Presented at: Advancing International Pediatric Clinical Research webinar series: Assent and Consent in the Field: Culture, Context, and Respect
The second conference in the series, “Time to Listen: Hearing from Young People in Clinical Research,” focused on the perspectives of young people and the adults who care for them in clinical research and product development. The two hour webinar featured a moderated panel and was hosted twice, from 9-11 am EST and 8-10 pm EST, with similar content but different speakers and panelists, to allow for wide attendance and global participation.
Developed by: MRCT Center Health Literacy Workgroup
Thank you to Dr. Farah Asif and colleagues at the Shaukat Khanum Memorial Cancer Hospital And Research Centre, Lahore, Pakistan for helping us translate, adapt text, and provide these flyers in Urdu.
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.
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.
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
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.
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
