The application forms for submissions to all review bodies can all be completed through the Integrated Research Application System (IRAS). This national on-line system captures all the necessary information for the relevant approvals. It replaced previous forms such as the NRES form and COREC form.
The key IRAS forms are:
- REC application form
- R&D application form
- Site specific information (SSI) form
When completed, the forms can be signed electronically and submitted to the applicable review bodies.
Sponsorship and insurance
A sponsor is an individual, organisation or group taking legal responsibility for the arrangements to initiate, manage, monitor and report on a study. The sponsor could be CUH, the University of Cambridge, a charity, another trust or university, or a commercial organisation. A sponsor may also finance a study; this is often the case with pharmaceutical research. However, a sponsor is not synonymous with a funder.
Cambridge University Hospitals usually sponsors studies alone or jointly with the University of Cambridge, e.g. when the protocol has been designed by a University employee, or when the University manages the funding.
When the sponsor is CUH, usually the study will be covered by NHS indemnity schemes. If the sponsor is a university, a charity or commercial organisation, indemnity needs to be provided under their insurance policies.
Note: protocol indemnity lies in general with the employer of the author. If you are a University employee and want to set up a study you need to contact the University Research Operations Office to apply for an insurance letter.
When third parties are involved, e.g. other research sites, the sponsor may need to put contracts in plac. to set out the roles and responsibilities regarding indemnity, intellectual property, finance and confidentiality. When tissue samples are being collected for a study the sponsor may need to set up tissue transfer agreements.
Protocol and peer review
All studies need a protocol. This is the full description of the research. The protocol describes the hypothesis, objectives, methodology and statistical analysis. The protocol can also be used as a research manual, e.g. when other sites are involved in the study. It is a mandatory requirement of the submission to the Research Ethics Committee, the R&D department, and other relevant agencies.
All research, except non-doctoral student research needs to be externally peer reviewed. The critique report needs to be submitted to the research ethics committee. Scientific review is often provided during the grant application process. When a fellowship grant or departmental funds are being used, the R&D department can arrange independent review of your proposal and provide you with a critique report.
Research projects involving NHS patients, identifiable data or tissue require a favourable opinion from a Research Ethics Committee (REC) before they can proceed. Studies involving anonymous data or tissue, or research involving NHS staff or NHS facilities may not always need ethical review. Please contact the R&D department when in doubt.
RECs safeguard the rights, safety, dignity and well-being of people participating in research in the NHS. There are about 80 NHS RECs in the UK, including 66 in England. REC members are volunteers.
There are currently five RECs in the East of England, three of which meet in Cambridgeshire. You can ask for your study to be reviewed by a local committee, but certain types of studies may need to be reviewed by a specific REC.
RECs are required to give an ethical opinion within 60 calendar days of receipt of a valid application.
Please see the links below for REC contact details and meeting dates.