This process is managed through a single on-line system based on the national Integrated Research Application System (IRAS) application form. This system, which replaced the previous NRES forms, captures all the necessary information needed by different agencies. Two important processes are the ethical approval of the study and then gaining NHS Trust approval (R&D approval) for the study to commence.

Ethics approval

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.

The Research Ethics Committee will review the study ensuring that it is properly designed, necessary, of value and ethical. They are particularly interested in protecting the rights and safety of any potential research participants.

In order to go through the ethics approval system, several items need to be in place prior to submission. All research studies require a sponsor, funding and the scientific value of the research assessed by means of independent external peer review.

The sponsor of the study is the organisation who takes on the overall responsibility for the research and this could be the Trust, a charity, other Trust or Univerisity or a commercial organisation (see further guidance below).

All research studies should be appropriately funded to cover the costs of the research procedures, researchers time and use of facilities.

NHS Trust approval (R&D approval)

When the appropriate ethics approval is in place and before the study can commence, R&D needs to undertake a governance assessment of the study to confirm that the research will be carried out safely using the hospitals facilities and is in line with appropriate policies and procedures together with national and EU legislation and is compliant with the Research Governance Framework. This review can be undertaken in parallel with the ethical approval process.

All departments involved in the research need to be aware of the study and satisfied that there are appropriate resources in place to undertake this research. Where support departments are involved in the research, the study will also be reviewed by those involved, for example Pharmacy.

These approvals are vital to protect patients and their data as well as to protect the researchers themselves and their sponsoring institution from avoidable risks.

When both the ethics approval is in place and the governance checks are complete, Trust R&D approval is issued and the study can commence.

The application process

To start a new clinical research project, the research team need as a minimum ethics and R&D 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). The necessary forms for these submissions can be completed through IRAS.

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.

Alongside the steps of peer review, establishing sponsorship arrangments and determining funding, researchers can be completing in the forms in IRAS. These multi-purpose, online documents form the basis of all future steps in the application and authorisation processes.

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 are part of the submissions to the research ethics committees, the R&D Department, and any other relevant agency. 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.

Independent scientific review or ‘peer review’ is an essential process when setting up a research project. It is a requirement for the sponsor to ensure that each protocol has been submitted for adequate peer review before R&D approval can be given. The R&D Office will accept peer review from external funding bodies, multi-centre research groups or a review that is leading to a named University grant. For projects not so covered, a peer review will be arranged by the R&D Department. Please note that this review should take place before submitting to an ethics committee, and therefore time should be allowed in order for this to be done.

For further guidance about peer review issues please contact the R&D department.

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.

CPFT normally sponsors studies either solely or as co-sponsor with the University of Cambridge.

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

Note: NHS Indemnity does NOT currently cover non-NHS employees who have designed the protocol for a study. The protocol indemnity usually stays with the employer of the author/chief investigator. If you are a substantive University employee you need to contact University Research Services. For more information about university insurance, please visit the university's webpages

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

When the ethics application form is complete, the investigator needs to approach the local allocation system of the National Research Ethics Committees for an appointment to present their research proposal. For studies sponsored by CPFT, researchers should not book in their study until they have had confirmation from the R&D department to do so.

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.

Additional approvals

Additional external approval is required from the MHRA if the research involves the use of medicines and the practical and safety issues will need to be addressed before the project starts with the Trust’s Pharmacy department which is responsible for these aspects of safety. It is best to consult pharmacy at an early stage when designing a study.

The page was last updated on 27 March 2018 by aient.

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