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Table 1 Individuals and exchanges involved in the ethics and R&D approvals of the substantive study

From: Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better

Setting/ Type of approvalNumber of named individuals from organisationNumber of recorded exchanges outside IRASNumber of pages of text generated from exchangesNumber of interviewees
Local R&D approval and study assurances, in conjunction with Clinical Research Network (CRN). Primary outcomes - decisions on CRN support and approval of access to GP practices1511063.59 patients and carers
14 GP practice staff
NHS Research Ethics Committee (REC)19459.59 patients and carers
Sponsor (University)176731.5NA
Research passportNo separate organisation37a14.5aNA
Organisation 11010130.54 consultants
Organisation 247823.53 nurses
Organisation 3, process not completedb2125
Organisation 4, process not completedb6279.5
Organisation 5, process not completedb2145.5
Other (e.g. funder, original employer)6included aboveincluded aboveNA
TOTAL8149119330c
  1. a As the study was associated with a service development project which was not taken up as expected by Organisations 3, 4 and 5, we decided against conducting interviews with their members of staff. The complexity of R&D approvals was a contributing factor
  2. b Some of the communication was conducted from a now closed institutional email account. We had recorded the contents of exchanges, but had not saved the emails. As a result, these particular figures are an underestimate
  3. c Patients and carers are included in two boxes, as they were a core concern for two approvals. The remaining 14 interviewees (above the total of 30 in the table) were not covered by specific rules