Publicaties

BACKGROUND: Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of and to further build on these developments, there is a need for model consent clauses for rare diseases research, in order to improve data interoperability, to meet the informational needs of participants, and to ensure proper ...

Sharing metadata, individual participant data and summary data, as a complement to results dissemination and trial registration requirements, is perceived to be advantageous by enabling faster and more accurate meta-analyses and reducing the need for additional trials. To date, various models of data access have been utilized in order to manage clinical trials data sharing and access in line with the rights and interests of sponsors, researchers ...

Doping control samples may be used for research purposes by the World Anti-Doping Agency (WADA)-accredited laboratories after their compulsory storage period has expired. This study investigates opinions of stakeholders toward the governance of antidoping research on these samples and to evaluate the current framework. Semistructured interviews were conducted with stakeholders in antidoping research. The distinction between research and quality ...

The EU Data Protection Regulation has wide‐ranging implications for research based on anonymized personal genomic and genetic data given the realistic risk of re‐identification. [Image: see text]

Access to detailed variant data is key to inform and verify the interpretation of genomic data. Clinical laboratories can play a significant role in sharing patients' data through public variant databases. To facilitate data sharing, various public databases, such as ClinVar and DECIPHER have been established, which accept data submission from laboratories, clinicians, researchers, and patients. Despite clear benefits to sharing, questions may ...

Blockchain-based platforms are emerging to provide solutions for technical and governance challenges associated with genomic data sharing. Providing capabilities for distributed data stewardship and participatory access control along with effective ways for enforcement of the data access agreements and data ownership are among the major promises of these platforms.

The Global Alliance for Genomics and Health (GA4GH) proposes a data access policy model-"registered access"-to increase and improve access to data requiring an agreement to basic terms and conditions, such as the use of DNA sequence and health data in research. A registered access policy would enable a range of categories of users to gain access, starting with researchers and clinical care professionals. It would also facilitate general use and ...