JMillum_Post-trial_obligations_WMA_2012

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Joseph Millum, Ph.D.
Clinical Center Department of Bioethics/Fogarty
International Center – National Institutes of Health, USA
Expert Conference on the Revision of the Declaration of
Helsinki, 6 December 2012
Post-trial obligations to host communities
Disclaimer
 The views expressed are my own and do not represent
the views of the NIH, PHS, or DHHS
 But they do owe a debt to my colleagues at the
Clinical Center Department of Bioethics (Christine
Grady, Seema Shah, Dave Wendler)
Declaration of Helsinki (2008)
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.
Exploitation
 A exploits B when A takes unfair advantage of B’s
situation (Wertheimer).
 E.g. price gouging
Responsiveness and exploitation
 The responsiveness requirement prevents exploitation
by identifying a benefit which is sufficient to make the
gains to host communities fair
 Analogy with health systems of high-income countries
A criticism of responsiveness
 Fairness is a matter of how much people receive, not
what type of benefit they receive
 Clinical research can therefore be non-exploitative
even if the benefits to participants and host
communities are unrelated to the knowledge gained
by the research (cf. Fair Benefits framework)
Two questions
1. In principle, what benefits should disadvantaged or
vulnerable populations or communities receive after
the completion of a research project?
2. In practice, what specific policies would result in
disadvantaged or vulnerable populations or
communities receiving these benefits?
Amending Paragraph 17
17. Medical research involving a disadvantaged or
vulnerable population or community is only justified if
the population or community receives a fair level of
benefits, for example, 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
sufficiently from the results of the research.
Conclusions
 The responsiveness requirement is supposed to
prevent exploitation
 Exploitation is taking unfair advantage of another’s
situation
 Exploitation can be preventing by ensuring that
disadvantaged or vulnerable groups get a fair level of
benefits
 Responsiveness is one way, but not the only way, to
ensure that everyone gets a fair level of benefits.