TISSUE SAMPLES AS ‘GIFTS’ FOR RESEARCH: A QUALITATIVE STUDY OF FAMILIES AND PROFESSIONALS
MARY DIXON-WOODS
University of Leicester
DEBBIE CAVERS
University of Edinburgh
CLARE J JACKSON
University of Leicester
BRIDGET YOUNG
University of Liverpool
JOANNE FORSTER
Leicester Royal Infirmary
DAVID HENEY
University of Leicester
KATHY PRITCHARD-JONES
Royal Marsden Hospital/Institute of Cancer Research
ABSTRACT
Current policy in many countries, including the UK, is that tissue samples used
for medical research should be treated as ‘gifts’ from patients. This approach is
increasingly criticised. Among the solutions proposed is introducing an individual
property rights regime for tissue donors. We report a qualitative study of the views
of 79 family members of children with cancer and 54 health professionals in the area
of paediatric oncology. We argue that systems of governance and regulation need to
respect the values of donors. A charitable trust model might be more consistent with
the values of solidarity and reciprocity expressed by the study participants than an
individual property rights approach.
A INTRODUCTION
Research use of human tissue has become increasingly
controversial. In this context, the view that samples of human biological
material for use in research should be regarded as ‘gifts’ has come
under scrutiny.
(1) The UK Medical Research Council (MRC) guidance
in the area offers two reasons for describing tissue samples as being
exchanged as part of a ‘gift relationship’. First, the ‘gift relationship’
underlines the altruistic motivation for research participation.
(2) It
thus, though not referencing it explicitly, invokes Richard Titmuss’s
classic comparative analysis of blood donation (Box 1).
(3) Titmuss saw
the voluntary unpaid donation of blood as encouraging the kind of
society that fosters altruism, and he saw systems that involve payment
for blood as corrosive of fellow-feeling. However, Titmuss assumed
not only that blood would be freely given, but also that it would
be distributed within a voluntary, not-for-profit system. The same
assumption cannot be made of modern biotechnology and medical
science, where the boundaries between not-for-profit and commercial
research are not always distinct.
(4)
Second, the MRC guidance uses the notion of ‘gift’ to resolve
the legal uncertainty over ownership, suggesting that any property
rights that donors might have in their donated samples are transferred,
together with the control of the samples, to the recipients of the gifts.
This draws on a legal understanding, where gifts are seen as the
voluntary transfer of property with no expectation of return.
(5) (6) The
MRC Working Group that developed the guidance did recognise that
research conducted on ‘gifted’ tissues may be profit-generating,
(7) but
recommended that there were no ethical or legal reasons to prevent
donors being asked to give up any right to future profits arising from
research using their samples, provided proper consent was sought.
The ethos of the ‘gift relationship’ has, however, been criticised
for demanding altruism and a ceding of control from donors, while
obscuring the (potential) economic value of the tissues and allowing
commercial exploitation.
(8) (9) (10) (11) A particular focus of concern is the
‘commodification’ of human tissue, where ‘commodification’ is used to
describe the process by which human materials become invested with
economic value and are used to serve the interests of commerce.
(12) (13)
(14) Controversies in this area have been given renewed significance by
two recent cases in the US. In one of these, Washington University
v Catalona,
(15) the court ruled against the prominent prostate cancer
researcher William Catalona, finding that Washington University
‘owned’ all human material in a tissue bank that Dr Catalona had
established using samples that had been freely given by his patients.
(16)
In the other case, Greenberg v Miami Children’s Hospital Research
Institute,
(17) families of children with Canavan disease freely provided
tissue samples which were then used to patent the gene for the
disease and associated tests and introduce a licensing fee regime. It
was ruled that the researchers and the hospital involved had the right
to patent their work.
(18)
1 Proposals for a property rights regime
Various proposals have been made to respond to the perception,
which derives in large part from legal cases involving disputes over
tissues used in research, that people feel disempowered, lack trust in
research, wish to have more control over tissues that they donate, and
should potentially be able to benefit financially in some way. These
proposals include recognising individual property rights for tissue
donors.
(19) The property model includes a number of variants, ranging
from direct payment of royalties through to various benefit-sharing
schemes.
Perhaps three principal arguments in favour of awarding
individual property rights to those who consent to donating tissues for
research can be identified. One, rarely argued, is that the introduction
of market incentives would increase the supply of tissues, as has
been proposed might occur if payments were allowed for blood and
organs.
(20) Increased supply might lead to improvements in diagnosis
and treatment of diseases. We might call this the ‘incentivisation of
participation’ argument.
A second argument, which we might deem the ‘control and
autonomy’ argument, lies at the core of many analyses of the benefits
of a property rights regime for human tissues. The imperative for
this approach derives from an apparent ‘public crisis of confidence’
in research.
(17) Arguing that the fundamental problem with the consent
model is that it does not provide a means by which the ‘subject’ can
exercise continuing control of his or her materials, Laurie proposes
that a personal property paradigm would serve
an all-important role in completing the picture of adequate protection for
the personality in tandem with the other protections such as autonomy,
confidentiality, and privacy. However, the added value of a property
model lies in its ability to empower individuals and communities and
to provide the crucial continuing control over samples or information
through which moral and legal influence may be exerted. (p.316)(17)
In arguing for this approach, Laurie is refreshing proposals dating
from the 1970s and 1980s, including that of Lori Andrews, who
argued that ‘people’s body parts are their personal property’.
(21) A
prime factor in Andrews’ argument is that ‘people have an interest in
what happens to their extracorporeal body parts’. One solution to the
apparent crisis is then to award people property rights over their own
tissues, the better to secure control over the destiny of their bodily
material.
A third argument might be termed the ‘fairness’ argument. It is
now well over a decade since an editorial in Nature commented that,
‘[i]n the past, the prospect of novel treatment resulting from a better
understanding of disease has generally been seen as sufficient reward.
This formula is no longer sufficient, chiefly because it does not
provide any mechanisms for ensuring that other potential benefits are
made available to contributors’.
(22) This argument would be concerned
with addressing the so-called ‘double-standard’,
(23) where tissue donors
are denied any (financial) interest in products that may be developed
from their tissue, but researchers are allowed to appropriate any
profits through the intellectual property rights (usually in the form
of patents) that they exercise. It has been suggested that ‘fairness’
demands that profits be distributed among those who contributed to
the research in an equitable manner, possibly in the form of influence
over access, pricing, and terms guiding ownership and control of
downstream developments:
We believe it is unacceptable to presume that patients, subjects,
disease-associated advocacy groups, foundations, and government (and,
in turn, taxpayers) are all pure altruists, as policies and practices now
do presume, especially when these stakeholders have contributed in a
meaningful way to the research enterprise. It is wholly unfair to these
groups for their ‘investments’ to be wholly appropriated by firms or
universities with no commitment to return to the community something
of value that they can access and afford. We believe that there has
been a market failure with respect to the value added to the research
enterprise by patient and subject groups, and that ways should be found
to respect their contributions (p. 969).(24)
The fact that members of communities who contributed human
materials may later, because of prohibitive cost, experience difficulties
in gaining access to products based on research conducted on those
materials is seen as an especially lamentable aspect of unfairness.
Indeed, this lay at the heart of the Greenberg Canavan disease case.
2 The need for empirical research
The property rights movement has, thus far, primarily developed
within the academic literature, and has often treated individual
legal cases as indications of a general public unease (rather than,
for example, of specific grievance).
(25) However, there are significant
dangers in treating examples of litigation (which often concern
unusual and extreme cases, and are few and far between) as evidence
of more general attitudes and of introducing ‘solutions’ that are illsuited
to the problems that they aim to solve. Without better evidence
about the motivations and experiences of donors, forms of regulation
and governance might be introduced that fail to support what donors
themselves value. Despite a large theoretical literature, there is only
a small body of research that has looked at the views of donors
themselves, and this work has been limited mainly to those providing
samples for large scale ‘genetic’ databases rather than banks of
material ‘left over’ after therapeutic interventions. In particular, there
has been little work that has directly addressed the extent to which
people consider biological material for research to be ‘gifts’.
These issues are of particular significance for tumour banks,
which represent important resources for cancer researchers,
(26)
especially for the study of rare diseases such as childhood cancer
(Box 2).
(27) (28) Questions about research use of tissue from children are
especially interesting and important because of the recent history
of controversies involving tissues and organs retained from children
post-mortem,
(29) which led to the Human Tissue Act 2004. In this
paper we report a large qualitative study of families of children
with cancer and professionals who care for children with cancer. We
focus on how far those involved in consenting to the use of tissues
for research, and those involved in seeking such consent, see those
who give consent as making ‘gifts’ of tissue. We were interested
particularly in situations where the tissues are collected from living
children as part of their routine care, and the samples are ‘surplus’ to
diagnostic and therapeutic requirements.
NOTES
1 Levitt M, Weldon S. ‘A well-placed trust? Public perceptions of the governance
of DNA’ databases.
Critical Public Health 2005; 15: 311–321.
2 Medical Research Council.
Human Tissue and Biological Samples for Use in
Research (London: Medical Research Council, 2001) available at
www.mrc.ac.uk/
Utilities/Documentrecord/index.htm?d=MRC002420 (last accessed 19.02.08)
3 Titmuss R.
The Gift Relationship (London: Allen and Unwin, 1970).
4 Weir R, Olick RS.
The Stored Tissue Issue (Oxford: Oxford University Press,
2004).
5 Mason JK, Laurie GT. ‘Consent or property? Dealing with the body and its parts
in the shadow of Bristol and Alder Hey’ MLR 2001; 64: 710–729.
6 Tutton R. Person, ‘Property and gift: exploring languages of tissue donation to
biomedical research’. In Tutton R, Corrigan O (eds).
Genetic Databases: Socioethical
Issues in the Collection and Use of DNA (London: Routledge, 2004).
7 Medical Research Council.
Human tissue and biological samples for use in
research. Report of the Medical Research Council Working Group to develop
Operational and Ethical Guidelines. (London: Medical Research Council,
1999).
8 See, eg, Scheper-Hughes N. ‘Bodies for sale – whole or in parts’
Body and
Society 2001; 7: 1–8.
9 Tutton R. Gift relationships in genetics research. Science as Culture 2002; 11:
523–542.
10 Waldby C. ‘Stem cells, tissue cultures and the production of biovalue’ Health
2002; 6: 305–323.
11 Haddow G, Laurie G, Cunningham-Burley S, Hunter KG. ‘Tackling community
concerns about commercialisation and genetic research: a modest interdisciplinary
proposal’
Soc Sci Med 2007; 64: 272–282.
12 Waldby C, Mitchell R.
Tissue Economies: Blood, Organs and Cell Lines in Late
Capitalism (Durham, NC: Duke University Press, 2006).
13 Dickenson D. ‘Consent, commodification and benefit-sharing in genetic research’
Developing World Bioeth 2004; 4: 109–124.
14 Andrews L., Nelkin, BA. ‘Whose body is it anyway? Disputes over body tissue
in a biotechnology age’
Lancet 1998; 351: 53–57.
15 490 F 3d 667 (8th Cir 2007).
16 Andrews L. ‘Who owns your body? A patient’s perspective on Washington
University v Catalona’
J Law Med Ethics 2006; 34: 398–407.
17 264 F Supp 2d 1064 (US DC Florida 2003).
18 For discussion, see Anderlik MR, Rothstein MA. ‘Canavan decision favours
researchers over families’
J Law Med Ethics 2003; 31: 450–454.
19 Laurie G.
Genetic Privacy: A Challenge to Medico-legal Norms (Cambridge:
Cambridge University Press, 2002).
20 Radcliffe-Richards J, Daar AS, Guttmann RD, Hoffenberg R, Kennedy I, Lock
M, et al, for the International Forum for Transplant Ethics. ‘The case for
allowing kidney sales’ Lancet 1998; 351: 1950–1952.
21 Andrews LB. ‘My body, my property’
Hastings Cent Rep 1986; 16: 28–38.
22 Editorial. ‘Gene donors’ rights at risk’
Nature 1996 (May 2); 381: 1.
23 Bovenberg J. ‘Whose tissue is it anyway’
Nat Biotechnol 2005; 8: 929–933.
24 Merz JF, Magnus D, Cho MK, Caplan AL. ‘Protecting subjects’ interests in
genetics research’
Am J Hum Genet 2002; 70: 965–971.
25 Dixon-Woods M, Wilson D, Jackson C, Cavers D, Pritchard-Jones K. ‘Human
tissue and ‘the public’: the case of childhood cancer tumour banking’
Biosocieties
(in press, accepted January 2008).
26 Oosterhuis JW, Coebergh JW, van Veen EB. ‘Tumour banks: well-guarded
treasures in the interest of patients’ Nat
Rev Cancer 2003; 3: 73–77.
27 McHale J, Habiba M, Dixon-Woods M, Cavers D, Heney D, Pritchard-Jones K.
‘Consent and childhood cancer tissue banking: the impact of the Human Tissue
Act 2004’
Lancet Oncol 2007; 8: 266–272.
28 Sebire N, Dixon-Woods M. ‘Towards a new era of tissue-based diagnosis and
research’
Chronic Illness 2008; 3 (in press)
29 See, eg,
The Royal Liverpool Children’s Inquiry Report 2001 (The Redfern
Report) (London: HMSO, 2001).
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