Research Ethics

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Human tissue biobanks: the balance between consent and the common good
Zisis Kozlakidis, Robert JS Cason, Christine Mant and John Cason
Research Ethics 2012 8: 113
DOI: 10.1177/1747016112442031

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442031
2012
REA10.1177/1747016112442031Kozlakidis et al.Research Ethics

Article

Research Ethics

Human tissue biobanks: the 8(2) 113123

The Author(s) 2012
Reprints and permission:
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DOI: 10.1177/1747016112442031

the common good rea.sagepub.com

Zisis Kozlakidis
Department of Infectious Diseases, Kings College London, and School of Law,
Birkbeck College London, UK

Robert JS Cason
School of Law, Birkbeck College London, UK

Christine Mant
Department of Infectious Diseases, Kings College London, UK

John Cason
Department of Infectious Diseases, Kings College London, and National Institute of Health
Researchs Comprehensive Biomedical Research Centre, Guys and St Thomas NHS
Foundation Trust, UK

Abstract
Biobanks are currently archiving human materials for medical research at a hitherto
unprecedented rate. These valuable resources will be essential for developing
personalized medicines and for a better understanding of disease susceptibilities.
However, for such scientific advances to benefit everyone, it is crucial that biobanks
recruit donations from all sections of the community. Unfortunately, other initiatives,
such as transplant programmes, have clearly demonstrated that ethnic minorities are
under-represented. Here we suggest that this issue deserves serious consideration to

Corresponding author:
Dr J. Cason, Department of Infectious Diseases, Kings College London, 2nd Floor Borough
Wing, Guys Hospital, London SE1 9RT, UK
Email: john.cason@kcl.ac.uk

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114 Research Ethics 8(2)

avoid biobanks evolving into ethnically biased archives which unwittingly promote race-
specific research. Specifically, this necessitates research ethics committees engaging in a
re-assessment of the relative merits of individual personal sovereignty and the common
good.

Keywords
biobanks, research ethics, individual rights, societal responsibility

Introduction
Biobanks are archives of biological materials, collected for a variety of purposes
including: preservation of plant seeds (e.g. the Svalbard Global Seed Vault); stor-
age of human materials for transplants (e.g. corneal biobanks); artificial insemina-
tion; forensic investigations; and to aid conservation of endangered species
(Leon-Quinto et al., 2009). Some biobanks collect a single sample type (e.g. DNA
in a genebank), whilst others preserve a variety of materials to enable compre-
hensive cellular, genomic and proteomic studies of the same individual. Biobanks
can also be subdivided into those which aim to answer one specific question and
others which have no specific research problem in mind (systematic biobanks,
such as the Infectious Diseases Biobank [IDB] at Kings College London [KCL]:
Williams et al., 2009).
Until recently the modus operandi of most medical researchers was to use fresh
clinical materials to test a hypothesis. The premise was either proven, or not, and
then the process repeated to answer subsequent questions. This approach is highly
wasteful since those tissues not directly needed to examine each argument are usu-
ally discarded (often as a condition of the research ethics permissions). In contrast,
clinical biobanks can archive and distribute material to multiple researchers, hence
maximizing the usage of every donation. Biobanks can also facilitate the under-
standing of rare diseases by either gradually accumulating sufficient amounts of
materials or, by networking with other biobanks.
The potential of biobanks for advancing medicine were recognized in 2009
by Time magazine, which considered them to be one of the ten ideas that are
changing the world right now (Park, 2009). As an example, one study that the
IDB is assisting is KCLs investigation of the human immune response dynam-
ics stimulated by vaccination against the H1N1 influenza virus. This project
has characterized changes in the expression of each (of ~36,000 per individ-
ual) human gene in lymphocytes from 75 subjects before and after vaccination
and compared these results to the concentrations of some plasma proteins
(HIRD, 2010).
Large-scale population-based clinical archives such as the Biobank UK will also
allow extensive genome-wide association studies to identify genetic markers for
susceptibility to individual diseases, for example, by the UK Biobanks donations
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Kozlakidis et al. 115

from over 500,000 volunteers (UK Biobank, 2011). Similarly, the characterization
of other host polymorphisms which predict the efficacy of specific drug regimens
for individual patients will become more widespread, leading to personalized treat-
ments. This revolution in prescribing is already happening. Amongst patients with
human immunodeficiency virus (HIV) infections, abacavirTM is not given to those
with the genotype HLA-B*5701, since this drug can cause life-threatening hyper-
sensitivity reactions in such individuals (Mallal et al., 2002). Similarly, there is
increasing evidence that patients infected with hepatitis C virus with specific poly-
morphisms around the IL28 gene do not benefit from interferon and ribavirin
therapy (Holmes et al. 2011; Ge et al., 2009).
The identification of such genetic markers is critically dependent upon the
demographic characteristics of the populations studied, and this in turn makes the
recruitment strategies of clinical archives critical. In addition, the establishment of
biobanks has raised old and new ethical challenges. Indeed, blood collection con-
travenes the first dictum of medical ethics, Hippocratess call to first do no harm,
since this invasive procedure carries a 0.6% risk of an adverse event (Garozzo et
al., 2010). To make this risk acceptable, there are important moral issues concern-
ing consent, usage, ownership of samples, as well as patient confidentiality.
Biobanks, and their regulators, can draw on historic ethical precedents to provide
guidance to develop appropriate moral operational strategies. For example, the
German Ethics Council has proposed that biobanks should be established on the
basis of: confidentiality; informed consent; ethics review; sample quality-control;
and transparency (Deutscher Ethikrat, 2010). One of the most fundamental, yet
neglected, ethical problems revolves around the practical requirement for biobanks
to collect samples which are a representative selection of the community. How this
is achieved in practice has re-ignited the classical ethical debate regarding the bal-
ance between respecting the autonomy of individuals and pursuing the common
good. Research ethics committees (REC) need to be actively engaged in develop-
ing novel ethical policies and influencing legislators, so as to avoid future treat-
ment disparities.

Genetic representation
One fundamental aspect of biobanking is the concept of ensuring adequate genetic
representation. This is a crucial issue for clinical archives as large influential
research studies will become increasingly dependent upon such resources.
Consequently, if samples held by such archives are unrepresentative of society as
a whole, future treatments for those not initially represented are likely to become
increasingly compromised as the era of personalized medicine comes to the fore.
Unfortunately, there are well-acknowledged problems in recruiting organ and
tissue donations from ethnic minorities (Bratton et al., 2011; Salim et al., 2010),
and in the USA educational schemes have been introduced to address this specific
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116 Research Ethics 8(2)

issue (Callender and Miles, 2010). Whilst there is little available data regarding
the demographics of biobank volunteers, one US study suggested that 60% would
be willing to donate to bio-repositories, though ethnic minorities, women and
those without a degree expressed concerns that the government would have access
to their information (Kaufman et al., 2009). Explanations for the reticence of eth-
nic minorities to participate in transplant programmes, and possibly also biobanks,
probably include multiple factors. Undoubtedly the history of scientific
imperialism/bio-colonialism by western medicine has alienated many in devel-
oping nations from conventional medicine (Emerson et al., 2011). Even within
contemporary western democracies there have been examples of scientific racism,
notably the 42-year-long Tuskegee syphilis study of impoverished African-
Americans (Crenner, 2011; Roy, 1995).
This antipathy to western medicine may explain the reluctance of the Indonesian
government to share samples of H5N1 influenza virus with the international sci-
entific community (Gelling, 2007). Unfortunately, some politicians have exacer-
bated these tensions. The past president of South Africa, T. Mbeki, gave undue
credence to those who refute the evidence that HIV causes acquired immunodefi-
ciency syndrome (AIDS) (Mbeki, 2000) and, in the USA, L. Farrakhan has claimed
that the influenza virus vaccination programme is a genocidal governmental con-
spiracy (UPI, 2009). Inevitably such comments negatively impact upon public
confidence in medical initiatives. Indeed, one study of gay and bisexual ethnic-
minority men in the USA indicated that 45% of respondents approved the state-
ment that HIV does not cause AIDS (Hutchinson et al., 2007). One suggestion to
restore public faith in biobanks includes the formation of tissue-trusts to serve
the interests of the common good (Emerson et al., 2011), which would involve
donors and community members being actively engaged in the process of research
governance.
The issue of genetic representation in biobanks is critical to ensuring that per-
sonalized medicine does not end up being a two-tier system of haves and have
nots. Sadly this is already the case for white as opposed to black children needing
bone marrow transplants in the UK (John, 2004). This moral dilemma needs to be
addressed by ethics regulators with immediacy to avoid a similar trend amongst
biobank donations. The IDB is located in a highly ethnically diverse region of
London UK. Encouragingly, an early audit of HIV-infected donors to the IDB
revealed that the demographics of the volunteers and the local multi-ethnic com-
munity matched census-derived demographic data acceptably (Kozlakidis et al.,
2011). However, in this instance it was not possible to establish whether this rep-
resented either self-interest or the true altruism necessary to sustain large clinical
archives.
The underlying ethical issues can be condensed down to the conflict between:
the current rights of an individual not to contribute samples to medical research

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Kozlakidis et al. 117

versus the future rights to enjoy probable future equality of medical treatment for
his/her sons, daughters and their descendants. Indeed, the question arises whether
any individuals have the exclusive and absolute moral right to exclude their entire
gene-line from future medical advances? If we uphold such a right, how do we
equitably balance this moral argument against the rights of the as yet unborn
progeny? In most ethical, legal and religious traditions, unborn children have few,
if any, rights, and none exist for future potential-humans the gene line.

Protecting informed consent and addressing health

inequalities
A cornerstone of contemporary medical ethics is the act of obtaining informed
consent (IC) prior to the commencement of a study. Traditionally, IC is consid-
ered to be specific to a particular research study (Greely, 2007). This highly
prescriptive view of IC can be counterproductive, since it inadvertently pro-
motes wastage of samples not needed in the original study in a way which the
donors might not have supported given the choice (Johnsson et al., 2008).
Moreover, this strict interpretation of IC effectively destroys the future poten-
tial of biobanks, as it requires researchers to contact each donor again and
again for consent to each and every new research project, however similar it is
to the last one. Indeed, the real advantage of clinical archives is that their sam-
ples can be used in multiple future experiments which have not yet been
planned, using technologies which have not been developed, to answer ques-
tions which have not yet been formulated. This dialectic between (the pre-
sumed) absolute requirement for specificity of sample usage in ICs and the
functioning of biobanks have led many to question whether IC should be
viewed as a moral absolute (Laurie, 2008; Hoeyer et al., 2005).
An alternate suggestion is that altruism, solidarity and reciprocity should be
considered as having an equivalent moral basis to that of IC (Knoppers and
Chadwick, 2005). This problem was addressed in the Council of Europes biobank-
ing recommendations, which state: consent need not be specific, but it must be as
specific as possible with regard to unforeseen uses (Council of Europe, 2006).
Such broad consent (BC: also referred to as open consent) has been proposed
as best practice for biobanks (Hansson et al., 2006; NRES, 2011; Cambon-
Thomsen et al., 2007; Haga and Beskow, 2008; Wendler, 2006) and normally
involves specific prohibitions which preclude samples from being used for trivial
or controversial studies. In the UK, such exclusions include studies involving cos-
metics, investigations into reproduction, contraception or stem cells, as well as use
in animal models. Those who favour BC over IC are not without opponents, who
view BC as a dilution of ethics which could destroy public trust (Hofmann, 2009;
Caulfield, 2007). In practice, this criticism does not seem to be borne out by

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118 Research Ethics 8(2)

experience (Lipworth et al., 2009), and supporters of BC consider it to be morally

equivalent to IC provided it is combined with robust systems of research govern-
ance (Elger and Caplan, 2006).
For many, the argument has now moved on to more controversial fields such as
whether consent in any form should be abandoned altogether for biobanks,
genebanks and population databases (Kaye, 2004). Indeed, there was an attempt
by deCODE Genetics Ltd. to establish the Health Sector Database (HSD) com-
prising the medical records, genealogical and genetic data of all Icelanders on a
basis of presumed consent (Wright, 2011). The HSD project proved to be contro-
versial and was criticized over their policies on privacy and consent and the scheme
was prevented from starting by a 2003 legal ruling by the Icelandic Supreme
Court.
In countries such as the UK, which provide free healthcare, there is also debate
as to whether there should be a moral obligation for patients to automatically per-
mit any residual clinical material (taken for diagnostic tests) to be used in medical
research: i.e. an opt-out as opposed to the current opt-in system. Such opt-out
archives are already operating (e.g. the Vanderbilt DNA genebank) and have stim-
ulated new approaches to governance as well as innovative public education strat-
egies (Pulley et al., 2010).
We suggest that should biobanks fail to capture samples that are truly repre-
sentative of society, then the issue of consent may need to be significantly re-
addressed and replaced by an opt-out system for patients attending NHS
appointments. This is not an issue of minimizing tissue wastage but one of the
inclusion of all members of society. The introduction of an opt-out consent process
might have certain drawbacks, i.e. that it would disadvantage those who are less
educated or robust enough to complain or opt-out of the accepted system. In
addition, there is a cognitive bias towards accepting the default situation, so donors
are more likely to accept passively that their samples are used than actively to
object. Whilst on face value these appear to be powerful moral arguments against
an opt-out system, in extremis the failure to adopt such a system may adversely
affect the healthcare of their descendants, thereby further exacerbating pre-exist-
ing inequalities. We would suggest that concerns regarding the latter situation sig-
nificantly outweigh an individuals rights and that donation of samples to
biobanks should be considered an altruistic societal obligation.

Different laws across Europe

An additional complication in the regulation of biobanks is the apparent lack of
a standardized legal framework between, as well as within, individual states.
The historical necessity for studying different diseases affecting each member

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Kozlakidis et al. 119

state of the European Union (EU), for example endemic malaria in areas of
Spain and Greece and inflammatory bowel disease and breast cancer in northern
Europe, meant that in each case different set of rules and regulations were imple-
mented. As a result there are currently slightly different consent forms in each
country and for each type of material collected (Zika et al., 2010). The necessity
for the harmonization and standardization of ethics and law has been led to rec-
ommendations by the EU (BBMRI, 2009) and the suggestion that if all countries
simply abide by a tight interpretation of the Helsinki Declaration further regula-
tion would be counterproductive (Hansson, 2011).
In the UK there are circumstances whereby legislation permits research on
tissues (from the living) to proceed without the consent of the donors. However,
such samples are usually anonymized residual diagnostic materials and are
frequently not stored under ideal conditions for subsequent research studies.
For example, the provenance of these materials is unknown (e.g. the number
of freezethaw cycles they have undergone) and consequently not suitable for
transcriptome analyses (due to inappropriate storage conditions). Consequently,
such samples are often of limited value since they could result in the genera-
tion of misleading research data.

Role of ethics committees to strike the balance

Human biobanks are facilitating medical research, which will have profound
implications for the way patients are treated. Whilst there has been debate regard-
ing the introduction of BC instead of IC, in Europe the former has been accepted
as a gold-standard for clinical archives. In many countries the primary responsi-
bility of RECs is: to ensure that the research respects the dignity, rights, safety
and well-being of individual research participants (Tinker and Coomber, 2004).
However, there is usually no requirement for such committees to make judge-
ments on the broader ethical implications of their decisions in a societal context
and over the longer term for research generally. The issue of genetic inclusion into
biobanks is particularly pertinent and deserves serious consideration given the
development of the first race-specific drug (BIDIL; see http://www.bidil.com/).
We suggest that this issue should be addressed by RECs considering applica-
tions by biobanks, which should also take a lead in suggesting (and approving)
steps to avoid demographic imbalances in such collections. These could involve
the opt-out and presumed consent approaches to obtain donations from hospital
patients. Another, approach might be to re-brand biobanks as a necessary public
health measure (akin to historic actions such as the: mandatory confinement of
tuberculosis patients; iodinization of salt; water fluoridation; and vaccination pro-
grammes). Such public health initiatives are generally widely accepted without

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120 Research Ethics 8(2)

significant disquiet. Alternatively, or additionally, the potential benefits of biobanks

should be publicized more vigorously and combined with educational programmes
directed towards those communities who are found to be under-represented.
RECs are central to these debates and may involve them re-assessing their role.
Should they restrict their moral remit solely upon the duty of care to the research
participant? Or, should this be widened to include their moral responsibilities to
society as a whole? Indeed it would be unfortunate if future generations came to
regard early 21st century medicine as complicit in discriminating along racial lines
through neglecting policies which could redress any longer term disadvantage. We
therefore suggest that RECs should carefully consider the following points when
assessing applications for biobanks and population-based studies:

1. Ensure that such projects have a clear policy, and plan, to recruit volunteers
who are representative of local and national demographics.
2. Place greater emphasis on the long-term and broader societal impact of the
research studies.
3. Consider alternative ethical models to IC for obtaining tissue donations for
medical research.

Whether minority ethnic groups later choose to take part in the clinical research
from which the biobanks are built remains to be seen. However, without engaging
in the first scientific step, no further benefits can follow.
Furthermore, ethics committees are not usually set up to provide a legal opinion
but are there to strike a moral balance between the individual and society. We
would thus like them to seriously reconsider this balance in the case of specific
consent and opt-in policies when collecting samples for biobanks.

Conclusions
The issues raised in this article are not restricted to RECs, but also need to be con-
sidered at the level of legislators and national regulatory agencies. However, ethics
committees are in an excellent position to lead the moral debate on this topic and
are relatively free from different legal rules to make independent judgements.
How should research help balance the need to respect autonomy against the
requirements of justice to address health inequalities?

Acknowledgements
The IDB is grateful for funding from Guys and St Thomas Charity and from the National
Institute of Health Researchs comprehensive Biomedical Research Centre at Guys and St
Thomas NHS Foundation Trust UK. In addition, the participation of donors and the enthusi-
asm of the IDB staff are greatly appreciated.

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Kozlakidis et al. 121

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