Trust, Respect, and Reciprocity
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This document summarizes a study on data sharing practices and ethics in Vietnam. The study explored stakeholders' attitudes, experiences and expectations regarding sharing individual-level clinical research data through interviews and focus groups. Key findings included the importance placed on trust, respect and reciprocity in the local research culture. Existing Vietnamese laws and guidelines do not prohibit data sharing but do not specifically address it either. There is a need to develop culturally appropriate policies and best practices for data sharing in Vietnam to maximize benefits while respecting local needs and expectations.
![254 Journal of Empirical Research on Human Research Ethics 10(3)
Ethical Considerations
This study, including the protocol, informed consent forms,
and outline interview guides were reviewed and approved
by the ethics or institutional committees of the Hospital for
Tropical Diseases, Ho Chi Minh City, Vietnam; Children’s
Hospital 1, Ho Chi Minh City, Vietnam; National Hospital
for Tropical Diseases, Ha Noi, Vietnam; Provincial Center
for Preventive Health Care, Ha Nam, Vietnam; and Oxford
Tropical Research Ethics Committee, Oxford, United
Kingdom (OXTREC, Reference 1051-13).
Before initiating the study, all interview and group discus-
sion participants had the study explained to them in a way
that allowed them to understand the purpose, procedures,
risks, benefits, and alternatives to study participation. Those
who agreed to take part were asked to sign a consent form to
confirm that they had been adequately informed about the
study and that they agreed to participate. All participants
were compensated with a small amount of cash (US$10) or
provided with lunch for the time spent participating in the
study. Participants who traveled to the study site were also
reimbursed an amount based on the distance traveled accord-
ing to standard policy (average amount ~US$10). Study tools
are available in the online appendix (jre.sagepub.com/
supplemental) of this article. Interview transcripts are avail-
able, please contact the corresponding author for details.
Information that could identify participants have been
redacted to preserve privacy.
Results
Views About a Novel Initiative
There was interest among all study participants in how data
can be shared, though very few had ever practiced non-col-
laborative data sharing or had any prior awareness of the
potential issues that could arise. Knowledge of the increas-
ing requirements for data sharing by journals and funders
was also uncommon. Among the researchers interviewed,
collaborative data sharing and cross-institutional partner-
ships were common with national and international collabo-
rators, as well as with students for educational purposes.
The current dearth of non-collaborative data sharing among
Vietnamese researchers was not perceived as a problem. The
novel concept of sharing was introduced to study participants
as an initiative from international funders, scientific publish-
ers, and institutions. There was general acceptance that this
wouldintuitivelyfitintotheframeworkofVietnameseresearch
as a part of ongoing development through education, grants
and publication involving international partners. This view
was summed up by researchers as follows:
I think it [data-sharing practice] is the same everywhere in the
world. Science is not the invention of Vietnamese people.
What and how we do science, we learn from teachers.
(Researcher–Male-I-18)
It [data-sharing practice] is the same everywhere. You don’t go
to your neighbors to explain everything about what you’re
doing. For me, the problem is not active refusal to give
information. I don’t think it is an active process: people trying
to keep information. Just for everybody, probably all humans,
it’s not natural to give out all information all the time. So I
don’t think it is a problem just in Vietnam because I travel a lot:
Africa, Europe, US . . . I don’t think it is worse here. It is not
different, not better. (Researcher–Male-I-26)
Despite acceptance that data sharing may become more
common, it was not seen as a current priority. Multiple
researchers referred to an “unwritten rule” that requires
researchers to focus on the scientific and technical aspects
of a project in development, while minimizing the paper
work. An ethics committee member clarified this by
explaining,
. . . no one can imagine the way ahead because they only pay
attention to the technical aspects [of research]. Data sharing is
not a priority [in Vietnam] at this point. (Ethics committee
member–Male-I-15)
This was supported by a number of researchers who said
that the need to promote or develop policy on data sharing
was not a top priority in the competitive and resource-lim-
ited realm of academic science.
When patient representatives were first asked if they
were willing to share their data, there was some reluctance.
In each case, as information was provided about the type of
data that could be shared and for what purpose, this quickly
evolved to join the collective acceptance of this new initia-
tive with a prevailing attitude of benevolence and trust:
You know, when I was invited here, I just thought it’s because I’ve
been recruited to research on dengue fever in this hospital. . . . One
staff informed me something about the possibility of sharing of
my personal information . . . and my initial reaction was objection
. . . then from the beginning of this discussion, I changed my mind
and I am now willing to share information. It’s a change between
acceptable and unacceptable. Now that I know sharing my
information is for common good sake, I have changed my mind,
and I am willing to allow sharing. But ideally, everything should
be anonymized. (Patient representative–Male-G-02-03)
Vietnam is now in a transition period. We must sacrifice and
accept inconvenience for development and we are strongly
willing to contribute. Information is such a trivial thing to
consider. Moreover sharing of my information doesn’t affect
my life in any way. (Patient representative–Female-G-01-07)
Principle Versus Practice
Although the general principle of data sharing as a growing
global trend with an upcoming role in Vietnamese research
was accepted, a different picture emerged when researchers
were asked about sharing data from their own studies. During](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-4-320.jpg)
![Merson et al. 255
initial discussions, researchers often disagreed with the
notion that sharing their individual-level data was accept-
able. One ethics committee member embodied the typical
response heard from many others by claiming,
Requesting raw data from someone? It is synonymous with
being disrespectful! (Ethics committee member–Female-I-09)
Fueled by the intention of maintaining patient privacy
and academic competitive advantage, clinical research data
have long been protected as confidential information.
Promoted by the confidentiality that was historically inher-
ent to pharmaceutical industry trials, this mind-set is also
prevalent in Vietnam. This may have contributed to the fre-
quent (and often strong) initial objections to sharing the
data from one’s own research. The idea that research data
belong to the funder and that such ownership precludes the
investigator from sharing was also a commonly quoted bar-
rier. The public nature of sharing data directly challenged
Vietnamese researchers’ views on data confidentiality.
When considering the implementation of non-collaborative
data sharing, researchers and ethics committee members
made it clear that discussions of any data-sharing plans
should occur at the initial stage of a research project.
Views About Acceptable Data Sharing
After further discussion of some of the benefits and risks of
sharing data, the participating researchers were asked to
consider under what conditions they would or would not
agree to share their data. As most researchers interviewed
for this study were not yet engaged in non-collaborative
data sharing, a theoretical exchange of ideas ensued on
what the researchers envisaged as acceptable data sharing.
There was consensus that secondary uses of data must con-
tribute to scientific knowledge. This concept was central to
most discussions, with particular emphasis placed on data
uses that addressed the health needs and priorities of the
Vietnamese community.
Next on the list of requirements for acceptability were
criteria that demonstrate respect to the data provider, includ-
ing transparent exchange of information, timely analysis,
and feedback to the data provider:
. . . there is a condition: it must be fair. If you receive my data,
you should give me feedback, I mean everything I need as part
of a collaborative relationship. If sharing is unfair, no one
wants to do anything. (Ethics committee member–Male-I-15)
Avoidance of conflict with the outcomes of the primary
research was also considered important:
For a student, I think it is acceptable to share data to give them
the direction for their thesis. For a colleague, if their purpose of
study is different from mine, for example, I do clinical research
but my colleague only requests epidemiological data which
does not interfere with my final results . . . then I think it is
acceptable. A pharmaceutical company might wish to use my
data as control group, which is acceptable if their research
doesn’t affect my final results . . . if their research design is
similar to mine, then it interferes. (Ethics committee
member–Female-I-22)
Researchers also discussed the importance of respecting
the ethical commitments made when the data were
collected:
I think the most important point is who ‘stands in front of the
patients’! I mean the original researcher must bear full
responsibility for the ethical aspects of the research. . . . The
original researchers must take into account every single side of
their research [including data sharing]. (Researcher–Male-I-27)
Many other researchers agreed that respect is an impor-
tant cultural pillar that must be demonstrated by restricting
duplication of existing studies, avoiding incongruity with
the primary study results and ensuring that primary research-
ers have oversight of all potential ethical issues. It was also
made clear that the data provider has a professional respon-
sibility to liaise with the data user to ensure that the dataset
is fully understood and that misinterpretation is avoided.
Other factors commonly associated with increased accep-
tance of data sharing were as follows: having an existing
relationship with the secondary data user, primary research
being complete and published, increased age of the dataset
and the perceived decline in utility, and limiting the amount
of data shared as a proportion of the total data collected. A
number of researchers and ethics committee members also
stressed the obligation of the data user to contribute to
building research capacity in Vietnam, though methods for
doing so were not clear.
Consensus was strong among participants engaged in
education, that sharing data with Vietnamese students who
lack the resources to initiate independent data collection is
important and has clear benefits:
In foreign countries, students are granted money to do research
on their own but it is not the same in Vietnam. We should
simplify the procedures to help students practice on real
datasets. (Government officer–Male-I-13)
This highlights the common attitude that leveraging data
sharing as a way to develop Vietnamese research is of core
importance. Expanding access to data within Vietnam is
thought to promote science nationally, delivering on the
expectations of scientific benefit and capacity building with
a local focus. Some researchers felt that sharing data out-
side of Vietnam would endanger the likelihood of achieving
these local benefits, suggesting that when the data user is in](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-5-320.jpg)
![256 Journal of Empirical Research on Human Research Ethics 10(3)
another country, there is less assurance that any local bene-
fit will be realized.
Trust
Although not explicitly raised as a topic by participants,
trust emerged as a theme throughout theoretical and practi-
cal discussions with all participants. The importance of per-
sonal and professional relationships in the culture of
scientific research in Vietnam was highlighted by ubiqui-
tous concerns regarding non-collaborative working prac-
tices. Trust in data quality, trust in secondary data users, and
trust in researchers collecting data were each addressed
from a variety of angles by respondents.
Data quality was the primary concern of many senior
researchers and government officials. Many felt that the
ability of a secondary data user to trust the data in a dataset
would be compromised when direct involvement or link to
data collection is absent. This strengthened the popular sen-
timent that data providers should have oversight of the out-
puts of data users’ prepublication. Others felt that increased
quality standards in data collection, management, and tabu-
lation should be met before datasets are shared:
I think data sharing is a good idea but data quality should be the
first step. (Ethics committee member–Male-I-25)
Some participants extrapolated this risk to a potential
reduction in the overall quality of science. It was felt that
openly available data would discourage the likelihood of
studies being replicated and promote uses of data that could
be flawed:
I worry about another risk: if something has been done,
obviously no one wants to do it again. Someone else did it, and
then you just want to do other things. So there will be no one
who cross-checks the results. This fact carries the risk of lack
of verification [of shared datasets]. We only move forward but
no one looks back for any potential gaps or mistakes in the
past. (Researcher–Male-I-16)
The concept of relationships is a critical component of
research collaboration in Vietnam. The trust built through
collaboration is described as the “oil which lubricates the
machine” of cooperation. Vietnamese researchers consid-
ered non-collaborative data-sharing models where the con-
fidence that exists between known collaborators is absent.
Without this link, there was concern that primary research-
ers could not prevent harms such as distortion of data or
conflict of results with the original analysis:
What if the requestors figure out mistakes in the owners’dataset?
No one wants that (laughter). (Researcher–Male-I-18)
What if the requestors analyze and generate results different
from the original owner? I have witnessed this scenario myself.
They might use two different statistical methods, particularly
foreign researchers pointing out mistakes in Vietnamese
articles. (Researcher–Male-I-23)
Researchers generally did not accept the surrender of
oversight of scientific and ethical standards to unknown
data users. A number of individuals expressed trust in what
were referred to as “prestigious institutions,” including the
World Health Organization, and considered them more
acceptable as data users, but when it came to sharing data
with an anonymous individual, there was hesitation.
Concern was also raised regarding the potential economic
impact and commercial exploitation. Multiple participants
referred to the use of Indonesian H5N1 strains for vaccine
development during the 2000s:
You know, Indonesia got H5N1, they didn’t want to give data
to the international community. They argued that they [the
international community] do research to produce vaccines, to
gain big profit by selling products at an expensive price while
my patients are dying. . . . I think they are somewhat reasonable:
it seems unfair. This story is very sensitive and subtle. If they
keep going that way, there will be a time when cooperating
stops! Unfortunately, such stories are still so common. . . .
Sharing should have contributions from both sides. (Ethics
committee member–Male-I-15)
There was consensus among ethics committee members
that a contract between the data provider and data user, to
define the terms of data use, could help to overcome con-
cerns regarding unknown collaborators. Potential areas to
be addressed in such contracts are outlined below in the
Best Practices section.
Among patient representatives, there was a high level of
confidence in the decisions of the research doctors.
Consensus that data could be shared at the discretion of the
researchers was unwavering. There was little concern for
the future of the information. When potential personal risks
were discussed, including exploitation, stigmatization, and
loss of confidentiality, management of these risks was vol-
untarily given to researchers. The assignment of trust was
independent of the nationality of the researcher. It was
unclear whether this reflects confidence in international sci-
ence, the research governance provided by the Vietnamese
government, the strong involvement of Vietnamese doctors
in all research, or other reasons. Representatives did not
consider their input on the use of data to be a priority. A
patient representative summed this up in a statement typical
to the range of discussions on the topic:
No, I don’t have any concerns! You are a research institution;
you should inform the region about their health problems to
help them. We don’t have any concerns. You can give feedback
to us as individuals if it helps us in some way to promote
benefits or to prevent harms. That’s all! I see no reason to hide
information! The more public it is, the better! Even [data on]](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-6-320.jpg)
![Merson et al. 257
diseases with the possibility of stigmatization and discrimination
should also be public! (Patient representative–Male-G-01-05)
In contrast to the researchers, patient representatives did
not consider the use of data for commercial profit to be a
threat. After considering the risks and benefits of contribut-
ing to commercial research, one representative clarified the
acceptance of data sharing for commercial purposes with-
out direct benefit by stating,
We should not claim tangible benefits from pharmaceutical
companies because in doing so we push drug prices higher.
(Patient representative–Female-G-02-01)
The only concern identified by patient representatives was
media and profiteers misusing patient data for the vested inter-
ests of companies. Although there was no objection to profits,
there was disdain for current trends in the misuse or misrepre-
sentation of facts to embellish marketing campaigns:
I am concerned about the possibility . . . that people might
unreasonably trust a product’s quality. Media should be
responsible for such misinterpretations. In foreign countries,
there are medical staff in the newspaper to control the messages,
but we still can’t do the same thing in Vietnam. (Patient
representative–Female-G-02-02)
Sharing my information to researchers is good but don’t share
it with the media. (Patient representative–Male-G-02-3)
Media or those who interpret the implications of the data in the
media, should be qualified and make sure the interpretation is
accurate. (Patient representative–Female-G-02-01)
Expectations and Best Practice
In the interest of determining best practices for data sharing
in Vietnam, the key issues of consent, reciprocity, and
authorship are explored below.
Consent
Opinions about the need to obtain consent for sharing data,
and how much information is considered sufficient to make
an informed decision, focused on practicalities and feasibil-
ity more than ethics. It was broadly agreed by all participants
that to share data that have already been collected for a com-
pleted study, the responsible Ethics Committee could make
a decision on behalf of the study participants. Reasons given
to support this included the impracticality and resource
requirements of tracing and contacting participants. There
was agreement among patient representatives and research-
ers that the risk of disrupting someone’s day with an unnec-
essary phone call, or accidentally breaching the privacy of a
patient by re-contacting him or her to give additional con-
sent for data sharing, was greater than the potential risks in
sharing the data. Regarding contacting patients to obtain
additional consent, a patient representative noted,
I think the action of trying to establish individual identities to
re-contact is ethically problematic in itself. (Patient
representative–Female-G-02-01)
As well as informing the consent process, this consensus
may demonstrate that data sharing is perceived as a rela-
tively low-risk activity.
In considering what information should be given pro-
spectively to study participants, there was heterogeneity in
responses from research professionals. Responses spread
evenly across a spectrum ranging from the requirement of
explicit details of data-sharing plans to providing minimal
information about future uses of data. In the opinion of one
ethics committee member, “Broad consent is no consent at
all” (Ethics committee member–Male-I-07). In contrast, a
researcher took a different view:
There is no need to obtain another consent from patients for
secondary [data] use except, perhaps for rare diseases only.
And even if so, we should explain very generally because there
more we explain, the more nervous the patients will be.
(Researcher–Female-I-10)
Patient representatives were familiar with the principle
and practice of obtaining informed consent. When asked if
data sharing should be discussed in the informed consent
process or if patients should be consulted regarding data
sharing, there was strong consensus that this was unneces-
sary. In line with many responses regarding governance,
representatives empowered researchers with the responsi-
bility to make decisions on their behalf. This typical senti-
ment came from one representative:
We trust you [researchers]. You can use my information for
different purposes. How should I know? We trust you! There is
no reason to prevent data sharing. (Patient representative–Male-
G-01-01)
When pressed to consider that consent was a standard
requirement of conducting research, another patient repre-
sentative suggested,
Perhaps you can explain in the consent form: “your information
is only used for scientific development to promote health.” I
would like to do that. According to this statement, other
researchers can access my data to do further research. (Patient
representative–Female-G-01-02)
Reciprocity
When asked how to ensure that data sharing was imple-
mented in a favorable and sustainable way in Vietnam,
participating researchers proposed reciprocal models that](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-7-320.jpg)
![258 Journal of Empirical Research on Human Research Ethics 10(3)
supported capacity building and academic recognition for
the data provider. As discussed above, benefiting scientific
knowledge (ideally with relevance to Vietnam) was consid-
ered to be a core element of acceptable data sharing. This
suggests that capacity building as a part of a data-sharing
arrangement is seen as an important requirement for data
sharing to be seen as acceptable. Indeed, capacity strength-
ening was explicitly stated to be a basic requirement by
many:
At least, we expect investment in capacity building for us
[Vietnamese researchers]. It is a very important point.
(Researcher–Male-I-11)
The provision of resources was also seen as important to
support data sharing locally. As doctors often undertake
research as a task in addition to their regular job, it was
considered important that compensation for the resources
needed to share data was provided either by the funder or
the data user. A researcher summed up the effect of the
resource inequality between those driving data-sharing pol-
icies and Vietnamese researchers by explaining,
Scientific work in Vietnam and foreign countries is different.
Vietnamese contribute great effort to do science, while personal
financial gain and prestige are generally meager in comparison
to developed countries. Their [Foreigners] salary is high and
salary is their main source of income. Living on a meager
salary, [Vietnamese] staff sometimes work tirelessly to generate
a database. In the future, if salaries are in accordance to
Vietnamese scientists’ contribution, I think the interest in data
sharing will increase. (Researcher–Male-I-11)
Academic recognition was highlighted as critical by
most senior Vietnamese researchers. This was proposed to
be in the form of authorship on any papers resulting from
secondary use of data. Researchers were also happy to be
invited as collaborators, and subsequently authors, by data
users. Some respondents said that it was important to ensure
that those who collected the data are given appropriate
credit for their efforts. Others stated that securing author-
ship was a means by which they could fulfill their responsi-
bility as investigators to their patients by controlling the
ethical and scientific standards applied to secondary data
use:
Being an author is synonymous with holding ethical and
scientific responsibility. Therefore, the secondary [data] user is
the first author, then name of the owner of the original data
stands next to it. (Researcher–Male-I-27)
When current international authorship guidelines were
discussed with researchers and ethics committee members,
it was accepted that requiring authorship as a condition of
data sharing does not fit with international publication
guidelines. Consequently, participants suggested that if the
data provider is not an author, a review of the paper by the
data provider should be required before publication. This
concept contrasted with the views of most foreign research-
ers and some junior Vietnamese researchers interviewed.
There was consensus among these groups that authorship
should not be assigned on the basis of data provision:
Data comes from the patients, not from the investigators. So if
others have some good ideas [about how to use data], they
should use it. It is not my topic, so no, no . . . I don’t want to be
the author! Maybe you’ve to mention where the data came
from and the sponsors [in the acknowledgement section].
(Researcher–Male-I-26)
Governance
Under the governance structure of the Vietnamese health
care system, decisions regarding clinical research are dele-
gated to the institutional scientific and ethics committees.
There was agreement among all participating researchers,
government officers, and ethics committee members that
decisions regarding data sharing would also fall to these
committees. All stakeholders shared the view that approval
should be contingent on mitigating the risks of sharing data
seen to be of increased sensitivity. Categories of potentially
sensitive data included genetic and genomic data, and data
about mental health and rare diseases. Community-level
data that could lead to the stigmatization of specific ethnici-
ties or were related to infectious disease outbreaks were
also found to need increased governance. Rigorous de-iden-
tification was thought adequate to protect individuals, but
oversight of the purposes for which data are used was con-
sidered important when results could have implications for
communities or Vietnam:
. . . data implying differences among countries in term of
lifestyle or such things, is sensitive. For example, when
analysis points out that there is a difference between Thailand
and Vietnam in terms of lifestyle, habit . . . which informs
external people’s point of view, I consider it sensitive. It
reminds me of a multi-site research on children who have
experienced sexual abuse. If it is published, it will identify
differences among Vietnam, Cambodia and Thailand. Then it is
sensitive. That’s it. Otherwise, proportion, rate, number of
cases . . . among countries, is the responsibility of media
to publish. Analysis of such data is not of concern.
(Researcher–Male-I-06)
Discussion
The study results above examine the experiences, under-
standings, attitudes, and perceptions of data sharing among
selected stakeholders in Vietnamese clinical research. The
results delineate the expectations of what would constitute](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-8-320.jpg)
![Merson et al. 259
good data-sharing practice in Vietnam. In this “Discussion”
section, we build on these findings to address how to sup-
port the development of culturally appropriate and locally
acceptable data-sharing practice in Vietnam.
A significant finding of this study is the high level of
trust placed in researchers by patient representatives. Patient
representatives expressed willingness to entrust researchers
with all decisions regarding the use of their data. They
showed a low level of interest and lack of concern for per-
sonal risk with respect to data sharing. This contrasts with
more mixed findings from Western countries where privacy,
confidentiality, and distrust of for-profit institutions are
more common (Lemke, Wolf, Hebert-Beirne, Smitha,
2010; Trinidad et al., 2010). Participants in this study also
showed a high level of acceptance of broad consent for data
sharing and rejected the need or desire to be contacted for
re-consent to share data for new purposes. These attitudes
may be attributed to the culture in which the patient–doctor
relationship is hierarchical and the doctor’s role is highly
regarded, as described in a well-known Vietnamese saying
“Luong y nhu tu mau” [“Doctors are gentle mothers”]
(Donnelly, 2006).
This high level of trust grounds the rationale for
Vietnamese researchers’ sense of ethical and professional
responsibility toward their patient and thus, the need for
oversight of the ethics of all future uses of data. From this
point of view, Vietnamese researchers collectively assert
that authorship should be shared with the data provider to
ensure that the duty of the investigator who “stands in front
of the patients,” to protect the scientific and ethical integrity
of the data, is achieved. Although the sharing of authorship
with data providers has been supported elsewhere (Vickers,
2006) as a means to prevent misinterpretation of data, this
claim is incongruous with international guidelines.
According to the International Committee of Medical
Journal Editors’ “Defining the Role of Authors and
Contributors,” authors must meet four criteria. “Substantial
contribution . . . to data acquisition” fulfills only one of these
criteria. These recommendations state that “Contributors
who meet fewer than all four of the . . . criteria for authorship
should not be listed as authors, but they should be acknowl-
edged” (International Committee of Medical Journal Editors,
2013). This has been directly addressed in the context of
data sharing by others who concluded that authorship is not
appropriate when sharing of data is a researcher’s only con-
tribution to a particular article (Rohlfing Poline, 2012).
Co-authorship is additionally important to the academic rec-
ognition systems within Vietnam and can build trust with
data providers. However, this approach may prompt con-
cerns of selective reporting as it excludes the benefit of
accountability when the data provider can prevent the publi-
cation of papers that corrects errors in the original research
(Rising, Bacchetti, Bero, 2008; Smith Roberts, 2006).
These are important considerations for funders, publishers,
and others imposing data-sharing requirements to promote
equity and ensure the returns sought by lower income data
providers.
The altruistic prioritization of community benefit over
personal interests is also evident in the views of the patient
representatives. The significance assigned to community
benefit over individual benefit mirrors the trend described
in ethics guidelines of other resource-limited settings
(Lairumbi, Parker, Fitzpatrick, English, 2011). As exist-
ing guidelines and policies on data sharing are mostly
driven by well-resourced Western institutions and publish-
ers, it is important to ensure that the development of data-
sharing practice in Vietnam takes into account the priorities
of the study participants who provide the data.
The findings of this qualitative study provide insights
into the challenges related to sharing clinical and public
health research data collected in Vietnam. The data col-
lected represent the experience of a small number of gov-
ernment officers, ethics committee members, researchers,
and research participants and are therefore not meant to
characterize any specific population. However, individuals
from a range of locations, socio-economic backgrounds,
and levels of experience with data sharing were included in
the population, and consistency in the findings suggests that
the ideas presented reflect many of the key issues regarding
data sharing in the Vietnamese context. Additional study
limitations include the challenges of elucidating partici-
pants’ perspectives about a novel and unfamiliar topic.
Background and introductory discussions with the study
staff may have affected participants’ initial opinions of data
sharing. Furthermore, discussion of perspectives about data
sharing in the absence of a regulatory framework was met
with a cautious response, as it is not customary for stake-
holders to discuss issues that fall outside of their assigned
responsibilities.
Best Practices
One of the outcomes of this study is a framework docu-
ment, drafted by the lead authors and revised during a
series of workshops with ethics committee members and
researchers in Ho Chi Minh City between December 2014
and June 2015. The final document is expected to be pub-
lished by the end of 2015. This exercise was a practical
way to define the foundation of best practice informed by
the major research institutes in the region. The resulting
framework is now a tool to initiate ideas and discussion
among the committees responsible for governing data shar-
ing and should continue to evolve. The document is char-
acterized by a culture of reciprocity, relying on professional
trust rather than legal guarantees. This is consistent with
views of data sharing in other developing settings
(Tangcharoensathien, Boonperm, Jongudomsuk, 2010).
According to the contributors to this framework document,
key principles of data sharing in Vietnam that should
underpin governance and policy are](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-9-320.jpg)
![260 Journal of Empirical Research on Human Research Ethics 10(3)
•• to ensure that the rights and interests of research par-
ticipants and their community are safeguarded,
including preserving privacy, the right to dignity,
protection from harm, and appropriate sharing of
benefits;
•• to protect rights and interests of primary researchers,
particularly given the potential inequalities in
resources available to support local analysis and
publishing; and
•• to be transparent and accountable.
High levels of trust in researchers were found among
patient representatives. Thus, it is understandable that broad
consent was accepted among the Vietnamese study popula-
tion, who rejected the need or desire to be contacted for re-
consent for new uses of data. However, despite this inherent
trust, the autonomy of participants should be respected and
reinforced. In addition, the range of opinions among
researchers and ethics committee members about appropri-
ate forms of consent may relate to the novelty of the topic
and is worthy of further exploration as data-sharing initia-
tives evolve across Vietnam.
In line with the International Ethical Guidelines for
Biomedical Research Involving Human Subjects (The
Council for International Organizations of Medical
Sciences, 2002) and the work of others (Mascalzoni, Hicks,
Pramstaller, Wjst, 2008; Murphy et al., 2009), we believe
that a participant’s autonomy should be supported through
the provision of information regarding all potential uses of
data during a robust informed consent process, potentially
supplemented by feedback about secondary uses of data.
Providing participants with an option to receive further
information on the original consent form may decrease
unwanted feedback. In addition, public engagement activi-
ties about data sharing should extend beyond the individual
to include community engagement.
Compliance with best practices in data sharing is depen-
dent on available financial and technical resources. This is
especially important in low- and middle-income settings
(Pisani AbouZahr, 2010), and Vietnam is no exception.
To promote local engagement in the development of best
practices, we recommend engagement with the government
and policy makers to prioritize and formalize such
initiatives.
Research Agenda
This study has produced a number of novel findings about
data sharing in Vietnam, which deserve further exploration
to identify appropriate policy responses. Determining the
best way to obtain informed consent for data sharing and
how to inform the community of developing ideas around
the topic should be prioritized. As policy is centrally devel-
oped in Vietnam, relevant government actors should be
consulted to determine what information will best support
the current priorities. Additionally, as data sharing is intro-
duced to Vietnam, it is important to track its uptake, chal-
lenges, and evolution of practices to determine how to
support such sharing and ensure that the priorities and
returns to the Vietnamese community are protected.
Educational Implications
Researchers participating in this study were found to have
a number of reservations about sharing the data collected in
their own studies. We argue that these reservations are
motivated by concerns that can be addressed by appropri-
ate data-sharing policies and practices. First, concerns
about the sensitivity of sharing data were attributable to the
absence of explicit government policy. Within a health care
system that relies heavily on legal framework, a lack of
official policy can stagnate action. Adding to this concern
is a lack of awareness of established data-sharing guide-
lines on de-identification and preparation of data for shar-
ing. Second, reservations were found to arise from
misconceptions regarding data ownership. Beliefs that all
data belong to the research funders and that research data
are protected and copyrightable by intellectual property
law (The Association of Learned Professional Society
Publishers [ALPSP], 2014) were common. Third, misgiv-
ings about competitive advantage were partly attributable
to the lack of familiarity with the novel concept of data
sharing and its potential benefits. These findings suggest
that there is opportunity to facilitate the uptake of locally
appropriate data-sharing practice in Vietnam through the
provision of training and resources. When the knowledge
gaps are addressed, we believe that the development
of ideas around culturally appropriate uptake will be
promoted.
The findings of this study additionally highlight the need
to inform the developers of international data-sharing poli-
cies about the priorities of stakeholders in low- and middle-
income countries. International funders and publishers
should consider the results of this and further studies to
ensure that the interests of all research communities are
safeguarded by the policies they develop.
Authors’ Note
Ideas expressed in this article are the sole responsibility of authors
and do not necessarily reflect the views of their organizations or
funders.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with
respect to the research, authorship, and/or publication of this
article.
Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article: This](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-10-320.jpg)
![262 Journal of Empirical Research on Human Research Ethics 10(3)
for biobanking. American Journal of Public Health, 99, 2128-
2134. doi:10.2105/AJPH.2008.157099
National Institutes of Health. (2015). NIH sharing policies
and related guidance on NIH-funded research resources.
Retrieved from http://grants.nih.gov/grants/sharing.htm
Nature Journal. (2015). Policies: Availability of data, material
and methods. Retrieved from http://www.nature.com/authors/
policies/availability.html
Parker, M., Bull, S. (2015). Sharing public health research data:
Towards the development of ethical data-sharing practice
in low- and middle-income settings. Journal of Empirical
Research on Human Research Ethics, 10(3), 217-224.
doi:10.1177/1556264615593494
Pisani, E., AbouZahr, C. (2010). Sharing health data: good inten-
tions are not enough. Bulletin of World Health Organization,
88, 462-466. doi:10.2471/BLT.09.074393
Public Library of Science. (2015). PLOS editorial and publishing
policies: Sharing of data, materials, and software. Retrieved
from http://www.plosone.org/static/policies.action#sharing
Rising, K., Bacchetti, P., Bero, L. (2008). Reporting bias in
drug trials submitted to the Food and Drug Administration:
Review of publication and presentation. PLoS Medicine, 5,
e1000017. doi:10.1371/journal.pmed.0050217
Rohlfing, T., Poline, J.-B. (2012). Why shared data should
not be acknowledged on the author byline. NeuroImage, 59,
4189-4195. doi:10.1016/j.neuroimage.2011.09.080
Sahoo, U. (2012). Clinical research in Asia—Opportunities and
challenges. Cambridge, UK: Woodhead Publishing.
Science Magazine. (2015). General information for authors:
Data and materials availability. Retrieved from http://
www.sciencemag.org/site/feature/contribinfo/prep/gen_info.
xhtml#dataavail
Smith, J., Firth, J. (2011). Qualitative data analysis: The frame-
work approach. Nurse Researcher, 18(2), 52-62.
Smith, R., Roberts, I. (2006). Patient safety requires a new
way to publish clinical trials. PLoS Clinical Trials, 1(1), e6.
doi:10.1371/journal.pctr.0010006
Tangcharoensathien, V., Boonperm, J., Jongudomsuk, P.
(2010). Sharing health data: Developing country perspec-
tives. Bulletin of World Health Organization, 88, 468-469.
doi:10.2471/BLT.10.079129
Thomas, D. R. (2006). A general inductive approach for analyzing
qualitative evaluation data. American Journal of Evaluation,
27, 237-246. doi:10.1177/1098214005283748
Trinidad, S. B., Fullerton, S. M., Bares, J. M., Jarvik, G. P., Larson,
E. B., Burke, W. (2010). Genomic research and wide data
sharing: Views of prospective participants. Genetic Medicine
Journal, 12, 486-495. doi:10.1097/GIM.0b013e3181e38f9e
Vickers, A. J. (2006). Whose data set is it anyway? Sharing raw
data from randomized trials. Trials, 7, 15. doi:10.1186/1745-
6215-7-15
Vietnamese Government. (2002). Ordinance on the state emer-
gency in case of great disasters or dangerous epidemics (No.
71/2002/ND-CP). Retrieved from http://www.chinhphu.vn/
portal/page/portal/chinhphu/hethongvanban?class_id=1_
page=400mode=detaildocument_id=10921
Vietnam Government. (2005). Law on intellectual property rights
(No. 50/2005/QH11). Retrieved from http://www.chinhphu.
vn/portal/page/portal/chinhphu/hethongvanban?class_
id=1mode=detaildocument_id=30015
Vietnam Government. (2007). Law on prevention and control of infec-
tious diseases (No. 03/2007/QH12). Retrieved from http://www.
chinhphu.vn/portal/page/portal/chinhphu/hethongvanban?class_
id=1;_page=1mode=detaildocument_id=51257
Vietnam Ministry of Health. (2005). Decision on protection
of confidential information in the government health care
sector (No. 14/2005/QD-BYT). Retrieved from http://
thuvienphapluat.vn/archive/Quyet-dinh/Quyet-dinh-14-
2005-QD-BYT-Quy-che-bao-ve-bi-mat-nha-nuoc-trong-
nganh-y-te-vb53325t17.aspx
Vietnam Ministry of Health. (2010). Circular on guiding the
confidential protection of trial data in drug registration
(No. 05/2010-TT-BYT). Retrieved from http://www.moj.
gov.vn/vbpq/Lists/Vn%20bn%20php%20lut/View_Detail.
aspx?ItemID=25125
Vietnam Ministry of Health. (2010). Regulation on informa-
tion and reports on epidemic contagious diseases (No.
48/2010/TT-BYT). Retrieved from http://vanban.chinhphu.
vn/portal/page/portal/chinhphu/hethongvanban?class_
id=1;mode=detaildocument_id=99852
Vietnam Ministry of Health. (2013). Regulation on speaking and pro-
viding information to the press (No. 4445/QĐ-BYT). Retrieved
from http://www.vaac.gov.vn/Desktop.aspx/Van-ban-phap-quy/
Bo-Y-te/999D588C8B3D433D8E47C71643033FD1/
Vietnam Ministry of Health General Statistics Office of
Vietnam. (2003). Survey and Assessment of Vietnamese Youth
(SAVY) (ICPSR24387-v1). Ann Arbor, MI: Inter-university
Consortium for Political and Social Research [distributor].
doi:10.3886/ICPSR24387.v1
Walport, M., Brest, P. (2011). Sharing research data to improve
public health. Lancet Journal 377, 537-539. doi:10.1016/
S0140-6736(10)62234-9
Wellcome Trust. (2003). Sharing data from Large-scale biologi-
cal research projects: A system of tripartite responsibility.
Retrieved from http://www.wellcome.ac.uk/stellent/groups/
corporatesite/@policy_communications/documents/web_
document/wtd003207.pdf
Wellcome Trust. (2010). Policy on data management and sharing.
Retrieved from http://www.wellcome.ac.uk/about-us/policy/
policy-and-position-statements/wtx035043.htm
Wertheim, H., Barton, S., Merson, L., Thwaites, G. (2014, July).
The Oxford University Clinical Research Unit in Vietnam:
Past, present, and future. International Presence of Research
in Asia - Newsletter of International Cooperation Initiative, pp.
33-35. Retrieved from http://www.kooperation-international.
de/fileadmin/public/downloads/itb/info_14_07_31_SAG.pdf
Author Biographies
Laura Merson is the head of Clinical Trials Unit at Oxford
University Clinical Research Unit, Vietnam. Her main research
interests include exploring issues in sharing biomedical research
data, efficient trial designs, and changing the paradigm of clinical
research in outbreaks and emerging infections. She contributed to
the study design, implementation, interpretation of data, and writ-
ing the manuscript](https://image.slidesharecdn.com/d96952a0-bee5-4c3a-83af-2665d26aaf98-170117043143/85/Trust-Respect-and-Reciprocity-12-320.jpg)
Trust, Respect, and Reciprocity
- 1. Journal of Empirical Research on Human Research Ethics 2015, Vol. 10(3) 251–263 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1556264615592387 jre.sagepub.com Ethics and Best Practices in Data Sharing in Low and Middle Income Settings The sharing of individual-level clinical research data is increasingly seen as a high priority by researchers, medical publishers and research funders in high-income settings. Data sharing offers clear potential to expedite scientific innovation, increase the efficiency of research investment and improve the quality of analysis (Mello, Francer, & Wilenzick, 2013). In response to these potential benefits, an emerging consensus around the development of policy, infrastructure, and best practice in data sharing has arisen. To date, these activities have been concentrated in high- income regions where well-resourced institutions explore options for sharing their large volumes of research outputs. Initiatives in these settings have resulted in a variety of solutions to the technical, governance, practical, and ethical challenges of this new paradigm in research enhancement (Gøtzsche, 2011). There are, however, fewer initiatives to inform the development of solutions for the same chal- lenges in low- and middle-income settings (Manju & Buckley, 2012). This article focuses on initiatives where clinical data generated in biomedical research are made available to sec- ondary researchers to address novel research questions without direct collaboration with the primary researchers. The roots of this movement in clinical research stem from the Human Genome project, and founding models for data release were set out in the Bermuda Principles and the Fort Lauderdale Agreement (Human Genome Organisation, 1996, 1997; Wellcome Trust, 2003). Data sharing has gained momentum in recent years as an increasing number of stakeholders have embraced the potential benefits and formulated policies that promote and in some cases man- date data sharing (European Federation of Pharmaceutical Industries andAssociations & The Pharmaceutical Research and Manufacturers of America, 2014; Godlee & Groves, 2012; National Institutes of Health, 2015; Nature Journal, 2015; Public Library of Science, 2015; Science Magazine, 2015; Walport & Brest, 2011; Wellcome Trust, 2010). The vast majority of these policies originate from institu- tions in high-income countries. There is, however, an increasing recognition of the importance of medical research conducted in low- and middle-income settings to address the disproportionate disease burden faced by these 592387JREXXX10.1177/1556264615592387Journal of Empirical Research on Human Research EthicsMerson et al. research-article2015 1 Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam 2 Children’s Hospital 1, Ho Chi Minh City, Vietnam 3 Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam 4 National Hospital for Tropical Diseases, Ha Noi, Vietnam 5 University of Oxford, UK Corresponding Author: Laura Merson, Oxford University Clinical Research Unit, Hospital for Tropical Diseases, 764 Vo Van Kiet street, District 5, Ho Chi Minh City, Vietnam. Email: Lmerson@oucru.org Trust, Respect, and Reciprocity: Informing Culturally Appropriate Data-Sharing Practice in Vietnam Laura Merson1 , Tran Viet Phong1 , Le Nguyen Thanh Nhan2 , Nguyen Thanh Dung3 , Ta Thi Dieu Ngan4 , Nguyen Van Kinh4 , Michael Parker5 , and Susan Bull5 Abstract International science funders and publishers are driving a growing trend in data sharing. There is mounting pressure on researchers in low- and middle-income settings to conform to new sharing policies, despite minimal empirically grounded accounts of the ethical challenges of implementing the policies in these settings. This study used in-depth interviews and focus group discussions with 48 stakeholders in Vietnam to explore the experiences, attitudes, and expectations that inform ethical and effective approaches to sharing clinical research data. Distinct views on the role of trust, respect, and reciprocity were among those that emerged to inform culturally appropriate best practices. We conclude by discussing the challenges that authors of data-sharing policies should consider in this unique context. Keywords data sharing, clinical data, ethics, biomedical data, Vietnam, qualitative methods, information dissemination, access to information
- 2. 252 Journal of Empirical Research on Human Research Ethics 10(3) countries (The Interacademy Medical Panel, 2013). This has driven recent growth in both the volume and diversity of global health research funding, collaborations, studies, and outputs. The terms of these initiatives increasingly include requirements to share the individual-level data col- lected. This has created an urgent need for research to inform the development of effective, ethical, and sustain- able approaches to data sharing in low- and middle-income settings. To address the current dearth of evidence in this area, the Public Health Research Data Forum funded an international collaborative study comprising a systematic literature review (Bull, Roberts, & Parker, 2015) and empir- ical studies in five low- and middle-income countries with strong local and international research programs (Cheah et al., 2015; Denny, Silaigwana, Wassenaar, Bull, & Parker, 2015; Hate et al., 2015; Jao et al., 2015; Parker & Bull, 2015). The aim was to explore the data-sharing experiences, attitudes, perceptions, and expectations of stakeholders in health research, to inform the development of best practices in each region. In Vietnam, the Oxford University Clinical Research Unit, the Hospital for Tropical Diseases, the Children’s Hospital 1, and the National Hospital for Tropical Diseases implemented the study. The Oxford University Clinical Research Unit has held strong research collabora- tions with each of these hospitals for up to 24 years (Wertheim, Barton, Merson & Thwaites, 2014). These col- laborations have produced hundreds of clinical, laboratory, and epidemiological studies and associated datasets. The dynamics of these collaborations serve as a microcosm of the developing clinical research landscape in Vietnam (Sahoo, 2012). With increasing research outputs, driven both locally and through international collaborations, the Vietnamese research governance framework is rapidly evolving to accommodate the increased scope and volume of activity. Sharing of indi- vidual-levelclinicalresearchdataisnotspecificallyaddressed in existing research regulations or guidelines to date. There are, however, a number of recent regulations that may influ- ence the development of guidelines on the type of informa- tion that can be shared, with whom it can be shared, and what can be done with it (see Box 1). None of the existing Vietnamese laws or guidelines con- flict with the principles or activities of data sharing, with the exception of restrictions on initial reporting of severe infec- tious diseases. The Official Instruction for Management of Scientific Research describes how to manage research activities including the sharing of research results as abstracts (Ho Chi Minh City Department of Health, 2011). The Circular on Guiding the Confidential Protection of Trial Data in Drug Registration details how to deal with confidential data in clinical trial results submitted for regis- tration purposes (Vietnam Ministry of Health, 2010). These two documents most closely relate to how research outputs can be shared. The gap between the topics addressed in these documents and current international models of non- collaborative data sharing need to be addressed through local research, engagement, and policy development. Addressing this gap is central to the objectives of this study. Although non-collaborative sharing of clinical research data is relatively novel in Vietnam, successful examples of sharing public health data are available. The Ha Noi School of Public Health (2014), Vietnam’s foremost public health institution, for example, has clear guidelines to govern the use of shared datasets for secondary analysis by students. Demographic surveillance studies such as the Survey and Assessment of Vietnamese Youth (SAVY) offer a success- ful example of data sharing by the provision of open online access to survey data from 9,000 households across the country (Vietnam Ministry of Health & General Statistics Office, 2003). The ethical importance of exploiting the benefits of data sharing is especially critical to Vietnam. Maximizing the sci- entific benefits of research to improve patient outcomes locally will help to address current global inequalities in research resources and disease burden. Furthermore, meeting the data-sharing requirements of international funders and publishers is imperative to avoid compromising access to their support. But international data-sharing policies should not be imposed without consideration of local research cul- ture, needs, and expectations. This study explores stakehold- ers’ understandings, perceptions, experiences, attitudes, and concerns about sharing individual-level clinical data. This article investigates expectations of what good Vietnamese data-sharing practice should be. We also address how to sup- port the development of a culturally appropriate data-sharing practice and locally acceptable policy inVietnam . Box 1. Existing Vietnamese Regulations, Which Should Be Considered When Developing Data-Sharing Guidelines. • Ordinance on the State of Emergency in Case of Great Disasters or Dangerous Epidemics, Vietnam Government (2002) • Decision on Protection of Confidential Information in the Government Health Care Sector, Vietnam Ministry of Health (2005) • Law on Intellectual Property Rights, Vietnam Government (2005) • Law on Prevention and Control of Infectious Disease, Vietnam Government (2007) • Regulation on Information and Reports on Epidemic Contagious Diseases, Vietnam Ministry of Health (2010) • Circular on Guiding the Confidential Protection of Trial Data in Drug Registration, Vietnam Ministry of Health (2010) • Official Instruction for the Management of Scientific Research, Ho Chi Minh City Department of Health (2011) • Regulation on Speaking and Providing Information to the Press, Vietnam Ministry of Health (2013)
- 3. Merson et al. 253 Method This study is a qualitative assessment of views on data shar- ing of health research stakeholders in Vietnam. A consor- tium of investigators designed this study collaboratively for implementation across five sites (Parker Bull, 2015). The central design was adapted in Vietnam to collect the most locally relevant information. Data collection took place across Vietnam between March and October 2014. A total of 48 participants were selected by purposive sam- pling with a focus on maximizing diversity of background, experience, role, and geography (Table 1). Participants included government officers (2) with roles in research policy development; ethics committee members (7), with research experienceandaroleindecisionmakingatamajorVietnamese research institution; researchers (24) from a cross-section of educational backgrounds and experiences, working in local and international, academic and commercial institutions; and clinical research participants enrolled in observational, inter- ventional or cohort studies, with their family members (15) from northern and southern, urban and rural centers. Individual interviews were selected as the preferred data collection method for most researchers, government offi- cers, and ethics committee members to create a secure envi- ronment for the open sharing of ideas. Focus group discussions were used to exchange ideas between those less familiar with data sharing, including junior researchers, research participants, and the participant’s family members. Interviews and discussions were recorded, transcribed ver- batim, and checked against the recordings, and then trans- lated to English (where required), de-identified, verified, and uploaded to NVivo 10 software. In-depth interviews were guided by open-ended questions based on an interview guide (available as Supplementary Material to the online edition of this article at jre.sagepub.com/supplemental) developed iteratively throughout the study in discussion with the other research sites. The interview questions addressed knowledge, expe- riences, attitudes, concerns, expectations, governance, and culturally appropriate means of data sharing. Questions were selected on the basis of the participant’s experiences and responses as well as based on the need for further exploration of particular topics. Three focus group discussions with research participants and their family members (collectively referred to as patient representatives) were facilitated. Research participants were selected based on recent or current enrollment into one of three studies led by a Vietnamese doctor at a Vietnamese government hospital: a longitudinal influenza surveillance study (rural northern Vietnam), an observa- tional study of dengue infection (urban northern Vietnam), or a clinical trial of tuberculosis meningitis treatment (urban southern Vietnam). An additional focus group dis- cussion was also organized with junior researchers in Ho Chi Minh City. Discussion topics and questions were piloted before recruitment to tailor context-specific lan- guage, optimize structure, and ensure that questions were appropriately focused and/or open. The choice to collect data via discussion group was made to facilitate the exchange of opinions among group members who had less familiarity with data sharing. Discussions began with an introductory session on terms, definitions, and examples of data, data management, and models of data analysis to inform the discussion. Study staff endeavoured to provide information about data sharing in an unbiased way, draw- ing on discussions in the literature about perceived advan- tages and concerns. Researchers were selected via snowball sampling after the initial identification of individuals inter- ested in the topic and those whose work was subject to data-sharing requirements. The validity of data collected was enhanced through trian- gulation as questions overlapped participant groups and data collection methods to approach the same topics in a variety of ways. Topics were discussed with diverse stakeholders to vali- date responses through multiple sources and allow for a range of opinions on the same topics. Responses from interviews and group discussions were consolidated and compared for analy- sis. Preliminary findings were discussed via fortnightly tele- conferences with collaborators at the five project sites. Data were initially coded with descriptive nodes generated from an analytic framework developed during a collaborative work- shop (Smith Firth, 2011). The initial coding structure was then expanded to include inductive descriptive codes gener- ated through close reading of the Vietnamese data (Thomas, 2006). Data were initially coded by T.V.P. in collaboration with L.M. The coding framework was refined following the cross- coding of a sample of transcripts by investigators from the five study sites. During a cross-site analysis meeting, themes emerging from the Vietnamese data were charted and dis- cussed with co-investigators. Table 1. Participant Composition by Data Collection Method. Male Government employed Vietnamese national Urban dweller Personal interviews 17/28 (60%) 18/28 (64%) 24/28 (86%) 28/28 (100%) Focus group discussions 8/20 (40%) 0/20 (0%) 17/20 (85%) 14/20 (70%) All participants 25/48 (52%) 18/48 (38%) 41/48 (85%) 42/48 (88%) Refusals 1/2 (50%) 2/2 (100%) 2/2 (100%) 2/2 (100%)
- 4. 254 Journal of Empirical Research on Human Research Ethics 10(3) Ethical Considerations This study, including the protocol, informed consent forms, and outline interview guides were reviewed and approved by the ethics or institutional committees of the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Children’s Hospital 1, Ho Chi Minh City, Vietnam; National Hospital for Tropical Diseases, Ha Noi, Vietnam; Provincial Center for Preventive Health Care, Ha Nam, Vietnam; and Oxford Tropical Research Ethics Committee, Oxford, United Kingdom (OXTREC, Reference 1051-13). Before initiating the study, all interview and group discus- sion participants had the study explained to them in a way that allowed them to understand the purpose, procedures, risks, benefits, and alternatives to study participation. Those who agreed to take part were asked to sign a consent form to confirm that they had been adequately informed about the study and that they agreed to participate. All participants were compensated with a small amount of cash (US$10) or provided with lunch for the time spent participating in the study. Participants who traveled to the study site were also reimbursed an amount based on the distance traveled accord- ing to standard policy (average amount ~US$10). Study tools are available in the online appendix (jre.sagepub.com/ supplemental) of this article. Interview transcripts are avail- able, please contact the corresponding author for details. Information that could identify participants have been redacted to preserve privacy. Results Views About a Novel Initiative There was interest among all study participants in how data can be shared, though very few had ever practiced non-col- laborative data sharing or had any prior awareness of the potential issues that could arise. Knowledge of the increas- ing requirements for data sharing by journals and funders was also uncommon. Among the researchers interviewed, collaborative data sharing and cross-institutional partner- ships were common with national and international collabo- rators, as well as with students for educational purposes. The current dearth of non-collaborative data sharing among Vietnamese researchers was not perceived as a problem. The novel concept of sharing was introduced to study participants as an initiative from international funders, scientific publish- ers, and institutions. There was general acceptance that this wouldintuitivelyfitintotheframeworkofVietnameseresearch as a part of ongoing development through education, grants and publication involving international partners. This view was summed up by researchers as follows: I think it [data-sharing practice] is the same everywhere in the world. Science is not the invention of Vietnamese people. What and how we do science, we learn from teachers. (Researcher–Male-I-18) It [data-sharing practice] is the same everywhere. You don’t go to your neighbors to explain everything about what you’re doing. For me, the problem is not active refusal to give information. I don’t think it is an active process: people trying to keep information. Just for everybody, probably all humans, it’s not natural to give out all information all the time. So I don’t think it is a problem just in Vietnam because I travel a lot: Africa, Europe, US . . . I don’t think it is worse here. It is not different, not better. (Researcher–Male-I-26) Despite acceptance that data sharing may become more common, it was not seen as a current priority. Multiple researchers referred to an “unwritten rule” that requires researchers to focus on the scientific and technical aspects of a project in development, while minimizing the paper work. An ethics committee member clarified this by explaining, . . . no one can imagine the way ahead because they only pay attention to the technical aspects [of research]. Data sharing is not a priority [in Vietnam] at this point. (Ethics committee member–Male-I-15) This was supported by a number of researchers who said that the need to promote or develop policy on data sharing was not a top priority in the competitive and resource-lim- ited realm of academic science. When patient representatives were first asked if they were willing to share their data, there was some reluctance. In each case, as information was provided about the type of data that could be shared and for what purpose, this quickly evolved to join the collective acceptance of this new initia- tive with a prevailing attitude of benevolence and trust: You know, when I was invited here, I just thought it’s because I’ve been recruited to research on dengue fever in this hospital. . . . One staff informed me something about the possibility of sharing of my personal information . . . and my initial reaction was objection . . . then from the beginning of this discussion, I changed my mind and I am now willing to share information. It’s a change between acceptable and unacceptable. Now that I know sharing my information is for common good sake, I have changed my mind, and I am willing to allow sharing. But ideally, everything should be anonymized. (Patient representative–Male-G-02-03) Vietnam is now in a transition period. We must sacrifice and accept inconvenience for development and we are strongly willing to contribute. Information is such a trivial thing to consider. Moreover sharing of my information doesn’t affect my life in any way. (Patient representative–Female-G-01-07) Principle Versus Practice Although the general principle of data sharing as a growing global trend with an upcoming role in Vietnamese research was accepted, a different picture emerged when researchers were asked about sharing data from their own studies. During
- 5. Merson et al. 255 initial discussions, researchers often disagreed with the notion that sharing their individual-level data was accept- able. One ethics committee member embodied the typical response heard from many others by claiming, Requesting raw data from someone? It is synonymous with being disrespectful! (Ethics committee member–Female-I-09) Fueled by the intention of maintaining patient privacy and academic competitive advantage, clinical research data have long been protected as confidential information. Promoted by the confidentiality that was historically inher- ent to pharmaceutical industry trials, this mind-set is also prevalent in Vietnam. This may have contributed to the fre- quent (and often strong) initial objections to sharing the data from one’s own research. The idea that research data belong to the funder and that such ownership precludes the investigator from sharing was also a commonly quoted bar- rier. The public nature of sharing data directly challenged Vietnamese researchers’ views on data confidentiality. When considering the implementation of non-collaborative data sharing, researchers and ethics committee members made it clear that discussions of any data-sharing plans should occur at the initial stage of a research project. Views About Acceptable Data Sharing After further discussion of some of the benefits and risks of sharing data, the participating researchers were asked to consider under what conditions they would or would not agree to share their data. As most researchers interviewed for this study were not yet engaged in non-collaborative data sharing, a theoretical exchange of ideas ensued on what the researchers envisaged as acceptable data sharing. There was consensus that secondary uses of data must con- tribute to scientific knowledge. This concept was central to most discussions, with particular emphasis placed on data uses that addressed the health needs and priorities of the Vietnamese community. Next on the list of requirements for acceptability were criteria that demonstrate respect to the data provider, includ- ing transparent exchange of information, timely analysis, and feedback to the data provider: . . . there is a condition: it must be fair. If you receive my data, you should give me feedback, I mean everything I need as part of a collaborative relationship. If sharing is unfair, no one wants to do anything. (Ethics committee member–Male-I-15) Avoidance of conflict with the outcomes of the primary research was also considered important: For a student, I think it is acceptable to share data to give them the direction for their thesis. For a colleague, if their purpose of study is different from mine, for example, I do clinical research but my colleague only requests epidemiological data which does not interfere with my final results . . . then I think it is acceptable. A pharmaceutical company might wish to use my data as control group, which is acceptable if their research doesn’t affect my final results . . . if their research design is similar to mine, then it interferes. (Ethics committee member–Female-I-22) Researchers also discussed the importance of respecting the ethical commitments made when the data were collected: I think the most important point is who ‘stands in front of the patients’! I mean the original researcher must bear full responsibility for the ethical aspects of the research. . . . The original researchers must take into account every single side of their research [including data sharing]. (Researcher–Male-I-27) Many other researchers agreed that respect is an impor- tant cultural pillar that must be demonstrated by restricting duplication of existing studies, avoiding incongruity with the primary study results and ensuring that primary research- ers have oversight of all potential ethical issues. It was also made clear that the data provider has a professional respon- sibility to liaise with the data user to ensure that the dataset is fully understood and that misinterpretation is avoided. Other factors commonly associated with increased accep- tance of data sharing were as follows: having an existing relationship with the secondary data user, primary research being complete and published, increased age of the dataset and the perceived decline in utility, and limiting the amount of data shared as a proportion of the total data collected. A number of researchers and ethics committee members also stressed the obligation of the data user to contribute to building research capacity in Vietnam, though methods for doing so were not clear. Consensus was strong among participants engaged in education, that sharing data with Vietnamese students who lack the resources to initiate independent data collection is important and has clear benefits: In foreign countries, students are granted money to do research on their own but it is not the same in Vietnam. We should simplify the procedures to help students practice on real datasets. (Government officer–Male-I-13) This highlights the common attitude that leveraging data sharing as a way to develop Vietnamese research is of core importance. Expanding access to data within Vietnam is thought to promote science nationally, delivering on the expectations of scientific benefit and capacity building with a local focus. Some researchers felt that sharing data out- side of Vietnam would endanger the likelihood of achieving these local benefits, suggesting that when the data user is in
- 6. 256 Journal of Empirical Research on Human Research Ethics 10(3) another country, there is less assurance that any local bene- fit will be realized. Trust Although not explicitly raised as a topic by participants, trust emerged as a theme throughout theoretical and practi- cal discussions with all participants. The importance of per- sonal and professional relationships in the culture of scientific research in Vietnam was highlighted by ubiqui- tous concerns regarding non-collaborative working prac- tices. Trust in data quality, trust in secondary data users, and trust in researchers collecting data were each addressed from a variety of angles by respondents. Data quality was the primary concern of many senior researchers and government officials. Many felt that the ability of a secondary data user to trust the data in a dataset would be compromised when direct involvement or link to data collection is absent. This strengthened the popular sen- timent that data providers should have oversight of the out- puts of data users’ prepublication. Others felt that increased quality standards in data collection, management, and tabu- lation should be met before datasets are shared: I think data sharing is a good idea but data quality should be the first step. (Ethics committee member–Male-I-25) Some participants extrapolated this risk to a potential reduction in the overall quality of science. It was felt that openly available data would discourage the likelihood of studies being replicated and promote uses of data that could be flawed: I worry about another risk: if something has been done, obviously no one wants to do it again. Someone else did it, and then you just want to do other things. So there will be no one who cross-checks the results. This fact carries the risk of lack of verification [of shared datasets]. We only move forward but no one looks back for any potential gaps or mistakes in the past. (Researcher–Male-I-16) The concept of relationships is a critical component of research collaboration in Vietnam. The trust built through collaboration is described as the “oil which lubricates the machine” of cooperation. Vietnamese researchers consid- ered non-collaborative data-sharing models where the con- fidence that exists between known collaborators is absent. Without this link, there was concern that primary research- ers could not prevent harms such as distortion of data or conflict of results with the original analysis: What if the requestors figure out mistakes in the owners’dataset? No one wants that (laughter). (Researcher–Male-I-18) What if the requestors analyze and generate results different from the original owner? I have witnessed this scenario myself. They might use two different statistical methods, particularly foreign researchers pointing out mistakes in Vietnamese articles. (Researcher–Male-I-23) Researchers generally did not accept the surrender of oversight of scientific and ethical standards to unknown data users. A number of individuals expressed trust in what were referred to as “prestigious institutions,” including the World Health Organization, and considered them more acceptable as data users, but when it came to sharing data with an anonymous individual, there was hesitation. Concern was also raised regarding the potential economic impact and commercial exploitation. Multiple participants referred to the use of Indonesian H5N1 strains for vaccine development during the 2000s: You know, Indonesia got H5N1, they didn’t want to give data to the international community. They argued that they [the international community] do research to produce vaccines, to gain big profit by selling products at an expensive price while my patients are dying. . . . I think they are somewhat reasonable: it seems unfair. This story is very sensitive and subtle. If they keep going that way, there will be a time when cooperating stops! Unfortunately, such stories are still so common. . . . Sharing should have contributions from both sides. (Ethics committee member–Male-I-15) There was consensus among ethics committee members that a contract between the data provider and data user, to define the terms of data use, could help to overcome con- cerns regarding unknown collaborators. Potential areas to be addressed in such contracts are outlined below in the Best Practices section. Among patient representatives, there was a high level of confidence in the decisions of the research doctors. Consensus that data could be shared at the discretion of the researchers was unwavering. There was little concern for the future of the information. When potential personal risks were discussed, including exploitation, stigmatization, and loss of confidentiality, management of these risks was vol- untarily given to researchers. The assignment of trust was independent of the nationality of the researcher. It was unclear whether this reflects confidence in international sci- ence, the research governance provided by the Vietnamese government, the strong involvement of Vietnamese doctors in all research, or other reasons. Representatives did not consider their input on the use of data to be a priority. A patient representative summed this up in a statement typical to the range of discussions on the topic: No, I don’t have any concerns! You are a research institution; you should inform the region about their health problems to help them. We don’t have any concerns. You can give feedback to us as individuals if it helps us in some way to promote benefits or to prevent harms. That’s all! I see no reason to hide information! The more public it is, the better! Even [data on]
- 7. Merson et al. 257 diseases with the possibility of stigmatization and discrimination should also be public! (Patient representative–Male-G-01-05) In contrast to the researchers, patient representatives did not consider the use of data for commercial profit to be a threat. After considering the risks and benefits of contribut- ing to commercial research, one representative clarified the acceptance of data sharing for commercial purposes with- out direct benefit by stating, We should not claim tangible benefits from pharmaceutical companies because in doing so we push drug prices higher. (Patient representative–Female-G-02-01) The only concern identified by patient representatives was media and profiteers misusing patient data for the vested inter- ests of companies. Although there was no objection to profits, there was disdain for current trends in the misuse or misrepre- sentation of facts to embellish marketing campaigns: I am concerned about the possibility . . . that people might unreasonably trust a product’s quality. Media should be responsible for such misinterpretations. In foreign countries, there are medical staff in the newspaper to control the messages, but we still can’t do the same thing in Vietnam. (Patient representative–Female-G-02-02) Sharing my information to researchers is good but don’t share it with the media. (Patient representative–Male-G-02-3) Media or those who interpret the implications of the data in the media, should be qualified and make sure the interpretation is accurate. (Patient representative–Female-G-02-01) Expectations and Best Practice In the interest of determining best practices for data sharing in Vietnam, the key issues of consent, reciprocity, and authorship are explored below. Consent Opinions about the need to obtain consent for sharing data, and how much information is considered sufficient to make an informed decision, focused on practicalities and feasibil- ity more than ethics. It was broadly agreed by all participants that to share data that have already been collected for a com- pleted study, the responsible Ethics Committee could make a decision on behalf of the study participants. Reasons given to support this included the impracticality and resource requirements of tracing and contacting participants. There was agreement among patient representatives and research- ers that the risk of disrupting someone’s day with an unnec- essary phone call, or accidentally breaching the privacy of a patient by re-contacting him or her to give additional con- sent for data sharing, was greater than the potential risks in sharing the data. Regarding contacting patients to obtain additional consent, a patient representative noted, I think the action of trying to establish individual identities to re-contact is ethically problematic in itself. (Patient representative–Female-G-02-01) As well as informing the consent process, this consensus may demonstrate that data sharing is perceived as a rela- tively low-risk activity. In considering what information should be given pro- spectively to study participants, there was heterogeneity in responses from research professionals. Responses spread evenly across a spectrum ranging from the requirement of explicit details of data-sharing plans to providing minimal information about future uses of data. In the opinion of one ethics committee member, “Broad consent is no consent at all” (Ethics committee member–Male-I-07). In contrast, a researcher took a different view: There is no need to obtain another consent from patients for secondary [data] use except, perhaps for rare diseases only. And even if so, we should explain very generally because there more we explain, the more nervous the patients will be. (Researcher–Female-I-10) Patient representatives were familiar with the principle and practice of obtaining informed consent. When asked if data sharing should be discussed in the informed consent process or if patients should be consulted regarding data sharing, there was strong consensus that this was unneces- sary. In line with many responses regarding governance, representatives empowered researchers with the responsi- bility to make decisions on their behalf. This typical senti- ment came from one representative: We trust you [researchers]. You can use my information for different purposes. How should I know? We trust you! There is no reason to prevent data sharing. (Patient representative–Male- G-01-01) When pressed to consider that consent was a standard requirement of conducting research, another patient repre- sentative suggested, Perhaps you can explain in the consent form: “your information is only used for scientific development to promote health.” I would like to do that. According to this statement, other researchers can access my data to do further research. (Patient representative–Female-G-01-02) Reciprocity When asked how to ensure that data sharing was imple- mented in a favorable and sustainable way in Vietnam, participating researchers proposed reciprocal models that
- 8. 258 Journal of Empirical Research on Human Research Ethics 10(3) supported capacity building and academic recognition for the data provider. As discussed above, benefiting scientific knowledge (ideally with relevance to Vietnam) was consid- ered to be a core element of acceptable data sharing. This suggests that capacity building as a part of a data-sharing arrangement is seen as an important requirement for data sharing to be seen as acceptable. Indeed, capacity strength- ening was explicitly stated to be a basic requirement by many: At least, we expect investment in capacity building for us [Vietnamese researchers]. It is a very important point. (Researcher–Male-I-11) The provision of resources was also seen as important to support data sharing locally. As doctors often undertake research as a task in addition to their regular job, it was considered important that compensation for the resources needed to share data was provided either by the funder or the data user. A researcher summed up the effect of the resource inequality between those driving data-sharing pol- icies and Vietnamese researchers by explaining, Scientific work in Vietnam and foreign countries is different. Vietnamese contribute great effort to do science, while personal financial gain and prestige are generally meager in comparison to developed countries. Their [Foreigners] salary is high and salary is their main source of income. Living on a meager salary, [Vietnamese] staff sometimes work tirelessly to generate a database. In the future, if salaries are in accordance to Vietnamese scientists’ contribution, I think the interest in data sharing will increase. (Researcher–Male-I-11) Academic recognition was highlighted as critical by most senior Vietnamese researchers. This was proposed to be in the form of authorship on any papers resulting from secondary use of data. Researchers were also happy to be invited as collaborators, and subsequently authors, by data users. Some respondents said that it was important to ensure that those who collected the data are given appropriate credit for their efforts. Others stated that securing author- ship was a means by which they could fulfill their responsi- bility as investigators to their patients by controlling the ethical and scientific standards applied to secondary data use: Being an author is synonymous with holding ethical and scientific responsibility. Therefore, the secondary [data] user is the first author, then name of the owner of the original data stands next to it. (Researcher–Male-I-27) When current international authorship guidelines were discussed with researchers and ethics committee members, it was accepted that requiring authorship as a condition of data sharing does not fit with international publication guidelines. Consequently, participants suggested that if the data provider is not an author, a review of the paper by the data provider should be required before publication. This concept contrasted with the views of most foreign research- ers and some junior Vietnamese researchers interviewed. There was consensus among these groups that authorship should not be assigned on the basis of data provision: Data comes from the patients, not from the investigators. So if others have some good ideas [about how to use data], they should use it. It is not my topic, so no, no . . . I don’t want to be the author! Maybe you’ve to mention where the data came from and the sponsors [in the acknowledgement section]. (Researcher–Male-I-26) Governance Under the governance structure of the Vietnamese health care system, decisions regarding clinical research are dele- gated to the institutional scientific and ethics committees. There was agreement among all participating researchers, government officers, and ethics committee members that decisions regarding data sharing would also fall to these committees. All stakeholders shared the view that approval should be contingent on mitigating the risks of sharing data seen to be of increased sensitivity. Categories of potentially sensitive data included genetic and genomic data, and data about mental health and rare diseases. Community-level data that could lead to the stigmatization of specific ethnici- ties or were related to infectious disease outbreaks were also found to need increased governance. Rigorous de-iden- tification was thought adequate to protect individuals, but oversight of the purposes for which data are used was con- sidered important when results could have implications for communities or Vietnam: . . . data implying differences among countries in term of lifestyle or such things, is sensitive. For example, when analysis points out that there is a difference between Thailand and Vietnam in terms of lifestyle, habit . . . which informs external people’s point of view, I consider it sensitive. It reminds me of a multi-site research on children who have experienced sexual abuse. If it is published, it will identify differences among Vietnam, Cambodia and Thailand. Then it is sensitive. That’s it. Otherwise, proportion, rate, number of cases . . . among countries, is the responsibility of media to publish. Analysis of such data is not of concern. (Researcher–Male-I-06) Discussion The study results above examine the experiences, under- standings, attitudes, and perceptions of data sharing among selected stakeholders in Vietnamese clinical research. The results delineate the expectations of what would constitute
- 9. Merson et al. 259 good data-sharing practice in Vietnam. In this “Discussion” section, we build on these findings to address how to sup- port the development of culturally appropriate and locally acceptable data-sharing practice in Vietnam. A significant finding of this study is the high level of trust placed in researchers by patient representatives. Patient representatives expressed willingness to entrust researchers with all decisions regarding the use of their data. They showed a low level of interest and lack of concern for per- sonal risk with respect to data sharing. This contrasts with more mixed findings from Western countries where privacy, confidentiality, and distrust of for-profit institutions are more common (Lemke, Wolf, Hebert-Beirne, Smitha, 2010; Trinidad et al., 2010). Participants in this study also showed a high level of acceptance of broad consent for data sharing and rejected the need or desire to be contacted for re-consent to share data for new purposes. These attitudes may be attributed to the culture in which the patient–doctor relationship is hierarchical and the doctor’s role is highly regarded, as described in a well-known Vietnamese saying “Luong y nhu tu mau” [“Doctors are gentle mothers”] (Donnelly, 2006). This high level of trust grounds the rationale for Vietnamese researchers’ sense of ethical and professional responsibility toward their patient and thus, the need for oversight of the ethics of all future uses of data. From this point of view, Vietnamese researchers collectively assert that authorship should be shared with the data provider to ensure that the duty of the investigator who “stands in front of the patients,” to protect the scientific and ethical integrity of the data, is achieved. Although the sharing of authorship with data providers has been supported elsewhere (Vickers, 2006) as a means to prevent misinterpretation of data, this claim is incongruous with international guidelines. According to the International Committee of Medical Journal Editors’ “Defining the Role of Authors and Contributors,” authors must meet four criteria. “Substantial contribution . . . to data acquisition” fulfills only one of these criteria. These recommendations state that “Contributors who meet fewer than all four of the . . . criteria for authorship should not be listed as authors, but they should be acknowl- edged” (International Committee of Medical Journal Editors, 2013). This has been directly addressed in the context of data sharing by others who concluded that authorship is not appropriate when sharing of data is a researcher’s only con- tribution to a particular article (Rohlfing Poline, 2012). Co-authorship is additionally important to the academic rec- ognition systems within Vietnam and can build trust with data providers. However, this approach may prompt con- cerns of selective reporting as it excludes the benefit of accountability when the data provider can prevent the publi- cation of papers that corrects errors in the original research (Rising, Bacchetti, Bero, 2008; Smith Roberts, 2006). These are important considerations for funders, publishers, and others imposing data-sharing requirements to promote equity and ensure the returns sought by lower income data providers. The altruistic prioritization of community benefit over personal interests is also evident in the views of the patient representatives. The significance assigned to community benefit over individual benefit mirrors the trend described in ethics guidelines of other resource-limited settings (Lairumbi, Parker, Fitzpatrick, English, 2011). As exist- ing guidelines and policies on data sharing are mostly driven by well-resourced Western institutions and publish- ers, it is important to ensure that the development of data- sharing practice in Vietnam takes into account the priorities of the study participants who provide the data. The findings of this qualitative study provide insights into the challenges related to sharing clinical and public health research data collected in Vietnam. The data col- lected represent the experience of a small number of gov- ernment officers, ethics committee members, researchers, and research participants and are therefore not meant to characterize any specific population. However, individuals from a range of locations, socio-economic backgrounds, and levels of experience with data sharing were included in the population, and consistency in the findings suggests that the ideas presented reflect many of the key issues regarding data sharing in the Vietnamese context. Additional study limitations include the challenges of elucidating partici- pants’ perspectives about a novel and unfamiliar topic. Background and introductory discussions with the study staff may have affected participants’ initial opinions of data sharing. Furthermore, discussion of perspectives about data sharing in the absence of a regulatory framework was met with a cautious response, as it is not customary for stake- holders to discuss issues that fall outside of their assigned responsibilities. Best Practices One of the outcomes of this study is a framework docu- ment, drafted by the lead authors and revised during a series of workshops with ethics committee members and researchers in Ho Chi Minh City between December 2014 and June 2015. The final document is expected to be pub- lished by the end of 2015. This exercise was a practical way to define the foundation of best practice informed by the major research institutes in the region. The resulting framework is now a tool to initiate ideas and discussion among the committees responsible for governing data shar- ing and should continue to evolve. The document is char- acterized by a culture of reciprocity, relying on professional trust rather than legal guarantees. This is consistent with views of data sharing in other developing settings (Tangcharoensathien, Boonperm, Jongudomsuk, 2010). According to the contributors to this framework document, key principles of data sharing in Vietnam that should underpin governance and policy are
- 10. 260 Journal of Empirical Research on Human Research Ethics 10(3) •• to ensure that the rights and interests of research par- ticipants and their community are safeguarded, including preserving privacy, the right to dignity, protection from harm, and appropriate sharing of benefits; •• to protect rights and interests of primary researchers, particularly given the potential inequalities in resources available to support local analysis and publishing; and •• to be transparent and accountable. High levels of trust in researchers were found among patient representatives. Thus, it is understandable that broad consent was accepted among the Vietnamese study popula- tion, who rejected the need or desire to be contacted for re- consent for new uses of data. However, despite this inherent trust, the autonomy of participants should be respected and reinforced. In addition, the range of opinions among researchers and ethics committee members about appropri- ate forms of consent may relate to the novelty of the topic and is worthy of further exploration as data-sharing initia- tives evolve across Vietnam. In line with the International Ethical Guidelines for Biomedical Research Involving Human Subjects (The Council for International Organizations of Medical Sciences, 2002) and the work of others (Mascalzoni, Hicks, Pramstaller, Wjst, 2008; Murphy et al., 2009), we believe that a participant’s autonomy should be supported through the provision of information regarding all potential uses of data during a robust informed consent process, potentially supplemented by feedback about secondary uses of data. Providing participants with an option to receive further information on the original consent form may decrease unwanted feedback. In addition, public engagement activi- ties about data sharing should extend beyond the individual to include community engagement. Compliance with best practices in data sharing is depen- dent on available financial and technical resources. This is especially important in low- and middle-income settings (Pisani AbouZahr, 2010), and Vietnam is no exception. To promote local engagement in the development of best practices, we recommend engagement with the government and policy makers to prioritize and formalize such initiatives. Research Agenda This study has produced a number of novel findings about data sharing in Vietnam, which deserve further exploration to identify appropriate policy responses. Determining the best way to obtain informed consent for data sharing and how to inform the community of developing ideas around the topic should be prioritized. As policy is centrally devel- oped in Vietnam, relevant government actors should be consulted to determine what information will best support the current priorities. Additionally, as data sharing is intro- duced to Vietnam, it is important to track its uptake, chal- lenges, and evolution of practices to determine how to support such sharing and ensure that the priorities and returns to the Vietnamese community are protected. Educational Implications Researchers participating in this study were found to have a number of reservations about sharing the data collected in their own studies. We argue that these reservations are motivated by concerns that can be addressed by appropri- ate data-sharing policies and practices. First, concerns about the sensitivity of sharing data were attributable to the absence of explicit government policy. Within a health care system that relies heavily on legal framework, a lack of official policy can stagnate action. Adding to this concern is a lack of awareness of established data-sharing guide- lines on de-identification and preparation of data for shar- ing. Second, reservations were found to arise from misconceptions regarding data ownership. Beliefs that all data belong to the research funders and that research data are protected and copyrightable by intellectual property law (The Association of Learned Professional Society Publishers [ALPSP], 2014) were common. Third, misgiv- ings about competitive advantage were partly attributable to the lack of familiarity with the novel concept of data sharing and its potential benefits. These findings suggest that there is opportunity to facilitate the uptake of locally appropriate data-sharing practice in Vietnam through the provision of training and resources. When the knowledge gaps are addressed, we believe that the development of ideas around culturally appropriate uptake will be promoted. The findings of this study additionally highlight the need to inform the developers of international data-sharing poli- cies about the priorities of stakeholders in low- and middle- income countries. International funders and publishers should consider the results of this and further studies to ensure that the interests of all research communities are safeguarded by the policies they develop. Authors’ Note Ideas expressed in this article are the sole responsibility of authors and do not necessarily reflect the views of their organizations or funders. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This
- 11. Merson et al. 261 research was funded by the Wellcome Trust Strategic Award (096527) on behalf of the Public Health Research Data Forum. The Public Health Research Data Forum brings together more than 20 health research funders who are committed to increasing the availability of health research data in ways that are equitable, ethical, and efficient, and will accelerate improvements in public health (see www.wellcome.ac.uk/publichealthdata). References The Association of Learned Professional Society Publishers. (2014). ALPSP STM believe data should be freely available. Retrieved from http://www.alpsp.org/Ebusiness/AboutALPSP/ ALPSPStatements/Statementdetails.aspx?ID=55 Bull, S., Roberts, N., Parker, M. (2015). Views of ethical best pactices in sharing individual-level data from medical and pub- lic health research: A systematic scoping review. Journal of Empirical Research on Human Research Ethics, 10(3), 225-238. doi:10.1177/1556264615594767 Cheah, P., Tangseefa, D., Somsaman, A., Chunsuttiwat, T., Nosten, F., Day, N., . . . Parker, M. (2015). Perceived ben- efits, harms and views about how to share data responsibly: A qualitative study of experiences with and attitudes towards data- sharingamong research staff and community representatives in Thailand. Journal of Empirical Research on Human Research Ethics, 10(3), 278-289. doi:10.1177/1556264615592388 The Council for International Organizations of Medical Sciences. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Retrieved from http:// www.cioms.ch/publications/layout_guide2002.pdf Denny, S. G., Silaigwana, B., Wassenaar, D., Bull, S., Parker, M. (2015). Developing ethical practices for public health research data sharing in South Africa: The views and experi- ences from a diverse sample of research stakeholders. Journal of Empirical Research on Human Research Ethics, 10(3), 290-301. doi:10.1177/1556264615592386 Donnelly, T. T. (2006). The health-care practices of Vietnamese- Canadian women: Cultural influences on breast and cervical cancer screening. Canadian Journal of Nursing Research, 38(1), 82-101. EuropeanFederationofPharmaceuticalIndustriesandAssociations The Pharmaceutical Research and Manufacturers of America. (2014). Joint principles for responsible clinical trial data sharing. Retrieved from http://www.phrma.org/phrma- pedia/responsible-clinical-trial-data-sharing Godlee, T., Groves, T. (2012). The new BMJ policy on shar- ing data from drug and device trials. British Medical Journal, 345, e7888. doi:10.1136/bmj.e7888 Gøtzsche, P. C. (2011). Why we need easy access to all data from all clinical trials and how to accomplish it. Trials, 12, 249. doi:10.1186/1745-6215-12-249 Ha Noi School of Public Health. (2014). PhD of public health degree. Ha Noi, Vietnam: Ha Noi School of Public Health. Hate, K., Meherally, S., Shah More, N., Jayaraman, A., Bull, S., Parker, M., Osrin, D. (2015). Sweat, skepticism and uncharted territory: A qualitative study of opinions on data sharing among public health researchers and research participants in Mumbai, India. Journal of Empirical Research on Human Research Ethics, 10(3), 239-250. doi:10.1177/1556264615592383 Ho Chi Minh City Department of Health. (2011). Official instruc- tion for management of scientific research (No. 4000-SYT- NVY). Retrieved from http://thuvienphapluat.vn/archive/ Huong-dan-4000-SYT-NVY-huong-dan-quan-ly-hoat-dong- nghien-cuu-khoa-hoc-vb135174.aspx Human Genome Organisation. (1996). Report of the Second International Strategy Meeting on Human Genome Sequencing. Retrieved from http://dukespace.lib.duke.edu/ dspace/bitstream/handle/10161/7715/1996%20Bermuda%20 meeting%20report.pdf?sequence=1 Human Genome Organisation. (1997). Report of the International Strategy Meeting on Human Genome Sequencing. Retrieved from http://dukespace.lib.duke.edu/dspace/bit- stream/handle/10161/7733/1997%20Bermuda%20meet- ing%20report%20%26%20revised%20delegates%20list. pdf?sequence=1 The Interacademy Medical Panel. (2013, May 24). A call for action to strengthen health research capacity in low and middle income Countries. Retrieved from http://www.iamp- online.org/call-action-strengthen-health-research-capacity- low-and-middle-income-countries International Committee of Medical Journal Editors. (2013). Defining the role of authors and contributors. Retrieved from http://www.icmje.org/recommendations/browse/roles-and- responsibilities/defining-the-role-of-authors-and-contribu- tors.html Jao, I., Kombe, F., Mwalukore, S., Bull, S., Parker, M., Kamuya, D., Molyneux, S., Marsh, V. (2015). Involving research stake- holders in developing policy on sharing public health research data in Kenya: Views on fair process for informed consent, access oversight and community engagement. Journal of Empirical Research on Human Research Ethics, 10(3), 264-277. doi: 10.1177/1556264615592385 Lairumbi, G. M., Parker, M., Fitzpatrick, R., English, M. C. (2011). Ethics in practice: The state of the debate on promot- ing the social value of global health research in resource poor settings particularly Africa. BMC Medical Ethics, 12, 22. doi:10.1186/1472-6939-12-22 Lemke, A. A., Wolf, W. A., Hebert-Beirne, J., Smitha, M. E. (2010). Public and biobank participant attitudes toward genetic research participation and data sharing. Public Health Genomics, 13, 368-377. doi:10.1159/000276767 Manju, R., Buckley, B. S. (2012). Systematic archiving and access to health research data: Rationale, current status and way forward. Bulletin of the World Health Organization, 90, 932-939. doi:10.2471/BLT.12.105908 Mascalzoni, D., Hicks, A., Pramstaller, P., Wjst, M. (2008). Informed consent in the genomics era. PLoS Medicine, 5(9), e192. doi:10.1371/journal.pmed.0050192 Mello, M. M., Francer, J. K., Wilenzick, M. (2013). Preparing for responsible sharing of clinical trial data. The New England Journal of Medicine, 369, 1651-1658. doi:10.1056/ NEJMhle1309073 Murphy, J., Scott, J., Kaufman, D., Geller, G., LeRoy, L., Hudson, K. (2009). Public perspectives on informed consent
- 12. 262 Journal of Empirical Research on Human Research Ethics 10(3) for biobanking. American Journal of Public Health, 99, 2128- 2134. doi:10.2105/AJPH.2008.157099 National Institutes of Health. (2015). NIH sharing policies and related guidance on NIH-funded research resources. Retrieved from http://grants.nih.gov/grants/sharing.htm Nature Journal. (2015). Policies: Availability of data, material and methods. Retrieved from http://www.nature.com/authors/ policies/availability.html Parker, M., Bull, S. (2015). Sharing public health research data: Towards the development of ethical data-sharing practice in low- and middle-income settings. Journal of Empirical Research on Human Research Ethics, 10(3), 217-224. doi:10.1177/1556264615593494 Pisani, E., AbouZahr, C. (2010). Sharing health data: good inten- tions are not enough. Bulletin of World Health Organization, 88, 462-466. doi:10.2471/BLT.09.074393 Public Library of Science. (2015). PLOS editorial and publishing policies: Sharing of data, materials, and software. Retrieved from http://www.plosone.org/static/policies.action#sharing Rising, K., Bacchetti, P., Bero, L. (2008). Reporting bias in drug trials submitted to the Food and Drug Administration: Review of publication and presentation. PLoS Medicine, 5, e1000017. doi:10.1371/journal.pmed.0050217 Rohlfing, T., Poline, J.-B. (2012). Why shared data should not be acknowledged on the author byline. NeuroImage, 59, 4189-4195. doi:10.1016/j.neuroimage.2011.09.080 Sahoo, U. (2012). Clinical research in Asia—Opportunities and challenges. Cambridge, UK: Woodhead Publishing. Science Magazine. (2015). General information for authors: Data and materials availability. Retrieved from http:// www.sciencemag.org/site/feature/contribinfo/prep/gen_info. xhtml#dataavail Smith, J., Firth, J. (2011). Qualitative data analysis: The frame- work approach. Nurse Researcher, 18(2), 52-62. Smith, R., Roberts, I. (2006). Patient safety requires a new way to publish clinical trials. PLoS Clinical Trials, 1(1), e6. doi:10.1371/journal.pctr.0010006 Tangcharoensathien, V., Boonperm, J., Jongudomsuk, P. (2010). Sharing health data: Developing country perspec- tives. Bulletin of World Health Organization, 88, 468-469. doi:10.2471/BLT.10.079129 Thomas, D. R. (2006). A general inductive approach for analyzing qualitative evaluation data. American Journal of Evaluation, 27, 237-246. doi:10.1177/1098214005283748 Trinidad, S. B., Fullerton, S. M., Bares, J. M., Jarvik, G. P., Larson, E. B., Burke, W. (2010). Genomic research and wide data sharing: Views of prospective participants. Genetic Medicine Journal, 12, 486-495. doi:10.1097/GIM.0b013e3181e38f9e Vickers, A. J. (2006). Whose data set is it anyway? Sharing raw data from randomized trials. Trials, 7, 15. doi:10.1186/1745- 6215-7-15 Vietnamese Government. (2002). Ordinance on the state emer- gency in case of great disasters or dangerous epidemics (No. 71/2002/ND-CP). Retrieved from http://www.chinhphu.vn/ portal/page/portal/chinhphu/hethongvanban?class_id=1_ page=400mode=detaildocument_id=10921 Vietnam Government. (2005). Law on intellectual property rights (No. 50/2005/QH11). Retrieved from http://www.chinhphu. vn/portal/page/portal/chinhphu/hethongvanban?class_ id=1mode=detaildocument_id=30015 Vietnam Government. (2007). Law on prevention and control of infec- tious diseases (No. 03/2007/QH12). Retrieved from http://www. chinhphu.vn/portal/page/portal/chinhphu/hethongvanban?class_ id=1;_page=1mode=detaildocument_id=51257 Vietnam Ministry of Health. (2005). Decision on protection of confidential information in the government health care sector (No. 14/2005/QD-BYT). Retrieved from http:// thuvienphapluat.vn/archive/Quyet-dinh/Quyet-dinh-14- 2005-QD-BYT-Quy-che-bao-ve-bi-mat-nha-nuoc-trong- nganh-y-te-vb53325t17.aspx Vietnam Ministry of Health. (2010). Circular on guiding the confidential protection of trial data in drug registration (No. 05/2010-TT-BYT). Retrieved from http://www.moj. gov.vn/vbpq/Lists/Vn%20bn%20php%20lut/View_Detail. aspx?ItemID=25125 Vietnam Ministry of Health. (2010). Regulation on informa- tion and reports on epidemic contagious diseases (No. 48/2010/TT-BYT). Retrieved from http://vanban.chinhphu. vn/portal/page/portal/chinhphu/hethongvanban?class_ id=1;mode=detaildocument_id=99852 Vietnam Ministry of Health. (2013). Regulation on speaking and pro- viding information to the press (No. 4445/QĐ-BYT). Retrieved from http://www.vaac.gov.vn/Desktop.aspx/Van-ban-phap-quy/ Bo-Y-te/999D588C8B3D433D8E47C71643033FD1/ Vietnam Ministry of Health General Statistics Office of Vietnam. (2003). Survey and Assessment of Vietnamese Youth (SAVY) (ICPSR24387-v1). Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor]. doi:10.3886/ICPSR24387.v1 Walport, M., Brest, P. (2011). Sharing research data to improve public health. Lancet Journal 377, 537-539. doi:10.1016/ S0140-6736(10)62234-9 Wellcome Trust. (2003). Sharing data from Large-scale biologi- cal research projects: A system of tripartite responsibility. Retrieved from http://www.wellcome.ac.uk/stellent/groups/ corporatesite/@policy_communications/documents/web_ document/wtd003207.pdf Wellcome Trust. (2010). Policy on data management and sharing. Retrieved from http://www.wellcome.ac.uk/about-us/policy/ policy-and-position-statements/wtx035043.htm Wertheim, H., Barton, S., Merson, L., Thwaites, G. (2014, July). The Oxford University Clinical Research Unit in Vietnam: Past, present, and future. International Presence of Research in Asia - Newsletter of International Cooperation Initiative, pp. 33-35. Retrieved from http://www.kooperation-international. de/fileadmin/public/downloads/itb/info_14_07_31_SAG.pdf Author Biographies Laura Merson is the head of Clinical Trials Unit at Oxford University Clinical Research Unit, Vietnam. Her main research interests include exploring issues in sharing biomedical research data, efficient trial designs, and changing the paradigm of clinical research in outbreaks and emerging infections. She contributed to the study design, implementation, interpretation of data, and writ- ing the manuscript
- 13. Merson et al. 263 Tran Viet Phong is a researcher at Oxford University Clinical Research Unit, Vietnam. He is interested in bioethics research and advocacy for policy development. He contributed to data collec- tion, transcription, and translation; coding and interpretation of data; and writing the manuscript. Le Nguyen Thanh Nhan is the head of Outreach and International Department at Children’s Hospital 1, Ho Chi Minh City. His pri- mary research focus is enterovirus-71 infection. He contributed to the design, planning, and implementation of this research; con- sulted on the results; and supported administrative coordination. Nguyen Thanh Dung is the head of Department of General Planning at Hospital of Tropical Diseases, Ho Chi Minh City, Vietnam. He contributed to the design, planning, and implementa- tion of this research; consulted on the results; and supported administrative coordination. Ta Thi Dieu Ngan is the head of the Department of Scientific Research Management at the National Hospital for Tropical Diseases in Ha Noi, Vietnam. She contributed to the design, plan- ning, and implementation of this research; consulted on the results; and supported administrative coordination. Nguyen Van Kinh is the director of the National Hospital for Tropical Diseases in Ha Noi, Vietnam. He has been a principal inves- tigator of various research studies on infectious diseases, including HIV/AIDS, viral hepatitis, dengue hemorrhagic fever, influenza, and hand, foot, mouth disease. He contributed to the design, planning, and implementation of this research; consulted on the results; and sup- ported administrative coordination. Michael Parker is a professor of bioethics at the Ethox Centre, University of Oxford. His main research interest is in the many practical ethical aspects of collaborative global health research, including those arising in the sharing of data and biological samples internationally. Together with partners in Kenya, Thailand, Malawi, South Africa, and Vietnam, he co-ordinates the Global Health Bioethics Network that is a program to carry out ethics research and build ethics capacity. He contributed to the conceptual development of the study and the writing of the manuscript. Susan Bull is a senior researcher at the Ethox Centre, University of Oxford. She led this multi-site study, which was conducted with col- laborators from the KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya; the School of Applied Human Sciences, University of KwazuluNatal,SouthAfrica;theMahidol–OxfordTropicalMedicine Research Unit, Mahidol University, Bangkok, Thailand; and the Society for Nutrition, Education and Health Action (SNEHA), India. She contributed to the conceptual development of the study, the development of data collection and analyses methods, and the writing of this manuscript.