The obvious ethical problems posed by this study concern
(a) the fact that all patients admitted to the intensive
care unit over a six month period were included in the study without
their knowledge or consent, and (b) the fact that blood
samples obtained from all patients were tested for HIV infection
without the consent of the patients, with the information that blood
samples had been tested for the infection being given to patients only
after the test had been done.
At first sight the decision to override the patients' right to full
information, and to give or to refuse consent to inclusion and testing,
seemed to all members of the research ethics committee to be so
fundamentally at variance with the ethical principles governing
research involving patients that it seemed impossible to give ethical
approval for the study. However, during lengthy discussions with the
investigators several considerations emerged.
Firstly, the information being sought by the investigators was
clearly
going to be of crucial importance to the community, not only in South
Africa or in Africa as a whole but also worldwide. The importance of
the study was perceived to be twofold. If it showed that a patient's
HIV status significantly worsened his or her chances of a favourable
outcome from intensive care-to a degree comparable to the poor
prognosis associated with criteria already established for
non-acceptance for admission to an intensive care unit-then the
clinicians who have to make decisions on allocating the community's
scarce intensive care resources would have to include HIV positivity
among the criteria for non-acceptance. If, on the other hand, the study
showed that HIV positivity per se did not adversely affect a patient's
likelihood of a favourable outcome, then the current widespread
tendency to include HIV positivity among the criteria for
non-acceptance into intensive care facilities would become manifestly
unjust. Such information gained from the study would be of life and
death importance to the large and increasing numbers of people who are
HIV positive.
Secondly, the study entailed no interventions of any sort different
from those that are necessary and are carried out in standard intensive
care. The blood samples that would be tested for HIV infection would be
aliquots of samples taken for other necessary clinical purposes. Apart
from the HIV testing, the study did not depart from normal standard of
care and consisted essentially of analysis of data that would be
recorded even if the study were not undertaken.
Thirdly, apart from the HIV testing, the "injury" that
would be
done to the patients as a result of not being given the opportunity to
consent to or to refuse inclusion in the study was considered to be so
small as to be virtually not appreciable and entirely analogous to the
"injury" to patients whose hospital records are reviewed for
retrospective research projects. Given the importance of the study, the
failure to ask patients for permission to analyse data necessarily
generated during their clinical care did not seem to be material.
Fourthly, testing the patients' blood for HIV infection without their
consent and only informing them afterwards posed an important ethical
dilemma. In considering this aspect of the study, the committee took
into account several considerations. It agreed that there is no such
thing in ethics-and particularly in the increasingly complex field
of
bioethics-as a simple and absolute ethical rule that must be
observed
in every conceivable situation. Virtually every ethical dilemma
necessarily poses the problem of competing and conflicting ethical
obligations. There are no absolutely satisfactory resolutions of
ethical dilemmas, and the best that one can hope to achieve is to
accord, with justice, preference to those ethical considerations (or
"rules") that seem in the particular circumstances to be of
preponderant weight.
The committee was also at pains to satisfy itself that the effective
performance of the proposed study could not be achieved if any of the
subjects were not to have their blood tested for HIV infection. Unless
it could be shown, scientifically, that it was absolutely essential to
include all admitted patients in the study, the committee would not
have considered the proposed testing of blood without consent as
ethical.
The committee was also strongly influenced by the fact that the
results of the HIV tests would remain strictly confidential to only one
investigator and that all potential linkage of the results of the tests
to identifiable individuals was to be destroyed at the end of the
study. The situation, as the committee saw it, was analogous to the
anonymous and unlinked testing of attenders at antenatal and sexually
transmitted disease clinics, for epidemiological purposes. This
testing, to be of value, has to include all attenders, and for this
reason consent to testing of aliquots of attenders' blood samples
taken for other purposes is not obtained. This practice has ethical
approval throughout the world, on the basis that the community's need
for reliable epidemiological data outweighs by far the almost
imperceptible injury done to the patient's autonomy. From a practical
point of view, the clinic attender is in the same situation as he or
she would have been if HIV testing had not been done at all. Similarly,
for the patients in this study the end result was the same as it would
have been if their blood samples had never been tested, with the sole
difference that, if they so wished, they would be informed of the
outcome of the test. Weighing the importance of the study in terms of
the welfare of the community against the almost imperceptible injury
that would be inflicted on patients, the committee was satisfied that
the proposed method of obtaining complete data regarding the patients'
HIV status was ethically acceptable.
In the outcome, it seems that the committee's view on the ethics
of this study was vindicated by the fact that no patient expressed any
objection to the fact that his or her blood had been tested in this
fashion. Furthermore, the fact that only two patients elected to be
informed of the result of the test is in keeping with the general
reluctance of well people to undergo HIV testing and suggests that if
inclusion in the study depended on a patient's consent to HIV
testing-even if effectively performed anonymously-then it is
quite
likely that the study would not have produced a reliable outcome.
Acknowledgments: The University of Natal's ethics committee is a
subcommittee
of the postgraduate committee.
Y K Seedat, chairman of postgraduate
committee
Medical School,
University
of Natal,
Durban,
South Africa
Members of the ethics committee
are:
Y K Seedat (chairman)
M Adhlkari
M
H Cassimjee
V Gathiram
V B Jogessar
J Moodley
D J
Pudifin
J V Robbs
S R Thomson
J R van Dellen
E M
Barker
Coopted members:
E M Barker
S
Downes
R Gcaba
D J McQuoid-Mason
M E de Haas
U
Govind
