The principle of informed consent
has become almost the cornerstone of medical ethics discussions
in the West. Sometimes it seems as if no other principle in medical
ethics can hold a candle to the supremacy of this principle. The
principle derives its validity from the more basic principle of
autonomy, which in turn is based on the even more fundamental
principle of respect for persons. In fact the simplest and most
profound conclusion of Annas' and Grodin's lengthy 1992 study
of the Doctors' Trial at Nuremberg is that "the need to respect
the humanity and self-determination of all humans is central to
the ethos not only of medicine and human experimentation but of
all civilized societies". Even though in recent years ethicists
have more and more recognized that there are some limitations
on the principle of autonomy, it is still recognized as one of
the most important imperatives in all medical ethics decision-making,
both in clinical situations and in human subjects research. Many
ethicists would argue that, as Annas, Grodin, and Katz put it,
"without the informed consent of the competent subject, there
really is no defensible justification for using human beings as
research subjects". Our focus in these following pages will
be on the use of informed consent in biomedical research settings.
In its simplest terms, the principle requires that you tell potential
volunteers what the proposed research is about, what you hope
to learn by it, what will be expected of them, and what they can
expect will happen to them during (and even after) the experiment.
Prospective volunteers should also be told what their rights are
as participants in the trial, and what their responsibilities
are as well. They should probably be given a written "Bill
of Rights and Responsibilities" to keep. (I have written,
and included in Appendix III, a sample Bill of Rights and Responsibilities
for volunteers in HIV vaccine trials.) Prospective volunteers
must also be assured that they can quit their participation in
the study anytime they wish, without any kind of penalty or cost.
Some ethicists have suggested that subjects should also be told
what company, institution, or government agency is sponsoring
the research, so they can decide whether or not they wish to support
that agency's or company's research. Although this is not standard
practice right now, it does not seem like an unreasonable recommendation.
At least as important as the content of what they must be told,
subjects must also be able to competently deliberate and freely
choose, "without the intervention of any element of force,
fraud, deceit, duress, overreaching, or other ulterior form of
constraint or coercion".
In its simplest terms, this is what the principle requires. In
practice, things are rather more complex. And when investigators
are doing research in developing nations, yet another layer of
complexity is added to an already troublesome tangle of issues.
Several functions are intended to be served by application of
this principle. The principle is partly intended to promote self-reflection
in the biomedical research community and to promote self-scrutiny
and rational decision-making among investigators. But the principle's
primary function is to promote the autonomy of individuals and
to insure the protection of vulnerable subjects.
Applying this principle to each individual volunteer may be much
more difficult in developing nations, where levels of literacy
are much lower than in developed nations, where beliefs about
the nature and causation of disease may be different from those
held by the researchers, and where the notion and value of personal
identity and individuality may be strikingly different than that
held in western nations. Because of these factors the principle
of informed consent, which has been one of the cornerstones of
biomedical ethics since its origins in The Nuremberg Code, will
be problematic in developing nations.
And yet the ethical guidelines are very clear: ethical standards
governing human subjects research must be no less stringent in
developing nations than they are in developed nations. International
Ethical Guidelines #15 is quite explicit: When a sponsoring agency
submits its research proposal to ethical review in the country
of origin (as it is required to do), the "ethical standards
applied [to research in developing nations] should be no less
exacting than they would be in the case of research carried out
in that country [of origin]".
This single sentence alone underlines one of the key problems
faced by research sponsors: conditions in some underdeveloped
communities may be significantly different than in developed communities,
yet the ethical standards must be applied just as stringently
as they are anywhere. This is good ethics, but it presents researchers
with some almost insurmountable problems. There must be utmost
regard for individual autonomy in decision making. Every single
subject must be fully informed and must give free consent. "The
investigator is required to ensure that each prospective subject
is clearly told everything that would be conveyed if the study
were to be conducted in a developed community."
"Everything?" the intelligent reader might ask. "Everything,"
emphasizes the Guidelines. That will include a variety of kinds
of information, including "the aims and methods of the research;
the expected duration of the subject's participation;... any foreseeable
risks or discomfort to the subject;... the extent to which confidentiality
of records in which the subject is identified will be maintained;...
whether the subject or the subject's family or dependants will
be compensated for disability or death," and all the possible
harms and hazards that may be attendant on participating in the
research.
In the case of HIV vaccine research specifically, this principle
requires informing prospective subjects about what a vaccine is
and what an immune system is, as well as about
the concepts of randomization, blinding [and double-blinding], placebos, informed consent, and risk/benefit, concepts which [may not be] easily understood in the cultural context of many developing countries.
Ethical guidelines require that prospective research subjects be fully informed of all these aims, purposes, methodologies, and hazards associated with their participation in research protocols for which they are considering volunteering.
* To see the citations associated with material in this chapter, see a published printed copy of the book, or contact the author directly.
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