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Who Provides R&D Approval?

Commercial

Commercial research is defined as research that is funded and sponsored by a commercial organisation.  A study is defined as industry sponsored and funded if a commercial company has developed the study protocol and is fully funding the additional costs of hosting the trial within the NHS. These trials must be supported by a Clinical Trials Agreement and appropriate indemnification.  

The Co-ordinators for Commercial research in NHS GG&C are:

Click here for further information on Commercial Research, including details on the specific therapy areas covered by each Portfolio Team

Non Commercial NHS GG&C Sponsored 

A ‘sponsor’ is defined as – an individual or organisation that takes on responsibility for confirming there are proper arrangements in place to initiate, manage, monitor and finance a study. Sponsors must also ensure that appropriate indemnity is in place before research begins. 

The Co-ordinators for Non Commercial research Sponsored by NHS GG&C are:

Click here for further information on NHS GG&C Sponsored Research, including details on the specific therapy areas covered by each Portfolio Team

Non Commercial NHS GG&C Hosted

For all Non Commercial studies that aren’t Sponsored by NHS GG&C, the Research Facilitators will be: 

Click here for further information on NHS GG&C Hosted Research, including details on the specific therapy areas covered by each Portfolio Team

Low Risk Non Commercial NHS GG&C Sponsored and NHS GG&C Hosted

The Proportionate Review (PR) Team deal with the approvals for all “low risk” studies.  We have deemed "low risk" studies to be all Study Types from the IRAS Form that are: 

  1. Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
  2. Study involving qualitative methods only
  3. Study limited to working with human tissue samples (or other biological samples) and data (specific project only)
  4. Study limited to working with data (specific project only)
  5. Research tissue bank or Research database
  6. Patient Information Centres (PIC)
  7. “Other” studies