Infrastructuring Readability: Framing and Overflowing in Writing Assistant Software for Biomedical Research Informed Consent Forms

This article analyzes the development process of a software solution designed to assist researchers in writing biomedical research–informed consent forms. Funded by a Swiss ethics committee, the purpose of the software is to enhance the readability of such documents to improve biomedical research participants’ understanding of the information disclosed therein and to reduce the editing work of research ethics committees. Drawing on an embedded ethnographic research, we show how concerns that emerge in ethics reviews shape ethics committee IT infrastructure and how, in turn, this infrastructure contributes to redefining research ethics. We demonstrate that while the software reinforces the biomedical framing of research ethics, it also generates unexpected overflows. By forming new collectives, this infrastructuring process furthers expertise on informed consent forms while giving rise to new areas of inquiry and redefining the issue of readability in biomedical research. Thus, we provide insights into the complex entanglements between research ethic, computer programs, and writing practices. We conclude by reflecting on the role played by our research team during the software's development and outline proposals on how ethnographic methods can contribute to make research ethics review accountable.