The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar in May. Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.
This webinar was the third of the three webinars in the Digging Deeper series. Megan Frone of the National Cancer Institute discussed a case about returning genetic/genomic results and secondary findings.
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.
Presented on: July 27, August 17 and September 21, 2023
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar. Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.
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.
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.
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.
Details: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870).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.
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.
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.
