1. The Select Committee was appointed in March 2001 to review issues arising out of the Human Fertilisation (Research Purposes) Regulations 2001. The Regulations extended the purposes for which research on human embryos could be undertaken under licence from the Human Fertilisation and Embryology Authority (HFEA) from purposes concerned with reproduction in the Human Fertilisation and Embryology Act 1990 to three additional purposes:

(a)  increasing knowledge about the development of embryos,

(b)  increasing knowledge about serious disease, or

(c)  enabling any such knowledge to be applied in developing treatments for serious disease.

It is important to keep in mind that the Regulations are concerned only with research, not with treatment.

2. The Committee considered a considerable body of oral and written evidence and examined both the scientific and ethical aspects of its terms of reference in depth.

3. Concerns had been expressed about the Regulations on three main grounds:

(a)  that they were unnecessary, because developments in adult stem cell research made research on early human embryos unnecessary;

(b)  that they were unethical as they permitted the use of early human embryos for wide-ranging research purposes; and

(c)  that they represented a significant step on the path to human reproductive cloning.

We examined each of these issues.

4. Stem cells are cells found in the embryo (ES cells), but also in many parts of the human body, which have the capacity to develop ("differentiate") into different cell types. As such, they have great potential for use in therapies to regenerate tissues in a wide range of serious, but common, diseases. Recent developments in research on adult stem cells have led some to claim that work on ES cells is no longer necessary. We examined in detail the potential of stem cells for developing new therapies and the relative advantages and disadvantages of adult stem cells and ES cells. Adult stem cells have great therapeutic potential and research on them should be strongly encouraged. Nevertheless there is a clear scientific case for continued research on ES cells, in order that the full potential of adult stem cells for therapy can be realised and because it is likely that some therapies will need to use ES cells.

5. The public debate reflects strongly differing views on whether or not the early embryo should be given the full protection due to a person. We set out the arguments in the body of the report. The Committee believes that the issue cannot be looked at in isolation but must take account of the law as it has developed over the last 30 years. That is the background to the Committee's conclusion that whilst respecting the deeply held views of those who regard any research involving the destruction of the early embryo as wrong, and having weighed the ethical arguments carefully, it is not persuaded, especially in the context of the current law and social attitudes, that all research on human embryos should be prohibited.

6. Most research on early embryos uses "surplus" embryos left over from IVF treatment. But the 1990 Act allows embryos to be created for research. The number created has been much smaller than the number of surplus embryos donated for research. In the Committee's view embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need that cannot be met by the use of surplus embryos.

7. The 14 days limit on research on early human embryos should remain.

8. Cell nuclear replacement (CNR) involves the replacement of the nucleus of an egg with the nucleus of a cell from another individual (to produce an embryo that is the "clone" of the donor). The implantation of such an embryo in a woman (commonly called "reproductive cloning") was made a specific criminal offence by the Human Reproductive Cloning Act 2001. There have been calls to prohibit the use of CNR for research purposes as well. The majority scientific view seems to be that CNR is more likely to be used as a research tool, which would assist the understanding of the behaviour of adult stem cells and how they might be manipulated, than as the basis for general therapies in its own right. In the Committee's view that is a sufficiently serious and important objective, particularly if the potential of adult stem cells is to be realised, to justify the use of CNR, if licensed by the HFEA, provided that (as with embryos created by IVF for research) embryos are not created by CNR unless there is a demonstrable and exceptional need that cannot be met by the use of surplus embryos.

9. We have examined the issues surrounding reproductive cloning, mainly because of the fear that allowing CNR for research purposes would increase the likelihood of its being used to try to produce a cloned baby. There are very strong scientific and ethical objections to reproductive cloning. The Committee unreservedly endorses the legislative prohibition on it and calls on the Government to support any moves to negotiate an international ban. However, we do not believe that the risk of reproductive cloning is such as to justify prohibiting the use of CNR for research. The HFEA has an excellent record in ensuring that IVF clinics comply with the law, and the Committee is satisfied that its regulatory powers, now reinforced by a specific statutory prohibition, provide sufficient protection against the development of CNR leading to reproductive cloning in the United Kingdom.

10. The Committee also considered a number of other issues arising out of the Regulations.

REGULATION

11. The HFEA's role is crucial to the effective regulation of research on human embryos and the maintenance of public confidence in the regulatory regime. The Government should keep the funding of the HFEA under review and ensure that it is commensurate with its increased responsibilities. It is also important that there should be closer monitoring of the outcomes of research licensed by the HFEA, and the Committee invites the HFEA and the Department of Health to consider how such a review might be undertaken and updated on a regular basis.

THE WORDING OF THE REGULATIONS

12. There is no definition of "serious disease" in the Regulations, which could cause uncertainty. We invite the Department of Health to draw up guidance on the matter.

13. There is not a perfect match between the basic research on stem cells that currently needs to be undertaken and the wording of the purposes in the Regulations. While the Regulations can be construed without strain so as to encompass basic research, the Government should consider putting the matter beyond doubt when a legislative opportunity arises.

A STEM CELL BANK

14. Stem cell "lines" derived from a single early human embryo can be maintained in culture, in principle indefinitely. As more of these lines are developed it is important that a stem cell bank should be set up for research purposes as a matter of urgency to ensure that there is a single body responsible for the custody of stem cell lines, ensuring their provenance and purity and monitoring their use. In that way stem cell lines can be made widely available to reputable researchers and an overview maintained of their use. Over time this will reduce the need for research on early human embryos.

INFORMED CONSENT

15. To ensure that informed consent to the donation of embryos for research is freely given—and seen to be freely given—it should be standard practice that the prospective researcher is not the same as the person giving the IVF treatment. The "immortality" of stem cell lines makes the operation of procedures for giving informed consent particularly important where the research is intended to lead to their generation. The Committee recommends that the authorities concerned ensure that the implications arising from the "immortality" of stem cell lines are fully covered in obtaining informed consent from donors.

The Committee's detailed conclusions and recommendations are as follows:

stem cell research

  (i)  Stem cells appear to have great therapeutic potential for the treatment of many disorders that are both common and serious and for the repair of damaged tissue.

  (ii)  Until recently most research on stem cells has focussed on ES cells from animals and the derivation of ES cell lines from them; cell lines from human ES cells have the potential to provide a basis for a wide range of therapies.

  (iii)  Recent research on adult stem cells, including stem cells from the placenta and umbilical cord, also holds promise of therapies; and research on them should be strongly encouraged by funding bodies and the Government.

  (iv)  To ensure maximum medical benefit it is necessary to keep both routes to therapy open at present since neither alone is likely to meet all therapeutic needs.

  (v)  For the full therapeutic potential of stem cells, both adult and ES, to be realised, fundamental research on ES cells is necessary, particularly to understand the processes of cell differentiation and dedifferentiation.

  (vi)  Future developments might eventually make further research on ES cells unnecessary. This is unlikely in the foreseeable future; in the meantime there is a strong scientific and medical case for continued research on human ES cells. (i-vi paragraph 3.22)

status of the early embryo

  (vii)  Whilst respecting the deeply held views of those who regard any research involving the destruction of a human embryo as wrong and having weighed the ethical arguments carefully, the Committee is not persuaded, especially in the context of the current law and social attitudes, that all research on early human embryos should be prohibited (paragraph 4.21).

  (viii)  Fourteen days should remain the limit for research on early embryos. (paragraph 4.22)

  (ix)  Embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos. (paragraph 4.28)

cell nuclear replacement and cloning

  (x)  Basic research is a necessary step to developing treatments and facilitating the potential use of adult stem cells and should be permitted under the Regulations in the same way as more directly applied research to which it is designed to lead, provided that it is subject to strict regulation. (paragraph 5.4)

  (xi)  Although there is a clear distinction between an IVF embryo and an embryo produced by CNR (or other methods) in their method of production, the Committee does not see any ethical difference in their use for research purposes up to the 14 days limit. (paragraph 5.13)


  (xii)  Even if CNR is not itself used directly for many stem cell-based therapies, there is still a powerful case for its use, subject to strict regulation by the HFEA, as a research tool to enable other cell-based therapies to be developed. However, as with embryos created by IVF for research, CNR embryos should not be created for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos. (paragraph 5.14)


  (xiii)  If CNR is permitted in certain limited circumstances, oocyte nucleus transfer should also be allowed for research purposes. (paragraph 5.20)


  (xiv)  Given the high risk of abnormalities the scientific objections to human reproductive cloning are currently overwhelming. (paragraph 5.21)


  (xv)  There are further strong ethical objections in addition to those based on the risk of abnormalities, although not all the arguments deployed against reproductive cloning are equally valid. The most powerful are the unacceptability of experimenting on a human being and the familial and child welfare considerations arising from the ambiguity of the cloned child's relationships. (paragraph 5.21)


  (xvi)  The Committee unreservedly endorses the legislative prohibition on reproductive cloning now contained in the Human Reproductive Cloning Act 2001. (paragraph 5.21)


  (xvii)  The HFEA has an excellent record in ensuring that IVF clinics comply with the law, and we are satisfied that its regulatory powers, now reinforced by a specific statutory prohibition, provide sufficient protection against the development of CNR leading to reproductive cloning in the United Kingdom. (paragraph 5.24)


  (xviii)  The Government should take an active part in any move to negotiate an international ban on human reproductive cloning. (paragraph 7.22)

legislation and regulation

  (xix)  At an appropriate time, perhaps towards the end of the decade, the Government should undertake a further review of scientific developments, particularly of the progress of adult stem cell research and therapies, and of the development of stem cell banks, with a view to determining whether research on human embryos is still necessary. (paragraph 8.4)


  (xx)  The Government should keep the funding of the HFEA under review and ensure that its resources are commensurate with its increased responsibilities. (paragraph 8.5)

  (xxi)  The HFEA and the Department of Health should consider how a review of the outcomes of research licensed under the Act might be undertaken and updated on a regular basis (paragraph 8.6)

  (xxii)  The Department of Health should examine with the HFEA the possibility of drawing up indicative guidance as to what constitutes serious disease (paragraph 8.9)

  (xxiii)  When the Government bring forward legislation they should consider making express provision for such basic research as is necessary as a precursor for the development of cell-based therapies (paragraph 8.15)

  (xxiv)  The separation of clinical and research roles should be standard practice for donation of eggs or embryos. The prohibition in the United Kingdom of payment to donors for gametes has been an important element in preventing undesirable commercialisation of this aspect of assisted reproduction and should be strictly maintained (paragraph 8.21)

  (xxv)  The Department of Health should consider either establishing a body similar to the Gene Therapy Advisory Committee with oversight of clinical studies involving stem cells, or extending the membership and remit of GTAC to achieve the same ends. The Committee sees no other special need at present for additional regulation of the use of stem cells in the treatment of patients (paragraph 8.23)

  (xxvi)  The Department of Health's proposals to establish a stem cell bank overseen by a steering committee, responsible for the custody of stem cell lines, ensuring their purity and provenance and monitoring their use, are endorsed. As a condition of granting a research licence, the HFEA should require that any ES cell line generated in the United Kingdom in the course of that research is deposited in the bank. Before granting any new licence to establish human ES cell lines, the HFEA should satisfy itself that there are no existing ES cell lines in the bank suitable for the proposed research. (paragraph 8.29)


  (xxvii)  The HFEA should ensure that the implications arising from the "immortality" of stem cell lines are fully covered in obtaining informed consent from donors giving embryos for the potential establishment of ES cell lines for research. To prevent future restrictions in using ES cell lines (and therefore minimise the need to generate new ES cell lines) the HFEA should not permit ES cell lines be generated from donated embryos unless informed consent places no specific constraint on their future use. Where parents wish to restrict the type of research which can be undertaken, for example specifically for reproductive purposes, the embryos donated should be used for purposes other than the generation of ES cell lines. (paragraph 8.33)