NHS Research Ethics Committee (REC) – Proportionate Review Service

  • No Material Ethical Issues Tool For your application to be suitable for proportionate review, it should meet one of the study types listed in the No Material Ethical Issues Tool (NMEIT).
  • Proportionate Review Service FAQ This leaflet answers frequently asked questions about the Proportionate Review Service. The Proportionate Review Service is designed to ensure an appropriate level of ethical review for low-risk research studies.
  • Submitting your application Flowcharts and tools to help you assess your research, how to book, and where to submit your application.

Proportionate Review (PR) Pilot

A review of the PR service identified areas which could be improved by measuring time in working days rather than calendar days, as previously measured, thereby reducing the time pressure on the REC staff and REC members which is significantly impacted by counting non-working days such as weekends and bank holidays. The potential areas for improvement include REC staff working with applicants after submission to ensure that the application is valid and can be reviewed without being rejected due to not meeting the validation criteria and REC members clarifying issues relating to the application or requesting further information before issuing an initial opinion, rather than issuing a provisional opinion and requesting the clarification or information as part of this process.

A 6 month pilot involving 15 RECs was undertaken between March and August 2016 to test a revised proportionate review process which allowed up to 5 working days for REC staff to validate the application and work with the applicant and 5 working days for the REC members to review the application and make any clarifications with the applicant, followed by a further 5 working days (maximum) to complete the administrative process and manage any responses to provisional opinions which may be required.

The pilot indicated that under the revised process, applications were more likely to proceed to review on the first submission rather than requiring a resubmission due to not meeting the validation criteria and applications were more likely to receive a favourable opinion as the first opinion issued after the application was reviewed. Additionally, the mean number of days which was taken to issue a final opinion was 13 calendar days (for RECs not in the pilot it was 11 days) which suggests that allowing the additional time for applications which require more support does not significantly increase the average time required. It does however add benefit to those applications which require additional support. Whilst the percentage changes were not significantly high, they were considered to provide marginal gains which in a broader context would add value.

An analyis of the PR pilot is available here: PR Pilot Analysis