INNOVATIVE PARTNERSHIPS IN TYPE 1 DIABETES RESEARCH RELEASE DATE: June 26, 2003 RFA: DK-03-015 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) National Eye Institute (NEI) (http://www.nei.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.847, 93.855, 93.867, 93.837, 93.853 and 93.361. LETTER OF INTENT RECEIPT DATE: October 16, 2003 APPLICATION RECEIPT DATE: November 13, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), National Eye Institute (NEI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), and the Office of Dietary Supplements (ODS) invite applications to support collaborations between investigators who focus their research efforts on type 1 diabetes or its complications and researchers from other research areas with expertise relevant to type 1 diabetes research. The purpose of this Request for Applications (RFA) is to attract new research talent to type 1 diabetes research, strengthen the ongoing efforts of type 1 diabetes researchers by providing access to specialized expertise or technologies relevant to their research, and facilitate the formation of interdisciplinary research partnerships to investigate significant biological and medical problems associated with type 1 diabetes. Applications should propose collaborative research partnerships between independent principal investigators, at least one currently pursuing research relevant to type 1 diabetes and one (or more) with expertise relevant to some aspect of type 1 diabetes that is not currently being applied by the investigator to research on this disease. This RFA encourages type 1 diabetes researchers to act as "talent scouts" by identifying and recruiting leading scientists with relevant scientific expertise to the field of type 1 diabetes research. A similar RFA (DK-02-023) was issued in 2002. We anticipate that a future solicitation will provide an opportunity for expanded support for successful collaborations funded through the current RFA. RESEARCH OBJECTIVES Background Type 1 diabetes is an autoimmune disease characterized by the destruction of the insulin-secreting beta cells of the pancreas mediated by lymphocytes of the immune system. The incidence of type 1 diabetes appears to be increasing worldwide. Although the disease may occur at any age, the onset of type 1 diabetes peaks prior to twenty years of age. In some populations, about one percent will develop type 1 diabetes during their lifetime. Those affected with type 1 diabetes suffer from devastating complications including accelerated onset of cardiovascular and peripheral vascular diseases, neuropathy, nephropathy, retinopathy and premature mortality. Objectives and Scope The objectives of this RFA are to attract new research talent to type 1 diabetes research, strengthen the ongoing efforts of type 1 diabetes researchers by providing access to specialized expertise or technologies relevant to their research, and facilitate the formation of interdisciplinary research partnerships to investigate significant biological and medical problems associated with type 1 diabetes. Generally, pilot and feasibility applications (such as the "seed" collaborative R01 applications solicited through this RFA) are expected to have little preliminary data and are reviewed based on the development of unique hypotheses and supporting literature. While no preliminary data from the collaboration between the two investigators mentioned above are required, applicants should include some preliminary data relevant to the proposed project from the partner currently working in the area of type 1 diabetes. Some information documenting the ability of the collaborator regarding the technology or expertise s/he will be providing to the partnership should also be provided. Applications should propose collaborative research partnerships. The recruited research partner may have worked on a project relevant to diabetes and its complications, but this should not have been a significant focus of his/her research effort. Review criteria (see below) will include consideration of whether one partner is new to diabetes research and is likely to make substantial contributions to the diabetes research effort. The application will be judged in the context of the objectives of the RFA (see above); a major objective is attracting new talent to diabetes research. Each of the research partners should be a successful independent investigator with a track record of successful research accomplishments. The collaborating investigators need not be at the same institution. If at separate institutions, the application should document how the collaboration will be achieved. One potential mechanism for collaboration between two independent laboratories might be a shared postdoctoral fellow or other research staff position. Funds for travel between the collaborating laboratories may be included in the budget proposal, and each research partner should request funds to attend one meeting in Bethesda, MD. Each of the research partners will serve as a principal investigator on an R01 grant application within a collaborative R01 project. The level of effort proposed by the collaborating independent investigators should be appropriate for the scope of the project. R01 applications submitted in response to this RFA may address any topic relevant to type 1 diabetes and its complications ranging from fundamental research on etiology and pathogenesis to applied research focused on the development of methods for prevention, improved treatment, or cure. R01 applications may involve collaborations between diabetes researchers and investigators in diverse fields including, but not limited to, cardiovascular disease, nephrology, ophthalmology, neuroscience, molecular virology, immunology, infectious disease, genetics, epidemiology, behavioral and/or psychosocial research, biophysics, materials science, bioengineering, bioimaging, developmental biology, cell biology, cell signaling, structural biology, genomics, proteomics, or bioinformatics. Examples of types of research projects that are responsive to this RFA include but are not limited to: o Development and/or testing of strategies to prevent or reverse type 1 diabetes and its macro- and microvascular complications o Research to discover the biochemical mechanisms by which diabetes genes function to create susceptibility to diabetes and its complications o Identification of viral or environmental triggers of type 1 diabetes and mechanisms by which such triggers initiate an autoimmune response o Development and/or testing of measures to identify and quantify the risk of developing type 1 diabetes or to assess response to therapy to prevent or reverse the autoimmune process and beta cell loss (i.e. pathogenic T-cell assays, imaging of beta cell mass or inflammation, etc.) o Development and/or testing of devices to measure glucose in blood, saliva or other body fluids and/or deliver insulin which offer advantages over current devices, and the development of closed loop systems for glucose sensing and insulin delivery o Research to prevent or reduce hypoglycemia in type 1 diabetes o Research to identify islet stem cells, understand their differentiation, growth and development, and develop improved methods for isolation, maintenance, growth and propagation, or differentiation of beta cells/islets o Research on signaling pathways involved in the regulation of normal pancreatic beta cell function o Research on strategies to develop new or improved sources of beta cells/islets or to enhance the regeneration or viability of beta cells/islets o Development and/or testing of improved methods of immunoalteration of beta cells/islets or of the immune response in an attempt to prevent autoimmune and host-versus-graft destruction of beta cells/islets o Development of immunobarrier technology to protect transplanted islets or engineered insulin-producing cells from autoimmune destruction or rejection o Definition of the genetic, molecular or cellular processes and the sequence of events in the pathogenesis of hyperglycemia-induced injury so that potential sites for intervention can be identified o Development or testing of innovative pharmacological agents and interventions to prevent or halt the progression of type 1 diabetes or its long-term complications o Development of animal models of type 1 diabetes and its complications which closely parallel the human disease useful for exploring the pathogenesis and therapy of type 1 diabetes or its complications o Development of strategies and tools to improve diabetes management and outcomes o Development of tests that will facilitate clinical trials such as measures of risk for diabetes and/or complications or measures of response to therapy o Development of proteomic approaches to the study of type 1 diabetes and its complications (e.g. study of insulitis and autoimmunity recurrence; identification of beta cell-specific proteins in plasma; identification of markers for monitoring pancreatic beta cell differentiation, development, function, and mass) MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism to support collaborative research projects. For collaborative R01 projects, a group of investigators must submit simultaneously at least two, but typically not more than three, R01 grant applications with a collaborative research project. R01 grant applications may be from a single institution or several institutions, and may include shared resources. Collaborative R01 research projects must demonstrate the interdependence of the individual components. For this RFA, the R01 grant mechanism is being used to "seed" collaborative research partnerships. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2004. Projects that are not funded in the competition described in this RFA may be re-structured and designed as traditional R01s, and submitted as NEW applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application at: https://grants.nih.gov/grants/funding/phs398/phs398.html This RFA 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. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The participating ICs intend to commit approximately $4 million in FY 2004 to fund 12 to 15 new projects in response to this RFA. These awards are intended to provide seed funding to initiate research collaborations. Applicants for collaborative R01 grants may request a project period of up to 2 years. The combined budgets for all of the R01 applications within a collaborative group may not exceed $300,000 in direct costs per year. We anticipate that a future solicitation will provide an opportunity for expanded support for successful collaborations funded through the current RFA. Because the nature and scope of the proposed research will vary from project to project, it is anticipated that the size of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Applicants from institutions that have a Diabetes Endocrinology Research Center (DERC), a Diabetes Research and Training Center (DRTC), or a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center(s) as a resource for conducting the proposed research. In such a case, a letter of agreement from either the principal investigator or the GCRC program director should be included with the application. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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: James F. Hyde, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Rm. 603 Bethesda, MD 20892-5460 Telephone: (301) 594-7692 FAX: (301) 435-6047 E-mail: jh486z@nih.gov John Paul Ridge, Ph.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Diseases 6700-B Rockledge Drive, Room 5259 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 E-mail: jr34g@nih.gov Peter A. Dudley, Ph.D. Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: pad@nei.nih.gov Cristina Rabadan-Diehl, Ph.D. Vascular Biology Research Program Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute Rockledge II, Room 10186 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0545 FAX: 301-480-2858 E-mail: cr225k@nih.gov Paul L. Nichols, Ph.D. National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 2108 6001 Executive Blvd. Bethesda, MD 20892 Phone: 301-496-9964 FAX: 301-401-2060 E-mail: pn13w@nih.gov Nell Armstrong, PhD, RN Program Director National Institute of Nursing Research 6701 Democracy Blvd, Rm. 710 Bethesda MD 20892-4870 Phone: 301-594-5973 FAX: 301-480-8260 E-mail: armstrongn@nih.gov Rebecca B. Costello, Ph.D., F.A.C.N. Deputy Director Office of Dietary Supplements National Institutes of Health 6100 Executive Blvd., Room 3B01 Bethesda, Maryland 20892-7517 Phone: (301) 435-2920 FAX: (301) 480-1845 E-mail: CostellB@od.nih.gov o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 Email: CalvoF@extra.niddk.nih.gov o Direct your questions about financial or grants management matters to: Kathleen J. Shino, M.B.A. Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 708 Bethesda, MD 20892-5456 Telephone: (301) 594-8869 FAX: (301) 480-3504 E-mail: ShinoK@extra.niddk.nih.gov Pamela G. Fleming Grants Management Officer National Institute of Allergy and Infectious Diseases Division of Extramural Activities 6700-B Rockledge Drive, Room 2119 Bethesda, MD 20892-7614 (Regular Mail) Bethesda, MD 20817 (Express Mail) Phone: (301) 402-6580 FAX: (301) 493-0597 E-mail: pf49e@nih.gov Chris Davis Grants Management Specialist National Eye Institute 6120 Executive Blvd, Suite 350 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 496-99977 E-mail: cad@nei.nih.gov Susan Lowenthal Grants Management Specialist National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7155 Bethesda, MD 20892-7926 Telephone: 301-435-0159 FAX: 301-480-3310 E-mail: sl262k@nih.gov Karen Shields Grants Management Branch National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 3290 6001 Executive Blvd. Bethesda, MD 20892 Phone: 301-496-9231 FAX: 301-402-0129 E-mail: ks26n@nih.gov Diane E. Drew Grants Management Specialist National Institute of Nursing Research 6701 Democracy Boulevard, Room 710 One Democracy Plaza Bethesda, MD 20892-4870 (Courier Delivery: Bethesda, MD 20817) Phone: 301-594-2807 FAX: 301-451-5651 or 301-402-4502 E-mail: diane_drew@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel, including PIs of Collaborative R01s o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK 6707 Democracy Boulevard, Rm. 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8885 FAX: (301) 480-3505 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 R01 APPLICATIONS: All application instructions outlined in the PHS 398 application kit are to be followed, with the following requirements for R01 applications: 1. For these collaborative R01 projects, the individual components must be submitted as one packet accompanied by a cover letter that lists the principal investigators, their institution(s), and their identical project titles. To facilitate proper processing and review, include this letter with each of the individual R01s, and, in each R01 grant application, list the collaborating projects and principal investigators on page 2, under "Performance Sites." In addition, the DESCRIPTION (page 2) for each R01 grant application within a collaborative R01 project should be the same and the applicants should define in the DESCRIPTION how and why the individual participants propose to collaborate. 2. The RESEARCH PLAN section should be included in ONLY one of the R01 grant applications. All of the remaining R01 grant applications within the collaborative R01 project should refer to the RESEARCH PLAN from the designated R01 application, rather than duplicate the RESEARCH PLAN. Applicants should elaborate on the significance and nature of the collaboration in an Introduction section of the "Research Plan" of each component R01. 3. Those collaborative R01 applications that do not include, but only refer to, the RESEARCH PLAN must include the following information in their application: face page, DESCRIPTION, Performance Sites, and Key Personnel, Research Grant Table of Contents, modular budget, budget justification, biographical sketches of PI and other key personnel, resources and environment, and checklist. Sections for Human Subjects Research and/or Vertebrate Animals must also be completed, if appropriate. 4. Collaborative R01 applications will use the "MODULAR GRANT" and "JUST-IN- TIME" concepts, with direct costs requested in $25,000 modules. The combined budgets for all of the research projects in a collaborative R01 application may not exceed $300,000 in direct costs per year. For these collaborative R01 projects, each R01 grant application must include its own budget. The total direct costs for a collaborative R01 project are limited to $300,000 in direct costs per year, and these funds should be distributed, as appropriate, among the PIs within the collaborative project. In addition, each research partner should request funds to attend one meeting in Bethesda, MD. 5. Although preliminary data are not required for these seed R01 applications, they may be included. 6. Sections a-d of the Research Plan of the R01 application may not exceed 15 pages, including tables and figures. 7. R01 appendix materials should be limited, and should not be used to circumvent the page limit for the research plan. Copies of appendix material will only be provided to the primary reviewers of the application and will not be reproduced for wider distribution. The following materials may be included in the appendix: o Up to five publications, including publications, 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 be stapled as sets. o Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 15 page limit of items a-d of the research plan. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Collaborative R01 applications requesting up to $250,000 per year in direct costs 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application and all appendices must be sent to: Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK 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 process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by an appropriate national advisory council or board. Collaborative R01 grant applications will NOT be reviewed individually, but as components of a single research project, and, as such, the individual R01 applications within a collaborative R01 project will be assigned the same priority score and receive the same reviewers' comments within the individual summary statements. 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 The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The 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. SIGNIFICANCE: Does this study address an important problem in type 1 diabetes research? If the aims of the 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? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Preliminary data are not required for these seed R01 applications. INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATORS: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is the research partnership innovative? Does the partnership include an independent investigator new to type 1 diabetes research with appropriate expertise to contribute significantly to diabetes research? Is the research partnership interdisciplinary and does it merge scientific expertise based upon strong experimental rationale and sound project goals? ENVIRONMENT: Does the scientific environment in which the 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, the following items will be considered for each R01 application within a collaborative R01 project in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 16, 2003 Application Receipt Date: November 13, 2003 Peer Review Date: February/March 2004 Council Review: May, 2004 Earliest Anticipated Start Date: July 1, 2004 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 HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY 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 "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_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 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 https://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://stemcells.nih.gov/index.asp 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm The Office of Dietary Supplements (ODS) was mandated by Congress in 1994 and established within the Office of the Director, National Institutes of Health (NIH). The Dietary Supplement Health and Education Act (DSHEA) [Public Law 103-417, Section 3.a] amended the Federal Food, Drug, and Cosmetic Act "to establish standards with respect to dietary supplements." This law authorized the establishment of the ODS. 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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