Blockchain-enabled Clinical Study Consent Management

Written informed consent (WIC) is required in the context of voluntary participation in a clinical trial. The trial participant gives WIC in accordance with various regulatory requirements. We present a framework concept for a blockchain-based distributed ledger solution, which aims at implementing...

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Veröffentlicht in:Technology innovation management review Jg. 10; H. 2; S. 14 - 24
Hauptverfasser: Jung, Hans H., Pfister, Franz M.J.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Ottawa Talent First Network 01.02.2020
Carleton University
Schlagworte:
ai ethics
Archives & records
Artificial intelligence
Blockchain
Business models
Clinical medicine
clinical study
Clinical trials
Cryptography
Data acquisition
Data collection
Distributed ledger
Documentation
Ethical standards
Ethics
health artificial intelligence (ai)
Informed consent
Machine learning
Medical research
Participation
platform business model
Studies
written informed consent
Germany
ISSN:1927-0321, 1927-0321
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Abstract Written informed consent (WIC) is required in the context of voluntary participation in a clinical trial. The trial participant gives WIC in accordance with various regulatory requirements. We present a framework concept for a blockchain-based distributed ledger solution, which aims at implementing simple and secure management of WIC documentation, along the entire data value chain from acquiring consent to academic publication, and (commercially) exploiting the results of a clinical study. This may include (but is not limited to) clinical deployment, security monitoring, and conformity with data privacy and ethical standards. Thus, we present a potential "Health AI" application that goes beyond WIC documentation, to enabling the creation of a holistic data provenance trail graph. Such a framework concept aims to create sustainable value for study participants, clinicians, data scientists, and ultimately consumers. The framework's usefulness is relevant for ensuring the ethical development of artificial intelligence applications in the healthcare domain.
AbstractList Written informed consent (WIC) is required in the context of voluntary participation in a clinical trial. The trial participant gives WIC in accordance with various regulatory requirements. We present a framework concept for a blockchain-based distributed ledger solution, which aims at implementing simple and secure management of WIC documentation, along the entire data value chain from acquiring consent to academic publication, and (commercially) exploiting the results of a clinical study. This may include (but is not limited to) clinical deployment, security monitoring, and conformity with data privacy and ethical standards. Thus, we present a potential “Health AI” application that goes beyond WIC documentation, to enabling the creation of a holistic data provenance trail graph. Such a framework concept aims to create sustainable value for study participants, clinicians, data scientists, and ultimately consumers. The framework’s usefulness is relevant for ensuring the ethical development of artificial intelligence applications in the healthcare domain.
Author Pfister, Franz M.J.
Jung, Hans H.
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Snippet Written informed consent (WIC) is required in the context of voluntary participation in a clinical trial. The trial participant gives WIC in accordance with...
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StartPage 14
SubjectTerms ai ethics
Archives & records
Artificial intelligence
Blockchain
Business models
Clinical medicine
clinical study
Clinical trials
Cryptography
Data acquisition
Data collection
Distributed ledger
Documentation
Ethical standards
Ethics
health artificial intelligence (ai)
Informed consent
Machine learning
Medical research
Participation
platform business model
Studies
written informed consent
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