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Regulatory Bodies

Regulatory Bodies

The R&D Department will advise you of which approvals your study needs:

  • Health Research Authority (HRA): The HRA was established in December 2011. Its main purposes now, in accordance with the Care Act 2014, are to protect and promote the interest of patients and the public in health and social care research, co-ordinate and standardise practices relating to regulation, recognise and establish Research Ethics Committees (RECs), be a member of UK Ethics Committee Authority (UKECA), promote transparency in research and provide approvals for the processing of confidential information relating to patients.
  • NHS Research Ethics Committee (REC) approval:  Depending on the research project you may require NHS REC approval, or 
  • University Ethics Approval:  If your research project does not involve NHS patients, their records or tissue, NHS premises or facilities, but does involve healthy volunteers (such as DHFT staff) then you may need University Ethics approval.
  • Medicines and Healthcare Products Regulatory Agency (MHRA) approval: If your research project is a Clinical Trial involving an Investigational Medicinal Product (CTIMP) or a trial of using Medical Device then you will need MHRA approval.
  • Confidentiality Advisory Group (CAG):  If you wish to access patient information without obtaining consent  then you will need approval from CAG.
  • Gene Therapy Advisory Committee (GTAC)  If your research project involves project involves Gene Therapy then you will need to seek advice from GTAC.

Other Potential Approvals

The R&D Department will advise you on the specific requirements for your research study. Amongst some of the approvals required are:

  • Relevant contract to conduct research at DHFT

 If you do not have any contractual relationship with the NHS and you are proposing to carry out research in the NHS then you will need a contract to carry out this research. The Research Passport system will enable you to obtain permission for research from NHS organisations.

  • Data Protection

Any personal identifiable data that is collected or transferred during the research project needs to be appropriately safeguarded to ensure confidentiality of those participating in the research.  

  • Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER)

The research projects that require exposing participants to any ionising radiation require IRMER approval (even if the exposure is part of routine clinical care). Procedures including but not limited to X-rays including mammograms and fluoroscopy, CT scans, DEXA scans, radiotherapy and radionucleotide imaging require IRMER approval.

  • An Administration of Radioactive Substances Advisory Committee (ARSAC) 

The research projects that requires the administration of radioactive substances to patients or other persons that is outside of routine clinical practice will require ARSAC review and approval. Procedures including but not limited to PET scans, bone scans, Multi Gated Acquisition Scan (MUGA) and brachytherapy require ARSAC approval.