experiments that are already planned and then to give broader consent for storage
and future use for certain types of research. These guidelines also highlight the
importance of written consent and the need for information to potential
participants to be presented in a form they can understand.
Similarly the use of personal information in medical research has proven con-
tentious. The MRC has issued guidance stating that researchers should ensure that
they have each person's explicit consent to obtain, hold and use personal infor-
mation where this is practicable [61].
12.3 Ethical review
12.3.1 Research ethics committees
To a certain extent the regulatory focus has now shifted from an emphasis on
obtaining consent to ensuring compliance with codes of research practice,
following the introduction of ethical review. Since 1968 official NHS policy has
been that local research ethics committees LRECs) should be established to
oversee clinical research within the NHS. LRECs are governed by Department of
Health guidelines 1991) in which their function is defined as advising on whether
aresearch proposal is ethically acceptable. The Department of Health is currently
engaged in a consultation exercise on draft new governance arrangements for NHS
research ethics committees [62]. Ethics committees are envisaged as independent
bodies, comprising both health care professionals and lay persons, who are
charged with the responsibility of protecting the rights and well-being of human
subjects involved in a trial. The DoH guidelines recommend that the first question
to be asked by each research ethics committee is whether the scientific merit of the
proposal has been correctly assessed by the researcher. The committee must take
into account any discomfort or distress which the project may cause the research
subject, any hazards which may arise during the project and precautions which
should be introduced to deal with them. It must then carefully assess the extent to
which the health of the research subject will be affected by involvement in a trial.
Para. 7.3 of the present guidelines states that:
`Benefit may be weighed against risk in two different ways. First and most
obviously the patient may benefit. This is typified in a therapeutic trial where at
least one of the treatments offered may be beneficial to the patient. Benefits may
be considerable, for example, in cancer treatment and may counter balance even
high risk to the individual. Second, society rather than the individual may
benefit. In such situations however large the benefit, to expose a participant to
anything more than a minimal risk needs very careful consideration and would
rarely be ethical.'12.3.2 The limitations of research ethics committees
Although the existence of ethics committees is clearly desirable, there are
considerable limitations to their effectiveness as a mechanism for scrutinising and
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