affair. In the cases of the student or inexperienced or methodologically innovative
researcher, competence must be secured by appropriate supervision and support,
clear lines of accountability and, where necessary, physical oversight of the
research activity. The same rules as apply to the student or inexperienced nurse in
anovel situation, apply also to the individual learning a new research technique.
Here the emphasis must lie on appropriate 'supervision ± an otherwise experi- enced professional learning a new technique may not require the same kind of supervision as the greenhorn student. Nevertheless, a supervisory mechanism will be required. Supervisory mechanisms include piloting of the method, and peer review of the research design and of interim and final results, as well as more traditional means of educational supervision. An important feature of supervision is that supervision is not identical to hier- archical reporting. So in a clinical team running a clinical trial, it may be that the principal investigator with overall responsibility for the trial, financially and administratively, is a new consultant physician. His or her research experience in this kind of clinical trial may be limited. The senior nurse on the team, acting as research nurse, may have considerable experience, however, even though from the point of trial management he or she reports to the principal investigator. 'The Declaration of Helsinki requires any biomedical research project to be led by a physician, even if only nominally.) In this situation, it is clear that thesupervisory'
role may in reality fall to the research nurse, rather than the designated principal
investigator.
Each individual member of the clinical team is thus responsible for his or her
own tasks, as well as participation in the generic task of quality oversight of the
project. Hence, in addition to each individual's competence 'or supported competence 'in the case of supervised work), there isteam competence '± can this
group function effectively as a team to ensure that the ethical and quality
obligations to carry out the research to a certain standard are met? This is a very
brief summary of the implications of research governance 'orgood clinical
practice 'for research and clinical teams.
12.11 Recruitment and consent
The voluntary informed consent of the individual research participant is essential.
In certain kinds of research consent may be impossible 'for instance research with
babies or young children, or incapacitated subjects who are unable to give
consent). In certain circumstances, consent may not be sought because the
research project is of great collective importance, consent would be impractical,
and the risk of harm to the participants is minimal. The details of these exceptions
are complex, and cannot be covered here; the reader is referred to the excellent
guidelines prepared by the UK Medical Research Council on research with the
mentally incapacitated and on the use of personal medical information in research.
Consent is important because it respects the autonomy of individuals: their right
to privacy, their right to determine what can be done to their bodies, and their right
to choose whether or not to assist others in activities which may not benefit them
directly. Justifications of departures from the consent standard may rest on legally
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