NLM SMALL GRANT PROGRAM RELEASE DATE: August 14, 2002 PA NUMBER: PAR-02-148 (see Notice of Inactivation, NOT-LM-03-001) EXPIRATION DATE: 6/30/2005, unless reissued. National Library of Medicine (NLM) (http://www.nlm.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 The National Library of Medicine (NLM) Small Grants Program provides research support of up to $75,000 per year (direct costs) for up to two years for new research projects in areas of high relevance to the mission of the NLM. Small grants are short-term awards designed to support basic and clinical research to answer specific, targeted research questions or to perform pilot or feasibility testing. Both new and more experienced investigators are encouraged to apply for grants under this announcement. The R03 may be used to support individuals transitioning from postdoctoral status to their first independent research position. The award may also support investigators at institutions that do not have extensive research resources. RESEARCH OBJECTIVES This Small Grant (R03) Program provides support for feasibility and/or pilot testing projects, testing of new techniques, secondary analysis of existing data, or development of innovative or high-impact projects. High-impact research involves studies in which the technological, methodological, or theoretical approach to a problem lacks an historical precedent or sufficient preliminary data, but whose successful outcome would have a major effect on a scientific area. The R03 grant project may or may not lead to a subsequent successful R01 application. Critical research areas include: representation of medical knowledge in computers; organization and retrieval issues for image databases; enhancement of human intellectual capacities through virtual reality, dynamic modeling, artificial intelligence, and machine learning; medical decision-making; linguistic analyses of medical languages and nomenclatures; investigations of topics relevant to health information or library science; and bioinformatics issues relevant to genomics or other large research data-sets. Important informatics application areas include: Health Care Delivery and Clinical Medicine: e.g. patient safety; privacy, confidentiality, and information security; disaster management; disease management Public Health and Health Services: e.g. health promotion; outcome analysis Bioinformatics Research: genomics, proteomics; imaging; neuroinformatics The long-term goal of this NLM program is the development of practical, useful knowledge and theory about medical informatics applications and strategies that can contribute to the health of the American people by predicting, preventing, or resolving health problems. It is expected that successful applicants will disseminate the findings of their research projects by publishing in (hardcopy or electronic) professional journals, developing a website, presenting at scientific meetings, and/or conducting training. MECHANISM(S) OF SUPPORT This PA will use the NIH R03 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants may request up to $75,000 per year for one or two years in direct costs. Support is provided for Facilities and Administration (F & A) costs at the organization's negotiated rate. Subcontractual costs are treated as direct costs and must be within the total direct cost cap established for this program. 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(s) 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. Health organizations and academic centers in the 23 eligible IDeA states and Puerto Rico https://grants.nih.gov/grants/guide/rfa-files/RFA-RR-00-006.html and historically black universities and colleges are welcome. 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 an eligible 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 A small grant application should include the following elements: o Statement of the research problem and documentation of its significance o Rationale for the project and methodology o Description of the data gathering and analysis o Description of how the findings will be interpreted and applied o Implications for future research o Plan for dissemination of the findings to the target/peer community 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: Susan M. Sparks, PhD Extramural Programs National Library of Medicine Rockledge 1, Suite 301 6705 Rockledge Drive MSC 7968 Bethesda, MD 20892 Telephone: (301) 594-4882 FAX: (301) 402-2952 Email: sparkss@mail.nlm.nih.gov o Direct your questions about peer review issues to: Merlyn M. Rodrigues, M.D., Ph.D. Extramural Programs National Library of Medicine Rockledge 1, Suite 301, 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 594-4253 FAX: (301) 402-2952 Email: rodrigm@mail.nlm.nih.gov Direct your questions about financial or grants management matters to: Chris Robey Extramural Programs National Library of Medicine Rockledge 1, Suite 301 6705 Rockledge Drive MSC 7968 Bethesda, MD 20892 Telephone: (301) 496-4221 FAX: (301) 402-0421 Email: Robeyc@mail.nlm.nih.gov 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 RECEIPT DATES: Applications submitted in response to this program announcement 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: The NLM Small Grant program is covered by the NIH policy requiring all applications requesting up to $250,000 per year in direct costs to be submitted in a modular grant format. 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. Biographical sketch: If you are in training or in fellowship status at the time of application you should list in your biographical sketch the position you will occupy at the time of award with the expected start date in that position. If the position is contingent on receipt of the award then you should describe it as "contingent on award". Research plan: Do not exceed a total of ten pages for the following parts (a.-d.): Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and Research Design and Methods. Tables and figures are included in the 10-page limitation. The 10-page limitation does not include parts e. through i. (Human Subjects Research, Vertebrate Animals, Literature Cited, Consortium/contractual Arrangements, Consultants). SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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 addition to the mailing to Center for Scientific Review, send two signed photocopies, including the checklist, to Merlyn M. Rodrigues, M.D., Ph.D. Extramural Programs National Library of Medicine Rockledge 1, Suite 301, 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 594-4253 FAX: (301) 402-2952 Email: rodrigm@mail.nlm.nih.gov 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 Applications submitted for this PA will be assigned for review to the National Library of Medicine, whose scientific review group, convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm), will evaluate applications for scientific and technical merit. 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 National Library of Medicine's Board of Regents. 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 principal investigator 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 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: In addition to the general criteria above, your application will also be reviewed with respect to the following: o Adequacy of documentation of the need for and potential significance of the project. o Plans for dissemination of findings. 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_20 01.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: (if applicable) 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 https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: (if applicable) 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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 93.879, 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.

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