Vulnerability_Ritter

Institut für Ethik und Geschichte der Medizin
Protecting Vulnerable Subjects
Addressing vulnerability in the Declaration of Helsinki
Expert Conference on the Revision of the Declaration of Helsinki
5 – 7 December 2012, Cape Town
Elisabeth Ritter, M.A., M.mel.
Dr. phil. Hans-Jörg Ehni
University of Tübingen
Outline
1. Fields of discussion and major questions
2. Vulnerability in the DoH
3. Suggestions for the current revision process of the DoH
Fields of discussion and major questions
– Defining “vulnerability”
– Listing of vulnerable groups
– Protection of vulnerable subjects
Vulnerability in the Declaration of Helsinki
Defining vulnerability
“9. Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and
rights. Some research populations are particularly vulnerable and
need special protection. These include those who cannot give or
refuse consent for themselves and those who may be vulnerable
to coercion or undue influence.” (DoH 2008)
Vulnerability in the Declaration of Helsinki
Listing of specific vulnerable groups:
“9. […] those who cannot give or refuse consent for themselves
and those who may be vulnerable to coercion or undue influence.”
(DoH 2008)
Vulnerability in the Declaration of Helsinki
Special protection:
“17. Medical research involving a disadvantaged or vulnerable
population or community is only justified if the research is
responsive to the health needs and priorities of this population
or community and if there is a reasonable likelihood that this
population or community stands to benefit from the results of
the research.” (DoH 2008)
Suggestions for the current revision process of the DoH
9. Medical research is subject to ethical standards that
promote respect for all human subjects and protect their
health and rights. Some research subjects are vulnerable
and have an increased likelihood of incurring additional
and greater wrong. They need special protection.
Suggestions for the current revision process of the DoH
17. Medical research involving a vulnerable population or
community is only justified if the research is responsive to
the health needs and priorities of this population or
community, if there is a reasonable likelihood that this
population or community stands to benefit from the results
of the research and if the research cannot be equally
carried out with other research subjects.
Thank you.
Elisabeth Ritter
Institut für Ethik und Geschichte der Medizin
Gartenstr. 47, 72074 Tübingen
elisabeth.ritter@uni-tuebingen.de