A policy Delphi study to validate the key implications of data sharing (KIDS) framework for pediatric genomics in Canada

Vasiliki Rahimzadeh,Gillian Bartlett,Bartha Maria Knoppers

doi:10.1186/s12910-021-00635-1

Vasiliki Rahimzadeh, Gillian Bartlett + Show 1 more

Open Access

https://doi.org/10.1186/s12910-021-00635-1

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Abstract

BackgroundThe highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was therefore developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. This study qualitatively explored areas of consensus and dissensus of the KIDS Framework from the perspectives of Canadian clinician-scientists, genomic researchers, IRB members, and pediatric ethicists.MethodsTwelve panelists participated in a three-round online policy Delphi to determine the desirability, feasibility, relative importance and confidence of twelve individual statements of the KIDS Framework. Mean and IQR were calculated from panelists’ ratings to determine the strength of consensus and polarity. Qualitative content analysis of panelists’ written responses was used to assess degree of support. Statements were validated when their combined ratings and qualitative rationales indicated high-moderate consensus (at least 70% agreement across two contiguous categories), low to no polarity (IQR at least 1.0) and strong support.ResultsNine original, and one new statement reached consensus. These statements outlined essential elements of the informed consent process, including a realistic evaluation of benefits and risks and assurance of future ethics oversight for secondary data use. Discrepant views on appropriate protections for anonymized and coded i.e. de-identified genomic data were primary sources of dissensus.ConclusionsThe validated statements provide institutions with empirically supported best practices for sharing genomic and associated clinical data involving children from the perspectives of key stakeholders. Concerted efforts to quantify informational risks that can be conveyed to patients and families are further needed to align data sharing policy with stakeholder priorities.

Highlights

The highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing
As computational capacities evolve to support more sophisticated geno/phenotypic analyses, so too must oversight bodies such as institutional review boards (IRB) [7, 8] and data access committees (DAC) be responsible for ensuring data protections are commensurate with anticipated benefits and realistic informational risks to children and their families [9, 10]
Ten panelists from the top four Canadian provinces for pediatric genomics research by gross federal funding participated in Round 1 (6 male, 4 female); 12 panelists in Round 2 (7 male, 5 female); and

Summary

Introduction

The highly sensitive nature of genomic and associated clinical data, coupled with the consent-related vulnerabilities of children together accentuate ethical, legal and social issues (ELSI) concerning data sharing. The Key Implications of Data Sharing (KIDS) framework was developed to address a need for institutional guidance on genomic data governance but has yet to be validated among data sharing practitioners in practice settings. Children’s consent-related vulnerability, coupled with the highly identifying nature of genomic data can accentuate ethical, legal and social issues (ELSI) of sharing such data [6]. To address a need for improved ethics guidance, the lead author developed the Key Implications for Data Sharing (KIDS) framework for pediatric genomics in consultation with expert members of a special pediatric taskforce within the Global Alliance for Genomics and Health [13]. While the KIDS Framework lays a principled foundation for the responsible sharing of genomic and associated clinical data involving children, its potential implementation has yet to be evaluated empirically

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