National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
John E. Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH) (http://www.nibib.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
Title: Recovery Act Limited Competition: Framework Programs for Global Health Signature Innovations Initiative (R24)
Request for Applications (RFA) Number: RFA-OD-10-007
Catalog of Federal Domestic Assistance Number(s)
Release Date: January 26, 2010
Letters of Intent Receipt Date: February 22, 2010
Application Due Date: March 22, 2010
Peer Review Date(s): June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (URL Activation Date):
Expiration Date: March 23, 2010
Due Dates for
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Research Resources Program Objectives
The ARRA Framework Programs for Global Health Signature Innovations Initiative will provide short-term support to U.S. universities and their partners to build capacity to train postdoctoral investigators to carry out innovative, multidisciplinary research in Global Health and to attract new investigators with diverse expertise into this research field. Institutions should propose to build research or research training infrastructure and develop training resources and activities that will provide the university community with the tools, concepts, mentoring, and opportunities that will nurture innovative multidisciplinary approaches to Global Health research that go beyond sharing viewpoints to actively working together on common research problems. The initiative emphasizes hands on, problem solving, and collaborative approaches. This FOA is consistent with the goals of the FIC Strategic Plan (http://www.fic.nih.gov/about/plan/stratplan_fullversion.pdf ) to support and facilitate global health research in both communicable and non-communicable diseases, build partnerships between health research institutions in the U.S. and abroad, and train the next generation of scientists to address global health needs.
Background: The Fogarty International Center’s (FIC’s) Framework Programs for Global Health (FRAME) are breaking new ground in developing a multidisciplinary or systems approach to Global Health research education. The approach acknowledges that global health issues are complex, cross national borders, and have biomedical, social/political, technological, legal/regulatory, and economic dimensions that frequently require novel and integrated solutions. Moreover, many of the major developments in health research in the past decade that will significantly impact global health have arisen from the interface of disciplines, such as the integration of life sciences, engineering, and computational science that made possible the genomics ‘revolution’. FRAME programs have catalyzed significant curricular development in global health on 35 campuses in the US and in low- and middle-income countries (LMICs) and have allowed universities to respond to a growing demand by their students and faculty for more training, and more varied pathways, into this critical research area. Participating Schools within these institutions represent over seventeen different disciplines including Medicine, Public Health, Arts and Sciences, Law, Engineering, Environmental Sciences, Business, Veterinary Sciences, and others. The new administrative entities created through the Frameworks have in many cases become institutionalized as new Centers for Global Health, serving the entire university community. A list of current institutional awards and abstracts can be found on our website at http://www.fic.nih.gov/programs/training_grants/framework/index.htm.
This FOA retains the signature features of the FRAME Program while addressing a gap in the scope of these projects. While some universities have begun to incorporate multidisciplinary viewpoints in their classroom materials, few have challenged students from diverse disciplines to work together on research projects in global health or provided training opportunities for postdoctoral investigators to translate this team paradigm into their research practice. However, it is not until scientists actually try to collaborate with others outside their fields that the power and the barriers to a systems approach become apparent. At the same time, trainees may benefit from an environment that challenges them to try novel approaches and seek out unfamiliar or emerging technologies and complementary expertise to incorporate into innovative solutions that have the capacity to be transformative. It is likely this will require innovative training models and new partnerships within and beyond the university community.
Objectives: Applications should propose activities that will increase the infrastructure and opportunities at the participating institution(s) for multidisciplinary research training in Global Health and that will allow postdoctoral investigators from disciplines that have not traditionally been associated with global health research to have a pathway into this research area. Specifically, the objectives of this FOA are to:
In addition, all proposals should address the intent of the ARRA to preserve and create jobs, promote economic recovery in the United States, accelerate the pace of scientific discovery, and spur technological advances in science and health.
Scope: The proposed activities may encompass the many research fields in Global Health broadly or may be more focused, thematically or geographically, but should address the health concerns of populations living in low resource settings, particularly in LMICs. The applicant may propose completely new activities or build significantly on initiatives already in place at the university that will take these initiatives to a new level or result in a new use of available resources. The applicant should not propose to merely sustain an initiative already in place.
The specific hands-on training projects may take many forms. For example, a multidisciplinary research team might undertake to design a “product” that addresses a specific health need, taking into consideration (as applicable) issues of access, infrastructure, barriers to adoption, affordability, scalability, regulatory and legal environment, data management, disposal and recycling, technology transfer, evaluation of effectiveness, and others, where considerations of implementation may significantly impact initial design. Projects should be realistic in scope and time scale so as not to generate superficial solutions to fundamental problems nor impose “parachute” solutions that will not be appropriate or sustainable. Projects may also benefit from integration with funded research and research training programs.
Participants and Consortia: The application must include participation by at least three Schools of distinct disciplines (such as Public Health, Engineering, and Computer Science), either at the applicant institution or among a consortium. We particularly encourage the inclusion of Schools or Departments with expertise in Technology and Computer Sciences, although all disciplines are welcome. Applicants may choose to form consortia that include other academic or research institutions outside the university that could provide synergistic or special expertise and experience, or that share common goals. These may include institutions in the U.S. or in LMICs (within the constraints of ARRA funding, see Section II.2 below). It is likely that many projects or training models would benefit from cooperative partnerships or joint training with individuals who work in the environments in which the products or research solutions would be deployed.
This one-year grant is intended to act as a catalyst. It is expected that the concept for the proposed infrastructure, resources, and training opportunities can be fully developed and activities initiated during this period. FIC anticipates, subject to the availability of funds, that there may be a follow on opportunity that will allow for the continued development and full implementation of the activities and infrastructure developed through this signature award.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Resource-Related Research Project (R24) award mechanism, which is a flexible and specialized mechanism designed to provide resources for problems where multiple expertise is needed to focus on a single complex problem in research or to enhance research infrastructure.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see ).
2. Funds Available
This initiative is supported by funds provided to the NIH
under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or
“ARRA”), Public Law 111-5. The Fogarty International Center has designated $2.7 million in FY 2010 to fund 6-10 grants, contingent upon the submission of a
sufficient number of scientifically meritorious applications.
Budget proposals are limited to $250,000 direct costs per year for single applicants and $400,000 direct costs per year for consortia for a period of one year. Consortia include the applicant university with at least one academic or research partner institution outside the university. Although other non-academic or non-research institution partners may participate in the program, such as non-governmental organizations (NGOs), they cannot be used to determine funding level.
Because the nature and scope of the proposed research
resources program will vary from application to application, it is anticipated
that the size of each award will also vary. Although
the financial plans of IC(s) provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of sufficient number of
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004. F&A costs for the applicant organization and consortium participants will be reimbursed at up to 8 percent of modified total direct costs (exclusive of tuition, fees, and equipment).
Personnel: Individuals (PD/PIs), faculty and staff designing, directing, and implementing the proposed research resource program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the U.S. or collaborating institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with trainees/participants are considered a regular part of an individual’s academic duties, then any costs associated with the mentoring and other interactions with trainees/participants are not allowable costs from grant funds.
Resource Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research resource program and must not duplicate items generally available from other sources at the applicant or collaborating institution. Expenses for foreign travel must be well justified, and must utilize U.S. carriers wherever possible. Applicants should include travel expenses to participate in a network meeting of all grantees supported as a result of this funding opportunity at NIH (or another venue identified by the program staff) during the grant period.
Participant Costs: Participant costs must be justified as specifically required for the proposed research resource program. Allowable participant costs depend on the educational level/career status of the individuals involved in the program. Amounts for all participants must conform to the established, consistently applied salary and wage policies of the U.S. or collaborating institution and reflect the percentage of time/effort devoted to the program.
This program is supported by funds provided to the NIH under the Recovery Act. The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from and institutions. Foreign organizations/institutions are not permitted as the applicant organization.
The following represent organizations/institutions that are eligible for funding:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research resources program as the PD/PI is invited to work with his/her organization 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 support.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
Number of Applications. FIC expects to fund only one application from any single institution. However, applicant institutions may also participate in consortia through applications submitted through other institutions as long as the programs are scientifically and programmatically distinct.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are not permitted in response to this FOA.
Note: This initiative is distinct from the Framework Programs for Global Health (R25), hence, this is not considered a renewal of Framework Programs for Global Health (R25) grants.
Institutional Commitment: Applications should include letters from the appropriate head research administrator at all participating institutions substantiating the institution’s commitment to the proposed research resource development and to sustaining the results of the proposed activities. The institution should state their commitment to overcoming any administrative obstacles to the implementation of the proposal, such as accommodation for participation by multiple Schools at the university or collaboration with other institutions. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and resources that can contribute to the planned program.
Developing country collaboration: While foreign institutions may not be applicants, consortia may include collaborating institutions from low- and middle-income countries as defined by the World Bank (according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).
Requirement for Multidisciplinary Participation: Participation by a minimum of three Schools of distinct disciplines is required. Applications that do not include three distinct disciplines may not be reviewed. For consortia, the three disciplines may be distributed among the partner academic institutions.
Pre-requisite activities in Global Health: All current or former U.S. FIC Framework Programs for Global Health grantee institutions are eligible to apply for this initiative. Other institutions are eligible to apply if they can demonstrate that the institution has a minimum of five research or research training grants or research contracts in Global Health topics involving significant participation by partners in low or middle income countries as defined by the World Bank, above (such as a role as key or significant personnel or listed performance site). At least three of these awards must be from the NIH. These awards must be active on the application receipt date for this FOA. The institution may be a subcontract on one of the awards. Alternatively, if a consortium of institutions applies as partners, the institutions applying must together meet this pre-requisite (i.e. as the sum of all the partners). Provide a Table in the appendix that lists the qualifying grants and contracts, including the following information: source of funding, name of PI, institution holding the award, grant or contract number, total amount of award, and end date. If there are questions about an institution’s eligibility, please contact the FIC Scientific contact (Section VII.1).
The current PHS 398 application instructions are
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section, Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
Submission, Review, and Anticipated Start Dates
Letters of Intent Receipt Date: February 22, 2010
Application Due Date: March 22, 2010
Peer Review Date(s): June/July 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: August 31, 2010
3.A.1. Letter of Intent
Although the Letter of Intent (LOI) is not required, not binding and does not enter into the review of the subsequent application, an applicant may choose to submit one. The information that the LOI contains allows IC staff to estimate and plan for the potential review workload. Prospective applicants are asked to submit a LOI that includes the following information:
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent by email to:
Flora Katz, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 402-0779
Email (preferred): email@example.com
3.B. Submitting an Application to the NIH
Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity 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 a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see theNIH Grants Policy Statement).
None of the funds appropriated or otherwise made available in ARRA may be used by any state or local government, or any private entity, for any casino or other gambling establishment, aquarium, zoo, golf course, or swimming pool. (ARRA Sec. 1604)
PHS398 Research Plan Component Sections
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following additional requirements:
The purpose of this FOA is to create opportunities and resources for multidisciplinary training for innovation in Global Health research. We expect schools within the university to work together, and some applicants may put together consortia of institutions to jointly develop training and resource plans. As such, within the research resources program plan, applicants should also address the following:
Evaluation Plan: Applications must contain an evaluation plan. The Plan should take into account the short time span of the initiative but be able to generate sufficient information to assess whether the projects initiated should be continued or how they might be modified to improve their impact. This might include an external review by appropriate subject matter experts in global health research and training who are not involved in the program and can make recommendations and assess the success of the initiative. A report on the results of the evaluation should be included as part of the final report for the grant. This section should be included within the 12 page limit of the Research Plan.
Training in the Responsible Conduct of Research: For those programs that intend to enroll trainees, every faculty must be familiar with and every student must receive instruction in the responsible conduct of research. Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research training program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction. Applicants may wish to consult the NIH website (http://bioethics.od.nih.gov/) for additional guidance.
Students who will participate in research involving human subjects must meet the NIH policy requirement for education in human subjects protections (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). Students participating in research with live vertebrate animals must also be enrolled in the institutional animal welfare training program for personnel who have contact with animals. The requirements for specific human subjects education and participation in the institutional animal welfare training program may be included as elements of required training in the Responsible conduct of Research.
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see ).
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.
Do not use the Appendix to circumvent the page limitations.. An application that does not observe the required page limitations may be delayed in the review process.
Applicants must provide a Table in the appendix that lists the qualifying Global Health grants and contracts to meet the eligibility requirements (Section III.3), including the following information: source of funding, name of PI, institution holding the award, grant or contract number, total amount of award, and end date. If there are questions about an institution’s eligibility, please contact the FIC Scientific Contact (Section VII.1)
No supplemental/update information will be accepted.Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group(s) convened by the Center for Scientific Review (CSR) and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research resources program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the program proposed).
Scored Review Criteria
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the research resources program proposed address an important problem or critical barrier to progress in the field of global health research? If the aims of the program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the program provide new training opportunities, new training models, and new resources for multidisciplinary research training in global health at the institution(s)? Will the program be transformative for the participating schools and, where applicable, institutions?
Investigator(s). Are the PD/PIs, collaborators, and other participants well suited to the program? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the program is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the program? Do the PD/PI(s) and other key personnel have the necessary experience in global health-related research and training to lead an effort in this area? Do the PD(s)/PI(s) have experience in leading a program involving multiple participating components? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?
Innovation. Do the proposed activities challenge and seek to shift current practice paradigms in research and training in global health by utilizing novel concepts, approaches or methodologies? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of concepts, approaches or methodologies proposed? Does the program promote and support “innovation” in global health research, as defined by the applicants, through its training paradigm and the resource infrastructure it will establish? Do all participating entities, both among the components of the university and within a consortium (where applicable) contribute to the innovation goals of the application?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the applicants proposed a program that will stimulate hands-on, problem solving-based training in a well-integrated multidisciplinary context? Are some of the activities directed towards producing specific global health “products”, as defined in this FOA? Do the applicants discuss why the three or more participating disciplines were selected and how they will be engaged? Does the program take advantage of global health research expertise at the participating institution(s)? Do the applicants discuss plans to implement and/or sustain the activities initiated under this award at the conclusion of the one-year award period and are these reasonable?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the program proposed? Will the program benefit from unique features of the institutional environment or collaborative arrangements? Have they created an environment that will encourage trainees and investigators to explore innovative approaches to global health research? Are appropriate letters of support from the research leadership of the participating entities included?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Resource Sharing Plans. s. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable. Reviewers will specifically address five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency), taking into account the characteristics of institutional programs or the unique circumstances for short-term training programs, detailed in NOT-OD-10-019. The review of this consideration will be guided by the principles set forth in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research resources program.
The following will be considered in making funding decisions:
Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General.
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the Notice of Award will be generated via email
notification from the awarding component to the grantee business official.
The terms of the NoA will reference the requirements of the Recovery Act.
In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
Grantees will be requested to enter information on long-term (greater than 6 months) trainees into the FIC CareerTrac system (https://careertrac.fic.nih.gov/Welcome.vm).
Grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.
Recovery Act-related reporting requirements will be incorporated as a special term of award.
Awardees will be required to submit financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated. Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.
This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application by an individual or entity and ending with the award of the competitive funds. Formal application includes the preliminary application and letter of intent phases of the program. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:
(i) the communication is purely logistical;
(ii) the communication is made at a widely attended gathering;
(iii) the communication is to or from a Federal agency official and another Federal Government employee;
(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency
official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or
(v) the communication is initiated by the Federal agency official.
For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 402-0779
Email (preferred): firstname.lastname@example.org
2. Peer Review Contact(s):
Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892 (For express mail use ZIP 20817 and remove “MSC 7840”)
Telephone: (301) 435-1021
FAX: (301) 480-3567
3. Financial/Grants Management Contact(s):
Ms. Rhea Hubbard
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 4 96-5710
FAX: (301) 594-1211
Required Federal Citations
The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf
Use of Animals in
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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, 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 and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see
to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide 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 funding opportunity 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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
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 (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 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available 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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (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.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy () investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at .
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. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
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