The Person Responsible (PR) is the individual named on a UK fertility clinic’s HFEA licence who is personally accountable to the HFEA for all licensed activities carried out at that clinic. The role is defined in the Human Fertilisation and Embryology Act 1990 (as amended) and is one of the most significant regulatory roles in UK fertility medicine.
What the Person Responsible Is Accountable For
The PR must be a clinician or scientist with the appropriate competence and qualifications to oversee licensed activities. They are responsible for ensuring the clinic operates in compliance with the HFEA Code of Practice and licence conditions, that all staff involved in licensed activities are suitably trained and supervised, that consent procedures are correctly applied, and that the premises and equipment meet the standards required for licensed work.
The PR is the primary contact for the HFEA in relation to compliance matters. They are expected to be involved in preparing for and responding to HFEA inspections, addressing any conditions or observations raised in inspection reports, and notifying the HFEA of any significant adverse incidents.
The Person Responsible cannot delegate the legal accountability that comes with the role. A clinic with excellent operational systems and a well-run laboratory still depends on the PR being engaged, informed and actively overseeing compliance. The role is not a figurehead position – it carries direct personal regulatory accountability.
Equipment and consumable standards that support HFEA compliance – including properly maintained storage vessels, validated vitrification kits and documented safety wear provision – underpin the Person Responsible’s ability to demonstrate compliance at inspection. Contact Cryolab to discuss your clinic’s equipment requirements.
