NINDS EXPLORATORY/DEVELOPMENTAL PROJECTS IN TRANSLATIONAL RESEARCH RELEASE DATE: July 26, 2002 PA NUMBER: PAR-02-138 (This PAR has been reissued, see PAR-05-157) EXPIRATION DATE: July 31, 2005, unless reissued. 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 Mechanism 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 NINDS encourages translational research projects that focus on neurological disorders. This PA requests applications for exploratory/developmental projects intended to discover potential targets for therapeutic intervention, to identify candidate therapeutics, or to develop assays, animal models, devices, or technologies for screening or developing therapeutics. Such projects, if successful, should lead directly to a therapy development project for a particular neurological disorder. This PA is one of three coordinated programs being released by NINDS to promote translational research, including "NINDS Cooperative Program in Translational Research" (https://grants.nih.gov/grants/guide/pa-files/PAR-02-139.html) and "NINDS Mentored Research Scientist Development Awards in Translational Research" (https://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. Background: Remarkable insights have been made recently into the molecular, genetic, and cellular bases of neurological disease. In many cases, developmental work must be completed before the basic research results can be translated into effective therapies. A key requirement for successful therapeutic development is the characterization of new assays, models, tools, and technologies that provide for reliable discovery and testing of therapeutic approaches. Scope of the Program: This PA is intended to encourage projects that provide tools and resources for therapy development. Proposed projects should relate directly to a disorder affecting the nervous system, and have a rational basis with regard to disease mechanisms, or potential therapeutics that have previously been shown to have efficacy. Possible goals of such projects include, but are not limited to: o Identification of targets for therapeutic intervention. Examples of methods for target identification include genetic, protein interaction, and cell viability screens. o Development of assays that permit the preliminary screening of candidate therapeutics. These include biochemical and cellular assays, modified model organisms, and electrophysiological or behavioral recording devices. Assays that can be used for high throughput screening are particularly encouraged. o Development of animal models that permit further evaluation of candidate therapeutics and/or toxicology studies. Examples include animals that have been modified genetically, chemically, or through any intervention that recapitulates critical features of a specific neurological disorder. Animal model development is appropriate only if it will lead directly to therapy development efforts, and is not appropriate if the models will be used to study disease mechanisms. o Development of tools and technologies that can be directly used for therapy development. Examples include novel gene therapy vectors, genetically- modified cells, in-dwelling drug delivery devices, microstimulators, and microelectronic recording devices. These tools or technologies should overcome existing obstacles to treatment and be capable of being directly applied to, or adapted for, delivery of potential therapeutics. o Preliminary identification of candidate therapeutics that can be evaluated through further preclinical testing. Such identification can be achieved using any of the assays or animal models described above. MECHANISM OF SUPPORT This PA will use the NIH Exploratory/Developmental Grants R21 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applications in response to this PA are limited to $125,000 per year direct costs, and a maximum of two years. The awards are not renewable. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). 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 o Domestic or foreign 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 Plan for Future Preclinical Testing: NINDS intends that each project, if successful, will initiate a process of therapy development. Therefore, it is essential that applicants describe how future steps in this process will be taken. For example, if the goal of a project is to identify a potential therapeutic or assay, the applicant should provide a plan describing how that therapeutic or assay will be used in subsequent preclinical testing. The plan should include, when appropriate, a list of collaborators who will participate in this process. Since translational research is intrinsically interdisciplinary, this plan will often involve cooperation among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations. 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: firstname.lastname@example.org 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@example.com 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 https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION PAGE LIMITS AND APPENDICES: Applications submitted in response to this PA are limited to 15 pages for sections A through D of PHS 398, and appendices are not permitted. APPLICATION RECEIPT DATES: Applications submitted in response to this PA will be accepted at the standard application deadlines, which are available at https://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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. 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 https://grants.nih.gov/grants/funding/submissionschedule.htm. The 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. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete 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 appropriate national advisory council or board 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? OTHER REVIEW CRITERIA: o The likelihood that completion of the exploratory/developmental research objectives will assist with translation of basic observations into one or more therapies for the neurological disorder under study. o The adequacy of the plan for how the project, if successful, will be used to initiate a process of therapy development, including, when appropriate, the adequacy of proposed interdisciplinary collaborations. 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 NINDS Exploratory/Developmental Projects in Translational Research 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. 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://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 https://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
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.