Center for Knowledge Infrastructures

The workshop will explore the meaning of “Informed Consent” and its implication for reusing human subject open data from and for biomedical research. Patients and volunteers donate their data in the context of research designs that are vetted and approved by ethics committees. When research data are released in open access – especially observational data - these can be reused to explore a number of new hypotheses. As we know from previous studies, biomedical data can be reused in many unpredictable ways – new research communities are formed around pre-existing data, and the free availability of research data increases innovation, knowledge integration, and reproducibility. At the same time, openness of data could also expose donors to surveillance and discriminatory research practices that not only have ethical implications, but also were never agreed upon by the donors at the moment of data collection. In this workshop, cases of both successful and controversial data reuse practices will be presented and discusses. We further discuss: Can and should we – and if yes how – filter the kinds of hypotheses that can be tested on a human subject dataset? Can and should we – and if yes how – permanently include ethical concerns in the provenance records of human subject datasets? How can we keep data donors actively “informed” about unpredictable reuses of research data?