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

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

Setting/ Type of approval	Number of named individuals from organisation	Number of recorded exchanges outside IRAS	Number of pages of text generated from exchanges	Number 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 practices	15	110	63.5	9 patients and carers 14 GP practice staff
NHS Research Ethics Committee (REC)	19	45	9.5	9 patients and carers
Sponsor (University)	17	67	31.5	NA
Research passport	No separate organisation	37^a	14.5^a	NA
Organisation 1	10	101	30.5	4 consultants
Organisation 2	4	78	23.5	3 nurses
Organisation 3, process not completed^b	2	12	5	–
Organisation 4, process not completed^b	6	27	9.5	–
Organisation 5, process not completed^b	2	14	5.5	–
Other (e.g. funder, original employer)	6	included above	included above	NA
TOTAL	81	491	193	30^c

^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
^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
^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

ISSN: 1472-6939