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.
- 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