Policy Recommendations for Addressing Privacy Challenges Associated with Cell-Based Research and Interventions
This paper was co-authored by PaSAGE team member Rosario Isasi.
In medicine, if there is extra biologic material from a test done, it can be used for research. Before this happens, any information that connects the sample from the person it was collected from is removed. This practice is becoming increasingly common in recent years. However, science is improving quickly. We have large databases of genetic information now and can use DNA to identify people. This means that the sample that though the sample is considered deidentified, it could be used to re-identify individuals.
This paper first outlines the issues with privacy and cell-based research. It then provides policy recommendations and governance plans. Finally, it identifies areas where more evidence is needed to make a good policy recommendation.
The first recommendation that the authors of this paper give is to change existing policy. They argue that existing legal and ethical policies should be extended to cover research with human biological material. Importantly, the biologic material must contain identifiable genetic information about a research participant.
The second recommendation that the authors of this paper make is to change governance processes. The role of research ethics committees (RECs) should be clarified. Right now, research ethics committees may lack experience with privacy. New policy should create a system to monitor and respond to the privacy challenges RECs may not be able to handle.