Deadline: February 15, 2020NIH Publishes RFI on Inclusion
Across the Lifespan Workshop II
The National Institutes of Health (NIH) recently published a request for information (RFI), NOT-OD-20-044, to solicit input concerning a planned follow-up NIH workshop on implementation of the new Inclusion Across the Lifespan policy, which addresses the recruitment and retention of pediatric, geriatric, and other underrepresented participants in clinical studies. NIH welcomes comments from all interested stakeholders, including the scientific community, patients, caregivers, advocacy organizations, and other members of the public. Topics that could be addressed include, but are not limited to, the following:
- 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.
Responses will be accepted through February 15, 2020. All comments must be submitted via email to NIAplanning@mail.nih.gov. Please include the notice number in the subject line and include your complete contact information with your response.