consent against the need for research to advance the knowledge and treatment
of mental disorders.'The Convention on Human Rights and Biomedicine provides that non-therapeutic
research on the incapacitated mayexceptionallybe carried out, provided that it
entails only minimal risks and burdens for the individual concerned and has the
aim of contributing:
`through significant improvement in the scientific understanding of the indivi-
dual's condition, disease or disorder to the ultimate attainment of results cap-
able of conferring benefit on the person concerned or other persons in the same
age category or afflicted with the same disease or disorder or having the same
condition *Article 17).'The revisions to the CIOMS guidance [86] suggest that in cases where prospective
subjects lack capacity to consent, permission should be obtained from a legally
appointed guardian or responsible relative Guideline 15). However, under English
law, in contrast to the situation with children, there is no available proxy consent-
giver for the incompetent adult [87]. As we saw in Chapter 7A, medical treatment
may be provided if it is in the patient's best interests [88]. Recent cases on consent
see Chapter 7A) have paid greater attention to human rights concerns in assessing
best interests and there are compelling arguments that theBolamtest is a wholly
inappropriate basis on which to determine whether an incompetent adult may be
enrolled in a research project. It is thus suggested that undertaking non-therapeutic
research on a mentally incompetent adult is prima facie unlawful [89].
These concerns over the legal uncertainty and the vulnerability of the mentally
incompetent adult led the Law Commission to propose that non-therapeutic
research may be undertaken in certain situations but subject to additional safe-
guards. In particular, it suggested that any such proposal should be referred to a
new mental incapacity research committee. This proposed new body would have
to be satisfied that it was desirable to have knowledge of the participant's inca-
pacitating condition, that any trial would not expose the participant to more than
negligible risk, and that this information could not be obtained by research on
those who were competent to consent [90]. Subsequently, a Government Green
Paper on mental incapacity has questioned whether it is desirable to establish yet
another body to scrutinise clinical trials [91], so that it seems unlikely that this
proposal will be enacted. However, as one commentator has pointed out, there are
advantages in referring this type of complex decision to a body which has built up
specialist knowledge, rather than leaving it to be determined at a local level [92].
12.4.3 Other vulnerable groups
Researchers should be conscious of the fact that other potential subject groups
may feel under particular pressure to participate in research, not through doubts
about their competence, but because their circumstances render them vulnerable.
Nurses will typically carry out research on patients, and patients may feel
compelled to participate out of a sense of obligation to the health professionals
treating them. Other groups who may feel a similar obligation are medical and
nursing students. Great care needs to be taken to explain rights to refuse or
266 Nursing Law and Ethics