All ESRC-funded research should benefit from appropriate ethics review. Such review exists to support the ethical aspects of high-quality research, to help researchers reach high standards, and to support and protect all the parties involved in research. Ethics scrutiny should assess the risks and benefits of a project, consider the balance between, and take a proportionate view of whether risks which cannot be eliminated may or may not be justified.
It is the responsibility of the researcher – guided by standards set by their professional society, disciplinary body and ROs – to determine the type of review that is required. However, the relevant REC is expected to ensure that the appropriate ethics review is undertaken, and the RO is expected to ensure that research will not proceed without securing the appropriate level of review.
The review body (eg principal REC, secondary REC, or NHS REC) will be determined by the issues raised by the research, the nature of the data to be obtained and the population of participants to be included in the project. This will apply to both single-discipline research and interdisciplinary research, especially where social and biomedical scientists are working together.
A light-touch review, when fully justified, identifies those projects where the actual or potential risk or harm to participants (and others affected by the proposed research) is minimal.
Light-touch reviews can be delegated by a principal REC, but at a minimum a REC sub-committee will monitor all proposals including those of students. Many student projects may require only a light-touch review, however this cannot be assumed. Projects, including student projects, which involve more than minimal risk should receive a full REC review. Some RECs have facilitated ethics review by establishing ethics protocols for commonly occurring situations with potentially vulnerable participants - for example, research undertaken with typically developing children in mainstream school settings. If the researcher can confirm that they are following an established protocol which has had full ethics review, and that this is appropriate for their research, a light-touch review may be justified. The use of these protocols can limit the number of research proposals that need to go to a full ethics review.
Expedited review (full ethics review that is conducted quickly and at short notice) may be appropriate in exceptional circumstances where research projects require a full review but have a short lead time and are commissioned in response to a demand of pressing importance.
Most RECs only permit expedited review in exceptional and clearly justified cases. Such exceptions may include external drivers which are outside the control of the researcher (eg access to a sample) where ethics clearance is required within a short timescale, or perhaps when fieldwork is linked to a particular event or period. An expedited review should meet the criteria required for a full review, and must not be carried out by REC members who are in a position of dependence with the applicant that could be perceived as a conflict of interest.
This framework provides examples of research that would normally require a full ethics review, because it will entail more than minimal risk. It is likely that much research activity will require full ethics review, and methods such as further analysis of data are not necessarily exempt from full review.