Description: The “Including Young People in Research” toolkit offers tools, checklists, and considerations to support the intentional inclusion of the youth perspective in pediatric clinical trials and product development. These materials can assist investigators, Institutional Review Boards (IRBs)/Ethics Committees (ECs), sponsors, and others working with children and adolescents to engage youth respectfully and thoughtfully, helping to ensure that their perspectives are valued, gathered, appropriately weighted, and integrated. We expect that individuals will adapt these tools to their local context and specific study needs. We invite you to watch our short companion video for additional details on how to use and adapt these tools.
Tools, checklists, and considerations to assist investigators, Institutional Review Boards (IRBs), Ethics Committees (ECs), sponsors, and those working with children and adolescents to thoughtfully engage youth and ensure their perspectives are valued, weighted, and integrated.
The fifth and final part of the FDA-supported virtual conference series on Advancing International Pediatric Clinical Research showcased select resources and materials from the larger body of work developed by the MRCT Center pediatric working group initiative, including highlights from the four prior webinars in this series.
iCAN, in collaboration with the MRCT Center, produced a three-part video series that showcases young people from around the globe who have been involved in medical care and clinical research. The youth in the videos share some their thoughts on various aspects of what is important about including and listening to young people in clinical research.
Dr. Gianna ‘Gigi’ McMillan, an academic bioethicist and member of the MRCT Center pediatrics project, recorded in-depth interviews with three young people from India, Spain, and the US to create this 2-part video series, Time to Listen. In part 1, young people share their experience in clinical research and best practice guidance on communicating and conveying information to children and adolescents. Part 2 shows young people’s responses after watching adults discuss the goal of elevating their perspective at an international webinar.
Published in: Exploring Drug Discovery and Development
Dr. Barbara Bierer is featured in the Exploring Drug Discovery and Development article “Scientists and communicators team up to increase clinical trial participation” a look at clinicians, researchers, and communicators developing more effective strategies to disseminate information about clinical trials to reach a wider audience.
MRCT Center colleagues Barbara E. Bierer, Laura G. Meloney, Hayat R. Ahmed, Sarah A. White authored a commentary in Cell Reports Medicine on “Advancing the inclusion of underrepresented women in clinical research.”
Published in:The Journal of Law, Medicine & Ethics
Joseph Liss, former Legal Fellow at the MRCT Center, David Peloquin, Mark Barnes and Barbara Bierer co-authored “Applying Civil Rights Law to Clinical Research: Title VI’s Equal Access Mandate,” published in The Journal of Law, Medicine & Ethics. Title VI of the Civil Rights Act of 1964 prohibits federally-funded educational institutions and health care centers from engaging in discrimination “on the ground of race, color, or national origin.” The authors argue that the Department of Health and Human Services (HHS) “has not used the full arsenal of legal and policy tools at its disposal to push for equal rights” to obligate institutions that receive federal funding for clinical research “to provide equal access to participation in clinical trials to racial and ethnic minority communities.”
Dr. Barbara E. Bierer and MRCT Center Program Manager, Laura G. Meloney, co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to consider to address the problem.
MRCT Center Senior Advisors, Luke Gelinas and David Strauss, MRCT Center Faculty Director, Barbara E. Bierer, and others co-authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making.
