In the UK, all research involving data collected from National Health Service (NHS) patients must be approved by a Research Ethics Committee. The THIN data collection was approved by the NHS South-East Multi-centre Research Ethics Committee (MREC) in 2003.
Under the terms of this ethics approval, studies using pre-collected, pseudonymised data must undergo scientific review to help ensure appropriate analysis and interpretation of the data. This approval was recently extended to studies involving data validation at GP level.
The independent Scientific Review Committee (SRC) was set up in July 2009. IMS Health Real World Evidence Solutions administers the SRC application process and can provide support to obtain scientific or ethical approval.
- Researchers wishing to use only data or data/GP validation (GP questionnaires, hospital discharge notes and death certificates) will need to receive approval from the SRC.
- Researchers wishing to obtain additional information from patients or carers (patient questionnaires etc) will need to seek approval from the MREC. In addition, they will need to seek approval from associated local Research and Development (R&D) offices.
Breakdown of level of approval required: