Research ethics committees are most relevant to this chapter. Their primary role
is to decide whether a particular research project is ethical or not by reviewing
its study protocol. Such committees usually comprise scientists, professionals and
lay people supported by an administrator. Standard questions for such a committee
• Are the research participants appropriately informed?
• Is the balance of risks and beneits posed by the research fair and reasonable?
• Are the research participants likely to be worse off for participating in research?
If so, does their consent represent a sufficient protection of their interests (or are
they being exploited)?
• Is the research likely to be useful and informative? (Ashcroft 2007 : 684)
Ethical review generally follows a particular pattern. Study protocols are
received from researchers, and are then reviewed by a single member, a small con-
sultation team or the full ethics committee. Applications may be approved at that
point; if not, they are returned to the applicant with queries before being reconsid-
ered and finally approved or rejected. The legitimacy of ethics committees derives
from the fact that they are lawfully established and adhere to a process of delib-
eration as a diverse group of experts (including lay people) who reach consensus
after discussion (Garrard and Dawson 2005 : 423). While review requirements dif-
fer between (and sometimes within) countries, Fig. 8.1 shows the most basic steps.
In assessing whether a protocol is ethically acceptable, research ethics com-
mittees refer to international guidelines (e.g. the Declaration of Helsinki), national
guidelines (e.g. UK Medical Research Council guidelines) and national law (e.g.
National Health Council of Brazil resolutions). A research ethics committee there-
fore seeks to protect the interests of research subjects by ensuring compliance with
ethical guidelines. Many countries (e.g. the US and the UK) have made it a criminal
offence to start medical research without ethical approval from the relevant research
ethics committee. This, de facto, gives ethics committees the role of a regulatory
authority, a position with 'immense power over the research that is carried out'
(McGuinness 2008 : 695).
The Nuremberg Code (1949) 4 and the World Medical Association's Declaration of
Helsinki: Ethical Principles for Medical Research Involving Human Subjects (1964)
placed responsibility for safeguarding research participants on the investigator. In
1975, however, the Tokyo revision of the Declaration of Helsinki introduced ethics
committee review of research as its second basic principle (Levine 1995 : 2312):
The design and performance of each experimental procedure involving human subjects
should be clearly formulated in an experimental protocol which should be transmitted to
a specially appointed independent committee for consideration, comment and guidance
(WMA 1975 ).
4 The Nuremberg Code of 1949 is a set of principles and rules to be observed when undertaking
research with human participants. It was developed after the Nuremberg trials in 1946 and 1947
of Nazi doctors who had committed atrocities against concentration camp internees as part of
medical research. It was superseded by the Declaration of Helsinki in 1964 (see Chap. 3 ).