RFA-DK-04-007: DIABETES ENDOCRINOLOGY RESEARCH CENTERS

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DIABETES ENDOCRINOLOGY RESEARCH CENTERS RELEASE DATE: February 12, 2004 RFA Number: RFA-DK-04-007 (This RFA has been renewed, see RFA-DK-06-012 and RFA-DK-06-014) EXPIRATION DATE: July 14, 2004, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.847 LETTER OF INTENT RECEIPT DATE: June 15, 2004 APPLICATION RECEIPT DATE: July 14, 2004 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 Supplementary Instructions 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) invites applications for Diabetes Endocrinology Research Center (DERC) grants to support research in diabetes mellitus and its complications, and in related areas of endocrinology and metabolism. The Diabetes Endocrinology Research Center program is intended to facilitate progress in basic and clinical research with the goal of translating basic research findings into new methods to treat, prevent and ultimately cure diabetes mellitus and its complications. DERCs support three primary research-related activities: (1) Biomedical Research Cores that provide resources to enhance the efficiency, productivity, and multidisciplinary nature of research in designated topic areas; (2) a Pilot and Feasibility Program designed to foster development of new investigators and to provide seed-support for innovative high-risk projects; and (3) an Enrichment Program to promote interdisciplinary interaction and training of investigators in areas of NIDDK interest. RESEARCH OBJECTIVES The DERCs are part of an integrated program of support provided by the NIDDK to enhance multidisciplinary research in diabetes and in related areas of endocrinology and metabolism. DERCs are intended to improve the efficiency and collaborative nature of diabetes research by providing shared access to specialized technical resources and expertise. In addition, DERCs provide a framework for fostering synergy between basic scientists and clinical investigators to promote rapid progress toward a treatment or cure for diabetes and its complications. A DERC must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, DERC applications require an associated program of excellence in biomedical research in diabetes and related areas of metabolism and endocrinology. This program of excellence should be evident in a consistent record of active NIH-funded research projects, program projects, or other peer-reviewed research. A high level of integration and close collaboration among center personnel from diverse scientific disciplines is an important feature of a successful DERC. Accordingly, the applicant should clearly state considerations for center membership with specific reference to the potential of members to form interactive, collaborative relationships. Center applicants should identify one or more central themes around which DERC investigators may be focused. Diabetes research often requires the use of specialized technologies and resources to support a cohesive research effort. The goal of the DERC program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas. DERCs are designed around the core concept. Cores are defined as shared specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary research activities of investigators. In a DERC, cores are designed to facilitate the progress of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the center. Each core should provide state-of-the art services to multiple funded research projects. A Center may support research at a single or set of cooperating institutions through an Institutional Core, or may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core. With a regional or national core the centers will service a specific research base that is expanded beyond DERC investigators who access Institutional Cores. Examples of DERC biomedical cores that would be considered responsive to this Request for Applications include: o gene expression o islet isolation and function o transgenic and ES-cell o genetics o immunology o protein chemistry and macromolecular structure o analytical biochemistry o pathology o monoclonal antibody production o proteomics o metabolism o imaging o bioinformatics o biostatistics o clinical research These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities. In responding to this RFA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institution. In addition to biomedical cores, DERC applications must include an administrative core that will be responsible for oversight and allocation of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the DERC Pilot and Feasibility Program. The DERC enrichment program should be designed to promote scientific exchange among investigators who have research interests in diabetes, endocrinology and metabolism, and between diabetes researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Although funds are not provided directly for training purposes, applicants may wish to describe how the core laboratories and program enrichment activities will provide training opportunities for center members. The DERC Pilot and Feasibility (P&F) program provides seed support for new and innovative research projects directed at basic biomedical and/or clinical questions relevant to diabetes and its complications. To be considered a viable P&F program, the center must support a minimum of two pilot projects and direct no more than 25% of the center direct costs, exclusive of equipment, into P&F projects. Up to $50,000 in direct costs per year for up to two years can be provided for each approved P&F project. This program is particularly directed at new investigators and established investigators new to diabetes research. Established diabetes investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the DERC P&F program. DERC applicants are encouraged to consult with NIDDK staff concerning plans for the development of a Diabetes Research Center and to obtain the NIDDK Administrative Guidelines for preparing a Diabetes Research Center application (See Application Procedures). MECHANISM OF SUPPORT This RFA will use the NIH Core Centers grant (P30) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The NIDDK accepts P30 applications only when submitted in response to an RFA. The receipt of competing continuation applications from three P30 DERC centers is anticipated in response to this solicitation. These applications will compete for the three anticipated awards along with other applications received in response to this RFA. The anticipated award date is April 01, 2005. This RFA uses just-in-time concepts and non-modular budgets. Follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. The total requested project period for applications submitted in response to this RFA may not exceed five years. The maximum dollar request in any budget period is limited to $1,000,000 in direct costs with the following exceptions. Not included in these direct cost limits are: 1) requests for equipment in the first year of a competitive award; 2) direct costs on subcontracts for the purpose of establishing collaborations and providing access to the research infrastructure to investigators at historically black colleges and universities (HBCUs), traditionally Hispanic institutions, health departments, community health centers or other agencies that focus on underserved populations and offer special opportunities to foster research to reduce or eliminate health disparities in populations disproportionately affected by diabetes; and 3) Facilities and Administrative (F&A) Costs associated with any subcontract. FUNDS AVAILABLE The NIDDK intends to commit approximately $4,000,000 in FY 2005 to fund three new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $1,000,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDDK 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 Faith-based or community-based organizations o Eligible agencies of the Federal government o Foreign institutions are not eligible to apply as the primary institution, however, subcontracts to foreign institutions are permitted INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed program 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. Because a DERC has a large and complex administrative structure, the principal investigator must have strong leadership abilities and demonstrated proficiency in managing a large, multicomponent project. SPECIAL REQUIREMENTS Successful DERC applications require an existing program of excellence in biomedical research in the area of diabetes, its complications, and in related endocrinology and metabolism research. To justify Center support, the DERC must serve a large research base that has a consistent and outstanding record of NIH and other peer-reviewed funding. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK Diabetes Research Centers (See Application Procedures). Applicants from institutions with a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources (http://www.ncrr.nih.gov/clinical/cr_gcrc.asp) are strongly encouraged to utilize the GCRC as a resource for enhancing clinical research programs within the DERC. In such a case, a letter of agreement from the GCRC program director or principal investigator should be included with the application. In addition, applicants should address the potential for integration, harmonization, and enhancement of DERC activities through cooperation with other core facilities existing at the applicant institution. Assurances should be provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the DERC. Core resources must precisely define issues regarding access to core services, including investigator eligibility requirements for services, and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations such as calculations that justify investment of funds in core services and policies for cost recovery from investigators for use of services should also be included. Cores also need to develop policies and procedures for implementing change. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that IP issues do not impede sharing of resources. The DERC must provide support for enrichment activities to foster multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research. While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might operate on a regional or national level and involve multiple Diabetes Research Centers (including other DERCs as well as Diabetes Research Training Centers, DRTCs). The application should include a statement regarding willingness to participate in such activities. The proposed budget should include travel for the Principal Investigator and Associate Center Director, or other key personnel, for an annual one-day meeting in Bethesda. The application should include a statement of willingness to attend an annual meeting of Diabetes Research Center Directors. 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: Kristin M. Abraham, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 607 Bethesda, MD 20892-5460 Telephone: (301) 451-8048 FAX: (301) 480-3503 Email: ka136s@nih.gov o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (for express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 E-mail: fc15y@nih.gov o Direct your questions about financial or grants management matters to: Mary K. Rosenberg Grants Management National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 722 Bethesda, MD 20892-5456 Telephone: 301-594-8891 Fax: 301-480-3504 E-mail: mr239s@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 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 NIDDK 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 National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (For express/courier service: Bethesda, MD 20817) Telephone: (301) 594-8897 FAX: (301) 480-3505 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Applicants should request a copy of Administrative Guidelines for NIDDK Diabetes Research Centers. These guidelines contain important additional suggestions and information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from staff listed under INQUIRIES or at: http://www.niddk.nih.gov/fund/other/guidelines.doc 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: http://grants.nih.gov/grants/funding/phs398/labels.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 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 752 Bethesda, MD 20892-5452 (Courier use ZIP 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 from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete applications will not be reviewed. Incomplete and/or non-responsive applications will be returned to the applicant without further review. 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 Undergo a process in which only those application 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 written critique o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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? 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? 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? INVESTIGATOR: Is the investigator 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 (if any)? 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 in the determination of scientific merit and the priority score: The goals of the DERCs are to advance our understanding of biological systems relevant to diabetes and its complications, and to facilitate development of new methods to treat, prevent and ultimately cure diabetes and its complications. In the written comments, reviewers will be asked to discuss aspects of the application listed below in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighing them as appropriate for each application. The most important component of the DERCs is the quality (strengths, breadth and depth) of its established, independently supported, ongoing base of diabetes research at the institution(s) to be served by the Center. Specific review criteria are: o Scientific excellence of the research base served by the Center that must have a broad and central focus in diabetes and may extend to related research in metabolism and endocrinology. The relevance of the separately funded research to the Center objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, including their appropriateness, impact, relevance, modes of operation, suitability of facilities, and ability to provide unique services. Renewal applications must document the use, impact, quality control, and cost effectiveness of each core, demonstrate progress of developmental research in the cores, and show evidence of consistent evaluation and evolution of cores to meet changing needs. Progress will be judged in part by publications supported by the cores. While a minimum of two users (exclusive of Pilot and Feasibility projects) are required to establish a core, a greater number of users will be considered to be more cost effective. o Scientific and administrative abilities of the Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the Diabetes Research Center. o The qualifications, experience, accomplishments, and commitment of the Center investigators and their inter-relatedness and collaborations. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. The scientific merit of submitted pilot and feasibility studies will be evaluated using NIH review criteria and prioritized on the basis of Significance, Approach, Innovation, Investigator and Environment. In competing renewal applications, emphasis is placed on the pilot and feasibility program as a whole, including past track record and management of the program. Quality of the P&F program will be assessed on the basis of: (1) the proportion of projects successfully converted to external funding sources, (2) use of the program to support high impact or paradigm-shifting research, and (3) the extent of support provided for bench to bedside and other clinical research efforts. o The Administrative organization proposed, including: coordination of ongoing research; establishment and maintenance of internal communication and cooperation among DERC investigators; mechanisms for prioritizing usage and for systematic evaluation of needs for existing or new shared resources; mechanisms for selecting and replacing essential personnel within the Center; mechanisms for reviewing the use of and administering funds for the pilot and feasibility program, and management capabilities. o The appropriateness of the DERC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. o Institutional commitment to the program, including lines of accountability for management of the DERC grant and a commitment to establish new positions as necessary. o Although the DERCs do not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in diabetes and related metabolic and endocrine disorders will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities, is of particular importance. Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center will also be considered. 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. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. 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: June 15, 2004 Application Receipt Date: July 14, 2004 Peer Review Date: October, 2004 Council Review: February, 2005 Earliest Anticipated Start Date: April 01, 2005 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1,1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 http://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 http://grants.nih.gov/grants/policy/policy.htm. 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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