Step 2 – Setting up your research project

Setting up your research project

 

To open a research project you need to ensure you have the correct infrastructure and support to run the study. Key points to address are:

1) Funding
2) Sponsorship
3) Feasibility

 1. Funding 

All research will have a cost implication which will need to be covered before the research can open.

This cost could include the following:

  • The time of the research team and other NHS staff involved in the project
  • Additional diagnostic tests and procedures over and above normal clinical practice
  • Additional hospital visits over and above normal clinical practice
  • Increased lengths of stay over and above normal clinical practice
  • Additional software or equipment
  • Data analysis
  • Course fees for research degrees
  • Travel to conferences
  • The use of NHS buildings and facilities
  • R&D and departmental set up fee/s

 

It is essential that all costs associated with the project are identified at the planning stage to ensure these costs can be added to the funding application. If you require assistance with this please contact the R&D department.

 Where can you apply for funding?

There are a number of different funding steams to consider including charities, pharmaceutical companies or professional bodies. Possible funding routes can be found at www.rdfunding.org.uk. Please keep in mind that funding will need to be secured before you are able to proceed with study set up. Therefore apply for grants that fit within your timescale.

Another opportunity for funding is available from the National Institute of Health Research, NIHR that have a number of different grant programmes;

  • Research for Patient Benefit
  • Invention for Innovation
  • Programme Grants for Applied Research
  • Programme Development Grants

R&D are able to work with develop and complete your grant application, this includes support for cost attribution. Please contact the R&D team for advise and support.

2. Sponsorship

Who is Sponsoring the Study?

The sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study, but is not necessarily the funder.  You will need to identify an institution that is willing to take on this role before you are able to apply for any research approvals.

If you would like the Royal Surrey County Hospital Trust to consider acting as Sponsor for your study it is important you approach the R&D department early in the development of your trial.  The Trust will need to assess the risk/benefit ratio before any decision can be made.

To apply for trust sponsorship you are required to present your project to the R&D committee and  submit the following supporting documents:

  • Detailed protocol
  • Patient information sheet
  • Informed consent form
  • Principle/Chief Investigator CV
  • GP letter, advertisement (if applicable)
  • Confirmation of Funding arrangements
  • 2 External Peer Reviews
  • Chief Investigators current CV signed & dated with evidence of GCP training

 

Note: All documents must be final versions and have version control and date

R&D will review all documents and if required offer advice to ensure ICH/GCP compliance.

R&D committee will decide if the trust should sponsor the study and you will be informed of the committees response within 5 working days.

To book onto an R&D committee please contact the R&D department.

3. Feasibility

When developing a study it is important to consider the infrastructure within your own department and the supporting departments to ensure the study is feasible.

Remember, research requires the collection of data, informed consent and the maintenance of trial documentation in accordance with ICH GCP, all of which is additional to standard practice.  It must not be assumed that current staff will be able to assist with your research.  If your department is research active there may be staffs in place that are able to support you.  If not you may require additional resources.

It may be that additional equipment, staff time and space is required to run the study. This can be included in your funding application.

Support departments may have their own departmental requirement which means they need additional resource or alternatively need to plan to support the study.

One way of obtaining additional support for infrastructure and support service is by considering the National Institute of Health Research portfolio.  To find out more about the National Institute of Health Research and how to get your study onto the portfolio please click the link below;

Support Services

It is essential that the feasibility of the study is considered at the earliest stage of project development.

The best way to do this is to contact the R&D department once you have a proposal.  This form will register your trial with R&D and can start conversations with the relevant support services.

If found feasible, you  will be able to continue with your application.

The main support services that will need to be considered are:

  • Pharmacy
  • Pathology
  • Radiology

Pharmacy

When a study involves a drug, pharmacy involvement is essential. The pharmacy department at the Royal Surrey County Hospital is very experienced in conducting clinical trials and are currently supporting over 110 trials across the trust.

The pharmacy will be responsible for:

  • Processing drug deliveries
  • Arranging drug storage
  • Dispensing the study drug
  • Patient consultations
  • Drug accountability
  • Drug reconciliation
  • Drug destruction

By discussing the research with pharmacy they will be able to feedback as to whether the study is feasible and the time that is required to set up the study within the pharmacy department.

Please note the trust is currently unable to sponsor studies using an investigational medicinal product. If you are not sure if your study is classified as a study of trial medicinal product please review the MHRA algorithm below;

MHRA algorithm

Pathology

When a study involves analysis of human samples the pathology department must be consulted.

Pathology will be able to assess the feasibility of the research along with advising whether or not the department is able to resource the additional work.

The pathology department will also be able to advise as to whether or not the trust holds the correct Human Tissue Authority (HTA) license to conduct the research.

Radiation

If your study involves radiation, you not only need to consider feasibility but also the additional regulatory requirements.

Research involving exposure to radiation will need to be compliant with IRMER (Ionising Radiation Medical Exposure Regulations 2000).

This regulation applies to ‘the exposure of patients or other person voluntarily participating in medical or biomedical, diagnostic or therapeutic research programmes’.  This is to ensure that all exposure to radiation is justified, REC approved and risks are understood by the participants.

It is essential that Investigators work with clinical radiation experts at protocol development.

 If radioactive substances are injected and this is not standard care then an ARSAC certificate is required.  IRAS will generate the application but only if you select yes for section a) of 2c on the filter page (Fig 2).

R&D website

 

 

If you fail to do so, IRAS will filter out radiation related questions making your approval invalid.

This can delay your projects approval!

 For more information please see trust IRMER research procedures or visit:

 

www.arsac.org.uk

 

 

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