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Practice Statement. Other organisations, such as the APPLICATION OF ETHICAL PRINCIPLES
Medical Protection Society in the UK and a number of When considering human clinical research in the context
university departments, are often consulted by British of critical care, the concept of respect for persons is linked
doctors regarding issues relating to ethics. With respect to to the ethical principle of autonomy. In human research,
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the expected composition of such bodies in the USA, respect for persons demands that participants receive
Europe and Australia, the following applies: USA recom- adequate information and enter voluntarily without coer-
mendations suggest that Research and Ethical Boards cion. Surrogate consent may be applicable in critical care
(REBs) should have five or more members, including at areas when research activities are being considered.
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least one scientist, one non-scientist and one person not Other important and relevant ethical principles for
affiliated with the institution. The REB should include researchers are beneficence and non-maleficence.
people knowledgeable in the law and standards of prac- Beneficence in the research context is expressed by the
tice and professional conduct. Special memberships are researcher’s responsibility to minimise the risk of harm
advocated for handicapped or disabled concerns, if or discomfort to any research participants. Research pro-
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required by the protocol under review. The European tocols should be designed to ensure that respect for
Forum for Good Clinical Practice (EFGCP) suggests that dignity and wellbeing takes precedence over expected
REBs include two practising doctors who share experience knowledge benefits. With regard to justice in research, this
in biomedical research and are independent from the requires that within a population there is a fair distribu-
institution where the research is conducted; one lay tion of ‘benefits and burdens’ for research participation,
person; one lawyer; and one paramedical professional, although the proportion of these will vary depending on
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e.g. nurse or pharmacist. Healthcare research in Austra- the research activity.
lia is performed in accordance with guidelines issued by
the NHMRC, while in New Zealand the guidelines are When recruiting research participants it is important to
issued by the Health Research Council (HRC). Both ensure that any initial approach is made appropriately.
Councils have statutory authority, and health service and When the study involves recruitment of hospital inpa-
university Human Research Ethics Committees (HRECs) tients, this approach should be made by someone directly
(Australia) and both Health and Disability Ethics Com- involved in their care, with the aim of seeking permission
mittees and Institutional Ethics Committees (IECs) (New to then be approached by the investigators specifically
Zealand) are bound to consider research proposals in about the research. If the study involves recruitment of
accordance with the relevant recommended processes individuals from the community, this can be done by
and procedures outlined below. In subsequent discussion public display (e.g. flyers, published advertisements),
the above committees in both countries are referred to as providing the contact details of the researcher. Control of
ethics committees (ECs) for clarity, and operate in accor- involvement is then with the participant to make contact
dance with the following: with the researcher. While these processes may be inter-
preted as reducing or slowing recruitment, the principles
● The NHMRC National Statement on Ethical Conduct in of respect and autonomy for persons are upheld as the
Human Research 2007, is aimed primarily at research- potential for coercive recruitment is reduced. Another
ers, and provides a summary of principles. 8 guiding value in ethical research is that of integrity. This
● The NHMRC Human Research Ethics Handbook 2001 value requires that the researcher be committed to the
expands these principles, offers commentary and legal search for knowledge and to the principles of ethical
discussion, and is aimed at both HREC members and research, conduct and results dissemination. 8
researchers. 83
● The NHMRC Values and Ethics: Guidance for Ethical HUMAN RESEARCH ETHICS COMMITTEES
Conduct in Aboriginal and Torres Strait Islander Health
Research provides guidance to researchers, HRECs and Human Research Ethics Committees (HRECs) play a
Aboriginal-specific HRECs or subcommittees on the central role in the international system of ethical supervi-
conception, design and conduct of research involving sion of research involving humans. HRECs review pro-
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Aboriginal and Torres Strait Islanders. It has the posals for research involving humans to ensure that the
same status as the National Statement. The documents research is soundly designed, and is conducted according
are to be used together. to high ethical standards such as those articulated in
● The New Zealand Operational Standard for Ethics Com- Australia in the National Statement on Ethical Conduct
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mittee (OS) provides guidance on principles that in Human Research 2007 (known as the National State-
should be considered when reviewing research ment). Many other countries have similar systems and
proposals. statements or guidelines. While HRECs primarily fulfil a
● In addition, the HRC Guidelines on Ethics in Health guardian role, an often overlooked secondary purpose set
Research expands on the above standards and should out in the preamble to the National Statement is to ‘facili-
be used in combination (both documents are avail- tate research that is, or will be, of benefit to the research-
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able online, see Online resources). er’s community or to humankind’. Thus HRECs are seen
● Individual Institutional/Hospital Research Ethics as having a role in promoting good research and good
Committees (IECs/HRECs) and Regional Ethics Com- ethical practice, as well as guarding against poor research
mittees have their own requirements for research pro- and poor ethical practice.
tocol ethics submission, compliance, monitoring and For a series of useful case studies related to complex and
complaints handling. challenging research governance debate, refer to NHMRC’s