guidance issued to researchers often explicitly excluded certain women from
biomedical research, particularly if they were pregnant or of child-bearing age.
While explicit exclusions are now less common, in the UK the DoH Guidelines
state that if it is intended to use women as research subjects, the possibility of their
being orbecoming pregnantshould always be considered, and the researcher
should always justify the recruitment of women of child-bearing age [99]. This
provision raises important questions concerning the autonomy of both pregnant
women [100] and women of child-bearing age. While the justifications for such
explicit exclusions are generally couched in the rhetoric of protecting women and
their unborn children, it is more likely to be due to fears of liability for any
teratogenic impact on the unborn child. However, Merton has convincingly argued
that such fears are more apparent than real, since no successful claim has been
brought and a proper warning of known and unknown risks would in all prob-
ability extinguish the strict liability claims of both subjects and their children for
either pre-natal or preconceptual harm [101]. Furthermore, excluding women
from research may ultimately be a more dangerous legal stance; pharmaceutical
researchers in particular leave themselves open to law suits by excluding women,
given that their products are then aggressively marketed to women.
The second factor responsible for changing the way in which clinical trials are
viewed has been the HIV/AIDS pandemic, which has further politicised the field of
clinical research. Patients with these conditions have campaigned for just alloca-
tion of access to research and have characterised clinical trials as treatment when
there is no proven treatment for a medical condition *thereby further blurring the
dichotomy between research and therapy, noted at the beginning of this chapter).
Stimulated by these developments, patients with other diseases, notably breast
cancer and Alzheimer's disease, and their families, have become more vocal about
access to experimental drugs and treatments and have asserted the right to par-
ticipate in trials. Consequently, being a research subject is no longer viewed as an
unqualified sacrifice ± rather it is seen as a potentially risky opportunity. The
upshot is that researchers, long sensitised to the need forprotection ofresearch
subjects, must now also focus on the need toincludeindividuals and groups. All
researchers should thus bear in mind the need for increased efforts to recruit
certain populations, including patients with AIDS, minorities, the elderly and
women. This constitutes one aspect of good experimental design of a research
protocol, as well as fulfilling the general ethical obligation of fairness or justice.
12.4.6 Review of research and compensation
If a clinical trial is approved by a research ethics committee, then as we have seen,
the conduct of that research is left up to the research team and there are limited
possibilities for review. However, if a research subject is injured as a result of
defective drugs or surgical appliances, they may be able to bring an action under
the Consumer Protection Act 1987, arguing that a defective product was supplied.
Although liability under the Act is strict, the real problem for a litigant taking
action is the likelihood of researchers invoking the `state of the art' defence, i.e. that
any defects in the product were not ascertainable given the state of scientific
knowledge when it was marketed. In all other cases where injury results from
268 Nursing Law and Ethics