Application process Additional approvalsEU CTIMPSCommercial research

Protocol and peer review | Sponsorship | Approval by ethics committees

 

To start a new clinical research project, you need as a minimum ethics and R&D management approval,  and depending on the scope of the research additional approvals by for example the MHRA (for medicines and medical devices) or GTAC (gene technology), to name just two. The necessary forms for the submissions to these agencies can now be completed through the national Integrated Research Application System (IRAS). This new system, which replaced the previous NRES forms,  captures all the necessary information needed by all these agencies.

 

In the case of our R&D Department here at CUH, we will up-load the information which you provide us on the IRAS R&D form onto our research database, ReDa, which enables us to keep track of your project and remind you when certain things need to be done.

 

 

 

Protocol and peer review

 

All research studies need a protocol describing how the research will be conducted. The protocol describes the research question: hypothesis, objectives, primary outcome and if applicable secondary outcomes, justifies the importance, and the methodology of how it will be answered. The study will be regulated by the Trust and external agencies in accordance with what is involved in the research project and its scope.

Protocols arepart of sthe submissions to the research ethics commitees, the R&D Department, and any other relevant agency, filed on our research database: ReDa research database. The research project will be monitored throughout the lifetime of the project based on the protocol.

Groups starting a project may not have the full range of skills to ensure a successful outcome. For example, they may need the support of specialists such as statisticians, health economists or may benefit from public involvement in the design of their study.

 

 

Sponsorship

 

A sponsor is an individual, organisation or group taking legal responsibility for the arrangements to initiate, manage, monitor and report on a study. A sponsor may also finance a study but does not normally do so. A sponsor is not synonymous with funder, so the sponsor should not be confused with a funding agency.

 

Cambridge University Hospitals normally sponsors studies as either alone or as joint sponsor with the University of Cambridge.

 

A sponsor takes on the legal responsibility and liability for the study. If the sponsor is CUH or another NHS entity, the study is covered by NHS indemnity rules. If the sponsor is the University, a charity or commercial organisation, indemnity is provided differently under their insurance policies.

 

Note: NHS Indemnity does NOT currently cover non-NHS employees who have designed the protocol for a study. The protocol indemnity stays in general with the employer of the author. If you are a University employee you need to contact University Research Services.

 

 

 

A sponsoring organisation needs to ensure that it has properly considered the risks of a project and how to manage them. All applications must therefore be approved by the clinical divisional director of the departments in which the study will take place. This is to say that the work described in the protocol can take place practically and without danger to their other operations. This is particularly important for particular types of study where additional approvals are required for the use of medicines, devices, radiation, data or tissue.

 

If third parties are involved, the sponsor will put in place one or more contracts to set out the respective roles and responsibilities. These contracts may include:

• A contract between the Trust as sponsor and another Trust or University. This contract typically covers indemnity, intellectual property, confidentiality, financial and termination issues.

 

• A participating site agreement between the sponsor and any subsidiary sites within a multi-site study. The Trust may be the hub of a large study or a spoke in someone else's study.

 

• A tissue transfer agreement if tissue from the Trust's patients is to be sent to another organisation for research.

 

Approval by ethics committees

 

All medical research projects using patients, identifiable data or tissue require a favourable opinion from a committee of the National Research Ethics Service (NRES) before they can proceed. Studies involving anonymised data or tissue, or research involving NHS staff and NHS facilities may not always need ethical review, please see the NRES guidance.

 

When a researcher has a complete, peer-reviewed protocol, including identified staff and resources, an organisation prepared to sponsor it and an agency prepared to fund it in principle, they must fill in the forms in IRAS. These multi-purpose, online documents form the basis of all future steps in the application and authorisation processes. The key forms are:

• REC application form (this will be reviewed by ethics)

• R&D application form (this is reviewed by the R&D Department)

• SSI Form: Site specific information - this can be in several copies, one for each of the sites involved in the study. These are reviewed and approved by each individual site’s R&D Department or ethics if it is a non NHS site.

When the form is completed, the investigator needs to approach the local allocation system of the National Research Ethics Committees for an appointment to present their research proposal.

 

Most single-site studies on the Cambridge Biomedical Campus will normally be considered by the Cambridge Central Research Ethics Committee, but owing to pressure of work, they may offer applicants speedier appointments at more distant committees in the region.

Certain types of study require approval by a committee which has recognised expertise in certain types of research. The central allocation system of NRES ensures that your study is sent to the right committee. It is likely that you will need to go this route if your study:

• Is a clinical trial of a medicinal product or medical device

• Involves vulnerable people (e.g. prisoners or adults with incapacity)

• Involves children

• Involves setting up a tissue bank

• Is happening on a number of different sites

The process of getting an opinion from an ethics committee takes time and needs to be planned early. The R&D Officers can provide advice on this.

 

Please see t5he list of required documents for an an ethics application here: National Research Ethics Service application

 

 

 

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