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. These burdens are especially pronounced for clinical and research networks that are of transnational scale, because the legal compliance burden for outbound international data transfers from the EEA is especially high. Legislatures, courts, and regulators in the EU should therefore implement the following three legal changes. First, the responsibilities of particular actors in a data sharing network should be delimited through the contractual allocation of responsibilities between collaborators. Second, the use of data through secure data processing environments should not trigger the international transfer provisions of the GDPR. Third, the use of federated data analysis methodologies that do not provide analysis nodes or downstream users access to identifiable personal data as part of the outputs of those analyses should not be considered circumstances of joint controllership, nor lead to the users of non-identifiable data to be considered controllers or processors. These small clarifications of, or modifications to, the GDPR would facilitate the exchange of biomedical data amongst clinicians and researchers.

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. Some initiatives try to confer value onto data sharing by making researchers' individual contributions to research visible (i.e., contributorship) or by quantifying the degree to which research data has been shared (e.g., data indicators). So far, the role of downstream evaluation and funding distribution systems for reputational incentives remains underexplored. This interview study documents the perspectives of members of funding agencies on, amongst other elements, incentives for data sharing. Funding agencies are adopting narrative CVs to encourage evaluation of diverse research outputs and display diversity in researchers' profiles. This was argued to diminish the focus on quantitative indicators of scientific productivity. Indicators related to open science dimensions may be reintroduced if they are fully developed. Shifts towards contributorship models for research outputs are seen as complementary to narrative review.

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. AIM: To understand funding agencies' perspectives on policy interventions to encourage data sharing. METHODS: Members of funding agencies were recruited to participate in semi-structured interviews. Nearly all funding agencies are situated in European countries. Interview transcripts were analyzed through inductive content analysis. RESULTS: Mandates for cohort data sharing are not supported by agencies due to data protection regulations and the preconditions for issuing mandates. Recommendation of platforms may be based on certification schemes, such as repository accreditation. Monitoring mechanisms for cohort data sharing are currently absent, which complicates assessing compliance of researchers with funding agencies' policies and evidence production. Funding agencies are not imposing conditions on data access committees. CONCLUSIONS: Policy measures that, in some ways, restrict the decision-making authority of researchers in terms of data sharing are not generally supported. Concrete steps are proposed to enable evidence-based policy making. Incentive design is paramount if funding agencies do not wish to impose restrictions on the decision-making authority of 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. OBJECTIVE: The aim of this study is to describe in depth the concerns about acquiring credit for data sharing within epidemiological research. METHODS: A total of 17 participants linked to European Union-funded data-sharing platforms were recruited for a semistructured interview. Transcripts were analyzed using inductive content analysis. RESULTS: Interviewees argued that data sharing within international projects could challenge authorship guidelines in multiple ways. Some respondents considered that the acquisition of credit for articles with extensive author lists could be problematic in some instances, such as for junior researchers. In addition, universities may be critical of researchers who share data more often than leading research. Some considered that the evaluation system undervalues data generators and specialists. Respondents generally looked favorably upon alternatives to the current evaluation system to potentially ameliorate these issues. CONCLUSIONS: The evaluation system might impede data sharing because it mainly focuses on first and last authorship and undervalues the contributor's work. Further movement of crediting models toward contributorship could potentially address this issue. Appropriate crediting mechanisms that are better aligned with the way science ought to be conducted in the future need to be developed.

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. METHODS: Seventeen participants involved in developing data sharing platforms or tied to cohorts that are to be submitted to platforms were recruited for semi-structured interviews to share views and experiences regarding data sharing. RESULTS: Credit and recognition, the potential misuse of data, loss of control, lack of resources, socio-cultural factors and ethical and legal barriers are elements that influence decisions on data sharing. Core values underlying these reasons are equality, reciprocity, trust, transparency, gratification and beneficence. CONCLUSIONS: Data generators might use data sharing platforms primarily for collaborative modes of working and network building. Data generators might be unwilling to contribute and share for non-collaborative work, or if no financial resources are provided for sharing data.

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

Background: 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. Methods: PubMed, Web of Science, and Google Scholar were queried for original research articles, editorials, and opinion articles on incentives for data sharing. Articles were included if they discussed incentive mechanisms for data sharing, were applicable to biomedical sciences, and were written in English. Results: Although coauthorship in return for the sharing of data is common, this might be incompatible with authorship guidelines and raise concerns over the ability of secondary analysts to contest the proposed research methods or conclusions that are drawn. Data publication, citation, and altmetrics have been proposed as alternative routes to credit data generators, which could address these disadvantages. Their primary downsides are that they are not well-established, it is difficult to acquire evidence to support their implementation, and that they could be gamed or give rise to novel forms of research misconduct. Conclusions: Alternative recognition mechanisms need to be more commonly used to generate evidence on their power to stimulate data sharing, and to assess where they fall short. There is ample discussion in policy documents on alternative crediting systems to work toward Open Science, which indicates that that there is an interest in working out more elaborate metascience programs.

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. Concerns over the multiplicity and long-term sustainability of platforms, lack of resources, access of commercial parties to medical data, credit and recognition mechanisms in academia and the organization of data access committees are outlined. Within these areas, solutions need to be devised to ensure an optimal functioning of platforms.

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. Within the ISL, the Code of Ethics refers to the Helsinki Declaration as a guiding framework for anti-doping research. However, inasmuch as anti-doping research structurally differs from human subject research as considered by the Helsinki Declaration, the applicability of the latter to anti-doping research can be called into question. In this work, we discuss how key principles of the Helsinki Declaration apply to anti-doping research and highlight frictions, incompatibilities and misalignments. Furthermore, we indicate possible solutions for operationalizing the Helsinki principles within the context of anti-doping research.

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

Background. 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. Nevertheless, these labs may face difficulties in obtaining ethics approval for anti-doping research due to its distinct differences from traditional biomedical research. Therefore, our aim was to investigate potential difficulties in obtaining ethics approval for anti-doping research.Methods. Semi-structured interviews were conducted with stakeholders in anti-doping research to investigate their experiences toward the ethics review process of their research proposals. Interviews were transcribed, de-identified, coded and analyzed.Results. The interviews indicated that large discrepancies in the evaluation of anti-doping research proposals exist. A majority of the laboratories could not acquire ethics approval for the administration of substances not approved for medical use. Some laboratories faced obstacles to obtain ethics approval for substances approved for clinical use. Respondents communicated that ethics committees often lack background knowledge about the anti-doping context.Conclusions. Disapproval of research proposals may originate from concerns over the safety of the study, the fact that there is seldom a direct benefit to the participant, the consideration that volunteers may be incentivized to use prohibited substances, a lack of background knowledge about anti-doping, or the focus of research ethics committees on health research.

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. The distinction between research and quality assurance in the International Standard for Laboratories (ISL) is neither well-understood nor interpreted uniformly by WADA-accredited labs. Most laboratories would not seek ethics approval for research on doping control samples. Interviewees considered that athletes should be better informed on what antidoping research can entail. A consistent and uniform approach toward the consent should be employed worldwide. Standards and safeguards should be implemented to reduce the risk of reidentification. Centralization of the Informed Consent Form in the ADAMS (Anti-Doping Administration & Management System) database would facilitate providing more information and allow the implementation of the right to withdraw.

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. Presently, athletes can access their data of the Haematological Module in the Anti-Doping Administration and Management System (ADAMS). However, granting athletes access to this data has been a matter of debate within the anti-doping community. This article investigates whether an athlete has a right to access the contents of their ABP profile. We approached this discussion by comparing the nature of ABP data with that of forensic and medical data and touched on important concerns with ABP data disclosure to athletes such as potentially allowing for the development of alternative doping techniques to circumvent detection; and making athletes vulnerable to pressure by the media to publicly release their data. Furthermore, given that ABP data may contain medically relevant information that can be used to diagnose disease, athletes may over-interpret its medical significance and wrongly see it as a free health check. We argue that safeguarding the integrity of the ABP system must be seen as the most essential element and thus a departure from immediate data disclosure is necessary. Two different strategies for delayed data disclosure are proposed which diminish the chances of ABP data being misused to refine doping techniques.