and Human Services (HHS)
EXPIRED
NINDS COOPERATIVE PROGRAM IN TRANSLATIONAL RESEARCH RELEASE DATE: July 26, 2002 PA NUMBER: PAR-02-139 (This PAR has been reissued, see PAR-05-158) EXPIRATION DATE: July 31, 2005 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators (PIs) o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA Recent discoveries across a broad range of research areas in the neurosciences offer promising opportunities for treatment of neurological disorders. As part of its mission to reduce the burden of neurological disease, NINDS is committed to encouraging the "translation" of these discoveries into new treatments. The goal of this PA is to implement a program of cooperative agreements that will support milestone-driven projects focused on the identification and pre-clinical testing of new therapeutics. The program will facilitate the effective review and research administration of translational research projects and will accelerate the translation of discoveries in basic research to treatment in the clinic. This PA is one of three coordinated programs being released by NINDS to promote translational research, including "NINDS Exploratory/Developmental Projects in Translational Research" (http://grants.nih.gov/grants/guide/pa-files/PAR-02-138.html) and "NINDS Mentored Research Scientist Development Awards in Translational Research" (http://grants.nih.gov/grants/guide/pa-files/PAR-02-140.html). RESEARCH OBJECTIVES Definition of Translational Research: Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The scope of this program includes only activities directly focused on therapy development necessary to begin clinical testing. Mechanistic or basic studies will not be supported, nor will clinical trials. Projects will typically include either an assay that has demonstrated relevance to a neurological disorder, or candidate therapeutics that have a significant effect in a disease model. Background: Opportunities for discovery and progress in the treatment of neurological diseases have never been greater. Remarkable advances have been made recently in our understanding of the molecular and genetic bases of disease, and the potential therapeutic opportunities offered by these scientific findings create an opportunity for basic, applied, and clinical scientists to combine and coordinate their efforts. The realization of the potential for translating accumulated new knowledge will depend on the cooperation and partnering of public and private funding organizations, universities, academic medical centers, research institutes, contract research organizations, biotechnology companies, and pharmaceutical companies. Collaborative arrangements between drug and device companies and academic medical centers will be needed, with a spirit of sharing in the risks and rewards of the effort being inherent to the relationships. By combining investigators from diverse fields of basic and clinical neuroscience, new perspectives and insights can be brought to bear on research findings. To accomplish this will require that innovative clinicians join forces with basic biologists with an interest in applying their work to human disease. These collaborations may be enhanced by the participation of applied scientists, such as epidemiologists and population geneticists, and the advice of chemists, physicists, and statisticians. New and emerging technologies, such as combinatorial chemistry, high-throughput screening, and functional genomics will be needed to support the collaborations, and to bring the translational process to fruition. The NINDS Cooperative Program in Translational Research is intended to catalyze the development of partnerships between basic and clinical investigators, and to stimulate agreements between the academic and industrial sectors, so that translational research in neuroscience can flourish as a cooperative, iterative process leading to new and effective interventions for neurological disorders. Stages of Translational Research: Translational research proceeds through a number of stages toward therapy development. Specific project milestones can be defined based on these stages, and applications should include a linear timeline or flowchart of project tasks and milestones. Early stages lead to the identification and characterization of candidate therapeutics, and late stages include preclinical development and submission of an Investigational New Drug (IND) or Investigational Device Exemptions (IDE) application to the Food and Drug Administration (FDA). In many cases, early-stage projects will be unable to achieve an IND or IDE within a single project period. Implementation: The NINDS Cooperative Program in Translational Research is implemented through three coordinated cooperative agreements mechanisms, and NINDS program staff will have a significant, although not dominant, role in the planning and execution of the supported activities. It is intended for the extramural research community to use the translational research initiatives flexibly and creatively, and in whatever combinations are necessary, to achieve the most rapid and effective development of clinical interventions for neurological disorders. Collaboration among awardees will be encouraged and facilitated by NINDS program staff. Investigators working on the same disease will have the opportunity to share data, materials, and expertise. It is expected that lessons learned and techniques developed within one disease community will be relevant to the efforts of other communities. Relationships between academia and industry will be important, and NINDS program staff will assist with establishing them whenever possible. An oversight committee composed of program staff will assess the responsiveness of applications, manage the development of collaborations and networks within the program, and assess progress toward and achievement of milestones. NINDS will consider requests for administrative supplements to support new collaborations and networks among awardees, or for the exploration of new and important research questions in translational research. Components of the Program: Translational Research Conferences (U13) Translational research conferences are used flexibly to meet the needs of research communities with translational research efforts at different stages of development. All meetings must have a translational research focus, and be directly relevant to a clinical intervention for a neurological disorder. Multi-year conference plans must include annual milestones toward disease intervention. The following objectives would be appropriate for conferences, but this list is not all-inclusive, and applicants are encouraged to use this support mechanism creatively to further the goals of translational research. o Establish and implement collaborations between basic, applied, and clinical scientists. o Compare experimental results, and identify and prioritize short-term research needs. o Develop a comprehensive long-term strategy for translational research on the neurological disorder under study. o Disseminate research priorities and results. o Educate translational investigators and students. Single-Component Translational Research Projects (U01) These cooperative agreements support translational research projects that are focused on a single problem or approach in therapy development for a neurological disorder. The research is focused on a neurological disorder, or a group of closely related neurological disorders. NINDS strongly encourages collaboration or consultation between basic and clinical scientists. Consortium agreements are permitted. In some cases, Steering Committees and external advisory committees are appropriate. Each research project will include the following common features. o Translational Research Focus: The research project is dedicated to obtaining experimental results that will have a direct impact on clinical intervention for a neurological disorder. o Milestones: Specific milestones of progress toward disease intervention must be met prior to funding of the next budget period. NINDS program staff will consult with awardees on the evaluation of progress toward milestones. Research project funding can be used to support the translational research process through an IND or IDE application to the FDA. Projects may, however, collaborate on relevant Phase I, II, and III clinical trials that are supported with other NINDS funding mechanisms. Multi-Component Translational Research Projects (U54) These cooperative agreements will support research programs that take a multidimensional or comprehensive approach to therapy development. Multi- Component Translational Research Projects support interdisciplinary teams of investigators who are dedicated to translational research focused on a neurological disorder or a group of closely related neurological disorders. Any combination of scientific methods can be used to impact the treatment or prevention of the disease. Multi-Component Translational Research Projects are appropriate for applicant institutions that are able to conduct high-quality, balanced translational research on a neurological disorder, and that will give the effort high priority and visibility within the institution. Multi-Component Translational Research Projects are not only expected to conduct a wide spectrum of research activities, but also to contribute significantly to the development of specialized research resources, the development of improved research model systems, and the expansion of the research base through collaborative research with basic and clinical scientists in other institutions. NINDS strongly encourages Multi-Component Translational Research Projects to be collaboratively designed and implemented, for example by including basic scientists working at the cellular and molecular levels, physicians experienced in patient-oriented research, and, in some cases, population scientists experienced in studying the patterns of disease. Each Multi-Component Translational Research Project will include the following common features. o Translational Research Focus: Multi-Component Translational Research Projects are dedicated to obtaining experimental results that will have a direct impact on clinical intervention for a neurological disorder. o Minimum Number of Components: Multi-Component Translational Research Projects must include a minimum of three components, which can be research projects or cores. o Milestones: Specific milestones of progress toward disease intervention must be met prior to funding of the next budget period. NINDS program staff will consult with awardees on the evaluation of progress toward milestones. o Steering Committee: Each Multi-Component Translational Research Project has a Steering Committee to assist the program with overall management. The Steering Committee will include the Multi-Component Translational Research Project PI, project leaders, and NINDS program staff. o External Advisory Committee: Each Multi-component Translational Research Project has an advisory committee composed of experts not otherwise associated with the activity. Multi-Component Translational Research Project funding can be used to support the translational research process through an IND or IDE application to the FDA. Projects may, however, collaborate on relevant Phase I, II, and III clinical trials that are supported with other NINDS funding mechanisms. MECHANISMS OF SUPPORT This PA will use the NIH U13 Conference, U01 Research Project, and U54 Specialized Center award mechanisms. These are cooperative agreement award mechanisms in which the PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NINDS staff being substantially involved as a partner with the PI, as described under the sections "Cooperative Agreement Terms and Conditions of Award." The maximum that may be requested in support of conferences by the U13 award mechanism is $150,000 per year direct costs. The total project period for an application submitted in response to this PA may not exceed five years. This PA uses just-in-time concepts. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the federal government INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Consultation with NINDS Program Staff: Due to the unique requirements of the NINDS Cooperative Program in Translational Research, applicants are strongly encouraged to consult with NINDS program staff as plans for an application are being developed. This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines, including the scope of projects within the program and the requirement that project objectives be milestone driven. U13 Cooperative Agreement Terms and Conditions of Award: These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and NINDS Project Scientists. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the conferences. Awardees are responsible for identifying specific milestones toward disease intervention that will be achieved during the project period, when multi-year conferences are supported. Awardees agree to participate in the overall coordination of NINDS research efforts in translational research. This participation may include collaboration and consultation with other translational research awardees, and the sharing of information, data, and research materials. 2. NINDS Program Staff Responsibilities Each project will have the support of one or more Project Scientists from NINDS program staff who are assigned an administrative role for the neurological disorder being studied and have expertise in the implementation of the NINDS Cooperative Program in Translational Research. The NINDS Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. They will work with conference organizers to determine the subjects to be discussed, to identify speakers, and to formulate an agenda. An important part of the NINDS Cooperative Program in Translational Research is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different neurological disorders. NINDS Project Scientists will have the primary responsibility for this overall coordination. NINDS Project Scientists will be responsible for assessing the progress of multi-year conferences toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project. The program director will be responsible for normal stewardship of the award, and may also serve as a Project Scientist. 3. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and NINDS may be brought to arbitration. An arbitration panel will be composed of three members one chosen by the awardee, a second member selected by NINDS, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. U01 Cooperative Agreement Terms and Conditions of Award: These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and NINDS Project Scientists. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. Awardees are responsible for identifying specific milestones toward disease intervention that will be achieved during the project period. Awardees agree to participate in the overall coordination of NINDS research efforts in translational research. This participation may include collaboration and consultation with other translational research awardees, and the sharing of information, data, and research materials. Awardees will retain custody of and have primary rights to data developed under these awards, subject to government rights of access consistent with current HHS and NIH policies. 2. NINDS Program Staff Responsibilities Each project will have the support of one or more Project Scientists from NINDS program staff who are assigned an administrative role for the neurological disorder being studied and have expertise in the implementation of the NINDS Cooperative Program in Translational Research. The NINDS Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. NINDS Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project. The NINDS Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the NINDS Cooperative Program in Translational Research and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract. An important part of the NINDS program in translational research is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different neurological disorders. NINDS Project Scientists will have the primary responsibility for this overall coordination. The program director will be responsible for normal stewardship of the award, and may also serve as a Project Scientist. 3. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and NINDS may be brought to arbitration. An arbitration panel will be composed of three members one chosen by the awardee, a second member selected by NINDS, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. U54 Cooperative Agreement Terms and Conditions of Award: These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and NINDS Project Scientists. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. Awardees are responsible for identifying specific milestones toward disease intervention that will be achieved during the project period. Awardees are responsible for establishing an external advisory committee composed of experts not otherwise associated with the activity. Awardees agree to participate in the overall coordination of NINDS research efforts in translational research. This participation may include collaboration and consultation with other translational research awardees, and the sharing of information, data, and research materials. Awardees will retain custody of and have primary rights to data developed under these awards, subject to government rights of access consistent with current HHS and NIH policies. 2. NINDS Program Staff Responsibilities Each project will have the support of one or more Project Scientists from NINDS program staff who are assigned an administrative role for the neurological disorder being studied and have expertise in the implementation of the NINDS Cooperative Program in Translational Research. The NINDS Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. NINDS Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project. The NINDS Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the NINDS Cooperative Program in Translational Research and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract. An important part of the NINDS program in translational research is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different neurological disorders. NINDS Project Scientists will have the primary responsibility for this overall coordination. NINDS Project Scientists will have a single NIH vote on the Steering Committee. The program director will be responsible for normal stewardship of the award, and may also serve as a Project Scientist. 3. Collaborative Responsibilities A Steering Committee will make strategic decisions with regard to goals and research implementation, including the establishment of shared resources and the development of collaborations. The Steering Committee will meet at least annually. The Steering Committee will be composed of the project PI, and other investigators who are leaders of individual projects within the award or leaders of efforts at consortium sites, if applicable, and one or more NINDS Project Scientists. The project PI and the project or consortium site leaders will each have one vote, and the NINDS Project Scientists will have a single NIH vote. The project PI will serve as chairperson of the Steering Committee. Awardees will be required to accept and implement the procedures approved by the Steering Committee. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and NINDS may be brought to arbitration. An arbitration panel will be composed of three members one chosen by the Steering Committee (with NIH not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NINDS, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Thomas Miller, Ph.D. Technology Development National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2139 Bethesda, MD 20892 Telephone: 301-496-1779 FAX: 301-402-1501 Email: [email protected] o Direct your questions about peer review issues to: Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3208 Bethesda, MD 20892 Telephone: 301-496-5980 FAX: 301-402-0182 o Direct your questions about financial or grants management matters to: Rebecca Claycamp Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3290 Bethesda, MD 20892 Telephone: 301-496-9231 Fax: 301-402-0219 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION PAGE LIMITS: Applications submitted in response to this PA for Translational Research Conferences (U13) or Single-Component Translational Research Projects (U01) are limited to 25 pages for sections A through D of PHS 398. Applications for Multi-Component Translational Research Projects (U54) are limited to 25 pages per component for sections A through D of PHS 398. SPECIAL INSTRUCTIONS FOR MULTI-COMPONENENT TRANSLATIONAL RESEARCH PROJECT APPLICATIONS: Since the PHS 398 application form is designed primarily for the traditional research project grant (R01) application, several sections have to be modified and expanded so that the form can be used to provide the information needed for a Multi-Component Translational Research Project application. Prepare a detailed table of contents that will enable reviewers to find specific information readily. Present the projects first and the core units last. Identify each component by title, and assign each project a number and each core unit a capital letter that reflects the order in which the projects and core units are presented in the application, and provide the name of the investigator responsible for each component. Applicants should prepare only a single face page for the entire application, not one for each component. The title should be followed by "(U54)". In the Key Personnel table provided, list the PI for the overall Multi- Component Translational Research Project and the investigator responsible for each component project or core. List the investigators in the same order in which their individual components are presented. Under "Role on Project" state the investigator's role (e.g., "Investigator, Project 1", "Co- investigator, Core B", or "Consultant, Project 3"). For the entire Multi-Component Translational Research Project, as well as for each project and core, prepare the standard "Detailed Budget for Initial Budget Period" and the "Budget for Entire Proposed Project Period." Identify each budget page (e.g., "Composite", "Project 1", etc.). Place the composite budget pages first, followed by the projects and cores. All budgets (composite, projects, and cores) will be in this one section. Individual project budgets should not be included with the project research plans. Put the biographical sketch for the PI of the Multi-Component Translational Research Project first, followed by the other biographical sketches in alphabetical order. Put all of the biographical sketches together in one section immediately after the budget section. Biographical sketches are required for all key personnel and consultants who participate in the research projects and core units. Present all Resources pages in one section. The Research Plan of each research project or core should consist of a title page, Description (use form page 2 of form PHS 398 for this), and sections on Specific Aims, Background and Significance, Preliminary Studies/Progress Report, Research Design and Methods, Human Subjects Research (if appropriate), Vertebrate Animals (if appropriate), Literature Cited, Consortium/Contractual Arrangements (as appropriate), and Consultants, as described in the PHS 398 instructions. The Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods sections for each research project or core, taken together, should not exceed 25 pages. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. MODULAR GRANT APPLICATIONS: The NINDS Cooperative Program in Translational Research will not use modular grant procedures (http://grants1.nih.gov/grants/funding/modular/modular.htm). SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NINDS staff member who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact NINDS program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from NINDS staff that NINDS will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the NINDS staff member who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and four signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) In order to facilitate the review of applications, the applicant should, at the same time, mail or deliver one copy of the application to: Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 3208 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness and adherence to program goals and objectives by NINDS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NINDS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the NINDS advisory council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the PI and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. RESOURCE SHARING: A sharing plan for the distribution of unique research resources developed through Single-Component Translational Research Project or Multi-Component Translational Research Project activities should be included in the application. The sharing plan should preserve research freedom and publication rights, while ensuring appropriate implementation of the Bayh-Dole Act (35 U.S.C. 200 et seq.) and dissemination of research resources. A Federal Register Notice published on December 23, 1999, titled "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice," provides further information, and is available at http://www.ott.nih.gov/policy/rt_guide_final.html. The application should include a request for the funds necessary to implement the sharing plan. DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: U13 Translational Research Conferences o The importance of the translational research objective to the neurological disorder under study. o The involvement of basic and clinical scientists in the conception, design, and proposed implementation of the conferences, as appropriate. o The adequacy of proposed milestones for multi-year awards. o The qualifications of the conference organizers and the proposed participants. o The adequacy of the plans to seek out and encourage the participation of women, persons with disabilities, and underrepresented minorities. o The participation of junior investigators and students in the conferences. o The appropriateness of the proposed format and location of the conferences. o The plans to distribute the results of the conferences, as appropriate. U01 Single-Component Translational Research Projects o The importance of the translational research objective to the neurological disorder under study, and its likelihood of completion within the project period. o The adequacy of the experimental design and methods to achieve the research objectives; including the involvement of basic and clinical scientists in the conception, design, and proposed implementation of the project. o The adequacy of proposed project milestones, and the feasibility of achieving them. o The qualifications of the basic and clinical investigators to conduct the proposed research, and the appropriateness of the time commitments of each investigator to the conduct to the project. o The scientific environment in which the translational research work will be done, and the unique features, if any, of the environment to support the proposed work. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o Appropriate plans for the rigorous management and quality control of research data or materials from human subjects. U54 Multi-Component Translational Research Projects Individual Projects: o The importance of the translational research objective to the neurological disorder under study, and its likelihood of completion within the project period. o The adequacy of the experimental design and methods to achieve the research objectives; including the involvement of basic and clinical scientists in the conception, design, and proposed implementation of the project. o The adequacy of proposed project milestones, and the feasibility of achieving them. o The qualifications of the basic and clinical investigators to conduct the proposed research, and the appropriateness of the time commitments of each investigator to the conduct to the project. o The scientific environment in which the translational research work will be done, and the unique features, if any, of the environment to support the proposed work. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o Appropriate plans for the rigorous management and quality control of research data or materials from human subjects. Core Resources: o The degree to which plans indicate that core resources effectively and efficiently support the research activities in a manner that cannot be supported through available resources. o Adequacy of the justification for each specialized resource as essential for the conduct of project research, or collaborative projects. o The qualifications of core managers. o The appropriateness of the requested budgets to conduct each shared resource operation. Overall Program Organization: o The scientific qualifications, scientific and administrative leadership capabilities, and adequacy of the time commitment of the PI. o Adequacy of the planning and evaluation process to include: determining translational research productivity of existing projects and resources; discontinuing activities of low productivity; initiating new activities in response to important translational research opportunities; establishing collaborations; and the use of a Steering Committee and external advisors. o The degree to which the organization and leadership of the project promote and facilitate scientific interactions and the effective use of core facilities. o The effectiveness of proposed interdisciplinary interactions. o The adequacy of tangible institutional commitments that will enable and facilitate the research objectives. A single priority score will be assigned to the Multi-Component Translational Research Project application as a whole after discussing all of the review elements. The score will be based on the overall quality of the research projects, the overall effectiveness and adequacy of core resources, and the overall program organization and capability. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants1.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.853, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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