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Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type.
This study involved the use of NHS premises only; therefore, under the Governance Arrangements for Research Ethics Committees, a REC review was not required.
Table 3 shows aspects of the REC review process.
REC review is a cornerstone of international guidelines on research with human participants.
Thus, whether REC review is required for any particular study depends on the requirements of national laws and policies.
The shortcomings of protocols that are identified during REC review have not been compared by sponsor type though.
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Most RECs review the research that is conducted at their own institutions.
Since the HRA incorporates the National Research Ethics Service NRESS), whose research ethics committees (RECs) review and provide ethical opinions on all research using NHS patients, it seemed logical that the HRA plays a greater role in monitoring publication outcomes.
Of those who responded (n = 9), RECs reviewed an average of 3.8 protocols per meeting (median: 2.5, range 1 - 10) and an average of 42.3 protocols per year (median: 22; range 1-150).
However, by still relying on comprehensive ethics review at each project site in each country, the potential for global bottlenecks and incongruence remain, with multiple RECs reviewing a research project that seeks to aggregate and use data on a global scale.
Additionally, the trust has its own REC to review the scientific and ethical merits of projects proposing access.
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