Transcript Ethics

What is ethics?
Retha Britz
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Retha Britz Copyright 2013 All
rights reserved for this
presentation
Ethics is:
 Sub-discipline of philosophy
 Study of the concepts involved in practical
reasoning- “good” vs “bad” & “right” vs “wrong”,
choice, freedom, virtue
 Submit actions to the measure of obligation (duty
e.g. duty to respect)
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 How we ought to do/behave [in certain situations]
being moral beings
 Reasons for the behaviour
 Moral principles
Morality is:
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Has to do with duty, obligation, principles of
conduct, serving ethics for the more
Morality and ethics of people amount to the
same thing
What makes research
on/with humans ethical?
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Retha Britz Copyright 2013 All
rights reserved for this
presentation
Eight (8) Principles with Benchmarks
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Comprehensive list of practical guidance/measures
(benchmarks) to determine the extent to which
research satisfies the principles (references)
Provides unified and consistent ethical guidance
Differences in health, economic, social and cultural
aspects of a research setting change the weight or
priority of benchmarks
When benchmarks compete,
them
(requires judgment)
Minimize the risk of exploitation
Benchmarks of ethical
research (Emanuel et al)
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Collaborative Partnership
Social Value
Scientific Validity
Fair Subject Selection
Favorable Risk-Benefit Ratio
Independent Review
Informed Consent
Respect for Recruited Participants and
Study Communities
Collaborative Partnership
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Develop partnership between researcher &
community (representation of parties)
Collaboration: involve partners in sharing
responsibilities to assess value, planning,
conducting and overseeing research
Mutual respect: community’s values, culture,
traditions and social practices in design
Pts and community to benefit from research
Share benefits
Social Value
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Specify the beneficiaries of the research –
who will benefit?
Assess what benefits
Social value for the host community must be
specified and enhanced (disseminate results
in appropriate language and format
Scientific Validity
Science and ethics do not conflict
Valid science = ethical requirement
Scientific design realize:
 Social value of primary beneficiaries
(credible data used by specified beneficiaries)
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Scientific objective
Research is feasible within social, political
and cultural context to be conducted in
Fair Subject Selection
A fair selection of target villages, tribes or city
neighbourhoods from which pts will be
recruited
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Study population to ensure valid science
Minimize risk of research for study population
Collaborative partnership developed and
social value realized
Identify and protect vulnerable populations
Favorable Risk-Benefit Ratio
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Risks vs benefits for individuals in the
context in which they live (social value, collaborative
partnership etc)
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Favorable for community
Independent Review
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Required to
conflict of interest and ensure
public accountability through mandated by
laws & regulations
Transparency and reviews:
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Disagreement may reflect how ethical
requirements are met not whether they are met
Conflicts arise due to different
guidelines/regulatory requirements not having
good ethical justification or insensitive
Independent and competent reviews
Informed Consent
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Involve community in establishing recruitment
procedures & incentives consistent with cultural,
political, social practices
Disclose information & obtain consent in
culturally acceptable and linguistically
appropriate formats
Implement supplementary community and
familial consent procedures
Ensure free choice (refuse or withdraw)
Respect for Recruited Pts and
Study Communities
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Develop and implement procedures to
protect/maintain confidentiality of pt info
Pts know they have the right to withdraw
Provide information that becomes available
during the research
Develop strategies to inform pts & community
of research results
References
BLACKBURN, S., ed. 2008. Dictionary of philosophy. New York: Oxford. 407 p.
EMANUEL, E.J., WENDLER, D., KILLEN, J. and GRADY, C. 2004. What Makes
Clinical Research in developing countries ethical? The benchmark of ethical
research. Perspective, 198:930-937, 1 Mar.