18 October 1999
To: All Persons Responsible
Dear Colleague,
Disclosure of Confidential Information to Researchers
The HFEA, while not established as a research body, is very supportive of infertility research especially follow-up studies. To facilitate such work the HFEA has obtained legal advice on the disclosure of confidential information to researchers by licensed centres. This letter makes it clear that such studies can be done, but only if they are conducted in compliance with legislative requirements, and explains the procedure that clinics should in future adopt. By so doing clinics will be able to reassure their patients that information about their treatments will not be given to "outsiders" without their knowledge and permission. The procedures explained below are required by current legislation.
The HFEA's lawyers have advised that designating the name of a researcher on a centre's licence may not be sufficient to justify disclosure of confidential information to that person. Consequently, licensed centres should not permit researchers access to records or data containing identifying information without first obtaining consent to such disclosure. Such consent should be to disclosure to a specific named researcher or researchers and be obtained from the individual(s) (patients) concerned in accordance with section 33(6)(b) of the 1990 Act as amended by the Human Fertilisation and Embryology (Disclosure of Information) Act 1992. If those researchers change during the course of the project, a separate consent from the patients concerned must be obtained authorising the release of confidential information to the new researcher(s). The consent form that should be used for this purpose can be found at Annex A of the Code of Practice (4th edition).
In practice this means that the Person Responsible or someone acting on their direction should, in the first instance, write to the clinic's patients. In addition to explaining the purpose of the project, consent to disclosure of information to the named researcher(s) should be obtained for that specific study, hi seeking to obtain such consent the relevant patients may find it reassuring to know that the individual researcher(s) are, or will be, designated on the centre's licence and be subject to the statutory duty of confidentiality. Once such consent has been obtained the researcher should then also write to the consenting individuals explaining the research in more detail and seeking their explicit consent to participate in the particular project.
If the researcher wishes to conduct follow up studies on children, then the licensed clinic, in accordance with the procedure described above, would first have to obtain consent from patients to their names being passed to the researcher. The researcher would then have to contact the patients to discover, first, whether any children had been born as a result of the treatment, and, second, that they are prepared for their children to be included in the study. Direct contact between researchers and children without the consent of their parents (i.e. those who received treatment services) is not permitted. Thus, while it is not possible for a researcher ever to see information recorded on a licensed clinic's files about a child born as a result of treatment, information should be available from other sources such as the parents or the child's general medical records.
Please note that the HFEA needs to be notified in advance of the name(s) of any researcher(s) to be included on a centre's licence.
You may wish-to contact Danielle Marx (Policy Manager) on 0171 539 3308 if you require any further guidance on this subject from the HFEA.
Yours sincerely,
Suzanne McCarthy
Chief Executive
Page last updated: 24 August 2012