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Biobanks and the Return of Research Results: Out with the Old and In with the New?



In 2009, Time magazine named “biobanks” as one of the 10 ideas changing the world. These organized collections of human biological material and associated data have been identified as “vital research tools in the drive to uncover the consequences of human health and disease.” Since their inception, however, biobanks have faced ethical and legal challenges. Whether these pertain to informed consent, access by researchers, commercialization, confidentiality, or governance, biobanks must continue to address jurisdictional matters, operational difficulties, and normative frameworks that strive to stay abreast of current scientific innovation. Yet, with some biobanks now having completed their recruitment objectives 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.
614 journal of law, medicine & ethics
Biobanks and
the Return of
Research Results:
Out with the Old
and In with the
Ma’n H. Zawati and
Amélie Rioux
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
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 resultswinter 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
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
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 resultswinter 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
(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 prediction70 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 resultswinter 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.
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
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.
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.
1. A. Parks, “10 Ideas Changing the World Right Now: Biobanks,”
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2. Center of Genomics and Policy, P3G Lexicon - Popgen, avail-
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9. M. K. Cho, “Understanding Incidental Findings in the Context
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10. See, e.g., LifeGene Ethics Group, Lifegene Ethics Policy
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Files/104/20100916_LifeGene_Ethics_Policy4.3.docx> (last
visited August 29, 2011).
11. See, e.g., CARTaGENE, Information Brochure for Participants,
Université de Montréal, available at <http://www.cartagene.> (last visited
August 29, 2011).
12. See, e.g., Generation Scotland, Scottish Family Health Study
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(last visited September 21, 2011); Generation Scotland, FAQs
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13. S. Wallace and A. Kent, “Population Biobanks and Return-
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August 29, 2011).
620 journal of law, medicine & ethics
15. See, e.g., CARTaGENE, supra note 11.
16. See, e.g., ALSPAC Ethics and Law Committee, Policy Guidance
Regarding Divulging Biomedical Information to Individual
Participants, University of Bristol, 2010, available at <http://>
(last visited August 29, 2011).
17. B. M. Knoppers and L. Kharaboyan, “‘Deconstructing’ Biobank
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E. W. Clayton, and J. G. Fletcher et al., “Managing Incidental
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(2008): 219-248.
19. S. M. Wolf, B. N. Crock, and B. Van Ness et al., “Managing
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20. M. J. Khoury, “The Case for a Global Human Genome Epidemi-
ology Initiative,” Nature Genetics 36, no. 10 (2004): 1027-1028.
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mittee of Ministers to Member States on Research on Biologi-
cal Materials of Human Origin, Strasbourg, 2006, available
at <> (last visited
August 29, 2011).
22. Public Population Project in Genomics (P3G) Secretariat, avail-
able at <> (last visited August 29,
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at <
Form%20ENG.pdf> (last visited August 29, 2011).
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Files/104/20100916_LifeGene_Ethics_Policy4.3.docx> (last
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25. See ALSPAC Ethics and Law Committee, supra note 16.
26. B. M. Knoppers and M. H. Abdul-Rahman (Zawati), “Biobanks
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27. See CARTaGENE, supra note 11.
28. UK Biobank, Ethics and Governance Framework version 3.0,
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docs/EGF20082.pdf> (last visited August 29, 2011).
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-
able at <> (last
visited August 29, 2011).
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
Research Report, 2002.
39. Id., at s. 13.1.8.
40. Singapore Bioethics Advisory Committee, Ethical, Legal and
Social Issues in Genetic Testing and Genetics Research: A
Consultation Paper, Singapore, 2005, available at <http://
Research.pdf> (last visited September 21, 2011, See Annex D).
41. Id., at s. 5, para. 5.1.
42. Id.
43. A. L. Bredenoord, H. Y. Kroes, E. Cuppen, M. Parker, and J.
J. M. van Delden, “Disclosure of Individual Genetic Data to
Research Participants: The Debate Reconsidered,Trends in
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44. M. G. Hansson, “A Minimal Ethical Framework for Biobank
Research,Methods in Biobanking, Methods in Molecular Biol-
ogy 675 (2011): 39-59.
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-
tional Ethical Guidelines for Epidemiological Studies, 2009.
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
Obligation to Feedback Individual Findings to Participants?”
Medical Law Review 12, no. 3 (2004): 239-267.
51. S. B. Haga and L. M. Beskow, “Ethical, Legal, and Social Impli-
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ics 60 (2008): 505-544.
52. See Knoppers and Kharaboyan, supra note 17, at 678.
53. V. Ravitsky and B. S. Wilfond, “Disclosing Individual Genetic
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54. J. Couzin-Frankel, “What Would You Do?” Science 331, no.
6018 (2011): 662-665.
55. Canadian College of Medical Geneticists and Canadian Asso-
ciation of Genetic Counselors, Joint Statement on the Process of
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able at <
pdf> (last visited August 29, 2011).
56. Id., at s.7.
57. Id.
58. Organization for Economic Co-operation and Development,
Guidelines for Human Biobanks and Genetic Research Data-
bases (HBGRDs), Paris, 2009.
59. Id.
60. Western Australia Department of Health, Oce of Popula-
tion Health Genomics - Public Health Division, Guidelines for
Human Biobanks, Genetic Research Databases and Associated
Data, Perth, Australia, 2010.
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.
66. F. A. Miller, R. Christensen, and M. Giacomini et al., “Duty to
Disclose What? Querying the Putative Obligation to Return
Research Results to Participants,Journal of Medical Ethics
34, no. 3 (2008): 210-213, at 212.
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
Cancer Institute, National Institutes of Health, Workshop on
Release of Research Results to Participants in Biospecimen
Studies, Workshop Summary, Bethesda, Maryland, March 4,
2011, at Recommendation 2.5.
72. Id., at 45.
73. R. Fabsitz et al., “Ethical and Practical Guidelines for Report-
ing Genetic Research Results to Study Participants: Updated
Guidelines from a National Heart, Lung, and Blood Institute
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74. See Couzin-Frankel, supra note 54, at 664.
75. See, e.g., P. Riegman and E. van Veen, “Biobanking Residual
Tissues,Human Genetics 130, no. 3 (2011): 357-68. A. M.
Tassé, “Biobanking and Deceased Persons,Human Genetics,
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Hens, E. Lévesque, and K. Dierickx, “Children and Biobanks:
A Review of the Ethical and Legal Discussion,” Human Genet-
ics 130, no. 3 (2011): 403-413.
76. B. M. Knoppers and M. H. Zawati, “Population Biobanks and
Access,in S. Rodota and P. Zatti, eds., Il Governo Del Corpo: Trat-
tato Di Biodiritto (GiuEditore, 2011): 1181-1194; id.
... During that visit, a number of physical measurements are taken, including bone density and blood pressure. All biobanks return any critical values (those that could pose a serious danger to their lives) discovered during these measurements to participants [45]. Some biobanks could even extend the return period to include abnormal findings from laboratory tests performed before the samples are stored [45]. ...
... All biobanks return any critical values (those that could pose a serious danger to their lives) discovered during these measurements to participants [45]. Some biobanks could even extend the return period to include abnormal findings from laboratory tests performed before the samples are stored [45]. In both cases, if critical medical values are identified, the participant is informed. ...
... In both cases, if critical medical values are identified, the participant is informed. If the situation warrants, they may be escorted to an emergency medical treatment center [45]. Here again, such return falls within reciprocity for mutual respect. ...
In this chapter, I demonstrate that, despite certain limitations, reciprocity is the most suitable conceptual grounding for relational autonomy in population biobanks. The result of which, as I will show, is a more appropriate conception of autonomy that is capable of theoretically framing the disclosure of information during the consent process. This is so because, when compared to individualistic autonomy, reciprocity-based relational autonomy offers a more solid basis on which complex, ongoing, and multilateral relationships can both be acknowledged and sustained.
... Participants have often provided consent for their data and samples to be stored in a biobank and to be used for future research: that is, as a resource for other researchers and irrespective of the type of genetic testing or technology. Moreover, as opposed to disease-specific biobanking 20 , longitudinal biobanks provide general results but usually do not communicate individual results 21 . This may have to change, however, as researchers accessing longitudinal studies will increasingly obtain findings that would meet the ACA criteria. ...
... Offering to return individual results for WGS-based testing within the research context can be seen as creating a therapeutic misconception, as the goal of research is to produce generalizable findings 21 . Offering the possibility of future information as a form "of consideration for taking part" (REF. ...
Full-text available
Genetic testing based on whole-genome sequencing (WGS) often returns results that are not directly clinically actionable as well as raising the possibility of incidental (secondary) findings. In this article, we first survey the laws and policies guiding both researchers and clinicians in the return of results for WGS-based genetic testing. We then provide an overview of the landscape of international legislation and policies for return of these results, including considerations for return of incidental findings. Finally, we consider a range of approaches for the return of results.
... This has led to questions such as what kind of results should be shared with the subject, how should such results be communicated to the subject, and by whom? (De Clercq et al. 2017;Wolf 2013;Zawati and Rioux 2011). On the other hand, some authors have argued that returning results to the research subject is not to be encouraged, particularly when it is not clinically relevant as this may lead to misinterpretation and to the creation of unnecessary anxiety, thus leading to psychological, social, or economic harm to the subjects (Budimir et al. 2011). ...
The establishment of MyCohort in 2005 showed that there is a growing interest on the part of the Malaysian government in the creation of biobanks in the country. This project can be considered as the biggest and most comprehensive cohort study in Malaysia, where hundreds of thousands of human samples are stored for epidemiological and biomedical research. However, little is known about the current issues or the situation related to biobank research in Malaysia. There are pressing issues that need answers such as the governance of the national biobank as well as other privately owned biobanks in the nation, the public perspectives and perceptions regarding biobanks, and other matters such as the ethical, legal, and social issues related to biobank research. This article will highlight the status and issues related to biobank research in Malaysia and provide suggestions on future research practices that we feel need to be seriously considered. These suggestions are designed to advance and enlighten researchers’ knowledge, as well as provide the public with information on issues associated to biobanking. Good governance increases public knowledge and trust, and religious acceptance of biobank research and accountability can lead to increased participation in biobank research. The direct implications of the discussion about the ethical, legal, and social issues of biobanks are pertinent for the foundation of knowledge relating to biobanks, as well as the forward gestures for future medicine for mankind.
... Should the findings be returned to the child or to the parents? [5,10,14,[17][18][19][20][21][22]. ...
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Background: Genomic sequencing of children in research raises complex ethical issues. This study aims to gain more knowledge on the attitudes towards the inclusion of children as research subjects in genomic research and towards the disclosure of pertinent and incidental findings to the parents and the child. Methods: Qualitative data were collected from interviews with a wide range of informants: experts engaged in genomic research, clinical geneticists, persons with mental disorders, relatives, and blood donors. Quantitative data were collected from a cross-sectional web-based survey among 1227 parents and 1406 non-parents who were potential stakeholders in psychiatric genomic research. Results: Participants generally expressed positive views on children's participation in genomic research. The informants in the qualitative interviews highlighted the age of the child as a critical aspect when disclosing genetic information. Other important aspects were the child's right to an autonomous choice, the emotional burden of knowing imposed on both the child and the parents, and the possibility of receiving beneficial clinical information regarding the future health of the child. Nevertheless, there was no consensus whether the parent or the child should receive the findings. A majority of survey stakeholders agreed that children should be able to participate in genomic research. The majority agreed that both pertinent and incidental findings should be returned to the parents and to the child when of legal age. Having children does not affect the stakeholder's attitudes towards the inclusion of children as research subjects in genomic research. Conclusion: Our findings illustrate that both the child's right to autonomy and the parents' interest to be informed are important factors that are found valuable by the participants. In future guidelines governing children as subjects in genomic research, it would thus be essential to incorporate the child's right to an open future, including the right to receive information on adult-onset genetic disorders.
... Common recommendations among medical researchers have been to suggest that research participants should employ the "donor" model (Clayton & McGuire, 2012;Dressler et al., 2012;Miller, Mello, & Joffe, 2008). Common among IRBs and ethicists has been a preference for the "legal contract" (Bredenoord, Onland-Moret, & Van Delden, 2011;Zawati & Rioux, 2011) or "collaborative" models (Beskow, Burke, Fullerton, & Sharp, 2012;Murphy et al., 2008). There was also evidence that among research participants, the "doctorpatient" or "altruistic" models might be operative (Hunter, Corcoran, Leeder, & Phelps, 2012;Kelley et al., 2015;Michie, Henderson, Garrett, & Corbie-Smith, 2011;Ruiz-Canela, Valle-Mansilla, & Sulmasy, 2011). ...
Full-text available
The rise of large cohort-based health research that includes genetic components has increased the communication challenges for researchers. Controversies have been amplified over requirements for re-consent, return of results, and privacy protections, among other issues. This study extended research on the impact that the perceived role of "research participant" might have on communication expectations to illuminate research participants' preferences for re-consent. The study employed an online survey of participants in a long-standing cancer genetics registry. Results confirmed previous exploratory findings that research participants endorse multiple mental models of participant roles in research (doctor-patient, collaborator, donor, legal contract, etc.). Regression analyses indicated that high and low salience of different models of the role of research participant are related to different communication expectations. However, the pattern of relationships among roles is relevant. The results of the regression analysis also indicated that preference for mandatory re-consent and its relationship to mental models of roles are related to attitudes of trust, benefits, and informational risks. The discussion identifies implications as including the use of explicit approaches to address role relationships in communication with research participants. It also points to implications for methodological approaches in mental model research.
... Increasingly, stored samples will be obtained for entire genome searches for disease-related genes or for pharmacogenomics to assess drug metabolism and related genes, Furthermore, on-line direct-to-consumer solicitation of deoxyribonucleic acid (DNA) samples will exacerbate consent and competency issues (Howard et al., 2011). Although current positions on consent to genetic testing and research may provide general guidance, they neither address next-generation sequencing nor consider informational issues raised by biobanks such as secondary uses of samples, recontact when new information becomes available, confidentiality, destruction of samples, or the return of incidental findings (Tasse´, 2011;Zawati and Rioux, 2011). With the rise of new sequencing technologies and biobanking, there is little doubt that informed consent in genetic testing and research faces great challenges in the years to come. ...
This chapter discusses the important role that informed consent plays in healthcare and medical research involving genetic testing. The requirement of informed consent for treatment and research poses additional difficulties for certain populations. The ethical challenges posed by the informed consent process for newborns, children, adolescents and incompetent adults are each addressed separately. This chapter also highlights two recent developments that have implications for informed consent: next‐generation genetic sequencing technologies and biobanking. These developments increase uncertainty over the predictive value of genetic test results. They also raise ethical concerns about the disclosure of the results of genetic tests to individuals and families, and the storage and future use of samples and data. In order to protect the interests of patients and research participants, these issues need to be addressed in the informed consent process. Key Concepts Informed consent must be obtained before medical treatment or participation in medical research. Parental consent is generally required for research involving children and adolescents. Parental consent must be exercised in the best interests of the child or adolescent. In some circumstances, adolescents may be authorised to consent themselves for medical care or research. Whenever possible, assent from the child should be obtained according to his or her level of development and capacities. Research involving children and adolescents should present no more than minimal risk, unless there is a prospect of direct benefit. Explicit parental consent is not required for newborn screening since it is traditionally justified by the right of the child to receive the potential health benefits from screening. The storage of newborn bloodspots has increased the demand that newborn screening samples be made available for research. Biobanking involving children or newborn bloodspots has the potential to generate new medical knowledge but poses ethical challenges. The volume of data produced by next‐generation sequencing poses new challenges for informed consent, especially because of the possibility of discovery of incidental findings. The return of results in paediatric genetic studies raises complex issues for the use of next‐generation sequencing where incidental findings are revealed. Genetic research and diagnostic testing can also pose challenges for competent adults given the familial nature of genetic information. Research on incompetent adults is now allowed if it provides at least an indirect benefit to the related population, but few guidelines exist to allow legal representatives to make decisions about such participation. Biobanking involves the storage of biological samples, often for future research of an uncertain nature. Broad consent has been used to address this issue. Re‐consent of participants may be necessary if the research framework changes.
... 32 The consent process should also allow the research participant the opportunity to decline receipt of his or her results either at the time of initial consent or at some future time. 33 However, there are some limitations on what can be stated up front in the consent form. Also, care should be given as to how these results are disclosed to the research participant, and several competencies of persons returning results to research participants are outlined in the I-PWG 2006 publication. ...
Full-text available
The ease with which genotyping technologies generate tremendous amounts of data on research participants has been well chronicled, a feat that continues to become both faster and cheaper to perform. In parallel to these advances come additional ethical considerations and debates, one of which centers on providing individual research results and incidental findings back to research participants taking part in genetic research efforts. In 2006 the Industry Pharmacogenomics Working Group (I-PWG) offered some 'Points-to-Consider' on this topic within the context of the drug development process from those who are affiliated to pharmaceutical companies. Today many of these points remain applicable to the discussion but will be expanded upon in this updated viewpoint from the I-PWG. The exploratory nature of pharmacogenomic work in the pharmaceutical industry is discussed to provide context for why these results typically are not best suited for return. Operational challenges unique to this industry which cause barriers to returning this information are also explained.
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Between December 2012 and September 2013 the United Kingdom government oversaw one of the largest destructions of a collection of human-derived samples ever conducted. Approximately 7,753,000 DNA samples and 1,766,000 DNA computerized profiles associated with the UK's policing National DNA Database (NDNAD) were destroyed or deleted. This paper considers this moment of exceptional erasure and the consequent implementation of new processes for routinely discarding and keeping samples and their associated computer records. It is divided into two parts. The first discusses the rapid growth of the NDNAD; the changing legal, ethical and political landscape within which it was promoted and contested; and the developments that led to the decision to limit its scope. The second shifts focus to the operational challenge of implementing the destruction of samples and deletion of records. The NDNAD case allows us to examine the labour and continuing uncertainties involved in erasure of biological data and the emerging norms and practices associated with collecting DNA in differing formats. It also sheds new light on the importance, interconnection and ongoing instability of the ethical and practical biovalue of genetic collections: as the paper argues, far from ending the NDNAD, a more rigorous regime of erasure has helped, for the moment at least, to secure its future.
While the disclosure of research findings is relevant to all types of biomedical research, it has garnered particular attention with respect to genetics and genomics research due to some of the unique aspects of the data and the high public profile of the field. In this chapter, we review the attitudes of stakeholders (research participants, policymakers, and researchers) to define areas of consensus regarding the issue of returning research results across and within groups. In addition to stakeholder attitudes about obligations and interest in research results, other major related issues related to returning research results, such as informed consent, communication of research results, and cost, are discussed. Given the consensus between stakeholders to return summary reports of a study's outcomes and individual research results of clinical significance, we conclude that the time has come to encourage, if not require, researchers to consider these issues in the developmental planning stages of a project and to plan and budget accordingly.
The field of genetic research has revolutionized modern medicine and will continue to do so in the years to come. For the people whose biological materials form the basb for this research, however, the research process may also lead to personal discoveries-namely, it may expose information about their health, genetic predispositions, and other gene-linked characteristics. Researchers who uncover this kind of personal genetic information are likewise confronted with the question of whether they should- or must-provide their subjects with feedback about their results. For subjects and researchers alike, the answer is unclear. Presently, there is little guidance as to these parties' rights and responsibilities when it comes to the return of genetic results in a research setting. As a result, neither party has a clearly defined understanding of what to expect from the research relationship. This Article draws on recognized ethical and legal foundations to propose that genetic researchers should owe three limited legal duties to their research subjects regarding planning for, acquiring informed consent about, and reporting certain genetic findings. Considering the wide variation among individuals in terms of what genetic information they would like to know, this Article balances concerns for individual autonomy with the right to acquire personal health information, and it weighs those interests against the potential cost to socially beneficial genetic research. In balancing these considerations, this Article's proposals for a limited set of duties offer a careful step toward clearly defining the rights and responsibilities of genetic researchers and their subjects.
Full-text available
Genetic research gained a new momentum with the completion of the Human Genome Project in 2003. Formerly entered on the investigation of single-genes research, genetics now targets the whole genome, its environment and the impact on genomic variation. Indeed, increasing our understanding of common disease risk and human health, population genomics draws on basic data on genomic variation and on lifestyle behaviours and environmental factors. But, the study of normal genomic variation across whole populations requires the collection of data and biological samples from individuals on a longitudinal scale. Consequently, in Canada and the rest of the world, large-scale biobanking initiatives have emerged. As for the participants in these population biobanks, they provide DNA and personal information with no individual benefit and are followed up over time through recontact and access to administrative health record systems. The benefits are systemic: better disease/health research, targeted drug delivery and improved health care programs based on an understanding of the role of the environment in the expression of genetic risk factors. However, achieving these goals requires statistical power and, in order to do so, sharing data across studies and countries is crucial. This chapter will first examine, from an international perspective, how the importance of access is reflected in different national legislation and international guidelines. Secondly, taking the example of CARTaGENE, a Quebec population biobank, we will demonstrate how the novel and complex nature of population longitudinal studies is interacting with the ethics governance surrounding access and how this uneasy, but nonetheless mandatory, relationship can sometimes risk defeating the very purpose of a resource, facilitating good science.
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Human genomic research will influence the practice of medicine by further exploring the vast potential of large-scale biobanks and associated pharmacogenomics and clinical research initiatives. While population studies of normal genomic variation may assist in understanding heterogeneity and allow for targeted therapies, researchers may well discover incidental findings – discoveries that go beyond the aims of the intended study – especially when using whole genome sequencing technologies. Policies as well as literature have dealt with the issue of managing these findings in research in general, but a review of international norms governing genomic research will give us a more comprehensive look at the state of the legal and ethical guidance.
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Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using “biobank” here to refer both to collections of samples and collections of data). This article reports recommendations from a 2-year project funded by the National Institutes of Health. We analyze the responsibilities involved in managing the return of incidental findings and individual research results in a biobank research system (primary research or collection sites, the biobank itself, and secondary research sites). We suggest that biobanks shoulder significant responsibility for seeing that the biobank research system addresses the return question explicitly. When reidentification of individual contributors is possible, the biobank should work to enable the biobank research system to discharge four core responsibilities to (1) clarify the criteria for evaluating findings and the roster of returnable findings, (2) analyze a particular finding in relation to this, (3) reidentify the individual contributor, and (4) recontact the contributor to offer the finding. We suggest that findings that are analytically valid, reveal an established and substantial risk of a serious health condition, and are clinically actionable should generally be offered to consenting contributors. This article specifies 10 concrete recommendations, addressing new biobanks as well as those already in existence. Genet Med 2012:14(4):361–384
As technology makes it easier to sequence people's DNA for research, scientists are facing tough decisions over what information to give back.
Given the burgeoning of genetic research and proliferation of human genetic databases, especially in the biomedical sphere, this paper explores whether the existing laws and regulatory structures for governing genetic databases in England and Wales are adequate. Through a critical survey of relevant rules, bodies and practices, it argues that the current UK framework is far from ideal in at least five major areas: (1) forms and styles of law used, especially the separate legislative regimes for physical biomaterial and data; (2) core definitions; (3) formal regulatory bodies, licensing and notification requirements; (4) ethics committees and other advisory panels; and (5) enforcement powers and sanctions. Such shortcomings could have major implications for stakeholders, hamper efforts to achieve European or international harmonisation of genetic database principles and practices, and undermine the UK’s standing as a world leader in genetics and biotechnology. Drawing on comparative analysis of governance strategies adopted in Estonia, Iceland and Sweden, the paper identifies alternative options and lessons from experiences abroad, suggesting possible avenues for reform that may warrant serious consideration in the UK.
Despite extensive debate, there is no consensus on whether individual genetic data should be disclosed to research participants. The emergence of whole-genome sequencing methods is increasingly generating unequalled amounts of genetic data, making the need for a clear feedback policy even more urgent. In this debate two positions can be broadly discerned: a restrictive disclosure policy (‘no feedback except life-saving data’) and an intermediate policy of qualified disclosure (‘feedback if the results meet certain conditions’). We explain both positions and present the principal underlying arguments. We suggest that the debate should no longer address whether genetic research results should be returned, but instead how best to make an appropriate selection and how to strike a balance between the possible benefits of disclosure and the harms of unduly hindering biomedical research.
Health-care research relies largely on human materials stored in highly specialised biorepositories. Medical translational research on tissues can be performed using a variety of resources in distinct situations. The best known is the secondary use of pathology archives where paraffin-embedded tissues are stored for diagnostic reasons. Another is collecting and storing frozen material obtained from leftover surgical diagnosis. Such residual tissues can either be used directly in research projects or used in the context of a clinical trial with new interventional medicinal products. The latter can make the regulations governing the use of these materials for medical research much more complicated. The use of residual materials is very distinct from biobanking projects for which tissue is specifically collected. This article describes the consequences of using residual human material from different sources in distinct situations and why signed informed consent is not always the preferred choice of individual countries regarding the use of residual material. In addition, signed informed consent is overdone when using residual tissues in medical research. We maintain that the opt-out system is a balanced choice if certain requirements are met, relating to sufficient transparency about using residual tissue for research, the purpose of such research and to the confidentiality of the data used in that research. Finally, the international exchange of samples can be based on the laws and regulations of the countries of origin. Respecting these form the basis of what can and cannot be done in the country where the research on the samples is being performed.