FOI2020/00420: Approval times for research protocols submitted to IRBs in England and Wales
Case reference FOI2020/00420
Published 26 May 2021
Request
Request Received: 30 November 2020
RE: Approval times for research protocols submitted to IRBs in England and Wales
I am requesting data that UKRI, or one of its constituent bodies, holds on the duration of the research approval process for study protocols submitted to Institutional Review Boards in England and Wales.
I am frequently astonished by the inefficiency and duplication of activity in the processes that support the review and approval of protocols for research studies conducted in the UK.
In a paper published earlier this year in BMC Medical Ethics, a UK site had the worst performance in Europe for approving a 66-site pan-European brain injury study.
The median time from protocol submission until the required IRB approval was obtained to start the study was 114 days (IQR 75-224). The fastest required IRB approval was obtained after one day in Serbia and Romania, whereas the longest time was found in a center in the UK (535 days).
Research England's 2019 Delivery plan states that; "High-quality data and analysis is at the heart of what we do. Data, analysis and system intelligence drive all our policy and funding activities and underpin the critical monitoring and evaluation of all of our policy and funding interventions."
This gives me confidence that data is available on the relative performance of IRB approval process at the institutions you fund.
Response
Response Sent: 18 December 2020
The United Kingdom (UK) does not have Institutional Review Boards (IRBs) but an equivalent role for clinical or NHS-based research is performed by the Research Ethics Committees (RECs), which are overseen by the Health Research Authority. The REC Directory2 provides information on Research Ethics Committees3 (RECs) within the UK Health Departments' Research Ethics Service. Non-NHS research is reviewed by internal research ethics committees established by each Research Organisation. For information about the success rates and time to approval of studies reviewed by RECs, please contact the Health Research Authority 4 who may hold the information and for information about the time to approval of non-NHS related research protocols, please contact the individual Research Organisations. UKRI is not aware of any central body collecting this information.
Documents
This is UK Research and Innovation's response to a freedom of information (FOI) or environmental information regulations (EIR) request.
You can browse our other responses or make a new FOI request.