Donation of 'spare' fresh or frozen embryos to research: Who decides that an embryo is 'spare' and how can we enhance the quality and protect the validity of consent?

Medical Law Review

Volumn 20, Issue 3, 2012, Pages 255-303

  Scott, Rosamund ^a   Williams, Clare ^b   Ehrich, Kathryn ^c   Farsides, Bobbie ^d  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b BRUNEL UNIVERSITY   (United Kingdom)

^c KING'S COLLEGE LONDON   (United Kingdom)

^d BRIGHTON AND SUSSEX MEDICAL SCHOOL   (United Kingdom)

Author keywords

Donation of fresh or frozen embryos to research including stem cell research; Ethical and legal issues in donation of fresh or frozen embryos to research; Quality and validity of consent for donation of embryos to research

Indexed keywords

ARTICLE; EMBRYO DISPOSITION; EMBRYO TRANSFER; ETHICS; FREEZING; HUMAN; INFORMED CONSENT; LEGAL ASPECT; POLICY; QUALITATIVE RESEARCH; STEM CELL RESEARCH; UNITED KINGDOM;

EMBRYO DISPOSITION; EMBRYO TRANSFER; FREEZING; GREAT BRITAIN; HUMANS; INFORMED CONSENT; ORGANIZATIONAL POLICY; QUALITATIVE RESEARCH; STEM CELL RESEARCH;

EID: 84865540308     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fws013     Document Type: Article

References (71)

1. For conflicting views on this, see eg D Hoffman and others, 'Cryopreserved Embryos in the United States and their Availability for Research' 79 Fertil Steril 1063-9, indicating that fresh embryos are better for stem-cell research. For a contrary view, see A Sjo gren and others, (2004) 9 Reprod Biomed Online 326-9 which directly compares fresh and frozen embryos. In this study, 'the efficiency by which frozen-thawed embryos gave rise to new hES cell lines was 3.7 times better than with fresh surplus embryos'. The authors continue: 'These findings suggest that frozen-thawed embryos are superior to fresh surplus human embryos in hES cell establishment, which also avoids specific ethical problems associated with embryo donation in a fresh IVF cycle.' (At 326.)2003
2. Department of Health, Stem Cell Research: Medical Progress with Responsibility, (Department of Health, London 2000),. House of Lords Select Committee on Stem Cell Research, Stem Cell Research: Report from the Select Committee (The Stationary Office, London 2002) 25.http://www.doh.gov.uk/ cegc
3. An exception from the perspective of ethics is S Holm, 'The Spare Embryo - A Red Herring in the Embryo Experimentation Debate' 1 Health Care Analysis 63-6. R Morgan's 'Embryonic Stem Cells and Consent: Incoherence and Inconsistency in the UK Regulatory Model' (2007) 15 Med Law Rev 279-319 is concerned with other important issues.1993
4. Above as detailed in the 'asterisk' note. For further details of this aspect of our research, see K Ehrich, C Williams, and B Farsides, 'Fresh or Frozen? Classifying 'Spare' Embryos for Donation to Human Embryonic Stem Cell Research' (2010) 71 (12-6
5. The interviews were conducted by Kathryn Ehrich and the EDGs by Bobbie Farsides.
6. See also HFEA, above, n 6, Licence conditions T57, R18.
7. HFEA, above, n 6, 'Interpretation of Mandatory Requirements', Box 22B.
8. A related question here is whether there should be a national grading process for embryos. There is an attempt to do this by the Association of Clinical Embryologists and there is a published grading system for blastocysts.
9. See eg HFEA, Expert Group on Multiple Births after IVF, One Child at a Time: Reducing Multiple Births after IVF (October 2006). Current figures are that more than 25% of IVF pregnancies in the UK are still multiple, that is, 40% of all IVF births are twins or tripletshttp:// www.oneatatime.org.uk
10. See HFEA, The Scientific and Clinical Advances Group, 'Embryo Transfer Review', SCAG(04/03)01,,http://www.hfea.gov.uk/docs/SCAG_Embryo_ Transfer_April03.pdf
11. HFEA Expert Group, above, n 15, Executive Summary, 8-9.
12. Personal communication: Peter Braude, Emeritus Professor, and former Head of Department of Women's Health/Centre for PGD, King's College London.
13. Our emphasis.
14. Regarding other empirical work here see also M Svendson and L Koch, 'Unpacking the 'Spare Embryo': Facilitating Stem Cell Research in a Moral Landscape' (2008) 38/1 Soc Stud Sci 93-110
15. HFEA, above, n 6, our emphasis.
16. Holm, above, n 7, 64.
17. Our emphasis.
18. Embryos cannot be kept longer than 14 days under the HFE Act 1990 (as amended), s 3(4).
19. HFEA, above, n 6.
20. As noted earlier, this is now 10 years in the UK under the HFE Act 1990 (as amended), above, n 1, s 14(4).
21. Above, n 3.
22. MRC Steering Committee, above, n 6.
23. Regarding each of these elements, see, respectively, Re M.B. [1997] 8 Med LR 217, Chatterton v Gerson [1981] 1 All ER 257, Re T (Adult: Refusal of Treatment) [1992] 4 All ER 649.
24. See also HFEA, above, n 6, Licence conditions T57, R18.
25. Re J (A Minor) (Child in Care: Medical Treatment) Fam 15; Regina (Burke) v General Medical Council (Official Solicitor and others intervening), above, n 311993
26. Re M.B. above, n 40, 224.
27. Above, n 40. There is no English case law that can be cited for the requirements of a valid consent to research. However, it is commonly understood that the requirements of capacity, information, and voluntariness are also relevant to the validity of consent to research. For a recent statement of this, see eg Nuffield Council on Bioethics: Human Bodies: Donation for Medicine and Research (Nuffield Council on Bioethics, London 2011),
28. The caveat 'almost' allows for the case of a twin birth.
29. HFEA, above, n 6, 'Interpretation of Mandatory Requirements', Box 22B.
30. In the form for donation to stem-cell research, 'Consent Form: Patient Consent to Research: Derivation of Human Embryonic Stem Cell Lines', the phrase 'embryos that are surplus/unsuitable for treatment' is also used. S Franklin, C Hunt, G Cornwell, V Peddie, and others, 'hESSCO: Development of Good Practice Models for hES Cell Derivation', (2008) 3(1) Regen Med 105-16
31. Above, n 40.
32. Re T, above, n 40.
33. [2002] EWCA Civ 565.
34. S Pattinson, 'Undue Influence in the Context of Medical Treatment' (2002) 5(4) Med L Int 305-17
35. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Healthcare Decisions: The Ethical and Legal Implications of Informed Consent in the Patient- Practitioner Relationship, Volume 1: Report (Washington, US GovernmentPrinting Office 1982) 66-8.
36. E Jackson, Medical Law: Text, Cases and Materials (2nd edn, Oxford University Press, Oxford 2009) 490.
37. MChoudhary and others, 'Demographic, Medical and Treatment Characteristics Associated with Couples' Decisions to Donate Fresh Spare Embryos for Research' (2004) 19/9 Human Reproduction 2091-6.
38. PGD involves removing a single cell from a day 3 embryo and testing it for a serious genetic condition. 'Affected embryos' are those that have tested positive for a serious genetic condition. For further discussion, see eg R Scott and others, 'The Appropriate Extent of Preimplantation Genetic Diagnosis: Health Professionals' Views on the Requirement for a 'Significant Risk of a Serious Genetic Condition'' (2007) 15(3) Med L Rev 320.
39. Choudhary and others, above, n 79, 2094, our emphasis.
40. This does not imply that a live birth would necessarily have resulted, only that there would have been a good chance of this happening.
41. Our emphasis.
42. JA Thomson 'Embryonic Stem Cell Lines Derived from Human Blastocysts' (1998) 282 Science 1145-7.
43. 'First Human Embryo Stem Cell Success' 221 Bionews. This was at King's College London using 'affected' PGD embryos. 2003
44. Personal communication, Professor Peter Braude, above, n 19. We discussed SET in Part 1 above. On the use of blastocysts in treatment and SET, see eg DK Gardner and others, 'Blastocyst Score Affects Implantation and Pregnancy Outcome: Towards a Single Blastocyst Transfer' (2000) 73/6 Fertil Steril 1155-8.
45. E Haimes and K Taylor, 'Fresh Embryo Donation for Human Embryonic Stem Cell (HESC) Research: the Experiences and Values of IVF Couples Asked to be Embryo Donors' Human Reproduction 2142-2150.(2009) 24
46. Haimes and Taylor, Above, n 94, 2144, our emphasis.
47. E. Haimes and K. Taylor, "The Contributions of Empirical Evidence to Socio-Ethical Debates on Fresh Embryo Donation for Human Embryonic Stem Cell Research", (2009) Bioethics 334-341
48. Haimes and Taylor, Above, n 94, 2144, 2147.
49. Haimes and Taylor, Above, n 97, 336, n 8. 110 A number of PCTs fund the stimulation cycle but not the subsequent freezing (250-850) nor the replacement cycle (300-990). Personal communication: Professor Peter Braude, above, n 19.
50. See also eg Holm, above, n 7.
51. HFEA, above, n 6, eg R.27: 'The centre must establish, implement and comply with documented procedures to ensure that clinical and research roles are separated.'
52. Jackson, Above, n 71, 766.
53. For recent discussion, see N Manson and O O'Neill, Rethinking Informed Consent in Bioethics (CUP, Cambridge 2007).
54. Such embryos would be what Søren Holm has called 'finally spare', and in relation to which there would be no possibility of coercion. Above, n 7, 66.
55. EL Stephenson, C Mason, and PR Braude, 'Preimplantation Genetic Diagnosis as a Source of Human Embryonic Stem Cells for Disease Research and Drug Discovery' (2008) BJOG 158-65
56. American Society for Reproductive Medicine: Ethics Committee Report, 'Donating Spare Embryos for Stem Cell Research', (2009) 91/3 Fertil Steril, 667-670. The Committee expressed the same view in its earlier opinion in 2002.
57. C McLeod and F Baylis, 'Donating Fresh Versus Frozen Embryos to Stem Cell Research: in Whose Interests?' (2007) 219 Bioethics 465-77.
58. HFEA, above, n 6, T86 and T87.
59. For recent evidence, see eg T El-Toukhy and others, 'Delayed Blastocyst Development Does Not Influence the Outcome of Frozen-thawed Transfer Cycles' (2011) 118 BJOG 1551-6
60. W Schoolcraft 'Live Birth Outcome with Trophectoderm Biopsy, Blastocyst Vitrification, and Single-nucleotide Polymorphism Microarray-based Comprehensive Chromosome Screening in Infertile Patients' Fertil Steril 638-40 (which also involved biopsy for chromosome testing).(2011) 96/3
61. For discussion of couples' highly personal views about their embryos and how this contributes to the difficulties of making decisions about frozen embryos, see eg R Nachtigall and others, 'Parents' Conceptualization of their Frozen Embryos Complicates the Disposition Decision' Fertil Steril 431-4. There is a significant body of literature on this issue.(2005) 84/2
62. For discussion of ways to help people make decisions about frozen embryos, see eg G Fuscaldo and others, 'How to Facilitate Decisions about Surplus Embryos: Patients' Views' Human Reproduction 3129-38(2007) 22/12
63. K Hug, 'Motivation to Donate or Not Donate Surplus Embryos for Stem- Cell Research: Literature Review' (2008) 89/2
64. Fertil Steril, 263-77
65. On the question of what information should be given to couples before they freeze their embryos see S de Lacey, 'Patients' Attitudes to their mbryos and their Destiny: Social Conditioning?' (2007) 21 Best Pract Res Clin Obstet Gynaecol 101-12
66. S Sheldon, 'Evans v. Amicus Health Care: Revealing Cracks in the "Twin Pillars"', (2004) 16 Child and Family Law Quarterly 437-52
67. Above, n 59.
68. S Parry, '(Re)constructing Embryos in Stem Cell Research: Exploring the Meaning of Embryos for People involved in Fertility Treatments' (2006) 62/10 Social Science and Medicine 2349-59.
69. K Hug, Above, n 129-275
70. Who also lists other factors. See also Parry, above, n 135, for further UK evidence that 'only when classified as unsuitable for reproductive treatments did participants consider their use in medical research as potentially legitimate' (at 2353).
71. (Of course, as noted earlier, couples can choose a storage term of less than the statutory maximum, and can then elect to extend the term if they wish.) We acknowledge Haimes' and Taylor's interesting alternative suggestion that couples should not be approached for donation to research in their first cycle of IVF because (amongst other reasons) in subsequent cycles they 'would be better informed by experience and reflection, as well as by documentation, about the possible uses of their embryos, whatever the quality'. Haimes and Taylor, above n 97, 340; see also above n 94, 2149. However, for all the reasons argued here, we frame our recommendation more strongly. In the course of our argument, we believe we have addressed (to the extent that space has allowed) their various reasons for rejecting McLeod's and Baylis's suggestion that the donation of fresh embryos to research is not in patients' interests. McLeod and Baylis, above n 121.