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Research During the Pandemic: Views from Both Sides of the Fence
Abstract:
The SARS-CoV-2 pandemic has affected practically every aspect of life across the globe for the past year or more; the practice of clinical research not the least. Clinician scientists attempting to start or continue work both related and unrelated to the disease itself have faced ethical, oversight, or regulatory challenges. No aspect of the clinical trial enterprise was unaffected. These narratives detail some of the barriers encountered and how the investigators coped (or didn't cope). Common themes emerged, ranging from a need to contribute, which drove the researchers to frustration with real and perceived obstructions (both old and new). The narratives disclose common ethical issues related to research during a pandemic: issues both qualitatively and quantitatively different from other human subject research; challenges both new and novel, as well as those previously seen, but writ large in the face of the crisis. The narratives also offer words of advice from the trenches and speak to successes, both large and small, and to the value of teamwork and focus on a common goal.
Insights
The COVID-19 pandemic created significant ethical and regulatory challenges for clinical research, impacting clinician scientists globally. Investigators navigated these obstacles, highlighting the need for teamwork and adaptive strategies in human subject research.
Area of Science:
- * Clinical Research Ethics
- * Pandemic Response in Healthcare
Background:
- * The COVID-19 pandemic profoundly disrupted global clinical research operations.
- * Clinician scientists faced unprecedented ethical, regulatory, and oversight challenges.
Purpose of the Study:
- * To detail barriers encountered in clinical research during the pandemic.
- * To explore how investigators coped with these challenges.
- * To identify common themes, ethical issues, and offer advice for future research.
Main Methods:
- * Qualitative analysis of investigator narratives and experiences.
- * Identification of recurring themes and challenges in clinical trial conduct.
Main Results:
- * Common themes included the drive to contribute amidst frustration with obstructions.
- * Ethical issues were qualitatively and quantitatively different during the pandemic.
- * Both novel and pre-existing challenges were amplified by the crisis.
Conclusions:
- * Clinical research faced unique ethical and logistical hurdles during the pandemic.
- * Investigator resilience, teamwork, and focus were crucial for navigating challenges.
- * Lessons learned offer guidance for future pandemic research and human subject protection.
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