Dataset Information

Development of a consent resource for genomic data sharing in the clinical setting.

ABSTRACT:

Purpose

Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing.

Methods

To determine whether the consent form and video accurately conveyed key data sharing concepts, we surveyed 5,162 members of the general public. We measured comprehension at baseline, after reading the form and watching the video. Additionally, we assessed participants' attitudes toward genomic data sharing.

Results

Participants' performance on comprehension questions significantly improved over baseline after reading the form and continued to improve after watching the video.

Conclusion

Results suggest reading the form alone provided participants with important knowledge regarding broad data sharing, and watching the video allowed for broader comprehension. These materials are now available at http://www.clinicalgenome.org/share . These resources will provide patients a straightforward way to share their genetic and health information, and improve the scientific community's access to data generated through routine healthcare.

SUBMITTER: Riggs ER

PROVIDER: S-EPMC6292744 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Development of a consent resource for genomic data sharing in the clinical setting.

Riggs Erin Rooney ER Azzariti Danielle R DR Niehaus Annie A Goehringer Scott R SR Ramos Erin M EM Rodriguez Laura Lyman LL Knoppers Bartha B Rehm Heidi L HL Martin Christa Lese CL

Genetics in medicine : official journal of the American College of Medical Genetics 20180613 1

<h4>Purpose</h4>Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing.<h4>Methods</h4>To determi ...[more]

PMID: 29899502

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Project description:BackgroundIn 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.ObjectiveThis 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.MethodsThe 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.ResultsWe 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.ConclusionsBlockchains 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.

Project description:BACKGROUND:There has been considerable investment and strategic planning to introduce genomic testing into Australia's public health system. As more patients' genomic data is being held by the public health system, there will be increased requests from researchers to access this data. It is important that public policy reflects public expectations for how genomic data that is generated from clinical tests is used. To inform public policy and discussions around genomic data sharing, we sought public opinions on using genomic data contained in medical records for research purposes in the Australian state of Queensland. METHODS:A total of 1494 participants completed an online questionnaire between February and May 2019. Participants were adults living in Australia. The questionnaire explored participant preferences for sharing genomic data or biological samples with researchers, and concerns about genomic data sharing. RESULTS:Most participants wanted to be given the choice to have their genomic data from medical records used in research. Their expectations on whether and how often they needed to be approached for permission on using their genomic data, depended on whether the data was identifiable or anonymous. Their willingness to sharing data for research purposes depended on the type of information being shared, what type of research would be undertaken and who would be doing the research. Participants were most concerned with genomics data sharing that could lead to discrimination (insurance and employment), data being used for marketing, data security, or commercial use. CONCLUSIONS:Most participants were willing to share their genomic data from medical records with researchers, as long as permission for use was sought. However, the existing policies related to this process in Queensland do not reflect participant expectations for how this is achieved, particularly with anonymous genomics data. This inconsistency may be addressed by process changes, such as inclusion of research in addition to clinical consent or general research data consent programs.

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Dataset Information

Development of a consent resource for genomic data sharing in the clinical setting.

Purpose

Methods

Results

Conclusion

Publications

Development of a consent resource for genomic data sharing in the clinical setting.

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