email Dr Kerns
Sponsors of phase III HIV vaccine
trials in developing nations may ask to be excused from the requirement
to fully inform each individual prospective subject and to obtain
each individual prospective subject's free and uncoerced consent.
They could base their request on the difficulty (or impossibility)
of explaining such complex material to persons in communities
with less than optimum literacy, and/or on the length of time
it would take to so educate each individual subject. They might
also base their request on the perceived difficulty of finding
large numbers of persons who are "so situated as to be able
to exercise free power of choice," that is, who are completely
free of any possibility of coercion, constraint, duress, or intimidation.
That is, they could ask instead to invoke the principle of proxy
consent.
If research sponsors do ask to resort to proxies for consent,
using perhaps tribal chiefs, military officers, or local health
officials, as they have often done in the past, then those proxies
will have to possess certain qualifications. The ERC will doubtless
require that those who would be proxies 1) be competent to make
reasoned judgments, 2) have adequate knowledge and information
on which to base their judgments, 3) have emotional stability,
and 4) have a commitment to the "incompetent" subjects'
interests, which is "free of conflicts of interest and free
of controlling influence by others who may not seek the [subject's]
best interests".
It would probably not be difficult to find proxies who would meet
qualification #1 and #3, that is, who are legally competent and
emotionally stable. It may be more difficult, however, to find
proxies who will have adequate knowledge and information about
all the various aspects of HIV vaccine trials. And it might be
even more difficult to find proxies who would satisfy condition
#4, that is, who are completely free of conflicts of interest,
particularly if they are in positions of influence and power.
In the case of army recruits, for example, finding a proxy who
has a commitment to the subjects' best interests and well being
may take some doing. Even if such proxies could be found, and
even if such proxies could be adequately informed and educated
about the risks (and benefits?) to volunteers who participate
in this research, there is still the task of insuring that these
proxies are not subject to coercion, to undue influence, or to
undue inducement.