Publication
Published on: August 1, 2024
Published in: The Journal of Bone and Joint Surgery
The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research
Resource Type: Publication
Pediatric drug development issues during public health emergencies
Publication (book chapter)
Published on: August 2024
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.
The Occasional Human Sacrifice: Medical Experimentation and the Price of Saying No, by Carl Elliott. New York: W.W. Norton & Company, 2024
Publication
Published on: June 21, 2024
Published in: Journal of Medical Humanities
E-Book: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies
Publication
Published in: August 2024
Published in: Frontiers in Pharmacology & Frontiers in Medicine
Editorial: Building the Clinical Research Workforce: Challenges, Capacities, and Competencies
Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials
Publication
Published on: June 24, 2024
Published in: Cancer
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.
Proposed Increases in Government Authority Over Research Misconduct Proceedings
Publication
Published on: June 20, 2024
Published in: JAMA
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.
A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19
Publication
Published on: May 31, 2024
Published in: The Journal of Law, Medicine & Ethics
Summary: COVID-19 illuminated the need for equity-informed practices in public health. This manuscript, to which Sylvia Baedorf Kassis and Dr. Barbara Bierer contributed, presents a community-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with between community health centers and the populations they serve.
First, do no harm: a global perspective on diversity and inclusion in clinical trials
Publication
Published on: May 8, 2024
Published in: Nature Reviews Drug Discovery
Description: New requirements for clinical trial sponsors to submit diversity action plans to the US Food and Drug Administration (FDA) are an important step to embed planning for diverse representation in clinical trial research. These must not, however, be implemented in ways that are detrimental to other countries’ health and research interests. It is possible for those making operational decisions on country and site selection to address the needs of underserved populations in other countries at the same time as meeting US regulatory expectations — for example, by addressing barriers to diverse recruitment. Site selection should follow purposeful engagement in the local and regional culture, considering the needs of the local population, and proceed only if the trial is responsive to those needs.
Ethical Considerations in Decentralized Clinical Trials
Publication
Published on: March 1, 2024
Published in: Journal of Bioethical Inquiry
Description: Barbara Bierer and Sarah White summarized salient ethical issues in the design and conduct of decentralized clinical trials, including participant safety, privacy and confidentiality, consent, digital access and proficiency, and trial oversight. Given the increasing involvement of decentralized study components, it is necessary to develop processes and cooperative solutions to promote safe, ethical trials, as well as focus on decreasing burden and increasing access for all participants.
