SECONDARY ANALYSES IN DIABETES, DIGESTIVE AND KIDNEY DISEASES Release Date: March 11, 2002 PA NUMBER: PA-02-077 (This PA has been modified, see PA-05-094) EXPIRATION DATE: June 2, 2005, unless reissued. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (www.niddk.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 Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications to support the secondary analysis of existing data sets relevant to diabetes and endocrine and metabolic diseases, digestive diseases and nutrition, including obesity and eating disorders, and kidney, urological, and hematological diseases. The goal of this NIDDK program is to facilitate performance of short term projects that explore innovative approaches that are not readily supported by other funding mechanisms and that can be conducted using existing data sets. RESEARCH OBJECTIVES The specific objectives of this announcement on Secondary Analyses In Diabetes, Digestive And Kidney Diseases are to support the following: (a) research on secondary analyses of data related to the epidemiology of disease areas of NIDDK, (b) preliminary projects using secondary analysis that could lead to subsequent applications for individual research awards, (c) rapid analyses of new databases and experimental modules to inform the design and content of future studies, (d) the archiving of datasets to be made publicly available for research purposes related to diseases areas of NIDDK, including both epidemiological studies and multi-center clinical trials. Research that employs analytic techniques that demonstrate or promote methodological advances in patient oriented and epidemiologic research is also of interest. International comparative analyses are encouraged. Applications that are innovative and high risk with the likelihood for high impact would be especially encouraged. Background Patient oriented and epidemiologic research projects, particularly multi-center projects, typically generate data with potential utility beyond the specific hypotheses and questions for which they were designed. Often data are not fully analyzed, especially when unexpected research questions emerge after the end of the project"s funding period. Analyzing such existing data sets can therefore provide a cost- effective means to test specific hypotheses that have not been adequately examined. The further analysis of existing research data may also be prompted by a need to confirm new findings or to aid in the development of new research questions. Applicants may conduct secondary analyses using data from a variety of sources. These would include investigator-initiated research activities, cooperative agreements, and contracts or from other public or private sources. Sources may be large, nationally representative data sets such as those of the National Center for Health Statistics or smaller, regional or locally based data sets. Also appropriate for secondary analyses are relevant cross-sectional and longitudinal survey data collected by Federal, State, and local government agencies. Secondary data analyses of these data may serve as an economical alternative to expensive and time-consuming new data collection projects. Applicants may also secure access to other data sets that may or may not be in the public domain, such as those collected under research grant funds, sponsored by private entities, or originally collected for purposes other than research, such as health care administrative datasets. In addition to the examination of specific research hypotheses, existing data sets may also be used to cross-validate exploratory analyses in ongoing studies, to test complex statistical models, and in special circumstances to provide comparison groups for experimental studies. Meta-analysis, in which results from multiple studies may be compared or combined, is considered to be a form of secondary data analysis for the purpose of this program announcement. Moreover, secondary analysis is appropriate for many types of data, including qualitative information, and may also cover the integration of quantitative and qualitative data. The specific subject areas are restricted to those on which NIDDK conducts research, which include diabetes and endocrine and metabolic diseases, digestive diseases and nutritional disorders, including obesity and eating disorders, and kidney, urological, and hematological diseases. All data analyses must concern patient oriented or epidemiologic research designed to elucidate the etiology, incidence, prevalence, natural history, pathophysiology, or response to therapy of the above mentioned disorders. Support for the creation of publicly archived data sets would be for information that could be applied to the subject areas of interest. Plans for archiving must include adequate dataset documentation and explanation so that it can be used by researchers not associated with the original study. Provision for easy accessibility of archived datasets is required. MECHANISM OF SUPPORT This PA will use the NIH R21 award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed two years. Exploratory/developmental grants (R21) are limited to 2 years and $100,000 per year in direct costs. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. The grants cannot be renewed, however, a no-cost extension of up to one year may be granted prior to expiration of the project period. Investigators are encouraged to seek continued support after completing an exploratory/developmental grant project through a research project grant (R01). This PA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. 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 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. Investigators new to diabetes and digestive and kidney diseases are encouraged to apply. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues. o Direct inquiries regarding programmatic issues in digestive diseases and nutrition to: James E.Everhart, MD, MPH Chief, Epidemiology and Clinical Trials Branch Division of Digestive Diseases and Nutrition 2 Democracy Plaza, Room 655 6707 Democracy Boulevard, MSC 5450 Bethesda MD 20892-5450 Telephone: (301) 594-8878 Fax: (301) 480-8300 E-mail: firstname.lastname@example.org o Direct inquiries regarding programmatic issues in diabetes, endocrinology, and metabolism to: Catherine C. Cowie, PhD Director, Type 1 Diabetes Clinical Trials Program Division of Diabetes, Endocrinology, and Metabolism National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 691 6707 Democracy Boulevard, MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8804 Fax: (301) 480-3503 E-mail: email@example.com o Direct inquiries regarding programmatic issues in kidney, urological, and hematological diseases to: Paul W. Eggers, PhD Program Director Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 615 6707 Democracy Boulevard, MSC 5458 Bethesda, MD 20892-5458 Telephone: (301) 594-8305 Fax: (301) 480-3510 E-mail: firstname.lastname@example.org o Direct inquiries regarding fiscal matters to: Ms. Kathleen J. Shino National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 708 6707 Democracy Boulevard, MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8869 Fax: (301) 594-9523 E-mail: ks48e@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. SPECIFIC INSTRUCTIONS FOR R21 APPLICATIONS All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R21 applications: 1. R21 applications will use the "MODULAR GRANT" and "JUST-IN-TIME" concepts, with direct costs requested in $25,000 modules, up to the total direct costs limit of $100,000 per year. 2. Although preliminary data are not required for an R21 application, they may be included. 3. Sections a-d of the Research Plan of the R21 application may not exceed 15 pages, including tables and figures. 4. R21 appendix materials should be limited, as is consistent with the exploratory nature of the R21 mechanism, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the assigned reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to 10 manuscripts, including manuscripts (submitted or accepted for publication), abstracts, patents, or other printed materials directly relevant to the project. These may be stapled as sets. O Surveys, questionnaires, data collection instruments, and clinical Protocols. These may also be stapled as sets. O Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) 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: Applications are restricted to $100,000 per year in direct costs and must 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. 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) APPLICATION PROCESSING: Applications must be received by/or (postmarked) or mailed 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 on the basis of established PHS referral guidelines. An appropriate 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 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 the 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 (1) Significance: Does this study address an important problem? If the aims of your application are achieved, how will scientific knowledge be advanced? 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 the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the 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? 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 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. (See Inclusion Criteria included in the section on Federal Citations, below) 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 Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," 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 It is the policy of NIH 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 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 the following website: 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. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 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. 93.847, 93.848, and 93.849. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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, and 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. See comment 3 The PHS 398 specifies up to 10 manuscripts.
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