Presented at: Advancing International Pediatric Clinical Research webinar series: Facilitating Pediatric Medicines Development: Models of Global Cooperation
Discussion topic: The FDA Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck).
Drs. Bierer and Clark will introduce the recently released MRCT Center’s Diversity Framework, titled Achieving Diversity, Inclusion, and Equity In Clinical Research. After providing a brief introduction, background, and contextual orientation to listeners, Drs. Bierer and Clark will highlight the ways in which stakeholders can contribute to increasing diverse representation in clinical research and, ultimately, improving health equity and public health domestically and abroad.
Presented at: MRCT Center webinar and public launch, “Equity by Design (EbD) in Clinical Research: The EbD Metrics Framework”
Dr. Barbara E. Bierer moderated this webinar, in which MRCT Center Program Manager Dr. Willyanne DeCormier Plosky introduced the background and structure of EbD Metrics Framework and panelists Yasmeen Long (Faster Cures, Milken Institute) and Dr. Rodrigo Garcia (PPD, Thermo Fisher Scientific) discussed their experiences in testing and utilizing it.
The EbD Metrics Framework is a tool developed by the MRCT Center in collaboration with colleagues from professional, trade, academic, regulatory, and patient advocacy organizations. It is designed to advance organizational diversity, equity, and inclusion (DEI) efforts; orient users toward potential entry and follow-up strategies; and provide guidepost measures for assessing and reporting on progress. To access the tool, please visit the EbD Metrics Framework page.
Presented at: Advancing International Pediatric Clinical Research webinar series: Assent and Consent in the Field: Culture, Context, and Respect
The third conference in the series, “Assent and consent in the field: culture, context, and respect,” focused on the cultural context of assent and the challenges and solutions encountered on the ground. The 2-hour agenda featured a moderated panel of experts who shared their experiences with assent around the world, including how to manage the tension between an (ideal) ethical framework and cultural context. The webinar was hosted twice on 28 June 2022 at 9-11 am EDT & 29 June 2022 at 8-10 pm EDT with similar content but different speakers and panelists, to allow for wide attendance and global participation.
Presented at: MRCT Center webinar and public launch, “Supporting IRB Efforts to Advance Diversity and Inclusion in Clinical Research”
Does the IRB play a role in addressing the problem of diversity, inclusion, and equity in clinical research? It is true that the need for change must be systemic and embraced at all levels of the clinical research enterprise, and while IRBs are not the primary driver for assuring diversity, inclusion, and equity in clinical research, IRBs can and should serve as a checkpoint for reviewing research for the principles of DEI. This webinar introduced tools and resources created for IRBs and HRPPs to help drive the change.
Presented at: MRCT Center webinar and public launch
The IRB can play an important role in championing the creation of research materials for participants that are clear and understandable. Please join us as we launch a new online Health Literacy training for IRB members and staff. The webinar launch will review health literacy concepts and introduce the online training which is designed to be a self-paced opportunity to learn and apply health literacy principles to the IRB role. The training also offers a facilitation guide to support continued conversations with colleagues about how to implement lessons learned.
Presented on: March 24, 2022 at 1:00 pm to 2:00 pm ET
Location: Virtual
The practice of returning IRR is consistently identified by participants as something that participants not only desire but also expect. Returning IRR demonstrates participant-centricity and respect.
A taskforce was convened during 2021 to update and further develop the MRCT Center’s guidance on Returning Individual Research Results to Participants – these resources and tools are ready to be shared, on a new, easy-to-navigate, dedicated website.
This one-hour webinar will include a review of IRR and its importance, a patient advocate describing her own lived experience with IRR, and a live demonstration of the new tools and website.
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.
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.
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.
Released on: July 14, 2021, 11:00 AM.-12 noon. EDT
Discussion Topic: MRCT Center Driving Inclusion in Clinical Research webinar: Simplifying the Complexity of Translation in Clinical Research
Presented at: MRCT Center Leaning In Webinar Series
Moderated by MRCT Center Faculty Director, Barbara Bierer, with guest speakers:
Megan Kasimatis Singleton, JD, MBE, CIP, Associate Dean, Human Research Protections; Director of the Human Research Protections Program, Office of Human Subjects Research, Johns Hopkins University School of Medicine
María José Reyes, MD, Internal Medicine and Infectious Diseases, Medical Director, PanAmerican Clinical Research
Ann E. Taylor, MD, Chief Medical Officer, AstraZeneca