Ethics Guidance for Occupational Health Practice 9th Edition - Book - Page 105
5.54. After a favourable opinion by a REC has been given, the researcher should not
deviate from the protocol without the written prior approval of the REC, except
where necessary to protect participants or when changes only involve logistical
or administrative aspects that have no ethical implications. However, if an
investigator is in any doubt, it is better to seek REC consent for any protocol
amendments. The principal investigator is required to inform the REC of any
adverse events (this most often applies to clinical trials, but it might include a
breach of confidentiality or participant complaint) and when a reviewed project
has been completed.
5.55. Similar arrangements for ethical review of research studies are in place in many
other countries such as across Europe, North America and Australasia where
RECs are often referred to as “Institutional Review Boards”. However, although
low- and middle-income countries are increasingly addressing these issues,
problems can arise because formal arrangements for ethical approval are not
ubiquitous. If research is to be undertaken in occupational populations in
countries that are less developed, the researcher should make all reasonable
attempts to obtain an independent ethical review and, failing that, comply
with the principles of good ethical practice.
Proportionate review
5.56. The notion of proportionate ethical review has been developing over the past
decade. Key drivers included the potential workload for RECs and the
consequent slow turn round times for researchers. Proportionate ethical review
provides for different levels of procedure for projects dependent on an
initial evaluation of the risk. This assessment of the risk may be determined by
a checklist approach or by a categorisation of specific ‘high risk’ research.
5.57. The HRA has published information and guidance on its approach to
Proportionate Review 87 . Applications which are usually suitable for
Proportionate Review are:
Research using prospectively collected data or tissue that is anonymous to the
researcher.
Research using existing tissue samples which are not anonymous and already
taken with consent for research.
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