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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Bibliographic Details
Published in:Technology innovation management review Vol. 10; no. 2; pp. 14 - 24
Main Authors: Jung, Hans H., Pfister, Franz M.J.
Format: Journal Article
Language:English
Published: Ottawa Talent First Network 01.02.2020
Carleton University
Subjects:
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
Online Access:Get full text
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Summary: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.
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content type line 14
ISSN:1927-0321
1927-0321
DOI:10.22215/timreview/1325