email Dr Kerns
By international agreement, all
medical research which involves human beings is subject to at
least three overarching ethical principles:
1. The principle of beneficence
requires that researchers, in addition to refraining from doing
deliberate harm (non-maleficence), must make every reasonable
effort to maximize benefits and goods, and to minimize harms and
burdens.
This principle gives rise to norms requiring that the risks of research be reasonable in the light of the expected benefits, that the research design be sound, and that the investigators be competent both to conduct the research and to safeguard the welfare of the research subjects.
2. The principle of autonomy derives from the principle of respect for persons and requires that "those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination". This principle also requires that the rights of persons not entirely capable of self-determination be fully protected, and that vulnerable persons be made secure from harm or abuse.
3. The principle of justice requires that every person be given what is rightly due to them, and that the potential benefits and burdens of medical research be fairly distributed. Here too, "special provisions must be made for the protection of the rights and welfare of vulnerable persons".
The importance of articulating these
principles became glaringly evident during the Nuremberg Trials
in Germany following world war II. The world then saw what grotesque
and tragic violations of the rights of human beings could be perpetrated,
even by physicians, in the name of medical science. Out of that
tragic awareness came the first clearly articulated set of ethical
standards for human subjects research. It was completed in 1947,
and has become known as The Nuremberg Code. This code acknowledges
that research involving human subjects is necessary, useful and
good, but insists that such research is acceptable only if certain
ethical principles are scrupulously adhered to.
Because the human subjects in the Nazi medical experiments had
come from among prisoners in the concentration camps, and because
their personal autonomy had been so cruelly violated, the principle
of autonomy is the ethical axiom that is given the strongest emphasis
in The Nuremberg Code. The first and central ethical demand
in the code is that "the voluntary consent of the human subject
is absolutely essential". This is the first clear statement
of the principle of informed consent. We will be returning to
a fuller discussion of this principle later, but for now one point
needs to be emphasized: the principle of informed consent requires
that each research volunteer be fully informed about the experiment
in which they will be participating. Each prospective subject
must be told
the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
In addition to being properly informed, prospective volunteers must also be able to choose freely, without any elements of deceit or coercion, whether they will participate in the research, and they must furthermore be of age, and "competent" to so decide. More on those issues later. For now, we will focus on what "inconveniences and hazards reasonably to be expected" might result from a volunteer's participation in HIV vaccine research. Some of them are not minor.