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Key legal and ethical considerations in creating shareable data. This chapter clarifies the different legal requirements of the European Union Member States, and the impact of the General Data Protection Regulation (GDPR) on research data management. It shows how sharing personal data can often be accomplished by using a combination of obtaining informed consent, data anonymisation and regulating data access. The supporting role of ethical review in managing legal and ethical obligations is also highlighted in this chapter.

Focus on:

legal and ethical obligations towards research participants and the different legal requirements of EU Member States
how protecting data properly protects against violating laws and promises made to participants
the General Data Protection Regulation and its relevance in research
informed consent, anonymisation and access controls to facilitate creating shareable data
relevant elements in a consent form
anonymisation techniques for quantitative and qualitative data
relevant DMP questions on these topics

Learning outcome(s)

After completing this module you should:

Be aware of your legal and ethical obligations towards participants and be informed of the different legal requirements of EU Member States;
Understand how protecting your data properly protects you against violating laws and promises made to participants;
Understand the impact of the General Data Protection Regulation (GDPR; European Union, 2016a);
Understand how a combination of informed consent, anonymisation and access controls allows you to create shareable personal data;
Be able to define what elements should be integrated into a consent form;
Be able to apply anonymisation techniques to your data;
Be able to answer the DMP questions which are listed at the end of this chapter and adapt your own DMP.