UK's Department of Health consults on disclosure of identifying information for research

On 8 October 2009, the UK's Department of Health (DH) announced the launch of a public consultation regarding amendments made to the draft Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations. The Regulations establish a process for determining whether identifying information held on a fertility treatment register maintained by the Human Fertilisation and Embryology Authority (HFEA) is justified to be disclosed for the purposes of research, when it was not practicable to obtain consent to the disclosure from the persons to whom the information related.

Since 1991, the HFEA has maintained a register of information that is one of the most comprehensive data banks of its kind in the world - including information about the use of donors of gametes and/or embryos, the patients, their partners and any resulting children. It is commonly considered to be a valuable resource in that if available to researchers it could help to answer questions regarding the long-term health and social effects of certain fertility treatments.

In certain instances consent is not reasonably practicable to obtain. For example, seeking consent to release identifying information to researchers about a child resulting from treatment may be problematic once the successfully pregnant mother leaves the clinic's care for routine medical care during her pregnancy and then becomes a busy newborn mother. Thus, a key amended provision would allow research bodies to seek access to identifying information recorded on the HFEA's register, from 1 October 2009, about a child born as a result of fertility treatment, where it is not practicable to obtain consent to the disclosure from the child’s parent or guardian.

This is the second consultation conducted by the UK Government on the disclosure Regulations. The first public consultation exercise which was held earlier this year, from 5 January - 30 March, when considering Regulations that might help implement the Human Fertilisation and Embryology (HFE) Act 2008 provisions. The draft Regulations were amended in response to the first consultation and the Government now seeks comment on the amendments. The consultation will remain open for comments until 2 December 2009. Once public opinion, including the opinion of practitioners and advocacy groups, has been consulted in the development of the Regulations then they will be subject to the approval of Parliament. If passed through both Houses of Parliament, the Government has timetabled commencement into law from 10 April 2010.

The Regulations also provide specifics about the amount the HFEA can charge for the collation and provision of this information - ranging from £250 per half day to a maximum of £5,000. Another key amended proposal is to increase the powers of the National Information Governance Board for Health and Social Care (NIGB) to take on part or all of the HFEA's statutory function of assessing applications from research bodies for disclosure, provided the HFEA requests this assistance.