12.3.3 Research fraud and deception
A further obstacle to ensuring accountability of researchers is that cases of
deception and fraud have been reported with increasing frequency throughout the
1990s [74]. Since scarce funding leads to pressure to demonstrate results for
money invested and to publish widely for career advancement, there is consider-
able temptation to falsify results. Recently numerous prestigious journals have
acknowledged the extent of research fraud [75]. Although the Royal College of
Physicians have stressed the necessity of following good practice and indicated in
1991 the need to establish a body to investigate allegations of fraud, no action has
yet been taken on this proposal [76]. In the meantime it remains the case that it is
the threat of litigation that holds researchers accountable. A more general problem
with publishing research is that articles are much more likely to secure publication
if the conclusions are positive, with the result that published research provides
only a very incomplete picture of research projects actually undertaken [77].
12.4 Vulnerable groups of research subjects
Researchers need to be sensitive to the fact that some groups of potential subjects
may be particularly vulnerable to pressure to participate in medical research,
either because of doubts regarding their competence to participate or because of
their situation where vulnerability is exacerbated by institutional and attitudinal
factors. Particular concerns have been raised regarding research on children or
mentally incompetent adults, and it is widely recognised that these groups should
be accorded special protection. A specific failing identified by the Griffiths Review
at North Staffordshire was the lack of specific guidance to researchers on how valid
consent is to be obtained in vulnerable groups. Too often it was simply assumed
that researchers were aware of the useful guidance contained in the Royal College
of Physicians' guidelines. Once again this highlights the need for researchers to be
fully informed of their legal obligations and current professional guidance.
12.4.1 Children
While most research may be undertaken on competent adults, the different
developmental, physiological and psychological differences in children, which
make age- and development-related research important for their benefit, may
necessitate the use of child subjects [78]. As we saw in Chapter 10, the law permits
achild to consent to medical treatment if she is over 16 or isGillick-competent [79].
The Department of Health Guidelines provide that these principles apply to
therapeutic research, but stress that research proposals should only involve children where it is absolutely essential to do so and the information cannot be obtained using adult subjects' [80] In the case of non-therapeutic research, the guidelines suggest thatthe child must be subject to no more than minimal risk as a
result of his/her participation' [81]. Once again, no guidance is provided on the
nature of minimal risk, although the British Paediatric Association has stressed the
special need for caution in weighing up risks and benefits where research on
264 Nursing Law and Ethics