Biobank research: who benefits from individual consent?
BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5647 (Published 04 October 2011) Cite this as: BMJ 2011;343:d5647
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We agree with Nicolson that engaging the public is important, and
that there is a need to increase awareness and understanding of medical
research. However, in the context of biobank research this is not
primarily in order to enable an informed decision to be made regarding
what a specific tissue sample can be used for, but rather to offer insight
so that people can "voice their wants, concerns and recommendations" in a
general debate on this kind of research.
Furthermore, we do not find it problematic in itself that individuals
are treated differently in medical research than in healthcare. Healthcare
exists for the direct benefit of the individual while medical research is
a collective project aimed at improving healthcare for the benefit of all,
and this cannot be done in an optimal way without restricting some
choices. This does not imply that individual rights are sacrificed for the
public good, but is a result of weighing different interests that all
individuals have against each other.
Although it is true that evidence "that translates into improved
patient care and changes the health and well-being of patients is neither
straightforward nor guaranteed", we argue that facilitating biobank
research is important because it offers a possibility to advance
healthcare at virtually no individual cost or risk. In a world where
medical advances are not manna from heaven, this is enough.
Competing interests: No competing interests
We agree with Stewart and Harrison that the process of informing
patients about what their tissue samples will be used for can be
important, and that there are good reasons for doing this. However, there
are also good reasons for not doing so, in particular for not always being
specific about the exact uses that the samples will be put to. This is
because prospectively collected samples may later become valuable
retrospective samples, and specific consent can seriously limit their
usefulness.
So rather than requiring specific informed consent for prospective
collection, storage and use of tissue samples, we argue that general
information should be given about the currently planned research and the
possibility that the samples will later be used in other research (after
approval by an ethics review board). We do not believe that this would
lead to less enthusiastic engagement of patients and doctors.
Competing interests: No competing interests
We concur with many of the excellent points made by Stjernschantz
Forsberg et al, regarding hurdles to the use of 'tissue excess to
diagnostic requirements' for research. These barriers are understood by
translational researchers across the disciplines. However, we believe that
prospective collection of informed patient consent is important for a
number of reasons. Consenting patients for tissue donation ensures that
clinicians are truly at the centre of the multidisciplinary team required
for successful translational research, as they are crucial to the tissue
consenting/collection process. Furthermore, consenting patients offers the
chance to explain details of the research to patients and allow them to
embrace the work that they are helping to make possible.
The process of
informing and consenting patients for excess tissue donation is not
prolonged and patient appreciate being central to the research which aims
to eventually improve outcomes from the disease from which they are
suffering. We have found that the process of Scottish urologists
consenting their patients for the use of kidney cancer tissue for Scotland-wide research has allowed enthusiastic engagement of patients and
surgeons from across Scotland with the Scottish Collaboration On
Translational Research into Renal Cell Cancer (SCOTRRCC) project.
Competing interests: No competing interests
Forsberg et al [1] have added to a long-running ethical debate,
arguing that restricting personal choice concerning the use of leftover
materials, samples, and associated data by research, could increase the
chance of direct or indirect benefit for healthcare. Rather than
restricting personal choice, there is a need to engage with the
public/patients, as equal partners in the process.
Dixon-Woods et al [2] have noted that the patient in medical care is
an autonomous agent whose choices are to be respected, while the research
participant is perceived as a na?ve agent whose choices are constrained.
People in medical research currently do not have the same rights as people
receiving medical care. For example, because there is no legal obligation
in the Data Protection Act [3] to inform people when their anonymised data
are being reused for research purposes, there is no reason to either
inform people when this is occurring, or ask them to consent to their
records reuse.
When participants do not receive their preferred treatment in
randomised controlled trials, there may be difficulties with recruitment.
Zelen's design [4] can address these difficulties by randomising
participants before consent has been sought [5]. People receiving the
control (standard treatment) are not asked for consent. People randomised
to the experimental group are consented as usual, but to the certainty of
receiving the experimental treatment only. People who's anonymised
tissue/sample/data is being accessed and reused by research could be
likened to people in the control arm of a Zelen's design study, unaware
they're taking part in a study.
Forsberg et al [1] are correct to cite Alder Hey as a reminder of the
dangers of medical paternalism. People ought to be fully aware when they
are taking part in research, and their capacity to make a choice should
arguably not be automatically disregarded whether or not supported by the
law. Research may be less likely to be accused of acting in a paternalist
fashion, if it respects the individual whose tissue/sample/data are
accessed. Working with a better informed public as active partners in
research could give them greater awareness and understanding about medical
research. Informing people and raising awareness about such research could
enable an informed decision to be made (if asked to do so).
One logical conclusion Forsberg et al [1] can be seen to hint at is
that personal choice can be a barrier for translational medicine. This
would be based on the assumption that materials/samples/data reuse
research will deliver results that make a difference to people's health
and well-being. Translational medicine faces the barrier of converting
research findings into medical practice and healthcare policy [6].
Evidence that translates into improved patient care and changes the health
and well-being of patients is neither straightforward nor guaranteed. It
may be more beneficial to improve how research deals with participants;
and to seek to understand and tackle the barriers to recruiting people to
research.
By engaging the public and empowering them to be equal partners in
tissue/sample/data reuse, there is a possibility to (begin to) redress the
imbalance between public and researcher awareness and understanding. By
enabling greater public awareness and understanding, public misconceptions
may be lessened. Increased public concerns would not be a negative
consequence from increased public awareness about medical research, but
only for researchers who seek access to tissue/sample/data. What is needed
is engagement with the public to honestly inform them about
tissue/sample/data reuse, and empower them to voice wants, concerns and
recommendations.
References
[1 ]Forsberg JS, Hansson M, Eriksson, S. Biobank research: who
benefits from individual consent? BMJ 2011;343:d5647 doi:
10.1136/bmj.d5647
[2] Dixon-Woods M et al. Beyond "misunderstanding": written
information and decisions about taking part in a genetic epidemiology
study. Soc Sci Med 2007, 65(11):2212-2.
[3] Data Protection Act. 1998 www.opsi.gov.uk/acts/acts1998/ukpga
_19980029 _en_1 accessed 15 July 2010.
[4] Zelen M. A new design for randomized clinical trials. N Engl J
Med 1979;300:1242-1245
[5] Torgerson DJ, Roland M. What is Zelen's design? BMJ. 1998 Feb
21;316(7131):606
[6] Sung NS, Crowley WF Jr, Genel M, Salber P, Sandy L, Sherwood LM,
et al.: Central challenges facing the national clinical research
enterprise. JAMA 2003, 289:1278-1287
Competing interests: No competing interests
The key step in the argument given in this piece involves the
assessment of the potential risks and benefits of these research
practices. The authors claim that the risks associated with Biobanks are
minimal and are significantly outweighed by the benefits. There are those
who disagree.(1) However, even if we could agree about the level of risk
and benefit threatened or promised by biobanking, different people would
weigh those risks and benefits differently: for some, control of personal
information is very important and for others it is less so. For this
reason, the authors' argument seems to me an unproductive route to take,
even though I am sympathetic with it.
Instead, it is a mistake to suggest that broad consent cannot be
informed consent and constitutes a breach of autonomy.(2) There are many
ordinary decisions that we make that are properly informed and exemplify
the appropriate exercise of autonomy but which do not involve 'specific'
consent. We often decide to allow others to make decisions for us. If I am
late getting to the restaurant I might call ahead to ask one of the other
diners to order for me: "You decide for me. I don't eat seafood or
sprouts."
These decisions are perfectly acceptable, autonomous decisions but
the information that makes them informed is different from the specific
individual consent case. In the broad consent cases, the relevant
information is about the person (or institution) that will be making the
decision for me. In biobanking, the relevant information might be about
the overall goals of the research supported by the Biobank and details of
the decision-making processes within the institution - how are decisions
made about suitable research and by whom?
Broad consent is a perfectly legitimate form of informed consent. We
do not need a broader notion of autonomy, we simply need a proper
understanding of the one we have.
1. Hoppe, N. Risky Business: Re-Evaluating Participant Risk in
Biobanking. In: Lenk C, Hoppe N, Beier K, Wiesemann C, editors. Human
Tissue Research: A European Perspective on the Ethical and Legal
Challenges. Oxford: Oxford University Press; 2011. p. 35-45.
2. Sheehan, M. Can Broad Consent be Informed Consent? Public Health
Ethics 2011; doi: 10.1093/phe/phr020
Competing interests: No competing interests
Re:Broad Consent is Informed Consent
In our research group we have argued extensively for broad consent to
future research. (1-3) We agree with Sheehan that broad consent is
informed consent, and argue that implementing policies of broad, presumed
or no consent are all ways to further the good that can be achieved
through biobank research.
However, on our view the default position in biobank research needs
to be changed, from requiring consent in the name of respecting
individuals to accepting that research is carried out on stored tissue
samples and data without consent (but with appropriate safeguards such as
ethics review and adequate data protection), because this respects
another, arguably stronger, interest of the same individuals, namely that
of optimizing healthcare.
Although it is true that "for some, control of personal information
is very important and for others it is less so", it is also true that what
is important for a person in a certain situation may be less important to
that person in another situation. For example, somebody who feels strongly
about the right to decide what a sample can be used for when healthy might
feel differently when diagnosed with cancer. The problem is of course,
that most of us do not know beforehand what kind of medical advances we
will need, and it is often too late to contribute to them when do. So,
everybody has an interest vested in as much and as productive research as
possible being carried out, i.e. in implementing a system that facilitates
this end.
References
1. Hansson MG, Dillner J, Bartram CR, Carlson JA, Helgesson G. Should
donors be allowed to give broad consent to future biobank research? Lancet
Oncol 2006; 7(3): 266-9.
2. Hansson MG. Ethics and biobanks. Br J Cancer 2009; 100(1): 8-12.
3. Hansson MG. For the safety and benefit of current and future
patients. Pathobiology 2007; 74: 198-205.
Competing interests: No competing interests