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Data Literacy: Enhancing Trust and Transparency
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April 3, 2025

9:00 am ET - 10:00 am ET

Location:

Global Development of a Clinical Research Workforce: Tools and Resources

Webinar

April 3, 2025 @ 9:00 am – 10:00 am

Join us on April 3 from 9 – 10 am ET for a webinar dedicated to Global Workforce Development: Tools and Resources, featuring a keynote by Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS). Dr. Rago will share insights on CIOMS initiatives to define and synthesize professional competencies essential for clinical research and the need for cooperative agreements to harmonize workforce development efforts.

The session will also highlight the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities of recruiting and retaining a diverse and capable workforce.

Sally Armstrong, CEO of PRAXIS Australia, will share how PRAXIS Australia has used the JTF Framework in their educational offerings, including courses, workshops, and immersive onsite training programs.

Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), will discuss ACRP’s  “Partners Advancing the Clinical Research Workforce,” an initiative aimed at building a diverse and qualified clinical research workforce through training programs, educational resources, and collaborations with industry leaders, based on the JTF Framework, to address the needs of the clinical research field by providing pathways for new entrants and career advancement for existing professionals.

This webinar will provide actionable and practical strategies to support global clinical trial professionals.

Key topics:

  • Utilizing the JTF Framework to define and develop competencies in clinical research
  • Developing the education and training paradigm for the clinical research workforce
  • Recruiting and retaining a diverse and representative clinical research workforce

Bioethics Collaborative

April 3, 2025

10:00 am ET - 11:00 am ET

Location:

Data Literacy: Enhancing Trust and Transparency

Webinar

April 3, 2025 @ 10:00 am – 11:00 am

A key aspect of health literacy—especially in clinical research—is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.

The MRCT Center and PHUSE are collaborating to develop a suite of resources, including videos and infographics, to enhance data literacy in the clinical research context. Join us for this webinar as we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.

Key Topics:

  1. Advancing Data Literacy as a Component of Health Literacy
    • Explore how understanding research data supports informed decision-making and aligns with broader health literacy efforts.
  2. Applying Plain Language and Visual Tools to Data Communication
    • Learn how the MRCT Center and PHUSE have used plain language and infographics to make clinical research data more accessible.
  3. Empowering Participants with Transparent and Actionable Information
    • Identify ways to integrate data literacy resources into your clinical research processes to support research trust and engagement.

Bioethics Collaborative

April 10, 2025

1:00 pm ET - 3:30 pm ET

Location:

hybrid

Congressional Investigations into Research Activities and Update on DOJ’s Restrictions on Sharing Bulk Sensitive Personal Data with China and Other Countries of Concern

April 10, 2025 @ 1:00 pm – 3:30 pm

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.

Abstract: Congressional Investigations into Research Activities

In recent years, congressional investigations of biopharma companies, research institutions, and universities have frequently involved issues related to clinical research. We anticipate this trend to continue or even accelerate under the new Congress. During this session, we will begin with an overview of congressional investigations, including: (1) Congress’s authority to investigate; (2) the types of information requests that Congress sends private parties; and (3) the mechanics of congressional hearings. We will then provide key takeaways from recent congressional investigations involving clinical research and predict areas of focus in the coming years, taking into account recent actions of the Trump Administration. We will end with a discussion of the various risks of such investigations and provide best practices to mitigate such risk and effectively respond to investigations. Amish Shah, counsel at Ropes & Gray and former Senior Associate White House Counsel and congressional investigator, will lead the session.

Update on DOJ’s Restrictions on Sharing Bulk Sensitive Personal Data with China and Other Countries of Concern

On January 8, 2025, the U.S. Department of Justice published in the Federal Register a Final Rule entitled “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons.” Most provisions of the Final Rule will take effect on April 8, 2025, unless delayed by the administration of President Trump. The Final Rule imposes sweeping restrictions on providing access to health data, biometric data, human ‘omic data and biospecimens from which such data may be derived, as well as other categories of sensitive personal data, to the People’s Republic of China, certain other “countries of concern,” and “covered persons” that have ties to those countries. Notably, the Final Rule does not exempt de-identified, pseudonymized or anonymized data except in limited circumstances. During this session we will provide an overview of the Final Rule’s likely effect on research activities, including a discussion of the Rule’s research exemptions.

CLE credits will be available.

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

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

May 29, 2025

1:00 pm ET - 3:00 pm ET

Location:

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

Meeting

May 29, 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.

We invite you to attend the next virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) to learn about, present updates, and coordinate ongoing activities with the JTF Framework.

Bioethics Collaborative

June 4, 2025

1:00 pm ET - 3:30 pm ET

Location:

Therapeutic Misconception Revisited 

June 4, 2025 @ 1:00 pm – 3:30 pm

Location: Hybrid

Topic: Therapeutic Misconception Revisited

Abstract: The lines between research and care continue to blur. Pragmatic research studies comparing accepted therapies are increasingly embedded seamlessly into clinical practice. More and more, participation in research deemed promising is offered to patients before standard therapies are exhausted, sometimes as a first-line option. While the concept of “therapeutic misconception”—in very broad strokes, the tendency for individuals to misapply attributes of clinical care to research—has been a mainstay of research ethics for over 40 years, these developments provide an occasion, and perhaps even an urgent need, to revisit it and related topics. How exactly should we understand the therapeutic misconception and what it involves, particularly in cases where the line between research and care really is vague and hard to determine? Even more basically, how should we understand the relationship between research and care in the first place? Are concerns over therapeutic misconception still important, or do they perhaps reflect naïve understandings of research and care and the relation between them–particularly in cases where current options are limited? 

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.

June 5, 2025

10:00 am ET - 12:30 pm ET

Location:

hybrid

Meeting of The Research, Development, and Regulatory Roundtable (R3)

June 5, 2025 @ 10:00 am – 12:30 pm

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.

Topic: TBD

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

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

September 8, 2025

9:30 am ET - 1:00 pm ET

Location:

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

Meeting of the Bioethics Collaborative 

September 8, 2025 @ 9:30 am – 1:00 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 25, 2025

10:00 am ET - 12:30 pm ET

Location:

hybrid

Meeting of The Research, Development, and Regulatory Roundtable (R3)

September 25, 2025 @ 10:00 am – 12:30 pm

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.

Topic: TBD

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

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

November 13, 2025

1:00 pm ET - 3:30 pm ET

Location:

hybrid

Meeting of The Research, Development, and Regulatory Roundtable (R3)

November 13, 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.

Topic: TBD

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

Deliverables

Projects

Research, Development, and Regulatory Roundtable (R3)

December 8, 2025

9:30 am ET - 1:00 pm ET

Location:

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

Meeting of the Bioethics Collaborative 

December 8, 2025 @ 9:30 am – 1:00 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.