From 28 April 2026, the new clinical trials regulations will change the constitution requirements for Research Ethics Committees (RECs) that review clinical trials of an investigational medicinal products (CTIMPs) and how many members must be in attendance at full REC meetings.
Constitution of RECs
The new regulations will update the minimum membership requirements for RECs that review CTIMPs. From 28 April 2026, each REC must have an appointed Chairperson and a minimum of 5 members in total (including the appointed Chairperson). We’ll continue to make sure that the number of committee members in all RECs is sufficient so that full meetings of the RECs are quorate.
The REC membership will collectively reflect the qualifications and experience to review the science, medical aspects, and ethics of research applications.
RECs will have at least 1 member who is a lay member (an individual who does not have a formal qualification related to, or professional experience in, the field of clinical research or healthcare). This will mean that the way RECs are constituted and operate will continue to align with international standards.
We do not expect this change to impact current RECs or their members. However, we'll continue to monitor REC membership to make sure that all committees are appropriately constituted before the new regulations take effect.
Attendance requirements for full meetings of the REC
To be able to review a CTIMP under the current regulations, a full REC meeting must have at least 7 members (including an appointed Chairperson) present to issue an opinion.
While the intention will still be to arrange meetings with at least 7 REC members present, the new regulations will allow a decision to be issued if 5 members are present (including an appointed Chairperson and at least 1 lay member).
This adjustment makes sure RECs continue to align with the standards set by the International Council for Harmonisation Good Clinical Practice (ICH GCP) and will not compromise the quality of the REC's review of research applications.
RECs that review gene therapy trials
The 2025 clinical trials regulations will remove the ‘Gene Therapy Advisory Committee’ definition within the current 2004 clinical trials regulations.
Although the definition will be removed, there will still be RECs within the UK with specific expertise in reviewing applications involving gene therapies, which sponsors will still be able to submit their application to.
If a sponsor submits a CTIMP involving gene therapy to a REC not recognised as one that reviews gene therapy applications, this could result in the REC seeking independent expert advice from a REC that is flagged to review these applications. For further information please read the approvals process for applications guidance.
All RECs that are flagged as being recognised to review applications involving gene therapies will continue to be identified within our REC directory.
CTIMPs involving adults with incapacity in Scotland
As stated in the new 2025 clinical trials regulations, the changes in REC constitution and meeting attendance requirements detailed on this page will not apply to RECs in Scotland that review CTIMPs involving adults lacking capacity.
RECs in Scotland that review CTIMPs involving adults lacking capacity will continue to operate under the Adults with Incapacity (Scotland) Act 2000.