R&D Approval


NHS Grampian is obliged to meet national research guidelines set out in the Link opens in new windowResearch Governance Framework. It is essential that all clinical research activity is registered and approved by the Research and Development Office on behalf of NHS Grampian prior to a study commencing.

 

When is it Required?

R&D Management Permission (also known as R&D Management Approval) is required for research involving:

  • NHS staff
  • Patients
  • Tissues
  • Organs
  • Data
  • NHS facilities
  • NHS equipment

Please note - NHS indemnity cover (for negligent harm) is only extended to employees involved in research that have R&D Management Permission from the Research and Development Office. Liability for any activity that has not been registered and approved will not be accepted by NHS Grampian.

 

How Do I Apply - Non Commercial Research?

The documents required to gain R&D Management Permission which must be obtained prior to study start-up are:

  • Signed R&D version of the IRAS form, including signature from sponsor 
  • Completed and signed (by local investigator) SSI form, including any relevant authorisations e.g support departments (SSI is generated within IRAS)
  • Ethics favourable opinion letter
  • External authorisations e.g. MHRA authorisation , FHEA, GTAC, ARSAC licence, if required
  • Caldicott Guardian approval, if required
  • Research passport application, honorary contract or letter of access, if required
  • Copies of all study documentation approved by ethics e.g. protocol, consent form, patient information sheet
  • Copy of peer review if study has no external funding
  • CV, signed and dated for all members of the research team
  • Copy of any grant application and subsequent award letter where relevant
  • Insurance certificate (not required for University of Aberdeen)
  • Evidence of attendance at a Good Clinical Practice (GCP) course within the last 2 years
  • Clinical Trial Agreement (if required)


Providing electronic documents will speed up the process considerably.
Please send to grampian.randdpermissions@nhs.net

Please contact the R&D Office on 01224 553846 for any further information or guidance.

 

 

How Do I Apply - Commercial Research?

For details on how to gain R&D Management Permission for Commercial Research please see the Commercial Studies section of the website.