The goal of this research project was to develop and validate a tool to assess the degree of responsibility of health innovations, what we call the In Fieri RIH Assessment Tool.
The Tool is based on the RIH framework, which makes explicit the value domains and attributes to be considered throughout the life cycle of an innovation and in light of the context in which the users of the innovation are located. The project was based on two methodological components.
First, international experts participated in a two-round Delphi prioritization exercise that took place on a secure web-based platform. Four categories of experts participated in the study: 1) scholars in the field of Responsible Research and Innovation; 2) engineers working in the health sector; 3) bioethicists; and 4) health technology assessment professionals. These experts used closed-ended questions to assess the level of importance of the attributes of a draft version of the tool, the clarity of its definitions, and the appropriateness of its scales. Free-text fields were used to comment and suggest additional relevant attributes. In Round 2, the experts received the results of the previous round, a redesigned version of the tool, and again commented on the level of importance and clarity of the attributes. Expert participation was anonymous. The tool was enriched and consolidated in each round with the feedback received. The results of the study have been published in this article.
The second component of the project aimed to assess the reliability of the tool by applying it to 25 different innovations and measuring the degree of inter-rater agreement. The study consisted of the following steps: (1) information sources were collected and validated for clarity and relevance; (2) the ratings of the two evaluators were independently entered into a database; (3) descriptive and analytical statistics to establish the degree of agreement for each of the attributes were generated; and (4) discrepancies in the ratings were discussed to identify possible sources of confusion. The results of this study can be found in this article, which makes the final version of the Tool available.
A user guide has been developed to support the application of the tool.
Project Lead: Hudson Silva