What is a 'Person Responsible'?

The 'Person Responsible' is a specific legal role defined by the Human Fertilisation and Embryology Act 1990.

The Act says each clinic will have a named Person Responsible who is the individual regarded as having supervisory responsibility for activities licensed under the provisions of the Act.

Effectively, they are the person responsible for making sure that the clinic complies with the requirements of the law and HFEA rules. As part of this they are responsible both for the quality of service provided and the ethical issues faced in providing that service.

The Person Responsible is subject to an assessment by an HFEA Licence Committee and there is an inspection of the premises where the activities are performed.

The Person Responsible is the point of contact at a clinic for:

• The dissemination and collection of information and Directions (new rules).
• The organisation of inspections and risk assessments.
• The reporting of adverse incidents and
• The person who will be responsible for putting changes into place and working with the HFEA on follow up inspections or communications.

Global expansion of assisted conception has underlined the need for worldwide standards of safety and quality in the transfer of tissue and gametes leading to the introduction by the EU of a regulatory framework - The EU Tissues and Cells Directive. This was incorporated into UK law with effect from 5 July 2007.

To ensure compliance with the Directive every Centre will have to appoint a 'responsible person'. In the UK this will be the same as the Person Responsible.

The Centre will be licensed and inspected in a similar way to the present legislation excepting that there will be wider requirements as indicated below.

The Directive requires, by law, every Centre to:

• Implement a comprehensive quality system.
• Comply with the requirements of licensing including conditions for the import and export of tissues.
• Have written agreements with third parties.
• Staff will be trained to perform tasks competently.
• Ensure the traceability of tissues, products and materials using a unique coding system.
• Select, evaluate and obtain the consent of donors according to the Directive's standards.
• Receive, test, process, store and distribute tissues according to the Directive's standards.
• Report serious adverse incidents.

Read about the job requirements (download PDF 19.3Kb) of a Person Responsible.