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614 journal of law, medicine & ethics
Biobanks and
the Return of
Research Results:
Out with the Old
and In with the
New?
Ma’n H. Zawati and
Amélie Rioux
Introduction
In 2009, Time magazine named “biobanks” as one
of the 10 ideas changing the world.1 These organized
collections of human biological material and associ-
ated data2 have been identified as “vital research tools
in the drive to uncover the consequences of human
health and disease.”3 Since their inception, however,
biobanks have faced ethical and legal challenges.4
Whether these pertain to informed consent, access
by researchers, commercialization, confidentiality, or
governance, biobanks must continue to address juris-
dictional matters, operational diculties, and nor-
mative frameworks that strive to stay abreast of cur-
rent scientific innovation.5 Yet, with some biobanks
now having completed their recruitment objectives6
and with research currently being performed on their
data and samples, one topic has become the focus
of ongoing debates: the return of research results to
participants.
One of the driving forces behind the continued pres-
ence of discussion on this issue is the use of innovative
technologies,7 such as next-generation sequencing
and the noticeable advancement in “omics” practices.8
As one author indicates, “deciding how to deal with
genomic research results has become increasingly
pressing as technologies for genome-wide analysis
have become readily available.”9
That being said, while the traditional debate cen-
tered around whether or not biobanks should return
research results, emerging discussions have raised
numerous issues that are more focused on the modali-
ties of any eventual return, and this, especially in light
of the advances in data production and analysis by
researchers using these biobank infrastructures. Part
I first reviews the current practices undertaken by
various biobanks with regard to the return of research
results. This section focuses on population biobanks,
since they present interesting dimensions not often
Ma’n H. Zawati, LL.B., LL.M., is a lawyer and an Academic
Associate at the Centre of Genomics and Policy at McGill Uni-
versity. Mr. Zawati coordinates the ELSI and Privacy Task
Force of the Canadian Partnership for Tomorrow Project, a
pan-Canadian research study of 300,000 Canadians that
explores how genetics, environment, lifestyle, and behavior
contribute to the development of cancer and other chronic
diseases. His work focuses on the legal and ethical aspects of
population genomics and on the duties of health professionals
in medical research. Amélie Rioux, LL.B., has a Civil Law
degree from the University of Montreal and is a Research As-
sistant at the Centre of Genomics and Policy. She also holds
a Bachelor’s degree in Microbiology and Immunology and
a Graduate Diploma in Health Management from McGill
University. She specializes in projects focusing on the com-
munication of genetic information, immunization, and nano-
technologies. Ms. Rioux also participated in the creation of a
database for Genome Canada.
return of research resultswinter 2011 615
Zawati and Rioux
covered in the literature. Then, while focusing more
specifically on the return of individual research
results, this article analyzes both the literature as well
as ethical and legal norms surrounding the return of
research results in biobanks at large in Part II, as well
as the thorny and emergent discussions surrounding
this topic in Part III.
However, before embarking on any analysis, it is
important to clarify terminology and to exclude issues
tangential to discussions on the return of research
results in the particular context of biobanks. First of
all, biobanking studies generally oer three dierent
types of “communication”: (1) initial feedback upon
assessment and lab analysis prior to storage; (2) gen-
eral results (also known as aggregate); and (3) indi-
vidual research results. The first type of communica-
tion is very common in many biobanks.10 Feedback is
usually provided immediately,11 sent later by mail,12 or
sent to the physician unless the participant refuses.13
The feedback covers the results of measurements that
include blood pressure, lung function, bone density,
height, weight, and estimated amount of fat.14 When
abnormal measurements at recruitment are observed,
the personnel will encourage participants to contact a
physician.15 Moreover, biobanks that perform lab anal-
yses of biological material prior to storage can provide
these as a matter of course.16 Most importantly, the
caveats attached to this initial feedback of measure-
ments and lab analyses serve to avoid the therapeutic
misconception that the assessment is equivalent to a
medical check-up.17 Regarding our analysis, we argue
that this specific type of communication cannot be
described as research results, since no actual research
is undertaken at this stage.
Secondly, we posit that the issue where research
reveals vital, life-threatening information that poses
an immediate danger to the participants or to family
members is distinct from the debate surrounding the
return of research results in biobanking generally and
depends on the ambit of the duty to rescue those in peril
in dierent jurisdictions. The reason for this exclusion
is that the obligatory nature of such disclosure may
be (or not) legally or ethically mandated. Using these
cases as examples can skew the debate on the return
of research results, since many researchers in various
jurisdictions cannot ignore such an obligation irrespec-
tive of the nature of their biobank.
Finally, often flanking the return of
research results are “incidental findings”
or discoveries “concerning an individual
research participant that [have] potential
health or reproductive importance and
[are] discovered in the course of conduct-
ing research but [are] beyond the aims
of the study.”18 Although having similar
return modalities,19 these findings will also
be excluded from our analysis, as we do not
consider them as “research results” per se
due to their incongruity with the objectives
of the studies they unexpectedly arise in.
Part I. Biobanks and Return of Research
Results: Current Practices
In order to increase the understanding of common
disease risk and human health, population genom-
ics has utilized basic data on genomic variation, life-
style behaviors, and environmental factors.20 This is
especially evident in the increasing number of global
population biobanks that collect data and biological
samples on a longitudinal scale. Usually created to
provide the infrastructures necessary to foster future
unspecified research, this specific type of biobank is
defined as a collection of biological materials that has
the following characteristics:
(1) the collection has a population basis; (2) it
is established, or has been converted, to supply
biological materials or data derived therefrom
for multiple future research projects; (3) it
contains biological materials and associated
personal data, which may include or be linked
to genealogical, medical and lifestyle data and
which may be regularly updated; [and] (4) it
receives and supplies materials in an organized
manner.21
Concentrating on the return of research results in
these biobanks, two pertinent approaches can be iden-
tified: the return of general results, and the return of
individual research results. These approaches are not
mutually exclusive and some biobanks do both.
In order to present a general overview of the current
practices of such biobanks, nine population biobanks
While the traditional debate centered around
whether or not biobanks should return
research results, emerging discussions have
raised numerous issues that are more focused
on the modalities of any eventual return, and
this, especially in light of the advances in data
production and analysis by researchers using
these biobank infrastructures.
616 journal of law, medicine & ethics
SYMPOSIUM
were selected randomly from the list of Charter mem-
bers of the Public Population Project in Genomics’
(P3G) Secretariat website.22 Included in this analysis
are the following: LifeGene (Sweden); Lifelines (Neth-
erlands); Estonian Genome Project; UK Biobank;
Generation Scotland (Health Study); CONOR (Nor-
way); ALSPAC (UK); Ontario Health Study (Canada);
and CARTaGENE (Quebec).
A. General Results
In all nine biobanks, two avenues of communica-
tion are used to return general results: newsletters
and websites. The Ontario Health Study states that
“[s]ummaries of findings from research studies will
be published and available on [the] website as they
become available [….] This information will also be
shared with participants via email newsletters.”23 In
addition to the traditional avenue of scientific publica-
tion, where clinical impact information trickles down
to physicians, the public funding and public nature
of population biobanks is also not without influence
on the communication of overall findings to partici-
pants and the wider community — the aim being to
“influence public health strategies (including, where
appropriate, the introduction of newly discovered risk
factors).”24 Yet, “the primary concern […] is not to the
health of the participant but to acquire information
for the benefit of humankind.”25
B. Individual Research Results
The raison d’être of population biobanks is to serve as
a resource for future unspecified research. Hence, as
it will be seen from the examples below, the norm is
a “no-returns” policy. Such population infrastructures
being largely longitudinal and epidemiologic — and
not disease-specific — there should be no “individual”
results.26 This is the case of CARTaGENE, which clearly
states in its Information Brochure to participants that
“[n]o results from future research projects using data
or samples will be communicated to participants by
CARTaGENE.”27 UK Biobank holds a similar stance,
but expands by clarifying that:
[…] the value of such feedback is questionable
because the data would be communicated out-
side of a clinical setting and would not have been
evaluated in the context of the full medical record.
[…] Further, it is not likely to be constructive, and
might even be harmful (including causing undue
alarm and having potentially adverse eects on
insurance and employment status), to provide
information without prior counselling or support.
For these reasons, UK Biobank will generally not
provide health information to participants[…].28
The same approach towards individual research
results is followed by Generation Scotland,29 ALSPAC, 30
and LifeGene.31 That being said, ALSPAC and LifeGene
have both included exceptions to this approach in cases
where they are “reasonably certain that the benefits of
disclosure clearly outweigh any possible risks to the
participants or their families,”32 or where the informa-
tion retrieved reveals “a very high risk of a preventable
and serious disease.”33 However, the last exception falls
within the immediate danger category, which we previ-
ously excluded from this debate.
There are, however, biobanks (albeit a minority) that
provide individual research results to participants. In
both biobanks, a general practitioner plays an impor-
tant role in the process — a role that is generally not
present in biobanking initiatives. Nevertheless, the
Estonian Genome Project, where initial enrollment
is done in a general practitioner’s oce, allows par-
ticipants to access their “genetic data, hereditary char-
acteristic and genetic risks obtained as a results (sic)
of genetic research.”34 As for Lifelines, validated and
clinically significant information will be returned to
participants via their general practitioner who initially
enrolled them in the research project.35
That being said, with whole-genome and whole-
exome sequencing becoming increasingly common
research tools, and where pertinent research results
will be revealed as a matter of routine,36 fundamen-
tal questions emerge from this discussion. What do
the norms governing the return of research results in
genetic research advocate with regard to individual
information? Do they echo the current practices of
biobanks? Would they allow researchers to communi-
cate directly with their participants, if it means attri-
tion in their cohort? Under what circumstances would
this be authorized by the biobank? Should biobanks
themselves play this role?
In order to answer these questions, we first review
the current literature and ethical and legal norms.
PART II. The Old — To Return or Not to
Return Individual Research Results?
That was the question. Indeed, for some time, a debate
ensued in the literature — supported by ethical and
legal norms — on whether biobanks of any nature
should return individual research results or not. This
section briefly summarizes this traditional debate.
Using the HumGen International database,37 an
online resource specializing in legal and socio-ethical
issues in human genetics, documents covering the ethi-
cal, legal, and social issues of biobanks were located
using the keyword “biobank.” In order to focus only on
pertinent documents, the keyword “communication of
results” was added to the search keys. Only documents
return of research resultswinter 2011 617
Zawati and Rioux
that discussed the return of results were retained for
the purpose of this analysis. Since there are not many
norms specifically pertaining to biobanks, ethical and
legal norms pertaining to genetic research at large
were also retained and analyzed. As for the literature,
the PopGen module of the HumGen International
database as well as Google Scholar and PubMed were
used to retrieve the pertinent literature on the return
of research results. The keywords used were “biobanks”
and “communication of results” for the PopGen mod-
ule, and “biobanks” and “return of research results” for
both Google Scholar and PubMed.
Without being exhaustive, most of the literature and
norms retrieved either reject any return of research
results or support their disclosure, albeit with some
conditions. This last category sets the stage for an in-
depth discussion of the emerging issues surrounding
the return of research results debate that follows.
A. No Obligation to Return Individual Research Results
Current norms rarely explicitly reject any obligation
to return individual research results. Nevertheless,
the Singapore Bioethics Advisory Committee’s 2002
Human Tissue Research Report38 rebus any duty to
disclose individual results:
[…] donors should not expect any personal or
direct benefit from the donation of tissue, includ-
ing information of any medical condition or pre-
disposition or likelihood of such discovered in
the course of research on the sample. Likewise,
researchers and tissue bankers should not be under
an obligation to disclose such information to the
donors, unless they have agreed to do so in advance
of the donation.39
The Singapore Bioethics Advisory Committee reiter-
ated this stance in its 2005 document, entitled Ethi-
cal, Legal and Social Issues in Genetic Testing and
Genetic Research.40 It posited that since “human genet-
ics research enhances our understanding of the genetic
basis of disease and how genetic and environmental
factors influence one’s health,”41 the main goal is not to
oer research participants or their families with “spe-
cific information about their genetic status or health.”42
While the available literature does not oer a clear
consensus on the return of individual research results,43
some authors advise against the return of individual
findings “since it implies assuming a responsibility
for the clinical significance for an individual based on
information about the odds ratio expressing risk only
for a study population.”44 According to the adherents
of this position, the main argument is that the only
benefit of these studies “is the health of future genera-
tions, including information about the long lead times
before scientifically significant results become clini-
cally significant.”45
Usually this position is specifically mentioned in
the consent forms of biobanks as well as their internal
documentation. According to some of them, obser-
vations made during research on data and samples
are “not likely to be constructive, and might even be
harmful (including causing undue alarm and having
potentially adverse eects on insurance and employ-
ment status).”46
B. Pro-Return of Individual Research Results
As to the norms advocating a return of research results,
the Council for International Organizations of Medi-
cal Sciences’ 2009 International Ethical Guidelines for
Epidemiological Studies47 states that “in light of con-
temporary standards for informed consent […] epi-
demiologists should make subjects aware of findings
that are clinically relevant to their individual health.”48
It is not clear, however, whether biobanks were con-
sidered in this discussion. Furthermore, they maintain
that the study’s policy towards the disclosure of find-
ings should be clearly communicated to participants in
the informed consent material. Exceptionally, “when
an investigator does not plan to do so, he or she must
obtain approval from the ethical review committee.”49
Based on conditions such as the clinical signifi-
cance of findings, some authors argue that population
biobanks need to reconsider their no-returns policy.50
“The long-term nature of a biobank augurs for one day
amassing a large amount of clinically relevant infor-
mation.”51 Moreover, as concerns genetic research spe-
cifically, “international policies are converging towards
an ethical duty to return individual genetic research
results to subjects, provided there is proof of validity,
significance and benefit.”52
It is the modalities of the return of research results
(proof of validity, utility, and actionability) that are
the subject of current debates, which will be now dis-
cussed. Indeed, reference to these three conditions
is emerging in genetic research.53 However, current
debates pertain to some outstanding issues, such as
the diculty in defining each criterion (e.g., clinical
utility, analytical validity, and actionability) in practi-
cal terms, and establishing thresholds for each.54
PART III. The New — The Modalities of the
Return of Individual Research Results
A. Ethical Norms and the Discretion of Researchers
First of all, it is important to note that most of the
recent ethics norms relating to the return of research
results do not clearly support one approach or the other
618 journal of law, medicine & ethics
SYMPOSIUM
(return vs. no-return), but rather leave that decision to
the researchers and provide them with guidance.
The Canadian College of Medical Geneticists &
Canadian Association of Genetic Counsellors’ 2008
Joint Statement on the Process of Informed Consent
for Genetic Research,55 for example, recommends that
“research participants […] be informed at the outset if
the results from the study will be disclosed and, if so,
in what manner (e.g. individually to each participant
or collectively as a study group through publication or
another means).”56 Further, the Joint Statement rec-
ommends that researchers protect the privacy and
confidentiality of individual participants during the
disclosure of results. It also urges researchers to “ide-
ally” allow participants to have the option to “decline
to be informed of study results at the time of enroll-
ment or at any time during the study.”57
More pertinent to biobanking is the OECD’s 2009
Recommendation on Human Biobanks and Genetic
Research Databases.58 Many similarities are found with
the Canadian Joint Statement. For instance, article
4.14 states that notwithstanding applicable laws and
appropriate authorities, participants may be provided
with feedback of individual-level results arising from
research. In doing so, the operators of the biobank will
need to oer appropriate information to the partici-
pant with regard to the consequences of receiving such
results and should, as also stated in the Joint Statement,
“inform the participant of their right to opt-out from
receiving such results.”59 Where this policy particularly
diers is in recommending that non-validated results
from scientific research using biobanks data or samples
should not be returned to participants — and that this
policy should be explained to them at the initial consent
process. This is a clear indication of the importance of
validation as a requirement of disclosure.
The 2010 Western Australia Guidelines for Human
Biobanks, Genetic Research Databases and Associated
Data60 reiterates the right of individuals to not know
their results.61 The Guidelines also recommend that if
individual results are returned to participants, then
the biobank operators should ensure that a trained
professional or counselor is available for the partici-
pants at appropriate times.62 The Guidelines state that
the researchers could return non-validated results if it
is ethically necessary to do so.63 In such cases, however,
they are requested to advise their participants about
“the dierence between research and clinical results,
clarifying the need for clinical testing of research
results.”64 Yet, no real definition is provided on what
“ethically necessary” means.
B. Proof of Analytic Validity, Clinical Utility, and
Actionability: Debate and Guidance
According to some authors, taking into consideration
these three conditions when deciding to return indi-
vidual research results to participants serves to “delimit
the future, open-ended scope of professional responsi-
bilities.”65 Yet, much debate has arisen on the use of such
conditions in practice.66 Indeed, some authors argue
that these conditions still require some refinement.67
More specifically, they posit that with analytic validity,
a lack of consistent criteria exists for determining when
the threshold for clinical validity has been obtained, due
to the latter being a “moving target, with (unclassified)
variants being reclassified based on scientific evidence
over time.68” Others believe that scientific validation of
data diers from clinical validation of information and
that “neither standard will be adequately approximated
by broad categories of research stage or type.69” As for
clinical utility, they argue that it varies widely, depend-
ing, on the “magnitude of the risk, the accuracy of the
risk prediction”70 to name but a few.
The 2010 NCI Workshop on Release of Research
Results to Participants in Biospecimen Studies provides
some clarification to this current debate by suggesting a
“smart filter,” which is presented in the workshop sum-
mary as a list of criteria that could be used to determine
whether to return results to research participants or
not.71 The document recommends that investigators as
The 2010 NCI Workshop on Release of Research Results to Participants in
Biospecimen Studies provides some clarification to this current debate by
suggesting a “smart filter,” which is presented in the workshop summary as
a list of criteria that could be used to determine whether to return results to
research participants or not. The document recommends that investigators
as well as Research Ethics Boards that identify and verify, respectively,
potentially returnable research results be the ones to use such filter.
return of research resultswinter 2011 619
Zawati and Rioux
well as Research Ethics Boards that identify and verify,
respectively, potentially returnable research results be
the ones to use such filter. As to what should be included
in the latter, the NCI Workshop summary enumerates
the following core principles: (1) the participant has
agreed to receive research results during the consent
process; (2) the results are analytically valid; (3) the
results are clinically significant or serious for the par-
ticipant; and, (4) the results are clinically actionable.
As for analytic validity, the same Workshop Statement
proposes a model where after the investigator identi-
fies the potentially returnable results, the Research
Ethics Board would review this result and determine
whether it should be returned to participants. In order
to do so, the workshop attendees recommended that
Research Ethics Boards seek guidance from laboratory
groups, among others. The clinical significance crite-
rion refers to the clinical importance of information to
the participant,72 but no further guidance is provided
in the workshop statement. As to the term “clinically
actionable,” the workshop attendees have posited that it
should be interpreted in the broadest way, i.e., that “the
result might not lead to a cure, but it could help the par-
ticipant better understand a clinical condition or plan
for the future.” In the same vein, some authors have
included surveillance and interventions to improve the
clinical course as examples of actionability.73
In brief, the NCI Workshop attendees proposed that
such filter should not become static, but rather adapt
and evolve through practice.
Conclusion
The “no-returns policy” used by some biobanks is cur-
rently being challenged, not only because of the emer-
gence of data-intensive science, but also because of the
growing voices advocating for the return of clinically
useful, analytically valid, and medically actionable infor-
mation. This is, of course, conditional on participants
opting to receive such results, when and if they emerge.
If one accepts that the “no returns” policy should be
revisited — and we believe it should — then the dis-
cussion should now focus on providing guidance to
researchers that have initially decided not to return
individual research results and that may wish to mod-
ify their practice to allow findings where the defini-
tional issues surrounding the three conditions are set-
tled. If so, do biobanks have to recontact hundreds of
thousands of participants and ask whether they would
like to receive certain information?74 Doing this could
be time-consuming, cumbersome, and constitute an
invasion of privacy (unless undertaken during regu-
lar recontact in longitudinal biobanks). Additionally,
more reflection is needed regarding the typology of
biobanks.75
Finally, it is important that biobanks remain in con-
trol of any disclosure of information emanating from
their collection since they are entrusted by the partici-
pants who altruistically gave their data and samples for
research. Clarity and transparence in policy embold-
ens such trust,76 and keeping abreast of current sci-
entific innovation and adapting one’s policies sustains
it. Return of research results is a sound example of an
issue that is influenced by rapid changes in technology,
but also in need of further reflection before additional
policy guidance is drafted.
Acknowledgements
The authors would like to acknowledge funding from the Canadian
Partnership Against Cancer through the Canadian Partnership for
Tomorrow Project. The authors would like to thank Adrian Thoro-
good for his assistance.
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29. See Generation Scotland, “FAQs,” supra note 12.
30. See ALSPAC Ethics and Law Committee, supra note 16.
31. See LifeGene Ethics Group, supra note 24.
32. See ALSPAC Ethics and Law Committee, supra note 16.
33. See LifeGene Ethics Group, supra note 24.
34. Estonian Genome Project, Gene Donor Consent Form, avail-
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35. See Wallace and Kent, supra note 13.
36. See Cho, supra note 9.
37. Centre of Genomics and Policy, Humgen International homep-
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38. Singapore Bioethics Advisory Committee, Human Tissue
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39. Id., at s. 13.1.8.
40. Singapore Bioethics Advisory Committee, Ethical, Legal and
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41. Id., at s. 5, para. 5.1.
42. Id.
43. A. L. Bredenoord, H. Y. Kroes, E. Cuppen, M. Parker, and J.
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44. M. G. Hansson, “A Minimal Ethical Framework for Biobank
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45. Id.
46. See UK Biobank, Ethics and Governance Framework, supra
note 14.
47. Council for International Organizations of Medical Science
(CIOMS) and World Health Organization (WHO), Interna-
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48. Id., at Commentary on Guideline 2.
49. Id., at Commentary on Guideline 5.
50. C. Johnston and J. Kaye, “Does the UK Biobank Have a Legal
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51. S. B. Haga and L. M. Beskow, “Ethical, Legal, and Social Impli-
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52. See Knoppers and Kharaboyan, supra note 17, at 678.
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54. J. Couzin-Frankel, “What Would You Do?” Science 331, no.
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55. Canadian College of Medical Geneticists and Canadian Asso-
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56. Id., at s.7.
57. Id.
58. Organization for Economic Co-operation and Development,
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59. Id.
60. Western Australia Department of Health, Oce of Popula-
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61. Id., at Article 4.21.
62. Id., at Article 4.22.
63. Id., at Article 4.23.
64. Id.
65. See Knoppers, supra note 7, at 17.
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67. See Bredenoord et al., supra note 43, at 45.
68. Id.
69. See Miller et al., supra note 66.
70. See Bredenoord et al., supra note 43, at 45.
71. Oce of Biorepositories and Biospecimens Research, National
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72. Id., at 45.
73. R. Fabsitz et al., “Ethical and Practical Guidelines for Report-
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74. See Couzin-Frankel, supra note 54, at 664.
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Hens, E. Lévesque, and K. Dierickx, “Children and Biobanks:
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76. B. M. Knoppers and M. H. Zawati, “Population Biobanks and
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