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).

Decision Tree 


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 thumb

Co-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



Zuletzt geändert: Mittwoch, 16. Oktober 2019, 13:10