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Local approvals

National approvals address the ethical and regulatory considerations of your project. At a local level, we need to consider feasibility and our capacity and capability to successfully deliver the study.

Contact the Research Office to discuss your project, they will advise you on:

  • assessing, arranging and confirming capacity and capability
  • contract negotiation
  • any training requirements and ensuring access to the hospital.

Apply for capacity and capability confirmation

The HRA approval process for the NHS in England brings together the assessment of governance and legal compliance with the independent ethics opinion. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

For KCH or KCL sponsored studies

Send your draft IRAS application form along with all supporting documents to [email protected].

Your study will be allocated to a Research Facilitator who will conduct a sponsorship review and support the CI and study team to prepare the documentation for REC/HRA submission. Where KCH are also a research site, the Research Facilitator will incorporate assessing, arranging and confirming the capacity and capability to deliver the study as part of this process.

For KCH hosted studies

Send a copy of the Local Information Pack to [email protected].

This should include the following documents:

  • IRAS form – confirm KCH has been added as site
  • Protocol
  • Regulatory approval confirming that KCH has been added as a research site
  • Approved local documents as applicable (PI sheet(s), consent form(s), GP letter, advertisement)
  • Organisation Information Document (OID) relevant to the participating NHS organisation
  • Relevant template contract or model agreement (if needed in addition to OID)
  • Schedule of Events or SoECAT
  • Pharmacy pack for CTIMPs
  • Investigator Brochure Summary Product of Characteristics (SmPC)
  • Pharmacy Manual
  • Any other documents that the sponsor wishes to provide to the site to support the set up and delivery of the study
  • Copy of HRA Initial Assessment letter (if one is issued) and (when issued) HRA Approval letter and final document versions
  • REC Favourable Opinion Letter
  • Amendment tools and regulatory approvals of amendments (if applicable)
  • KCH Principal Investigator CV and GCP Certificate

Your study will be allocated to a Research Facilitator who will work with the PI, site team and the sponsor organisation to assess, arrange and confirm the capacity and capability to deliver the study at King’s College Hospital.

Timescales

The Research Office strives to get every project approved as quickly as possible, in line with the national framework and the national metric of 60 days. Each project is unique and its complexity can impact on the approval time. It is important to note that the review is a two way process – we are reliant on you to respond to questions and requests to progress the project, and will assist you as best we can.

Amending your study

Once received, the approval is valid for the life of the project. It is the investigator’s responsibility to register any changes to the project with the Research Office. Changes to projects without prior approval will invalidate your work and constitute a breach of research governance. The Research Office will assist you with amendment submission. You may also check the HRA website for example scenarios to report amendments and the effect on your study.

How do I know that my project has been approved locally?

You will receive a confirmation of capacity and capability email from the Trust, listing your responsibilities as an investigator, requirements for reporting and the terms of the approval. You are expected to familiarise yourself with the terms and conditions.

You will also be required to create and maintain an Investigator Site File if one is not provided to you by the sponsor. The Research Office can provide a template Investigator Site File for you to use and assist you with any questions you may have.

Contracts and agreements

When projects are conducted across multiple sites, contracts and agreements are needed to protect the interests of the researchers and of the organisations supporting the research. You can work with your Research Facilitator to develop these agreements to clarify:

  • the responsibilities of each organisation
  • when funding is involved, the amounts, terms and conditions
  • how the results of the work will be handled, such as data ownership, intellectual property, and publication rights
  • the transfer of relevant materials under the Human Tissue Act.

I do not work at King’s College Hospital NHS Foundation Trust

All staff working on site are required to have approved access arrangements in place, and the need for this will be identified during the governance review.

King’s Health Partners (KHP) employees are eligible for a KHP Passport – an honorary contract issued by your employer that will allow you to work at each of the partner sites. You can get your Passport from the HR office of your employer.

You will need to get it signed by the relevant head of department or the line manager for the clinical areas you wish to work. Medical and dental staff will also need to have their application countersigned by the Trust’s Executive Medical Director.

If you work elsewhere – dependant on your employer – you will need either a Letter of Access or an Honorary Research Contract. The Research Facilitator reviewing your project will advise you which one is required and be able to issue site access when your project is approved.