A System-based Research Ethics Architecture for Meeting New Thresholds for Human Subject Protections in Research in the Latest ICH-GCP E6 (R3)

Abstract ICH-GCP guidelines have provided international ethical, scientific, quality standards for designing, conducting, recording, and reporting of clinical trials, and are hugely popular in the region. Recent revisions to its guidance; ICH-GCP; E6 (R3) have brought significant changes in both structure and content from its predecessor, affecting every aspect of trial conduct, oversight, and planning through reporting. The latest version of ICH-GCP E6 (R3) is ensuring the rights, safety welfare and the well-being of human rights subjects. It aims to adapt and stay relevant in the ever-evolving world of clinical trials, embracing diverse types and settings, and keeping pace with technological and methodological advances. There are many themes and structural changes in E6 (R3). In this article, we provide a detailed account of how the human subject system-based research ethics architecture (HS-SBREA) at Weil Cornell Medicine-Qatar (WCM-Q) addresses the many themes and structural changes in E6 (R3). Particularly the requirement to foster a culture of ethical conduct & build quality management systems to provide protection to human participants in clinical research. We believe that this can be achieved through a primacy of ethical principle-based approach. The focus on primacy of principles has long been established at WCM-Q as a goal for promoting the universal applicability of the four bioethical principles. This has been important in addressing the unique challenges posed by ethical relativism, which is an inevitable outcome of a diverse, rich heterogenous population in Qatar and within the professional biomedical workforce at WCM-Q. We address some of the themes in this discourse to contextualize our responses as a research institution and medical college.