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.

Communicating complex numeric information in clinical research

Publication

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.

Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

Publication

Published on: April 26, 2023

Published inInternational Journal of Clinical Trials

Description: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” describing the experience of conducting a multinational acupuncture study during the pandemic.

Bringing data monitoring committee charters into the sunlight

Publication

Published on: May 25, 2023

Published in: National Center for Biotechnology Information, NIH

Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.  

DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.