GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS (R01) RELEASE DATE: November 4, 2002 (see addendum NOT-TW-03-003) RFA: TW-03-006 Fogarty International Center (FIC) (http://www.nih.gov/fic/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Eye Institute (NEI) (http://www.nei.nih.gov/) National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib1.nih.gov/) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/) National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Drug Abuse (NIDA) (http://www.nida.nih.gov/ ) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov/) Office of Dietary Supplements (ODS) (http://ods.od.nih.gov/) Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/) LETTER OF INTENT RECEIPT DATE: January 18, 2003 APPLICATION RECEIPT DATE: February 18, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism 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 This RFA is intended to promote productive re-entry of NIH-trained foreign investigators into their home countries as part of a broader program to enhance the scientific research infrastructure in developing countries, to stimulate research on a wide variety of high priority health-related issues in these countries, and to advance NIH efforts to address health issues of global import. The specific goal of this initiative is to provide funding opportunities for the increasing pool of foreign biomedical and behavioral scientists, clinical investigators, nurses, and other health professionals with state-of-the-art knowledge of research methods to advance critical issues in global health upon their return to their home countries. After their term of research training, developing country participants supported by this RFA are expected to continue independent and productive scientific careers, including expert training and consultation and/or research of biomedical issues within their home institutions. RESEARCH OBJECTIVES As a part of its global health initiative under the Department of Health and Human Services (DHHS), the Fogarty International Center (FIC) of the National Institutes of Health (NIH), in partnership with the following Institutes, Centers, and Offices on this RFA: National Cancer Institute (NCI), National Eye Institute (NEI), National Heart Lung and Blood Institute (NHLBI), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute of Environmental Health Sciences (NIEHS), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA), Office of Behavioral and Social Science Research (OBSSR), Office of Dietary Supplements (ODS), and Office of Research on Women's Health (ORWH), invites applications from current and former NIH-supported foreign research trainees to compete for funds that will support their research efforts upon return to their home countries. In order to be eligible, foreign scientists must meet at least one of the following criteria: 1) at least two years of research training experience under a FIC-supported training grant (classified by the D43 "International Training Grant" mechanism). 2) one year of such D43 training experience coupled with one year of significant, well documented mentored research experience (e.g. through an NIH research award). 3) at least two years of research training experience through the NIH intramural Visiting Fellows Program. All training and research must either have been done in the U.S. or have been part of in-country research associated with a degree or mentored postdoctoral research under the D43 award mechanism and completed after September 1, 2000. Current NIH Visiting Fellows are particularly encouraged to apply as they begin their preparation to return home although they, too, may apply within two years of completion of training. Through various programs, the NIH has made a significant investment in training biomedical and behavioral researchers. For example, the NIH Visiting Fellows Program currently hosts more than 1,600 junior scientists from almost 100 countries for periods of one to five years. In addition, the NIH D43 research training and capacity building grant mechanism allows hundreds of foreign researchers to receive training at prominent institutions in both the United States and their home countries in a range of biomedical and behavioral research areas critical to advancing global health. In summary, training supported by NIH is critical to these young investigators as they develop independent research careers. As junior foreign scientists complete training programs in the U.S., many find it difficult to secure the support needed to continue their research projects and careers in their home countries. The Global Health Research Initiative Program (GRIP) provides the opportunity for junior foreign scientists to compete for such funds through a peer-reviewed process. This is a critical adjunct in the continuation of promising independent research careers that will be of benefit to the investigators' home countries and the world at large. Women and underrepresented minority scientists in their countries are especially encouraged to apply for these re-entry grants. Project proposals should be geared towards the research interests of the applicant and focus on high-priority health and healthcare problems in the investigator's home country that also carry global importance and also are of interest to the collaborating NIH Institutes, Centers, and Offices listed on the first page of this RFA. It is expected that research topics will be diverse. Specific research interests of partnering ICs can be found on the ICs' websites as listed at the beginning of this RFA. Research related to women's health, including studies of gender differences in disease onset and progression, identification of behavioral strategies that are effective in encouraging healthy lifestyles in young girls and women, as well as behavioral strategies to encourage prevention of diseases such as STDs and diseases with higher prevalence among women (including infectious diseases, lupus, multiple sclerosis and depression) are particularly encouraged. Research focused on behavioral and social determinants and their effects on health is also encouraged. All research must be performed in accordance with NIH and U.S. Government regulations regarding the responsible conduct of research. This RFA precludes the support of research involving enrollment in pilot studies for clinical trials or the actual support of clinical trials since the resources and infrastructure to support and oversee such trials generally exceed the resources available under this award mechanism. Applicants are encouraged to visit the website of the Office for Human Research Protection (OHRP) (http://www.hhs.gov/ohrp/), that outlines these regulations. For information on animal protection in research, see http://grants.nih.gov/grants/olaw/olaw.htm. This RFA contributes to the FIC mission and to the broad NIH initiative to reduce health disparities among nations by strengthening research infrastructure in developing countries, particularly those with the least economic resources. Additionally, it provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home. Evaluation of the program will occur on an ongoing basis. Because this is a program to move research trainees to the status of independent investigator, there are several outcomes to be measured: o development of the laboratory capabilities or research projects o training of other potential researchers o publications in local journals as well as international peer-reviewed journals o participation in workshops, seminars, and international conferences o collaborations with past mentors as well as others o attraction of funding from other sources As part of its assessment of the impact and scientific productivity of this program, FIC plans to track researchers and their trainees for at least five years after beginning their independent research. Evaluation may focus on the success of the researchers (as measured by the number and quality of publications, presentations, courses, awards, subsequent employment, etc.), their sustained commitment to research careers, their ability to attract funding for their work, their contributions to future international collaborations, their influence on the development of scientific research in their countries, and their ability to act as consultants, teachers, and role models to other local investigators and further disseminate the lessons learned. Metrics should be stated both for the success of the individual researcher and the success in capacity building at the home institution, including the impact of the program on research at the institution in the home countries of researchers and their trainees. MECHANISM OF SUPPORT This RFA will use the NIH Research Project Grant (R01) mechanism using the modular grant format. If an application has a significant collaboration with a NIH intramural laboratory, the application will be converted to the cooperative agreement (U01) mechanism and awarded as a cooperative agreement. This RFA is issued for fiscal year 2003 (FY03). FIC and our NIH partners expect that a similar RFA will be issued annually for the next several years, depending on the availability of funds. Applications submitted in response to this RFA may have a project period of no less than three years and no more than five years. An applicant can request up to two modules of $25,000 each, or total direct costs of $50,000 per year, plus facilities and administrative (F&A) costs up to a maximum of eight percent for a foreign institution. The Principal Investigator (PI) is expected to devote at least 50 percent of his/her total effort to this project. This RFA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Animal facility information must be provided in the application. See http://www.iacuc.org/ and http://grants.nih.gov/grants/olaw/olaw.htm for International Animal Care and Use Committee (IACUC) guidelines. Because an investigator can receive a maximum of five years of support under the GRIP program and this specific GRIP award is not renewable, any future application will be considered an unsolicited competing application based on this project and will compete with all investigator-initiated applications submitted to NIH through the Center for Scientific Review (CSR). FUNDS AVAILABLE The participating ICs intend to commit approximately $1.5 million in FY03 to fund up to 30 new awards in response to this RFA. An applicant may request a project period from three to five years and a budget of direct costs of up to $50,000 per year. The PI is expected to devote at least 50 percent of his/her total effort to this project. 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 ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds, the receipt of a sufficient number of meritorious applications, and geographic balance. The earliest anticipated award date is July 2003. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your foreign institution is from a developing country and 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 of developing countries o Faith-based or community-based organizations Only institutions in developing countries are eligible to apply. Institutions in countries which have the least economic resources are particularly encouraged to apply. For the purpose of this RFA, the following geographic regions or countries can apply: North Africa, West Africa, East Africa, Central Africa, Southern Africa, Russia, the Newly Independent States, Eastern Europe, the Middle East (except Israel), India, Asia (except Japan, Singapore, South Korea, and Taiwan), the Pacific Islands region (except Australia and New Zealand), Latin America, and the Caribbean. INDIVIDUALS ELIGIBILE TO BECOME PRINCIPAL INVESTIGATORS Any individual from an eligible institution who meets the eligibility criteria below is invited to develop an application in conjunction with their home institution. Women and individuals from underrepresented racial and ethnic groups in their countries, as well as individuals with disabilities, are always encouraged to apply for NIH programs. Only applicants from institutions in eligible developing countries are eligible to apply. In order to be eligible, applicants must meet at least one of the following criteria: 1) at least two years of research training experience under a FIC- supported training grant (classified by the D43 "International Training Grant" mechanism). 2) one year of such D43 training experience coupled with one year of significant, well-documented mentored research experience (e.g. through an NIH research award). 3) at least two years of research training experience through the NIH intramural Visiting Fellows Program All training and research, to meet eligibility requirements, must have either been done in the U.S. or have been part of in-country research associated with a degree or mentored postdoctoral research under the D43 award mechanism, and completed after September 1, 2000. Applicants must return to a research position in their home country institution in order to carry out research supported by this award. The award will be made to the home institution on the investigator's behalf only after the investigator has arrived in that country. Therefore, the application must be submitted by the institution to which the applicant has returned or will be returning. It is expected that the PI will demonstrate that he/she has an appointment at an academic or other institution in his/her home country and will demonstrate or provide a letter of support that that institution will have the capacity to support the research proposed. The GRIP award will support up to one-half the investigator's salary, commensurate with the salary structure of the home institution. Funds from the institution, national government, local science research council or other public or private organization may be used to support this program. The remainder of the funds from this grant may pay for equipment, travel, supplies, or other research personnel's salary working on the same research project. In order to build upon experience, partnership, mentorship and prior investments, applicants are encouraged to submit applications in collaboration with the NIH-supported institution or intramural laboratory from which they have received or are receiving research training. Through letters of support, U.S. collaborators should demonstrate how this program will support ongoing research collaborations. For those applicants who are eligible through both a year of training and a year of significant mentored research, letters of support should be received from both mentors. While recognizing that this program is intended to foster the independence of the applicant, FIC recognizes the value of continued collaboration with NIH or U.S. mentors. This relationship should be documented in the application. Because of the desired ongoing relationship between the new investigator and the IC where training occurred, the NIH intramural researcher must have pre- approval of the Scientific Director from his or her NIH Institute through a letter to be submitted 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 four areas: scientific/research, eligibility, peer review, and financial or grants management issues. Direct your questions about scientific/research and eligibility issues to: Aron Primack, MD, MA Division of International Training and Research Fogarty International Center National Institutes of Health Bldg. 31, Room B2C39 31 Center Drive Bethesda, MD 20892-2220 Tel: (301) 496-4596 Fax: (301) 402-0779 Email: primacka@mail.nih.gov Direct your questions about peer review issues to: Don Schneider, Ph.D. Director, Division of Molecular & Cellular Mechanisms Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Rockville, MD 20892-7842 Tel: (301) 435-1727 Email schneidd@csr.nih.gov. Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center National Institutes of Health Building 31, Room B2C29 31 Center Drive Bethesda, Maryland 20892-2220 Tel: (301) 496-1670 Fax: (301) 594-1211 Email: butrumb@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by January 18, 2003, which includes the following information: o Descriptive title of the proposed research o Name, address, and telephone and fax numbers of the Principal Investigator o Names of other key personnel o Name and address of the 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 CSR staff to estimate the potential review workload and plan the review. Further information, including the answers to frequently asked questions about this RFA can be found at http://www.nih.gov/fic. 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: Aron Primack, MD, MA Division of International Training and Research Fogarty International Center National Institutes of Health Bldg. 31, Room B2C39 31 Center Drive Bethesda, MD 20892-2220 Tel: (301) 496-4596 Fax: (301) 402-0779 Email: primacka@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact NIH GrantsInfo, Telephone (301) 435- 0714, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 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 http://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 http://grants.nih.gov/grants/funding/modular/modular.htm. SUPPLEMENTAL INSTRUCTIONS: Applicants may request up to two modules, or $50,000, of direct costs per year and the application must be in modular format. The PI is expected to devote at least 50 percent of his/her total effort to this project. The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. It is understood that writing an application for such an R01 grant may be difficult and time-consuming. Therefore, it is encouraged that potential applicants seek assistance in such grant writing. Those being trained via the D43 grant mechanism should seek such assistance at or from their training institutions. Those within the NIH intramural program should seek such guidance within the NIH framework. Although there is a limit of 25 pages for these R01 applications, it is possible that applicants may only need 15 or fewer pages. The application should be complete and follow the format of the PHS 398. Help for completing these applications can be found on the NIH website. Examples of helpful information include: o http://www.niaid.nih.gov/ncn/grants/default.htm o http://www.nigms.nih.gov/funding/tips.html o http://www.niddk.nih.gov/fund/grants_process/grantwriting.htm o http://deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.htm o http://www.drugabuse.gov/Funding/Grantapps.html o http://www.nigms.nih.gov/funding/tips.html Applicants are strongly encouraged to call the program contacts listed in INQUIRIES with any questions regarding the adherence to the guidelines of their proposed project to the goals of this RFA. Budget Instructions Applicants will request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o Under Personnel: List all project personnel, including their names, percent of effort, and roles on the project. The PI is expected to devote at least 50 percent of his/her total effort to this project. The PI may only request support of up to 50 percent of his/her effort on this project. The PI's salary and any other salaries should be commensurate with the salary structure at the applicant institution. o Under Facilities and Administrative (F&A) Costs: F&A costs of up to eight percent should be shown under the calculation section on the Checklist Page of the PHS 398 application. The F&A cost calculation may not exceed eight percent of total direct costs less equipment. Applicants do not need to complete the section regarding agreements above the calculation section. Applicants should mark the modified total direct costs base box below the calculation section. Other Requirements o The applicant should list the date that he/she returned or expects to return to their home country. o The applicant must have a letter from the home institution describing its involvement in the ongoing research plan and the support of it including any financial and/or in-kind anticipated support. For investigators associated with the D43 grants program: include a letter from the U.S. mentor, outlining the nature of the future collaborative relationship, and how the NIH-supported laboratory or other program supported, and/or will support, a continued collaboration with the investigator, using all appropriate resources. The letter should also indicate the dates of research training and a summary of the program. For applicants eligible through one year of research training and one year of significant mentored research, letters outlining the nature of the future collaborative relationship from both mentors are required. These letters should indicate the dates of such training and research. o In the application, either in the biosketch or as part of the background information, include the dates of the training program and, when applicable, the research effort, a description of the training and research programs including the courses taken, and a summary of the program and of the research. Include evidence of at least two years of training or one year of training and one year of significant, well-documented research (e.g. the specific grant number). o For NIH Visiting Fellows: include the dates of the training as well as a letter from the NIH laboratory chief and Institute scientific director. This letter should also outline the nature of the future collaborative relationships with the NIH mentors. o The investigator must describe current or previous training under the D43 or the NIH intramural program. The applicant must provide a brief paragraph providing the grant number, the name and address of the NIH mentor or Principal Investigator of the D43 or other eligible grant, and a description of the training received. The trainee must have at least two years of such training or one year of such training and one year of significant well- documented research experience. If the latter, please include the grant number and a summary description of the research experience. o Include two further letters of reference relating to the abilities of the applicant investigator, specifically indicating the ability to become a leader in scientific pursuits. These can be attached at the end of the grant but before any appendices. o Checklist: This page should be completed and submitted with the application. Applications submitted by foreign or international institutions can request F&A costs up to a maximum of eight percent. Please see the web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the allowability of F&A costs for foreign and international organizations. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. 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 two of the face page of the application form and the YES box must be marked. The RFA label is available at: http://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 five signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 208892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by 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. (See http://www.nichd.nih.gov/funding/receipt_dates.htm for receipt date information.) 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC. 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 CSR 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 the FIC Advisory Board and possibly the Advisory Boards or Councils of co-sponsors. 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 including the career development of the Principal Investigator. o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, you may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important health problem and is it specifically a priority health issue in your home country? If the aims of your application are achieved, how will scientific knowledge be advanced and your research career be enhanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? Is your research hypothesis driven or hypothesis generating? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level as the Principal Investigator and other researchers (if any)? How will this award enhance your career development and help you achieve a position of scientific leadership in your home country? Do the letters of support document a strong commitment to help you develop your career? (5) ENVIRONMENT: Does the scientific environment, in which your work will be done contribute to the probability of success? Has your home institution made a convincing commitment to you (e.g. to provide a research/academic appointment and partial salary support)? Do the proposed experiments or studies take advantage of unique features of the scientific environment in your home country or employ useful collaborative arrangements? Is there evidence of institutional support in the developing country? What is the continuing commitment of the U.S. collaborating institution (e.g., the institution associated with the NIH D43, the NIH intramural program laboratory, or the research program) to further develop your career and research interests? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. o 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: January 18, 2003 Application Receipt Date: February 18, 2003 Peer Review Date: May 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Applications will compete with all other recommended applications for available funds. Criteria that will be used to make award decisions include: o Quality of the proposed project, as determined by peer review o Availability of funds o Geographic balance o Programmatic priority, including funding interests of collaborating NIH, or other cosponsors o Level of need as measured by economic resources in the applicant developing country Awards will not be made until applicants have actually returned to their home countries (or other developing countries). A change of grantee institution that involves the transfer of a grant to or between foreign institutions or international organizations requires competitive re-review and approval of the IC Advisory Council/Board. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of the NIH that women and members of minority groups, and their subpopulations, must be included in all NIH-supported clinical research projects, unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research – Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of a 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 IN THE PROTECTION OF HUMAN RESEARCH 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 in the NIH Guide for Grants and Contracts, 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://grants.nih.gov/grants/stem_cells.htm 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 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 date 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. 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 a 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. Because the applications are expected to cover many and varied areas, this RFA will probably be related to many priority areas of this activity including general public health, cardiovascular disease, diabetes, and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.989, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of the Public Health Service Act, as amended (42 USC 241 and 287b) and administered under Public Health Service (PHS) grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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