withdraw consent when research is proposed for these groups. Particular care may
also be necessary with pregnant women, or women of child-bearing age, in view of
the possible effects on the fetus should the research subject be or become pregnant
[93]. However, it is controversial to label them as `vulnerable' and it is important
that such women should not be excluded from research protocols, as discussed in
section 12.4.5.
12.4.4 Inducements and conflicts of interest
When recruiting members of vulnerable groups for clinical research, it is parti-
cularly important that LRECs examine the extent to which the patient may be
influenced by financial inducements. The DoH Guidelines for LRECs provide that
any payment to volunteers in trials should be limited to payment for expense, time
and inconvenience reasonably incurred [94].
Aside from inducements for subjects to enter trials, health care professionals
also need to be sure that inducements or perks from drug companies sponsoring
trials do not influence how they present benefits to potential participants. In 2000
it was reported that the outgoing editor of the prestigiousJournal of the American
Medical Associationhad called for restrictions on stock ownership and other
financial incentives for researchers, claiming that growing conflicts of interests
were tainting scientific research [95]. That this has come to be regarded as a
pressing ethical concern is reflected in the revised Declaration of Helsinki, which
hitherto had been silent on the need for transparency about economic incentives in
research. It now provides that all possible conflicts of interest should be disclosed
*para. 22, see section 12.2.3). In its recent guidance, the Medical Research Council
has pointed to the potential for conflicts of interest, where a researcher's scientific
judgement could be unduly influenced by a secondary interest, such as financial
gain or personal, academic or political advancement. It suggests that researchers
should automatically ask themselves, `Would Ifeel comfortable if others learn
about my secondary interest in this matter or perceived that Ihad one?'. If the
answer is negative, that signals that the interest must be disclosed and addressed
according to the appropriate policies established by employers, peer review bodies
or journals [96].
12.4.5 The pool of available research subjects
Given the historical emphasis on protecting research subjects from the impact of
research, the exclusion of potential subjects from consideration for clinical
protocols has only been identified as a significant bioethical issue since the 1980s.
This follows a paradigm shift in how enrolment in clinical trials is viewed [97].
While research on human subjects was initially perceived as a necessary aspect of
public health, and then as a transgression of individual rights tantamount to
torture, it has since the 1980s increasingly come to be regarded as an avenue of
access to better medical care. This shift was largely prompted by the thalidomide
and DES drug disasters, which led to criticisms of the policy of excluding pregnant
women from trials, given the catastrophic impact of these drugs on children born
to women who took them during pregnancy [98]. As noted above, pregnant women
have historically been categorised as a vulnerable group of patients, and as a result,
Clinical Research and Patients 267