Position Paper by Javara Inc.

The Integrated Research Organization (IRO) Framework: An Institutional Model for Integrating Clinical Research into Healthcare

Introduction

The Cures in Care Initiative, led by U.S. Congressman Jake Auchincloss (D-MA), is an important step toward expanding access to clinical trials by integrating research into routine healthcare. Yet many of the structural barriers affecting where studies are conducted, how patients access clinical research, and how efficiently research advances will remain unless Congress and other stakeholders adopt a broader framework for strengthening the nation’s clinical research infrastructure.

Technology is an important enabler, but it is not the solution. Healthcare organizations cannot become research-ready through technology alone.

Sustainable integration of clinical research into healthcare requires the governance, legal and regulatory architecture, workforce, financial stewardship, operational capabilities, quality systems, technology, and strategic capabilities needed to support research safely, consistently, and at scale.

Javara’s new position paper, The Integrated Research Organization (IRO) Framework: An Institutional Model for Integrating Clinical Research into Healthcare, presents the IRO Framework as a comprehensive institutional framework for integrating high-quality clinical research into routine healthcare delivery.

What Is the IRO Framework?

An Integrated Research Organization (IRO) is a standardized institutional framework that enables healthcare organizations to integrate high-quality clinical research into routine patient care.

The IRO Framework addresses the infrastructure gap that prevents many healthcare organizations from participating in clinical research consistently and at scale. Rather than focusing on individual studies, standalone technologies, or fragmented operational models, the IRO Framework identifies the institutional capabilities needed to make clinical research a sustainable component of patient care.

The Eight Domains of the IRO Framework

The eight-domain IRO Framework provides a complete operating model for healthcare-integrated clinical research:

• Legal Architecture and Governance
• Financial Management and Business Operations
• Standardized Operations
• Investigator and Workforce Development
• Technology Enablement
• Quality and Continuous Improvement
• Clinical Research Strategy and Business Development
• Clinical Research Ecosystem Integration

Together, these domains provide the institutional infrastructure required to integrate clinical research into healthcare safely, consistently, and at scale.

Building the Infrastructure for Healthcare-Integrated Clinical Research

The IRO Framework recognizes that healthcare organizations do not all need to independently build a comprehensive research enterprise. Organizations may develop these capabilities internally, partner with an established IRO, or adopt a hybrid approach that combines internal resources with external expertise.

The position paper also explores how sustainable investment in clinical research infrastructure can expand research capacity, improve operational efficiency, and increase equitable patient access to clinical trials.

Expanding Patient Access to Clinical Research

At its core, the IRO Framework is built around a simple idea: patients should be able to learn about, consider, and participate in appropriate clinical research opportunities through the healthcare relationships they already trust.

The ultimate purpose of the IRO is not operational efficiency. It is expanding patient access to clinical research.

Explore the IRO Framework

Download The Integrated Research Organization (IRO) Framework position paper below to explore the infrastructure gap facing clinical research, the eight domains of the IRO Framework, and a vision for making clinical research a routine component of healthcare. Or, click here to view on LinkedIn.

Authors

Jennifer Byrne
Founder, Chief Executive Officer, Javara

Linda McCarty, JD
Co-Founder, Chief Legal Officer, Javara