-
1
-
-
0037661420
-
-
(6th edn OUP 2009) at 417; see also O O'Neill, Autonomy and Trust in Bioethics Gifford Lectures, University of Edinburgh (CUP 2002). O'Neill argues against the equiparation of respect for autonomy with obtaining informed consent
-
TL Beauchamp and JF Childress, Principles of Biomedical Ethics (6th edn OUP 2009) at 417; see also O O'Neill, Autonomy and Trust in Bioethics Gifford Lectures, University of Edinburgh (CUP 2002). O'Neill argues against the equiparation of respect for autonomy with obtaining informed consent.
-
Principles of Biomedical Ethics
-
-
Beauchamp, T.L.1
Childress, J.F.2
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5
-
-
84883159187
-
-
Note
-
The Academy of Medical Sciences 'Personal Data for Public Good: Using Health Information in Medical Research' (2006)
-
-
-
-
6
-
-
33644831867
-
-
Note
-
For example, there is a sizeable literature on the limitations of the translating an informed consent model into the context of biobanking, see inter alia, J-A Skolbekken and others, 'Not worth the paper it's written on? Informed consent and biobank research in a norwegian context' (2005) 15 (4) Critical Public Health 335
-
-
-
-
7
-
-
56349159681
-
'Informed consent and human genetic database research'
-
M Hayry et al. (eds), Law, Medicine and Ethics (CUP 2007) 199. In the context of research uses of genetic data, Taylor has suggested a need for greater clarity on the necessity and proportionality of consent requirements for under the European Data Protection Directive
-
S Kristinsson and V Arnason, 'Informed consent and human genetic database research', in M Hayry et al. (eds), The Ethics and Governance of Human Genetic Databases, Law, Medicine and Ethics (CUP 2007) 199. In the context of research uses of genetic data, Taylor has suggested a need for greater clarity on the necessity and proportionality of consent requirements for under the European Data Protection Directive
-
The Ethics and Governance of Human Genetic Databases
-
-
Kristinsson, S.1
Arnason, V.2
-
8
-
-
84931306328
-
Genetic Data and the Law: A Critical Perspective on Privacy Protection
-
Cambridge Bioethics and Law (CUP 2012) at 217
-
Mark Taylor, Genetic Data and the Law: A Critical Perspective on Privacy Protection, Cambridge Bioethics and Law (CUP 2012) at 217
-
-
-
Taylor, M.1
-
9
-
-
0037329215
-
'Some limits of informed consent'
-
O O'Neill, 'Some limits of informed consent' (2003) 29 (1) Journal of Medical Ethics 4, 5
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(2003)
Journal of Medical Ethics
, vol.29
, Issue.1
, pp. 5
-
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O'Neill, O.1
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10
-
-
84857885719
-
'From Sidaway to Pearce and beyond: is the legal regulation of consent any better following a quarter of a century of judicial scrutiny?'
-
A MacLean, 'From Sidaway to Pearce and beyond: is the legal regulation of consent any better following a quarter of a century of judicial scrutiny?' (2012) 20 (1) Med L Rev 108
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(2012)
Med L Rev
, vol.20
, Issue.1
, pp. 108
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MacLean, A.1
-
11
-
-
73449138816
-
'Broad consent in biobanking: reflections on seemingly insurmountable dilemmas'
-
T Caulfield and J Kaye, 'Broad consent in biobanking: reflections on seemingly insurmountable dilemmas' (2009) 10 (2) Med L Int 85-100
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(2009)
Med L Int
, vol.10
, Issue.2
, pp. 85-100
-
-
Caulfield, T.1
Kaye, J.2
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12
-
-
42349088372
-
'From genetic privacy to open consent'
-
JE Lunshof and others, 'From genetic privacy to open consent' (2008) 9 Nat Rev Genet 406
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(2008)
Nat Rev Genet
, vol.9
, pp. 406
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-
Lunshof, J.E.1
-
13
-
-
38549099198
-
'Biobanks and blanket consent: the proper place of the public good and public perception rationales'
-
T Caulfield, 'Biobanks and blanket consent: the proper place of the public good and public perception rationales' (2007) 18 (2) King's Law Journal 209
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(2007)
King's Law Journal
, vol.18
, Issue.2
, pp. 209
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-
Caulfield, T.1
-
14
-
-
84862243500
-
'Tackling legal challenges posed by population biobanks: reconceptualising consent requirements'
-
M. Otlowski, 'Tackling legal challenges posed by population biobanks: reconceptualising consent requirements' (2012) 20 (2) Med L Rev 191.
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(2012)
Med L Rev
, vol.20
, Issue.2
, pp. 191
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-
Otlowski, M.1
-
15
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-
55549116026
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'When consent gets in the way'
-
P Taylor, 'When consent gets in the way' (2008) 456 Nature 32
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(2008)
Nature
, vol.456
, pp. 32
-
-
Taylor, P.1
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16
-
-
84883196551
-
-
Note
-
Salgo v Leland Stanford Junior University Board of Trustees 317 P 2d 170 (Cal, 1957), though this is a US case, and as such does not establish precedent in the UK
-
-
-
-
17
-
-
0004247602
-
A Patient's Right to Know: Information Disclosure, the Doctor and the Law
-
Medico-Legal Series (Ashgate Dartmouth 1989)
-
Sheila Mclean, A Patient's Right to Know: Information Disclosure, the Doctor and the Law, Medico-Legal Series (Ashgate Dartmouth 1989) at 183
-
-
-
Mclean, S.1
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18
-
-
84883172839
-
-
Note
-
Nuffield Council on Bioethics 'Human Bodies: Donation for Medicine and Research' (2011) at 151
-
-
-
-
19
-
-
84883152637
-
-
Note
-
The following discussion is based on a presumption that research participants are adult and competent at the time their consent was obtained and remain so. Specific legal issues are also raised by the ethical and practical challenges of obtaining valid consent for research from children or adults who lack capacity. These are important, but will not be considered further here. See further, JK Mason, and GT Laurie, Law and Medical Ethics, n 2 above, Chs 19 and 20.
-
-
-
-
20
-
-
0036868548
-
'Law medicine and trust'
-
MA Hall, 'Law, medicine and trust' (2002) 55 (2) Stanford Law Review 463 at 484
-
(2002)
Stanford Law Review 463 at
, vol.55
, Issue.2
, pp. 484
-
-
Hall, M.A.1
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22
-
-
84883190079
-
-
Note
-
Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. It is telling, for example, that the UK Government used the advent of the Clinical Trials Directive to undertake an overhaul of the governance of medical research generally in the UK.
-
-
-
-
23
-
-
84883185381
-
-
Note
-
See, for example s 45 of the Human Tissue Act 2004 and Schedule 4 with respect to DNA analysis
-
-
-
-
24
-
-
80155128997
-
'Consent forms in genomics: the difference between law and practice'
-
P Boddington and others, 'Consent forms in genomics: the difference between law and practice' (2011) 18 (5) European Journal of Health Law 491, 517
-
(2011)
European Journal of Health Law
, vol.18
, Issue.5
, pp. 491-517
-
-
Boddington, P.1
-
25
-
-
84883182195
-
-
Note
-
On the legal function of consent in a range of fields, see D Beyleveld and R Brownsword, Consent in the Law, Legal Theory Today (Hart Publishing, 2007) Ch 3
-
-
-
-
26
-
-
84883173538
-
-
Note
-
It is possible that the participant is unable to sign or mark a consent form her/ himself, in which case if may be acceptable for them to give their consent orally in the presence of a witness and have this recorded in writing (for example, Part 1, paragraph 3(i) to Schedule 1 to The Medicines For Human Use (Clinical Trials) Regs 2004)-for the purposes of this paper these will be taken as equivalent
-
-
-
-
27
-
-
84883180544
-
-
Note
-
NRES advises that RECs attend not only to the context of consent forms and information sheets, but also to other accompanying documents, such as questionnaires, letters of invitation, letters to GPs or other clinicians, or information sheets for relatives or carers, NHS National Research Ethics Service 'Standard Operating Procedures for Research Ethics Committees in the United Kingdom' v5.1 (March 2012) at 111.
-
-
-
-
28
-
-
84883139088
-
-
Note
-
NRES 'Information Sheets and Consent Forms Guidance', above, n 15 at 27
-
-
-
-
29
-
-
84868545367
-
-
A Study of Manifest and Latent Functions' Sociology of Health and Illness (in press and available online from 22 March 2012, DOI:10.1111/j.1467-9566.2012.01469.x)
-
N Armstrong and others, 'Do informed consent documents for cancer trials do what they should? A Study of Manifest and Latent Functions' Sociology of Health and Illness (in press and available online from 22 March 2012, DOI:10.1111/j.1467-9566.2012.01469.x).
-
'Do informed consent documents for cancer trials do what they should?
-
-
Armstrong, N.1
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30
-
-
84883154599
-
-
Note
-
NRES Information Sheets and Consent Forms Guidance, above, n 15 at 27
-
-
-
-
31
-
-
84883198359
-
-
Note
-
Boddington and others, above, n 25 at 492. The reference to 'legal requirements' here refers to the requirement to obtain informed consent, not to document it in a form.
-
-
-
-
32
-
-
84883156616
-
-
Most recently, LifeGene biobank in Sweden has run into serious difficulties after the Swedish Data Inspection Board ruled that it could no longer collect prospective data from its 500,000 participants nor, indeed, process those already collected. The reasoning was that participants could not give valid consent to a proposition about future health research because it was insufficiently explicit. See further here accessed 11 August 2012
-
Most recently, LifeGene biobank in Sweden has run into serious difficulties after the Swedish Data Inspection Board ruled that it could no longer collect prospective data from its 500,000 participants nor, indeed, process those already collected. The reasoning was that participants could not give valid consent to a proposition about future health research because it was insufficiently explicit. See further here:, http://ethicsblog.crb.uu.se/2011/12/ 20/the-swedish-data-inspection-board-stops-large-biobank/. accessed 11 August 2012.
-
-
-
-
33
-
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84900052359
-
'Developing an Appropriate Consent Model for Biobanks: In Defence of "Broad" Consent'
-
J Kaye and M Stranger (eds), (Ashgate 2009) 79. The Nuffield Council on Bioethics report in donation of bodily materials endorses the position 'that it is appropriate routinely to seek generic consent [of which broad consent is one kind] (where necessary in addition to specific consent) for the research use of blood and tissue', above, n 19 at 204
-
For example, M Otlowski, 'Developing an Appropriate Consent Model for Biobanks: In Defence of "Broad" Consent', in J Kaye and M Stranger (eds), Principles and Practice in Biobank Governance (Ashgate 2009) 79. The Nuffield Council on Bioethics report in donation of bodily materials endorses the position 'that it is appropriate routinely to seek generic consent [of which broad consent is one kind] (where necessary in addition to specific consent) for the research use of blood and tissue', above, n 19 at 204.
-
Principles and Practice in Biobank Governance
-
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Otlowski, M.1
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34
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80053306411
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'Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law'
-
For suggestions about ways to approach this
-
For suggestions about ways to approach this, see GT Laurie 'Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law' (2011) 130 Human Genetics 347
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(2011)
Human Genetics
, vol.130
, pp. 347
-
-
Laurie, G.T.1
-
35
-
-
36048933619
-
-
Note
-
Armstrong and others, above, n 30; M Dixon-Woods and others, 'Beyond "misunderstanding": written information and decisions about taking part in a genetic epidemiology study' (2007) 65 (11) Social Science & Medicine 2212
-
-
-
-
36
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66049100612
-
'More Information Less Understanding: A Randomized Study on Consent Issues in Neonatal Research'
-
Y Freer and others, 'More Information, Less Understanding: A Randomized Study on Consent Issues in Neonatal Research' (2009) 123 (5) Pediatrics 1301
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(2009)
Pediatrics
, vol.123
, Issue.5
, pp. 1301
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-
Freer, Y.1
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38
-
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84883194399
-
-
Note
-
Boddington and others, above, n 25 at 492
-
-
-
-
39
-
-
84883160251
-
-
For an example of such an interpretation of an instance in which a consent form specified samples would be used for 'medical research studies' (Unpublished, AccessCommittee for CLS Cohorts, 2009) 14, available here
-
For an example of such an interpretation of an instance in which a consent form specified samples would be used for 'medical research studies' see P Burton, 'Policy for use and oversight of samples and data arising from the 1958 birth cohort (National Child Development Study)' (Unpublished, AccessCommittee for CLS Cohorts, 2009) 14, available here, http://www2.le.ac.uk/projects/ birthcohort/document-downloads/POLICY.DOCUMENT.120609.pdf.
-
'Policy for use and oversight of samples and data arising from the 1958 birth cohort (National Child Development Study)'
-
-
Burton, P.1
-
40
-
-
84883157736
-
-
Note
-
Gillberg v Sweden, Application no 41723/06, 3 April 2012
-
-
-
-
41
-
-
84883148818
-
-
Note
-
Chatterton v Gerson [1981] QB 432 and Appleton v Garrett (1995) 34 BMLR 23
-
-
-
-
42
-
-
84883192525
-
-
Note
-
Sidaway v Board of Governors of the Bethlem Royal Hospital, above, n 17
-
-
-
-
43
-
-
84883147652
-
-
Note
-
Pearce v United Bristol Healthcare NHS Trust (1999) 48 BMLR 118
-
-
-
-
44
-
-
84883166179
-
-
Note
-
Chester v Afshar, above, n 17
-
-
-
-
45
-
-
84883176947
-
-
Note
-
It is also important to note that these treatment consent parameters have been developed exclusively in the context of the negligence action; this article addresses research conducted under a far wider set of legal regimes, both statutory and common law
-
-
-
-
46
-
-
0004263826
-
-
(3rd edn OUP 2010) 1205 at [8.01]. Cases confirming this in both the treatment and research contexts are: Airedale NHS Trust v Bland [1993] AC 789, [1993] 1 All ER 821 and Malette v Shulman (Canadian), Re F (Mental Patient: Sterilisation), and Re T (Adult: Refusal of Treatment), Chatterton v Gerson [1981] QB 432, [1981] 1 All ER 257 and Simms v Simms, A v A [2002] 2 WLR 1465, [2003] 1 All ER 669. On the continuum from treatment, experimentation, and research see Walker-Smith v GMC [2012] EWHC 503 (Admin) at [12]
-
A Grubb and others, Principles of Medical Law (3rd edn OUP 2010) 1205 at [8.01]. Cases confirming this in both the treatment and research contexts are: Airedale NHS Trust v Bland [1993] AC 789, [1993] 1 All ER 821 and Malette v Shulman (Canadian), Re F (Mental Patient: Sterilisation), and Re T (Adult: Refusal of Treatment), Chatterton v Gerson [1981] QB 432, [1981] 1 All ER 257 and Simms v Simms, A v A [2002] 2 WLR 1465, [2003] 1 All ER 669. On the continuum from treatment, experimentation, and research see Walker-Smith v GMC [2012] EWHC 503 (Admin) at [12].
-
Principles of Medical Law
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Grubb, A.1
-
47
-
-
84883196303
-
-
Note
-
This Act for the most part only applies in England and Wales. There is no equivalent legislation in Scotland, where the Human Tissue (Scotland) Act 2006 covers only tissues obtained for transplant purposes or from deceased persons.
-
-
-
-
48
-
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33644564440
-
'Inalienably yours? The new case for an inalienable property right in human biological material: empowerment of sample donors or a recipe for a tragic anti-commons?'
-
SCRIPT-ed
-
JA Bovenberg, 'Inalienably yours? The new case for an inalienable property right in human biological material: empowerment of sample donors or a recipe for a tragic anti-commons?' (2004) 1 (4) SCRIPT-ed 553
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(2004)
, vol.1
, Issue.4
, pp. 553
-
-
Bovenberg, J.A.1
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49
-
-
84883169207
-
-
Note
-
Section 3(2) of the Human Tissue Act 2004
-
-
-
-
50
-
-
84883144112
-
-
Note
-
Part 1, Paragraph 6, of Schedule 1 to the Human Tissue Act (HTA) 2004
-
-
-
-
51
-
-
84883159817
-
-
Note
-
'HTA Code of Practice 1: Consent' (Human Tissue Authority) at [117]
-
-
-
-
52
-
-
84883153654
-
-
Note
-
HTA 2004, s 9. The relevant date is 1 September 2006.
-
-
-
-
53
-
-
84883140064
-
-
Note
-
'HTA Code of Practice 1', above, n 56 at [36]
-
-
-
-
54
-
-
84883186394
-
-
Note
-
Nuffield Council on Bioethics (2011), above, n 19 at 204 [box 7.3].
-
-
-
-
55
-
-
84883186353
-
-
Note
-
This section of the HTA 2004 also applies in Scotland
-
-
-
-
56
-
-
84883182155
-
-
Note
-
Part 2, paragraph 10 to Schedule 4 of the HTA 2004
-
-
-
-
57
-
-
84883187553
-
-
Note
-
'HTA Code of Practice 9: Research' (Human Tissue Authority) at [52]. It is relevant to note here that although exemptions from s 45 also apply to nonconsensual DNA analysis for the purposes of clinical audit, education or training relating to human health and public health monitoring, there is no exemption for research conducted for non-health-related purposes.
-
-
-
-
58
-
-
84883138777
-
-
Note
-
DPA 1998 s 1(1). Under the Act 'personal data' means data, which is held by a public authority or on an automatically searchable filing system, that relates to a living individual who can be identified (a) from those data, or (b) from those data and other information which is in the possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion about the individual and any indication of the intentions of the data controller or any other person in respect of the individual.
-
-
-
-
59
-
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84883168062
-
-
Note
-
Schedule 1 to the DPA 1998
-
-
-
-
60
-
-
84883180929
-
-
Note
-
Both the broad requirement for explicit consent for the processing of sensitive data and the exception in the case of data processed for medical purposes under the European Data Protection Directive 95/46/EC that forms the basis for the UK DPA 1998 have recently been reinforced by the Anonymous, 'Opinion 15/2011 on the Definition of Consent' (01197/11/EN WP187: Article 29 Data Protection Working Party) at 6, 25
-
-
-
-
61
-
-
84883166045
-
-
Note
-
Schedule 3 to the DPA 1998
-
-
-
-
62
-
-
84883170902
-
-
Note
-
DPA 1998, s 33(2)
-
-
-
-
63
-
-
84883142743
-
-
Note
-
DPA 1998, s 33(1) and (4)
-
-
-
-
64
-
-
84883174777
-
-
Proposal for a new Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) Brussels, 25 January 2012 COM 11 final accessible at
-
Proposal for a new Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) Brussels, 25 January 2012 COM(2012) 11 final accessible at, http://ec.europa.eu/justice/data-protection/document/review2012/com_2012_11_en.pdf.
-
(2012)
-
-
-
65
-
-
84883136164
-
-
Note
-
Draft Recital 23 and draft Art 83(1)
-
-
-
-
66
-
-
84883204313
-
-
Note
-
Draft Recital 26
-
-
-
-
67
-
-
84883144606
-
-
Note
-
The change to a gender-inclusive approach arguably introduces an element of ambiguity regarding the meaning of 'them'
-
-
-
-
68
-
-
84883182340
-
-
Note
-
Art 29 Working Party Opinion 15/2011 on the Definition of Consent at 25
-
-
-
-
69
-
-
84883171800
-
-
Note
-
HTA 2004, s 3, these uses include public display and anatomical examinations conducted on no-excepted materials
-
-
-
-
70
-
-
84883156863
-
-
Note
-
As confirmed most emphatically by the Grand Chamber of the European Court of Human Rights in Evans v United Kingdom (2007) 95 BMLR 107
-
-
-
-
71
-
-
84883138204
-
-
Note
-
Paragraph 1 of Schedule 3 to the Human Fertilisation and Embryology Act 1990 (as amended)
-
-
-
-
72
-
-
84883192762
-
-
Note
-
Paragraph 3 of part 1 to Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations 2004
-
-
-
-
73
-
-
84883176974
-
-
Note
-
NRES SOPs v5.1, above, n 28 at 14. The Directive referred to here is Directive 2001/20/EC.
-
-
-
-
74
-
-
84883184339
-
-
Note
-
GAfREC applies to all health and social care research that falls within the remit of the NHS and the departments of health of the four UK administrations, Department Of Health, 'Governance Arrangements for Research Ethics Committees: A Harmonised Edition' (2011) at 9
-
-
-
-
75
-
-
84883152897
-
-
Note
-
Nuffield Council on Bioethics, 'Human Tissues: Legal and Ethical Issues' (1995) at [6.21].
-
-
-
-
76
-
-
84883142057
-
-
Note
-
Art 29, Working Party Opinion, above, n 74 at 25
-
-
-
-
77
-
-
84883161109
-
-
Note
-
Civil Evidence Act 1995, s 9(1). In Scotland, the equivalent provision may be found in the Civil Evidence (Scotland) Act 1988, s 5(1).
-
-
-
-
78
-
-
84883187145
-
-
Note
-
[2] FLR 365, [2004] 3 FCR 324, at [105]
-
-
-
-
79
-
-
84883190874
-
-
Note
-
However, in the instant case it was found that the clinicians had been negligent in failing to discuss with the parents the possibility of organ retention following post-mortem examination, so the consent forms were in effect documentation of negligent consent procedures. The relationship between consent forms and action in negligence is discussed further in section IV below.
-
-
-
-
80
-
-
84883148773
-
-
Note
-
AB v Leeds Teaching Hospital NHS Trust, above, n 85 at [105]
-
-
-
-
81
-
-
84883203997
-
-
Note
-
Sidaway, above, n17 per Lord Diplock at [658]
-
-
-
-
82
-
-
79951801101
-
'The right to withdraw from research'
-
For an account of the sources of this right and critical reflection on its existence
-
For an account of the sources of this right and critical reflection on its existence, see GO Schaefer and A Wertheimer, 'The right to withdraw from research' (2010) 20 (4) Kennedy Institute of Ethics Journal 329
-
(2010)
Kennedy Institute of Ethics Journal
, vol.20
, Issue.4
, pp. 329
-
-
Schaefer, G.O.1
Wertheimer, A.2
-
83
-
-
84883199977
-
-
Note
-
Human Tissue Act 2004, ss 5 and 45
-
-
-
-
84
-
-
84883140517
-
-
Note
-
Data Protection Act 1998, Part V
-
-
-
-
85
-
-
84883159310
-
'Data Protection Act: Claiming Compensation'
-
(Information Commissioner's Office 2007). accessed 13 November Data Protection Act 1998 s 3
-
'Data Protection Act: Claiming Compensation' (Information Commissioner's Office 2007), http://www.ico.gov.uk/upload/documents/library/data_ protection/practical_application/claiming_compensation.pdf. accessed 13 November 2011; Data Protection Act 1998, s 3.
-
(2011)
-
-
-
86
-
-
84883186792
-
-
Note
-
Data Protection Act 1998, s 10
-
-
-
-
87
-
-
84883162227
-
-
Note
-
All ER (D) 374 (Feb), [2003] EWHC 259 (QB)
-
-
-
-
88
-
-
84883198283
-
-
Note
-
Human Fertilisation and Embryology Act 1990, s 41
-
-
-
-
89
-
-
84883196816
-
-
Note
-
Human Fertilisation and Embryology Act 1990, s 18
-
-
-
-
90
-
-
84883160425
-
-
Note
-
The only direct remedy available to individuals is under the HFE Act 1990 s
-
-
-
-
91
-
-
84883182617
-
-
Note
-
which pertains to the civil liability to children born disabled due to acts or omissions on the part of the treatment facility
-
-
-
-
92
-
-
84883141338
-
-
Note
-
CTR 2004, Regulation 29. The consent forms comprise key elements of the information that must, under the CTR 2004, be supplied to the REC to inform their decision (Paragraph 3 of part 1 to Schedule 3).
-
-
-
-
93
-
-
84883142693
-
-
Note
-
CTR 2004, Regulations 12 and 50. For offences and penalties see Regulations and 52.
-
-
-
-
94
-
-
84883166710
-
-
Note
-
GAfREC, n81 above, at 2.3.1-2.3.6.
-
-
-
-
95
-
-
84883169349
-
-
Note
-
GAfREC, above, n 81 at [3.2.11]
-
-
-
-
97
-
-
84883189545
-
-
Note
-
The new Health Research Authority was established by The Health Research Authority Regulations 2011, SI 2011/2341, which came into force December 2011 in the wake of the publication of the Academy of Medical Sciences, 'A New Pathway for the Regulation and Governance of Health Research' (2011). Its functions are laid out in the Health Research Authority Directions 2011 (1 December 2011).
-
-
-
-
98
-
-
84883175457
-
-
Note
-
NRES SOPs v 5.1, above, n 28 at [3.56] and Annex G.
-
-
-
-
99
-
-
84883151330
-
-
Note
-
Laurie, above, n 3 at 110, 294; quoted section is from Grubb et al, above, n. at [13.98].
-
-
-
-
100
-
-
84883193316
-
-
Note
-
Note that a state's failure to provide adequate remedies for the protection of interests caught by the European Convention on Human Rights can be grounds for citizen action: Pretty v UK (2346/02) [2002] 2 FLR 45, (2002) 35 EHRR 1 at [61]
-
-
-
-
101
-
-
85011514343
-
-
Note
-
Grubb and others, above, n 50 at [19.61]; SHE Harmon and GT Laurie, 'Yearworth v. North Bristol NHS Trust: Property, Principles, Precedents and Paradigms' (2010) 69 (3) The Cambridge Law Journal 476, 484.
-
-
-
-
102
-
-
84883176129
-
-
Note
-
HTA 2004, s 32(8) and s 32(9)(c). The common law position is probably best reflected by the case of R v Kelly [1999] QB 621 which recognised property in human materials taken without authorisation and so constituting theft under the Theft Act 1968. The caveat here is that the recognition of property might be couched in terms of the 1968 Act itself and not necessarily as a general principle. The point remains moot.
-
-
-
-
103
-
-
84883166118
-
-
Note
-
EWCA Civ 37, [2009] All ER (D) 33 (Feb)
-
-
-
-
104
-
-
80855125005
-
-
Note
-
Cf S Cordell and others, 'Lost Property? Legal Compensation for Destroyed Sperm: A Reflection and Comparison Drawing on UK and French Perspectives' (2011) 37 (12) Journal of Medical Ethics 747 and B Lyons, '"The Good that is Interred in Their Bones": are there property rights in the child?' (2011) 19 (3) Med L Rev 372
-
-
-
-
105
-
-
0009023114
-
'Consent or property? Dealing with the body and its parts in the shadow of bristol and alder hey'
-
K Mason and G Laurie, 'Consent or property? Dealing with the body and its parts in the shadow of bristol and alder hey' (2001) 64 (5) The Modern Law Review 710
-
(2001)
The Modern Law Review
, vol.64
, Issue.5
, pp. 710
-
-
Mason, K.1
Laurie, G.2
-
106
-
-
84883198197
-
-
Note
-
Harmon and Laurie, above, n 112 at 492; Mason and Laurie, above, n 2 at 452
-
-
-
-
107
-
-
77956916074
-
-
Note
-
Ursin has argued that if research participants are recognised as having property interests in the tissues that they provide to biobanks, then the consent form holds the potential to be transformed from 'a confusing statement of autonomy and altruism, dependent on the vagueness of trust' to a more transparent and concrete contract protecting participants' property interests, see LO Ursin, 'Privacy and Property in the Biobank Context' (2010) 22 HEC Forum 211, 219
-
-
-
-
108
-
-
84883194510
-
-
Note
-
Yearworth, above, n 114, at [48]
-
-
-
-
109
-
-
84883160632
-
-
Note
-
Yearworth, above, n 114, at [59(h)]
-
-
-
-
110
-
-
84883174733
-
-
Note
-
Sandeman Coprimar SA v Transitos y Transportes Integrales SL [2003] EWCA Civ 113, [2003] QB 1270, 'The principles of the law of bailment have always overlapped with those of the law of contract, for bailment and contract often go hand in hand.' per Lord Phillips MR at [63].
-
-
-
-
111
-
-
84883161621
-
-
Note
-
Yearworth, above, n 114, at [57]
-
-
-
-
112
-
-
77957153154
-
-
(2nd edn, Sweet & Maxwell 1991) Ch 1, Parts IV(B) and (VI)
-
NE Palmer, Bailment (2nd edn, Sweet & Maxwell 1991) Ch 1, Parts IV(B) and (VI)
-
Bailment
-
-
Palmer, N.E.1
-
113
-
-
84883201352
-
-
Note
-
According to the doctrine of privity of contract, Price v Easton (1833) 4 B and Ad 433 Tweddle v Atkinson (1861) 1 B and s 393
-
-
-
-
114
-
-
84883201743
-
-
Note
-
Yearworth, above, n 114, at [48]
-
-
-
-
115
-
-
84883152580
-
-
Note
-
Gilchrist Watt and Sanderson Pty Ltd v York Products Pty Ltd [1970] 1 WLR 1262
-
-
-
-
116
-
-
84883202220
-
-
Note
-
Grubb and others, above, n 50 at [19.66]; Doodeward v Spence (1908) 6 CLR 406.
-
-
-
-
117
-
-
84883162827
-
-
Note
-
Moore v Regents of the University of California (51 Cal. 3d 120; 271 Cal. Rptr. 146; 793 P.2d 479).
-
-
-
-
118
-
-
84883191683
-
-
Note
-
Nuffield Council on Bioethics (1995), above, n 82 at [9.14].
-
-
-
-
119
-
-
84883145589
-
-
Note
-
Nuffield Council on Bioethics (2011), above, n 19 at 124-5
-
-
-
-
120
-
-
84883197413
-
-
Note
-
Catalona, above, n 131
-
-
-
-
121
-
-
84883186748
-
-
In English law, a gift requires a clear intention on the part of a donor to donate and either physical delivery of the goods or the execution and delivery of a deed or the effective declaration of a trust that will make a promise to give binding, MBridge (3rd edn, Clarendon Law Series, Oxford University Press, 2002) at Personal Property Law
-
In English law, a gift requires a clear intention on the part of a donor to donate and either physical delivery of the goods or the execution and delivery of a deed or the effective declaration of a trust that will make a promise to give binding,MBridge, Personal Property Law (3rd edn, Clarendon Law Series, Oxford University Press, 2002) at 94
-
-
-
-
122
-
-
84883202921
-
-
Note
-
Stair Memorial Encyclopaedia, The Laws of Scotland, Donation (reissue) 6. Animus Donandi at [21] Reliability of Evidence; Laurie, above, n 3 at 313.
-
-
-
-
123
-
-
84883146183
-
-
Note
-
Boddington and others, above, n 25 at 504
-
-
-
-
124
-
-
84883152622
-
-
Note
-
Gillberg v Sweden, above, n 40 at [87] and [93]
-
-
-
-
125
-
-
85109470917
-
'Conditional Gifts'
-
NPalmer and E Mckendrick (eds) (2nd edn, London LLP 1998)
-
R Chambers, 'Conditional Gifts', in NPalmer and E Mckendrick (eds) Interests in Goods (2nd edn, London LLP 1998) 430
-
Interests in Goods
, pp. 430
-
-
Chambers, R.1
-
126
-
-
84883141904
-
-
Note
-
Re Macleay (1875) LR 20 Eq 186; Bridge (n 116) 99
-
-
-
-
128
-
-
84883142600
-
-
Note
-
see also Palmer, Bailment. Ch 3 Part III.
-
-
-
-
129
-
-
84883163802
-
-
Note
-
L. & Y. Ry Co. v McNicoll (1919) 88 LJKB 601, per Atkin J approved by Scruton LJ in Oakley v Lyster [1931] 1 KB 148, at [153].
-
-
-
-
130
-
-
84883200104
-
-
Note
-
It is sufficient that the person in possession of the goods acts in such a way as to deprive the claimant of their property rights in the goods, this must be through action not omission, but harm need not be intended. Because a claimant must retain immediate possessory rights to be able to sue in conversion, this action is unlikely to be available to a research participant whose consent form recorded that they had relinquished these, see Sheehan, above, n 151 at Ch 8 Part II.
-
-
-
-
131
-
-
84883169690
-
-
Note
-
R v Bentham [2005] UKHL; [2005] 1 WLR 1057 'One cannot possess something which is not separate and distinct from oneself. An unsevered hand or finger is part of oneself. Therefore one cannot possess it.' per Lord Bingham at [8].
-
-
-
-
132
-
-
47049122849
-
Law and the Human Body : Property Rights
-
Ownership and Control (Hart 2007)
-
RJ Hardcastle, Law and the Human Body : Property Rights, Ownership and Control (Hart 2007) 161
-
-
-
Hardcastle, R.J.1
-
134
-
-
84883199484
-
-
Stair Memorial Encyclopaedia, The Laws of Scotland, 11 'Corporeal Moveable Property, (5) Original Acquisition of Ownership of Corporeal Moveable Property (g) Specificatio or Specification'. The doctrine of specification does not exist as such in English law, but an approximate equivalent may be identified in some older texts. There is precedent law for extending the doctrine of specification to include living organisms, albeit not human tissue (Kinloch Damph Ltd v Nordvik Salmon Farms Ltd (Outer House, Court of Session, 30 June 1999) unreported-available here cited in Hardcastle, above, n156 at 166)
-
Stair Memorial Encyclopaedia, The Laws of Scotland, 11 'Corporeal Moveable Property, (5) Original Acquisition of Ownership of Corporeal Moveable Property (g) Specificatio or Specification'. The doctrine of specification does not exist as such in English law, but an approximate equivalent may be identified in some older texts. There is precedent law for extending the doctrine of specification to include living organisms, albeit not human tissue (Kinloch Damph Ltd v Nordvik Salmon Farms Ltd (Outer House, Court of Session, 30 June 1999) unreported-available here, http://www.scotcourts.gov.uk/opinions/ca291499.html.-cited in Hardcastle, above, n156 at 166).
-
-
-
-
135
-
-
3042525453
-
'The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects'
-
Hastings Center Report
-
HS Richardson and L Belsky, 'The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects' (2004) 34 (1) Hastings Center Report 25
-
(2004)
, vol.34
, Issue.1
, pp. 25
-
-
Richardson, H.S.1
Belsky, L.2
-
136
-
-
84883198672
-
-
Note
-
These are the conditions of the 'Caparo test', Caparo Industries plc v Dickman [1990] 2 AC 605
-
-
-
-
137
-
-
84883197655
-
-
Note
-
Mason and Laurie, above, n 2 at 133-4
-
-
-
-
138
-
-
84883158895
-
-
Note
-
See eg Goodwill v Goodwill Pregnancy Advisory Services [1996] 2 All ER, [1996] 7 Med LR 129; Vowles v Evans [2003] 1 WLR 1607, CA; Fairlie v Perth and Kinross Healthcare NHS Trust 2005 SLT 1200 (OH)-these cases address the necessary characteristics of relationships giving rise to duty of care, rather than the specific facts of research relationships
-
-
-
-
139
-
-
84883181389
-
-
Note
-
Grimes v Kennedy Krieger Institute, Inc. 366 Md 29, 782 A2d 807 (2001) at [842]-[843]
-
-
-
-
140
-
-
84883202819
-
'Grimes v Kennedy Krieger Institute
-
The Court of Appeals Maryland distinguishes special relationships that may arise to the level of a contractual relationship between researchers and nontherapeutic research participants'
-
G Johnson, 'Grimes v Kennedy Krieger Institute, Inc: The Court of Appeals Maryland distinguishes special relationships that may arise to the level of a contractual relationship between researchers and nontherapeutic research participants' (2001) 9 University of Baltimore Journal of Environmental Law 75
-
(2001)
University of Baltimore Journal of Environmental Law
, vol.9
, pp. 75
-
-
Johnson, G.1
-
141
-
-
84883198682
-
-
Note
-
A related complex question is who would owe a duty of care when there might be a chain of researchers dealing with (anonymised) data and tissues and who have no direct relationship with the research participants
-
-
-
-
142
-
-
84883147587
-
-
Note
-
Yearworth, above, n 114, at [13]
-
-
-
-
143
-
-
84883151868
-
-
Note
-
Mason and Laurie, above, n 2 at 620
-
-
-
-
144
-
-
84883160373
-
-
Note
-
Simms v Simms and Another [2003] 2 WLR 1465
-
-
-
-
145
-
-
84883193980
-
On Liberty, in J S Mill: Utilitarianism
-
(Everyman's Library, London 1971) at 116
-
JS Mill, On Liberty, in J S Mill: Utilitarianism, On Liberty and Representative Government (Everyman's Library, London 1971) at 116
-
On Liberty and Representative Government
-
-
Mill, J.S.1
-
146
-
-
84883163371
-
-
Note
-
For a landmark consideration of the issues, especially regarding psychiatric injury, see McLoughlin v O'Brian [1983] 1 AC 410 (HL); for critical commentary
-
-
-
-
147
-
-
84858210126
-
'Rewriting the requirement for a "Recognized Psychiatric Injury" in negligence claims'
-
Oxford Journal of Legal Studies
-
see R Muheron, 'Rewriting the requirement for a "Recognized Psychiatric Injury" in negligence claims' (2012) 32(1) Oxford Journal of Legal Studies 77
-
(2012)
, vol.32
, Issue.1
, pp. 77
-
-
Muheron, R.1
-
148
-
-
84883191014
-
-
Note
-
Harmon and Laurie, above, n 112
-
-
-
-
149
-
-
84883180217
-
-
Note
-
Yearworth, above, n 114, at [50]. It has been suggested that Scots Law could deal with the same scenario as an example of 'gratuitous contract'
-
-
-
-
150
-
-
84883189769
-
'Contract Law-a solution to delictual problems'
-
see WW McBryde, 'Contract Law-a solution to delictual problems' (2012) 8 Scots Law Times 45
-
(2012)
Scots Law Times
, vol.8
, pp. 45
-
-
McBryde, W.W.1
-
151
-
-
84883162308
-
-
Note
-
For example, Reilly v Merseyside RHA [1995] 6 Med LR 246 (CA); Fairlie v Perth and Kinross Healthcare NHS Trust 2004 SLT 1200 (OH); Grieve v Salford HA [1991] 2 Med LR 295 (QBD)
-
-
-
-
152
-
-
84883177837
-
-
Note
-
McFarlane v Tayside Health Board [2000] AC 59, 2000 SC 1, HL; Chester v Afshar [2005] 1 AC 134, [2004] UKHL 41, above, n 17; Rees v Darlington Memorial Hospital NHS Trust [2004] AC 309, (2003) 75 BLMR 69
-
-
-
-
153
-
-
84883202940
-
-
Note
-
Yearworth, above, n 114, at [44(f)(v)]
-
-
-
-
154
-
-
85016368709
-
-
Note
-
Laurie, 'Personality, Privacy and Autonomy in Medical Law', in NR Whitty and R Zimmermann (eds) Rights of Personality in Scots Law:AComparative Perspective (Dundee University Press 2009) 453, 467; Mason and Laurie, above, n 2 at 120
-
-
-
-
155
-
-
84883159824
-
-
Note
-
Chester v Afshar, above, n 17 at [30]
-
-
-
-
156
-
-
84929734797
-
'Rights of personality property rights and the human body in Scots Law'
-
It has been suggested that under Scots law, damages may be awardable in solatium for the non-material injury to dignity that may follow from conduct that fails to respect someone's autonomy- 9 Edinburgh Law Review, cited in Laurie(2), above n 179 at 473
-
It has been suggested that under Scots law, damages may be awardable in solatium for the non-material injury to dignity that may follow from conduct that fails to respect someone's autonomy-see NR Whitty, 'Rights of personality, property rights and the human body in Scots Law' (2005) 9 Edinburgh Law Review, cited in Laurie(2), above, n 179 at 473
-
(2005)
-
-
Whitty, N.R.1
-
157
-
-
84883187979
-
-
The most likely article to be engaged in this context is Art 8, see Pretty v UK, above, n 111. The European Court of Human Rights has held that obligations on the State might 'involve the adoption of measures designed to secure respect for private life even in the sphere of the relations of individuals between themselves': X and Y v The Netherlands (1985) 8 EHRR 235, [1985] ECHR 8978/80 at paragraph [23] - such measures might include the provision of legal remedies; see also Airey v Ireland (1979) 2 EHRR 305 at [32]. All of this is of course subject to a state being able to show that interference with citizen rights was both necessary and proportionate to achieve a legitimate social end: Powell and Rayner v United Kingdom (Application 9310/81) (1990) 12 EHRR 355, [1990] ECHR 9310/81, para 41 and references therein.
-
The most likely article to be engaged in this context is Art 8, see Pretty v UK, above, n 111. The European Court of Human Rights has held that obligations on the State might 'involve the adoption of measures designed to secure respect for private life even in the sphere of the relations of individuals between themselves': X and Y v The Netherlands (1985) 8 EHRR 235, [1985] ECHR 8978/80 at paragraph [23] - such measures might include the provision of legal remedies; see also Airey v Ireland (1979) 2 EHRR 305 at [32]. All of this is of course subject to a state being able to show that interference with citizen rights was both necessary and proportionate to achieve a legitimate social end: Powell and Rayner v United Kingdom (Application 9310/81) (1990) 12 EHRR 355, [1990] ECHR 9310/81, para 41 and references therein.
-
-
-
|