Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot?

Rothstein, Mark A.; Zawati, Ma’n H.; Knoppers, Bartha Maria

doi:10.1177/1073110519857291

Cited by 2 publications

(5 citation statements)

References 16 publications

(15 reference statements)

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“…Moreover, in part because of institutional and geographical barriers to care and participation in research, many rare disease patients share rich health information about themselves online with patient support groups or researchers. In fact, there are numerous academic and commercial research efforts that enable remote participation of rare disease patients to overcome geographic barriers [27]. The public availability of patient information could potentially increase the risk of re-identification in research datasets.…”

Section: Privacymentioning

confidence: 99%

International Data Sharing and Rare Disease: The Importance of Ethics and Patient Involvement

Thorogood¹

2020

Rare Diseases

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Improving our understanding of rare disease and developing new therapies can only succeed through global collaboration. Whole genome sequencing is increasingly being deployed to diagnose rare disease, and can be combined with machine-learning tools that analyze patient photos to identify phenotypes. Clinical interpretation of genomes and phenotypic data in rare disease depends on sharing individual patient data internationally. Data sharing is essential in rare disease contexts, to support the diagnosis of patients, recruitment into trials, the development of precision diagnostics and therapies, and clinical trial transparency. The sharing of rich molecular and phenotypic data presents privacy risks for rare disease patients, though many want to see their data made available to improve their care and advance research. Informed consent, access governance, and access technologies are important to realize the benefits of data sharing while mitigating risks. Rare disease patients should be involved in the design of data sharing governance to ensure it responds to their particular needs and preferences.

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Section: Privacymentioning

confidence: 99%

International Data Sharing and Rare Disease: The Importance of Ethics and Patient Involvement

Thorogood¹

2020

Rare Diseases

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“…Online recruitment empowers researchers to virtually consent, enroll, assess, and recontact individual participants. Kits for collecting saliva or blood samples, for example, could be shipped directly to enrolled participants and returned by post, without any requirement that participants visit a collection site in person [ 6 ]. Approaching genomic research in this way might enable participant-driven studies and citizen science to an unprecedented degree [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

“…Kits for collecting saliva or blood samples, for example, could be shipped directly to enrolled participants and returned by post, without any requirement that participants visit a collection site in person [ 6 ]. Approaching genomic research in this way might enable participant-driven studies and citizen science to an unprecedented degree [ 6 ]. This emerging “direct-to-participant” (DTP) model of genomic research recruitment promises to vastly increase the capacity of researchers to efficiently recruit and enroll large numbers of demographically representative participants.…”

Section: Introductionmentioning

confidence: 99%

“…In principle, DTP genomic research need not operate solely within the borders of a researcher’s home country. As more of the global population connects to the internet, there is a growing interest among researchers to expand genomic studies abroad [ 6 ]. While doing so would likely produce more diverse participant cohorts capable of generating important scientific discoveries, international DTP genomic research also encounters significant regulatory hurdles.…”

Section: Introductionmentioning

confidence: 99%

“…While doing so would likely produce more diverse participant cohorts capable of generating important scientific discoveries, international DTP genomic research also encounters significant regulatory hurdles. It is often unclear, for example, whether researchers in one country would be permitted in law to recruit research participants in another [ 6 ]. One especially pernicious challenge in this context might be the return of research results to study participants.…”

Section: Introductionmentioning

confidence: 99%

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Returning individual research results in international direct-to-participant genomic research: results from a 31-country study

Lang

Zawati

2022

Eur J Hum Genet

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This paper summarizes the results of a 31-country qualitative study of expert perspectives on the regulation of international “direct-to-participant” (DTP) genomic research. We outline how the practice of directly recruiting participants for genomic studies online complicates ethics and regulatory considerations for the return of individual research results. As part of a larger project supported by the National Human Genome Research Institute, National Institutes of Health, we prepared and distributed to 31 global legal experts a questionnaire intended to ascertain opinions and perspectives on the way international DTP genomic research is likely to be regulated. We found significant disagreement across jurisdictions on the most favorable approach to managing such results, with some countries favoring return by default and others preferring to return only with the express consent of research participants. We conclude by outlining policy considerations that should guide researcher practices in this context. As international DTP genomic research evolves, jurists and ethicists should be attentive to the ways novel approaches to subject recruitment align with existing ethical and regulatory norms in research with human participants. This paper is a preliminary step toward documenting such alignment in the context of the return of individual research results.

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Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot?

Cited by 2 publications

References 16 publications

International Data Sharing and Rare Disease: The Importance of Ethics and Patient Involvement

International Data Sharing and Rare Disease: The Importance of Ethics and Patient Involvement

Returning individual research results in international direct-to-participant genomic research: results from a 31-country study

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