Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory.

The coming-into-force of the EU General Data Protection Regulation (GDPR) is a watershed moment in the legal recognition of enforceable rights to informational self-determination. The rapid evolution of legal requirements applicable to data use, however, has the potential to outstrip the capabilities of networks of biomedical data users to respond to the shifting norms. It can also delegitimate established institutional bodies that are responsible for assessing and authorising the downstream use of data, including research ethics committees and institutional data custodians.

Reward systems for cohort data sharing: An interview study with funding agencies.

Data infrastructures are being constructed to facilitate cohort data sharing. These infrastructures are anticipated to increase the rate of data sharing. However, the lack of data sharing has also been framed as being the consequence of the lack of reputational or financial incentives for sharing.

Policies to regulate data sharing of cohorts via data infrastructures: An interview study with funding agencies.

Background: Platforms are being constructed to stimulate cohort data sharing. Nevertheless, many policy barriers impede data sharing. Various interventions have been proposed to address these barriers, including incentive creation and data sharing mandates for researchers.

Credit and Recognition for Contributions to Data-Sharing Platforms Among Cohort Holders and Platform Developers in Europe: Interview Study.

Background: The European Commission is funding projects that aim to establish data-sharing platforms. These platforms are envisioned to enhance and facilitate the international sharing of cohort data. Nevertheless, broad data sharing may be restricted by the lack of adequate recognition for those who share data.

An agenda-setting paper on data sharing platforms: euCanSHare workshop.

Various data sharing platforms are being developed to enhance the sharing of cohort data by addressing the fragmented state of data storage and access systems. However, policy challenges in several domains remain unresolved. The euCanSHare workshop was organized to identify and discuss these challenges and to set the future research agenda.

Factors that influence data sharing through data sharing platforms: A qualitative study on the views and experiences of cohort holders and platform developers.

Background: Infrastructures are being developed to enhance and facilitate the sharing of cohort data internationally. However, empirical studies show that many barriers impede sharing data broadly.

Purpose: Therefore, our aim is to describe the barriers and concerns for the sharing of cohort data, and the implications for data sharing platforms.

Data Sharing in Biomedical Sciences: A Systematic Review of Incentives.

The lack of incentives has been described as the rate-limiting step for data sharing. Currently, the evaluation of scientific productivity by academic institutions and funders has been heavily reliant upon the number of publications and citations, raising questions about the adequacy of such mechanisms to reward data generation and sharing. This article provides a systematic review of the current and proposed incentive mechanisms for researchers in biomedical sciences and discusses their strengths and weaknesses.

Data sharing platforms and the academic evaluation system.

Data-level metrics could encourage scientists to openly share data - a goal of Open Science - if these DLMs became part of the academic reward system.

Anti-doping research and the Helsinki Declaration: (mis)match?

The fight against doping in sport is internationally coordinated by the World Anti-Doping Agency (WADA). Through its World Anti-Doping Code, WADA aims to harmonize anti-doping policies, rules and regulations. One key reference document bound to the Code is the International Standard for Laboratories (ISL), which mainly specifies the criteria that must be met for laboratory accreditation, as well as standards to adopt for the production of valid test results and evidentiary data.

Ethics Review in Anti-Doping Research: Experiences of Stakeholders.

The World Anti-Doping Agency is the international body coordinating anti-doping efforts, with the mandate of harmonizing anti-doping policy worldwide. With novel performance-enhancing compounds continuously entering the market, research is necessary to develop appropriate methods for their detection. WADA-accredited laboratories are required to spend 7% of their annual budget on this research and need to obtain ethics approval for studies involving human participants.

The Use of Samples Originating From Doping Control Procedures for Research Purposes: A Qualitative Study.

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.

Do athletes have a right to access data in their Athlete Biological Passport?

The Athlete Biological Passport (ABP) refers to the collection of data related to an individual athlete. The ABP contains the Haematological Module and the Steroidal Module, which are used for the longitudinal monitoring of variables in blood and urine, respectively. Based on changes in these variables, a statistical model detects outliers which indicate doping use and guide further targeted testing of the athlete.