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Ethics / MHRA

Applying for Ethical Approval

Does my research require Ethical Approval? 

Ethical approval from the appropriate NHS REC is required for any research proposal involving: 

  • Patients or users of the NHS.  This includes all potential research participants recruited by virtue of the patient or user's past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above 
  • Access to data, organs or other bodily material of past and present NHS patients
  • Fetal material and IVF involving NHS patients 
  • The recently deceased in NHS premises
  • The use of, or potential access to, NHS premises or facilities
  • NHS staff - recruited as research participants by virtue of their professional role or as applicants. If you are unsure whether your project requires ethical approval, you are advised to contact NRES for advice. This allows you demonstrate that, in the event of your research being audited or at publication stage, a proper process was followed.  

For further information on Ethics and their process, please visit the NRES website 

To apply for Ethical opinion or MHRA approval please visit the Integrated Research Application System (IRAS) here: www.myresearchproject.org.uk  

The local contact details for the Ethics Committee are:

South Central – Portsmouth
South West REC Centre
Level 3, Block B
Lewins Mead

Coordinator's email: scsha.sehrec@nhs.net
Coordinator's Tel: 0117 342 1382
Fax: 0117 342 0445


Applying for MHRA Approval 

The Medicines for Human Use (Clinical Trials) Regulations (2004) legally obligate  researchers to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) prior to starting a Clinical Trial of an Investigational Medicinal Product (CTIMP). A clinical trial algorithm has been produced by the MHRA to help determine whether you need a CTA or not.  

For commercially funded and sponsored clinical trials the commercial company will apply for a CTA on your behalf. 

For further details on the MHRA and their process, please visit the MHRA website. 

For guidance on developing CTIMPS please go to the Clinical Trials Tool Kit. 

Obtaining an EudraCT Number 

If your trial falls under The Medicines for Human Use (Clinical Trials) Regulations (2004) you are required to register your trial on the EudraCT database and obtain a EudraCT number using the on-line registration system. Each trial is allocated a unique number which becomes the main identifier for the trial. This number should be used on all correspondence with the MHRA, Ethics Committees and when reporting amendments or serious adverse events. 

To obtain a EudraCT number please go to the EudraCT webpage and follow the online instructions. 

To apply for Ethical opinion or MHRA approval please visit the Integrated Research Application System (IRAS) here: www.myresearchproject.org.uk

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Last updated - 30 May 2014
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