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December 8, 2025

10:00 am ET - 12:30 pm ET

Location:

Hybrid: In-person (Boston) and Virtual (Zoom) 800 Boylston St., Boston, MA

How Much Risk is Too Much? Revisiting the Ethics of Control Arms 

December 8, 2025 @ 10:00 am – 12:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

Topic: How Much Risk is Too Much? Revisiting the Ethics of Control Arms

This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.

December 9, 2025

10:00 am ET - 11:00 am ET

Location:

Mitigating Financial Toxicity for Participants in Clinical Trials

Webinar

December 9, 2025 @ 10:00 am – 11:00 am

Mitigating Financial Toxicity for Participants in Clinical Trials
Tuesday, December 9 | 10:00–11:00 AM ET

Hosted by the MRCT Center, in collaboration with Equitable Access to Clinical Trials (EACT), a project convened by LUNGevity Foundation.

Clinical trials are vital to advancing medical knowledge and care, yet participation can impose significant financial burdens on participants and their families—from travel and time away from work to uncovered medical and ancillary expenses.

This webinar will examine the sources and impact of these costs and highlight emerging strategies to reduce financial hardship for research volunteers. Presenters will also introduce tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation.

Panelists

Moderator
Dr. Barbara Bierer, Faculty Director, MRCT Center

November 30, 2022

Representation in Research ›

Bioethics Collaborative

December 9, 2025

1:00 pm ET - 3:30 pm ET

Location:

hybrid

The HALT Fentanyl Act and its effect on research involving controlled substances; Declaration of Taipei

December 9, 2025 @ 1:00 pm – 3:30 pm EST

The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topics: (1) The HALT Fentanyl Act and its effect on research involving controlled substances; (2) Declaration of Taipei

  1. HALT Fentanyl Act and Research.  On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances Act (“CSA”), and much of the political commentary and media attention related to the legislation have focused on this specific provision and its potential impact on the nation’s fentanyl crisis.  However, the HALT Fentanyl Act also contains numerous significant reforms related to research activities with controlled substances, including provisions streamlining the process for conducting research with any Schedule I controlled substance. We will discuss takeaways from the HALT Fentanyl Act that drug developers, academic medical centers, research institutions, and others involved in nonclinical or clinical research with controlled substances should consider for their ongoing and future research activities.
  1. The Declaration of Taipei, an ethical guideline by the World Medical Association (WMA) and adopted in 2016, for the collection, storage, and use of health data, biological materials, and health databases and biobanks. A meeting is taking place in December 2025 in Taipei, Taiwan, to discuss revisions to the Declaration of Taipei. Barbara Bierer is attending this meeting and will lead a discussion of key changes to the Declaration that were discussed at the meeting.

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

December 10, 2025

1:00 pm ET - 3:00 pm ET

Location:

Joint Task Force for Clinical Trial Competency (JTF) Global Biannual Meeting

Meeting

December 10, 2025 @ 1:00 pm – 3:00 pm

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, develops and disseminates standards and practices for the global clinical research workforce. By fostering a cohesive and collaborative approach, the JTF ensures that professionals have the competencies to conduct clinical trials ethically and effectively.

Our international team of investigators, educators, and clinical research professionals has developed and/or utilizes a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.

Join us on December 10, 2025, 1:00-3:00 PM for the Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting to hear about global perspectives on implementing the JTF Framework. Updates include:

  • From Translation to Transformation: Advancing Clinical Research Competencies in Pakistan through the Urdu JTF Framework
  • Advancing Professional Standards and Recognition for Australian Clinical Trials Professionals
  • Professional Development of the Clinical Research Workforce in New Zealand Public Hospitals
  • Designing Experiential Learning with a focus on JTF Competencies at North Carolina Central University
  • Using JTF competencies in designing a master level training program in Clinical Data Science

To learn more about the JTF Framework: https://mrctcenter.org/clinical-trial-competency/framework/overview/

All registrants will receive slides and a meeting summary after the meeting. This event is free.

Bioethics Collaborative

March 10, 2026

9:30 am ET - 12:30 pm ET

Location:

Hybrid: In-person (Boston) and Virtual (Zoom) 800 Boylston St., Boston, MA

Meeting of the Bioethics Collaborative 

March 10, 2026 @ 9:30 am – 12:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

Topic: TBD

This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.

September 8, 2026

10:00 am ET - 12:30 pm ET

Location:

Hybrid: In-person (Boston) and Virtual (Zoom) 800 Boylston St., Boston, MA

Meeting of the Bioethics Collaborative 

September 8, 2026 @ 10:00 am – 12:30 pm

Hybrid: In-person (Boston) and Virtual (Zoom)

800 Boylston St.
Boston, MA 02199

Topic: TBD

This meeting is open to sponsors of the Bioethics Collaborative. For more information about the Bioethics Collaborative and how to become a sponsor, click here.