Non commercial application process Additional approvalsEU Clinical trials Commercial researchFunding

Protocol and Peer review | Approval by Ethics Committees | Sponsorship | Honorary Contracts | Funding | Help with Financial Management

 

New research projects can now be initiated using the national Integrated Research Application System (IRAS) and a new basic form, the IRAS Form. This will replace the system you may be familiar with, based around the National Research Ethics System (NRES) with its NRES form. The new system should capture all the necessary information needed by all the agencies who will be interested in monitoring your project and should make life simpler for you. In the case of our R&D Department here at CUH, we will file the information which you fill in on your IRAS Form onto the national research database, REDA which enables us to keep track of your project and remind you when certain things need to be done.

 

For full information about the IRAS system, please see Integrated Research Application System (IRAS). These pages will give you some quick guidance on the major issues involved.

Protocol and Peer review

 

All research studies need a protocol describing how the research will be conducted. This defines the research question, why it is important and how it will be answered. The study will be regulated by the Trust and external agencies in accordance with what the researcher says in this document.

 

Protocols are included in the IRAS Form, filed on the research database of REDA research database and monitored throughout their lifetime.

 

Every protocol for health and social care research must be subjected to peer review by experts in the relevant field able to offer independent advice on its quality. We can help you find appropriate reviewers from a wide range of experts on and off the site.

 

Researcher 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.

 

 

Approval by Ethics Committees

 

All medical research projects using patients, their data or tissues and NHS staff require a favourable opinion from a committee of the National Research Ethics Service before they can proceed.

 

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 a IRAS Form . This multi-purpose, online document forms the basis of all future steps in the application and authorisation processes. It consists of three parts:

• Part A: The protocol for the study

 

• Part B: Sponsorship and funding details

 

• Part C/SIS Form: Site specific information - this can be in several copies, one for each of the sites involved in the study

When the form is completed, the investigator needs to approach the Ethics Committee for an appointment to present it.

 

Most single-site studies on the Cambridge Biomedical campus will normally be considered by the Cambridgeshire 2 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. They must therefore be logged with the Central Allocation System of NRES so that they can be 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 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. Our R&D Officers can provide advice on this.

 

You can quickly see what is required in an Ethics Application by downloading the appropriate checklists here.

 

> National Research Ethics Service - Applicants' Checklist

 

 

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Sponsorship

 

A Sponsor is an individual, organisation or group taking 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. The Sponsor should not be confused with funding agency.

 

We normally sponsor studies as the Cambridge University Hospitals NHS Foundation Trust either alone or as joint sponsor with the University of Cambridge.

 

A sponsor takes the legal 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.

 

 

 

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 Service Delivery Manager or Clinical 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.

 

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Honorary Contracts

 

As sponsor, the Trust needs to ensure that the research staff are properly qualified, trained, vetted and have appropriate contracts in order for them to qualify for NHS Indemnity cover.

 

Honorary Contracts are required by all researchers who do not already hold a substantive contract with the Cambridge University Hospitals NHS Foundation Trust, but who will come in contact with patients, their identifiable data or tissue, or will work on site within a Trust facility.

 

Someone working under an Honorary Contract is treated just like any other employee. They need to fill in an Application Form for an Honorary Contract, authorised by their current line manager or academic supervisor, provide two references.

 

In addition they need to fill in a Criminal Records Bureau Disclosure Application Form and a Pre-Employment Occupational Health Questionnaire (including up to date details of inoculations) both of which can be obtained from the R&D Department.

 

We will make sure these forms are passed rapidly to the right places, but applying for an Honorary Contract and getting the responses can take several weeks, so don't leave it until the last minute. You can't start work until you have a contract in place.

 

 

 

Funding and help with finance

 

The funding agency for a project is different from, and should not be confused with, the Sponsor.

 

Most research on the Cambridge Biomedical Campus is funded by grants from the National Institute of Health Research, the Medical Research Council, and charities such as the Wellcome Trust and British Heart Foundation.

 

The Trust has its own charity, the Addenbrooke's Charitable Trust, which funds some researchers and some projects on the site.

 

The R&D Department monitors existing and new sources of funding and alerts researchers to new competitions and calls for proposals.

 

 

Research Service Division at the University of Cambridge also provides a regular update regarding funding availability for non commercial studies

 

> Research Services Division

 

 

MHRA funding

 The MHRA is seeking applications for research funding as part of our Targeted Research Programme, which was launched on 6 November 2009. Please see link for further information.

 

  > Seventh Framework Programme

 

 

On this site:

> Funding

 

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Help with Financial Management

The Addenbrooke's Finance Department has special staff dedicated to managing research and development budgets. They can provide assistance with input to initial bids for funding right through to managing the money when it comes in.

 

 

Evgeny Dmitriev : 01223 257 251

• R+D Strategy
• R+D Financial Planning (NIHR and other)
• Financial interface with the University
• Allocation of new NHS funding

 

Pippa Bayfield (NHS/NIHR R+D) : 01223 257 298

• Preparation and maintenance of budget statements
• Costing New Bids
• Liaison with Budget holders
• Establishment Information

 

Kathy Thomson (Research Grants) : 01223 274670

• Preparation and maintenance of research accounts, balance information
• Costing new proposals
• Liaison with research grant holders
• Invoicing funders

 

> Finance Department ( for trust staff only)

 

 

 

 

 

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