email Dr Kerns
Since volunteers will indeed be
putting themselves at some degree of risk by their participation
in these trials, what responsibilities, if any, will research
sponsors have for the treatment and care of injured subjects?
Their first responsibility, of course, is to provide medical treatment
for any physical problems that may develop in a subject as a result
of their participation in the trial. That responsibility is clear
and uncontroversial. But what about the emergence of injuries
that are not susceptible to medical treatment? How should persons
who undergo injuries of this sort be dealt with? And what about
the possibility of subjects who may die as a result of their participation
in a research protocol? How should their survivors be compensated?
The CIOMS International Ethical Guidelines for Biomedical Research
Involving Human Subjects is very clear about the moral obligation
of researchers to compensate human subjects for any injuries caused
by their participation in an experiment. Guideline 13 of this
document, on the "Right of subjects to compensation"
reads:
Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependents are entitled to material compensation. The right to compensation may not be waived.
This statement of right to compensation seems clear and unambiguous. It is a right that cannot be waived or negotiated away. This principle is important and commendable. On the other hand, in the commentary on this Guideline 13, the document seems to radically limit the actual liability of researchers for providing such compensation. The commentary reads:
In some societies the right to compensation for accidental injury is not acknowledged. Therefore, when giving their informed consent to participate, research subjects should be told whether there is provision for compensation in case of physical injury, and the circumstances in which they or their dependants would [or would not] receive it.
This enormous limitation of sponsor
liability will probably apply to many if not most of the developing
nations in which phase III vaccine trials will take place. Countries
presently chosen by the Global Programme on AIDS as sites for
the first large scale HIV vaccine trials are Brazil, Tanzania,
Uganda, and Thailand. I do not know the extent to which these
countries presently have laws acknowledging the right to compensation
for accidental injury, but even if they do, whether they will
still have such laws in five years, or in ten or twenty years,
is anybody's guess. In fact in some countries, it is anybody's
guess what the overall social and legal structure will be like
in five or ten or twenty years when such requests for compensation
are likely to be pressed. With the rapidly changing political
climate in today's world, it would be difficult to predict what
any social structure will be like in twenty years.
If such suits for compensation are pressed against those who sponsored
the research (against a pharmaceutical company, for example, or
a government agency, or an educational institution), the suits
may seek large amounts of compensation and thus may require extensive
litigation. It may be an issue whether the legal structure of
a developing nation would even be able to support such extensive
litigation against a more affluent government or institution.
It might also be an issue whether the institution or company that
sponsored the research would be able to pay the costs of such
compensation, or even whether that sponsor would still be in existence
when the suits are pressed.
These considerations might severely limit the likelihood that
compensation would ever actually be granted in many cases. Guideline
12, on safeguarding confidentiality (which was discussed above)
says that "subjects should be told of the limits to the investigators'
ability to safeguard confidentiality". It seems to me that
there should be a similar clause in Guideline 13: Subjects should
be told of the possible limitations on their right to compensation
for injury. They should be made aware of the possibility that
such compensation might not ever be forthcoming.
Another unsettling limitation on the right to compensation for
injury, is that the Guideline focuses exclusively on compensation
for physical injuries, and says almost nothing about the
kinds of real non-physical injuries that can be inflicted by unjust
discrimination, for example. All the anti-discrimination laws
in developed nations that protect minorities and other disadvantaged
persons have been put in place because these societies recognize
that there are real injuries other than physical ones. Loss of
jobs, loss of housing, loss of income, loss of insurance, loss
of medical care, loss of reputation, and so on are just some of
the losses recognized by these laws. Why does this Guideline recognize
only physical injuries? The answer is probably that the International
Ethical Guidelines for Biomedical Research Involving Human Subjects
is a generic set of guidelines for all biomedical research,
and not just for research having to do with HIV and AIDS. However,
AIDS is a disease that exposes its sufferers to non-physical injuries
at least as much as it exposes them to physical injuries. Perhaps
this is more true of AIDS than of any other disease in recent
history. I believe that ethical guidelines for research involving
HIV/AIDS related drugs and vaccines should recognize the likelihood
and importance of non-physical injury, and should address that
sort of injury at least as thoroughly as it addresses physical
injury.
To sum up the matter of compensation for injury: The International Ethical Guidelines requires that compensation be promised and made available. Researcher sponsors should recognize and acknowledge the limitations on that "promise," particularly in those developing nations which have changing legal structures and some degree of social instability. They should make those limitations abundantly clear to persons who are considering volunteering for HIV vaccine research. It should be spelled out fully in the process of asking for each volunteer's informed consent.