Approval process

• Summary Flowcharts of the Approval Processes for industry and non-industry funded studies and who can provide assistance

Prior to initiating any research projects within the Royal Brompton & Harefield NHS Foundation Trust, all projects must be approved the Research Office to ensure that they meet all regulatory and Trust requirements.

This is in line with the DH Research Governance Framework which requires that systems must be in place to ensure that health care providers are aware of, and have given permission for, all research being conducted in or through their organisation, whether or not it is externally funded.  In addition all research must have a sponsor.  This applies to all research being carried out within the Trust where Trust facilities, patients, their tissue or data is being used.  It is a requirement that sponsor roles and responsibilities should be documented and agreed on a project-by-project basis.

Research on RB&HFT premises must not be initiated until you have received an approval letter from the Research Office.

Documentation Required:

The Trust must be in receipt of the following documentation before the governance review can be undertaken and the research authorised to commence:

• copy of project protocol (electronic copy where internal peer review is required)
• locked pdf IRAS ethics application form with hard copies of signature pages
• XML file of the locked IRAS ethics application form
• evidence of favourable ethical opinion
• evidence of scientific peer review (for externally funded projects)
• copy of patient information sheet, consent form, GP letter and any other  relevant project documents
• confirmation that all non-NHS investigators for the project have an Honorary Contract
• up to date CVs for all staff working on the project on RBHT premises
• evidence that any costs to the Trust will be covered

In addition, the Research Office must also be informed prior to any IRAS submission, other regulatory submission or locking of the ethics application if you wish the Trust to sponsor the study.

On receipt of the above documentation the Research Office will consider some but not necessarily all of the following requirements, which would need to be addressed subject to the nature of the research sponsor and/or funder:

• review of application and protocol. For projects which have not been externally-peer reviewed there will be  an internal scientific review
  
• intellectual property
• indemnity arrangements
• documented agreements:  commercial/confidentiality/MTA agreements
• regulatory requirements: clinical trials authorisation
• role of the sponsor:  identification and documentation of  responsibilities
• any costs to the Trust