Sharing and Safeguarding Pediatric Data

Patrinos, Dimitri; Knoppers, Bartha Maria; Laplante, David P.; Rahbari, Noriyeh; Wazana, Ashley

doi:10.3389/fgene.2022.872586

Cited by 3 publications

(2 citation statements)

References 43 publications

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“…A primer on data protection and privacy issues related to pediatric research has been developed that explores themes such as regulation of pediatric data protection and data sharing, including consent to data sharing under data protection laws compared with consent/assent to data sharing in the context of the application of research ethics requirements, data retention, the right to object to data processing, and data erasure under the GDPR. Indeed, while there are unique privacy considerations with pediatric data sharing, restricting data sharing can impede certain research on pediatric conditions, which are often distinct from those present in the adult population (40).…”

Section: Reidentificationmentioning

confidence: 99%

Open Data in the Era of the GDPR: Lessons from the Human Cell Atlas

Knoppers

Bernier

Bowers

et al. 2023

Annu. Rev. Genom. Hum. Genet.

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The Human Cell Atlas (HCA) is striving to build an open community that is inclusive of all researchers adhering to its principles and as open as possible with respect to data access and use. However, open data sharing can pose certain challenges. For instance, being a global initiative, the HCA must contend with a patchwork of local and regional privacy rules. A notable example is the implementation of the European Union General Data Protection Regulation (GDPR), which caused some concern in the biomedical and genomic data-sharing community. We examine how the HCA's large, international group of researchers is investing tremendous efforts into ensuring appropriate sharing of data. We describe the HCA's objectives and governance, how it defines open data sharing, and ethico-legal challenges encountered early in its development; in particular, we describe the challenges prompted by the GDPR. Finally, we broaden the discussion to address tools and strategies that can be used to address ethical data governance. Expected final online publication date for the Annual Review of Genomics and Human Genetics, Volume 24 is August 2023. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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Section: Reidentificationmentioning

confidence: 99%

Open Data in the Era of the GDPR: Lessons from the Human Cell Atlas

Knoppers

Bernier

Bowers

et al. 2023

Annu. Rev. Genom. Hum. Genet.

Self Cite

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“…The recent initiatives to help enable and foster data sharing practices for pediatric research and translate these into practice, also with respect to consent clauses, are reviewed by Patrinos et al [ 80 ]. Today, Denmark has perhaps one of the most effective health systems, based on the establishment of a national e-health portal, sundhed.dk, providing patient-oriented digital services.…”

Section: Concept For Population Monitoring Of Down Syndromementioning

confidence: 99%

Population monitoring of trisomy 21: problems and approaches

2023

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Trisomy 21 (Down syndrome) is the most common autosomal aneuploidy among newborns. About 90% result from meiotic nondisjunction during oogenesis, which occurs around conception, when also the most profound epigenetic modifications take place. Thus, maternal meiosis is an error prone process with an extreme sensitivity to endogenous factors, as exemplified by maternal age. This contrasts with the missing acceptance of causal exogenous factors. The proof of an environmental agent is a great challenge, both with respect to ascertainment bias, determination of time and dosage of exposure, as well as registration of the relevant individual health data affecting the birth prevalence. Based on a few exemplary epidemiological studies the feasibility of trisomy 21 monitoring is illustrated. In the nearer future the methodical premises will be clearly improved, both due to the establishment of electronic health registers and to the introduction of non-invasive prenatal tests. Down syndrome is a sentinel phenotype, presumably also with regard to other congenital anomalies. Thus, monitoring of trisomy 21 offers new chances for risk avoidance and preventive measures, but also for basic research concerning identification of relevant genomic variants involved in chromosomal nondisjunction.

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Assessment of Knowledge, Attitude, and Practices on Genetic Research Data Reuse for Future Research: Clinical Trial Investigators Perspectives

Devarinti,

Ganachari

2024

Asian Journal of Pharmaceutical Research and Health Care

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Introduction: According to the principle of good clinical practice, it is imperative that the personnel involved in the pharmaceutical or genetic research possess an educational background and comprehensive training. The clinical trial investigator must ensure the safeguard the privacy and confidentiality and prevent inadvertent reuse of research results of study participants. Aim: The objective of the current research is to assess the knowledge, attitude, and practices of clinical trial investigators concerning the reuse of genetic research data. Settings and Design: As a cross-sectional study, there was only one-time collection of knowledge, attitude, and practice on genetics and its data for future research from clinical trial investigators from the Tertiary Care Hospital and Clinical Research Centers in Belagavi Karnataka, India. Subjects and Methods: A study was conducted using validated knowledge, attitude, and practices questionnaire on the clinical trial investigators. Statistical Analysis Used: Data were analyzed using the SPSS software version 21one-way analysis of variance. Results: The present study was comprised n = 50 clinical trial investigators calculated by using the general formula for the calculation of sample size with a confidence of interval limit, of whom 64% exhibited awareness of genetic data reuse in clinical trials. Seventy-four percent of clinical trial investigators expressed concerns about confidentiality issues related to the reuse of genomic data. Conclusions: The lack of synchronized international conference on harmonization of technical requirements for pharmaceuticals for human use (ICH) guidelines directives concerning genomic sampling and data management in health-care research presents a formidable obstacle for pharmaceutical sponsors in achieving consistent and standardized genomic research samples and its data execution in pharmaceutical research on a global scale.

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Sharing and Safeguarding Pediatric Data

Cited by 3 publications

References 43 publications

Open Data in the Era of the GDPR: Lessons from the Human Cell Atlas

Open Data in the Era of the GDPR: Lessons from the Human Cell Atlas

Population monitoring of trisomy 21: problems and approaches

Assessment of Knowledge, Attitude, and Practices on Genetic Research Data Reuse for Future Research: Clinical Trial Investigators Perspectives

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