Info Sheet
Developed on: October, 2023
Developed by: The Global Health Network
Language: English
The Evolving Role of PI in the Oversight of Decentralized Clinical Trials
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Returning Individual Research Results and Data: Digging Deeper into Genetic Results and Secondary Findings
Webinar
Presented on: September 21, 2023
Presented at: Virtual
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.
Related Resources
ACMG/AMP Recommendations for Return of Secondary Findings
NASEM Returning Individual Research Results to Participants
Case Study: Responsibly Returning Secondary Findings
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
August 17, 2023: Digging Deeper into IRB/HRPP Responsibilities
Return of Individual Results website
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.
Returning Individual Research Results and Data: Digging Deeper Webinar Series
Webinar Series
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.
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.
Returning of Individual Research Results and Data: Digging Deeper into IRB/HRPP Responsibilities
Webinar
Presented on: August 17, 2023
Presented at: Virtual
Related Resources
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
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.
Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders
Public Comments
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.