Publication
Published on: January 18, 2024
Published in: Frontiers
Resource Type: Publication
Losartan in hospitalized patients with COVID-19 in North America
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.
Defining “recklessness” in research misconduct proceedings
Publication
Published on: September 5, 2023
Published in: Accountability in Research
Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application, and proposing a framework and factors to consider in recklessness determinations.
Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection–Inclusion Dilemma
Enhancing diversity of clinical trial populations in multiple sclerosis
Publication
Published on: August 9, 2023
Published in: Multiple Sclerosis Journal
As an outgrowth of an international workshop held in Dec 2022, Dr. Bierer collaborated with experts in multiple sclerosis to develop recommendations regarding diversity and inclusivity of participants in clinical trials investigating multiple sclerosis.
The Unresolved Challenge of Triage
Publication
Published on: August 29, 2023
Published in: JAMA
Dr. Barbara Bierer co-authored a commentary, “The Unresolved Challenge of Triage,” exploring the ethical and legal challenges of allocating limited care resources in a disaster setting in JAMA.
Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement
Publication
Published on: August 11, 2023
Published in: Med (Cell Press)
Description: Laura Meloney, Hayat Ahmed, and Barbara Bierer coordinated a modified Delphi process to establish consensus on recommendations for IRBs/ethics committees and institutions to promote diversity and inclusion in interventional clinical research. In this paper, they discuss the 25 consolidated recommendations across four themes.
Terms and conditions apply: an ethical analysis of mobile health user agreements in research
Publication
Published on: July 14, 2023
Published in: Journal of Law and the Biosciences
Description: Luke Gelinas, MRCT Center Senior Advisor, Walker Morrell, former MRCT Center Project Manager, and Barbara Bierer published an ethical analysis of terms of service and other agreements used in mobile health technologies in clinical research. Risks, mitigating strategies, and recommendations for disclosure (with points to consider) were discussed to help ensure the privacy interests and rights of participants.
Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomized, factorial, mixed-methods trial
Publication
Published on: July 29, 2023
Published in: The Society for Clinical Trials
Description: Colleagues in the UK, assisted by Dr. Bierer, assessed site staff experience in returning plain language summaries to participants after completion of a trial. Not only did the staff feel that the communication was important but there were no concerns or challenges in responding to participant questions. Operations and cost were both feasible.
