Application process

 

Getting started

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 National Research Ethics Service (NRES) form and Central Office for Research Ethics Committees (COREC) form.

The key IRAS forms are:

• Research Ethics Committees 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 Cambridge University Hospitals (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.

Insurance

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.

Agreements

When third parties are involved, e.g. other research sites, the sponsor may need to put contracts in place 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

Protocol

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.

Peer review

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.

NRES protocol guidance

---

Ethics review