A Belmont Report for Health Data

Parasidis, Efthimios; Pike, Elizabeth R.; McGraw, Deven

doi:10.1056/nejmp1816373

Cited by 31 publications

(21 citation statements)

References 4 publications

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“…(All our project proposals are vetted by university institutional review boards, charged with protecting human participants.) Certainly, social scientists can learn a lot from best practice in the protection and sharing of electronic medical records 13 and genomic data.…”

Section: The Human Screenome Projectmentioning

confidence: 99%

Time for the Human Screenome Project

Reeves¹,

Robinson²,

Ram³

2020

Nature

126

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Section: The Human Screenome Projectmentioning

confidence: 99%

Time for the Human Screenome Project

Reeves¹,

Robinson²,

Ram³

2020

Nature

126

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“…While the Health Insurance Portability and Accountability Act (HIPAA) provides guidance on de-identifying health information, there is a risk of re-identification from other data sets, particularly as more personal information becomes available online [46,47]. Ensuring adequate data privacy and transparency regarding data sharing may require additional expertise and deliberations outside the traditional IRB review, including patients and experts in data privacy and societal ethics [47,48]. To this end, we have included patients and an expert in electronic consent methods on our steering committee and use secure HIPAA-compliant systems for the collection of participant information and the conduct of study visits.…”

Section: Discussionmentioning

confidence: 99%

A Virtual Cohort Study of Individuals at Genetic Risk for Parkinson’s Disease: Study Protocol and Design

Schneider

Myers

Rowbotham

et al. 2020

JPD

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Background: The rise of direct-to-consumer genetic testing has enabled many to learn of their possible increased risk for rare diseases, some of which may be suitable for gene-targeted therapies. However, recruiting a large and representative population for rare diseases or genetically defined sub-populations of common diseases is slow, difficult, and expensive. Objective: To assess the feasibility of recruiting and retaining a cohort of individuals who carry a genetic mutation linked to Parkinson's disease (G2019S variant of LRRK2); to characterize this cohort relative to the characteristics of traditional, in-person studies; and to evaluate this model's ability to create an engaged study cohort interested in future clinical trials of gene-directed therapies. Methods: This single-site, 3-year national longitudinal observational study will recruit between 250 to 350 LRRK2 carriers without Parkinson's disease and approximately 50 with the condition. Participants must have undergone genetic testing by the personal genetics company, 23andMe, Inc., have knowledge of their carrier status, and consent to be contacted for research studies. All participants undergo standardized assessments, including video-based cognitive and motor examination, and complete patient-reported outcomes on an annual basis. Results: 263 individuals living in 33 states have enrolled. The cohort has a mean (SD) age of 56.0 (15.9) years, 59% are female, and 76% are of Ashkenazi Jewish descent. 233 have completed the baseline visit: 47 with self-reported Parkinson's disease and 186 without.

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“…Among the 19 shortlisted papers, seven focused on various forms of data sharing and/or data use, five addressed privacy concerns, and one paper addressed both topic areas. Articles in the data sharing area explored a broad range of issues including passive data collection [6]; [patient] participatory methods in data-intensive biomedical research [7] and disease surveillance [8]; data management, use/re-use, and sharing internationally [9] and under the GDPR [10]; posthumous data donation [11]; and human protection with regard to data sharing [12]. Papers focused on privacy looked at the use and understanding of anonymization and de-identification practices in the literature [13]; health information disclosure [14]; balancing privacy and data use under the GDPR [15]; activities that work against citizen and patient trust with regard to personal information [16]; and terms of use violations by researchers accessing online patient information [17].…”

Section: Discussionmentioning

confidence: 99%

Special Section on Ethics in Health Informatics

Petersen

Subbian

2020

Yearb Med Inform

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Summary Objective: To summarize significant research contributions on ethics in medical informatics published in 2019. Methods: An extensive search using PubMed/Medline was conducted to identify the scientific contributions published in 2019 that address ethics issues in medical informatics. The selection process comprised three steps: 1) 15 candidate best papers were first selected by the two section editors; 2) external reviewers from internationally renowned research teams reviewed each candidate best paper; and 3) the final selection of three best papers was conducted by the editorial committee of the Yearbook. Results: The three selected best papers explore timely issues of concern to the community and demonstrate how ethics considerations influence applied informatics. Conclusion: With regard to ethics in informatics, data sharing and privacy remain primary areas of concern. Ethics issues related to the development and implementation of artificial intelligence is an emerging topic of interest.

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A Belmont Report for Health Data

Cited by 31 publications

References 4 publications

Time for the Human Screenome Project

Time for the Human Screenome Project

A Virtual Cohort Study of Individuals at Genetic Risk for Parkinson’s Disease: Study Protocol and Design

Special Section on Ethics in Health Informatics

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