CH(01)08
06 June 2001
Dear Colleague,
The Human Fertilisation And Embryology Act 1990: Access To Confidential Information
The Human Fertilisation and Embryology Act 1990 exercises strict controls over who can have access to confidential, identifying information about patients, donors and their treatment. Unless specific consent is given by the patients/donors themselves, only the members and staff of the HFEA or those persons to whom an HFEA licence applies can have access to such information. This latter group is defined in Section 17(2) of the Act as follows:
(2) References in this Act to the persons to whom a licence applies are to -
(a) the person responsible,
(b) any person designated in the licence, or in a notice given to the Authority by the person who holds the licence or the person responsible, as a suitable person to whom the licence applies, and
(c) any person acting under the direction of the per son responsible or of any person so designated.
To the best of the Authority's understanding, very little use is made of sub-section (c). This sub-section allows for circumstances where it might not be practical to include staff on the licence. One example of this might be a private hospital where the nursing staff work in all departments, on rotation. The sub-section would also permit the use of temporary or casual staff but, in such cases, considerable caution must be exercised.
As you will know, the Authority has followed the practice of asking that all staff having access to identifying information be notified to the Authority so they can be named on the centre's licence. However, in some cases this has resulted in any staff involved in a unit, whether permanent or temporary and whatever their duties, being included on the licence. The Authority recognises that there may be circumstances where this is not necessary.
The HFE Act places a clear duty on the person responsible to ensure the integrity of the character and qualifications of any staff working within a licensed centre. Section 17(l)(a) of the Act states;
(a) That the persons to whom the licence applies are of such suitable character, and are so qualified by training and experiences, as to be suitable persons to participate in the activities authorised by the licence.
This requirement applies equally to temporary or casual staff. Many centres have informed the Authority that it has not been possible to make arrangements with local employment agencies to ensure that only known staff are supplied. However, the Authority would be concerned if a centre was to allow unknown temporary staff, who may only be present in the unit for one day to cover administrative work, to have access to confidential information, without any attempt to assess their suitability under Section 17(l)(a) or to ensure that they fully understood of the duty of confidentiality placed on them.
Where staff are to be employed under the direction of the person responsible or a designated staff member, the Authority strongly advises the centre to obtain completion of a personal declaration to indicate that the person fully understands the confidentiality requirements of the HFE Act, and is aware of the requirement of compliance with the HFEA's Code of Practice. A model version of such a form is attached. All persons responsible are asked to ensure that a copy of any model declaration form to be used in their centre is submitted to their inspector co-ordinator.
If you have any queries about this letter please contact your inspector co-ordinator or, alternatively, Jo Rippington in the Policy department, by phone at Paxton House or by e-mail at jo.rippington@hfea.gov.uk.
Yours sincerely,
Ruth Deech
Chairman
Confidentiality Declaration form (25 Kb)
Page last updated: 14 April 2009