The ethics principles set out in this framework provide the basis for reviewing research proposals. These principles should be considered in relation to the nature of the research outlined, the context in which it is undertaken and the accepted norms and standards set by professional societies, disciplinary bodies and research organisations (ROs). Researchers, ROs and research ethics committees (RECs) must ensure all proposals that have been recommended for funding by the ESRC are appropriately reviewed before the actual research commences.
Role of a REC
A REC should review the research proposal and make a proportionate judgement concerning whether there is an appropriate balance of risks and benefits of the research. RECs should give due regard to the consequences of the research for those directly involved in and affected by it, and to the interests of those who do not take part in the research but who might benefit or suffer from its outcomes in the future. RECs also need to balance the safety of researchers, especially where they are working in covert situations or conducting lone fieldwork, and the benefits of the research.
RECs should review research proposals in terms of their ethics probity which will include consideration of the design, outputs and proposed conduct of the research. These should be considered in terms of the ethics issues raised (for example, whether the method of recruitment proposed puts undue pressure on individuals to participate) and the way in which they are addressed. The scholarly or scientific standards or merits of the research are not the primary responsibility of the REC - these should be evaluated by appropriate peer review. Where the REC needs greater understanding of the scientific or scholarly merit of a proposal in order to make a judgment about ethics issues, it should seek the advice of an independent researcher with experience and expertise in the research methods and paradigm described in the proposal.
The knowledge and expectations that members of RECs bring to the ethics review of research proposals are fundamental to the way they are reviewing. This is particularly clear in some forms of qualitative research where it may be impossible or undesirable to obtain signed consent from each respondent at the outset of the research. Where more than one perspective or ethics principle applies to a specific case, clear ethics reasoning will be required and debate should be encouraged. Good ethics review requires sensitivity to the context in which a research study will be conducted, and good ethics reasoning requires careful thought and consideration.
Working collaboratively with researchers will best engage them in achieving the highest ethics standards in their work. Ethics review should be seen as a valuable part of research design, execution and dissemination rather than a troublesome hurdle to jump.
RECs may give a favourable opinion on the proposal as submitted, give a provisional approval subject to the researcher meeting specified conditions (which may require further review), or reject the proposal on ethics grounds. RECs should record and make clear how they come to their decisions, including whether ‘lead reviewers’ are designated for a proposal and whether decisions can be made on the basis of a majority view. The decision made for a proposal, and the grounds on which it was made, should be recorded and provided to the researchers, and a copy kept on file with the proposal for a specified minimum period consistent with the RO’s policy on information retention. This period should extend beyond the lifetime of the project.
Accountability of REC decisions should be ensured within RO governance structures, and opinions given by RECs should be open to scrutiny. Certain aspects of research may need to remain confidential; for example, intellectual property needs to be protected, as do research findings pre-publication. There should be clarity in REC operating procedures to ensure that this balance between openness and protection is consistently maintained.
Where a proposal does not meet the expected ethics standards or changes are required, it is important for the REC to give clear feedback on what needs to be amended. Where an ethics proposal of ESRC-funded research is rejected, the ESRC lead officer should be notified by the RO representative (which may be the PI or the RO’s research support office).
As part of RO governance, RECs should serve to maintain ethics standards throughout the research lifecycle of a project and effectively and rapidly support researchers in resolving ethics issues as they arise. Ongoing monitoring and support should be proportionate to the nature and degree of risk and harm encountered in the research.
Where a study design is emergent, the REC should agree, with the researchers, procedures for ongoing ethics review (for example through submission of staged ethics applications relating to different aspects of the work, or through a Project Advisory Group). Procedures for reporting to the REC (or a designated sub-committee) any unforeseen events that might challenge the ethical conduct of the research or which might provide grounds for discontinuing the study should be formally agreed with the researchers.
Where a REC or a designated sub-committee considers that a monitoring report or ad hoc audit by the RO has raised significant concerns about the ethics in the conduct of the study, it should request a full and detailed account of the research to be submitted for full ethics review conducted by the responsible REC. The REC should review the implications of the issues with assistance from non-conflicting advisory bodies, independent experts and mentors if required.
Where a principal REC or designated sub-committee considers that a study is being conducted in a way which is not in accord with the conditions of its review or in a way which does not appropriately protect the rights, dignity and welfare of research participants, it should initially arrange a meeting of all those concerned with a view to resolving the difficulties. In an extreme situation, the REC may withdraw its favourable opinion, and recommend to the appropriate body in the RO that the research be suspended or discontinued. The ESRC should be informed of this decision and reserves the right to recoup its grant funding in extreme cases of ethics and research misconduct, pending further investigation.