LAUSR

Abstract Objectives The way new health technologies are being developed and brought to market undermines the sustainability of health systems around the world and limits the emergence of innovations that could generate greater system-level benefits. While Responsible Research and Innovation (RRI) offers relevant principles to address this policy problem, there are no tools to assess whether an innovation qualifies as a Responsible Innovation in Health (RIH). Drawing on RRI and health policy research, we developed a RIH Tool that entails a three-step process: screening, assessment and rating. Methods To critically evaluate and improve the constructs of the Tool, we conducted an international Delphi study with experts (n = 19) in RRl, biomedical engineering, bioethics and Health Technology Assessment who were asked to examine: (1) the inclusion and exclusion criteria that should be used to identify whether an innovation may potentially qualify as a RIH (screening); (2) the responsibility dimensions and attributes that should be measured in more detail (assessment); and (3) the scoring system that should be applied (rating). Results A large number of insightful comments was shared by experts (221 comments in Round 1; 69 in Round 2) and, after the second round, consensus was achieved for 16 of the 20 survey questions pertaining to the importance, clarity and appropriateness of the constructs. Conclusion Further development of this Tool will help to bridge an important knowledge and policy gap by enlightening the decisions made at an early stage by innovation stakeholders, such as investors, technology developers, research funding agencies and policymakers.