The article discusses the importance of creating educational materials to improve public understanding of clinical research data, particularly in light of misinformation during the COVID-19 pandemic. It emphasizes the need for transparency and clarity in addressing issues like data privacy and the ethical sharing of information. Modern tools such as videos and infographics can make clinical research more accessible and build trust with patients and the public.
Description: Mark Barnes and colleagues at Ropes & Gray, and Barbara Bierer published an article that discusses the impact of PubPeer, an online platform that publicizes suspected data integrity concerns, on the research misconduct process and the institutional challenges of handling anonymous comments within current regulations. The authors propose processes to ensure that credible allegations are rigorously assessed while reducing burden on institutions tasked with their investigation.
Published in:Essentials of Translational Pediatric Drug Development (Academic Press)
Description: Mariana Kruger, Moji Adeyeye, and Barbara Bierer co-authored a book chapter entitled “Pediatric drug development issues during public health emergencies” in the book Essentials of Translational Pediatric Drug Development. In their chapter, the authors outline the regulatory and ethical issues that arise during public health emergencies, focusing on pediatric drug development.
Description: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors on a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.
Summary: The article examines a proposed increase in government authority over research misconduct proceedings and notes that academic and medical institutions should understand the public, political, and ethical pressures on the Office of Research Integrity (ORI) to enhance oversight of research integrity. Institutions can alleviate some of these pressures by making their research misconduct processes more exacting, efficient, and, when possible, more transparent regarding the outcomes of specific cases. This can lead to improved public trust in the scientific research enterprise.