Retained human tissues: A molecular genetics goldmine or modern grave robbing? A legal approach to obtaining and using stored human samples

Medicine and Law

Volumn 22, Issue 3, 2003, Pages 357-372

  Ellis, Ian ^a   Mannion, G ^a   Warren Jones, A ^b  

^a ALDER HEY CHILDREN S HOSPITAL   (United Kingdom)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

Anonymity; Consent; Genetic material; Grifting and abandonment; Human Tissue Act (UK); Human tissues; Molecular genetic testing; Ownership; Patents; Retained ogans

Indexed keywords

CADAVER; COMMERCIAL PHENOMENA; CONFIDENTIALITY; DNA SEQUENCE; ETHICS; GENETIC ANALYSIS; GOVERNMENT; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MOLECULAR GENETICS; ORGAN PRESERVATION; PUBLIC HEALTH; RESEARCH; REVIEW; RISK ASSESSMENT; SATISFACTION; SENSITIVITY ANALYSIS; STANDARD; UNITED KINGDOM;

EID: 0242334160     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (107)

1. see Report of a Census of Organs and Tissues Retained by Pathology Services in England Chief Medical Officer, Department of Health: 2000: HMSO
2. The Removal, Retention and Use of Human Organs and Tissue from Post-mortem Examination: Advice of the Chief Medical Officer: Department of Health: 2001: HMSO
3. since it has been recognised by the Chief Medical Officer in looking at retention post-mortem that the "taking and use of tissue during life has not appeared to raise the same level of concern", this is assessed only comparatively: The Removal, Retention and Use of Human Organs and Tissue from Post-mortem Examination: Chief Medical Officer's Advice: Department of Health: 2001: HMSO: at p7. However, use by research is to be taken to include genetic testing
4. a UK government White Paper on Genetics http://www.doh.gov.uk/genetics/whitepaper.htm, has been published, (June 2003). One of the major recommendations is to create a new criminal offence of testing an individual's DNA without their knowledge or consent for non-medical purposes. This will be by means of a new Bill that will regulate the removal, storage and use of human organs and tissues. The new offence will not cover medical situations where consent is impossible to obtain, or use by the police and courts. This new offence is intended to ensure the privacy of individuals and prevent people trying to obtain DNA covertly. This will be a UK-wide offence and will be a proper deterrent against the wrongful testing of genetic material.
5. The Royal Liverpool Children's Inquiry Report (Redfern Report): The Royal Liverpool Children's Inquiry: 30.1.01: http://www.rlcinquiry.org.uk/download/: Summary & Recommendations
6. this latter aspect is already available as professional misconduct, sanctioned by the General Medical Council see Resurrection of the body snatchers: A R Maclean: [2000] 150(6922) NLJ 174, 176
7. Supra 5; at p21
8. Supra 5: at p20, being a reduced group from the present 'spouse or any surviving relative'
9. the specific purpose of retention in this context being for post-mortem. In terms of a Coroner's post-mortem this extends only to helping establish the cause of death, but in the context of hospital post-mortems would also include retention for research and education. However, these recommendations clearly do not apply to retention for the purposes of transplantation. Consequently, organs obtained under a hospital post-mortem for research are treated as being 'use-bound' as are embryos for research: Human Fertilisation and Embryology Act (HFEA) 1990 (as amended): s15(4)
10. Supra 5: at pp21/22 & 24
11. Supra 5: at p24, but practicality dictates that this would not mirror specified wishes for organs taken from the same body
12. Supra 5: at p23
13. Supra 6: at p176: although it is to be noted that this was in reference to whether consent to retention for transplantation, which was frustrated by the recipient dying, would enable utilisation for research, the point is pertinent where the frustration is in the ability to elicit consent
14. Dobson v North Tyneside Health Authority [1996] 4 A11 ER 474 (CA): at p478
15. Retained Organs Commission: January 2002: http://www.nhs.uk/retainedorgans/consultanaprotocol.htm
16. ibid: which indicated that a presumption of linkage must be raised if the Health Authority are to pay the cost of the test
17. Supra 3
18. and it is notable that both differ from the plethora of regulatory guidance issued by the Department of Health (eg. Reference Guide to Consent for Examination or Treatment: Department of Health: 5.7.01: http://www.doh.gov.uk/consent/refguide.htm and Good practice in consent implementation guide: consent to examination and practice: Department of Health: November 2001: http://www.doh.gov.uk/consent/implementationguide.pdf), The Royal College of Pathologists (Guidelines for the retention of tissues and organs at post-mortem examination: The Royal College of Pathologists: March 2000: http://www.nhs.uk/retainedorgans/default.htm), or of the Retained Organs Commission (Information and Guidance Update: Retained Organs Commission: October 2001: http://www.nhs.uk/retainedorgans/default.htm)
19. Supra 3: at p38. The justification for this narrower application is provided by the need to clearly prescribe those from whom consent should be sought, although the full report is more widely addressed to include adults
20. Supra 3: at p41, as well as consideration of whether the latter contravenes Article 8 of the Human Rights Act (HRA) 1998, which provides for respect for private and family life (Supra 3: at p16) unless it can be construed as being within the ambit of "protection of health" (Article 8)
21. the Redfern Report indicated that the difference between these requirements is of little practical significance, but it is difficult to concur when what is presently being premised in varying forms for consent requires a plethora of options, all of which require sufficient information to enable a decision to be reached. Certainly, that has not been an inherent part of obtaining agreement to a 'lack of objection'
22. Supra 3: at p38
23. Supra 3: at p39: under the aegis of an independent commission
24. Supra 3: at pp18/19 & 41: the CMO's recommendation indicated that organs and tissue are to be brought into line with options for cremation/burial and deference to family wishes currently extended to stillbirths and fetuses over 24 weeks gestation. However, disposal of fetuses of less than this gestation period and tissue taken from stillbirths are presently outside of the Cremation (Amendment) Regulations 2000 and, consequently, the CMO's advised that this would require review. This only serves to highlight the requirement for a more encompassing review, where organs/tissue removed from living donors is presently treated as clinical waste, but that taken from cadavers is accorded far greater respect. While the moral considerations may be different, there is no factual difference in the human material and providing for lesser respect where the donor is living only serves to unjustifiably diminish autonomy
25. Supra 3: at p42
26. Supra 3: at p44/p45
27. However, the need for such a prediction is an onerous requirement where post-mortem examination can uncover unexpected results. Furthermore, this represents an equal problem to requirements that consent forms indicate the exact details of what is to be retained prior to the examination. However, the actual need to obtain consent to the removal and retention of additional organs/tissue can be dealt with by simply requesting additional consent, as indicated by The Royal College of Pathologists (Guidelines for the Retention of Tissues and Organs at Post-mortem Examination: The Royal College of Pathologists: March 2000: http://www.nhs.uk/retainedorgans/default.htm: at p9).
28. Nevertheless, this is to place families in the position of having numerous consent forms to sign over what could turn out to be a very extended period. This will surely invite refusal where it concerns samples of interest in numerous research initiatives and impose a requirement to obtain new samples for research where currently held samples would suffice and may well represent better evidence.
29. When it is then considered that communication with families could also include research feedback (Supra 3. at p43/44), this begins to represent a situation in which grieving could be adversely affected and ironically the principles of Art 8: HRA 1998 could be contravened. Furthermore, the rationale of time limiting retention where research per se has been consented to is somewhat inexplicable.
30. The Royal College of Pathologists suggests a similar approach, but in reference to a Coroner's post-mortem only. In these circumstances, time limits and notification are more appropriate in that they serve a more immediate purpose of establishing the cause of death and by virtue of being compulsory (above: at pp6&7)
31. for example: "Tissue Blocks and Slides: A Consultation Paper": ROC: November 2002;
32. "Qualitative Research to Explore Public Perceptions Regarding Retention of Organs and Tissue for Medical Practice, Teaching and Research - Research Report": ROC: June 2002;
33. "DNA Testing Protocol": ROC: January 2002, all available at: http://www.nhs.uk/retainedorgans/;
34. "Human Bodies, Human Choices: The Law on Human Organs and Tissue in England and Wales": Department of Health: July 2002: http://www.doh.gov.uk/tissue
35. "Unclaimed and Unidentifiable Organs and Tissue - A Possible Regulatory Framework": ROC: February 2002: http://www.nhs.uk/retainedorgans/
36. ibid: at p12-14
37. ibid: at p16-17
38. ibid: at p16
39. ibid: at p33
40. ibid: at p18-19
41. ibid: at p29-35
42. ibid: at p32
43. "Human Bodies, Human Choices: The Law on Human Organs and Tissue in England and Wales": Department of Health: July 2002: http://www.doh.gov.uk/tissue: at p16-18
44. ibid: at p17
45. particularly since the possibility of criminal liability is posited: ibid: at p19
46. see: "Response to 'Human Bodies, Human Choices' Consultation Report on the Law on Human Organs and Tissues in England and Wales": Human Genetics Commission: August 2002: http://www.doh.gov.uk/hgc/business publications response-hbhc.htm;
47. "Response to DoH Consultation Report - 'Human Bodies, Human Choices'". ROC: November 2002: http://www.nhs.uk/retainedorgans/
48. Supra 27: at p4
49. the private members bill reached its second reading in the House of Lords: HL Bill 85: 51/3: 2.5.95: HMSO
50. Hansard record of debates within the House of Lords: 7.2.97: column 1295-1298
51. Supra 3: at pp 14-15, p23, p27-28 and recommendations 1, 4 and 16
52. Supra 3: Recommendation 4: notably limiting the extent of the post-mortem; limiting the range of organs in terms of retention and use; time limiting retention; and providing options for disposal
53. this standard is reflected in the General Medical Council's guidance referred to in the CMO'S report: Supra 3: at p14
54. Supra 27: at p5
55. The Human Organ Transplant (Unrelated Persons) Regulations 1989: SI 2480: s3(2): HMSO. This is a high standard requiring assertion that the information has been received and sufficiently comprehended to form the decision
56. The Human Fertilisation and Embryology Act 1990 (HFEA) (as amended): Schedule 3: s3(1)(b). In practice, embryonic research requires two consent forms (general consent to embryonic research and specific consent to the particular research programme), both of which follow the 'full, informed consent' model: Embryo Research: Information for Patients: Human Fertilisation and Embryology Authority: May 2000
57. Human genetic databases: 20.3.01: http://www.publications.parliament.uk/pa/ld200001/ldselect/ldsctech/57/5701.htm:
58. see also Comments to Inform the Government Response to the House of Lord's Report on Genetic Databases: Human Genetics Commission (HGC): 11.7.01: http://www.hgc.gov.uk/business publications response database.htm in which the HGC expressed concern that the Data Protection Act 1998 may not adequately prevent/sanction inappropriate disclosures and indicated that fresh consent to research be required possibly in tandem with an 'opt-in' approach for individual research programmes
59. Obtaining and using data obtained for clinical purposes to require implied consent; 'primary use' (obtaining and using data obtained for specified research) to require informed consent; 'secondary use' (obtaining and using data other than for the original purpose of collection) express consent that this be decided by a Medical Data Panel, except for disease registries which require simple notification: ibid: 20.3.01: Chapter 7
60. Art 5 (b)
61. Section B: point 22
62. Council of Europe Convention on Human Rights and Biomedicine (ETS No 164)
63. Art 16(v)
64. Supra 56: at point 7.24.
65. However the courts have held that, where confidential medical information (without guaranteed anonymisation) is passed to a third party outside of the NHS structure, a breach of confidence will occur unless express consent is obtained: R v Department of Health, ex parte Source Informatics Ltd [1999] 4 A11 ER 185
66. Art 9 and see also Art 7 on holding identifiable genetic data. Within this must be considered the recommendation that, in order to protect privacy, those who do not want to know results of genetic screening should ideally not be screened: Council of Europe Recommendation No R(94)11 on screening as a tool of preventive medicine: point 2.5 and see also Council of Europe Recommendation No R(92)3 on genetic testing and screening for health care purposes
67. The Data Protection Act and Human Tissues: The Royal College of Pathologists: 2002: http://www.rcpath.org/news/data act.html
68. such as general notification. However, being unable to discover the source would also make these samples unsuitable for some purpose: recognised in Supra 56: 7.25-7.27
69. for more on this see: Genetic screening: A social impact too far?: A Warren-Jones; [2001] 4(5) Bio-Science Law Review 200-214;
70. Review of Ethical Issues in Medical Genetics: World Health Organisation: 2001 WHO/HGN/ETH/00.4: particularly at p86 which specifies that access be denied to those who are able to "coerce consent"
71. Supra 56: 7.20-7.44
72. This formed part of the recommendations of the Nuffield Council on Bioethics' Report: Human Tissue: Ethical and Legal Issues: 1995: http://www.nuffield.com/bioethics/publication/humantissue/rep0013051.html at 13.27;
73. and been utilised by the courts, as demonstrated by Human Stem Cells/BIOCYTE, where the Opposition Division stated that "in respect of cord blood - as well as the umbilical cord itself - ⋯[they have] been regarded as⋯having the legal status of 'res relicta',": [1999] Opposition Division Decision 15 July 1999 (unreported) at p33:
74. European Patent No: 0343217
75. Toward the right of commerciality: Recognizing property rights in the commercial value of human tissue: [1986] 34 UCLA Law Review 207-264: at p243
76. ibid: at pp244-248, in which the hospital acts as trustee for the purpose of discovering the nature of the illness and/or disposing of the tissue. However, this means that the donor could request return of the tissue and that any purpose extending beyond the original bailment would require consent of the bailor (donor).
77. Furthermore, where consent is not sought, the tissue would then become subject to claims in 'conversion' because it had been 'used or dealt with' outside of the terms of the bailment (ibid: at pp248-249) and the donor could sue in damages.
78. Nevertheless, Hardiman indicated that research without commercialisation would not give rise to 'conversion' (ibid: at p251: footnote 186), because there would be no financial loss requiring compensation
79. ibid: at p250: footnote 181.
80. In addition, Hardiman indicated that 'conversion' extends to destruction (ibid: at p248), but disposal which entails destruction is clearly within the terms of the original bailment
81. equally, in order to perceive any damages would mean commodifying the tissue itself and clearly this has never been within the scope of legal perception applicable in the UK. The Nuffield Council on Bioethics (Supra 72: at 13.25) rejected the possibility of 'rewarded gifting' (payment in kind) for obtaining tissue from either living or deceased donors; and commercial procurement is generally prohibited in the UK and Europe, evidenced by: The HFEA 1990 (as amended), s12(e); the Human Organ Transplants Act 1989, ss1-3 (which prohibits payment other than expenses and which extends to advertising); and the Council of Europe Recommendation No R(90)3 concerning medical research on human beings: Principle 13:
82. see also infra 75 for the International and European (respectively) perception that the human body or its parts, as such, cannot be commercialised
83. Supra 75: at pp253-256, although again this encounters problems with commodification
84. Supra 14: which can be seen as being suspended by statute for the purpose of post-mortem
85. Doodeward v Spence [1908] 6 CLR 406 (High Court of Australia);
86. R v Kelly [1998] 3 All ER 741 (CA)
87. R v Kelly [1998] 3 All ER 741 (CA)
88. Supra 14
89. in addition, the only action to have succeeded in restoring possession was that of Doodeward v Spence (Supra 85) as an action in detinue, which has now been superseded by statute.
90. Furthermore, claims to 'conversion' and 'bailment' were rejected by the court: Supra 14. However, requirements to extinguish claims from in vivo donors can be dealt with where the act of excision also severs possessory rights
91. Supra 87: at p750
92. except for a Coroner's post-mortem (which is statutorily imposed) donors can choose disposal, research and education or return
93. otherwise than for children
94. (1988) 202 Cal.App. 3d 1230;
95. Patient denied rights to own tissue: L Dayton: 127 (1726) New Scientist 21.7.90, concerning a donor who attempted to claim a property right in excised tissue which had led to the patenting of the mo-cell line
96. in the technical sense of having been synthesised (identified, classified and copied) and generally including purification, as opposed to merely being severed
97. Art 4 and Art 21 (respectively). Although the UK is not bound by these provisions, they represent guiding principles
98. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions: L213 OJ EC 30.7.98 adopted into UK legislation largely as Schedule A2: UK Patents Act 1977
99. Chapter IV: point 4.3
100. Hormone Relaxin [1995] 6 OJ EPO 388: this is because even if "..every gene in the human body [could be]..cloned, it would be impossible to reconstitute a human being"
101. Recital 26
102. Recital 24: Deriving from Recitals, these provisos have not been incorporated into domestic legislation and are generally accepted as having no force of law. Nevertheless, it has been argued that they retain applicability by virtue of non-legal factors (Why Recital 26 of the EC Directive on the Legal Protection of Biotechnological Inventions should be implemented in National Law):
103. D Beyleveld: ([2000] 1 IPQ 1-26) and certainly they are being premised as requirements for the future
104. Supra 56: in terms of the first proviso (consent) at points 122, 1.23 & Chapter 7 and the latter proviso (function) at points 1.28, 8.14, 8.20 & 8.30
105. American Home Products v Novartis Pharmaceuticals [2000] RPC 547
106. however, where the sequence is already disclosed, purposive construction to establish scope of protection should have the effect of removing such raw materials