Practical Barriers and Ethical Challenges in Genetic  Data Sharing

Simpson, Claire L.; Goldenberg, Aaron J.; Culverhouse, Rob; Daley, Denise; Igo, Robert P.; Jarvik, Gail P.; Mandal, Diptasri; Mascalzoni, Deborah; Montgomery, Courtney G.; Pierce, Brandon L.; Plaetke, Rosemarie; Shete, Sanjay; Goddard, Katrina A.B.; Stein, Catherine M.

doi:10.3390/ijerph110808383

Cited by 22 publications

(16 citation statements)

References 30 publications

(37 reference statements)

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“…This is a significant concern of some data producers because they see access review either as a mechanism to maintain control of downstream use of data or as an opportunity to collaborate with data users. 32…”

Section: Discussionmentioning

confidence: 99%

“You want the right amount of oversight”: interviews with data access committee members and experts on genomic data access

Shabani

Borry

2016

Genetics in Medicine

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Section: Discussionmentioning

confidence: 99%

“You want the right amount of oversight”: interviews with data access committee members and experts on genomic data access

Shabani

Borry

2016

Genetics in Medicine

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“…60 It is similar to PERSPECTIVE's association with BCAC. Although consortia can provide tremendous support for efficient data sharing, they have some limits.…”

Section: Conclusion: Facilitating Future Data Sharingmentioning

confidence: 94%

Ethical challenges and innovations in the dissemination of genomic data: the experience of the PERSPECTIVE project

Lévesque

Knoppers²,

Simard³

2015

AGG

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Abstract:The importance of making genomic data available for future research is now widely recognized among the scientific community and policymakers. In this era of shared responsibility for data dissemination, improved patient care through research depends on the development of powerful and secure data-sharing systems. As part of the concerted effort to share research resources, the project entitled Personalized Risk Stratification for Prevention and Early Detection of Breast Cancer (PERSPECTIVE) makes effective data sharing through the development of a data-sharing framework, one of its goals. The secondary uses of data from PERSPECTIVE for future research promise to enhance our knowledge of breast cancer etiologies without duplicating data-gathering efforts. Despite its benefit for research, we recognize the ethical challenges of data sharing on the local, national, and international levels. The effective management of ethical approvals for projects spanning across jurisdictions, the return of results to research participants, and research incentives and recognition for data production, are but a few pressing issues that need to be properly addressed. We discuss how we managed these issues and suggest how ongoing innovations might help to facilitate data sharing in future genomic research projects.

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“…29 In accessing the dbGaP, there is variation in whether IRB approval is required. 30 However, in gaining IRB approval for data submission to dbGaP, some researchers reported that IRBs restricted release of data to dbGaP by requiring the reconsent of research participants. 31 The National Cancer Institute (NCI) has issued best practices for NCI-supported "biospecimen resources," which cover operational, technical, ethical, legal, and policy aspects of biospecimens.…”

Section: Specimen and Data Accessmentioning

confidence: 99%

Biobanking Research and Privacy Laws in the United States

Harrell¹,

Rothstein²

2016

J. Law. Med. Ethics

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Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU-US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

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Practical Barriers and Ethical Challenges in Genetic Data Sharing

Cited by 22 publications

References 30 publications

“You want the right amount of oversight”: interviews with data access committee members and experts on genomic data access

“You want the right amount of oversight”: interviews with data access committee members and experts on genomic data access

Ethical challenges and innovations in the dissemination of genomic data: the experience of the PERSPECTIVE project

Biobanking Research and Privacy Laws in the United States

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