Blockchain-Based Dynamic Consent and its Applications for Patient-Centric Research and Health Information Sharing: Protocol for an Integrative Review.

Background: Blockchain has been proposed as a critical technology to facilitate more patient-centric research and health information sharing. For instance, it can be applied to coordinate and document dynamic informed consent, a procedure that allows individuals to continuously review and renew their consent to the collection, use, or sharing of their private health information. Such has been suggested to facilitate ethical, compliant longitudinal research, and patient engagement. However, blockchain-based dynamic consent is a relatively new concept, and it is not yet clear how well the suggested implementations will work in practice. Efforts to critically evaluate implementations in health research contexts are limited.

Objective: The objective of this protocol is to guide the identification and critical appraisal of implementations of blockchain-based dynamic consent in health research contexts, thereby facilitating the development of best practices for future research, innovation, and implementation.

Methods: The protocol describes methods for an integrative review to allow evaluation of a broad range of quantitative and qualitative research designs. The PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) framework guided the review's structure and nature of reporting findings. We developed search strategies and syntax with the help of an academic librarian. Multiple databases were selected to identify pertinent academic literature (CINAHL, Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science) and gray literature (Electronic Theses Online Service, ProQuest Dissertations and Theses, Open Access Theses and Dissertations, and Google Scholar) for a comprehensive picture of the field's progress. Eligibility criteria were defined based on PROSPERO (International Prospective Register of Systematic Reviews) requirements and a criteria framework for technology readiness. A total of 2 reviewers will independently review and extract data, while a third reviewer will adjudicate discrepancies. Quality appraisal of articles and discussed implementations will proceed based on the validated Mixed Method Appraisal Tool, and themes will be identified through thematic data synthesis.

Results: Literature searches were conducted, and after duplicates were removed, 492 articles were eligible for screening. Title and abstract screening allowed the removal of 312 articles, leaving 180 eligible articles for full-text review against inclusion criteria and confirming a sufficient body of literature for project feasibility. Results will synthesize the quality of evidence on blockchain-based dynamic consent for patient-centric research and health information sharing, covering effectiveness, efficiency, satisfaction, regulatory compliance, and methods of managing identity.

Conclusions: The review will provide a comprehensive picture of the progress of emerging blockchain-based dynamic consent technologies and the rigor with which implementations are approached. Resulting insights are expected to inform best practices for future research, innovation, and implementation to benefit patient-centric research and health information sharing.

Trial Registration: PROSPERO CRD42023396983; http://tinyurl.com/cn8a5x7t.

International Registered Report Identifier (irrid): DERR1-10.2196/50339.