Our principles provide the basis for the ethics review of research proposals submitted to ESRC. Proposals should be considered in relation to the nature and context of the outlined research. The applicant should also be guided by standards set by their professional societies, disciplinary bodies and research organisations (ROs).
All ESRC-funded research must be subject to an appropriate ethics review. Where the risk of substantive harm to participants (and others affected by the proposed research) is minimal, a light-touch review may be appropriate.
An ethics review must be proportionate to the potential risk or harm that the research imposes. Risks should be balanced against benefits and, where possible, risks should be minimised. Ethical considerations are different where there is minimal risk of serious harm, and moderate risk of minimal harm. These considerations apply whether the research involves primary use as well as the re-use of data.
Researchers are responsible for identifying potential ethics issues that may arise within a project and determine the appropriate type of review that’s required, guided by their professional ethics codes and standards of the RO. If only a light-touch review is required it must be fully justified. Research proposals involving human participants and personal data may require full review by the appropriate research ethics committee (REC) which has been established and operates in accordance with the principles and guidelines set out in this framework.
Researchers and ROs should avoid duplication of ethics review.
A single review process should be agreed in collaborative research involving more than one organisation or multidisciplinary research. The principal investigator should ensure that participating organisations and collaborative researchers are satisfied that the research proposal has received adequate ethics review, and that regular monitoring of the conduct of the research takes place and is promptly reported to all organisations and researchers involved.
RECs should review research proposals in a way that is independent, competent and timely. Ethics reviews should strive to notify researchers of their decision within a month of receiving a submission, and researchers and the research process should not be disadvantaged by RECs which are not sufficiently resourced to comply. ROs have a duty to make sure their RECs are functioning appropriately, and are resourced to do so. Ethics review timeframe should not exceed 60 days maximum unless there are circumstances beyond the control of the RO.
Freelance researchers, or ROs without their own procedures for independent review, must arrange for ESRC-funded research to be submitted to an ethics review procedure that observes the Framework guidance. This could be the REC of the grant-holding RO or an independent expert or advisory group.
All data collection and analysis involving human participants or personal data should receive light-touch or full ethics review before the research commences. Research involving individuals or groups who come under the remit of the Mental Capacity Act 2005 should be reviewed by the appropriate REC. Normally this will be a REC recognised by the Secretary of State and Welsh Ministers and operating under Governance Arrangements for Research Ethics Committees (GAfREC). Research conducted in Scotland should be reviewed by the Scotland ‘A’ REC which is operating under the Adults with Incapacity (Scotland) Act 2000.
While researchers may be required by their RO to submit a basic set of standard information for all research proposals to a REC, researchers and their ROs should consider whether the way it is presented should vary between RECs depending on the research they review. Research paradigms differ between disciplines and a ‘one size fits all’ approach is not always appropriate. Application forms and procedures should be kept as brief as possible and could be tailored to the requirements of particular disciplines.
In the majority of cases research proposals should be submitted for REC review immediately after notification of funding, but it could also be prior to a pilot study so that participants’ interests are protected; prior to seeking the agreement of potential research sites and gatekeepers so they can be assured of its good standing; or prior to the main data collection.
ESRC applicants should include additional costs incurred in carrying out an ethics review in the cost claimed on their proposal. These are eligible costs under the arrangements for research councils to meet a proportion of the full economic costs of research, and the applicant should factor into the proposal the time required for necessary ethics review and necessary training and accreditation (for example, for projects requiring use of the ESRC Administrative Data Research Network). This does not affect RECs’ duty to carry out ethics review in a timely manner.
Funded proposals should normally commence no sooner than three months following our formal notification of funding, to allow for recruitment of staff and ethics review. If an ethics review is required at a later stage in the project, this should be discussed with the lead ESRC officer when confirmation of funding is received, and funding arrangements will need to be agreed. At a minimum we expect that ethics review will be carried out prior to the stage in the project when the research requiring ethics review will be undertaken.
If review by the REC shows that a project requires major changes which will alter it substantially and the project can no longer retain ESRC support, payments may be suspended and the grant terminated. This is likely to be an extremely rare occurrence, since the proposal will already have been assessed by independent peer-review which should identify such severe problems.
Monitoring and reporting of research should be proportionate to the nature and degree of risk and harm anticipated and occurring within the research. Further detail is provided under research organisations and research ethics committees.
As research progresses, further ethics issues may arise. Principal investigators should check through the implications of the issues and have these reviewed by the appropriate REC. Non-conflicting advisory bodies, independent experts and mentors may also assist in this process.
Approval for minor changes to a project following REC review is delegated to the RO. When the RO determines that the changes are not minor the applicant must go back to their RECs to review the project changes. If the issues are serious enough to require substantial changes to the project (or a termination of the grant), or ongoing monitoring shows that a project requires major changes which will alter it so much that it can no longer attract our support, the ESRC lead case officer should be contacted (see also ‘When to contact ESRC’).
ESRC-funded student projects involving more than minimal risk of harm must be given careful consideration and possibly a full ethics review. It cannot be assumed that all students’ projects involve minimal risk. In many cases student research may be managed at school or department level and overseen by a light-touch departmental ethics committee using an initial checklist. The review process can also be expedited by established RO protocols for commonly occurring research. It should always be made clear to potential research participants in the information sheet or consent form that the study is a student-led project.