Another contested feature is the extent to which placebos should form part of
RCTs. At the time of writing, under UK law patients may be given new treatments,
established treatments or placebos, depending on the group to which they are
allocated. However, a further controversial amendment to the Declaration of
Helsinki now states that the use of so-called placebo controlled trials is only
acceptable if there is no standard proven treatment of the disease being investi-
gated *para. 29) [55]. Guideline 7 of the revised version of the CIOMS guidelines
[56] provides that any decision to use placebos in place of the best current method
`requires a sound scientific and ethical reason', and the commentary on this
guideline adds that a placebo-control group need not be untreated, since the
treatment to be tested and a placebo may each be added to the standard treatment.
12.2.6 Research using personal information or human tissue
Many significant medical advances have resulted not from research trials involving
human subjects, but from the use of personal health information or human tissues
samples retained following post mortem examinations. For instance, such
research has improved understanding of suspected health hazards, facilitated
recognition of the epidemiology of new diseases such as new variant CJD and its
relation to the BSE epidemic) and led to ways of reducing cot deaths. For many
years such research was seen as less ethically problematic than research on human
subjects, especially as well co-ordinated use of such material can reduce the
research demands on patients and the need for animal research. Yet more recently
such research has become hugely contentious. In particular, public outcry over
unauthorised retention of children's organs at both Bristol Royal Infirmary and
Alder Hey Hospital in Liverpool has led to subsequent public inquiries and
recommendations for legislation [57].
In the meantime new guidelines have been issued by a number of professional
organisations [58]. Interim guidance promulgated by the BMA highlights the
importance of recognising the emotional implications for grieving relatives of a
request to retain tissue [59]. Given the findings of the Bristol and Alder Hey
inquiries, it stresses that parents and relatives should have the opportunity to
receive as much detail as possible about the post mortem examination and sub-
sequent use of tissues, although any request to receive only limited information
should be respected Guideline 2). The document also recommends viewing
consent-giving as a process rather than a single event, so that relatives should be
given the opportunity to speak to various health professionals at different stages
before making a final decision about long-term use and retention of tissue
Guideline 4). However, whilst recognising this, the BMA also takes the view that
where possible, it should be the responsibility of the `responsible clinician'
normally the consultant) to obtain consent, unless relatives have built up a
particular rapport with another member of the team with whom they would prefer
to discuss the matter Guideline 5). Relatives should be made aware that they may
consent to certain pieces of tissue being used and not others, and that they may
authorise some uses of tissue but not others Guideline 9).
New MRC guidelines similarly focus on consent [60]. They recommend a two-
part consent process, the donor first being asked to consent to the specific
260 Nursing Law and Ethics