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 | 37a | 14.5a | NA |
| Organisation 1 | 10 | 101 | 30.5 | 4 consultants |
| Organisation 2 | 4 | 78 | 23.5 | 3 nurses |
| Organisation 3, process not completedb | 2 | 12 | 5 | – |
| Organisation 4, process not completedb | 6 | 27 | 9.5 | – |
| Organisation 5, process not completedb | 2 | 14 | 5.5 | – |
| Other (e.g. funder, original employer) | 6 | included above | included above | NA |
| TOTAL | 81 | 491 | 193 | 30c |
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