Ethics Guidance for Occupational Health Practice 9th Edition - Book - Page 94
For example, there may be standard guidelines on the conduct of clinical audit.
The Caldicott Guardian will be a source of advice on the use of patient data.
5.11. All research studies undertaken in the NHS and involving either staff or
patients require HRA approval. However, there might be further stages and
approval required depending on the nature of the study. The researcher must
make sure they are fully familiar with the governance structure and when and
how to apply for approval [REF Integrated Research Application System]. They
should also be mindful of national differences in legislation and/or process if
their research involves more than one UK nation.
5.12. If the research involves accessing confidential patient information without
consent in England and Wales, an application must be to the Confidentiality
Advisory Group (CAG) 71 . If the research involves ionising radiation an
application may need to be made to Radiation Assurance 72.
Ethical research and research guidelines
5.13. It is important that researchers, together with any sponsors, consider ethics
issues from the early stages of a research project. The sponsor is the individual
or organisation (or group of individuals or organisations) that takes on
responsibility for confirming there are proper arrangements to design, promote,
recruit the subject, conduct, deal possible foreseeable scenarios with ethical
implication, process the data, communicate the result, monitor, finance and
take legal responsibility for the conduct of a study. Researchers must therefore
be skilled not only in the scientific aspects of research but also have the training
to be aware of and implement appropriate ethical standards.
5.14. Research activity is defined in terms of general aims and
specific objectives which will often highlight potential ethics issues, because
they imply certain forms of methodology and of data collection. For example,
the aim of research may be to explore individual differences within relatively
small numbers of subjects; any participants must understand the purpose and
function of such research before agreeing to take part. Conversely, research
may involve large-scale group comparisons, with data aggregated to protect
identity and minimise disclosure risks. Ethical considerations must therefore be
addressed from the outset of all programmes.
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