The three RECs in the Leicestershire, Northamptonshire and Rutland Strategic Health Authority were included in the project, which was conducted between February 2004 and February 2005. Members of the committees gave their oral consent to participation in autumn 2003. Purposive sampling was used to select applications for inclusion in the project. Sampling, which was conducted by EA, an REC administrator, aimed to represent different types of studies and different types of applicants. The different types of studies were as follows:
- Intervention: a study that intervenes in the normal clinical care of a patient or health service user.
- Non‐intervention: a study that does not include an intervention but seeks to measure outcomes or processes.
- Qualitative: a study that uses distinctive qualitative research methods.
The types of applicants were:
- Novices: applicants who had not previously applied to the REC.
- Experienced: applicants who had submitted at least one previous application to the REC.
Over a 12‐month period, each application was reviewed by all three RECs and all of them prepared a decision letter. Each application was assigned a “lead” REC before any committee considered the application, and applicants received the decision letter of the lead REC only. The two non‐lead RECs were sent this application as a “dummy”, despatched as one of the many applications for each meeting, and not labelled as “the dummy” (although it may sometimes have been possible for members to guess). Over the course of the project, each committee reviewed 12 dummy applications and 6 applications as the lead committee.
Three decision letters for each application were generated for analysis. Under governance arrangements for RECs1
and guidance on standard operating procedures,2
there were four formal decisions available to RECs:
- Favourable: the application is ethically acceptable.
- Provisional: amendments to the application or further information are required before a final decision can be made.
- Unfavourable: the application is ethically unacceptable.
- Outside remit: the application is deemed to fall outside the remit of governance arrangements for RECs.
Patterns of agreement in decisions were assessed descriptively. Agreement was further assessed using the κ statistic, which indicates the proportion of observed agreement that cannot be explained by chance. The one “favourable” decision was grouped as “provisional” for this analysis.