Notice Number: NOT-TR-13-001
Release Date: October 15, 2012
National Center for Advancing Translational Sciences (NCATS)
The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), seeks comments from all key stakeholders in the scientific and public health communities on the development of a research agenda utilizing the community engagement infrastructure developed through the Clinical and Translational Science Awards (CTSA) program to achieve its broad clinical and translational goals. Key stakeholders include all investigators involved in bringing basic science through the translational pipeline to improve health in the community; those public and private partners who fund such research and services; and others including clinicians, patients, and community leaders seeking better diagnostics, treatments, preventions and cures.
The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human health, diseases and conditions. The CTSA program, which funds a consortium of medical research institutions to improve clinical and translational research, plays an essential role in meeting the NCATS mission. In fiscal year 2011, the NIH invested $460,566,000 in the current CTSA sites to participate in a variety of activities supporting translational science including: the conduct of translational research, training and developing the next generation of translational scientists, and developing innovative methods and technologies to strengthen translational research (see http://www.ctsacentral.org/).
Since early in the development of the CTSA program, the NIH has recognized that community engagement plays a critical role in fostering collaborative research partnerships and enhancing public trust in clinical and translational research. For several years community engagement activities and research were required components of CTSA applications. The funding received by CTSA institutions provided them with the opportunity to be flexible in designing community engagement programs specific to their needs while supporting the translational science enterprise of each institution. The CTSA National Consortium Community Engagement Key Function Committee was established to coordinate community and practice engagement projects across CTSA sites. Diverse projects addressed the need to educate the public and academics about the community engagement process, establish healthy living programs, provide community needs assessments, and develop an infrastructure to facilitate community-based participatory research. These types of activities have enhanced the research capabilities of the CTSA institutions including connecting with hard to reach patient populations for clinical trials and opportunities to speed the dissemination and implementation of research findings.
NCATS is now interested in capitalizing on the NIH investment in the development of community engagement partnerships and infrastructure to support and conduct translational research. This RFI is soliciting input from a variety of key stakeholders requesting their input on the development of a research agenda that would leverage the community engagement capability of the CTSA institutions to solve critical roadblocks in the translational research process.
Public comment is sought on the development of a research agenda building on the CTSA community engagement projects, collaborations, and infrastructure to facilitate the conduct of translational research. Possible areas for comments include, but are not limited to:
1. Appropriate role and activities of community engagement capabilities of the CTSA institutions.
2. Specific population and public health research challenges, such as changing health-related behavior or addressing health conditions of at risk populations that requireeffective community engaged translational research and the potential for testing of novelapproaches.
3. Specific research questions and/or types of translational research that the CTSAcommunity engagement partnerships, infrastructure, and/or researchers are best suited toaddress.
4. Techniques and/or tools the CTSA community engagement infrastructure could create ormake available that would enhance the conduct of translational research, e.g. practicebased research networks, electronic and administrative databases, consent procedures,connections with hard to reach patient groups and communities for clinical trials, etc.
5. Translational research questions of most interest to patients, providers, policy makers,researchers and other key stakeholders associated with the community engagementcomponent of CTSA sites.
6. The role community-based participatory research can play in addressing high priorityclinical and translational research questions of critical importance to other NIH-fundedresearch.
7. Opportunities to advance studies of dissemination and implementation of new orrepurposed therapeutics, behavioral interventions, effective prevention programs, anddiagnostics in routine practice settings within CTSA institutions.
8. Developing definitions, scientific measures, metrics, and outcomes for community engagement research and model programs.
9. Training opportunities within the CTSA infrastructure to prepare researchers in theconduct of translational research in community-based settings and in collaboration with community groups.
To respond to any of the points above or others, please identify the critical issues(s) and recommended approaches. Responders are free to address any or all of the above items.
All comments must be submitted electronically to: CTSA-CEInformation@mail.nih.gov.
Responses to this RFI will be accepted through 11/15/2012. Responders will receive an electronic confirmation acknowledging receipt of a response, but will not receive individualized feedback on any suggestions. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.
This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the NIH, and/or NCATS. NCATS does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
Proprietary, classified, confidential, or sensitive information should not be included in your response. NCATS will not de-identify responses, so please do not include identifiable information if you want to make confidential comments. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Please direct all inquiries to:
ATTN: RFI on Enhancing Community- Engaged Research through the Clinical and Translational Science Awards (CTSA) Program
National Center for Advancing Translational Sciences
6701 Democracy Blvd, Room 9113, MSC 4874
Bethesda, MD 20892-4874
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