Public Views on Models for Accessing Genomic and Health Data for Research: Mixed Methods Study.

Helen Daniels,Kerina H Jones,Emma Squires,David V Ford

doi:10.2196/14384

Abstract

BackgroundThe literature abounds with increasing numbers of research studies using genomic data in combination with health data (eg, health records and phenotypic and lifestyle data), with great potential for large-scale research and precision medicine. However, concerns have been raised about social acceptability and risks posed for individuals and their kin. Although there has been public engagement on various aspects of this topic, there is a lack of information about public views on data access models.ObjectiveThis study aimed to address the lack of information on the social acceptability of access models for reusing genomic data collected for research in conjunction with health data. Models considered were open web-based access, released externally to researchers, and access within a data safe haven.MethodsViews were ascertained using a series of 8 public workshops (N=116). The workshops included an explanation of benefits and risks in using genomic data with health data, a facilitated discussion, and an exit questionnaire. The resulting quantitative data were analyzed using descriptive and inferential statistics, and the qualitative data were analyzed for emerging themes.ResultsRespondents placed a high value on the reuse of genomic data but raised concerns including data misuse, information governance, and discrimination. They showed a preference for giving consent and use of data within a safe haven over external release or open access. Perceived risks with open access included data being used by unscrupulous parties, with external release included data security, and with safe havens included the need for robust safeguards.ConclusionsThis is the first known study exploring public views of access models for reusing anonymized genomic and health data in research. It indicated that people are generally amenable but prefer data safe havens because of perceived sensitivities. We recommend that public views be incorporated into guidance on models for the reuse of genomic and health data.

Highlights

We are witnessing a rapid expansion in the availability and use of genomic data to inform research and clinical care
Perceived risks with open access included data being used by unscrupulous parties, with external release included data security, and with safe havens included the need for robust safeguards
This is the first known study exploring public views of access models for reusing anonymized genomic and health data in research. It indicated that people are generally amenable but prefer data safe havens because of perceived sensitivities

Summary

Introduction

Background We are witnessing a rapid expansion in the availability and use of genomic data to inform research and clinical care. Precision medicine, where treatments and medication regimes are informed by individual http://www.jmir.org/2019/8/e14384/ This included describing the study purpose; the focus on the reuse in deidentified form of genetic data collected for research, as distinct from the process of data collection for clinical purposes; types of genetic data and wider health data; and how data can be accessed in terms of the 3 main models (open access, released externally, or within a data safe haven). Data may be used in anonymous form, identifiable data are needed to process the primary research data for reuse and enable linkage to health data Through these examples, we provided practical descriptions of each operating model, and how the ethical and other regulatory permissions needed for researchers to access the data can vary. There has been public engagement on various aspects of this topic, there is a lack of information about public views on data access models

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