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15 February 2006

All research projects are considered on a case by case basis. Any underlying policy is used to inform the deliberations the HFEA licence committee which will rule whether a particular research project should be allowed to go ahead. In each case, the licence committee consider the origin and number of gametes that may be used in the course of the research and this is monitored throughout the life of the project

Following today's meeting, HFEA staff will now bring together the extra information requested, including

• building on existing good practice from the conduct of medical trials,
• comparison with the rules protecting 'vulnerable' groups of people in research trials
• standards for the information given to people taking part, including an honest assessment of the timescale and success of the research.
• work on understanding the potential financial relationships between research centres and the clinics recruiting and handling the donors.

A revised recommended structure for the policy, which includes the information requested, will be put together for discussion at the May meeting of the Authority. This document will be published on the HFEA website before that meeting.

Dame Suzi Leather, Chair of the HFEA, said:

"The ethics and scrutiny of research projects is an important area of public concern and we are determined to do this to the best of our ability. We are committed to maintaining a broad consensus on embryo research and it is important that we strike a balance between providing safeguards for patients and the interests of scientists.

"The Authority members have an enormous breadth of knowledge and experience and, in our discussion today, they raised a number of important issues around the proposals that we discussed today where they felt our deliberations would benefit from extra information.

"We have asked HFEA staff to bring together this extra information, in particular on models to ensure protection of people coming forward to donate eggs, sperm and embryos, and we will discuss these proposals further at our next public meeting in May."

Ends

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Notes to editors

The HFEA started to look at donation for research as part of its review of of egg, sperm and embryo donation in 2005 ('The SEED Review'). Proposals for a coherent policy around donation for research have been reviewed in the context of the ethical problems of research in Korea and were discussed at a public meeting of the Authority on 15 Feb 2006.

Decisions of the acceptability of any research project - including details of how the researchers will obtain the eggs, sperm or embryos that they proposed to use - are always carried out by an HFEA licence committee on a case by case basis. Any overall policy would be used to inform, but not determine, these decisions.

People have been donating eggs, sperm and embryos to medical research for many decades, for example to help investigate techniques around egg freezing. Hundreds of eggs are currently donated directly to research each year.

Research involving eggs and sperm alone (ie not involving the creation of embryos) does not fall within the remit of the HFEA and is overseen by local research ethics committees.

The HFEA licences and regulates research projects which involve the use or creation of embryos (such as disease-specific and patient-specific stem cells). An integral part of the regulation of embryo research is close scrutiny of how and where the clinics obtain the eggs, sperm or embryos for their research project. This includes ensuring that those people who donate eggs sperm and embryos have proper information about the consequences and risks of their donation and ensuring their consent is given freely and voluntarily.

Page last updated: 11 March 2009

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