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 inCancer

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 inJAMA

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 inThe 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 inNature 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 inJournal 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.

Returning Individual Research Results from Digital Phenotyping in Psychiatry

Publication

Published on: May 8, 2023

Published in: American Journal of Bioethics

In collaboration with Barbara Bierer and others, MGB authors Francis Shen and Benjy Silverman developed a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research. Read HERE.

Deprioritization of Ongoing Clinical Trials

Publication

Published on: October 1, 2023

Published in: Ethics & Human Research

Barbara Bierer, Deborah Zarin, and Luke Gelinas described in “Deprioritization of Ongoing Clinical Trials” the importance, ethical considerations, and challenges of ensuring that clinical trials continue to exhibit scientific relevance and value once initiated. Published in Ethics and Human Research, they suggested a framework to monitor ongoing trials and potential actions for responding to those findings of periodic review.