Mahsa Shabani

University of Amsterdam | UVA · Faculty of Law

This article provides a critical review of new policies in China, the United States, and the European Union that characterize genomic data as a national strategic resource. Specifically, we review policies that regulate human genomic data for economic, national security, or other strategic purposes rather than ethical or individual rights purposes.

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...

In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European d...

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 shar...

In the recent years the importance of secondary uses of health data for clinical, research and policy making purposes has been further stressed in view of the availability of health-related data collected in traditional and non-traditional settings. However, processing health data - which are sensitive type of personal data - requires adopting adeq...

Biological samples containing DNA that is attributed to deceased relatives, can now undergo genetic testing at a reasonable cost due to revolutionary improvements in sampling, sequencing, and analytical techniques. This artifact DNA testing, or ‘artDNA’, includes genetic analysis of hair locks, stamps, envelopes with saliva traces or teeth. ArtDNA...

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...

Due to ongoing developments in mobile health research and consumer genomics services, genomics mobile applications are set to become an increasingly important tool for biomedical researchers, offering to generate new insights into human health and shake up traditional research methods. However, as with other areas of mobile health research, current...

Data sharing platforms are being constructed to make clinical cohort data more findable, accessible, interoperable, and reusable. Their primary purpose is to enhance the sharing of data. However, the lack of incentives for data sharing has been conceptualized in both scientific literature and policy documents as a problem of science policy. As plat...

Questions of consent and public interest research loom large

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 t...

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. Concern...

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. Concern...

Data sharing: interests, impediments and restrictions. The sharing of data is of increasing importance. Data sharing platforms are currently built, aiming to make data more findable, accessible, interoperable and reusable. These platforms are, however, unable to address non-technical factors that may influence data sharing. Various factors, such as...

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. Me...

Enabling researchers’ access to large volumes of health data collected in both research and healthcare settings can accelerate improvements in clinical practice and public health. Because the source and subject of those data are people, data access governance has been of concern to scientists, ethics and regulatory scholars, policy-makers and citiz...

In the recent years collection of health and genomic data for biomedical research purposes has been expanded beyond traditional research settings. In doing so, various online tools and platforms are being utilized to collect data from various sources including Electronic Health Records, mHealth applications, disease registries and patient generated...

Background Ethics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts...

The implementation of the EU General Data Protection Regulation (GDPR) has had significant impacts on biomedical research, often complicating data sharing among researchers. The recently announced proposal for a new EU Data Governance Act is a promising step towards facilitating data sharing, if it can interplay well with the GDPR.

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 shar...

Here, we argue that, in line with the dramatic increase in the collection, storage and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to both enable wide access and protect against possible harms. However, the merits and limitations of di erent governance frameworks...

Governance of health and genomic data access in the context of biobanking is of salient importance in implementing the EU General Data Protection Regulation (GDPR). Various components of data access governance could be considered as ‘organizational measures’ which are stressed in the Article 89(1) GDPR together with technical measures that should b...

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 t...

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement shoul...

The article proposes the integration of data-level metrics within data sharing platforms to visualize and reward sharing behavior. Connections between these platforms, ORCID profiles, the Funder Dashboard in OpenAIRE and DataCite's Event Data Service should be established. This would enable funders to observe all data sharing behavior of cohort dat...

In response to concerns related to privacy in the context of COVID-19, recently European and national Data Protection Authorities (DPA) issued guidelines and recommendations addressing variety of issues related to processing of personal data for preventive purposes. One of the recurring questions in these guidelines related to the rights and respon...

Whole genome/exome sequencing (WGS/WES) has become widely adopted in research and, more recently, in clinical settings. Many hope that the information obtained from the interpretation of this data will have medical benefits for patients and – in some cases – also their biological relatives. Because of the manifold possibilities to reuse genomic dat...

The rapidly evolving popularity of direct-to-consumer genetic genealogy companies has made it possible to retrieve genomic information for unintended reasons by third parties, including the emerging use for law enforcement purposes. The question remains whether users of direct-to-consumer genetic genealogy companies and genealogical databases are a...

Personal genomic data and the related health data are valuable resources for both public-funded research, and for-profit entities in development of new drugs, therapies, and diagnostic tests. In order to access to large datasets, pharmaceutical and biotech companies have developed partnerships with public and private entities such as direct-to-cons...

Issue/problem Collection, storage and sharing RWD raise concerns regarding the privacy, data protection and governance of access. To date, the concerns related to consent and adequate safeguards for data protection in conventional research and health care settings are being discussed in details in the literature. However, collection of RWD from ind...

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 i...

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 cli...

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 wer...

In their Policy Forum “Toward unrestricted use of public genomic data” (25 January, p. 350), R. I. Amann et al. argue that once data has been cleared for release to the public domain by institutions, it should be open for use without further restrictions. However, they neglect the key point that researchers and their institutions are entrusted by r...

This book will present globally the main results and findings from the facts and figures collected by the different workpackages through the analysis of the literature, through the interviews and from the tools developed in the project. This material was enriched by the inputs from the external experts we have invited in the two conferences of cons...

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...

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 labo...

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, s...

Rapid advances in microarray and sequencing technologies are making genotyping and genome sequencing more affordable and readily available. There is an expectation that genomic sequencing technologies improve personalized diagnosis and personalized drug therapy. Concurrently, provision of direct-to-consumer genetic testing by commercial providers h...

Forensic geneticists are in a race to develop methods based on DNA methylation for various forensic applications, including age estimation. We argue that using epigenetic biomarkers could reveal a broad range of health and life-style related information, therefore it is necessary to develop adequate safeguards to protect the privacy of the individu...

Genetic data contain sensitive health and non-health-related information about the individuals and their family members. Therefore, adopting adequate privacy safeguards is paramount when processing genetic data for research or clinical purposes. One of the major legal instruments for personal data protection in the EU is the new General Data Protec...

While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized resear...

Patients are increasingly being encouraged and supported to access and control their own medical and genomic data. We argue that well-established and transparent raw genomic data retention and returning policies are imperative to enable patients to practice their rights to access and control raw data.

Discussions regarding responsible genomic data sharing often center around ethical and legal issues such as the consent, privacy, and confidentiality of individuals, families, and communities. To ensure the ethical grounds of genomic data sharing, oversight by both research ethics and Data Access Committees (DACs) across the research lifecycle is w...

Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of...

We propose a standard model for a novel data access tier - registered access - to facilitate access to data that cannot be published in open access archives owing to ethical and legal risk. Based on an analysis of applicable research ethics and other legal and administrative frameworks, we discuss the general characteristics of this Registered Acce...

Facilitating the responsible access to genomic research data is an emerging ethical and scientific imperative. Data Access Committees (DACs) assess the ethical footing and scientific feasibility of the data access requests and evaluate the qualification of applicants to ensure they are bona fide researchers. Through semi-structured interviews, we e...

Sharing results of genomic research through controlled-access databases has gained momentum in recent years. Principles and policies drafted by international and national organizations and funding bodies promulgated data-sharing practices among researchers in order to optimize the use of databases and to strengthen their statistical power. Given th...

Purpose: Genomic researchers benefit from broad access to large and information-rich datasets. Data Access Committees (DACs) are established as a governance mechanism to assess data access requests for the purpose of approval or disapproval. This paper explores the perspectives of DAC members and experts on components of access review and functiona...

Historically, research ethics committees (RECs) have been guided by ethical principles regarding human experimentation intended to protect participants from physical harms and to provide assurance as to their interests and welfare. But research that analyzes large aggregate data sets, possibly including detailed clinical and genomic information of...

Purpose: Genomic data sharing is vital for optimizing the use of public-funded research data. Data access committees (DACs) have been introduced as a core component of governance in controlled-access models. However, the tasks, structure, and functionality of DACs often remain unstudied. This article investigates the role and adequacy of DACs in ac...

In parallel with massive genomic data production, data sharing practices have rapidly expanded over the last decade. To ensure authorized access to data, access review by data access committees (DACs) has been utilized as one potential solution. Here we discuss core elements to be integrated into the fabric of access review by both established and...

In order to study the relationship between genes and diseases, the increasing availability and sharing of phenotypic and genotypic data have been promoted as an imperative within the scientific community. In parallel with data sharing practices by clinicians and researchers, recent initiatives have been observed in which individuals are sharing per...

Sharing genomic research data through controlled-access databases has increased in recent years. Policymakers and funding organizations endorse genomic data sharing in order to optimize the use of public funds and to increase the statistical power of databases. Well-established data access arrangements and data access committees (DACs)—responsible...

Aim: Introducing data sharing practices into the genomic research arena has challenged the current mechanisms established to protect rights of individuals and triggered policy considerations. To inform such policy deliberations, soliciting public and research participants' attitudes with respect to genomic data sharing is a necessity. Method: Th...

In order to study the relationship between genes and diseases, the increasing availability and sharing of phenotypic and genotypic data has been advanced as an imperative within the scientific community. In parallel with data sharing practices by clinicians and researchers, recent initiatives have been observed in which individuals are sharing pers...

In the last few decades, great progress has been made in both genetic and genomic research. The development of the Human Genome Project has increased our knowledge of the genetic basis of diseases and has given a tremendous momentum to the development of new technologies that make widespread genetic testing possible and has increased the availabili...