and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
Fogarty International Center (FIC), (http://www.fic.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center on Minority Health and Health Disparities (NCMHD), (http://www.ncmhd.nih.gov)
Title: Framework Programs for Global Health (R25)
Announcement Type
This is a modification of PAR-05-050.
Update: The following update relating to this announcement has been issued:
Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PAR-06-067
Catalog of Federal Domestic Assistance Number(s)
93.989, 93.399, 93.307
Key Dates
Release Date: November 10, 2005
Letters of Intent Receipt Date(s): December 23, 2005
Application Receipt Dates(s): January 20, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 12, 2006
Earliest Anticipated Start Date: September 30, 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: January 21, 2006.
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Fogarty International Center invites applications for up to three years of support for the creation of new, multidisciplinary programs that will foster Global Health research and teaching within and between institutions, to be called Framework Programs for Global Health. The goals of these Programs will be to encourage greater involvement of NIH-funded researchers in Global Health, to facilitate greater collaboration and interactions among Global Health research and training programs at domestic and foreign sites, to bring new participants into the Global Health discussion, and to engage the next generation of scientists and health workers to choose careers in Global Health. Two core activities will be to create an administrative framework to bring multiple schools (engineering, business, chemistry, biology, communications, public health, medicine, dental, environmental studies, and others) together on the topic of Global Health and to develop multidisciplinary Global Health curricula at the undergraduate and graduate levels. Each program should leverage and enhance currently funded Global Health projects at the institution, supported by NIH and other sponsors, as well as encourage new training opportunities, collaborations and research areas. To ensure that institutions support the Framework at the highest level, letters from the University President, Provost, or other Institutional Director will be required. The Fogarty International Center anticipates funding seven to eight new comprehensive and planning grant awards in fiscal year (FY) 2006.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
1. Research Objectives
Fogarty International Center invites applications for up to three years of support for the creation of new, multidisciplinary programs that will foster Global Health research and teaching within and between institutions, to be called Framework Programs for Global Health. The goals of these Programs will be to encourage greater involvement of NIH-funded researchers in Global Health, to facilitate greater collaboration and interactions among Global Health research and training programs at domestic and foreign sites, to bring new participants into the Global Health discussion, and to engage the next generation of scientists and health workers to choose careers in Global Health. Two core activities will be to create an administrative framework to bring multiple schools (engineering, business, chemistry, biology, communications, public health, medicine, dental, environmental studies, and others) together on the topic of Global Health and to develop multidisciplinary Global Health curricula at the undergraduate and graduate levels. Each program should leverage and enhance currently funded Global Health projects at the institution, supported by NIH and other sponsors, as well as encourage new training opportunities, collaborations and research areas. To ensure that institutions support the Framework at the highest level, letters from the University President, Provost, or other Institutional Director will be required. The Fogarty International Center anticipates funding seven to eight new comprehensive and planning grant awards in FY06.
Background:
As the world becomes an increasingly global community, there is a need for new, integrated, and multidimensional approaches to Global Health. Health concerns have become the shared concerns of many nations and health crises can rapidly spread from one country to another. These health threats include infectious diseases such as HIV/AIDS, malaria, and drug-resistant TB, as well as emerging and re-emerging diseases such as SARS and the threat of pandemic influenza. In addition, because of the demographic transition in the developing world, non-communicable diseases and conditions such as those related to trauma and injury, obesity, tobacco use, adverse impacts of the environment, mental health, cancer, and cardiovascular disease represent an increasing disease burden on a global scale. These health challenges encompass biomedical, social, environmental, political and economic dimensions and, consequently, may best be addressed through multidisciplinary teams and interdisciplinary approaches.
Universities and other institutions of research and teaching in the U.S. and abroad play critical roles in conducting Global Health research and in training the next generation of scientists and professionals in Global Health. To fully harness the expertise in these institutions and include faculties of law, medicine, public health, engineering, journalism and others, new strategies are required. Greater coordination among faculties would energize the Global Health enterprise. At the same time, by bringing multiple schools together around a common concern of Global Health, it would be expected that undergraduates and graduate students would become engaged in this field. An increasing number of institutions have begun to recognize the inherent research interest of Global Health problems and welcome the opportunity to use their substantial creative resources to make a contribution to global welfare by further expansion of Global Health activities.
The purpose of this award is to catalyze and support the efforts of universities and other educational institutions with significant activities in Global Health that are ready to commit to shaping an integrated Program in this area. For the purposes of this PA, "global health activities" are defined as research, teaching, clinical care, prevention, and outreach activities directed towards addressing health concerns that contribute a significant burden of disease in low- and middle-income countries and are of general concern to the international health community. US awards in Global Health are expected to involve partnerships and interactions with institutions in the affected countries. Examples of Global Health areas include HIV/AIDS, malaria, tuberculosis, respiratory and diarrheal diseases, as well as the significant burdens of mental illness, cardiovascular disease, and environmental health impacts in developing countries, among many others. Topics included in FIC programs provide other examples.
Specifically, the objectives of this PA are (1) to increase interactions and joint activities among investigators already engaged in Global Health teaching and research within a campus and among institutions; (2) to encourage new investigators from diverse faculties and disciplines and new institutions to enter the Global Health field; and (3) to build curricula and develop educational opportunities that will engage the next generation of scientists and health workers to consider careers in Global Health. The activities initiated under this award will create a framework of support for Global Health initiatives. To ensure that institutions support the Framework at the highest level, letters of support from University Presidents, Provosts, or Institutional Directors, and some evidence of institutional commitment, are required. U.S. and developing country institutions are invited to submit applications for Framework Awards. However, recognizing the complexities of putting together the teams necessary to develop a Framework Program, institutions from low- and middle-income countries may choose to submit applications for 2-year Planning Grants, as described below, and to compete for full awards at a later time.
Framework Programs
Core Activities: Curricula Development and Administration of the Framework Program
A core activity of the Framework Programs should be development of new curricula and educational opportunities in global health areas at the undergraduate, graduate, and/or postgraduate levels. Curricula may be developed for a single institution or involve joint curricula or joint degree programs developed for use by all Framework partners (see Eligible institutions, below). Curricula should be multi- or inter-disciplinary, provide opportunities for hands-on experience, and encourage interactions between disciplines and institutions that have not traditionally worked together on global health issues. A variety of approaches and models are encouraged. It is expected that, in many cases, the Framework Program will be pedagogically innovative at the institution(s).
All institutions should consider developing a foundational set of workshops and courses that address topics appropriate to a broad range of research areas and can serve as a common resource to meet the needs of diverse projects within the university and collaborating institutions, thereby providing a "glue" for the Framework program. For example, all students who will participate in research projects should receive training in Human Subjects and the Responsible Conduct of Research. Workshops in bioethics and informatics may similarly provide core skills that are universally required to carry out scientific research. In designing these courses, applicants should consider the range of important determinants of global health, including social, behavioral, and environmental aspects, as well as the gender dimensions of research and care in this field, and link critical educational programs within the institution(s) to bring these aspects into the Framework Program. The basic set of offerings should be inclusive and should encourage interactions among all members of the Framework community.
In Framework Programs from institutions in low- and middle-income countries, or in Framework Programs from US institutions that are developing Framework curricula and programs in partnership with institutions in low- and middle-income countries, once a set of workshops or courses are established that meet these generalized and common needs, the institutions may choose to initially concentrate their advanced curricula in a more focused area that addresses their current strengths, faculty resources, and perceived national public health priorities. The focus area must still use multidisciplinary approaches and be topically broad. For example, "mental health" or "infectious diseases" would be acceptable, while focus on a single disease such as major depression or HIV/AIDS would not be allowed. Applicants should justify the choice of a focus area and provide well-defined capacity building goals in this area for the institution(s) involved. The Framework built around this focus area may serve as a model that can be expanded to include other areas in the future.
All other institutions should develop a broad curriculum, integrating infectious, chronic, behavioral and environment-related health concerns. However, the educational opportunities developed under the Framework may take a variety of forms, as appropriate to each institution's strengths and needs.
The curriculum developed through this program, whether focused or broad, should be truly multidisciplinary. It should involve novel interactions and synthesis between disciplines rather than parallel offerings or the expanded inclusion of students from other disciplines into established programs. To foster a culture of multidisciplinary dialogue and teamwork among both students and faculty, at least three Schools within the institution must be formal participants in the proposed Framework program. These schools should involve distinct disciplines. That is, three departments within a School of Medicine, such as Immunology, Infectious Diseases, and Obstetrics, would not be sufficient. Instead, innovative programs involving Schools of Medicine, Nursing, Dentistry, Biological Sciences, Public Health, Veterinary Sciences, Chemistry, Ecology and Environmental Studies, Economics, Business, Engineering, International Relations and Political Science, Law, Computer Sciences, Social and Behavioral Sciences, Arts and Humanities, and others are encouraged. While not every course or activity will bring these disciplines together, a portion of the curricula should specifically address this goal.
Many of the programs sponsored by the Fogarty International Center are by their nature multidisciplinary and provide examples of the types of multidisciplinary and interdisciplinary approaches that may be developed in a Frameworks curriculum. Examples include the Health, Environment, and Economic Development Program; Ecology of Infectious Diseases Program (which studies ecological and biological mechanisms that govern the relationships between anthropogenic environmental changes and the transmission dynamics of infectious diseases, in many cases generating mathematical models); AIDS International Training and Research Program (biomedical and behavioral science); Stigma (which explores the role of Stigma in Health); Informatics Training for Global Health (informatics as applied to health research); International Training and Research Program in Environmental and Occupational Health(biomedicine, epidemiology, and engineering control technology); International Cooperative Biodiversity Groups (drug discovery, biodiversity conservation, and economic development); and others. Groups studying HIV/AIDS, tuberculosis, malaria, or diarrheal disease may choose to team with groups studying Brain Disorders in developing countries to offer a course on the mental health sequelae of infectious diseases. There are many possible combinations. More information on Fogarty programs can be found at http://www.fic.nih.gov.
Institutions must have, or be significantly involved in, a minimum number of active NIH awards in global health areas to be eligible to apply for a Framework grant (see Eligible Institutions, below). It is expected that key personnel on these awards will work together to develop associated curricula. In this way, curricula development may become one means of increasing interactions among these groups, promoting joint training opportunities and allowing for more efficient use of funds to achieve goals common to each of their projects.
Under "Core Activities", applicants should address each of the three areas that follow.
A. Purpose and goals of the curricula to be developed: What are the specific goals that the institution wishes to address through the curricula to be developed? How will the set of proposed offerings contribute to the framework for an integrated program in Global Health? In light of the specific goals of your institution in initiating a Global Health Program, how would the opportunities at the Institution change if the proposed curricula were implemented?
B. Course Content: Applicants should describe the courses (both didactic and experiential) to be developed through the Framework award. You should be as specific as possible in describing the proposed program, including courses to be offered, length of courses or workshops, frequency of classes, who will teach the courses and under what departmental or other auspices, selection criteria for participants entering the program, and target enrollment once the program is established. Where distance learning courses are proposed, you must include opportunities for individual mentoring and interaction with students, as well as address infrastructure requirements to access the courses. Finally, the approval process for new courses at the institution(s) should be described, how this will be navigated for the Framework courses in aggregate, and how this might impact pilot courses and workshops to be implemented during the grant period.
The application must propose the development of new courses. Current offerings at the institution may be included in support of the Framework, but simply listing these together would not be sufficient. In addition, for all institutions, but particularly for institutions in which there is already a strong foundation in Global Health curricula and activities, the value added by the Framework Program must be explicitly discussed.
C. Administration of the Framework Program: All applications should describe how the Framework Program would be administered in a way that would maximize contributions from three or more schools at the university and from any potential partners. As activities must be coordinated across the entire campus or among several institutions, it may be useful to appoint a Program Administrator or develop a Framework Administrative Group. Such a resource may provide significant added value to new and ongoing research training grants at the institution, facilitate logistics and integration of foreign students into Framework activities, help with preparations for courses and conferences, match potential trainees and opportunities, arrange for lectureships and other activities of the Framework, and provide a useful point of contact for those interested in learning more about Global Health.
Supporting Activities
Activities that complement and expand upon the proposed curricula development or provide further collaborative opportunities across multiple schools and research programs should be proposed. They should contribute to creating a Framework identity and more visibility for Global Health on campus and at all collaborating institutions, as well as bring new researchers and new students into the Global Health discussion by increasing activity, interactions, and information in the Global Health area.
Applications should describe supporting activities in detail and offer specific examples of each activity. For example, if visiting lectureships or structured opportunities for student research experiences are proposed, include letters from potential lecturers or from research programs willing to accept students for short research experiences. Also discuss how students would be prepared for these experiences, including preparatory work on Human Subjects concerns and the Responsible Conduct of Research. If conferences are proposed, the potential topics to be addressed, participants to be included, and how such a conference would integrate with and further the goals of creating a Framework program should be described. Clinical activities can be supported only in the context of currently funded clinical research projects that have already undergone peer review and IRB approval. For example, students may work under a funded project for a short research experience. Framework programs may not offer to fund small faculty research grants from the award. However, competitive funding to allow new investigators to integrate into ongoing projects, carry out networking and planning activities that would lead to new research applications with new collaborators, and otherwise increase research interactions in the spirit of broadening the global health research arena, will be allowed. Such activities should not involve any human subjects work that would require a new IRB approval.
Structure of the Proposed Framework Program
Applicants should describe the structure of the proposed Framework program. All participating departments, Schools, and partner institutions should be described and plans for how these diverse entities will be coordinated and integrated must be discussed. If details of these entities are provided in the Resources or another earlier section, that information does not need to be repeated here. Rather, refer to that information and instead focus on issues of coordination and integration. For example, if partnering between units at distant sites, how will communication between the parts be coordinated and maintained so as to produce integrated curricula and training activities? Will there be a continuing liaison with the university leadership? Are there any practical challenges within the University structure that must be overcome in order to initiate a Framework program, such as credit for junior faculty who participate in the program outside of their departments, distribution of overhead from grants to the Framework program, faculty release time to work on curricula, administrative challenges, and others? How will these be tackled?
In addition, applicants should describe the relationship of the proposed Framework program to funded Global Health projects at the institution. How will the proposed program leverage and include those projects? A list of all funded research and training programs currently at the University in the area of Global Health should be provided. This list will be used for establishing eligibility and determining the richness of the environment as a basis for a Framework Program. Those programs and associated personnel from this list who will specifically work on the Framework award should be indicated.
Plans for evaluation of the design of the Framework Program overall and of individual courses, workshops, and activities should be an important component of the structure of each Program and should be discussed in the application. An internal and/or external board of advisors should be established to provide advice during the development of the program and to provide counseling and monitoring as it is implemented.
Finally, applicants should describe the long-term vision of the Institution in the area of Global Health. How will the proposed curricula and other activities help attain that vision? How will the Institution sustain and build upon the activities initiated under this award at the conclusion of the award period?
Evidence of Institutional Commitment
As the purpose of this PA is to shape a Framework for Global Health that will catalyze the expansion and coordination of Global Health activities across institutions, it is important that the institutions are fully committed to implementing the products of this grant and sustaining them into the future. Consequently, institutions must provide some evidence of that commitment. This may take the form of in kind contributions, matching funds, or other means, at the discretion of the applicant. In addition, applications must include a letter of commitment from the respective University Presidents or comparable Institution Director in support of the activities proposed, including a commitment to implement the curricula developed under this award, pending approval through established university processes. Where there is more than one institution participating, letters of commitment should be included from each partner institution.
Planning Grants: Applicants from low- and middle-income country institutions only
Applicants from low- and middle-income country institutions only may apply for a 2-year planning grant or a 3-year Framework award. Planning grants can provide support to assess needs at the institution; develop collaborations and needed resources; augment faculty and administrative expertise needed to carry out a Framework Program; generate preliminary curricula and carry out pilot activities; and organize, plan, prepare, and assemble an application for a Framework award. Applicants may choose to assemble an advisory board made up of internal and/or external scientists working in Global Health, including those with experience in setting up trans-institutional programs, to help guide planning for and development of the Program. To maximize the benefit of a planning grant, activities undertaken during the planning grant should contribute to the coherence and capacity of the Global Health community on campus irrespective of the outcome of a subsequent Framework award application.
Applicants should state a clear definition of Global Health in the context of their institutions and state their vision of what a Global Health Program could achieve on their campus. This vision statement should guide the development of specific aims describing the activities to be undertaken during the planning grant period that will result in a full application in the time allotted. A Timeline may be useful. Applicants should justify the need for such a program at their institutions and document the expertise and ongoing grants at the institution that this program will build upon. If a focus area is chosen, a strong justification for this choice should be stated, and how more inclusive foundational courses, workshops, or activities might be structured that deal with skills and topics of interest to the entire research community. Collaborations among at least three schools at the institution or among partner institutions must be identified, and appropriate letters of commitment from the respective University Presidents or comparable Institution Directors at each of these components should be included.
Interests of Collaborating NIH Institutes and Centers
Fogarty International Center (FIC) is interested broadly in promoting global health training and research in the US and abroad. Any institution or institutional partnerships fulfilling the requirements of this PAR may be funded by FIC. The Fogarty International Center, the international component of the NIH, addresses global health challenges through innovative and collaborative research and training programs and supports and advances the NIH mission through international partnerships.
The National Cancer Institute (NCI), the U.S. Federal Government's principal agency for cancer research and training, is interested in supporting global health through curriculum development and training efforts that focus on preventing and controlling the global burden of tobacco use. The World Health Organization reports that, already, tobacco use is responsible for about 5 million deaths each year worldwide (one in ten adult deaths), a figure that is expected to increase to about 10 million deaths annually by 2020. Increasingly, tobacco use and tobacco-caused diseases are shifting from developed countries to low- and middle-income nations, which can ill afford the enormous death, disease and financial burden that increased tobacco use will bring. In addition to educational and programmatic interventions, it is widely recognized that tobacco control policies, such as tobacco tax increases, smoke-free workplaces and public places, and bans/restrictions on the marketing of tobacco products can have a major impact on decreasing and preventing tobacco use. Multidisciplinary training programs that consider the behavioral, socio-cultural, economic, and policy factors that help determine tobacco use are needed to equip scientists and practitioners with the appropriate knowledge and skills to effectively combat the tobacco epidemic.
The National Center on Minority Health and Health Disparities (NCMHD) is interested in increasing global health research and training opportunities in colleges and universities that serve minority populations in the United States, including Historically Black Colleges and Universities, Hispanic-serving colleges and universities, and tribal colleges. To this end, applications are encouraged from these institutions either as the applicant institution or as partners with other universities. The applicant institution must meet the eligibility criteria stated in this PAR, but may partner with any institution in the US or abroad (please see definition of partner under Eligible Institutions , below). For each partnering institution, the application should list key personnel from the minority-serving institution, provide a letter of support from the president of the institution, and budget funds specifically to support activities with this institution.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity will use the NIH Research Education Project Grant (R25) award mechanism(s).
As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
FIC and collaborating NIH partners intend to commit up to $750 K in FY06 to fund up to five new Framework awards and three new planning grants in response to this PA. For a Framework award, an applicant may request a project period of up to three years and a budget of up to $125,000 direct costs per year. For a planning grant, applicants may request a project period of up to two years and a budget of up to $25,000 direct costs per year. Applications that exceed these limits will not be reviewed. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
We anticipate a limited competition for planning grant awardees in 2008, allowing these grantees the opportunity to submit full proposals for Framework awards. The applicant organization's administration must provide the necessary management for the transfer of funds and material to the collaborator(s) and any subcontracts (consortium). Subcontracts (consortia) may only charge eight percent F & A costs of applicable direct costs.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
As the purpose of this PA is to act as a unifying mechanism for Global Health research-related activities across a campus, only one application will be accepted from any single institution. Similarly, institutions may only be partners in one application. However, separate campuses within one university system (for example, the University of California) will be considered separate institutions for the purposes of this PA. Separate institutions may be defined as those having separate grants administration capabilities. Separate campuses in close geographical proximity that belong to one university system, however, are strongly encouraged to submit a joint application, particularly where faculty have joint appointments at both institutions. Current awardees, or institutions listed as partners on current awards, may not submit a new application either as applicant institution or as a partner institution (with partners as defined below).
The eligibility criteria for domestic and foreign institutions differ. If there is any uncertainty about eligibility, applicants are strongly encouraged to discuss their potential interest and the eligibility of their institutions with the FIC Program Officer. Failure to meet the following criteria by the time of peer-review will disqualify the application from consideration:
applicant institution eligibility criteria (i.e. eligible country and pre-requisite number of currently funded grants); inclusion of three Schools with differing areas of expertise as participants; inclusion of appropriate letters of support from University leadership; budget within cost cap; and proposed development of new curricula.
U.S. Institutions: Applicant institutions must have a minimum combination of 5 research grants, training grants, or cooperative agreements in Global Health areas, awarded to one or more of the participating schools within the institution. Four of these awards must be from NIH while the fifth award may be from NIH or be an equivalent Global Health award from another funding agency. For this PA, "Global Health awards" are defined as those that address serious health concerns in low- and middle-income countries and must involve international partnerships and activities in those countries.
An eligible award should have the following characteristics:
a. It must be active as of September 2006. No cost extensions are considered active grants. If a no cost extension is anticipated but has not yet been issued, a letter from the PI of that grant stating that there is an intention to request a no-cost extension and that sufficient funds will be available at the time of that request to justify a no cost extension, must be included in the application.
b. The direct costs must be greater than or equal to $100K per year.
c. Eligible grants are those that use the NIH R, U, P, D43, or T37 award mechanisms, or comparable mechanisms from other funding agencies, and do not include contracts. D43 awards are training grants to build global health research capacity in low- and middle-income countries through collaborations between US and low- and middle-income institutions.
d. Four of the awards must be made directly to the applicant institution (i.e. the PI must be on the faculty of the applicant institution). In recognition of the important role of collaboration between institutions in Global Health training and research, the fifth award may involve the applicant institution as a subcontract or involve a faculty member from the applicant institution as co-PI and key personnel on an award to a different institution.
e. While institutions may form partnerships for the application, the applicant institution (the institution of the PI) must be able to fulfill the grant eligibility requirement. That is, the requirement cannot be fulfilled as the sum of awards at all partnering institutions.
Please include a table in your application listing each qualifying grant with the following information: grant number, PI, funding source, direct costs/year, end date, and collaborating countries. For non-NIH grants, please list a program officer or other contact at the funding organization responsible for that grant.
Foreign Institutions: Foreign institutions applying for either planning grants or Framework awards must have a minimum of 3 research grants, training grants, or cooperative agreements in Global health areas important to public health concerns in their countries. Two of these awards must be from NIH while the third award may be from NIH or from an equivalent funding source external to the institution, including the research funding agencies of other countries, private foundations, and other sources. Allowable award mechanisms, annual minimum direct costs for each grant, and end dates are as described above and should be included in a table with the components listed above. Foreign institutions may be the direct recipients of the award or may be a foreign component/subcontract on a grant awarded to another institution. However, personnel from the foreign institution must be listed as key personnel on the grants cited. Eligible foreign countries are defined as low- and middle-income countries according to the World Bank list of economies (http://www.worldbank.org/data/databytopic/CLASS.XLS).
Multiple institutions may be "partners" on a single application: Many institutions work with collaborators from many countries on Global Health research. These collaborators may play roles in the Framework program without becoming partners on the application and may choose to submit their own Framework applications. In such cases, the collaborating institutions may plan to interact for some activities but do not plan to develop parallel framework curricula at their institutions.
Alternatively, institutions that have a history of working together and/or have common goals in the Global Health area may choose to submit an application together for the purposes of developing joint curricula, activities, or degree programs. These institutions will be named as partners in the application, with key personnel from each institution listed in the application, partner institutions listed as performance sites for the award, and appropriate budget provided to fulfill the roles of each partner. Partner institutions applying together may not also submit separate Framework applications.
Every institution to be included as a partner must be named (that is, open networks are not allowed) and each institution must submit a letter indicating their commitment to participating in a joint award. A PHS 398 Resource Format page must be provided for each partner institution. A key co-Investigator should be named as the coordinator at each partner institution. The maximum direct costs allowable will remain the same regardless of the number of institutions participating in the application. While the applicant institution (the institution of the Principal Investigator) must be from the US or an eligible foreign country, partners in the application may be in any country. The applicant institution must be able to fulfill the grant eligibility requirements above (i.e. the requirements cannot be fulfilled as the sum of awards at all partnering institutions), while additional partners need not fulfill these requirements on their own. Finally, as described under Core Activities , personnel from three or more schools representing distinct disciplines must be active participants in the design of curricula and other activities. These three schools may be distributed among the separate partner institutions.
Applicants must explain why the particular partnerships were chosen, how they add value to the proposed program, and why these partners have the potential to successfully develop a program together. This may be based on a prior history of working together, in which case evidence of established joint activities, with shared grants, publications, faculty or other interactions should be documented in the application. On the other hand, developing new multidisciplinary programs and programs involving multiple educational levels may bring new groups together who share a common vision but have not previously worked together. Formalizing such linkages by forming a joint program may create expanded research and training opportunities for all partners. Such a program may involve shared curricula, faculty and student exchanges, sharing of research resources, and even joint degrees. In addition, research institutions may need to partner with teaching institutions in order to provide both research and training components for a Framework Program.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Principal Investigators should be associated with one of the qualifying NIH grants (for example, as a listed key personnel), or be designated by their institutions to provide leadership in a trans-institutional Global Health program, and have demonstrated experience in international training or research programs.
2. Cost Sharing or Matching
Not applicable
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable
Section IV. Application and Submission Information
1. Address to Request Application Information
The 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) 710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications 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 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: December 23, 2005
Application Receipt Date(s): January 20, 2006
Peer Review Date: June/July 2006
Council Review Date: September 12, 2006
Earliest Anticipated Start Date: September 30, 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this document. Electronic submissions of letters of intent are acceptable.
The letter of intent should be sent to:
Dr. Flora Katz
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 402-0779
Email: [email protected]
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application 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)
Personal deliveries 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/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.
Upon receipt applications will be evaluated for completeness by CSR. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
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 http://grants.nih.gov/grants/policy/policy.htm.
The following restrictions should be observed. Salary support for an administrator to oversee and manage the entire Framework Program is allowable up to 50% salary and fringe benefits. The Program Director may receive salary and fringe benefits compensation for up to 25% professional effort devoted to the Framework Program. Note that tuition and salary support for research fellows to work for an extended period on Global Health research related projects, while recognized as an important component of any institutional program, would not be consistent with the aims of this program, nor would the award size allow for this cost. On the other hand, support of students, residents, and fellows during short research experiences is allowable, including cost of living, travel, and limited research expenses. FIC will hold a network meeting for Principal Investigators from all Framework Programs (including planning grants) each year on the NIH campus. Funds to travel to this meeting should be included in the budget.
Pre-Award 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 or competing continuation award if such costs: are necessary to conduct the project, and 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 or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Data sharing may include publications that discuss lessons learned in setting up a Global Health Program in a particular country or context, as institutions throughout the world increasingly consider this option. Investigators on Framework awards will meet once a year to share progress and experiences with each other. After the establishment of the network, investigators may also choose to make some or all of their curricula available to each other or to the general academic community, as consistent with their institutional intellectual policy guidelines. In some cases, it will be desirable to make selected portions of these curricula available over the World Wide Web so that institutions in low- and middle-income countries that do not have these awards might make use of the products of the Framework network in building their own curricula and Global Health Programs.
Sharing Research Resources
Not applicable
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by the Center for Scientific Review (CSR) in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
The following criteria apply to Framework Awards and should be applied to Planning Grants, where appropriate. Where Planning Grants would not encompass these activities in full, have the applicants stated clear and feasible specific aims that have the potential to lead to the development of a Framework Program in the time available that will meet these criteria? Most importantly, do the applicants (1) describe a clear vision for a Global Health Program with clearly defined goals and an appropriate scope; (2) justify the need for such a program on their campus; and (3) justify the choice of a focus area, if one is chosen?
Significance: Does this proposed program address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of this program on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed curricula and supporting activities address a need at the applicant institution to expand its offerings in the area of Global Health? Will these activities have a significant impact on the structure and opportunities at the applicant and other participating institutions?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are there adequate plans for the coordination and integration of the ongoing Global health projects, multiple schools and departments, and institutional partners that will participate in the Framework Program? Are the curricula to be developed likely to achieve the institution’s vision for Global health? In the curriculum plan, is there an adequate balance between didactic and experiential learning opportunities? Are the proposed curricula and supporting activities truly multi- or interdisciplinary, so that the disciplines synergize and challenge each other rather than run along parallel tracts? Is there an adequate evaluation plan? Finally, do the applicants discuss plans to implement the curricula once they are developed and to sustain the activities initiated under this award at the conclusion of the award period?
Innovation: Is the project original and innovative? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Are multiple scientific disciplines engaged and integrated in a thoughtful and creative manner?
Investigators: Do the Principal Investigator and the faculty identified as key personnel have the necessary experience in Global Health-related research and training to lead an effort in this area? Has the Framework Program taken advantage of the personnel involved in the qualifying and supporting global health grants listed in the application to lead and participate in the Framework Program? Does the Global Health Framework team bring complementary and integrated expertise to the project? For U.S. institutions, do the Principal Investigator and other key personnel have international experience relevant to the teaching goals? Have the key personnel committed adequate time to carry out the goals of this program? For applications involving multiple institutions, do the partnering institutions and personnel have a previous history of successfully working together and/or a strong justification for submitting a joint proposal?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment or employ useful collaborative arrangements? Are the facilities available or proposed adequate to carry out the proposed curricula and support activities once they are developed, including any requirement for information technology infrastructure? Finally, is there evidence of strong institutional commitment at the highest levels to supporting and sustaining a Framework Program on campus?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). This award will not support human subjects research that requires a new IRB approval. However, students and faculty may participate in research that has already been approved under a previously awarded grant.
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. The plan may include plans to share curriculum, electronic products, information, lessons learned on models for developing a global health program, and other products of the Framework Program.
2.D. Sharing Research Resources
Not applicable
3. Anticipated Announcement and Award Dates
Not applicable
Section VI. Award Administration Information
1. Award Notices
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A 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 NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
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.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement. These reports should include a summary of progress towards the goals of the Framework Program, such as expanded research training opportunities, projects, new curricula, student exchanges, recruitment outcomes, and program evaluations.
Section VII. Agency Contacts
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, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Dr. Flora Katz
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9591
FAX: (301) 402-0779
Email: [email protected]
2. Peer Review Contacts:
Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive
MSC 7840, Room 5136
Bethesda, MD 20892
Telephone: (301) 435-1021
FAX: (301) 480-3567
Email: [email protected]
3. Financial or Grants Management Contacts:
Mr. Randolph Williams
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
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 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-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 (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/publicaccess_manual.htm.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA 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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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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