Ethics Guidance for Occupational Health Practice 9th Edition - Book - Page 95
This is a precursor to deciding whether reference to a research ethics committee
is warranted; independent review is not a substitute for reflective analysis.
Guidelines
5.15. The first reference to ethical issues and research (experimental medicine) is that
of Thomas Percival’s code from 1803 which specified that ‘the physician may try
experimental treatments when all else fails, and when it can serve the public
good’ 73 . The norms of contemporary research ethics were codified by the
Nuremberg Code of 1947 in response to Nazi medical research and this has
been further developed by the World Medical Association 74.
5.16. Drawing on these principles, Emanuel and colleagues have defined seven
requirements that provide a systematic and coherent framework
for determining whether clinical research is ethical 75. These are summarised by
the authors and in the current context can be restated as being:
Social or scientific value: Evaluation of a treatment, intervention, or theory that
has potential to improve health and well-being or increase knowledge.
Scientific validity: Use of widely acceptable scientific principles and methods,
including statistical techniques, to produce reliable and valid data.
Fair subject selection: Selection of participants so that vulnerable individuals
are not unfairly targeted for risky research and the rich and socially powerful
not favoured for potentially beneficial research.
Favourable risk-benefit ratio: Minimisation of risks; enhancement of potential
benefits; risks to the participant are proportionate to the benefits to the
participant, the workforce as a whole and society.
Independent review: Where appropriate, review the research protocol, its
proposed participant population, and risk-benefit ratio by individuals
unaffiliated with the research.
Informed consent: Provision of information to participants about purpose of the
research, its procedures, potential risks, benefits, and alternatives, so that the
individual understands this information and can make a voluntary decision
whether to enrol and continue to participate.
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