ROs should establish 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.
RO policies and procedures should address the following:
- Criteria for identifying research which involves more than minimal risk and therefore requires full ethics review.
- 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:
- the dates of REC meetings
- the 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.
Os 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.