Open Data
More detailed information about ethical barriers and primary/secondary data use: DFG guidelines on Data Management in Psychological Science (https://www.dgps.de/fileadmin/documents/Empfehlungen/Data_Management_eng_9.11.16.pdf)
Ethical barriers
Data privacy and copyrights
Anonymization
or pseudonymization
Individuals and institutions cannot be
identified by combining various measures, including those collected across
multiple studies with the same participants
Right
to informational self-determination
Study participants need to be aware that their
anonymized data might be made available to third parties for secondary use and
that the purpose, nature and scope of that secondary use is currently not
forseeable. Explicit and specific informed consent for secondary use must be obtained
in case data cannot be fully anonymized. When data are fully anonymized, as
with survey responses or data from experimental procedures, such specific
consent does not necessarily have to be obtained as individuals can no longer
be identified. When in doubt, the local ethics committee or the DGPs central
ethics committee should be consulted.
Consent
forms and ethics application forms
Should be adapted to comply with ethical
recommendations. Examples can be found here: http://www.psy.ruhr-uni-bochum.de/zentralebereiche/ethik.html.de
Legal
restrictions
It is imperative to observe legal requirements
against the sharing of data where applicable. Not fully anonymized data of
individual participants who have denied their consent to potential secondary
use must not be shared. If data cannot be shared, an appropriate explanation
should be provided (e.g., in a footnote in the publication).19 Conversely, such
concerns should not be used as a justification not to share data when it is
legally and ethically unproblematic. Further, when legal restrictions to data sharing
apply, it should be stated which types of aggregated data or anonymized partial
data can be shared.
Scientific
use files: if data privacy is a concern
Scientific use files are de facto anonymized datasets that are shared
upon request with researchers at research institutions for scientific purposes.
Typically, these datasets cannot be freely distributed. Secondary users have to
sign non-disclosure and non-propagation agreements, and are required to delete
the raw data after a stipulated period.
Documentation
The process of anonymizing or pseudonymizing
the data should be documented comprehensively.
For illustration of the most important ethical considerations, take a look at the decision tree below (from https://www.dgps.de/fileadmin/documents/Empfehlungen/Data_Management_eng_9.11.16.pdf).
Rights and Duties of primary and secondary users
Data sharers
Rights
Right
of first use
Data sharers hold the right of first use to their data. If more than one researcher is involved, this
right should be negotiated prior to data sharing.
Right
to define an embargo for secondary use
Before publication, data can be stored in a
repository, being inaccessible for third parties.
Right
of information about secondary use
Data sharers have the right to be informed
about any secondary use of their data (i.e. publication, presentation or blog
post).
Duties
Share
data in a way that enables a meaningful secondary use
Informed consent about the use of data from the
study participants must be available and all data and corresponding metadata
have to be documented thoroughly and comprehensibly.
In
case of an embargo
An embargo has to be (1) announced as soon as
primary data are stored in a repository. (2) The end of the embargo period has
to be stated and (3) at the end of the embargo period, data have to be made
publicly available and open to secondary analyses without restriction – even if
data sharers have not yet used the data for publications themselves.
Secondary users
Duties
Inform
data sharers
Data sharers should be contacted to facilitate
a valid use of the data and to avoid misunderstandings. Information is
obligatory if reanalysis is made public (i.e. in presentations, publications or
blog posts). It has to be stated (1) with what aim data are used, (2) which
results were obtained and (3) where the results will be published.
Principle
of maximum knowledge advancement
Secondary users should strive to advance
knowledge in relation to a research question. They should not strive to damage
reputation of the data sharers.
Adequate
citation
Data shared by others have to be cited
adequately. Often, for this purpose, a citation reference in the repository can
be used. Secondary users should always refer to the original data set and not
to their own version of the data.
Data
protection and copyright
Secondary users should follow data protection
and copyright rules.
Transparency
and scientific diligence
Scientific standards for reinterpretation of
the data have to be valid at the time of secondary analysis. For evaluation of
the original analysis, scientific standards that were valid at the time of the
original analysis have to be applied.
Offering a co-authorship
Rules of thumbCo-authorship should always be offered if the contribution of the data sharers to the secondary use goes beyond the mere data sharing.
In case of doubt, contact data sharers and come to an agreement!
Co-authorship – yes or no?
Yes
No
Simple secondary data use
Reanalysis with the aim to reproduce original results (i.e. extracting effect sizes, computing means or distributions of variables)
x
Extended secondary use
Additional questions complementing or expanding the research question of the original publication
x
Orthogonal analyses which use the data to answer a different questions
x