Presented on: August 17, 2023
Presented at: Virtual
Case Study: IRB/HRPP Responsibilities
May 2, 2023 webinar: Returning Individual Research Results and Data to Participants
July 27, 2023 webinar: Digging Deeper into Pfizer’s Patient Data Return Solution
Return of Individual Results website
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.
Presented on: July 31, 2023
Details: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870). The MRCT Center applauds the FDA for providing this timely and informative guidance, and our comments are intended to further clarify and expand the Agency’s recommendations. Read more here.
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.
Presented on: July 27, 2023
Return of Individual Results Case Studies
Case Study: Implementing a Robust, Scalable Participant Data Return Solution
Return of Individual Research Results website
Comments submitted on: July 30, 2023
Comments submitted to: European Commission
Details: The MRCT Center submitted public comments on the proposed revision of the EU general pharmaceuticals legislation. In broad support of merging the Paediatrics Regulation with general pharmaceuticals legislation, our comments urged the European Commission to ensure pediatric medicines development remains an implementation priority to meet the needs of children throughout Europe.
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.
Comments provided on: June 30, 2023
Comments provided to: ICER
Comments provided on: July 5, 2023
Comments provided to: NIH
