Related Experiment Video
Updated: Jun 27, 2025

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences
Stefanie Weigold1, Susanne Gabriele Schorr1, Alice Faust1
1QUEST Center for Responsible Research, Berlin Institute of Health (BIH) at Charité - Universitätsmedizin Berlin, Berlin, Germany.
Background:
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.
Methods:
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.
Results:
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.
Discussion:
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.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Nurses' Legal Responsibilities I
The legal responsibilities of a nurse regarding informed consent include the following:
Blinding
Ethical Dilemmas II
Ethics in Research

