Enforcing Human Subject Regulations using Blockchain and Smart Contracts

Authors

  • Olivia Choudhury, PhD Postdoctoral Researcher, IBM Research, Cambridge, Massachusetts, USA.
  • Hillol Sarker, MS, PhD Postdoctoral Researcher, IBM Research, Cambridge, Massachusetts, USA.
  • Nolan Rudolph, BS Research Engineer, IBM Research, Cambridge, Massachusetts, USA
  • Morgan Foreman, BSPsy Healthcare Data Scientist, IBM Research, Cambridge, Massachusetts, USA.
  • Nicholas Fay, MCS Healthcare Data Scientist, IBM Research, Cambridge, Massachusetts, USA
  • Murtaza Dhuliawala, MCS MCS,Research Engineer, IBM Research, Cambridge, Massachusetts, USA
  • Issa Sylla, BA Research Engineer, IBM Research, Cambridge, Massachusetts, USA
  • Noor Fairoza, MS Dev Ops Engineer, IBM Research, Cambridge, Massachusetts, USA
  • Amar K Das, MD, PhD Director of Learning Health Systems, IBM Research, Cambridge, Massachusetts, USA

DOI:

https://doi.org/10.30953/bhty.v1.10

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

Abstract

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
system, IPFS

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Published

2018-03-23

How to Cite

Choudhury, O., Sarker, H., Rudolph, N., Foreman, M., Fay, N., Dhuliawala, M., Sylla, I., Fairoza, N., & Das, A. K. (2018). Enforcing Human Subject Regulations using Blockchain and Smart Contracts. Blockchain in Healthcare Today, 1. https://doi.org/10.30953/bhty.v1.10

Issue

Section

Research Article: Use Cases/Pilots/Methodologies