Participation of diverse volunteers for many different types of studies has taken center stage as one of the leading challenges in aging research. Both clinical trials and natural history studies have yet to demonstrate anywhere near adequate representation of diverse cohorts. A complete study of a disease state requires the inclusion of diverse cohorts of research participants in terms of race, ethnicity, gender, age, and status of disease. Diversity among research participants broadens scope and improves the generalizability of scientific investigations. In particular, classifications of race, ethnicity, socioeconomic status, sex/gender are multifactorial and dynamic in their influence on disease state warranting their abundant representation in research. The NIA Health Disparities Research Framework calls for studies that incorporate factors at environmental, sociocultural, behavioral and biological levels of analyses with robust diversity of the research participants. Many research areas of focus supported by the program divisions of NIA will benefit from this active effort in enhancing recruitment and retention of research participants.
The Division of Behavioral and Social Research supports social, behavioral, and economic research and research training on the processes of aging at both the individual and societal level. There is a need to have persons of a wide array of characteristics included in clinical trials and related research: small and large family groups, racial, ethnic, social, economic, linguistic, gender, cultural, educational and neighborhood.
The Division of Geriatrics and Clinical Gerontology supports clinical and translational research on health and disease in the aged, and research on aging over the human life span, including its relationships to health outcomes. Investigators often exclude children (defined here as individuals under age 18) or older adults (individuals ages 65 and older) either (1) explicitly, by limiting the age range of eligible participants in their exclusion criteria, or (2) implicitly, by excluding those with co-morbid conditions or polypharmacy use, both which are common in older populations. As a result, many interventions are inadequately tested in the very old and the very young. Recruitment needs to consider the age distribution of the disease/condition/study topic in the general population. Investigators should seek to understand better the historical and social context of historically vulnerable and consistently underrepresented groups to ensure their improved recruitment and representation in clinical trials and research.
The Division of Neuroscience fosters and supports extramural and collaborative research and training to further the understanding of neural and behavioral processes associated with the aging brain. Increased public and private investment in Alzheimer’s disease and related dementias research has spurred a rise in the number of therapeutic targets, drugs and other interventions that need to be tested in clinical trials. Further, a new challenge has emerged in recruiting healthy normal volunteers, as prevention trials seek to enroll subjects prior to evident symptoms of cognitive decline and dementia. For healthy volunteers, there is limited evidence base of optimal ways to reach these cohorts, which must also include underrepresented groups. Additionally, modern clinical trials in neurodegenerative disease research can be very invasive, requiring lumbar punctures and brain scans and sometimes infusions, surgical procedures and requests for brain donation after death. Much more work is needed to understand how to motivate participation, particularly in underrepresented groups for such invasive procedures.
Overall, NIA seeks investigators who are focused on improving the research tools, research methods and recruitment practices to produce a significant number of committed research participants to aging research. This targeted initiative seeks to focus teams of investigators and community members on the development and evaluation of innovative recruitment and retention methods and strategies that enhance diversity of research participants and ensure adequate representation of underrepresented populations in aging research. A priority of NIA is to advance the evidence base for strategies and processes that will increase enrollment in clinical studies. This initiative addresses Goal F.3. of NIA’s Strategic Directions for Research on Aging: “develop and implement strategies to increase inclusion of diverse populations in research.”.
This initiative will foster a collaborative network of teams to engage large diverse populations and accelerate research participant recruitment into aging research and NIA funded clinical studies. Collaboratory teams will support the creation of a portfolio of timely and essential enabling resources designed to enhance the recruitment and retention of a large diverse community population for aging research. The teams will be required to implement these resources either in a regional (community of greater than 20,000) or national scope (more than one geographic area) by organizing numerous local activities as part of the assembled team.
The team assembled must have the necessary expertise to pursue multiple questions or generate new knowledge regarding multiple problems, focus on innovative approaches, design multiple interventions, or develop multiple resources relevant to recruitment. It is expected that this collaborative network will result in a greater contribution to the initiative goals of enhancing diverse recruitment, than would occur if each team member worked independently. Teams should address recruitment challenges with expertise across multiple field domains that may exist outside of science (marketers, community organizers, pollsters, advertisers, communications, etc.). Teams should include community members and patient/volunteer liaisons to provide training on research participation with a primary goal of incorporating community members and patient/volunteer liaisons into the recruitment infrastructure.
A team should not include groups of investigators at the same institution who would normally interact and collaborate in the absence of a collaborative initiative. Additionally, the team should not focus on a single community population or single strategy for a single clinical trial/study.
The goal of this initiative is to improve research participant recruitment through method development, community engagement, evaluation strategies and community incorporation. Primary activities that should be completed by the teams within the project period are:
- Develop and evaluate innovative approaches to recruitment and retention
- Test new approaches and disseminate methods to the field
- Engage, educate and motivate community members to participate in research; facilitate their enrollment and demonstrate measurable success
- Incorporate community members and patient/volunteer liaisons into the recruitment infrastructure and enable them to be active partners in recruiting additional community members.
- Provide sustainable participants to active NIA funded clinical research
In order to successfully complete the primary activities above, teams are required to engage in three or more of the following types of activities; other team created activity types can also be utilized:
- Review progress of the last 10 years and evaluate successful methods
- Create a comprehensive analysis of populations across published studies
- Identify and address challenges that require expertise across multiple domains
- Design research programs that seek to understand cultural distinctions (values and beliefs) that hinder research participants and build cohesion with potential research participants
- Create collective goals between the research institution and the community members to enhance trust within the communities.
- Develop innovative strategies for increasing knowledge and awareness
- Support pilot studies to validate concepts and approaches
- Develop data sharing and information exchange platform
- Disseminate results and provide technical assistance
- Hold workshops and focused assistance forums, webinars
- Partner with community business entities to create active education centers
- Trial start up services, master agreements, central IRB training, protocol development, quality assurance checks
- Create mobile applications/technology, social media, visual, video or multimedia recruitment materials
- Establish a volunteer call center
- Increase physician awareness about the availability of clinical studies and enhance referrals to studies/registries Initiative Milestones
- Prepared a team with innovative outreach and recruitment plans
- Engaged community members in research participation education
- Inspired and recruited community members and patient/volunteer liaisons to become part of the recruitment infrastructure
- Enrolled community members into trial/research ready cohorts
- Facilitated enrollment of research participants into NIA funded clinical research
- Documented and evaluated approaches and disseminated information
An important goal is to build research capacity in recruitment and retention practice. Therefore, it is expected that research teams will provide opportunities for mentoring and career development to early career researchers and underrepresented populations poised to make contributions to this field of inquiry.
Deadlines: standard dates apply
Filed Under: Funding Opportunities