12.2 Regulation of clinical research
12.2.1 International declarations
The Declaration of Helsinki was promulgated largely as a result of the involvement
of health professionals in medical experimentation amounting to torture on stig-
matised social and ethnic groups in Nazi Germany. Indeed many ethico-legal
concerns raised by clinical research have their roots in the Nazi era. The aftermath
of the Nuremberg trials of Nazi war criminals witnessed the promulgation of the
Nuremberg Code, which in 1964 was revised and expanded by the World Health
Organisation's Declaration of Helsinki. This has subsequently been amended in
1975, 1983, 1989, 1996 and 2001 [11].
While the Nazi-era experiments remain some of the most appalling abuses of
research, numerous subsequent examples highlight the continuing need for
international regulation [12]. One of the major preoccupations is conducting
medical research on subjects in non-Western low income countries, where stan-
dards may be lower and subjects less likely to benefit from expensive drugs
marketed in the `developed' world. Trials of AIDs drugs and vaccines in particular
have prompted controversy [13]. Domestically, all nursing research carried out in
the UK should comply with the fundamental principles enshrined in this
declaration.
These stress that the first responsibility of the health professional is to his or her
patient, and that considerations related to the well-being of the human subject
should take precedence over the interests of science and society para. 5). Risks to
the patient should be carefully evaluated and researchers should be confident that
they can be satisfactorily managed, and that subjects are fully informed of them
para. 17). Furthermore, biomedical research must conform to generally accepted
scientific procedures, be approved by an appropriate ethical review committee,
carried out by those who are scientifically qualified and supervised by a clinically
competent medical professional paras 13±15). The 1975 revision of the Helsinki
declaration recommended codes of practice for researchers, and has resulted in
guidelines promulgated by national bodies, of which the most prominent are those
produced by the Royal College of Physicians [14], and the Royal College of Nursing
[15], as well as the guidelines which the Department of Health has issued for Local
Research Ethics Committees [16]. These are underpinned by similar principles to
those contained in the Helsinki declaration. More recently, the Council of Europe's
Convention on Human Rights and Biomedicine 1997) reaffirmed these
principles. It also stressed that the interests and welfare of the human being shall
prevail over the sole interest of society or science and that any intervention in the
health field, including research, must be carried out in accordance with relevant
professional standards and obligations [17].
Although such guidelines are useful in stipulating patient rights and stressing
the ethical obligations of researchers, they are not directly enforceable in law, and
indeed the UK has yet to sign the Convention on Human Rights and Biomedicine.
Moreover, inevitably guidance is framed in terms which leave considerable dis-
cretion to the researcher, particularly in assessing physical, psychological and
emotional harm.
254 Nursing Law and Ethics