Chapter 12
Clinical Research and Patients
A The Legal Perspective
Marie Fox
The issue of clinical research on human patients poses complex bioethical and
legal dilemmas for nurses who may be involved in research. Throughout the
1990s nurses have been assuming a greater role in conducting clinical research,
in part because involvement in research may help to validate their professional
status, and also due to the increasing emphasis on evidence based medicine.
Nevertheless, it has been argued that there are still too few nurse researchers and
that most nurses in practice are not sufficiently research aware [1]. In an attempt
to remedy this, the most recent national strategy for nursing, midwifery and
health visiting is committed to developing `a strategy to influence the research
and development agenda, to strengthen the capacity to undertake nursing, mid-
wifery and health visiting research, and to use research to support nursing, mid-
wifery and health visiting practice' [2]. Such initiatives make it imperative for
nurses to have a clear understanding of the ethical and legal implications of
engaging in clinical research.
The fundamental ethical and legal issue raised by research involves a balancing
exercise, between the interests of the health professional carrying out research and
of medical science itself on the one hand, and on the other, the welfare of those
human patients who are the subject of medical research [3]. Against that backdrop,
the aim of this chapter is to explore the legal framework within which clinical
research may be conducted. It is worth noting that there is a relative absence of
specific legal rules regulating research. Thus, although the Animals *Scientific
Procedures) Act 1986 regulates research which may lawfully be carried out on
animals [4], and the Human Fertilisation and Embryology Act 1990 imposes
constraints on experiments on human embryos, there is no comparable statutory
regime which licenses research on human patients. Equally, the common law in
this area is marked by the absence of case law pertaining specifically to medical
research. The only exception to this is in the case of drug trials. The upshot is that
the legal framework governing research largely draws on the principles laid down
in relation to consent to conventional medical treatment.
Given this absence of detailed domestic legal regulation, guidance for health
professionals derives mainly from principles enshrined in international declara-
tions and codes of practice promulgated by professional bodies. However, in the
future this is likely to change given the introduction of a new framework for