,

PHASE 4: Hypothesis formulation or
vaccine or medical device in a larger
literature review
group (several hundred people)
PHASE III : testing to several thousand PHASE 5: Research Design
people
PHASE IV: clinical trials done to several PHASE 6: Data collection
thousand people after the new drug,
vaccine or medical drug has been
registered and licensed for sale by the PHASE 7: Data analysis
Medical Control Council

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PHASE 8: Report writing and
© P Msweli 2020
dissemination of findings
WHY BE CONCERNED WITH RESEARCH ETHICS?
1. Professional Responsibility
2. To avoid reputational damage
3. Research can be harmful to:
• Participants
• To researchers
• To institutions
• To research communities

4. To avoid litigation
• In a scenario where a proposal is classified as Ethics Category 1
(exempt from Ethics and Biosafety Research Committee
Review) liability and responsibility arising from decisions based
on ethics are shouldered by the FRC and its members.

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EVOLUTION OF RESEARCH ETHICS, CODES AND
REGULATIONS: INTERNATIONAL LANDSCAPE

Guidelines for
Berlin Code Human
(1900) Experimentation Nuremberg Declaration
Much emphasis (1931) Focus on Code of Helsinki
on Beneficence therapeutic vs (1947) (1964)
and Autonomy nontherapeutic
informed consent

Council for
International
Organisations International
Belmont
of Medical Conference on
Report
Science Harmonisation
(1978)
(CIOMS) (1990)
Guidelines
(1982)

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 NUREMBERG TRIAL 1947:
precursor to Nuremberg Research
Ethics Code

23 people were tried (20 doctors and 3

administrators). Seven were sentenced to
death by hanging; nine were given prison
terms and seven were found not guilty.

Source: history.com Editors

URL: https://www.history.com/topics/world-war-ii/nuremberg-trials

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NUREMBERG CODE

The judgement by the war crimes tribunal at Nuremberg Germany, laid

down ten standards to which physicians must conform when carrying
out experiments on human subjects.

Key principles in the Nuremberg Code:

 Voluntary consent of the human subject – capacity to
consent, freedom from coercion and an understanding of
risks and benefits involved; and freedom to bring the
experiment to an end.
 Minimisation of risk and harm.
 The science and design of the study must yield fruitful
outcomes.

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 Declaration of Helsinki (1964) The central point
in DoH is the
Ten out of the principle that the
1964 12 ethics well-being of the
Adopted by research participant should
the World markers from take precedence
Medical the Nuremberg over the interests
Association Codes were of science
adopted.

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First Revision to the DoH adopted in Tokyo in 1975
 The revised DoH was drafted by three Scandininavian professors of
medicine
 The key addition was the requirement that independent committees review
research protocols
 Informed consent requirements were simplified for non-therapeutic research
 The document was an elaboration of the1964 version

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© P Msweli 2014
images.html
Second Revision to the DoH adopted in Venice in 1983
 Minor revision were made to the document adopted in Tokyo in 1975 (for
example, the word “doctor” was changed to “physician”

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Photo by Peter Velei:
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Third Revision to the DoH adopted in Hong Kong in 1989
 The key addition to the document was the requirement to submit the protocol
to a specially appointed committee independent of the researcher.

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Photo by Sean
© P Msweli 2014Pavone: http://www.123rf.com/photo_18193986_rainbow-bridge-spanning-tokyo-bay-with-
tokyo-tower-visible-in-the-background.html?term=tokyo%20city
BELMONT REPORT – OUTCOME OF THE
TUSKEDEE CASE
 As a result of the Tuskedee case the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioural Research was established
 The report sets forth the principles underlying ethically
acceptable conduct of research involving human
participants.
 Report is also the basis for the US Federal Regulations
governing research
 The Belmont report emphasises on the principles of
respect, justice, and beneficence.

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INFORMED CONSENT
 A consent given by well informed potential participants
about the nature of the research procedure, scientific
purpose,and about the risks and benefits of the study.
 Informed consent is given without subjecting the
potential participant to coercion, intimidation or undue
influence
 Participant’s understanding of the research aim and
objectives must be addressed by laying out the details
out in the language the participant understands, in a
culturally acceptable way.

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STAGES AND PROCESS OF INFORMED
CONSENT
Stages of informed Informed Consent Activities
consent
Before the commencement  Assessment of the local culture
of the study  Identification of risks and benefits before and
after the study
 Pilot testing
At the beginning of the  Information is presented with the aid of support
study material to enhance understand of the research
aims and objectives
 Risks and benefits of the study are presented
 Understanding is assessed
During the study  Reinforce key ethical principles
 Address issues of concern

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KEY ELEMENTS OF INFORMED CONSENT
 Description of research aims and objectives
 Description of potential risks
 Description of expected benefits
 Explanation of confidentiality and anonymity of participants
 Explanation of participants rights including the fact that
participation is voluntary
 Explanation of issues relating to remuneration/compensation for
injuries

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 WHAT MEMBERS OF THE RESEARCH ETHICS
COMMITTEE LOOK FOR IN YOUR ETHICS
PROPOSAL
WHAT THEY HOW THEY CHECK IT
CHECK
1. Respect and • Appropriate information to participants in a form and
Dignity of language they understand
participants • They check that there is a fair and humane way by which
consent will be obtained
• They check the type and nature of questions that
participants will be required to respond to
• Check if the questions are culturally correct and sensitive to
the value systems of the participants
• Check that the rights of vulnerable persons are protected
and South African regulations with respect to vulnerable
participants are complied with
2. Privacy and • Check for a declaration that guarantees protection of the
confidentiality participant’s privacy and confidentiality
3. Favourable • Check if proposal has outlined potential harm
balance of (psychologically, legally or economically), and measures
benefits and that will be taken to ameliorate potential risks.

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©risks
P Msweli 2020 • Check whether the direct benefit of the research has been
 WHAT MEMBERS OF THE RESEARCH ETHICS
COMMITTEE LOOK FOR IN YOUR ETHICS
PROPOSAL
WHAT THEY HOW THEY CHECK IT
CHECK
Fair subject and  Research must not exclude a class of people who are likely
community selection to benefit from research participation or in whom the
results of a specific kind of research are likely to be
applied.
 The sampling plan of the research project must be checked
for fair subject selection.
Professional  A Principal investigator according to the GCP (SA) carries
competence and the primary responsibility for securing participants’ safety
sufficient capacity and well being during the study.
Coercison, undue  A researcher must disclose the source and extent of
pressure and conflict funding to research participants.
of interest  Commercial affiliations or financial interests at the time of
proposing and reporting the research must be disclosed.

Research involving  The researcher should demonstrate an awareness of

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minors and applicable national and international laws, regulations and
© P Msweli 2014
vulnerable persons codes (eg Act No 38 of 2005 The South African Children’s
HOW TO SUBMIT A PROPOSAL FOR
ETHICAL CLEARANCE
The proposal submitted for ethical approval should
demonstrate that each of the following ethical aspects arenot
only addressed, but are discussed in a logical and cogent
fashion:
1. Respect and dignity of participants
2. Privacy and confidentiality
3. Balance of benefits and risks
4. Sampling plan – fair participant selection
5. Competence and capacity of researcher
6. Protocols and procedures followed in dealing with minors,
vulnerable persons (if applicable)

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