Notice Number: NOT-RR-10-010
Release Date: June 25, 2010
Response Date: July 30, 2010
National Center for Research Resources (NCRR), http://www.ncrr.nih.gov)
Accelerating translation of basic research advances into clinical applications to improve patient care is a key goal for the National Institutes of Health (NIH). NCRR’s Institutional Development Award (IDeA) program broadens the geographic distribution of NIH research funding and promotes the development or expansion of innovative state-of-the-art research centers and networks in IDeA-eligible states. Research supported by the IDeA program spans the full spectrum of basic and clinical sciences, encompassing all areas of health-related investigation. The objective of this RFI is to solicit input on how to: 1) strengthen clinical and translational research infrastructure in IDeA states, and 2) enhance the ability of IDeA institutions and investigators to fully participate in and expand ongoing NIH-funded clinical and translational research programs.
NCRR supports many aspects of clinical and translational research, enabling discoveries made at the molecular and cellular levels to move to animal-based studies and then to patient-oriented clinical research, ultimately leading to improved patient care. NCRR’s Clinical and Translational Science Award (CTSA) program supports a national consortium of research institutions to accelerate application of basic research to clinical care and to train clinical and translational investigators. Likewise, NCRR’s Research Centers in Minority Institutions (RCMI) Translational Research Network (RTRN) is a national consortium of clinical and translational researchers working in collaboration with community health care providers and the public to address health disparities in underserved populations. In addition, NCRR’s RCMI Infrastructure for Clinical and Translational Research (RCTR) initiative supports the development of infrastructure required to conduct clinical and translational research at minority-serving academic health centers. The National Primate Research Center (NPRC) resources enable NPRC staff scientists and investigators from the host institution and other research institutions to collaborate on research related to major human diseases.
The NIH recognizes that contributions from investigators in IDeA states are important and essential in fulfilling the promise of the NIH research agenda. The IDeA program serves unique populations, such as rural and medically underserved communities in IDeA eligible states. Several IDeA-funded centers currently support clinical and translational research and the program has the potential to significantly strengthen and expand eligible institutions capacity to conduct state-of-the-art clinical and translational research and leverage other NCRR-supported resources, such as the CTSA s, RCMI centers, the NPRCs, Biomedical Technology Research Centers (BTRCs) and the Biomedical Informatics Research Network (BIRN), along with other programs across the NIH. Young investigators mentored through the IDeA program in the conduct of clinical and translational research will be positioned to make inroads in addressing health disparities in medically underserved communities.
For the purpose of the RFI, clinical research is defined by the Office of Extramural Research, NIH, http://grants.nih.gov/grants/glossary.htm, as patient-oriented research, including epidemiologic and behavioral studies, outcomes research, and health services research. Patient-oriented research is research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which a researcher directly interacts with human subjects. It includes research on mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies, but does not include in vitro studies using human tissues not linked to a living individual. Studies falling under 45 CFR 46.101(b) (4) are not considered clinical research for purposes of this definition. Translational research includes two areas: One area concerns the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans. The second area concerns research aimed at enhancing the adoption of best practices in the community. Studies examining the cost effectiveness of prevention and treatment strategies are also an important part of translational science.
It is anticipated that the information received in response to this RFI will provide a useful snapshot of the status of NIH funded infrastructure for clinical and translational research in IDeA states and the successes and problems associated with developing or expanding such infrastructure. Some of the information you provide may be useful as case studies for consideration by NCRR staff and outside experts for planning purposes to support clinical and translational research infrastructure in IDeA institutions. As a result, the information provided will not be considered confidential. However, NCRR does not plan to release specific details about problems that are reported in response to this RFI. NCRR invites all interested parties including the general public to provide input on the following items. Respondents may address one or more items and do not have to address all items to submit a response to this RFI.
1) Interest in clinical and/or translational research
Comment on the relative importance of clinical and translational research within the overall context of biomedical and behavioral research at your institution and within your state generally. This may include emerging plans, if any, to increase the amount of clinical and/or translational research at your institution over the next few years, your interest in submitting applications for NIH funding to conduct such research and opportunities to conduct clinical and translational research focusing on health disparities in rural and other medically underserved communities.
2) The current infrastructure for conducting clinical and translational research at your institution
This could include but is not limited to a critical mass of investigators with expertise in clinical and/or translational research; physician scientists who are willing to participate in such research; clinical research education and training programs; availability of participants in research involving human subjects; access to diverse populations; Institutional Review Boards and regulatory support services for research involving human subjects; institutional interest in and support for clinical research, including clinical research space, equipment and release time for physicians and other clinical practitioners.
3) Key challenges to conducting clinical and/or translational research at your institution
These could include but are not limited to a lack of a critical mass of investigators with appropriate expertise; inadequate regulatory support for research involving human subjects; limited access to patient or participant populations; inadequate facilities and/or equipment; difficulty obtaining sufficient clinical release time for clinician scientists; limited access to or support for clinical research education and training opportunities or the need for collaboration with colleagues.
4) Key infrastructure enhancements and/or programmatic initiatives that could significantly enhance your ability to conduct clinical and/or translational research at your institution
This could include but is not limited to enhancements to institutional research training and career development efforts; improved coordination and synergy between clinical and translational research and training activities; collaborations across institutions within and between IDeA states; opportunities to leverage clinical and translational research resources, expertise and programs at other institutions, including those in non-IDeA states, such as NCRR-supported BBTRCs, NPRCs and other animal model resources, CTSA sites, RCMI sites and the RCMI Translational Research Network.
5) Issues associated with the extant COBRE initiative
The current phase-I Centers of Biomedical Research Excellence (COBRE) initiative supported by the IDeA program places significant emphasis on mentoring and career development of junior investigators. Comments are welcome on the advantages or disadvantages such an emphasis may present in the context of developing a clinical research center at your institution. This may include the key components that should be supported in order to develop or strengthen clinical and translational research centers using the existing COBRE mechanism.
6) Other issues
Please feel free to offer comment on any other issues pertaining to research infrastructure that may influence, positively or negatively, the ability to conduct clinical and translational research in institutions within IDeA states. These comments may include any other issues that may affect the ability of investigators to compete independently for peer-reviewed support to conduct clinical and translational research.
How to Submit a Response
Responses will be accepted through July 30, 2010. Responses by e-mail are preferred. Please use the address firstname.lastname@example.org to submit a response. The submitted information will be reviewed by NCRR and will be shared with other NIH Institutes and Centers that have an interest in this matter.
When responding to this RFI, please identify:
NCRR will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI submitted may be reflected in future solicitation(s). NCRR reserves the right to contact any responder that responds to this RFI for the sole purpose of enhancing NCRRs understanding of your RFI submission. The collected information will be analyzed and may appear in reports.This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
Inquiries regarding this notice may be directed to:
W. Fred Taylor, Ph. D
Director, IDeA Program
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Boulevard
Room 936, MSC 4874
Bethesda, MD 20892-4874
Telephone: (301) 435-0760
FAX: (301) 480-3770
This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government.