MacMillan

Ancillary care, the Declaration of
Helsinki and the obligations of global
research
Associate Professor John McMillan
John.mcmillan@flinders.edu.au
• 14. “The research protocol should describe
arrangements for post-study access by study
subjects to interventions identified as
beneficial in the study or access to other
appropriate care or benefits.”
• 33. Patients are entitled to share “other
appropriate care or benefits.”
Ancillary care
• Care that researchers might provide to
research subjects when they become unwell
during, but not because of, participation in
research.
• Particularly relevant in a developing world
context where care may be not unavailable
Weijer and LeBlanc
• Researchers don’t have a moral obligation to
provide ancillary care.
• An obligation to consult, negotiate and gain
the consent of the communities in the
developing world. The Journal of Law
Medicine and Ethics
UN Aids (2003): beneficence
…beneficence proposes to maximize benefits and minimize
harm to subjects. The obligation to maximize benefits goes
beyond the design of a trial and the conduct of a trial itself.
Weijer and LeBlanc respond
• An unrestricted moral obligation to “maximize
benefits” leads to an unstoppable chain of demands
upon researchers: if treating HIV for free is good,
then, surely building hospitals and staffing them in
perpetuity with free doctors and medical supplies is
better. And if that is better, then making everyone not
merely healthy but rich and happy is best of all. Right
action, according to this view, comes with a hefty
price tag.
UN Aids (2003): reciprocity
• With respect to the principle of reciprocity, subjects
who become infected contribute importantly to the
trial. Without such data, an efficacy trial could draw
no conclusions about the intervention studied. People
who contribute to this effort deserve something in
return
Weijer and LeBlanc respond
• The determination of the efficacy of an HIV
prevention intervention rests no more on those who
become HIV infected than those who do not. Thus,
the contribution to the determination of efficacy of
those who do and those who do not become infected
is equal. According to the principle of reciprocity,
either no group is deserving of reward, or both
groups are.
Thomas Pogge: A human
rights based approach
• Diachronic vs subjunctive harms.
Thomas Pogge: A human rights
based approach
• First: responsibility for institutional harms is sensitive
only to human rights deficits.
• Second, the human rights deficits must be causally
traceable to a social institution.
• Third, responsibility for the deficit is assignable only
to those who actively cooperate in designing or
imposing the relevant institutions.
• Fourth, it’s harming only if it is foreseeable that this
order results in deficits.
• Fifth: rights deficits are reasonably avoidable.
• Six: avoidability must be knowable.