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23 February 2005

Dear Colleague

Reporting of adverse incidents in research centres

Following a misunderstanding of what research centres should be reporting as adverse incidents, I am writing to clarify that research centres are expected to adhere by the requirements outlined in parts 2.23 to 2.26 of the Code of Practice (6th edition) and those set out in General Directions on Reporting Adverse Incidents (D2004/3).

Therefore all research centres must report all their adverse incidents to the HFEA within 12 working hours of the identification of the incident and submit an Incident Report Form within 24 working hours. Adverse incidents are defined as any event, circumstance, activity or action which has caused, or has been identified as potentially causing harm, loss or damage to patients, embryos and / or gametes, or to staff or a licensed centre. All breaches of the HF&E Act and / or breaches of the HFEA Code of Practice must be reported as an adverse incident to the HFEA.

If you require any additional information please do not hesitate to contact Stephanie Sullivan, Head of Clinical Governance and Patient Safety, either by telephone on 020 7291 8255 or via e-mail at stephanie.sullivan@hfea.gov.uk.

Yours sincerely

 

Angela McNab

Chief Executive

 

 

Page last updated: 24 August 2012

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