Request for Information - Inclusion Across the Lifespan

January 16, 2020

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We need you to weigh in and help shape the discussion at the IAL-II workshop! The Inclusion Across the Lifespan II Request for Information (RFI) was published recently and will be open until February 15. We welcome perspectives and comments from all interested stakeholders, including the scientific community, patients, caregivers, advocacy organizations, and the public on the following topics:

  • Challenges and barriers to enrollment of individuals of all ages in clinical research studies
  • Challenges and barriers to collection and reporting of participant-level data, including age at enrollment
  • Implementation strategies that address potential ethical challenges when including individuals under 18 years of age, frail or cognitively impaired older adults, and other vulnerable populations in clinical trials or clinical studies
  • Strategies and special considerations for including other underrepresented populations in clinical study designs that were not specifically addressed in the first workshop
  • Development, implementation, and dissemination of scientifically appropriate and ethical inclusion and exclusion criteria for clinical trials or clinical studies
  • The effect of developmental/aging stages on responses to biomedical and behavioral interventions and strategies to tailor study planning and implementation to life stages
  • How to overcome barriers to inclusion in clinical studies related to comorbidities, impairments, and disabilities
  • Practice- or evidence-based strategies and necessary adaptations in recruitment/retention methods, modified safety monitoring, and how to use life stage-specific and patient-oriented outcomes in clinical trials or clinical studies
  • Opportunities for education and outreach to clinical researchers, community physicians, and their patients about the importance of participation in research
  • Strategies to disseminate and support the adoption of proven implementation techniques and strategies that overcome barriers and maximize the inclusion of a broad range of diverse participants
  • Any other issues or concerns that NIH should consider regarding the implementation of optimal study designs that ensure the inclusion of participants across a broad range of ages and underrepresented groups

As noted, this is a trans-NIH initiative. Thus, we ask that you share this blog with colleagues in pediatrics and other applicable disciplines. All responses must be submitted via email. We hope you can also mark your calendars now for the September workshop and plan to join us in our next steps toward broadening inclusion for all!