Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints.

Abstract

Very little is known about the practice-oriented challenges and potential response strategies for effective and efficient translation of informed consent and study prioritization in times of a pandemic. This stakeholder interview study aimed to identify the full spectrum of challenges and potential response strategies for informed consent and study prioritization in a pandemic setting. We performed semi-structured interviews with German stakeholders involved in clinical research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and potential response strategies was reached. We conducted 21 interviews with investigators, oversight bodies, funders and research support units. For the first topic informed consent we identified three main themes: consent challenges, impact of consent challenges on clinical research, and potential strategies for consent challenges. For the second topic prioritization of clinical studies, we identified two main themes: perceived benefit of prioritization and potential strategies for prioritization. All main themes are further specified with subthemes. A supplementary table provides original quotes from the interviews for all subthemes. Potential response strategies for challenges with informed consent and study prioritization partly share common ground. High quality procedures for study prioritization, for example, seem to be a core response strategy in dealing with informed consent challenges. Especially in a research environment with particularly high uncertainty regarding potential treatment effects and further limitations for valid informed consent should the selection of clinical trials be very well justified from a scientific, medical, and ethics viewpoint.