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Attitudes of research participants and the general public towards genomic data sharing: A systematic literature review


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Aim: Introducing data sharing practices into the genomic research arena has challenged the current mechanisms established to protect rights of individuals and triggered policy considerations. To inform such policy deliberations, soliciting public and research participants' attitudes with respect to genomic data sharing is a necessity. Method: The main electronic databases were searched in order to retrieve empirical studies, investigating the attitudes of research participants and the public towards genomic data sharing through public databases. Results: In the 15 included studies, participants' attitudes towards genomic data sharing revealed the influence of a constellation of interrelated factors, including the personal perceptions of controllability and sensitivity of data, potential risks and benefits of data sharing at individual and social level and also governance level considerations. Conclusion: This analysis indicates that future policy responses and recruitment practices should be attentive to a wide variety of concerns in order to promote both responsible and progressive research.
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Attitudes of research
participants and the general
public towards genomic data
sharing: a systematic
literature review
Expert Rev. Mol. Diagn. 14(8), 1053–1065 (2014)
Mahsa Shabani*
Louise Bezuidenhout
and Pascal Borry
Department of Public Health and
Primary Care, University of Leuven,
Kapucijnenvoer 35 BOX 7001,
B-3000 Leuven, Belgium
Department of Sociology, Philosophy
and Anthropology, University of Exeter,
Exeter, EX4 4PJ, UK
Steve Biko Centre for Bioethics,
Faculty of Health Sciences, University
of Witwatersrand, Johannesburg, 2000,
South Africa
*Author for correspondence:
Tel.: +32 1637 9517
Fax: +32 1633 6952
Aim: Introducing data sharing practices into the genomic research arena has challenged the
current mechanisms established to protect rights of individuals and triggered policy
considerations. To inform such policy deliberations, soliciting public and research participants’
attitudes with respect to genomic data sharing is a necessity. Method: The main electronic
databases were searched in order to retrieve empirical studies, investigating the attitudes of
research participants and the public towards genomic data sharing through public databases.
Results: In the 15 included studies, participants’ attitudes towards genomic data sharing
revealed the influence of a constellation of interrelated factors, including the personal
perceptions of controllability and sensitivity of data, potential risks and benefits of data sharing
at individual and social level and also governance level considerations. Conclusion: This analysis
indicates that future policy responses and recruitment practices should be attentive to a wide
variety of concerns in order to promote both responsible and progressive research.
KEYWORDS:access • data sharing • genomic research • public and research participantsattitudes • public databases
In recent years, researchers have received an
impetus from funding organizations to share
data generated in the course of publicly
funded genomic studies. Indeed, it is widely
recognized that effective data sharing and open
access policies [1,2] are vital to unlock the
research potentials of databases and to increase
their statistical power. Sharing policies have
been pioneered by large international projects
such as the Human Genome Project and the
International HapMap project [3] that from
conception have published their results in the
public domain. The establishment of public
databases has further advanced genomic data
sharing practices [4] through hosting and dis-
tributing results of studies investigating the
interaction between genotypes and phenotypes.
Preeminent examples include the database of
Genotypes and Phenotypes (dbGaP) [5,6] and
the European Genome-phenome Archive [7]
that contain clinical information, genomic char-
acterization data and genomic data. With the
increasing number of databases, however, has
come an increasing range of data sharing and
privacy policies. In turn, a number of different
ways are emerging through which usersaccess
to these databases may be managed – either
through open-access mechanisms or in a con-
trolled fashion. In the latter format, access
requests to datasets are approved by the corre-
sponding Data Access Committees. The Malar-
iaGEN [8], the Wellcome Trust Case Control
Consortium [9] and the International Cancer
Genome Consortium [10] are examples of
research consortia that have embarked on
sharing their results through various public
databases [1113].
The process of developing and implement-
ing these data sharing policies has challenged
existing approaches to protecting the rights of
research participants, and mechanisms such as
informed consent have received much scrutiny. 10.1586/14737159.2014.961917 Ó2014 Informa UK Ltd ISSN 1473-7159 1053
Original Research
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In particular, the utility of a traditional one-off consent to
inform participants about a plethora of future uses has been
called into question. Alternatively, broad consent models have
also raised a number of unresolved issues, particularly relating
to the informational needs of research participants concerning
the future research agenda, potential risks or withdrawal
options [1417]. The alleged shortcomings of a broad consent in
data sharing context cast doubts on its value and have led some
to question the ethical footing of genomic data sharing practi-
ces in the absence of a valid model for consent [18]. Unsurpris-
ingly, such challenges are further amplified in the face of
retrospective research uses of data, when the original consent
did not encompass further research uses [19].
Further challenges have also been identified for safeguarding
the privacy of research participants on the basis of the identifi-
ability of data [20]. Indeed, the de-identifiability of genomic
data has been claimed an implausible promise, given that DNA
is a unique identifier. In addition, the availability of linkable
reference databases such as data in health care, administrative,
criminal or disaster response databases intensifies these concerns
and highlights the dangers of cross-referencing data in different
databases [21]. In this regard, the recent evidences of re-
identifiability of data [22,23] led the National Institutes of Health
(NIH) and Wellcome Trust to adjust the access policies to the
aggregate and individual-level databases [24].
The challenges of protecting individual data contributions
while maximizing the benefits of data sharing and reuse have
been subject to considerable international policy level deliber-
ations [25]. The Organization for Economic Cooperation and
Development Principles and Guidelines for Access to Research
Data from Public Funding (2007) [26], for example, were
drafted in order to provide broad policy recommendations to
the governmental science policy and funding bodies of mem-
ber countries on access to research data from public funding.
The Organization for Economic Cooperation and Develop-
ment guidelines highlight the significance of respect for the
legal rights and legitimate interests of all stakeholdersin view
of research data sharing, including the importance of privacy
and confidentiality of data on human subjects and other per-
sonal data. These principles and guidelines offer broad guid-
ance that allow institutions and research consortia to develop
detailed guidelines that cover various aspects of the gover-
nance of genomic data sharing [25,27]. In doing so, the NIH
proposed a draft policy in 2006 for the sharing of data
obtained in Genome-Wide Association Studies (GWAS) [28]
and solicited public comments on the draft, acknowledging
the importance of public input in developing the policies.
The received public comments articulated considerable con-
cerns, including those that impact the protection of research
participants. To name but a few, these concerns included
non-research use of data, stigmatization, informed consent,
return of results and oversight and governance of the data
repository, submission and access, which were ultimately sum-
marized in the preamble of the policy and reflected in some
provisions [29].
In order to extend GWAS Policy to encompass data from a
wider range of genomic research, the NIH recently issued a
new policy for Genomic Data Sharing after soliciting public
input on the draft [30]. The Policy mandates institutions plan-
ning to submit aggregate or individual-level data to ensure
research participants are informed about the future research
useof their data and broad data sharing, and also whether
these data will be available to other researchers through open
or controlled access. For studies performed before the effective
date of this policy, the conformity of data sharing plans with
the provisions of the obtained informed consent should be
ensured by the responsible bodies within the data submitting
institutions, such as, Institutional Review Boards. Likewise, in
order to submit data to European Genome-phenome Archive,
it has been asserted that controlled access datashould be
defined by the original informed consent signed by the partici-
pants involved in the study [7].
Despite these developments, how broad data sharingor
controlled access dataplans should be defined in the consent
forms remains a subject of discussion. Indeed, a number of
researchers recognizing these issues are investigating mecha-
nisms that could adequately fulfill the requirement of inform-
ing research participants about data sharing. Tasse
´et al.[19]
investigated such mechanisms in the context of the consent
experience of the ENGAGE consortium, where the participat-
ing research organizations were also encouraged to share their
results with the broader scientific community. In order to meet
the requirement of consent to enable reuse of the data, they
identified a broad number of mechanisms that were developed
by the participating research organizations such as broad con-
sent and multilayered consent, suggesting a need to adopt a
harmonized approach. In another study, Peppercorn et al.
investigated the ethical challenges of submitting GWAS results
to dbGaP, including the specific challenges associated with the
use of older data. Consequently, they outlined the considera-
tions to be observed by Institutional Review Boards when eval-
uating the consistency of data sharing plans with the wishes of
research participants on the basis of their original consent [31].
In order to establish the best practices and guidelines in pro-
tecting rights of research participants in view of genomic data
sharing and meeting their informational needs, it is imperative
to tap into the perceptions and views of research participants
and potential research participants on this matter. The impor-
tance of obtaining such input is rooted in the pivotal role of
publics contribution to genomics research, accentuating the
need to accommodate their views and concerns in future policy
makings [3235], leading to responsive and progressive genomics
research practices. In particular, the potential problems associ-
ated with sharing the results of genomic studies through public
databases in an open or controlled fashion, as discussed above,
require a clear understanding of public opinion. In order to con-
tribute to this end, this article offers a systematic review of exist-
ing literature that included the following question in their scope
of investigation: what are the public and research participants
attitudes toward genomic data sharing through public databases?
Original Research Shabani, Bezuidenhout & Borry
1054 Expert Rev. Mol. Diagn. 14(8), (2014)
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The results of this review form the basis of further discussion on
the sufficiency of current mechanisms governing genomic data
sharing and reveal areas requiring further consideration.
Data sources
The systematic search was conducted in the databases of MED-
LINE [PubMed], ISI Web of Science and Embase (FIGURE 1).The
search string used was: (Interview odds ratios (OR) focus group
OR opinion OR attitudes OR public perspectiveOR views
OR survey OR questionnaire) AND (genetic databaseOR
genomic databaseOR Biobank* OR biorepository OR data
sharing). The search was carried out twice by two of the authors
(M Shabani and L Bezuidenhout) between 18 November
2013 and 26 November 2013 but not limited to a specific date
of publication. In addition, the reference lists of selected articles
have been consulted in order to retrieve additional studies.
Study selection
Articles were included if they reported empirical studies (qualita-
tive and/or quantitative), were written in English, were pub-
lished in peer-reviewed journals and reported studies that
investigated the perceptions and attitudes of the general public
and research participants with regard to genomic data sharing in
the context of public databases (through public or controlled
access). After a pre-selection based on title and abstract screen-
ing, two authors independently evaluated the full texts in order
to determine their suitability for inclusion. In case of disagree-
ment, consensus was sought through discussion with the third
Data extraction & synthesis
The included articles were analyzed independently by two
authors (M Shabani and L Bezuidenhout). The study results
were extracted by using an inductive approach. The results
were classified in thematic categories, representing views and
attitudes of research participants and potential research partici-
pants toward genomic data sharing. The categories were dis-
cussed and refined by all authors at several occasions during
the analysis process. Both qualitative and quantitative findings
were integrated in an overall qualitative synthesis.
Our systematic search identified 15 articles (TABLE 1) that satisfied
the inclusion criteria of the study. The selected articles were
analyzed and relevant quotes retrieved. These quotes represent
general public and research participantsexpressions (PQ) along
with authorssummary quotes of results (AQ). Subsequently,
the analyses of the extracted quotes led to the development of
four main themes: (a) perceptions of sensitivity and controlla-
bility of genomic data, (b) pertinent benefits and (c) risks of
data sharing and (d) considerations aligned with the governance
of genomic data sharing. The identified themes encompass the
interrelated array of factors influencing individuals’ perceptions
toward genomic data sharing (FIGURE 2).
Perceptions of sensitivity & controllability of genomic data
Varying perceptions on sensitivity of data
In the studies analyzed, the respondentsperceptions of the sen-
sitivity of genomic data varied and encompassed many related
opinions on the downstream reuse of individual data. In two
studies, individuals were concerned that personal information
could be mined from their genomic data: I think it is the way
that I am about myself. I think Im more comfortable about
myself and what people know about me. And some people
could be embarrassed if it fell into the wrong hands and they
could be discriminated against in some way if theyre on some
file somewhere, maybe have a disability. Those are the only
things I could think of from someone elses point of view, that
the information could be used against them. For me, I dont
have those sorts of issues(PQ) [36], while the other participant
said: It wouldnt bother me, because, for one, I know scientists
arent really, you know, looking for personal stuff (…)
(PQ) [37]. The employment status, for instance, was mentioned
as a key factor in attributing importance to sensitivity of
Records identified through
database searching (n = 2495)
Web of Science (n = 723)
MEDLINE [PubMed] (n = 851)
Embase (n = 921)
Records after duplicates removed
(n = 1950)
Records excluded
(n = 1805)
Records screened
(n = 1950)
Full-text articles
assessed for eligibility
(n = 145)
Studies included
(n = 15)
Full-text articles
excluded, with reasons
(n = 130)
Exchange and sharing
of samples
Not a qualitative or
quantitative study
Not from the general
public or research
Duplicate study
Conference abstract or
workshop summary
Outside our research
Research in a pediatric
Figure 1. Flow diagram of electronic database searches.
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Table 1. List of the 15 studies addressing public and research participantsattitudes respecting genomic
data sharing.
Study (year) Design and study group Aim Ref.
Goddard et al.
Survey of 500 members of KPNW, an integrated
healthcare delivery system
To evaluate the interest in participating in a biobank and
reasons for nonparticipation
Haga and
10 focus groups with 100 participants (general
public mainly from African-American
To provide insight into concerns and expectations
regarding data sharing from the potential participants
Jamal et al.
Semi-structured phone interviews with
30 participants in two NIH research protocols
(ClinSeq [symptomatic and healthy individuals]
and WGMS)
To better understand the attitudes of research participants
toward confidentiality and data sharing
Kaufman et al.
A representative survey of 4659 US adults To assess the importance of privacy in the publics support
for and willingness to participate in the proposed national
cohort study
Kaufman et al.
Survey of 931 veterans who
receive Veterans Affairs health care
To provide quantitative measures of veterans’ attitudes
about the GMP
Lemke et al.
6 focus group with 49 individuals (28 in 3 public
focus group and 21 in 3 Nugene biorepository
participant focus group)
To develop a better understanding of stakeholdersviews
toward participants’ attitudes about research participation
and sharing of genetic research data
Ludman et al.
Telephone survey with 400 participants who
agreed to submit existing data to dbGaP
To study current research participants’ views of re-consent
for data sharing
McCarty et al.
Three focus groups with members of the PMRP To assess and compare feedback received from other
communication/consultation strategies with results from
focus groups discussion in relation to protocol changes of
the PMRP
McGuire et al.
Three focus group sessions with 15 participants
(patients and controls from a genetic study of
The study aims to describe research participantsattitudes
and judgments about data release and their preferences
for the varying levels of control over decision-making
afforded by the three presented alternative types of
McGuire et al.
A single-blinded, randomized controlled trial was
conducted with 323 eligible adult participants
being recruited into one of six genomic genome
studies at Baylor College of Medicine
To assess the impact of the three presented alternative
consent forms on research enrollment into an underlying
genomic study and participants data sharing preferences
Oliver et al.
Structured interview with 229 eligible participants
enrolled into a genome study
To explore the underlying factors influencing decisions
including judgments about the risks and benefits of data
sharing and issues of privacy vs data utility
Robinson et al.
Structured interview questionnaire with
229 eligible participants enrolled into a genome
To assess research participants’ objective and subjective
understandings of genomic research, including their
participation in genomic research, and examine the impact
of each on their recall and data sharing decision
Rahm et al.
Survey of 203 members of KPCO which is an
integrated healthcare delivery system
To know what potential participants understand about the
risks and benefits of providing samples in order to ensure
adequate informed consent
Trinidad et al.
10 focus group sessions with 79 participants
who are 1) current participants of the ACT
STUDY 2) surrogate decision makers and 3) three
age-defined cohorts
To explore the perceptions, beliefs and attitudes of
research participants and possible future participants
regarding GWAS and repository-based research
Trinidad et al.
6 focus group with 45 members of the Group
Health Cooperative
To learn about the views and expectations of prospective
participants for informed consent in genome-scale studies
ACT: Adults Changes in Thought; dbGaP: Database of Genotypes and Phenotypes; GMP: Genomic Medicine Program; GWAS: Genome-Wide Association Studies;
KPCO: Kaiser Permanente Colorado; KPNW: Kaiser Permanente Northwest; NIH: National Institutes of Health; PMRP: Personalized Medicine Research Project.
Original Research Shabani, Bezuidenhout & Borry
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genomic data, Im tenured, so Im not going to lose my
job – so I had said to [the genetic counselor], Im your ideal
person (...)(PQ) [36].
Three studies noted that these personal perceptions of sen-
sitivity of genomic data were influenced by elements such as
race, gender, age, marital status and/or educational level. For
instance,asitisreportedinonestudy:Hispanic participants
were significantly less likely to choose public data release
compared to non-Hispanic white participants (restricted
release OR: 2.94; confidence interval (CI): 1.16–7.43; no
release OR: 3.94; CI: 1.05–1.76). Unmarried participants,
including those who were divorced, widowed, separated or
release (OR: 2.40; CI: 1.05–5.44). When choosing between
restricted and public data release, participants with some
college or a college degree were also more likely to choose
restricted data release (some college, OR: 3.52; CI: 1.02–
12.14; college graduate, OR: 4.67; CI: 1.35–16.12)
(AQ) [38]. Also, according to Trinidad et al., participants in
the focus groups with a higher mean age were substantially
less worried about privacy and confidentiality than other
groups(AQ) [39].
In identifying the sensitivity of genomic data, some partici-
pants draw an analogy between genomic data and genomic
databases in one hand and other personal sensitive data such as
financial information and banks on the other hand. As
Trinidad et al. observed Some participants believed that health
information would be a less attractive target for ill-intentioned
individuals than other kinds of data (such as financial records
or credit card information) (…)(AQ) [39].
Personal perceptions
of potential risks
Perceptions of sensitivity and
controllability of genomic data
Personal perceptions
of potential benefits
• Research
advancement and
maximizing value of
Public and research
attitudes towards
genomic data
• Trust in institution
and researchers
• Privacy,
confidentiality and
data security concerns
Governance level
• Varying views on
sensitivity of data
• Controllability of
genomic data
• Helping others and
greater good
• Consent
• Transparency,
oversight and
• Objectionable
research uses and
• For-profit companies’
Figure 2. Factors influencing the public and research participantsattitudes toward genomic data sharing.
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Controllability of genomic data
The extent to which genomic data could remain under the con-
trol once widely shared was discussed in six studies. In one
study, maintaining control over genomic data was portrayed as a
right of participants: I think that, you know, some things – I
just believe that people have a right to control their information.
It doesnt matter whether anything bad would happen
(PQ) [36]. Moreover, for some participants, sharing genomic
data emerged as a salient barrier over controllability of data. For
instance, as it is reported in a study: (…) they felt a lack of con-
trol and that the data would be shared without their input any-
way(AQ) [40]. Other participant stated, Its out of your hands,
its out of your control(PQ) [40], while yet another stated that:
Theres no realistic way of controlling [the data], once you
share it. Lets face it(PQ) [39]. Similarly, the expected level of
control on genomic data varied among individuals. For instance,
a research participant mentioned: I would want to have some
control, but not crippling control … As far as restricting it to
people who had a legitimate reason to have the information, …
but not so crippling that you would have to say, well, Person A
can have it, but Person B cant(PQ) [41].
In a number of these studies, the role of consent mecha-
nisms in addressing concerns regarding controllability of data
was further interrogated. For example, one study noted that:
When respondents were questioned about how being asked for
consent for each study would make them feel, 81% agreed that
it would make them feel respected and involved, and 74%
agreed that they would feel that they had control’’ (AQ) [42].
However, some models of consent perceived to fall short in
meeting this need: …If I was signing a broad document like
that, I would understand that I was basically signing a blanket,
and it would just be going wherever, and Id have no control
(PQ) [43].
Potential benefits of genomic data sharing
Research advancement & maximizing value of resources
The benefits of data sharing were widely recognized by partici-
pants in many of the studies. The recognition of benefit often
surmounted concerns about data sharing: I dont think it would
affect my decision one way or the other, because it would be
based on various other factors. I dont think that would enter
into it. As several people have said, the more widely this infor-
mation is [shared] the better(PQ) [37]. Moreover, others com-
mented, It would be another reason to do it(PQ) [39] and Oh,
I think thats the important thing that they ought to share.
Thats the purpose of it(PQ) [37] or as Kaufman et al. reported:
(…) Those who were more willing to participate were also
more supportive of broader access to the database by various
users.(AQ) [44]. Genomic data sharing was also supported by
the majority of respondents in the Goddard et al. study. It was
observed that: Of those who would contribute to the biobank,
82% would also agree to have their information posted in a US
government database(AQ) [45].
In five studies, accelerating research advancement and maxi-
mizing the value of resources were identified as underlying
reasons that tipped the balance in favor of data sharing for par-
ticipants: Sharing my genetic information may be just the
missing piece that the researchers need to advance good health
and avoid diseases, and there may be something in my infor-
mation that stands out that they didnt get in all the other peo-
ple theyve been studying(PQ) [46].
On some occasions, the value of sharing to expedite research
progress outweighed the perceived associated risks such as pri-
vacy. According to one participant: At the same time as I can
see some tremendous assets to having [dbGaP], because you
can really do something powerful, I think theres always risk.
In this case, I tend to think, well, with that potential of where
we are in terms of understanding the genome, maybe thatsa
benefit and maybe, if its securely regulated and actually looked
after, maybe thats a risk worth taking(AQ) [39].
In addition, sharing data was favored as a means to enhance
the value of resources through improving the accessibility of
data for researchers: Most participants saw the pooling of
research resources as a reasonable approach to enhancing effi-
ciency, avoiding duplication of effort, hastening the develop-
ment of outcomes that would benefit public health, and creating
a reference of historical valuefor future generations(AQ) [39].
Helping others & greater good
In five studies, sharing genomic data in order to benefit others
was a reason for some participants to endorse data sharing:
Positive reasons they cited to share data included, to helppeo-
ple who had similar health problems and to contributeto
advancements in medicine (…)(AQ) [47]. Others also
expressed: Im just really serious about allowing the information
from my illness to be used to help others down the line. That to
me is the only benefit. Probably isnt going to help me, but it
may help future patients(PQ) [46] or I think there does have to
be an open exchange of information in order for some of these
really significant things to happen for peoples benefit(PQ) [39].
Sharing genomic data to serve greater good was another
underlying reason for some participants: I would like to think
that I am flexible enough to get it out for the greater good
(PQ) [41] or I think some very interesting things may turn up
because of that. That vast amount of information has got to
have some really positive effects for everybody(PQ) [39].
Individual perceptions of risks associated with data
Privacy, confidentiality & data security concerns
Respecting privacy in relation to genomic data sharing seemed
a critical issue for many participants: Despite their willingness
to have data submitted to dbGaP, however, many participants
also noted concerns about data privacy and future research
uses, including the potential use of their data by for-profit
entities(AQ) [48] or A third (34.6%) selected the risk of hav-
ing their identity revealed as most important, (…)(AQ) [46].
However, collecting data on a large scale diminished the per-
ceived risks of identifiability for some: You know, theres
something that feels more comfortable about a huge study.
Original Research Shabani, Bezuidenhout & Borry
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Youre kind of lost in that huge sea of information, and it
really seems like fewer risks(PQ) [39].
A part of these privacy concerns were linked to data security
issues, as one participant indicated: I just keep thinking if the
entire sequence is out there, one of these days the computers
are going to catch up with us and they will be able to trace it
back to us(PQ) [41]. For some, data security issues seemed
inevitable: (…) Weve all grown up realizing how nothing
seems to be sacred, and how the most secure information
somehow gets found and used and abused(PQ) [39].
In four studies, respecting confidentiality of participants was
raised as a decisive factor for some: In particular, discussants
believed they should be informed about how research partic-
ipantsconfidentiality would be protected(AQ) [37]. Nonethe-
less, others cast doubt on the possibility of treating genomic
data in a confidential fashion: I have to say I go back and
forth on this all the time. I want to hope that if I were to join
a study that was going to release my data I would be comfort-
able with it, because I think that ultimately thatswhats going
to happen with everybody – anonymously, obviously – and it
needs to happen for genomics to progress...ultimately, you
know, the way things are going... theres going to be no point
in keeping it confidential(PQ) [36]. It also has been indicated
in course of the McCarty et al. study that the majority
expressed (...) that the perceived risk of loss of confidentiality
would not have changed their decision to enroll(AQ) [47].
For-profit companiesaccess
Participants in seven studies reflected on for-profit companies
involvement in genomic data sharing. For some, sharing with
commercial companies conflicted with their original purposes
to participate in research: Many participants expressed misgiv-
ings about sharing data with for-profit entities; in half of the
sessions (A2, B1, B2, D1, D2), participants raised the issue
before we asked about it. These participants often perceived a
mismatch between the altruistic motivations of research partici-
pants and the fiscal goals of for-profit companies(AQ) [39].
On some occasions, the for-profit companiesaccess to data
has been criticized due to their sharing policies: And like I
said, these drug companies which pay so much more for the
research they dont want to share with anyone else(PQ) [40].
However, the necessity of for-profit companiesinvolvement in
advancement of genomics research was observed by some par-
ticipants: I dont see how you could avoid giving this out to
for-profit companies. If this study is of any use at all, they are
going to have to make it available to a wide group of experi-
menters, and there are no wide groups of experimenters that
dont have something to do with for-profit companies
(PQ) [39] or as Kaufman et al. report: (…) and 75% would
allow pharmaceutical company researchers to use their samples
and information(AQ) [42].
Objectionable research uses & discrimination
In five studies, sharing genomic data with a broader group of
researchers and for a variety of research purposes was
highlighted as an inhibiting factor for some participants. Itsa
leap of faith to go from a bunch of researchers to a Federal
database, and its not one – if I knew, I would never have
signed up for that [hypothetical] study if I thought even any of
that information was going to go off …(PQ) [39] and For
most participants, concerns began to arise as they considered
more distantusers of the data(AQ) [39].
Some participants also expressed their concerns regarding
future users: My concern would be much less around what the
research is about than where does the information go?
(PQ) [43],And who has access to it?(PQ) [43]. Part of the con-
cerns regarding further uses of data were rooted in utilizing data
for objectionable research purposes, as Trinidad et al. observed:
In some cases, the desire for re-consent was grounded in the
right of the individual participant to choose what could be done
with her information. For example, participants who found cer-
tain kinds of research morally objectionable (e.g., research seek-
ing to connect race with intelligence or alcoholism) wanted to
be able to opt out of such studies (…)(AQ) [43].
On the other occasions, the fear of utilizing data for discrim-
inatory purposes was mentioned by individuals: Because if you
release your [information], and you dont mind someone shar-
ing your information, it could go to the insurance companies,
your rates could go up(PQ) [37]. Therefore, to avoid discrimi-
nation risk, in one study, Almost unanimously, focus group
participants thought that insurance companies and employers
should be excluded from obtaining data for fear of discrimi-
nation(AQ) [41] or as Kaufman et al. reported: Nearly all
respondents (93%) said that it would be somewhat or very
important that it be illegal for insurers and employers to get
their study information (...)(AQ) [42].
Governance level considerations
Trust in institution & researchers
In five studies, trust in institutions and researchers was
expressed as an important factor in participantsendorsement
of data sharing: Trust in the institution that stored data was
again paramount(AQ) [40]. As a participant indicated in the
Lemke et al. study: It shouldnt be available to everyone but I
would trust that there are people in charge of that who are
looking in the right directions in terms of where that informa-
tion should go and where it shouldnt(PQ) [40]. Similarly,
according to the Rahm et al. study: (…) high willingness to
participate is likely due, in part, to trustin KPCO as their
healthcareprovider (…)(AQ) [49].
Conversely, this was an inhibiting factor for those who did
not trust other institutions, manifesting as objections to sharing
data with external bodies: I did understand it was going to be
shared with other researchers at Baylor, not just the primary
[investigator], but it definitely was not carte blanche to distrib-
ute it to any researcher(PQ) [41].
Trust in the institution also often outweighed potential con-
cerns. As Ludman et al. reported: Also in common with survey
responses, the trust in Group Health and ACT investigators
outweighed concerns regarding privacy, data security, or fear of
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discrimination(AQ) [48]. The effect that trust in researchers
had on facilitating decision making with regard to data sharing
options was investigated by Robinson et al. They noted that:
Compared to participants exhibiting no to low levels of trust
in medical researchers, those exhibiting some to high levels of
trust more often reported the decision was easy to make (…)
(AQ) [50].
Transparency, oversight & safeguards
Lack of sufficient knowledge concerning the processes of shar-
ing genomic data evoked concerns among research participants
in seven studies. It has been reported that participants: (…)
wanted to know more about how the data will be shared and
with whom(AQ) [40]. On other occasions, participants
expressed their concerns regarding the lack of information on
genomic data sharing: Well, I guess I dont know enough
about how they want to use the information(PQ) [36].
Other participants raised more detailed questions and
expressed their interest in obtaining further insights into those
details: I wouldnt have a problem [with data sharing], as long
as I knew to what extent I was being examined and by, in gen-
eral, what types of individuals(PQ) [43]. In addition, according
to Trinidad et al.: (…) one participant stated that the legiti-
macy of proposed uses of study data depends on how [the
study subject] understood what was going to be done with that
information(AQ) [43].
For many participants, trust in the ability of the original
institution to carry out the oversight tasks was important:
Current research participants, who generally expressed altruistic
motivations for research participation as well as strong trust in
Group Health, were willing to rely on Group Healths internal
review processes and trusted Group Health to be selective
about granting access to outside entities(AQ) [39]. This trust
was linked to an expectation of appropriate safeguards devel-
oped by the original institution: (…) I would hope that the
Group Health institution and the NIH and others would also
be very aggressive about safeguards(PQ) [39].
In addition, having knowledge about penalties, in case of
breach of protection appeared as a critical element for some:
Ill tell you what I missed – the consequences, like if this was
somehow released in a way that was not covered by any of
these policies. Whats in place to correct that, to fix it – thats
not addressed here(PQ) [40].
The role of informed consent in relation to genomic data shar-
ing was discussed from different angles by participants in nine
studies. For some participants, obtaining consent regarding the
process of sharing data constituted being informed and facili-
tated an awareness of secondary uses of [..] data(PQ) [37].
Similarly, according to Ludman et al. study: It was very
important or somewhat important to the majority (n = 329,
90%) of respondents that they were asked for their permission
to add their health and genetic information to the databank
(…)(AQ) [48].
Re-consent or obtaining consent for new research purposes
was discussed in some of the studies. For instance, according to
Trinidad et al.: Asking for additional permissions was per-
ceived as respectful, courteous,and the right thing to do;it
was also seen as a way of keeping research subjects involved in
the ongoing activities of the study(AQ) [43]. Likewise, a partic-
ipant commented that if researchers wanted to submit study
data to dbGaP: The key would be that they would come and
ask for your permission, If you signed up for something and it
was done, then ask for permission [for sharing], and if you give
your permission, then yes. But without asking, I dont think
so. I think thats a huge ethical breach(PQ) [43].
On other occasions, the significance of consent was under-
lined by the importance of being informed about sharing mod-
els or affording options within the consent form to enable
participants to show their preferences of sharing. As Haga and
ODaniel report, Although many expressed that the data-
sharing method would have little effect on their decision to
participate in a study, the vast majority of discussants believed
researchers should disclose it before they consented to partici-
pate in the study(AQ) [37].
The analysis of the articles in this study showed that, when
considering genomic data sharing, research participants and the
general public integrate personal perceptions regarding sensitiv-
ity and controllability of genomic data, perceived risks and ben-
efits and also considerations regarding the governance of
data sharing.
Most of the responses analyzed seemed to share fairly similar
views regarding the accrued benefits of genomic data sharing,
although they may have been distinguished by context. Accord-
ingly, public and research participants identified benefits such
as enhancing the value of data, accelerating research advance-
ment and ultimately benefiting others and serving a greater
good as the driving forces to support data sharing. These
seemed in concert with the underlying rationales behind the
data sharing policies [51]. In contrast, interpretations of the sen-
sitivity of genomic data and viability of associated risks were
heterogeneous and strongly influenced by contextual factors.
For instance, the repercussions of genomic data sharing were of
higher concern among younger individuals, who related these
concerns to their employment status or insurance coverage [36,39].
These findings may illuminate the relationship between individ-
ualssocio-economic background and their willingness toward
genomic data sharing [39]. Having in-depth insights regarding
these factors, genomic data sharing policies could avoid follow-
ing a one-size-fits-all model to protect heterogeneous group of
research participants with a variety of preferences and concerns.
Nonetheless, the recognition of notable similarities, particularly
in terms of benefits, may be valuable for the future global dis-
cussions in a broader context.
In addition, in the course of some previous studies, a differ-
ence between hypothetical and factual preferences of the individ-
uals has been observed. For instance, a study by Johnsson et al.
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demonstrated higher factual willingness to participate in biobank
research in 12 out of 22 pairwise comparisons may be owing to
influential factors such as altruism, trust and sense of duty exist-
ing in factual donors [52]. In the current review, while no recur-
ring pattern was observed that notably distinguishes attitudes
of general public from actual research participants, one study
revealed even real research participants, presumed to be
emotionally invested, make different judgments when respond-
ing to hypothetical versus actual choices. Participants were gen-
erally much more restrictive in their hypothetical data sharing
The associated risks of genomic data sharing were also
related to a number of other issues; whereas some risks con-
cerned individuals and their relativesrights, others were linked
to the interests of society in large. In terms of personal con-
cerns, fear of personal privacy breaches due to compromised
data security systems provoked concern among participants in
seven studies. Accordingly, in some individualsview, the elec-
tronic storage of genomic data and sharing through online
databases enhances potential data security risks and was deemed
hard to be effectively avoided if not impossible. Such privacy
concerns were sometimes observed as an inherent component
of modern life though, in which a wide spectrum of personal
data from medical to financial are inevitably being handled
electronically. In evaluating the magnitude of privacy risks cou-
pled with sharing various types of personal data, individuals
often tended to attribute a higher level of significance to finan-
cial data compared to genomic and health data.
Nonetheless, the awareness of associated privacy risks did not
always play an inhibiting role for individuals in the face of geno-
mic data sharing. Indeed, the presumed benefits of genomic
data sharing often outweighed participantspotential privacy
concerns. This confirms individuals hold idiosyncratic preferen-
ces of privacy-utility trade-off[41] in view of data sharing. Het-
erogeneity in terms of privacy preferences may be rooted in
personal perceptions of the privacy itself. This is in keeping with
previous studies on public perceptions concerning the notion of
genomic privacy [5358] that highlighted self-determination,
respect, confidentiality, discretion and controllability as key
influencing factors. These findings demonstrate the importance
of ensuring that the privacy protection policies should not be
premised on a narrow and static account of privacy, which
would not suit the interests of all research participants. For
instance, although anonymization of genomic data and respect-
ing confidentiality of data subjects have often been received as
legitimate expectations of individuals, for some individuals these
protections appeared less imperative. Additionally, as novel
approaches to data sharing and data discovery are being shaped,
adopting tailored models of privacy on the basis of the nature of
data sharing and its scope should be considered.
Furthermore, the notion of controllability of data was chal-
lenged by sharing data. The participants of the studies analyzed
frequently drew attention to the possibility that unrestricted
downstream usages of genomic data amplified concerns regard-
ing the further research purposes, particularly when they
contradicted the values and goals of research participants. Such
concerns, for instance, were recently illustrated in the landmark
case of Havasupai Tribe versus Arizona Board of Regents,
where further reuses of samples for a different purpose raised
research participantsobjection [59]. The uncertainty surround-
ing the breadth of the data accessible to a variety of users also
provoked concerns among the public. For instance, all studies
analyzed demonstrated uniform objection against the exploita-
tion of databases by insurance companies and employers. These
concerns were framed in a number of different ways, including
the fear of discrimination against individuals or family mem-
bers. It is important to highlight that the prevalence of these
concerns contrast to the dearth of empirical evidence concern-
ing discriminatory use of genomic data by insurance or
employment companies so far [6062].
Participants in some of the studies also had misgivings about
databases being accessible to commercial parties, given the pre-
sumed incongruence between the goals of private and public
bodies. Accordingly, the restrictive sharing polices often
adopted by private companies were seen as at odds with the
ultimate goal of data sharing polices to enlarge public good.
The objections against the for-profit companiesinvolvement in
public-funded research infrastructures and underpinning rea-
sons are also outlined in a number of previous studies [6365].
In those studies, fear of bias in research agenda, data withhold-
ing under the influence of financial incentives, undermining
social values such as altruistic donation and ultimately concerns
about fairness in sharing benefits of research were articulated as
paramount concerns among the public. Nonetheless, the
involvement of private companies in research was recognized as
important to boost scientific research in some studies. In this
regard, collaboration between public and private bodies was
viewed as essential in order to accelerate translation of research
findings into medical practice. In response to this need, con-
structing policies that reconcile private and public bodiesinter-
ests in the face of data sharing practices is a necessity.
In order to address concerns of participants over the scope
of future uses, the consent mechanism was conceived as a solu-
tion. Obtaining consent was seen both as a sign of respect to
research participants and as a medium to inform them about
how data will be shared and with whom. For instance, inform-
ing participants via the consent form about the permissibility
of commercial partiesaccess to data would allow those holding
concerns regarding such use to withdraw from a research.
Despite an enormous amount of attention being paid to the
role of consent in research, it must be recognized that what
constitutes the bestmodel of consent remains under discus-
sion [66]. In this regard, the sufficiency of the current models of
consent in the context of multiple research studies with geno-
mic data has been the focus of scholarly discussions. On the
one hand, a one-time broad consent as a feasible mechanism in
the face of large-scale longitudinal studies retains considerable
popularity, not the least because it spares researchers from a
burden of re-consent for each new study when the potential
risks for participants are minimal [67]. On the other hand,
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others have criticized a broad consent as lacking in specificity,
allegedly leaving individuals in the dark regarding the scope
and nature of future research [68]. Findings of Trinidad et al.
study, for instance, endorsed a need for explicit consent,
highlighting the insufficiency of a broad consent model in face
of the genomic data sharing practices [43]. Additionally, novel
approaches to consent mechanisms to ensure its dynamism in
the face of longitudinal studies have been suggested to better
fulfill the preferences of research participants that may change
over time. Such a model empowered by information technolo-
gies, Kaye claims, …allows a more cautious and interactive
relationship with participants or a dynamic consent – rather
than the one off broad consent that is currently the only practi-
cal solution for many projects or biobanks[68].
It is worth noting that, while an appropriate consent mecha-
nism could protect some interests and rights of participants, it
might yet leave some of the identified concerns unresolved. As it
is stressed in some of the studies analyzed, transparency and
accountability in data sharing policies are also recognized as the
contributing factors in meeting expectations of research partici-
pants. This was reflected in individualsinterest in understanding
the access agreement conditions applying to further uses, infor-
mation about oversight bodies and punishments in case of breach
of protections. Currently, some of the pertinent stewardship
responsibilities of data holders and obligations of users are being
framed within the variety of statutory and contractual provisions.
Failure in complying with provisions of contractual agreements
by users, for instance, sets legitimate grounds to revoke their
access permissions. However, it must be noted that oversight
over the enforcement of such agreements is currently poorly elab-
orated and implemented. This is mainly due to a distance
between data access committees and data users and also the lack
of adequate expertise in the data access committees to evaluate
several aspects of handling data by users including secure storage
and processing. Due to lack of funding or motivations, Data
Access Committees, particularly in small and single studies are
underdeveloped and may fall short in fulfilling the oversight
duties. Further investigation is required to suggest oversight
mechanisms on downstream uses of data in a way that suffice
both legal and ethical imperatives. Proposing a shared model of
oversight between data producing studies and usersinstitutions
could be a potential answer to resolve the shortcomings in the
oversight on data sharing practices. In accommodating a need for
sufficient oversight, participants favored adopting a balanced
approach in a way not to derail genomics research. As a research
participant puts it: I think the key is finding the right balance
between letting science and research go along and make great dis-
coveries and not throttling them back with public policy issues.
Ideally, we could kind of work them together so that science
could move ahead and the Congress and other bodies could work
alongside to make sure the protections are there[39].
Participants in the 15 included studies were solicited to reflect on
genomic data sharing issues in heterogeneous data sharing
settings. Given that both quantitative and qualitative studies were
included, the collected data were rather heterogeneous. Besides,
selection of quotes by authors in the reference studies and their
classifications inevitably impacts the analysis of quotes within the
current study. The included studies elicited attitudes of public
and research participants in the USA not necessarily on the basis
of a representative sampling, which may vary in other contexts.
Our study indicates that individualsperceptions regarding
genomic data sharing are influenced by multiple factors. The
majority of both public and research participants appreciate the
paramount benefits underlying data sharing policies. Mean-
while, the personal perceptions of sensitivity of genomic data
markedly impact their views on the magnitude of risks aligned
with genomic data sharing. However, none of the perceived
risks or benefits could be highlighted as the sole cause of deter-
ring or favoring perceptions toward data sharing. As it has
been shown, valuing benefits of research may outweigh risks of
privacy [46]. Also, trust in the original institutionsoversight
may overcome many of the concerns regarding re-identifiability
of shared data [40,48]. Needless to say, trust itself is a complex
and dynamic issue, which could be easily undermined if insti-
tutions fail to meet expectations that rendered them trustwor-
thy in the eyes of individuals [6973]. As the Nuffield Council
on Bioethics describes in the recently released document on the
use of biological data: Willingness to disclose personal data
may depend on many things, including how sensitive people
consider the data to be, the benefits they believe they or others
may receive from disclosure, the perceived risks to their own
interests or those of others, the level of confidence they have in
how subsequent use will be governed, the level of control they
may retain over the data and norms of social behavior in simi-
lar situations, among many other things[74].
It is therefore critical to address all factors underpinning the
individualsperceptions and attitudes regarding data sharing and
avoid overemphasizing the role of some elements at the cost of
neglecting others. It follows that it is critical to consider the role
of contextual elements when designing data sharing policies and
guidelines, particularly when the data subjects belong to cultur-
ally divergent environments, and hold various set of values, con-
cerns and perceptions. Additionally, introducing more clarity to
the data sharing policies may offset a presumed ambivalence
concerning associated risks and thus provide individuals with a
fair opportunity to take an informed decision, according to their
own personal risks and benefits analysis. Research with genomic
data may trigger types of risks and concerns that differ consider-
ably from research with human subjects that is associated with
more physical harms, requiring employing a tailored approach
in protecting rights of research participants.
Nonetheless, further investigation is required to obtain
insight into the expectations of individuals regarding oversight
of data sharing endeavors and also to safeguard against breaches
of protections. As was observed, devising stringent governance
mechanisms or sweeping regulations may not necessarily meet
Original Research Shabani, Bezuidenhout & Borry
1062 Expert Rev. Mol. Diagn. 14(8), (2014)
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the interests of individuals [75], if it negatively impacts data
sharing practices, so does advancement of research [76]. Having
insight into public perceptions will be influential in ensuring
that future policies are constructed in a manner responsive to
needs and concerns of the public and research participants.
In view of data sharing policies, genomic research will benefit
from a facilitated access to the generated genotypes and pheno-
types and other health-related data, and also an optimal and effi-
cient utilization of public resource will be ensured. Nonetheless,
implementing data sharing policies can alter the research data
collection, storage, use and sharing practices and challenge the
current governance mechanisms. Although the potential physical
harms associated with contributing to large-scale genomics
cohorts are deemed minimal, sharing data on a large-scale brings
an array of concerns such as privacy protection to the fore. In
response, international and national policies are being con-
structed to tackle the wide range of challenges associated with
data sharing practices. In order to inform such policy develop-
ments, due attention must be paid to identify the individuals
concerns in the wake of genomic data sharing. Despite the wide-
spread attention paid to the concerns surrounding participation
in research in general, data sharing concerns seem to have
remained on the periphery so far. The current review sheds light
on the key influencing factors identified within the existing
empirical evidence, suggesting further investigations to construct
mechanisms addressing the identified concerns.
Genomic data sharing is a growing practice that has recently
been endorsed and promoted by funding bodies and interna-
tional collaborative projects. Introducing new practices in col-
lection, storage, use and re-use of data to align them with the
data sharing purposes would influence individualsperspectives
toward research participation. Concurrently, perceptions of key
notions such as genomic privacy may evolve along the way,
entailing an ongoing assessment of the sufficiency of the cur-
rent protective mechanisms.
Financial & competing interests disclosure
This study is kindly funded by the Interfaculty Council for Development
Co-operation (IRO) of the University of Leuven and the FP7-project 835
EUcelLEX (grant agreement no. 601806). The authors have no relevant
affiliations or financial involvement with any organization or entity with
a financial interest in or financial conflict with the subject matter or
materials discussed in the manuscript. This includes employment,
consultancies, honoraria, stock ownership or options, expert testimony,
grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Key issues
Sharing genomic data through public databases may challenge the mechanisms established to protect rights of research participants.
Public and research participantsperspectives toward genomic data sharing should be sought and adequately addressed in the course of
governing genomic data sharing.
• Individuals understand the potential benefits accrued via data sharing while remaining wary of the potential concerns that might
endanger their personal rights or social benefits. Nevertheless, they favor genomic data sharing when they believe benefits outweigh
potential risks.
Key concepts such as privacy are construed in heterogeneous ways among the public, necessitating a tailored approach to be adopted
to protect privacy in the face of genomic data sharing.
• Research participants and the public are concerned about the breadth of data access, as well as subsequent research purposes,
suggesting de-identification of data may not resolve all the research participantsconcerns.
The role of consent mechanism addresses a number of concerns of the public and research participants in the context of genomic data
sharing, including representing a sign of respect and a mechanism to maintain control on data.
• Implementing robust oversight mechanisms and introducing higher transparency into the data sharing policies by the institutions will
build an atmosphere conducive to building trust among the public and research participants.
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... A few studies reported donors' motivations [27][28][29][30][31]. It is also known that knowledge about psychosocial attitudes toward biobanking may increase the effectiveness of the recruitment process [32]. The abovementioned studies, however, used simple methods for measuring psychosocial variables, mostly by single-question measurement. ...
... Many donors are aware that there are risks associated with biobank participation associated not only with sampling but also with data management such as privacy breaches. They are, however, open to collaboration [18,21,32,57]. ...
... Many declare donations for cancer research, while stem cell research, cloning, genetic engineering, research involving the combination of human samples with animals, or even research conducted abroad are much more controversial [24,25,63]. Most respondents also objected to research with stigmatising potential, i.e., on mental disorders, intelligence, homosexuality, or which had commercial implications [32]. Further, donors may be discouraged by their disapproval of the purpose of the research, concerns over the safety of the data [28,30], fear over the invasive nature of the sampling procedure (pain, sight of blood, needle injections) [29], fear over infection with HIV, the detection of genetic predispositions, the use of the sample contrary to the donor's values [22], commercial use of their samples and geographical distance from the biobank [57]. ...
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Over the past few decades, there has been a dynamic development of biobanks collecting human biological material and data. Advances in biomedical research based on biobanks, however, are highly dependent on the successful enrolment and participation of human subjects. Therefore, it is crucial to recognise those factors affecting the willingness of individuals to participate in biomedical research. There are very few studies pointing to the role of trust, preferred values and specific psychological factors. The aim of our study was the analysis of the most significant relationships between selected moral and psychological variables (i.e., preferred values, types of trust and personality) and willingness to donate biological material to biobanks. The research was carried out on a Polish representative national sample of 1100 people over 18 years of age. Statistical methods with regression models were used during the analyses. The willingness to donate samples to a biobank was associated with different types of trust and specific values. Based on regression analysis, the most important factors related to the willingness to donate material to biobanks seemed to be (1) trust towards scientists and doctors and (2) selected preferred values such as knowledge, self-development and tradition. Other values or personality traits did not seem to be as important in this context. The obtained results can be useful in building the social responsibility of biobankers and scientists, issuing more appropriate opinions by research ethics committees and planning better communication strategies between participants and biobanks.
... Different factors contribute to people's willingness to share data. Factors such as the level of identifiability, whether an overview of sharing practices is provided and the extent to which participants are informed are central elements that play an important role in people's privacy concerns [12][13][14][15][16]. ...
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Background Health data-driven activities have become central in diverse fields (research, AI development, wearables, etc.), and new ethical challenges have arisen with regards to privacy, integrity, and appropriateness of use. To ensure the protection of individuals’ fundamental rights and freedoms in a changing environment, including their right to the protection of personal data, we aim to identify the ethical approaches adopted by scientists during intensive data exploitation when collecting, using, or sharing peoples’ health data. Methods Twelve scientists who were collecting, using, or sharing health data in different contexts in Sweden, were interviewed. We used systematic expert interviews to access these scientists’ specialist knowledge, and analysed the interviews with thematic analysis. Phrases, sentences, or paragraphs through which ethical values and norms were expressed, were identified and coded. Codes that reflected similar concepts were grouped, subcategories were formulated, and categories were connected to traditional ethical approaches. Results Through several examples, the respondents expressed four different ethical approaches, which formed the main conceptual categories: consideration of consequences, respect for rights, procedural compliance, and being professional. Conclusions To a large extent, the scientists’ ethical approaches were consistent with ethical and legal principles. Data sharing was considered important and worth pursuing, even though it is difficult. An awareness of the complex issues involved in data sharing was reflected from different perspectives, and the respondents commonly perceived a general lack of practical procedures that would by default ensure ethical and legally compliant data collection and sharing. We suggest that it is an opportune time to move on from policy discussions to practical technological ethics-by-design solutions that integrate these principles into practice.
... Die in den Studien am häufigsten genannten Gründe, medizinische Forschung zu unterstützen, sind zumeist altruistischer Natur (Nobile et al. 2016). Konkret genannt werden meist der Wille, zur Entwicklung besserer medizinischer Therapien beizutragen (Shabani et al. 2014, Mazor et al. 2017, zukünftige Patientengenerationen zu unterstützen oder der Wunsch, nach einer positiv erlebten Behandlung selbst etwas zurückgeben zu wollen . Letztendlich sind für viele befragte Menschen der Wunsch und die Hoffnung entscheidend, dass ihre Daten zu einer besseren Gesundheitsversorgung beitragen. ...
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Dieses Open Access Buch befasst sich mit praktischen Fragestellungen datenreicher internationaler Verbund-Forschung. Die datenreiche Medizin spielt in Diagnostik und Therapie eine immer größere Rolle – gerade angesichts immer leistungsfähigerer algorithmischer Mustererkennung. Mithilfe wachsender Datenbestände sind diese Algorithmen zunehmend in der Lage, Krankheitssymptome zu erkennen, diese mit anderen Daten in Beziehung zu setzen und so entweder bei der Suche nach Krankheitsursachen zu helfen oder Therapien zu optimieren. Vor dem Hintergrund dieser Entwicklungen vereint der Sammelband multidisziplinäre Perspektiven auf die datengetriebene medizinische Forschung mit besonderem Blick auf die Frage der Einwilligung in die Sekundärnutzung medizinischer Daten. Dabei werden zum einen ethische Überlegungen in den Bereichen Patientenautonomie und -wohlergehen, Privatheit und Datensicherheit, sowie Verantwortungsdiffusion aufgeworfen, als auch konkrete rechtliche Fragen hinsichtlich der DSGVO-Konformität erörtert. Sozialwissenschaftliche Studien zur Art und Form der Einwilligung sowie dem Patientenverhalten runden den Band ab.
... The risk of privacy breach is among the most common and significant concerns reported by research participants and mentioned in public opinion surveys (Kaufman et al., 2009;Gaskell et al., 2013;Domaradzki and Pawlikowski, 2019). The strongly reverberated concerns are that the government, insurance companies, and employers could have access to such information, which might result in discrimination of the donors and their families (Porteri et al., 2014;Shabani et al., 2014). Data protection is of primary significance for building social trust, which is pivotal for the development of biobanks and their social perception (Levitt and Weldon, 2005;Toccaceli et al., 2009;Critchley et al., 2012;Domaradzki and Pawlikowski, 2019;Neethu, 2019). ...
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Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure–European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.
... These uses have inspired conversations around the ethics of collecting and sharing genetic data. Like health data broadly, people perceive risks to sharing their genetic data -such as privacy breaches and unauthorized uses -along with benefits, like aiding research and societal welfare [121,80]. Prior work shows that people are generally willing to share genetic data with researchers or with research databases and biobanks [118,69,116,62]. ...
People's privacy sentiments drive changes in legislation and may influence their willingness to use a variety of technologies. While single-point-in-time investigations of privacy sentiment offer useful insight, longitudinal study of people's privacy sentiments is necessary to better understand and anticipate evolving privacy attitudes. In this work, we use longitudinal survey data (n=6,676) to model Americans' sentiments toward collection and use of data for government- and health-related purposes in 2019, 2020 and 2021. After the onset of COVID-19, we observe significant changes in Americans' privacy sentiments toward government- and health-related data uses and find that Americans' privacy attitudes largely converged on these topics. We observe additional changes in the context of other national events such as the U.S. presidential elections and Black Lives Matter protests. Our results offer insight into how privacy attitudes may have been impacted by recent events, and these results allow us to identify potential predictors of changes in privacy attitudes during times of geopolitical (e.g., global pandemic) or national (e.g., political elections, the rise of the Black Lives Matter movement) change.
Background: Broad participation in genetic research is needed to promote equitable advances in disease treatment and prevention. Objectives: The objective of the study was to assess motivations for, and concerns about, genetic research participation. Methods: The Genetics in Research and Health Care Survey was sent in winter 2017-2018 to 57,331 adult Kaiser Permanente (KP) members from 7 US regions to assess attitudes about genetic testing in health care and research. The survey included an open-ended question on why members would or would not participate in genetic research. Open text responses to this question were coded in the qualitative analysis software Dedoose and analyzed using a thematic analysis approach. Code summaries were organized by major themes, subthemes, and exemplary quotes. Results: Of the 10,369 participants who completed the survey, 2,645 (25%) provided a comment describing reasons they would or would not participate in research involving genetic testing. Respondents who provided a text comment were 64% female, 49% non-Hispanic (NH) White, 17% Asian/Pacific Islander, 20% Hispanic, and 14% NH Black. The primary themes identified were (1) altruism; (2) decision-making and planning; (3) data use; and (4) data security. These major themes were consistent across each race and ethnic group. Conclusions: To promote broad participation in genetic research, it is important that recruitment materials address the primary motivators for genetic research participation, including altruism and the potential use of results for personal decision-making. Study materials should also address concerns about possible misuse of genetic information and fears over potential data breaches.
Background: This study examines rural patients' perceived importance of knowing or being consulted about researchers' access and use of their personal data (identifiable and de-identified health information, and identifiable and de-identified non-health information) across five scenarios. This study also examines their views on stewardship or governance of their personal information by researchers in their healthcare systems. Methods: We conducted a survey by mail. Data were analyzed using descriptive statistics. Multivariable regression analyses were conducted across each scenario and type of personal data with the same variables included in each model. Results: The majority of participants said it was "very important/absolutely essential" to know the purpose of the study, to be asked every time, and to know the policies governing researcher access and use of their identifiable health information. Just over two-thirds of respondents thought it "very important/absolutely essential" to know who serves on the data governance committee and to have a community member serve. Distrust in healthcare organizations was positively correlated with the scenarios while willingness to give permission to donate leftover biological specimens was negatively correlated. Conclusion: Our study findings indicate that the type of personal information being accessed and used generally matters to 1,407 patients living in rural Pennsylvania. We also demonstrate that knowing their healthcare organizations' governance policies and practices for managing their personal data is important to many rural Pennsylvania patients. Biomedical researchers need to recognize and attend to those differences as much as possible in order to expand opportunities for and participation in research by residents of these rural communities. Supplemental data for this article is available online at.
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Various data sharing platforms are being developed to enhance the sharing of cohort data by addressing the fragmented state of data storage and access systems. However, policy challenges in several domains remain unresolved. The euCanSHare workshop was organized to identify and discuss these challenges and to set the future research agenda. Concerns over the multiplicity and long-term sustainability of platforms, lack of resources, access of commercial parties to medical data, credit and recognition mechanisms in academia and the organization of data access committees are outlined. Within these areas, solutions need to be devised to ensure an optimal functioning of platforms.
This chapter discusses ethical, legal, and social issues (ELSI) centered around hereditary breast and ovarian cancer syndrome (HBOC). In the first half, we discuss ethical considerations in the context of decision-making on genetic testing, debates on incidental/secondary findings (IFs/SFs), and global trends in clinical and/or genetic data sharing, including with patients and their family members. In the second half, from the perspective of clinical ethics of cancer diagnosis and treatment, we introduce the importance of decision-making and care based on the shared decision-making (SDM) approach and practical points in prophylactic surgery. We also discuss dilemmas that arise regarding confidentiality between medical professionals and their patients. This includes disclosure of genetic information with genetic relatives, and challenges in family communication, in which carefully assessed and encouraging support may be needed for patients and family members.
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Biobank research deals with personal information and data from blood and tissue analysis, making the questions of legitimate recruitment of participants and handling of their data to be intimately connected with the issue of privacy. Thus, identification of the privacy interests of biobank participants is vital to the legitimacy of biobank projects. In this article, we ask: How do participants articulate the nature of privacy issues in biobanking? Here we report from a focus group study on biobank participants' view of privacy and consent in relation to biobank research. Based on our analysis, we found that participants viewed privacy as a concept that describes several dimensions of the fundamental need to be recognized and respected as an individual and as a person. Interestingly, the needs to be recognized and respected were also viewed as the basic purpose of biobank consent.
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The risks and benefits of research using large databases of personal information are evolving in an era of ubiquitous, internet-based data exchange. In addition, information technology has facilitated a shift in the relationship between individuals and their personal data, enabling increased individual control over how (and how much) personal data are used in research, and by whom. This shift in control has created new opportunities to engage members of the public as partners in the research enterprise on more equal and transparent terms. Here, we consider how some of the technological advances driving and paralleling developments in genomics can also be used to supplement the practice of informed consent with other strategies to ensure that the research process as a whole honors the notion of respect for persons upon which human research subjects protections are premised. Further, we suggest that technological advances can help the research enterprise achieve a more thoroughgoing respect for persons than was possible when current policies governing human subject research were developed. Questions remain about the best way to revise policy to accommodate these changes.
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The field of human genomics has led advances in the sharing of data with a view to facilitating translation of research into innovations for human health. This change in scientific practice has been implemented through new policy developed by many principal investigators, project managers and funders, which has ultimately led to new forms of practice and innovative governance models for data sharing. Here, we examine the development of the governance of data sharing in genomics, and explore some of the key challenges associated with the design and implementation of these policies. We examine how the incremental nature of policy design, the perennial problem of consent, the gridlock caused by multiple and overlapping access systems, the administrative burden and the problems with incentives and acknowledgment all have an impact on the potential for data sharing to be maximized. We conclude by proposing ways in which the scientific community can address these problems, to improve the sustainability of data sharing into the future.
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Respecting the confidentiality of personal data contributed to genomic studies is an important issue for researchers using genomic sequencing in humans. Although most studies adhere to rules of confidentiality, there are different conceptions of confidentiality and why it is important. The resulting ambiguity obscures what is at stake when making tradeoffs between data protection and other goals in research, such as transparency, reciprocity, and public benefit. Few studies have examined why participants in genomic research care about how their information is used. To explore this topic, we conducted semi-structured phone interviews with 30 participants in two National Institutes of Health research protocols using genomic sequencing. Our results show that research participants value confidentiality as a form of control over information about themselves. To the individuals we interviewed, control was valued as a safeguard against discrimination in a climate of uncertainty about future uses of individual genome data. Attitudes towards data sharing were related to the goals of research and details of participants' personal lives. Expectations of confidentiality, trust in researchers, and a desire to advance science were common reasons for willingness to share identifiable data with investigators. Nearly, all participants were comfortable sharing personal data that had been de-identified. These findings suggest that views about confidentiality and data sharing are highly nuanced and are related to the perceived benefits of joining a research study.European Journal of Human Genetics advance online publication, 27 November 2013; doi:10.1038/ejhg.2013.276.
Biobanks are promising instruments of biomedical research and of transnational medicine in particular. Ethical, legal and social issues associated with biobanking, however, have recently led to a more critical view on this concept. All efforts addressing these concerns have been grounded on well-established standards of biomedical ethics such as informed consent procedures, protection of individual autonomy, benefit sharing etc. By additionally highlighting the widely neglected aspect of trust, this book aims at broadening the horizon of the ELSI-debate and thus filling a gap in current research on biobanking. The contributions of leading experts and junior researchers cover a wide field of disciplines relevant for biobanking including law, ethics, medicine, public health, social sciences, philosophy and theology.
In this chapter I discuss trustworthiness as a quality of biobanks constructed and regulated in ways that make them serve the expectations donors have. Beginning with a short review of empirical studies of donor expectations and attitudes, I show that their concerns tend to revolve around issues of 1) personal control, 2) harmful uses of medical knowledge and 3) social fairness, in particular whether research is shaped by creed rather than medical need. I then rehearse the regulatory tendencies addressing these three issues, and identify an overall trend towards commercialization in particular in the areas of property law and research management. Then, the potential effects of this commercialization on the research agenda and research results are assessed based on available empirical studies. In conclusion, I point to the gap between donor expectations and the thrust of regulatory efforts. I argue that it is important that ethicists begin to address the wider innovation system surrounding biobanks if they wish that biobanks do not only preserve, but also deserve, the trust of the donating public.
Scientists are wary of public participation in policy that influences the work of scientific discovery and technological application. In the area of genetic science this is particularly troublesome. The science and its applications are extremely complex. How the public can play a part in guiding the process is not clear. Yet genetic possibilities affect individuals and social groups intimately and the exercise of social responsibility for policies is imperative. A solution lies in effective partnership between scientific experts and the general public within the framework of representative democracy. Goals of education, information transfer, and community building point to methods for public participation. The community meeting approach used in the development of health care priorities in Oregon is highlighted. Obstacles to participation come from our weak sense of community, widespread political alienation, endemic cynicism, and problems of social voice.
As genomic researchers are urged to openly share generated sequence data with other researchers, it is important to examine the utility of informed consent documents and processes, particularly as these relate to participants' engagement with and recall of the information presented to them, their objective or subjective understanding of the key elements of genomic research (e.g., data sharing), as well as how these factors influence or mediate the decisions they make. We conducted a randomized trial of three experimental informed consent documents (ICDs) with participants (n = 229) being recruited to genomic research studies; each document afforded varying control over breadth of release of genetic information. Recall and understanding, their impact on data sharing decisions, and comfort in decision making were assessed in a follow-up structured interview. Over 25% did not remember signing an ICD to participate in a genomic study, and the majority (54%) could not correctly identify with whom they had agreed to share their genomic data. However, participants felt that they understood enough to make an informed decision, and lack of recall did not impact final data sharing decisions or satisfaction with participation. These findings raise questions about the types of information participants need in order to provide valid informed consent, and whether subjective understanding and comfort with decision making are sufficient to satisfy the ethical principle of respect for persons.