Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era

Abstract

Background: Currently, many initiatives are devoted to optimizing informed consent for participation in clinical research. Due to the digital transformation in health care, a shift toward electronic informed consent (eIC) has been fostered. However, empirical evidence on how to implement eIC in clinical research involving neonates is lacking.Methods: Semi-structured interviews were conducted with 31 health care professionals active in Belgium or the Netherlands. All health care professionals had experience in conducting clinical research involving neonates. Interviews were audio-recorded, transcribed and analyzed using the framework method.Results: Interviewees generally supported the use of eIC in clinical research involving neonates. For example, eIC could enable parents to receive study feedback via the eIC system. Requirements were expressed for parental involvement to decide on which feedback would be appropriate to return. Moreover, experts specialized in presenting information and designing electronic systems should be involved. Broad consensus among health care professionals indicates that the face-to-face-interaction between parents and the research team is vital to establish a relationship of trust. Therefore, it is necessary that the use of eIC runs alongside personal interactions with the parents. Concerns were raised about the accessibility of eIC to parents. For this reason, it was suggested that parents should always be given the possibility to read and sign a paper-based informed consent form or to use eIC.Conclusions: Health care professionals' views indicate that the use of eIC in clinical research with neonates may offer various opportunities. Further development and implementation will require a multi-stakeholder approach.

How to balance valuable innovation with affordable access to medicines in Belgium?

“…An interactive electronic informed consent system may further improve transparency by offering an overview of the use of participants' data across research studies, which could be a potential solution for challenges posed by the General Data Protection Regulation (Kaye et al, 2015;Budin-Ljosne et al, 2017). At a Belgian level, empirical literature regarding electronic informed consent is scarce (De Sutter et al, 2021). Also, the Clinical Trial College, a Belgian governmental body, coordinated the development of guidance related to the use of electronic informed consent in interventional clinical trials (Clinical Trial College, 2021;Federal Public Service Health Food Chain Safety and Environment, 2021).…”