University Research Ethics Committee structure

Workstream 1  

Most research undertaken by staff and PGRs will be reviewed via Workstream 1, which will consist of 10 RECs, each with a Chair and 8 members including a deputy Chair, an Independent Member and Postgraduate Researcher. These members will be drawn from across the University and will have a range of disciplinary expertise. There will be at least one member from each faculty on each Research Ethics Review Committee.   

Workstream 2

Almost all research undertaken by UG and PGT students will be reviewed via Workstream 2.  

Workstream 3

This workstream covers any projects conducted as part of ALSPAC and any projects which, because of data or funding provided by the NIH, require review by a US registered IRB. 

WS3 will contain two Research Ethics Review Committees (RECs):

The Avon Longitudinal Study of Parents and Children (ALSPAC) is a four-generation prospective study. The ALSPAC Law and Ethics Committee (ALEC) comprises clinicians, researchers, and people with legal expertise and lay people, including study participants. The committee meets bi-monthly to consider applications for data collection projects using the ALSPAC cohort.  ALEC are deeply integrated into the ALSPAC project, they provide support and guidance considerably beyond the usual remit of an Ethics Committee - to the benefit of the project.  

The ALSPAC Ethics and Law Committee (ALEC) first registered as an Institutional Review Board (IRB) with the Office for Human Research Protections (OHRP) within the United States Department of Health and Human Services in 2003, to facilitate ethical approvals for US funded collaborators. IRB status is usually only relevant to US collaborators; exceptionally it is relevant to other collaborators working abroad and University of Bristol researchers seeking access to US datasets.  

Federal Wide Assurance (FWA), a perquisite of IRB registration, is provided by the University of Bristol (UoB) Vice Chancellor (VC).  

The second WS3 Review Group will be established and have IRB certification which will need to be applied for from the Office of Human Research Protections in the US.  

This committee will have data science experience and not be considered as a bio-medical panel.  

Projects qualifying for a WS3 will be routed to workstream 3 if the following applies:  

  • If a project involves the recruitment of the ALSPAC participant cohort, requiring a review by ALEC only;  
  • If a project is funded by US Public Health Services requiring an IRB review this will be undertaken by ALEC in the first instance whilst the Research Ethics and Integrity Manager obtains IRB certification for the Secondary Data Research Ethics Committee. Once IRB certification has been obtained, the Secondary Data Research Ethics Committee will review any future reviews requiring an IRB certification;  
  • If a researcher is seeking access to a US dataset, where an IRB review is required.  
  • If a researcher is working with a US collaborator requesting an IRB review.  
  • If the study involves accessing public datasets in line with the Digital Economy Act 2017the research ethics application will be reviewed by the Secondary Data Research Ethics Committee which will operate in line with UKSA guidelines. 

Workstream 4

WS4 will provide the flexibility to deal with particularly complex or pioneering projects, drawing members from workstreams 1-3 when deemed appropriate, plus experts with experience in the field where necessary, or convening a bespoke panel.   

Projects qualifying for a WS4 review should be novel (e.g., Complex tech / AI), ethically complex (e.g, global research projects) or of a magnitude that would exceed the capacity of WS1, 2 & 3 (e.g., EU Funded Large Consortium Bids).  

The process flow below outlines the mechanisms for triggering a WS4 review.  

There are currently 5 mechanisms identified that can trigger a WS4 review:  

  1. Prior agreement between the researcher and the Research Governance Team  
  2. WS1 Chair request for a WS4 expert / technical input  
  3. WS1 Chair request for a WS4 full review  
  4. WS1 Research Ethics Committee (REC) request for a WS4 expert / technical input  
  5. WS1 RERC request for a WS4 full review  

If an application is discussed in advance with the Research Governance Team (RGT), and the researcher has been granted a WS4 Code, the applicant will submit their ethics application on OREMS. By including the WS4 Code, the application will automatically proceed to the WS4 workflow via OREMS. The RGT will then proceed to convene a bespoke WS4 REC (see below).  

If an application is initially submitted to WS1 / 3, once the application has been validated (checked for completeness) by the RGT, the application will be assigned to a REC. REC Chairs will undertake an initial review and if they feel that either a bespoke WS4 REC is required to review an application, they will instruct the RGT to move the application to WS4 and convene a bespoke WS4 REC.  

If in the Chair’s view an expert or technical opinion is required, they will instruct the RGT to source an expert reviewer to be co-opted onto the REC for the review of this application. See ‘facilitating an expert / technical review’ process below.