S2-3 Sprumont DoH Vatican
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23.01.24
1
Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
Research in resource-poor settings:
an historical perspective
Prof. Dr. iur Dominique Sprumont
Academic Partner of WMA
Institute of Health Law, Neuchâtel (Switzerland)
CIOMS Executive Committee
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
“The past is a foreign
country; they do things
differently there”
L. P. Hartley
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23.01.24
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
Figure
Cesare Borgia (1475-1507)
Gaetano Donizetti (1747-1848)
Toulouse-Lautrec (1864-1901)
Édouard Manet (1832-1883)
Tongzhi Emperor (1856-1875) Al Capone (1899-1947)
Syphilis
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
left: unidentified subjects, nurse Eunice Rivers, Dr. David Albritton, and Dr. Walter Edmondson. National Archives
From: https://historycollection.com/20-photos-tuskegee-syphilis-study/
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
Tuskegee AL
Resource-Poor Settings: a natural condition?
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
Patients fromthe Guatemalan psychiatric hospital who participated as test subjects in the syphilis
experiments between 1946 and 1948 From: National Archives and Records Administration –
https://www.archives.gov/research/health/cdc-cutler-records?_ga=2.63382703.1080843694.1651240776-663863849.1649434776
Resource-Poor Settings: a natural condition?
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23.01.24
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
Holmesburg Prison seen from the air; Philadelphia, Pennsylvania
From: https://en.wikipedia.org/wiki/Holmesburg_Prison#/media/File:Holmesburg_Prison.jpg
Resource-Poor Settings: a natural condition?
“Here was a golden
opportunity to
conduct widespread
medical tests under
perfect control
conditions.”
Philadelphia Bulletin depicting Holmesburg
Prison in 1966 In: Cristina Mejia Visperas,
Skin theory : visual culture and the postwar
prison laboratory, New York University Press,
2022, p. 1
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
«Section IV. Experiments conducted solely for the acquisition
of knowledge
C. Captive groups shall never be used as the subjects of
experiments. Such captives include:
Military or civilian; prisoners of war; persons detained in
any place as a result of military invasion or occupation, or
for administrative or political reasons, persons detained
in mental hospitals, prisons, penitentiaries or
reformatories»
In: Ethical Research: The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation, Ulf Schmidt, Andreas
Frewer, and Dominique Sprumont (eds); Oxford University Press, April 2020, Appendix 2b, p. 563
Deleted under pressure of the
United States where drug
development relied extensively
on the use of prisoners: 50-90%
of initial drug trials conducted on
prisoners.
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23.01.24
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
History of Research in
Resources-Limited Setting v.
the History of Tropical
Medicine
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
– Caring for the individual health of the
exploiters/colonizers.
– Treating the community health of the
indigenous population:
– to protect the health of the
exploiters/colonizers,
– to maintain the workforce for the benefit
of the exploiters/colonizers.
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23.01.24
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
«Then my father discovers, after all these
years of feeling close to the Africans, their
relative, their friend, that the doctor is only
another actor of the colonial power, not
different from the policeman, judge or
soldier. How could it be otherwise?»
Jean-Marie Le Clézio, L’Africain, Mercure de France, 2004
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
– Low trust about medical research in
African-American population and beyond
– Low trust about public health
interventions in in African-American
population and beyond (HIV/AIDS, COVID)
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23.01.24
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
“The purpose of the Proposed Guidelines was to indicate
how the ethical principles that should guide the conduct
of biomedical research involving human subjects, as set
forth in the Declaration of Helsinki, could be effectively
applied, particularly in developing countries, given their
socioeconomic circumstances, laws and regulations, and
executive and administrative arrangements.”
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
“Assessment of risks and benefits: Few developing countries command
the resources or expertise – notably in toxicology or clinical
pharmacology – to support the complex regulatory apparatus now
considered mandatory for new drug development in industrialized
countries. However, it is essential that drugs of potential value against
diseases endemic in these countries be tested within the populations at
risk. Decisions relating to their investigation and subsequent use should
be made in the light of local judgement and experience, and directed to
practicable options rather than unattainable ideals. The community itself
should be equitably represented in the planning of such investigations,
but international advisory bodies can offer a valuable resource to
developing countries faced with such responsibilities.”
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
“Moreover, in recent years, many people, in
developed and developing countries alike, have
begun to see the beneficial and not only the
threatening aspects of research involving human
subjects; indeed such research, particularly
related to innovative therapy trials, is now actively
sought by potential beneficiaries.”
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
– Promoting research for the (health) benefits of
the targeted population
– Respecting the targeted population not only in
terms of autonomy but also participation from
the design of the study and its governance to the
dissemination of the results and their translation
into medical practice and public health
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23.01.24
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Lausanne, le 20 février 2019
FBM, 1ère année Master en médecine
WMA Meeting on the Revision of the Declaration of
Helsinki (DoH) – Research in Resource-Poor Settings Vatican City, January 18, 2024
Objectifs d’enseignement
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