Background: Very little is known about the practice-oriented challenges and mitigation 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 mitigation strategies for informed consent and study prioritization in a pandemic setting. Methods: We performed semi-structured interviews with German stakeholders involved in human subject research during the COVID-19 pandemic. We continued sampling and thematic text analysis of interview transcripts until thematic saturation of challenges and mitigation 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 categories: consent challenges, impact of consent challenges on clinical research, and potential response strategies for consent challenges. For the second topic prioritization of trials, we identified two main categories: need for prioritization of clinical studies and potential response strategies for prioritization of clinical studies. All main categories are further specified with subcategories. A supplementary table provides original quotes from the interviews for all subcategories. Discussion: Mitigation 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 mitigation 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.

The authors have declared no competing interest.

The project received funding from the Federal Ministry of Education and Research (01KI20123). The funder had no role in study design, data collection, analysis, and interpretation, or in writing the manuscript.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The research ethics committee of Charite - Universitaetsmedizin Berlin gave ethical approval for this work (Approval No: EA4/006/21).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

All data produced in the present work are contained in the manuscript. Full interview transcripts cannot be shared publicly because of participants privacy. Excerpts of the transcripts relevant to the study are provided within the paper (see supplementary table S4).