CENTERS OF EXCELLENCE IN MOLECULAR HEMATOLOGY RELEASE DATE: May 7, 2004 RFA Number: RFA-DK-04-015 Update: The following update relating to this announcement has been issued: January 26, 2010 - This RFA has been reissued as (RFA-DK-09-013). Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institute of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH) (http://www.niddk.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.849 LETTER OF INTENT RECEIPT DATE: October 15, 2004 APPLICATION RECEIPT DATE: November 16, 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 grant applications for Centers of Excellence in Molecular Hematology (CEMH). The NIDDK anticipates the award of three competing Core Center Grants (P30) in Fiscal Year 2005. The Centers of Excellence in Molecular Hematology are part of an integrated program of hematologic diseases-related research support provided by the NIDDK. The Centers currently funded in this program have provided a focus for increasing collaboration and improving the cost-effectiveness of supported research among groups of successful investigators at institutions with an established, comprehensive hematologic diseases research base. An open competition is invited, in order to renew and strengthen this program. RESEARCH OBJECTIVES The objective of these Core Centers is to bring together investigators from relevant disciplines to enhance and extend the effectiveness of research related to hematologic diseases and their complications. A Core Center must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the Core Center is to bring together clinical and basic science investigators in a manner that will enrich the effectiveness of hematologic diseases research. An existing program of excellence in biomedical research in the area of hematologic diseases and disorders is required. This research base must be in the form of NIH funded research projects, program projects, or other peer reviewed research that is already funded at the time of submission of a Center grant application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. The Core Center must have a central focus of research investigation. The central focus must be a hematologic disease, group of diseases or functional studies relating to hematologic diseases; at least half of the research proposed for inclusion in the Core Center must relate to this central focus. The purpose for development of Centers as an organizational mechanism is to promote the joint efforts of both basic scientists and clinical researchers. Areas addressed by the NIDDK CEMH should relate to announced hematologic research emphases of the NIDDK. The NIDDK Hematology Program's areas of emphasis include: o the molecular and cellular biology of hematopoiesis and hematopoietic stem cell biology o erythropoietin and hematopoietic growth factors o use of definitive stem cells as cell therapy tools for hematopoietic disorders, or definitive hematopoietic stem cells as cell therapy tools for other disorders o use of NIH-approved human embryonic stem cell (hESC) lines to explore the use of hESC as a model system, or as cell therapy tools o expressed erythroid molecular biological components and creation of reagents useful for study of the erythroid cell lineages o receptor biology and signaling o blood cell metabolism; membrane biology and ion transport; heme metabolism o globin biosynthesis and its genetic regulation o iron absorption, storage and metabolism; pathophysiology of iron overload, and strategies for therapeutic intervention o development of approaches and techniques for gene therapy using hematopoietic cells Examples of relevant investigations include but are not limited to the study of gene structure and function, the structural biology of proteins and the complex biochemistry of protein interactions, studies of the mechanisms of intracellular iron toxicity; investigation of the mechanisms of hematopoietic gene regulation and of differential gene expression during hematopoietic cell maturation and differentiation, and clinical research to test the efficacy and safety of therapeutic strategies derived from basic investigation. These studies will have as their ultimate goal the development of preventive, curative, or intervention strategies in the treatment of hematopoietic diseases. Concentration of efforts such as vector development, creation of animal models, and the application of advanced instrumentation will allow economies of scale and will generate technologies that will be broadly applicable to the understanding of molecular disorders. These centers also will serve the function of facilitating the training of new professional personnel to satisfy future manpower needs. Applicants should consult with the NIDDK Program staff listed below concerning plans for the development of the Center and the organization of the application. Centers of Excellence in Molecular Hematology are based on the core concept. Three to six cores usually are included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in a center to accomplish the stated goals of the Center. Examples of such resources include functional genomics and bioinformatics, transgenic animal, and cell preparation facilities. Multi-institutional domestic applications are encouraged. Such applications must feature existing collaborations among investigators, and specific documentation of existing collaborations must be included in the application. Multi-institutional center applications will be required to encourage regional or national use of cores. Cores that are used as a regional or national resource may be justified by what might be termed an "extended research base". Eligible investigators for such a core would be included in a "regional/national core investigator list". The extended research base for a regional or national core could include all investigators who might expect to use the core in some way. This might include investigators who would be expected to fully compensate the core service through a charge-back, and thus would not be obtaining direct financial assistance from the Center. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base, and will not be considered as part of the research base qualifying the institution as an applicant. Two other types of activities may also be supported with Center funding: a pilot and feasibility (P&F) program and an enrichment program. The P&F program provides modest short term support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to hematologic disease research, and, occasionally, at investigators already working in hematologic diseases who wish to make a substantial change in the direction of their research. In some Centers, the P&F program could be used to encourage clinical projects or translational research. By establishing ties with the institution's General Clinical Research Center (GCRC), the P&F project funds could be leveraged effectively to pursue such projects. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops. Most NIDDK-funded Centers are at institutions where the training of new investigators is a priority. The presence of a Center, with the resources it provides, should enrich any training experience and should be a positive factor when recruiting postdoctoral fellows and junior faculty. Applicants for a CEMH grant should present a plan for enhancing interactions with research training and career development programs. MECHANISM OF SUPPORT This RFA will use the NIH Core Center (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. Future competing continuation applications based on this mechanism will be accepted only in response to a separate announcement. The anticipated award date for this solicitation is July 1, 2005. This RFA uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. FUNDS AVAILABLE The NIDDK intends to commit approximately $3,000,000 in FY 2005 to fund three new and/or competing continuation grants in response to this RFA. An applicant should request a project period of five years and a budget for total costs of up to $1,000,000 per year. Although the financial plans of the NIDDK provides 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 A CEMH must be an identifiable organizational unit within a single university medical center or within a consortium of cooperating institutions with a university affiliation. Foreign institutions are not eligible to apply. 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. Women, individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities always are encouraged to apply for NIH programs. SPECIAL REQUIREMENTS To be eligible for a CEMH award, an institution must have a significant research base related to hematologic diseases. At least 50 percent of the already funded research base in a new application must be supported by the NIH. In competing continuation applications the percent may be less than 50 percent due to, for example, a growing research base of investigators entering hematologic diseases from other fields. The initial review group will determine the significance of the research base. A significant NIH funded research base (FRB) is defined as: the funding level, in annual total cost for the NIH fiscal year (October 1 to September 30), preceding receipt of CEMH applications. The research base includes peer-reviewed grants, cooperative agreements, and research contracts utilizing only the following mechanisms: P01, R01, R03, R18, R21, R24, R29, R33, R35, R37, U01, U10, U19, U24, U54, and K series awards, and N01 (excluding contracts that primarily fund the production of materials or services for support of research). Excluded from the NIH Funded Research Base are all funds from any source other than NIH. Principal investigators, plus Core Directors, are expected to participate in an annual meeting of grantees, usually in Bethesda, Maryland. The purpose of these meetings is to discuss scientific advances; the potential for collaborations, data and technology sharing; and other research opportunities. Funds for travel to the meeting should be requested in the budget. In some cases, two or more institutions that can demonstrate a credible plan for collaborative research networks using CEMH cores may wish to submit an application for a single CEMH award. Reviewers will look critically at the request for multi-institutional applications for the following indicators: a demonstration of exceptional need to establish collaboration between investigators at separate institutions; evidence of unique plans, such as the development of organized communications systems, to overcome the scientific and management challenges that are naturally a part of multi-institutional collaborations; specific plans to address anticipated budgetary issues in the transfer of funds and resources from one institution to another; and evidence of centralized authority of the CEMH Director for the purpose of management of the CEMH facilities at other sites. Multi-institutional CEMH applications may combine the NIH hematology funded research of all the investigators at the institutions participating in the proposed CEMH to meet the NIH Funded Research Base (FRB) requirement. A CEMH cannot use the FRB of an institution that is already part of another CEMH. A multi-institutional CEMH application must designate a lead institution that will receive the award and provide details of agreements regarding coordination and support of cores and activities at other participating institutions. DATA SHARING: All applications that list direct costs greater than $500,000 in any year of the proposed research must have a data sharing plan. This plan will be reviewed for: statements of willingness to share information fully; clarity of included Material Transfer Agreements; adequate and clear strategies for sharing results/data, tools, and new animal models with the research community and/or websites maintained by the NIH. 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: David G. Badman, Ph.D. Hematology Program Director National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 621 Bethesda, MD 20892-5458 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: firstname.lastname@example.org o Direct your questions about peer review issues to: Francisco O. Calvo, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Two Democracy Plaza, Room 752 Bethesda, MD 20892-5452 Telephone: (301) 594-8897 Email: email@example.com o Direct your questions about financial or grants management matters to: Aretina Perry-Jones Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 745 Bethesda, MD 20892-5456 Telephone: (301) 594-8862 FAX: (301) 480-3504 Email: firstname.lastname@example.org 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 program 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) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Prospective applicants should obtain a copy of the Administrative Guidelines for Centers of Excellence in Molecular Hematology. The Guidelines are available from the Program Director cited above, or from the NIDDK web site at: http://www.niddk.nih.gov/fund/other/centers.htm#Hematology 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/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typed 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 copies of the appendix material must 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) 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 program 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. If the application is not responsive to the RFA, the application will be returned. 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 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 written critique o Receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council REVIEW CRITERIA All applications responding to this RFA will be evaluated according to the review criteria as outlined in the NIDDK CENTERS OF EXCELLENCE IN HEMATOLOGY ADMINISTRATIVE GUIDELINES available on the NIDDK web site at http://www.niddk.nih.gov/fund/other/centers.htm#Hematology or from the program director listed under INQUIRIES, above. As part of the initial scientific review, which will result in an overall priority score for the P30 application, reviewers will rate each individual research core and, if requested, the clinical component, as well as the P&F program. The evaluation of the Enrichment program will be reflected in the score for the Administrative Core. The scores for each of these will appear in the summary statement. The review group will assign a descriptor, rather than a score, for the research base, the P&F program, and the Center Director. 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 proposed Center address important hematologic issues? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of this Center on the concepts or resources that drive this field? APPROACH: Are the conceptual framework, design, collaborations and cores 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 proposed Center have the potential to develop novel concepts, approaches or methods? Are the directions original and innovative? Does the proposed Center offer the prospect of challenging existing paradigms or develop new technologies or resources? INVESTIGATORS: Are the Center investigators appropriately trained and well suited to collaborate in the proposed Center goals? Does the experience and track record of the Principal Investigator inspire confidence in his/her ability to lead this group of investigators? ENVIRONMENT: Does the scientific environment in which the proposed Center will be set contribute to the probability of success? Do the proposed collaborations and cores take advantage of unique features of the scientific environment? 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: o The scientific excellence of the Center's research base (its strengths, its breadth and depth) as well as the relevance and interrelation of these separately funded research projects to the central theme(s) or focus of the Center and the likelihood for meaningful collaborations among Center investigators. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a CEMH and is the most important component of the review. The results of previous peer reviews of its content will weigh heavily in the assessment of the application's overall strength. o The qualifications, experience, and commitment of the Center investigators responsible for the individual research projects, and their willingness to interrelate with each other and contribute to the overall objectives of the CEMH. o The appropriateness and relevance of the proposed Cores and their modes of operation (such as how usage will be prioritized), facilities, and potential for contribution to ongoing research. Competing continuation applications must document the use, utility, quality control, and cost effectiveness of each Core requested to continue as part of the Center. Progress will be judged in part by the list of publications arising from the cores. At least two users are required to establish a core. However, a greater number of users will be considered to be more cost effective. o For all applications, four P&F studies should be submitted for evaluation as part of the review of the P&F program. In general for new applications, the proposed P&F projects will be examined to assess the eligibility of the P&F applicant and the adequacy of the selection process by which the individual studies were selected. For competing continuation applications, data should be supplied on the success of previously funded P&F projects in obtaining outside support. Applicants should refer to the Administrative Guidelines for CEMHs for specific details regarding the P&F program and its review by the IRG. o The scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program. o The administrative organization proposed for the following: (a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring; (b) Establishment and maintenance of internal communication and cooperation among the Center investigators; (c) Mechanism for selecting and replacing professional or technical personnel within the Core Center; (d) Mechanism for administering and reviewing the use of funds for the P&F program; (e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities; o The institutional commitment to the program, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center; o The academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions; o Efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to enhancing the objectives of the Center; o The appropriateness of the budgets for the proposed and approved work to be done in Core facilities, for P&F studies (these are restricted funds and are capped at $150,000), and for enrichment in relation to the total Center program. Requested Total Costs are limited to $1,000,000 per year (including the P&F program and subcontract facilities and administrative costs). For competing continuation applications, requested Total Costs should not exceed the $1,000,000 cap. Budgets may not be submitted in a modular format. 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 15, 2004 Application Receipt Date: November 16, 2004 Peer Review Date: February/March 2005 Council Review: May 2005 Earliest Anticipated Start Date: July 1, 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 WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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: 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. 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: 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 RFA 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). 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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