Enforcing Human Subject Regulations using Blockchain and Smart Contracts
Keywords:blockchain, clinical trial, “Common Rule”, data security and privacy, distributed ledger, healthcare and medical research, human subject regulations, hyperledger fabric, protection of human subjects, smart contracts
Recent changes to the Common Rule, which govern Institutional Review Boards (IRB), require implementing new policies to strengthen research protocols involving human subjects. A major challenge in implementing such policies is an inability to automatically and consistently meet these ethical rules while securing sensitive information collected during the study. In this paper, we propose a novel framework, based on blockchain technology, to enforce IRB regulations on data collection. We demonstrate how to design smart contracts and a ledger to meet the requirements of an IRB protocol, including subject recruitment, informed consent management, secondary data sharing, monitoring risks, and generating automated assessments for continuous review. Furthermore, we show how we can employ the immutable transaction log in the blockchain to embed security in research activities by detecting malicious activities and robustly tracking subject involvement. We evaluate our approach by assessing its ability to enforce IRB guidelines in different types of human subjects studies, including a genomic study, a drug trial, and a wearable sensor monitoring study.
Keywords: Blockchain, Data Sharing, Data Exchange, EHR, electronic health record, Ethereum, interplanetary file
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