Stepwise process of clinical trials in safety-conscious development of human assistive robots

Recent advances in the study of human assistive robots have led to requests for ethical review for clinical trials during the development process. In this environment, many developers have found it difficult to understand the criteria for these ethical reviews. One of the basic reasons for this difficulty is the methodology in robotics. That is, trials in the development of robotics are characterized as exploratory rather than confirmatory, with the current design being rapidly altered to achieve the final product. However, from the ethical and scientific viewpoints, it is requested to plan serial trials so that the objectives gradually shift from exploration to confirmation. That is, aspects of the design should be gradually fixed throughout the development process, and in the latter stages trials should be conducted that confirm the merits of a fixed design. To address this problem, we proposed a development process for human assistive robots in our previous work with the intention of helping developers identify the current phase of development and plan suitable experimental protocols. Based on this, in this paper we present a more refined approach that considers a stepwise process for developing the final product with enough safety measures to protecting users.