Research organisations (ROs) are responsible for ensuring that the research ethics committees (RECs) within their organisation act, and are seen to act, independently.
They should be free from bias and undue influence from:
- the RO in which they are located
- the researchers whose proposals they consider
- the personal or financial interests of their members.
The independence of a REC is founded on its membership, on strict rules regarding conflict of interests, and on regular monitoring and accountability for decisions made by the REC (see also Conflicts of interest, complaints and appeals).
RECs should be constituted and operate in accordance with ESRC guidelines.
Authority and mandate
The authority of a REC should be delegated through the research organisation’s (RO) usual governance mechanisms.
It should report to the appropriate RO authority. In defining a REC’s mandate and authority, the organisation should make clear the jurisdiction of a REC and its relationship to other relevant bodies or authorities both within and outside the RO.
ROs should ensure that there is a principal REC for their organisation, but may establish secondary RECs (for example faculty, school or department-based) if required.
Where more than one REC is established, the area of responsibility of each should be clear; it would normally be defined by an area of substantive and methodological expertise. There should be clear procedures to establish the relationship between RECs and to facilitate co-operation and common standards, including arrangements to escalate deliberations to a principal REC where necessary.
Secondary RECs that comprise members from only one discipline or a small number of closely related disciplines may be regarded as too closely aligned with the interests of researchers; ROs should therefore ensure the independence of these RECs and transparency of their procedures and decisions.
Principal RECs should also be wholly independent and impartial and are likely to be multidisciplinary, and apart from the requirement of at least one external member could include individuals from outside the RO, as well as those with the requisite skills and experience to evaluate more complex and ambitious research proposals.
Principal RECs are also likely to be more broadly based, leaving the work of reviewing proposals to RECs in faculties, schools or departments and to concentrate on policy matters and oversight of the secondary RECs.
Remit and responsibilities
RECs are responsible for reviewing all research involving human participants and personal data conducted under their auspices and undertaken by individuals employed by the organisation that does not come under the remit of the UK Health Departments and Health Research Authority. This REC responsibility may also include research that intends to re-use data from previous research.
RECs should review research proposals in a way that is independent, competent and timely. Ethics reviews should strive to notify a 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. Research organisations (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 unless there are circumstances beyond the control of the RO.
RECs should provide supportive, reflexive governance to researchers and operate a system of ongoing monitoring and supportive reflection that promotes mutual learning for researchers and REC members.
In some circumstances RECs may authorise other sub-committees or their chair to conduct reviews on research involving minimal risk. There should be no conflict of interest by anyone authorised by a REC to review research. A sub-committee or the REC Chair will be accountable to the REC and the appropriate organisational authorities for the decisions they make.
An organisation-wide REC might advise on broad strategy for ethics review and monitor performance overall, rather than consider individual proposals. Wherever they are located, RECs should follow the guidance of this framework, even at department level if this is where the decision to review a project is to be taken. If checklists are used to identify the type of review required, the checklists may be overseen by an independent review body at faculty, school or department level.
ROs should establish and publish working procedures and systems of documentation in relation to REC responsibilities.
These should include:
- terms of reference and responsibilities of RECs
- scope of the authority of RECs and supervisory arrangements where review is delegated
- what researchers can expect from their REC/ethics review; how long such a review will normally take; how to appeal against a decision which is considered unfair
- procedures for reporting decisions to the main REC where a review has been delegated
- training arrangements for REC members – successful framework implementation requires the development of minimum standards of training and competence, which should be kept up to date with the changing social science landscape.
The membership composition of a REC is fundamental to ensuring that it has the range of expertise and the breadth of experience necessary to provide competent and rigorous ethics review of the submitted research proposals, and to do so from a position that is independent of both the researchers and the RO in which it is located.
Its composition and independence are important in establishing the legitimacy of the opinions expressed and the decisions made, in the eyes of the community and wider society as well as the researchers and funders of research.
Principal RECs should be multidisciplinary and comprised of both men and women. They should include at least one external member with no affiliation to the RO in question. There should be a chairperson and members who have broad experience and expertise in the areas of research regularly reviewed by the REC, and members who have the confidence and esteem of the research community.
Principal RECs would also benefit from including individuals who reflect ethnic diversity, users of specialist health, education or social services (where these are the focus of research activities), individuals with experience of professional care or counselling, and individuals with specific methodological expertise (for example, quantitative or qualitative methods) relevant to the research they review.
A principal REC should include among its membership people who are collectively familiar with a range of philosophical approaches to research ethics and with the different perspectives seen in individual research proposals. Taking all of this into account, good practice would suggest that a ROs principal REC would need at least seven members.
Seeking advice outside the committee
A REC may seek advice and assistance from experts outside the committee in considering a research proposal. When this happens, the chair should establish that the experts have no conflict of interest in relation to the proposal.
Research organisations (ROs) should establish research ethics committee (REC) procedures that are sufficiently flexible to cause minimum delay to the progress of research, for example through triaging proposals for review for risk level so that proportionate review can take place, and offering informal consultation pre-application where necessary.
What RO policies and procedures should address
RO polices and procedures should address the criteria for identifying research which involves more than minimal risk and therefore requires full ethics review.
They should also address clear procedures and forms for submitting proposals for light-touch, expedited and full review.
The presentation of research proposals and supporting documents
While a basic set of standard information should be required for all research proposals, ROs should consider whether the required proposal information might vary between RECs in light of 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.
The point at which research proposals should be submitted for review
It is inappropriate and wasteful for organisations that fund research to require that ethics review be completed before a proposal for funding is submitted, as a significant proportion of proposals are not funded.
ROs and funding agencies should be flexible about the point at which a REC review is required.
In the majority of cases the point at which research proposals should be submitted for review will be 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.
Methods of decision-making, rationale and recording decisions
REC decisions and feedback to researchers should be clearly recorded and open to scrutiny. ROs’ procedures should ensure openness and accountability of REC decisions while maintaining confidentiality where this is required.
REC meeting administration and transparency
RECs should publish details of administration procedures, including:
- dates of REC meetings
- deadlines for submission of proposals to be considered at each meeting
- the procedure for preparation of agendas and distribution of papers to members in advance of meetings
- distribution of minutes following meetings
- minimum attendance for a quorum and procedures when meetings are not quorate
- details of procedures developed by the REC, for example electronic review.
Prompt notification of decisions
ROs should publish a timetable for completion of light-touch and full ethics review by RECs and a commitment to providing a decision within a timeframe, which should usually be around one month and should not exceed 60 days unless there are circumstances beyond the control of the RO.
Procedures for reporting
Reporting procedures should be agreed with the researchers regarding any unforeseen events that might challenge the ethics conduct of the research or which might provide grounds for discontinuing the study.