Request for Information (RFI): Invitation to Comment on Inclusion Across the Lifespan II Workshop
The NIH is Interested in Responses to 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 (e.g., sex/gender minorities, racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, people with comorbidities, and others who are not well represented in clinical research).
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 ages, sexes/genders, races/ethnicities, and other underrepresented participants in clinical trials or clinical studies.
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.
Please note: clinical research is NOT research in clinics. “Clinical research aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, tissues, or other samples.”
Deadline for application submission: February 15th, 2020