email Dr Kerns
Nor is it enough to simply provide
information to prospective subjects. In addition to that, there
must also be a determined and good faith effort on the part of
researchers to ascertain whether or not the prospective subject
has heard and adequately understood what you have told
him or her. The basic underlying intent of the requirement for
informed consent, after all, is for researchers to insure that
prospective subjects understand the purposes, procedures, risks,
and so on of the research, that is, that they have in their minds
the full measure of information necessary for making an informed
and free choice. Simply reading information, facts or data to
a prospective subject does not satisfy the intent of the principle
of informed consent, particularly when "the potential for
misunderstanding is considerable," as it will be with AIDS
vaccine trials. The intent of the principle is to insure that
each prospective subject fully understands what they might be
getting themselves into, so they can make a good decision based
on adequate and true information.
If this is true, then it is imperative that researchers make a
serious, good faith effort to assess the degree to which subjects
have actually heard and comprehended the information that has
been conveyed to them. An important question, therefore, is: After
providing all the requisite information to prospective subjects,
just how might such an assessment of the level of their understanding
be adequately accomplished?
Fortunately, this is not a new problem. Teachers and professors
for centuries have faced this problem almost daily. Teachers and
professors know well that simply giving a lecture, or providing
lecture notes, or assigning a good text is not by itself sufficient
to insure that the student has actually comprehended the material.
I am a professor at a community college and I teach adults, most
of whom have come back to school because they are highly motivated
to learn and earn a college degree. And yet, in spite of all their
good will and strong motivation, students often simply do not
"get" the information that professors try to provide
them. The information does not register, for any number of reasons.
Perhaps the student was distracted that day, or was not feeling
well, or was busy worrying about some other issue in his or her
life, or perhaps simply did not understand the importance of what
they had been told. So they did not learn it. Part of the professor's
task, in addition to teaching the necessary material, is to be
continually assessing the degree to which students are understanding
it.
The reasons for doing this assessment of their understanding are
twofold: a) so that you can see what they have gotten so far,
in order to do a better job of teaching the material still to
come (the so-called "formative" evaluation), and b)
to make a final assessment of whether they registered enough of
the material for you to certify that they now understand it (the
so-called "summative" evaluation).
At least the second purpose, the summative one, if not the first,
will be important for researchers. They will have to be able to
determine whether prospective subjects understood enough of the
material they were told so that they could now make an informed
decision about whether to participate in the trials or not.
How might researchers make such an assessment of understanding?
Is it enough to, at the end of a presentation, simply ask "Did
you understand all that?" Every teacher knows that that is
hardly a satisfactory assessment technique. Is it enough to look
into a student's eyes, after they have been given information,
and tell by the understanding look in their eyes that they have
comprehended the material? That, of course, is not adequate either.
The most common manner of dealing with the problem of assessment
is to require that students take some manner of test.
Methods of testing, of course, are almost limitless in their variety.
They range from true/false and multiple choice tests (which actually
are very poor indicators of student comprehension), through fill-in-the-blank
tests (which are slightly better indicators of understanding),
to short essay tests, longer essay tests, and oral response tests.
Whatever method of testing is ultimately determined best for assessing
the understanding of prospective subjects after they have been
given information about their participation in a vaccine trial,
it is at least clear that some method of assessing understanding
will be necessary. ERCs will probably require that researchers
have designed a clear method of assessing understanding, and have
explained the manner in which they will administer it.
Additional questions, however, will still need to be dealt with:
It will need to be determined what percentage of understood information
is acceptable for prospective subjects. 70 per cent is often a
good enough score to pass tests in a college course. ERCs will
have to decide whether it is acceptable if prospective volunteers
understand only 70 per cent of the information given to them.
Will it be acceptable, for example, if they do not understand
how a condom is used, or what the value is in using it, but they
do understand most of the rest of the material? Will it be acceptable
if they do not understand the risks involved in the probable social
discrimination which could result from their participation in
the trial, but they do understand most of the rest of the material?
Will it be acceptable if they do not understand that they might
receive a placebo, or that there may be some physical risks involved,
or that they will need to give blood periodically, or that they
will probably seroconvert to HIVAb+ and what that means, or that
the candidate vaccine is not a proven vaccine at all, and so on?
In other words, are there any essential pieces of information
that it will be imperative for them to understand, such that without
that understanding they could not be allowed to consent to participate
in the trial? That is, is any of the information in the informed
consent procedure essential information, information they must
have in order to participate? If any of the information is essential,
then they will need to understand all of that essential information.
If they are tested on the essentials, they will need to show that
they have understood 100 per cent of that essential information.
Understanding 80 per cent of it, or even 90 per cent of it, will
not be acceptable.
Earning 100 per cent on any test is rather a difficult chore,
as most of us know by humbling experience. Will a test, then,
contain some items that test for understanding of essential material,
and some items that test for understanding of material that is
not essential? Should it be absolutely required to understand
some of the items on the test, but on other items it would be
sufficient to understand only 70 per cent of them? Or might there
be two separate tests administered, one of which tests for essential
information, and the other of which tests for merely important
information? Would it then be necessary to score 100 per cent
on the one test, and 70 per cent on the other one?
Or perhaps it will be argued that testing of this sort is too
heavy a burden to place on prospective volunteers. Perhaps, it
may be said, such testing requirements will discourage many potential
subjects from even offering to participate in a trial. Might a
requirement of this sort, in fact, discourage so many prospective
volunteers that it would make procurement of enough volunteers
an even more daunting task than it is already. When we realize
how difficult it is going to be to find cohorts of several thousand
(or tens of thousands of) volunteers for phase III trials, might
it be that these testing requirements will simply place one more
high hurdle in the way of well-intentioned researchers?
In addition, might testing of this sort end up actually biasing
(that is, reducing the randomness of) the cohort of test volunteers
by selecting for those volunteers who find it easier to learn
information and take tests? This could run the risk of introducing
a socioeconomic bias into the selection of cohorts if there turns
out to be any correlation between socioeconomic grouping and familiarity
with test-taking, or ease of test-taking.
These are difficult issues. And, much as we might be tempted to
overlook them, these issues simply cannot be ignored or dismissed.
The principle of informed consent is absolutely essential to all
research involving human subjects, to such an extent that without
fully informed consent, no research with human subjects would
probably be justifiable at all. But that principle requires that
prospective subjects actually comprehend the information that
has been given to them. If the principle does require that subjects
understand the information before they are asked for their consent,
then researchers will need to design methods of accurately assessing
whether or not prospective subjects have understood the information
given to them. Only then is it likely that ERCs will allow researchers
to ask for subjects' consent.
These would seem to be heavy demands to place on researchers, if looked at from the researchers' point of view. Those who hold the Antithesis position insist, however, that requirements such as these are necessary if we are to adequately demonstrate respect for the autonomy of the volunteers participating in these trials. In demonstrating this respect, they say, there must be no exceptions.