1. PERSPECTIVE
Reforming Biobank Consent Policy:
A Necessary Move Away from Broad Consent
Toward Dynamic Consent
Dorit T. Stein1,2
and Sharon F. Terry1
The field of genomic-based medicine has power in
numbers. With the increasing ability of new technology
infrastructures to allow streamlined data sharing, there is a
rising potential for networks of data to accelerate genomic-
based translational research. Networks of registries and bio-
banks are being formed that allow researchers access to more
specimens and samples that further allow for studies of
greater statistical significance (Kaye et al., 2012). The summer
of 2013 saw a call from the Patient Centered Outcomes Re-
search Institute for ‘‘patient-powered research networks’’ and
‘‘clinical data research networks’’ with the hope that they will
be woven into a national clinical research network. This in-
crease in data sharing intensifies long-held concerns about
what is traditionally described as privacy and effective in-
formed consent. A shift from the current biobank (and its
associated registry; however, for the sake of this article, we
will limit our comments to biobanks) paradigm of broad
consent to a digitally based system of dynamic consent can
help alleviate concerns attached to open databases of infor-
mation and effectively involve participants in the research
process and trial results.
Attaining broad consent from individuals who participate
in biobanks is the current norm (Steinsbekk et al., 2013). It is
difficult for biobanks to achieve fully informed consent be-
cause the nature of future research is often unknown or
widely variable (Kaye et al., 2011; Kaye et al., 2012). Therefore,
until recently, it appeared that broad consent, in which donors
consent to a range of experiments before participating in a
biobank (Hofmann, 2009), was the only solution. Broad con-
sent assumes that there is minimal risk to an individual donor
and therefore that the benefit to research as a whole out-
weighs the risk an individual incurs by donating samples.
Some argue that broad consent is ethical on the basis that
consent can be revoked at any time, and in the event protocol
changes, an ethics review board will make an informed de-
cision of whether participants must be reconsented. Ethics
review boards can decide, for example, that the use of de-
identified information is sufficient to allow sample use with-
out reconsent from the participant (Kaye et al., 2011).
The argument for broad consent is sprinkled with a priori
assumptions. First, the notion that there is minimal risk to the
individual is no longer true in an age where even de-identified
information can be traced back to an individual using public
databases (Gymrek et al., 2013). Depositing a sample in a
biobank does not have the same risks as physically partici-
pating in a clinical trial, but the ‘‘informational’’ risk is still of
concern and can have unknown future adverse effects. Sec-
ond, even if the option to revoke consent is available, donors
cannot possibly revoke consent if they are not aware that their
data are being used or for what they are used. Information
sharing between biobanks and participants can somewhat
alleviate this problem, but in cases where data or samples are
already distributed, of course the individual cannot withdraw
from that analysis. Third, ethics review boards are not always
fully equipped to assess the safety of an individual’s infor-
mation because of the unknown downstream affects of open,
individual genetic information (Hofmann, 2009).
The aforementioned pitfalls of broad consent could justifi-
ably be overlooked in a previous era of limited communica-
tion between participants and biobank custodians, an era in
which reconsenting for new research purposes would be
costly and difficult, and would hinder the advancement of
said research (Hofmann, 2009). However, in a highly digitized
age with social media, electronic medical records, and ad-
vances in health information technology, it is time to re-
evaluate the process of broad consent and look to the
paradigm of dynamic consent.
United Kingdom academics and companies are testing
dynamic consent as part of the EnCoRe (Ensuring Consent
and Revocation) project (Wee, 2013). Dynamic consent is
based on a patient-centric information technology system that
allows individuals to set specific preferences for the use of
their data. The system also allows participants to modify,
change, or revoke their preferences over time. Participants can
also track and audit changes made to their privacy settings. In
addition, participants are able to choose when and how they
would prefer to be contacted for future studies or for the re-
porting of results (Wee, 2013).
The dynamic consent model is oriented around the partic-
ipant and involves ongoing communication between the bio-
bank, donor, and researchers. Ongoing communication fosters
a culture of respect between participants and researchers and
1
Genetic Alliance, Washington, District of Columbia.
2
University of California, Los Angeles, Institute for Society and Genetics, Los Angeles, California.
GENETIC TESTING AND MOLECULAR BIOMARKERS
Volume 17, Number 12, 2013
ª Mary Ann Liebert, Inc.
Pp. 855–856
DOI: 10.1089/gtmb.2013.1550
855

2. allows for more streamlined recruitment, consent, and re-
consent. If donors feel a sense of involvement with the research
and are treated as active, equal partners in the process, the
recruitment of participants will be strengthened because of
increases in confidence and trust in the research and re-
searchers. A patient-oriented system of consent could there-
fore have the effect of decreasing costs of recruitment into trials
(Kaye et al., 2012; Kuehn, 2013).
Broad consent practices usually result in the de-identifica-
tion of specimens. There are at least three issues with de-
identification. First, de-identification, while usually offered as
a means to protect participants most fully, actually cuts the
individuals off from being full participants. Next, while a
single snapshot in time is useful, it is not as scientifically
useful as is the longitudinal association of a sample and the
emerging phenotypes. For example, a breast cancer tumor
sample might be taken at the time of surgery, and de-identi-
fying the sample does not allow the researcher access to crit-
ical information, such as whether the cancer recurred, the
individual’s survival rate, and what other medical or non-
medical issues should be considered. Finally, even the accu-
racy of the term ‘‘de-identified’’ has become increasingly
scrutinized. Several scholars have shown that re-identification
is possible with two or more datasets (Gymrek et al., 2013;
Malin et al., 2001).
In the dynamic consent model, anonymity is not necessary
since ongoing communication allows donors to directly con-
sent for further research and or specific types of research
(Kaye et al., 2012; Terry et al., 2013). Because dynamic consent
calls for specific sharing preferences to be set before research,
the need to revoke consent will lessen since the types of re-
search allowed are clearly delineated (although the option to
revoke consent is still present). Dynamic consent also di-
minishes the work of external ethics review boards because
the individual can directly decide to consent to further re-
search.
The patient-oriented tenets of the dynamic consent ap-
proach foster an environment of respect and trust in research.
In combination with ongoing contact and communication,
trial enrollment can increase. Dynamic consent maintains
open lines of communication between biobanks, researchers,
and donors, thus allowing for trial results to be reported back
to the participant, a major weakness of current consent par-
adigms (Kaye, 2012). Including the preferences of the indi-
vidual in the dynamic system can mitigate even the ethical
dilemmas of reporting incidental findings.
A current limitation of most dynamic consent systems is the
potential of isolating certain disadvantaged groups with
limited access to technology (Steinsbekk et al., 2013). The use
of digital components also minimizes the face-to-face contact
between researchers and participants, although if a goal of the
research system is to vastly increase the number of partici-
pants in biomedical research, then some technology tools for
scaling must be implemented. The aforementioned short-
comings, however, can be mediated with further policy in-
terventions and the use of more ubiquitous technologies such
as text messaging and e-mail. Overall, a shift from a re-
searcher-oriented perspective to a patient-centered view can
undoubtedly benefit researchers, donors, and genomic-based
translational research as a whole.
References
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Identifying personal genomes by surname inference. Science
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Hofmann B (2009). Broadening consent—and diluting ethics? J
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Kaye J (2012). Embedding biobanks as tools for personalised
medicine. Norsk Epidemiol 21(2).
Kaye J, Curren L, Anderson N, et al. (2012). From patients to
partners: participant-centric initiatives in biomedical research.
Nature Rev Genet 13:371–376.
Kaye J, Whitley EA, Kanellopoulou N, et al. (2011). Dynamic
consent: a solution to a perennial problem? BMJ 343:d6900–
d6900.
Kuehn BM (2013). Groups experiment with digital tools for pa-
tient consent. JAMA 310:678–680.
Malin B, Sweeney L (2001). Re-identification of DNA through an
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Steinsbekk KS, Myskja BK, Solberg B (2013). Broad consent
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Terry SF, Shelton R, Biggers G, Baker D, Edwards K (2013). The
haystack is made of needles. Genet Test Molec Biomarkers
17:175–177.
Wee R (2013). Dynamic consent in the digital age of biology. J
Prim Health Care 5:259–261.
Address correspondence to:
Sharon F. Terry, MA
President & CEO
Genetic Alliance
4301 Connecticut Avenue, NW
Suite 404
Washington, DC 20008
E-mail: sterry@geneticalliance.org
856 PERSPECTIVE