Bioethical Considerations in Developing a Biorepository for the Pneumonia Etiology Research for Child Health Project

Article (PDF Available)inClinical Infectious Diseases 54 Suppl 2(suppl 2):S172-9 · April 2012with47 Reads
DOI: 10.1093/cid/cir1063 · Source: PubMed
Abstract
The Pneumonia Etiology Research for Child Health (PERCH) project has the potential to provide a highly valuable resource of biospecimens that may be used to inform future studies on the causes of pneumonia. Designing a biorepository for this complex project was done in collaboration with a wide range of experts including bioethicists. In this paper, we describe the most significant ethical issues encountered related to the biorepository, focusing on its structure and informed consent. We also outline the proposed approach to the PERCH biorepository, which was designed to be sensitive to the ethical, practical, and cultural challenges inherent to the study. Through this process, we concluded that biorepository governance plans and strategies for managing informed consent should be implemented in a way to allow for careful study in order to better understand the attitudes of and impact on the stakeholders involved in the study.
SUPPLEMENT ARTICLE
Bioethical Considerations in Developing
a Biorepository for the Pneumonia Etiology
Research for Child Health Project
Andrea N. DeLuca,
1
Alan Regenberg,
2
Jeremy Sugarman,
2,3,4
David R. Murdoch,
5,6
and Orin Levine
1
1
Department of International Health, International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health,
2
Johns Hopkins Berman
Institute of Bioethics,
3
Johns Hopkins School of Medicine,
4
Department of Healthy Policy and Management, Johns Hopkins Bloomberg School of Public
Health, Baltimore, Maryland;
5
Department of Pathology, University of Otago, and
6
Canterbury Health Laboratories, Christchurch, New Zealand
The Pneumonia Etiology Research for Child Health (PERCH) project has the potential to provide a highly
valuable resource of biospecimens that may be used to inform future studies on the causes of pneumonia.
Designing a biorepository for this complex project was done in collaboration with a wide range of experts
including bioethicists. In this paper, we describe the most significant ethical issues encountered related to the
biorepository, focusing on its structure and informed consent. We also outline the proposed approach to the
PERCH biorepository, which was designed to be sensitive to the ethical, practical, and cultural challenges
inherent to the study. Through this process, we concluded that biorepository governance plans and strategies
for managing informed consent should be implemented in a way to allow for careful study in order to better
understand the attitudes of and impact on the stakeholders involved in the study.
Since the publication of seminal pneumonia etiology
studies in the 1980s [13], significant technological
advances, particularly in the field of molecular diag-
nostics, have increased the potential to identify and
characterize the roles of both existing and previously
unrecognized pneumonia pathogens [4, 5]. These ad-
vances in laboratory diagnostics warrant renewed ex-
amination of the causes of pneumonia in both children
and adults.
The Pneumonia Etiology Research for Child Health
(PERCH) project is a multi country, case-control study
of children ,5 years of age who are hospitalized with
severe pneumonia. PERCH is funded by The Bill &
Melinda Gates Foundation and is designed to determine
the etiology of and risk factors for severe childhood
pneumonia in vulnerable populations at 7 stand-alone
sites. During project planning (2009–2010), the inves-
tigators consulted a wide range of experts to help design
an efficient, effective and ethically informed study.
The Johns Hopkins Bloomberg School of Public
Health (JHSPH) serves as the coordinating center for all
of the PERCH sites. The study protocol was designed to
incorporate expert advice while being sensitive to the
on-the-ground realities of 7 resource-limited country
settings. Protocol and consent templates were initially
reviewed and approved by the JHSPH institutional re-
view board (IRB). These materials were subsequently
modified with site specifications and requirements and
the approved by local ethics committees. The JHSPH
IRB then conducted a final review and approval of the
materials.
A major potential benefit of PERCH is the planned
biorepository of specimens from .12 000 children
across the world in order to inform future research into
thecausesofpneumonia.Collectionandstorageofbi-
ological specimens from sick children across study sites
in resource-limited countries in Africa and Asia rep-
resents a particularly complex aspect of the study.
Correspondence: Andrea DeLuca, MHS, Johns Hopkins Bloomberg School of
Public Health, Department of International Health, 855 N Wolfe St, Ste 600,
Baltimore, MD 21218 (andeluca@jhsph.edu).
Clinical Infectious Diseases 2012;54(S2):S172–9
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Infectious Diseases Society of America. All rights reserved. For Permissions,
please e-mail: journals.permissions@oup.com.
DOI: 10.1093/cid/cir1063
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Addressing the ethical challenges associated with the bio-
repository included development of strategies for governance
of the biorepository and informed consent for specimen
donation. Expert advice was sought in this regard from col-
leagues at the Johns Hopkins Berman Institute of Bioethics.
In this paper, we describe this collaborative approach to de-
veloping a biorepository for PERCH, which may serve as
a model to others engaged in similar endeavors. First, we pro-
vide a brief overview of the most significant ethical issues en-
countered with biorepositories, focusing on the issues associated
with their structure and informed consent. Next, we describe
the cultural challenges in the proposed research, highlighted
by the perspectives of participating investigators. Finally, we
outline the proposed approach to the PERCH biorepository,
which was designed to be sensitive to the ethical, practical, and
cultural challenges inherent to this research.
BACKGROUND
Biorepositories can extend the scope of biomedical research by
providing a large, accessible bank of biological specimens and
data. At the same time, they can present significant and complex
ethical challenges [69]. Issues range from those associated with
informed consent, privacy protection, and returning results to
individuals, to policies on access, secondary use of data, com-
mercialization, and benefit sharing. The involvement of multiple
countries, with variations in both cultural norms and levels of
access to resources, can pose additional challenges. These is-
sues are important and sometimes controversial, as evidenced
by the circumstances surrounding the testing of stored
specimens collected from the Havasupai tribe in Arizona
under a very broadly framed informed consent document. In
this case, the Havasupai understood that their biospecimens
would be used to study diabetes, which was prevalent among
the tribe. However, the specimens were subsequently used to
conduct unrelated research, including that related to psy-
chiatric disease. Alarmed by these uses, the Havasupai took
legal action against the university that had conducted the
research [10]. As this case makes clear, the issues are complex
and vitally important to a broad range of stakeholders. Sound
solutions need to be developed to ensure that biorepositories
are developed and maintained in such a way that does not
undermine their scientific value by overly limiting future
access, while at the same time ensuring that specimen donors
understand and are comfortable with the ways in which
biospecimens and related information can be used in the
future. Key stakeholders include the researchers and the
participants, but they also include the participants’ com-
munities, other researchers from both academia and in-
dustry, patients who stand to benefit from research findings,
funders, and others.
Although there is not broad consensus about the best ap-
proach to addressing these diverse challenges, an emerging body
of literature focuses on the need to adopt sound governance
models for biorepositories [1122]. A governance model de-
scribes how a biorepository is structured and functions. It
describes how stakeholders relate to one another in terms of
power and authority, and determines how decisions are made
about use of biospecimens and related issues. The literature
pertaining to biorepository governance generally reflects
a preference for independent ethical oversight, robust public
engagement, and access policies that promote data and ma-
terials sharing and collaboration. Proponents of these features
argue that they maximize the scientific value of the bio-
repository, benefit the largest number of stakeholders, and
encourage a sense of partnership and trust that is crucial to the
success of such collaborative endeavors [18]. A full analysis of
the ethical issues related to biorepositories is beyond the
scope of this paper. However, some brief details about 2 key
areas that needed to be addressed in designing the PERCH
biorepository are provided in order to set the stage for de-
scribing the approach that will be used in this project.
BIOREPOSITORY STRUCTURE AND
GOVERNANCE
One of the key decisions, particularly in the context of a multi-
site study involving partners with different levels of access to
resources, is whether to design a centralized or decentralized
biorepository. As described in Table 1, options include cen-
tralized biorepositories, semivirtual or hybrid banks, and fully
virtual or distributed banks [23]. These alternative models trade
off the potential for scientific benefit from any collected speci-
mens with improving research capacity at resource-limited sites.
A number of factors can help to guide the selection of the
particular structure of a biorepository (Table 2). Although there
are many practical and ethical concerns affected by the structure
of a biorepository, concerns about social justice are particularly
relevant in the presence of resource inequities such as those
found among sites participating in PERCH. Recognizing the
potential to exacerbate existing resource inequities by paying
Table 1. Types of Biorepositories
Type of
Biorepository Specimens Data
Centralized
biorepository
Stored centrally Stored centrally
Semivirtual/hybrid
model
Stored at multiple
collecting institutions
Stored centrally
Fully virtual/
distributed
Stored at multiple
collecting institutions
Stored at multiple
collecting institutions
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Table 2. Pros and Cons of Centralized Versus Decentralized Biorepositories
Issue
Centralized Decentralized
Pros Cons Pros Cons
Access Clear, simple, single institution
oversight for access and biorepository
quality assurance; access would
be easier and faster
Research sites may be reluctant to
participate if they feel that their
contributions are not acknowledged
Research sites may feel more vested in
the biorepository and therefore be
more willing to participate
Future studies and access to specimens
would depend on compliance of individual
investigators; decision-making may be
slower and more complicated
Cost Organizing research group or institution
may be able to centralize freezer and
equipment costs
Significant cost involved in setting up
the equipment, staff, and long-term
resource flow for an indefinite
biorepository
Research sites may have some preexisting
storage capacity, and costs of software
that would accurately track all specimens
and aliquots at sites should be minimal
A system to reimburse local investigators
for continued specimen storage and for
labor costs associated with future specimen
retrieval would need to be developed and
maintained
Logistics Standardized methods for shipping,
tracking, aliquoting, and storing
specimens; request for specimens
and subsequent retrieval and shipping
would be more straightforward
A comprehensive setup requires not
only funding but dedicated staff and
a broader scope of work to maintain
specimens after study completion
Research sites would maintain storage
of specimens in the same manner that
has been established during the
participant enrollment of the parent
study, but compliance will be more
difficult to establish; lapses at a site
could mean loss of specimens
Reliance on the research site’s capacity and
expertise to maintain the specimens in a
standardized way after the parent study
has ended; retrieval of specimens from
multiple locations could be complicated
and time-consuming
Security Resources could be devoted to
centralized regulatory oversight of
participant privacy, clinical data,
etc for all biorepository participants
Security in a safe locale depends on
moneyas long as there are funds
to maintain the specimens, they
are safe
Research sites may be motivated to
increase data and specimen security
if there is no central repository or
backup
Security of specimens may depend on local
and national infrastructure; backup systems
are not guaranteed
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insufficient attention to social justice is echoed in The Bill &
Melinda Gates Foundation global access grant agreement clause.
This clause requires investigators to make ‘‘good faith efforts’’ to
make the outputs of projects (tools, methods, and techniques)
accessible to the people most in need [24]. For PERCH, this
suggests the possibility of developing or ensuring capacity at
local sites. Nevertheless, centralizing a biorepository may
simplify logistics and increase efficient access to advanced
skills and tools. Alternatively, the central repository could be
placed at an institution that already offers advanced tools and
highly skilled local researchers.
INFORMED CONSENT FOR DONATION OF
SPECIMENS TO A BIOREPOSITORY
Although multiple models for obtaining informed consent for
biorepositories have been proposed [13, 2530], they tend to
endorse the need for disclosure of some basic information:
A reasonable assessment of risks to privacy: what they are, and
how they will be minimized.
The full range of individuals or groups with access to the
samples and data stored in the bank (eg, public or restricted to
certain investigators).
Any relevant financial interests of stakeholders.
A plan for the management of incidental information (ie,
what situations, if any, will lead to the disclosure of individual
results to participants or others).
Whether samples may be used in research that leads to the
development of commercial products, scientific publications,
etc, and if or how participants will benefit from such
developments.
The possibility that participants may withdraw their consent
at any time—information disclosed should include how to do
so, and what this will mean for the donated sample (eg, will or
can it be destroyed).
That participants do not own the donated sample.
That participants may request and be provided with (general)
results of the study or studies completed.
Each of these areas presents complicated terrain. For example,
although there appears to be consensus about the importance of
providing general study results to participants on request, there
are a range of responses that might fulfill this obligation. Careful
consideration needs to be given to the extent of investigators’
responsibilities. For example, participants could be presented
with prepublication findings. Alternately, ‘‘results’’ could be
interpreted to refer only to findings in peer-reviewed academic
publications. Furthermore, these results could be presented
as-is, with little or no further explanation, or they could be
summarized in detail to make them readily accessible and
comprehensible to diverse audiences.
Models of informed consent vary and range from providing
blanket consent for all potential uses of material to specific
consent for a particular research study. Although the former
may be desirable from a scientific and practical perspective, the
hazards of doing so are exemplified in the Havasupai case
described above. In contrast, specific consent comes at the
cost of efficiency and utility. Locating and obtaining consent
from all of the participants at a later date may be costly
and/or impossible, undermining some of the reasons for
having a biorepository. A variety of strategies are currently
in use along the spectrum between very specific and very
broad consent. Each strategy brings likely costs and benefits
(Table 3).
REPORTS FROM PERCH STUDY SITES
In addition to reviewing relevant information about bio-
repository practices in the academic literature, we also elicited
information from the principal investigators from each of the
7 PERCH study sites in order to get a better sense about
important contextual details. This included information
about capacities, resources, and any culturally rooted issues
that would be likely to affect the proposed plans to establish
a biorepository. We also elicited strategies that have been
employed for community engagement. Responses that were
especially useful in better understanding some the ethical
challenges in establishing a biorepository for PERCH are
summarized below.
Cultural Barriers to Research Involving the Collection of Blood
or Other Tissue Specimens
Some of the sites experienced resistance to blood specimen
collection during past research. In one study, stories spread
through the community that ‘‘Draculas’’ (blood suckers) and
‘‘Satanists’ had infiltrated the study clinics and hospitals. These
stories nearly brought the previous research to a complete halt.
Some less dramatic examples of resistance to the collection of
biological tissues followed a similar theme: fears of exploita-
tion at the hands of foreign entities. At 2 sites, study personnel
were accused of selling blood to foreigners from children
enrolled in a study. At a third site, staff members were accused
of shipping breast milk overseas for commercial purposes.
Concerns arose in another study site community about the
amount of blood being collected due to the appearance of
largebottlesthatwouldbeusedtoplacebloodsamplesinto
culture. In all of these cases, study personnel were able to
successfully respond by engaging with their local communities
and addressing the concerns. Strategies for public engagement
included meeting with community leaders such as traditional
healers (who were thought to be the source of some of the
rumors in at least one instance), inviting community leaders
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to observe study procedures in order to address their con-
cerns, and broader engagement through community-wide
meetings and appearances on radio talk shows.
Community and Public Engagement
PERCH sites provided information about their approach to
community engagement in past research. Some of these methods
include the following:
Community advisory boards.
Community sensitization in advance of study enrollment
(meetings, questions and answer sessions, etc).
Employing community agents as part of the study as field
workers, etc.
Dissemination of study results through local media outlets.
Obtaining ‘‘community consent’’ from local leaders (eg, tribal
chiefs and traditional healers).
In aggregate, the importance of utilizing a range of strategies to
engage with the local community is apparent. This can build
trust and enhance accountability via open communication and
transparency.
FINAL PERCH BIOREPOSITORY GOVERNANCE
STRUCTURE
The final PERCH biorepository was developed on the basis of
the scientific needs of the study and the relevant ethical
and cultural issues. The PERCH biorepository will include
independent ethical oversight, public engagement, and access
policies built into a governance structure.
With respect to structure, the preference would be to store
some volume of each specimen that is collected at the local study
site to enhance local capacity, and aliquots at a centralized
Table 3. Pros and Cons of Strategies for Consent and Its Withdrawal
Type of Consent Description Pros Cons
Specific informed
consent
Use of specimens and related data
only in immediate research
forbids any future study that is
not included in the original
consent
Adheres to a traditional view
of informed consent by
providing the specific
information needed to
decide about participation
in a study; protects individual
autonomy; generally less
vulnerable to legal challenges
Limits potential use of samples
(outside of recontacting donors);
may overemphasize risk and
understate the potential benefits
related to research with
biorepository specimens
Restricted consent Use of specimens and related data
in specific immediate research
and in future investigations directly
or indirectly associated with that
research
Provides enough information to
reassure participants that
future research will not conflict
with their wishes; some
empirical support [25]
Limits potential use of samples
and may still require recontacting
participants for informed consent
given unforeseen uses of
datawhich raises the same set
of problems as above in those
cases
Tiered consent Provision of a range of detailed options
to prospective research
participants along spectrum from
broad to specific consent
Provides individuals with more
control by offering a range of
options, thereby respecting
autonomy; encourages
participation by allowing
participants to opt out of some,
but not all, of the research
Complicates consent, potentially
decreasing comprehension; adds
significant administrative burden
to biobanking
Conditional
authorization
Subjects delegate autonomy to an
ethics review committee to approve
future proposed uses
Delegating autonomy to ethics
review committee is considered
an expression of autonomy;
practical, efficient use of
resources [26]; no need to
reconsent for future studies
Sacrifices individual rights for larger
research goalsthe more
general the consent, the less
‘‘informed’’ the participant; to be
informed, participants need to
understand the risks they are
agreeing to assume by
participating, and such risks
cannot be known at time of
consent in these cases; ethical
principles should not be discarded
for the sake of convenience
[13, 28]
One-time broad
consent
Allows the use of biological specimens
and related data in immediate research
and in future investigations of any kind
at any time [27]
Substantial empirical support that
this option is acceptable to
many participants and may
increase rates of participation
[30]; maximizes scientific value
of bank by facilitating access to
samples and lowers administrative
burden
Same as conditional, but more so
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storage site to increase the safety and security of specimens.
Unfortunately, this is infeasible for PERCH on logistical and
ethical grounds. In particular, only small volumes of some
specimens will be collected from each child. Therefore, in order
not to compromise PERCH study, volume-limited specimens
will only be stored at each individual site. Data about each
specimen, however, will be maintained in a central PERCH bi-
orepository database. Specimens that are not volume-limited
(eg, liquid medium from nasopharyngeal and oropharyngeal
swabs and postmortem specimens) or those that are renewable
(eg, extracted DNA and isolates) will also be stored at individual
sites, although eventually some of these specimens may be
contributed to a central biorepository. PERCH will therefore
be developing a semivirtual biorepository, with the possibility
of eventually developing a centralized biorepository with a sub-
set of samples that are also available at local sites. However, since
sites may have concerns about shipping materials, the details of
such an approach will need to be worked out in the future.
The agreed upon governance principles of the semivirtual
biorepository will do the following:
1. Facilitate future discovery by allowing stakeholders
access to study specimens. The executive committee will review
and approve requests for access. (The executive committee is
composed of all 7 PERCH project site principal investigators
[PIs], and 3 PERCH core team members, including the overall PI,
a co-PI, and the laboratory director.)
2. Encourage the transfer of future technological advances,
including vaccines and diagnostic tools developed from
biospecimens, to the most affected communities.
3. Consistently and purposefully consider the ethical
principles of beneficence, justice, and respect for persons in
all research requests.
4. Engage the communities at study sites.
5. Maintain a degree of independent ethical oversight through
the executive committee.
The PERCH executive committee will be primarily responsible
for implementing a biorepository structure based on these
governance principles. The executive committee is charged with
ensuring that the structure includes plans for the ethical over-
sight of all specimens and isolates that are procured for study
purposes. Table 4 outlines the involvement of all key stake-
holders, including study funders, teams, PIs, participants and
affected communities, and commercial enterprises, in the pro-
posed PERCH biorepository governance structure.
FINAL PERCH BIOREPOSITORY INFORMED
CONSENT LANGUAGE
For informed consent, the PERCH team will employ a hybrid
model, primarily using a restricted consent strategy supple-
mented by conditional authorization (Table 3). Future research
can only include studies designed to better understand the
causes of childhood diseases. The draft consent document
templates, subject to local IRB approval, also include specific
requests for permission to ship samples and data outside of the
country, as needed. In addition, the consent template discloses
that future testing may include genetic assays the results of
which will not be returned to the participants. Finally, potential
Table 4. Stakeholder Concerns and Responsibilities
Stakeholder Key Concerns Involvement in Governance Structure
Study funder Intended outputs of project (including tools,
methods, and techniques) to be made
accessible (with respect to cost, quantity,
and applicability) to the people most
in need within the developing countries
of the world
Global access plan serves as basis for
governance structure
PERCH investigators Completion of project aims; fairness in access
to specimens and future research opportunities;
maintenance of the biorepository
Responsible for oversight by way of the
executive committee; responsible for securing
biorepository funding
Study teams Fair access to study specimens from all sites;
equity in future research opportunities;
ownership of the biorepository
Responsible for oversight by way of the executive
committee; responsible for research requests of
specimens stored at study sites; responsible
for alerting and involving all PERCH principal
investigators
Study participants and
affected communities
Protection of privacy; fair benefits from future
technological developments
Key role in determining allocation of profits from
tiered pricing scheme if one is developed;
responsible for notifying advocacy networks
of findings
PERCH executive
committee
High-quality review of research requests; key
developments made accessible through research
and policy networks
Responsible for oversight by way of sample and
isolate sharing; responsible for notifying
colleagues of findings
Commercial enterprises Access to specimen; ownership of research results
and technologies arising from research
No role in oversight; key pricing tiers to fund
maintenance of specimens
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participants are told that future studies will be approved by
a committee charged with ensuring that the ‘‘children’s safety
and rights are respected.’’ The requests for permissions to store
specimens for future research are separated from the request for
permission for participation in PERCH so that both cases and
controls can be enrolled in the study while still opting out of
participation in the biorepository.
This consent format was created because of the need to in-
corporate permission from parents for storage and future testing
without knowing exactly where or when study specimens would
be tested. After consulting the sites, PERCH investigators
decided that the ‘‘childhood diseases’’ clause mentioned above
was appropriate to allow for future pathogen discovery. Most of
the sites agreed with this language, with a handful of local
adaptations.
CONCLUSIONS
The PERCH project is uniquely positioned to inform future
research on causes of childhood pneumonia. Establishing a bi-
orepository infrastructure at the outset that allows for this future
research was a critical component during project design. By
working with the 7 diverse study sites and their respective ethics
committees, a semivirtual biorepository was ultimately adopted
as the most feasible and best suited approach for the project,
given both the lack of long-term support for a centralized
repository and the opportunities involved for local site in-
vestigators in establishing a biorepository on site.
The PERCH team’s planning for biorepository governance
and management of informed consent illustrates the benefits
of funding mechanisms that promote careful preparation of
study design with the added benefit of expert consultation. In
this case, consultation with bioethicists facilitated the navi-
gation of the practical and ethical terrain surrounding the
development and governance of promising biorepositories.
Merely having an enhanced understanding of this terrain is
helpful, even in the absence of consensus about the best
methods for addressing concerns, and should lead to better
processes and outcomes in the long term. Furthermore, the
absence of strong consensus and a dearth of available data
suggest that biorepository governance plans and strategies for
managing informed consent should be implemented in a way
to allow for careful evaluation in order to better understand
the attitudes of and impact on key stakeholders. Careful ap-
proaches to capturing the perspectives of key stakeholders will
allow future efforts to be even better tailored to their prefer-
ences, needs and concerns.
Notes
Acknowledgments. We gratefully acknowledge the work of Alison
Boyce in reviewing the literature used to develop this paper.
Disclaimer. This article and its contents are solely the responsibility of
the authors and do not necessarily represent the official views of NCRR or
the National Institutes of Health.
Financial support. This work was supported by grant 48968 from The
Bill & Melinda Gates Foundation to the International Vaccine Access
Center, Department of International Health, Johns Hopkins Bloomberg
School of Public Health; the National Center for Research Resources
(NCRR), a component of the National Institutes of Health (NIH) and NIH
Roadmap for Medical Research (grant UL1 RR 025005); and the Niarchos
Foundation (Bioethics Rapid Response Initiative).
Supplement sponsorship. This article was published as part of a sup-
plement entitled ‘‘Pneumonia Etiology Research for Child Health,’’ spon-
sored by a grant from The Bill & Melinda Gates Foundation to the PERCH
Project of Johns Hopkins Bloomberg School of Public Health, Baltimore,
Maryland.
Potential conflicts of interest. All authors: No reported conflicts.
All authors have submitted the ICMJE Form for Disclosure of Potential
Conflicts of Interest. Conflicts that the editors consider relevant to the
content of the manuscript have been disclosed.
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  • Article · Mar 1986
  • [Show abstract] [Hide abstract] ABSTRACT: Biobank research has been the focus of great interest of scholars and regulatory bodies who have addressed different ethical issues. On the basis of a review of the literature it may be concluded that, regarding some major themes in this discussion, a consensus seems to emerge on the international scene after the regular exchange of arguments in scientific journals. Broad or general consent is emerging as the generally preferred solution for biobank studies and straightforward instructions for coding will optimise privacy while facilitating research that may result in new methods for the prevention of disease and for medical treatment. The difficult question regarding the return of information to research subjects is the focus of the current research, but a helpful analysis of some of the issues at stake and concrete recommendations have recently been suggested.
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