Version 1

The regulatory principles refl ect the HFEA’s key regulatory priorities from the Human Fertilisation and
Embryology Act.

They provide:

  • a summary of the key behaviours and outcomes the HFEA expects each licensed centre to demonstrate,
  • a means of communicating to the person responsible and staff at each licensed centre, patients, donors,
    donor-conceived people and the public the areas of compliance that the HFEA regards as key.

The principles inform every part of this Code of Practice. Each of the guidance notes in the Code is linked to one
or more principles and should be read in conjunction with these.

  • 1.

    treat prospective and current patients and donors fairly, and shall not discriminate against them unlawfully;

  • 2.

    have proper respect for the privacy, confidentiality, dignity, comfort and well being of patients and donors;

  • 3.

    have proper respect for the special status of the embryo when conducting licensed activities;

  • 4.

    take proper account of the welfare of any child who may be born as a result of the licensed treatment provided by them and any other child who may be affected by that birth;

  • 5.

    provide prospective and current patients and donors with sufficient, accessible and up-to-date information in order to allow them to make informed decisions;

  • 6.

    ensure that patients and donors have provided all relevant consents, before any licensed activity is undertaken;

  • 7.

    conduct all licensed activities with proper skill and care and in an appropriate environment, in accordance with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring;

  • 8.

    ensure that all premises, equipment, processes and procedures used in the conduct of licensed activities are safe, secure and suitable for purpose;

  • 9.

    ensure that all staff engaged in licensed activity are competent and recruited in sufficient numbers to guarantee safe clinical and laboratory practice;

  • 10.

    maintain proper and accurate records and information about all licensed activities;

  • 11.

    report all adverse incidents (including serious adverse events and reactions) to the HFEA, investigate all complaints properly, and share lessons learned appropriately;

  • 12.

    ensure that all licensed research that they undertake meets proper ethical standards, and is only undertaken where there is both a clear scientific justification and no viable alternative to the use of embryos;

  • 13.

    conduct all licensed activities with proper regard for the regulatory framework governing treatment and research involving gametes or embryos within the UK. including:

    • maintaining up to date awareness and understanding of legal obligations;
    • responding promptly to requests for information and documents from HFEA; and
    • co-operating fully with inspections and investigations by HFEA or other agencies responsible for law enforcement or regulation of healthcare.

Code of Practice edition: 8