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.
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.
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.
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.
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.
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.
Published on: June 19, 2023
Published in: Frontiers in Communication
Description: In their article entitled “Communicating complex numeric information in clinical research,” recently published in Frontiers in Communication, Dr. Barbara Bierer and Sylvia Baedorf Kassis present an overview of the numeric concepts that arise throughout the course of research participation, as well as important considerations when presenting such information.
Published on: May 25, 2023
Published in: Amp&rsand, the PRIM&R blog
Description: Dr. Willyanne DeCormier Plosky and Barbara Bierer published “New Tools to Support Inclusion of People with Disabilities in Clinical Research,” based on the recently released Accessibility by Design (AbD) Toolkit.
Published on: May 8, 2023
Published in: American Journal of Bioethics
Description: Dr. Barbara Bierer, Francis Shen, and others published a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research, with specific reference to psychiatry.
