Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?

2017 ◽  
Vol 15 (5) ◽  
pp. 469-474 ◽  
Author(s):  
Mahsa Shabani ◽  
Edward S. Dove ◽  
Madeleine Murtagh ◽  
Bartha Maria Knoppers ◽  
Pascal Borry
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access

scholarly journals Genomic Data-Sharing Practices

2019 ◽  
Vol 47 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Angela G. Villanueva ◽  
Robert Cook-Deegan ◽  
Jill O. Robinson ◽  
Amy L. McGuire ◽  
Mary A. Majumder
Keyword(s):  
Data Sharing ◽  
Medical Information ◽  
Public Information ◽  
Genomic Data ◽  
Data Access ◽  
Privacy And Security ◽  
Participant Engagement ◽  
Information Commons ◽  
Derived Data

Making data broadly accessible is essential to creating a medical information commons (MIC). Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency.

scholarly journals From the principles of genomic data sharing to the practices of data access committees

2015 ◽  
Vol 7 (5) ◽  
pp. 507-509 ◽  
Author(s):  
Mahsa Shabani ◽  
Bartha Maria Knoppers ◽  
Pascal Borry
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access

scholarly journals Demonstrating trustworthiness when collecting and sharing genomic data: public views across 22 countries

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Richard Milne ◽  
Katherine I. Morley ◽  
Mohamed A. Almarri ◽  
Shamim Anwer ◽  
Jerome Atutornu ◽  
...  
Keyword(s):  
Data Sharing ◽  
Online Survey ◽  
Medical Information ◽  
Genomic Data ◽  
Data Access ◽  
Genomic Research ◽  
Use Of Data ◽  
Using Data ◽  
The Uk ◽  
Public Views

Abstract Background Public trust is central to the collection of genomic and health data and the sustainability of genomic research. To merit trust, those involved in collecting and sharing data need to demonstrate they are trustworthy. However, it is unclear what measures are most likely to demonstrate this. Methods We analyse the ‘Your DNA, Your Say’ online survey of public perspectives on genomic data sharing including responses from 36,268 individuals across 22 low-, middle- and high-income countries, gathered in 15 languages. We examine how participants perceived the relative value of measures to demonstrate the trustworthiness of those using donated DNA and/or medical information. We examine between-country variation and present a consolidated ranking of measures. Results Providing transparent information about who will benefit from data access was the most important measure to increase trust, endorsed by more than 50% of participants across 20 of 22 countries. It was followed by the option to withdraw data and transparency about who is using data and why. Variation was found for the importance of measures, notably information about sanctions for misuse of data—endorsed by 5% in India but almost 60% in Japan. A clustering analysis suggests alignment between some countries in the assessment of specific measures, such as the UK and Canada, Spain and Mexico and Portugal and Brazil. China and Russia are less closely aligned with other countries in terms of the value of the measures presented. Conclusions Our findings highlight the importance of transparency about data use and about the goals and potential benefits associated with data sharing, including to whom such benefits accrue. They show that members of the public value knowing what benefits accrue from the use of data. The study highlights the importance of locally sensitive measures to increase trust as genomic data sharing continues globally.

scholarly journals Blockchain-based platforms for genomic data sharing: a de-centralized approach in response to the governance problems?

2018 ◽  
Vol 26 (1) ◽  
pp. 76-80 ◽  
Author(s):  
Mahsa Shabani
Keyword(s):  
Access Control ◽  
Data Sharing ◽  
Genomic Data ◽  
Data Access ◽  
Distributed Data ◽  
Data Ownership ◽  
Governance Challenges ◽  
Data Stewardship

Abstract 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.

scholarly journals A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study (Preprint)

2021 ◽  
Author(s):  
Faisal Albalwy ◽  
Andrew Brass ◽  
Angela Davies
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access ◽  
Patient Data ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Data Governance ◽  
Dynamic Consent ◽  
Patient Consent ◽  
Clinical Genomic

BACKGROUND In clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues. OBJECTIVE This study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance. METHODS The ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system. RESULTS We describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes. CONCLUSIONS Blockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials.

scholarly journals Patient-driven efforts to liberate clinical cancer genomic data

2018 ◽  
Author(s):  
Stephanie Wankowicz ◽  
Brooke Maile ◽  
Ken Deutsch ◽  
Adam Hayden ◽  
Erika Brown ◽  
...  
Keyword(s):  
Data Sharing ◽  
Phenotypic Diversity ◽  
Patient Empowerment ◽  
Genomic Data ◽  
Data Access ◽  
Patient Centered ◽  
Cancer Genomes ◽  
And Control ◽  
Right Of Access ◽  
Access Data

Cancer patients’ data, including clinical and genomic sequencing, typically reside within incompatible electronic health records (EHR) and/or proprietary databases in clinical laboratories or companies. Multiple academic and commercial consortia have initiated “top down” approaches to encourage data sharing, though these consortia represent a small percentage of the cancer patient population and may not capture the genomic and phenotypic diversity of the larger cancer community. Critically, patients have the unique power to liberate and share their own data, since the Health Insurance Portability and Accountability Act (HIPAA) gives patients a right to access all data in a computable format. Here, we partnered with patients to examine the feasibility of leveraging the HIPAA right of access provision to access their cancer genomic data in a computable format from both academic and commercial laboratories (n = 5 patients; 3 academic labs, 5 commercial labs). We observed wide heterogeneity in responses to requests, deliverables to patients, and patient effort required to access data. Multiple labs reported that these requests were the first of their kind and subsequently instituted procedural changes to facilitate data sharing with patients. Furthermore, individual patients expressed significant meaning attributed to having access to and control over their cancer genomes. While this experiment exposed multiple difficulties for patient genomic data access, we argue that these difficulties can be overcome with a patient-centered platform to facilitate these efforts. Toward that end, we propose and describe a patient-driven cancer genome collective to directly address this need and empower data liberation and donation to advance cancer research and patient empowerment.

scholarly journals A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study

10.2196/27816 ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. e27816
Author(s):  
Faisal Albalwy ◽  
Andrew Brass ◽  
Angela Davies
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access ◽  
Patient Data ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Data Governance ◽  
Dynamic Consent ◽  
Patient Consent ◽  
Clinical Genomic

Background In clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues. Objective This study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance. Methods The ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system. Results We describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes. Conclusions Blockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials.

scholarly journals Australia: regulating genomic data sharing to promote public trust

2018 ◽  
Vol 137 (8) ◽  
pp. 583-591 ◽  
Author(s):  
Lisa Eckstein ◽  
Donald Chalmers ◽  
Christine Critchley ◽  
Ruthie Jeanneret ◽  
Rebekah McWhirter ◽  
...  
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Public Trust
Sign in / Sign up

Export Citation Format

Share Document