APPENDIX 4
Memorandum submitted by Professor Austin Smith, Centre for Genome Research, University of Edinburgh
1. I hold an HFEA licence to derive stem cells from human embryos, to explore their use for therapy. I have a number of comments on the functioning of the HFEA and forthcoming issues that it will have to face.
2. The HFEA provides no guidelines for drawing up consent forms for embryo donors and gives no advice to the licence applicant. Also, the HFEA is liable to revise its opinion on a form's acceptability: I have had a form accepted on one occasion only for the HFEA to find fault with it subsequently. There is no evidence of any communication with local ethics committees. A consent form needs to be acceptable to the ethics committee and the HFEA and finalising a form can be a frustrating process. The HFEA should come up with a standard pro forma, after consultation with local ethics committees.
3. For research to progress, we will need stem cell banks with a wide range of cell types. Stem cell banks will need the force of law. At the moment there are few stem cell lines and all are in the hands of private companies. The HFEA seems to have had no view on this issue which is regrettable given the pivotal role it has in the creation of stem cell lines.
4. Because we may need a panel of embryonic stem cells for immunological reasons, e.g. from people with different ethnic backgrounds, embryos will also need to be created especially for research. We may need to prepare the public for this and the HFEA should play a role in this process.
5. While high staff turnover may be a factor, I have found HFEA's secretariat to be inefficient (my letters have been lost and telephone calls unanswered) and lacking in specialist knowledge. Unfortunately, the HFEA's committees seem insufficiently familiar with the science also. In responding to my queries, it seems that the HFEA looks to the Medical Research Council for specialist input, who in turn ask for my view, with the result that I am asked my view of a ruling which I am seeking. Research regulation seems to be at the margin of their activities.
6. In general, the HFEA is a slow and reactive body and a frustrating body to deal with. It effectively prevents inappropriate research but does nothing to facilitate appropriate research. The UK is in a strong position to be a world leader in this area of research and its applications. While robust regulation is important in such a sensitive area, this needs to be implemented without undermining the research. If underfunding is shown to be the cause of the HFEA's problems, I would welcome an increase in its expenditure limit.
July 2002
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