Publication
Released on: January 31, 2022
Published in: Journal of Clinical and Translational Science
Focus Area: Clinical Trials & Research
AACI Commentary: Promoting Equity by Design in Clinical Trials by Dr. Barbara Bierer and Dr. Timothy Rebbeck
The January 2022 Association of American Cancer Institutes (AACI) commentary entitled “Promoting Equity by Design in Clinical Trials”, is written by MRCT Center Faculty Director Dr. Barbara Bierer and Dr. Timothy Rebbeck, Associate Director, Diversity, Equity and Engagement at Dana-Farber/Harvard Cancer Center.
Engaging Youth Throughout Product Development: Why, When, Who, and How
Presentation
Presented on: November 17, 2021
Presented at: PRIM&R’s 2021 Advancing Ethical Research Conference and Social, Behavioral, and Educational Conference (AER21/SBER21)
Talking to Teens About Clinical Research: The Development of Educational Brochures By and For Youth
Presentation
Released on: November 17, 2021
Published in: PRIM&R’s 2021 Advancing Ethical Research Conference and Social, Behavioral, and Educational Conference (AER21/SBER21)
Talking with teens: Clinical research educational brochures for youth
Part 1: The Regulation of Digital Health Tools and Software as a Medical Device
November 9, 2021 @ 11:00 am – 1:00 pm
In recent years, FDA has increasingly focused on honing its approach to regulating digital health tools and technologies, including those used in the research setting. This presentation focused on the Agency’s risk-based approach to regulation in the digital health space, with a focus on when clinical decision support and artificial intelligence/machine learning software may be considered a medical device subject to FDA regulation.
Deliverables
Projects
Meeting Summary
Released on: November 9, 2021
Topics: 1) The Regulation of Digital Health Tools and Software as a Medical Device, and 2) Update on the Application of the European Union’s General Data Protection Regulation to Research
Publications
Part 2: Update on the Application of the European Union’s General Data Protection Regulation (GDPR) to Research
November 9, 2021 @ 11:00 am – 1:00 pm
In the past 18 months there have been several important developments related to the GDPR, including the Schrems II decision, the resulting European Data Protection Board guidance on cross-border data transfers, and the issuance of revised Standard Contractual Clauses. This presentation addressed how each of these items affects researchers.
Deliverables
Projects
Meeting Summary
Released on: November 9, 2021
Topics: 1) The Regulation of Digital Health Tools and Software as a Medical Device, and 2) Update on the Application of the European Union’s General Data Protection Regulation to Research
Publications
October 2021: Demystifying Schrems II for the Cross-Border Transfer of Clinical Research Data
September 2021: Comments on European Data Protection Board Guidelines 04/2021 on Codes of Conduct as Tools for Transfers
October 2020: How to Fix the GDPR’s Frustration of Global Biomedical Research
April 2020: Comments to the European Commission on the Challenges that GDPR Raises for Research
March 2020: Disruptive and Avoidable: GDPR Challenges to Secondary Research Uses of Data
February 2019: Guidance Regarding Interaction Between GDPR and EU Clinical Trials Regulation Leaves Several Questions Unanswered
January 2019: Letter to the European Data Protection Board on the Board’s November 2018 Draft Guidance on the Territorial Scope of the GDPR
Navigating Interactions Between DMCs and IRBs
Meeting Summary
Presented on: October, 2021
Developed by: MRCT Center Bioethics Collaborative
Advancing International Pediatric Clinical Research: Informing the Future from COVID-19 Lessons Learned
Webinar
Presented on: October 6 & 7, 2021
Presented at: Advancing International Pediatric Clinical Research webinar series: Assent and Consent in the Field: Culture, Context, and Respect
The first conference in the series was a three-hour webinar that focused on applying lessons learned—those sustained and those abandoned– during the COVID-19 pandemic to future work with children in clinical trials.
We invite you to browse the Day 1 & Day 2 speakers’ brief biographical details.
Each keynote speaker was followed by two moderated panel discussions to:
- Deliberate the appropriateness and timing of initiating trials in children, and the different age groups within the broad scope of “children,” using lessons learned from COVID-19 and applying that learning to future pediatric trials.
- Address infrastructure, both new and adaptations to existing structures, needed to conduct efficient and ethical pediatric clinical trials on a global scale.
This project is supported by the FDA (R13) Scientific Conference Grant Program.
Day One
Day Two
Related Webinars
Assent and Consent in the Field: Culture, Context, and Respect
Time To Listen: Hearing From Young People in Clinical Research
Patient Advocacy and Engagement in Clinical Research
Meeting Summary
Released on: October 1, 2020
Developed by: MRCT Center Bioethics Collaborative