Ethics Guidance for Occupational Health Practice 9th Edition - Book - Page 93
If these are obtained during the course of the research (a scheduled process
under the Act) then independent ethics review by a recognised research ethics
committee is a statutory requirement unless the samples can be held/stored in
a facility licensed by the Human Tissue Authority. If the tissue is obtained for
the purposes of audit, quality control or statutory health surveillance it is not
subject to these requirements. Another example is the tracing of subjects in
occupational cohort studies through the NHS Information Centre.
Another example is the Mental Capacity Act 2005. The Act applies to any
intrusive research within England and Wales, wherever it takes place, except for
clinical trials of investigational medicinal products. This may include research in
healthcare, social care, criminal justice and other settings. Finally, there is
statute relating to Clinical Trials of Investigational Medicinal Products (CTIMPs),
which will not apply in many occupational health situations.
Organisational requirement. The governance arrangements of the controlling
organisation require independent ethical review. The majority of universities,
the UK NHS, Ministry of Defence and His Majesty’s Prison and Probation
Service require independent ethics review for research, but not for audit and
service evaluation. The latter may be high risk or sensitive but are not governed
by the same ethical oversights as research for policy reasons.
5.08. Strict interpretation of these factors might lead to the conclusion that all
research involving human volunteers, their tissue or personal data, has the
potential for raising ethics issues and therefore should be submitted to
independent ethics review. The review will be proportionate to the risks faced
by volunteers from their participation in the research, the ethical issues arising
and the benefits of the research and is addressed more fully subsequently (see
Chapter 5, paragraphs 5.34 – 5.36 on Proportionate Review).
5.09. It is strongly recommended to utilise a decision tool (see 5.05)] in early phases
of developing a project to establish if ethical approval is required is.
5.10. If a project is not be deemed to be ‘research’, there is no need to apply for HRA
Approval or to an NHS REC. However, it is advisable to contact the clinical
governance or research and development (R&D) office of the organisation
where the project will be conducted to discuss what other local review
arrangements or sources of advice may apply.
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