Part I Overview Information

Department of Health and Human Services

Issuing Organization
Fogarty International Center (FIC) (http://www.fic.nih.gov)

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 Library of Medicine (NLM) (http://www.nlm.nih.gov)
National Human Genome Research Institute (NHGRI) (http://www.nhgri.nih.gov)

Title:  Informatics Training for Global Health (ITGH) (D43)

Announcement Type
This is a reissue of RFA-TW-03-008.

Request For Applications (RFA) Number: RFA-TW-09-001

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.879, 93.172

Key Dates
Release Date: December 24, 2008  
Letters of Intent Receipt Date: March 6, 2009
Application Receipt Date: April 3, 2009
Peer Review Date: July 2009
Council Review Date: August  2009
Earliest Anticipated Start Date: September 30, 2009
Additional Information To Be Available Date (Url Activation Date)
Expiration Date: April 4, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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

Section I. Funding Opportunity Description

1. Research Objectives

The Fogarty International Center (FIC), in collaboration with the National Library of Medicine (NLM) and the National Human Genome Research Institute (NHGRI), invites applications for the establishment or continuation of training programs in Informatics for Global Health to address the needs of low and middle income country (LMIC) institutions for information technologies and associated sciences to conduct and contribute to biomedical and behavioral research.  U.S. institutions, in partnership with LMIC institutions that have strong, independent or collaborative, funded biomedical and behavioral research and training programs, LMIC institutions with demonstrated informatics expertise, or networks of institutions linked by common research and training projects are eligible to apply with the goal of enhancing and further strengthening those activities. 

Applicants are expected to develop innovative training programs for LMIC biomedical and behavioral scientists, computer scientists, engineers, clinicians, librarians, and other health professionals that increase their capacity to design, manage, and use information systems for global health research. It is envisioned that LMIC institutions participating in the program may eventually serve as regional Centers of Excellence for global health informatics and/or bioinformatics training and research.  Training programs should be directed towards building informatics capacity in the foreign institution that can contribute directly to research in disease pathogenesis, transmission, prevention, diagnostics, or treatment.  

Informatics expertise can be seen as a cornerstone of institutional research capacity. 

As biomedical information has increased exponentially in recent years, computer-based tools have been developed to access and analyze this information and to aid the process of research design, data management, and data analysis.  The sheer volume of data generated in many biomedical and behavioral research projects and in clinical trials can no longer be effectively managed without electronic help.  Access to computers and the Internet is becoming more commonplace in research institutions throughout the developing world.  To take full advantage of these tools, however, individuals with the advanced skills to use them are critically needed. This need is even more pressing in the increasingly multidisciplinary and multi-site projects in global health, such as multi-site clinical trials, in which large datasets must be shared between distributed research groups.  Informatics expertise and technology are also expanding the technological toolkit available for clinical and public health research, using information systems linked to PDAs, smart phones, and other devices. Moreover, there is a need to learn how to archive and retrieve new types of data, such as the enormous amount of information contained within images. Finally, information technologies play increasingly important roles in education and communication within and between global research communities.

Despite the central role that informatics plays in global health, many institutions in LMICs have very few informatics experts and a very weak information technology infrastructure.  Databases and tools developed for more developed country applications often are inappropriate, ineffective, and not sustainable in LMIC settings.  Consequently, there is a critical need to train local experts who are able to develop local research applications or modify existing platforms to provide tools that are appropriate for the needs, culture, and infrastructure of their institutions and countries.

This solicitation is consistent with the goals of the FIC strategic plan (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm) to develop human capital to meet global health challenges; to support the development of research hubs (networked Centers of Excellence) in LMICs; to bolster the development of expertise in the use of information and communication technologies in support of research and research training; and is expected to contribute to enhancing implementation research in global health. 

RESEARCH TRAINING OBJECTIVES

This program is intended to increase the capacity of developing country scientists and medical professionals to design, access and use modern information technology in support of health sciences research. Informatics Training for Global Health (ITGH) encompasses training in the design of information systems; the modification and use of these systems to collect, manage, analyze, store and share data; bioinformatics, including analyses of human and pathogen genomes; computational biology and computer modeling; image analysis; and other related disciplines. 

The objectives of the ITGH Program are:

(1) To develop informatics research training programs at institutions in LMICs with strong global health research portfolios.  Over time, it is expected that these institutions will develop sustainable training programs within their own institutions and become regional, national, or international Centers of Excellence in Informatics related to research and training.

(2) To train individuals who will apply state-of-the-art information and communication technologies to global health research relevant to the needs of their countries and who will eventually function in their home institutions as trainers and leaders in these technologies;

(3) To address the specific research-related informatics needs of the biomedical research community of the foreign institution(s) and to raise awareness of and access to informatics resources within that community through targeted short-term training, workshops, and/or symposia;

(4) To initiate or enhance research activities in the foreign institution through the use of informatics expertise; and

(5) For more mature programs, the option to develop a network of institutions to jointly develop training and research opportunities in Informatics.  LMIC institutions with a critical mass of expertise and training programs in place may wish to help other LMIC institutions with more nascent programs develop their own informatics capacity.

To enhance training opportunities in informatics more broadly, sharing of curricular materials, the creation of open educational resources, and/or innovative use of quality distance learning, when appropriate and feasible, is also encouraged.

Trainees should be directly integrated into the research activities at the participating institutions.  Technologies and skills that are emphasized during training must be directly related to research applications, and capacity-building activities should be substantially focused on skills beyond basic computer operations.  Within that context, it is envisioned that trainees will represent a range of skill levels and responsibilities, as relevant to the specific research training and capacity building objectives of the program and the environment of the home institution.  While there is also a critical need for informatics experts to support health care delivery and design electronic systems to manage personal health information (e-Health), this program is focused on training for research applications.  However, it is recognized that the skills acquired and many platforms and applications that trainees develop for research purposes may have dual function in the e-Health arena, providing benefit to both communities.

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 D43 award mechanism(s). 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 http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The estimated amount of funds available for support of 5-6 projects awarded as a result of this announcement is $1.5 million for fiscal year 2009. An applicant may request a project period of up to five years and a budget of up to $230,000 direct costs. The applicant institution may request a Facilities and Administrative (F&A) cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Applicants from U.S. institutions must collaborate with one or more institutions in eligible developing countries (see "Project Organization", above) and must name an individual at each institution as a primary foreign collaborator or a PD/PI.  Eligible countries are defined as low- to middle-income countries (see http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS). Non-U.S. institutions must be non-profit public or private institutions. 

Eligible non-U.S. institutions with established global health informatics training programs may submit an application with or without U.S. partners, and with or without other LMIC partners, as described in Project Organization, above (Part II, Section I-1). At the time of application submission, the major non-U.S. institution (as applicant or collaborator) on each application must be a grant recipient or a substantial foreign partner on a minimum of four active international grant awards: two active FIC- or NIH-funded major research or research training grants (R, U, P, D43 mechanisms) and at least two additional NIH or equivalent non-NIH research or training awards from an international funding source external to the institution, such as the research funding agencies of other countries, private foundations, and other sources.  "Substantial" participation requires that scientists from the foreign institution must be listed as "key personnel" on the grant and/or the foreign institution should be listed as a performance site.  At least one of the four qualifying grants must be for research.  NIH R03 grants with less than $100,000 total costs/year do not contribute to eligibility, although they may increase the attractiveness of the foreign site as a research partner.  The program officer at FIC may be able to assist in determining eligibility of foreign institutions regarding active NIH grants. Applicants must include a table in the body of the application listing each qualifying grant with the following information:  grant number, PI, funding source, direct costs/year, and end date.

In addition, the LMIC institution must have sufficient computer infrastructure and Internet connectivity in place (subject to only modest enhancement) to build upon for a training program. 

Any individual foreign institution may only submit or be included on one application.  U.S. institutions may submit multiple applications as long as they involve different key personnel and are collaborations with different foreign partners.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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.

If applicants choose the Multiple PD/PI option, only one PD/PI may be designated at any single institution.  Each PD/PI must have strong research and research training experience in informatics or justify why they would be an effective PD/PI and must be able to assemble the requisite faculty and facilities to carry out the proposed research training activities.  The qualifications of each PD/PI will be an important consideration during review. 

2. Cost Sharing or Matching

3. Other-Special Eligibility Criteria

Number of Applications. Low and middle-income country (LMIC) institutions may only participate in a single application to this program, whether as the applicant or a collaborating institution.  U.S. institutions may participate in multiple applications as long as they involve collaborations with different and non-overlapping foreign institutions.

Resubmissions. Resubmissions are not permitted for this FOA.

Renewals: Renewal applications from grantees or groups holding current ITGH awards or who formerly held International Training in Medical Informatics (ITMI) awards are permitted in response to this FOA.

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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5939.

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

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.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the training plan, entitled “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 training program 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.

Project Organization

Project organization and partnerships should be appropriate to the status of informatics expertise and infrastructure at the major foreign institution.  While each program will follow its own trajectory, it is expected that programs will evolve over time. 

For new programs and those foreign institutions that do not yet have a critical mass of faculty expertise in informatics, a partnership between a research-active institution in a LMIC and a strong informatics center in the U.S. is required, in order to build a critical mass of trainees who can return to their countries and function as informatics experts in research at their institutions. It is expected that the US institution will serve as the applicant institution (the institution of the Principal Investigator, PI, with lead administrative responsibility) in these programs. It is recognized that achieving a critical core of experts may require several cycles of NIH support and the foreign partner would continue to benefit from the training opportunities at a U.S.center. While the goal of these training programs should be to develop informatics capacity specifically at a partner foreign institution, there may be compelling reasons to include more than one institution from that country within the training program.  For example, it may be the case that active research projects are carried out in a research institute or medical center that does not have the capability to develop didactic degree or certificate programs in informatics, or does not have a strong computer science or other undergraduate program that might supply appropriate trainees for the program.  In this case, a plan to develop a sustainable training center for informatics might require a coalition with an additional institution, such as a nearby university.  Alternatively, the research programs of two or more institutions may be tightly linked, with broad collaborations between their research and teaching faculty.   These multiple institutions may choose to collaborate with one or more US institutions to form a cohesive training program that will benefit all the foreign institutions and provide synergy without draining resources from the goal of building informatics research capacity at each institution.  If more than a single LMIC institution is proposed, at least one of these institutions must fulfill the full eligibility requirements of this FOA, including a pre-requisite number of active research and training grant support.  A strong justification must be provided why each institution is necessary to realize the objectives of the training program.

By contrast, some of the more mature programs (such as those that have received several cycles of prior informatics training awards or have equivalent experience) may have already developed a critical mass of expertise at the LMIC institution, have formed a recognized Informatics Core of researchers, consultants, and trainers, and have begun to set in place the curricula and degree programs that prepare them to serve as the training program center.  These foreign institutions may choose to apply with or without a U.S. partner or partners, and either the U.S. or the foreign institution may apply as the applicant institution. They should propose a plan to further develop and strengthen their informatics core, with the goal of becoming a regional Center of Excellence for Informatics. It would be expected that a significant amount of the training in their proposed program would take place completely at the foreign institution. The foreign institution must be willing to allocate faculty time and positions, space, and curricula to this area and the applicant should provide evidence of this commitment, such as a letter from the appropriate university leadership. For reasons discussed above, applicants may choose to include additional LMIC partner institutions within the training program.

Finally, some of the more mature programs may already be reaching out within their regions, countries, or internationally to other more nascent institutions who wish to build their own informatics training and research capacity.  In this case, the lead foreign institution, with or without U.S. partners, may apply as the applicant institution and may choose to include 2 or more other LMIC institutions as partners in an educational and training network.  The partners in such a network must be named and should be linked by shared research projects, such as the development of shared and interoperable databases, which can be used as training opportunities for trainees within the program.  Informatics training networks may choose to “piggy back” on established research networks such as those in HIV/AIDS, allowing them to leverage established infrastructure while contributing considerable value to the network through the training of informatics experts. The applicant institution must fulfill the eligibility requirements of the FOA.  A key collaborator must be named at each institution and the training plan should include a justification for developing a network and a description of how the network would function and communicate. A network may represent a further evolution of the training model developed through prior informatics training program support.

Types of Training

Many types of training plans could be considered responsive to this RFA. Program directors should develop a plan in consultation with all key collaborators that addresses the needs of the foreign institution(s).  While short-, intermediate- and long-term training in a wide range of relevant disciplines and skills is allowed, emphasis should be on intermediate to longer term training, including Certificate, Masters, and Ph.D. degree programs, postdoctoral and mid-career training, and advanced in-country research. The focus of the degree training should be informatics per se and not the associated fields to which the expertise will be applied, such as genomics, epidemiology, or biostatistics, although courses in and bridges to these disciplines may be integrated as one part of the overall program and will likely be a component of trainee research. Training may take place in the U.S. or the LMIC, however applicants are strongly encouraged to provide opportunities for trainees to conduct mentored research in their own countries on health issues of importance to those countries.

The training program might include but would not be limited to combinations of the following:

Short-term targeted training (less than three months) in the LMIC country.  Short courses and workshops may present overviews of global health informatics or address specific topics of interest to the local scientific, administrative, and policy communities.  Excellent examples of such short courses in the U.S. are the NLM-funded BioMedical Informatics Course at Woods Hole (http://www.mbl.edu/education/courses/special_topics/med.html) and the NHGRI-funded Computational and Comparative Genomics Course (http://meetings.cshl.edu/courses/c-ecg08.shtml) and Programming for Biology course (http://meetings.cshl.edu/courses/c-info08.shtml) at Cold Spring Harbor Laboratories.  Short courses are also a useful way to identify candidates for longer-term training. It is expected that, where feasible, some of these short courses will be open to NIH trainees in other programs in the region as a means of enhancing research capability and of fostering research collaborations among trainees from different programs within the country.  For a list of FIC-sponsored training programs and PIs, see http://www.fic.nih.gov/ and linked sites therein.  For programs from other NIH Institutes, see the corresponding websites. Enrollment of trainees in existing international short courses may also be a suitable avenue for training. 

Intermediate-term training (three to six months), such as intensive courses or tailored training carried out in the U.S. or in the foreign country in targeted subject areas.  In some cases, this might accommodate researchers and faculty who require specific informatics training to advance their research and teaching; training of medical librarians to enhance access to electronic resources for their institutions; and other topics.

Long-term advanced training (greater than six months) to develop a core of specialists who will become professional global health informatics research investigators and future leaders for global health informatics research at the host institution and in the region.  Training should be at Masters, Ph.D. or postdoctoral levels, although some training within the foreign country may initially be at the level of a Certificate.  Such training would normally require that trainees already have basic computer skills and a demonstrated aptitude for informatics applications. Since medical informatics and bioinformatics both benefit from individuals with preparation in both computer and biomedical or clinical sciences, and excellent candidates with both backgrounds may be rare, in special cases pre-Masters training will be allowed to enable exceptional students to acquire additional background skills and knowledge that will allow them to enter advanced training in these fields. Long-term trainees and post-doctoral fellows may also benefit from learning grant- and manuscript-writing skills through workshops or courses offered during their training, and should be encouraged to compete for grant support from other NIH or international programs, such as the Fogarty International Research Collaboration Award (FIRCA) or the Global Research Initiative Program for New Foreign Investigators (GRIP) (see http://www.fic.nih.gov/programs/research_grants/index.htm). 

Advanced in-country mentored research, generally of one to two years duration, undertaken by the trainee in her/his home country upon completion of the initial period of training under the program (Masters, Ph.D., Postdoctoral or other significant long-term training).  All projects must be independently peer-reviewed through scientific review procedures established by the training program faculty. Research involving human subjects, including use of data from previous studies that contains identifiable, private information from living individuals, must be conducted under an already funded, approved, and current grant protocol from the NIH (see Regulation 45CFR46.102F) and requires written documentation of education in the protection of human subjects.  Applicants should describe how requests for mentored research projects will be reviewed and evaluated, and how trainees will be mentored and monitored while carrying out this research. 

Integration of training with on-going clinical, biomedical or behavioral research in the home institution, or with collaborating sites and networks, is a fundamental and required aspect of this program. Applicants should give examples of opportunities of this nature that will be available to trainees in the program. Applicants and trainees should work together to plan and develop projects that complement the objectives of the linked research programs and are appropriate to local needs and resources.  Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed.  These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

Trainees

Trainees should be selected so as to optimize the impact of training on Global Health research at the LMIC institution(s) and should include individuals who are currently involved or will be involved in biomedical, behavioral, and/or clinical research in their home countries.  Selection criteria should also consider whether the trainee has an institutional base to return to after training that would allow them to further use and teach their new skills.  Applicants should describe strategies to encourage trainees to return to or remain in their home country.  Nascent programs should consider how to build a critical mass of experts at the foreign institution(s). However, as the needs of the institution are met, trainees may be recruited more widely from surrounding institutions in the region.  The "region" may be defined as deemed appropriate by the applicants.  Program directors are strongly encouraged to include women and individuals from underrepresented racial, ethnic, and socially disadvantaged groups in the country as trainees.

Required Elements of the Application

The application must include the following sections:

A discussion of the need for increased informatics expertise at the foreign institution.  This should include a description of the current informatics capacity, including skilled professionals and infrastructure at the institution, any barriers to use of this infrastructure, and any modest enhancements of this infrastructure that would be necessary to carry out the research-training program.  These descriptions can establish a baseline against which progress may be  measured and the impact and success of the program eventually evaluated.

A list of the ongoing NIH- and other funded biomedical and behavioral research and training projects at the foreign institution that the proposed training and capacity-building efforts will draw upon and support. Please specifically identify HIV/AIDS-related research, if any, in this category.  To meet the eligibility requirement at the major non-US institution (see Section III.1A, below) this list should be in the form of a Table within the main body of the grant application (not the appendix).

Identification of appropriate collaborators at all participating institutions, including a lead collaborator at each site.

Design of a training plan that addresses the needs identified and that provides for integration of informatics training with ongoing biomedical and behavioral research and training programs at the foreign site.  The training plan should include sufficient detail to judge the research opportunities available to trainees, availability of or need for new curricula to meet specific needs of the trainees, suggested short courses, and any other details that will create a clear picture of the training options.  Training may focus on strengthening a single area of Global Health Informatics or provide a broader set of options, as consistent with the needs of the institution.  Provisions for mentoring of students at both the U.S. (where relevant) and foreign sites should be emphasized. 

A detailed plan for recruitment of trainees to ensure that the most qualified individuals can be identified, and a description of the criteria and process for trainee selection.  One criterion of selection should be the likelihood that the chosen individuals will return to or remain in their home countries and contribute their new skills to the biomedical research and training enterprise there.  Thought should also be given to preparation of medium- to long-term trainees in English language and/or computer skills in the summer preceding studies in the U.S. or at the foreign site to allow them to make optimal use of their formal training period.  Fees for such courses are allowable costs.  Degree candidates must meet all entrance requirements of the degree-granting institution.

A discussion of how activities undertaken during the award period might begin to build a sustainable global health informatics research and training capability in the foreign institution, including five and ten year goals for the program and how current activities will contribute towards realizing those goals. 

Evidence should be provided of substantive institutional commitment at the foreign institution. This may include space, positions, faculty relief time, matching funds, infrastructure support, access to data and systems, trainee support during their re-entry period, a commitment to establish a degree or certificate program, synergies and economies of scale with other training programs at the institution, and others.

A plan for self-evaluation of the program.  Awardees will be requested to track and document the long-term impact of this training program on the success of the trainees, for example as measured by the number and quality of publications, electronic products, presentations, courses developed, awards, subsequent employment, involvement in research or public health, and career advancement; their sustained commitment to research careers involving informatics in their home countries; their ability to attract new funding for their work; their contributions to future international collaborations, conferences, and training; their influence on the development and use of informatics as well as on health policy relating to informatics in their countries; and their ability to act as consultants, teachers, collaborators and role models to other local investigators and further disseminate the lessons learned.  Metrics should eventually encompass both the success of the individual trainees and the success in capacity-building at the institution, including the impact of the program on biomedical and behavioral research capacity at the institution and the establishment or strengthening of informatics training capability.  FIC will provide awardees with an electronic trainee tracking system database, CareerTrac, to capture training and career highlights of program trainees.  An analysis of the impact of training resulting from each program will be considered an important criterion during any re-competition of this FOA.

For competing renewal applications, a discussion of the accomplishments in training and institutional capacity building during the previous periods of ITMI and ITGH support.  This should include a list of trainees and their accomplishments to date and, where appropriate, the percent of trainees that were trained in the U.S. and subsequently returned to their home countries. Any other parameters that measure the impact of these programs on the foreign country’s biomedical research, medical, or public health capacities should be described. 

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.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: March 6, 2009
Application Receipt Date: April 3, 2009
Peer Review Date: July 2009
Council Review Date: August  2009
Earliest Anticipated Start Date: September 30, 2009

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 in Section IV.3.A.

The letter of intent should be sent by email or post to:

Dr. Flora Katz
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31C, Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 402-9591
Fax:  (301) 402-0779
Email:  katzf@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing an Institutional Research Training Application including Ruth L. Kirschstein-NRSA Applications and the additional information in Section IV. 3.6 (http://grants.nih.gov/grants/funding/phs398/phs398.html ). 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 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.

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 renewal 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 or renewal 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 and Information

Follow the PHS 398 Instructions for “Preparing an Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Applications” with the additions or exceptions as noted below:

Project/Performance Sites: List the applicant institution and all of the collaborating institutions as Performance Sites.

Senior/Key Personnel: This FOA allows Multiple Program Directors. List applicant institution PD and include all PDs as Senior/Key Personnel.  At least ONE person at each of the collaborating institutions should be listed as Senior/Key Personnel.  If they are not a PD, list their role as “Collaborator.”  All Program Director(s) must be registered in the eRA Commons and must include the assigned Commons User ID.

Detailed Budget for Initial Budget Period

Budgets may include costs to support trainees for the various types of training proposed (tuition, academic fees, stipends, salary, travel, per diem, trainee self-only or family medical insurance). Note that health insurance is now included under Training Related Expenses category.   Institutions are referred to the policy for funding of tuition, fees, and health insurance at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for long-term trainees and tuition-free short courses.

Trainees may be paid a stipend, comparable to the scientist's professional level and compatible with established NIH guidelines, while undergoing training or conducting research in the U.S., or at a level comparable to that received by similar professionals in-country while undergoing training or conducting research at other participating institutions or in their home countries, but in no case to exceed the NRSA stipend levels described at http://grants.nih.gov/training/nrsa.htm. Applicants are encouraged to budget for adequate professional development opportunities for trainees including, but not limited to, attendance at international scientific conferences and workshops. Training-related expenses (such as books and English language proficiency or basic computer skills classes) may be included but should be described in the budget justification.

Additional trainee support of up to $15,000 direct costs per person per year for up to two years for advanced mentored research in the home country is allowable.  The program director is expected to ensure that activities to be supported receive appropriate review and guidance, as described above.

Costs for computer hardware and software for establishment of workstations in the home country institution for use by trainees are allowable.  In addition, costs to establish and maintain Internet connectivity at the foreign site, including telephone and Internet service provider fees, at a cost consistent with current rates available in the foreign country, are allowable.  Together, these costs should not exceed $25,000 per year without prior permission from FIC.

Budgets may include costs to support the administration of the program and grant.  The salary of the PI, other training faculty, and administrative staff must be commensurate with the salary structure and benefits at the corresponding institution. Collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, teaching, mentoring, as well as other program-related roles. The percent effort for administrative support at either the U.S. and/or the foreign site must be justified in relationship to the number of trainees expected to be in residence at either institution.

FIC will periodically convene network meetings of grantees and funds should be budgeted in the application to allow PIs and the key foreign collaborator at each participating institution to attend these meetings in each year of the award.

Provide a detailed budget justification explaining how requested funds will be used to optimize training of LMIC trainees and build capacity at the foreign institution(s).  All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories.  All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4) in the appropriate categories.  The total direct costs of the trainee participation budget should be identified on PHS Form 398 (budget form pages 4) in the "Other" category.  The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Participating institutions may request a Facilities and Administrative (F&A) cost allowance based on eight percent of the total allowable direct costs, exclusive of tuition and related fees and expenditures for equipment.  Note that using PHS 398 budget calculations, F&A costs on a subcontract become a part of the direct costs of the grant and are not included in the direct cost cap. 

Research Training Program Plan

Program Faculty: Describe the roles, responsibilities and commitments of the senior/key personnel from all partner institution(s). Training experience and accomplishments in this field should be described for each individual. Include letters from senior/key personnel and participating faculty defining their specific roles and time commitments in the proposed training program.

Training in Responsible Conduct of Research:  Applicants must include plans for training in responsible conduct of research for long-term trainees. Describe a plan to provide trainees with formal and informal instruction on scientific integrity and ethical principles in research.  For additional guidance on this provision see, http://grants.nih.gov/training/responsibleconduct.htm and http://bioethics.od.nih.gov/researchethics.html. NIH does not require a specific curriculum or format for instruction but the following areas should be included:  conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing.  The inclusion of international perspectives on these topics is strongly encouraged.

Trainees who will participate in research involving human subjects must meet the NIH policy requirement for education in human subject’s protection (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html). Applicants should describe plans to meet the requirements related to the protection of human subjects in all training-related research.  All trainees involved in human subjects research need documented evidence for education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from institutional (or ethical) review boards or committees at applicant and foreign institutions.  Research training involving human subjects should be mentored under an approved, funded research program award.

Appendix Materials

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 of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

To enhance training opportunities in informatics more broadly, sharing of curricular materials and/or the creation of open educational resources, where appropriate and feasible, is encouraged. In addition, ITGH programs should endeavor, whenever possible, to ensure that research results and training innovations are accessible to other ITGH programs and to relevant

programs in the home countries or internationally by means such as:  making presentations at local and international conferences and publishing results in local and international journals; exchanging newsletters, CD-ROMs or other products among grantees; inviting trainees from other NIH programs within the home institution, country, or region to apply for short-term workshops conducted within the foreign country; or posting materials on websites accessible to the public.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 following will be considered in making funding decisions:

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. 

The goals of NIH supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the biomedical, behavioral, and clinical research needs of the applicant countries.  The scientific review group will address and consider each of these criteria in assigning the applications overall score, weighting them as appropriate for each application.

Significance:  Does this research training program address an important need in the foreign institution and important health problems in the foreign country?

Training Program Director/Principal Investigator (PD/PI):  Does the Training PD/PI have the scientific background, expertise, and experience appropriate to direct, manage, coordinate, and administer the proposed research training program?  Does the PD/PI plan to commit adequate time to the program? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the research training program and the expertise of each of the PD/PIs?  Does the PD/PI team bring complementary and integrated expertise to the proposed research training program?  Does the leadership plan describe how multiple PD/PIs will benefit the program and the trainees?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  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 theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the training framework, design, 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?   

Institutional Training Environment, Commitment, and Resources:  Is the quality of the research environment for the proposed research training program appropriate?  Is the level of institutional commitment, quality of available facilities, courses, research and research training support suitable?  Is the proposed program to be an integral component of the applicant or collaborating institution’s overall research program/mission? 

2A. 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.

Training in the Responsible Conduct of Research: Plans for training in the responsible conduct of research will be assessed.

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 PHS 398 research grant application instructions, Research Plan, section 5.5, item 8 on Human Subjects).

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 PHS 398 research grant application instructions, Research Plan, sections 9 and 11 on the Inclusion of Women and Minorities and the Inclusion of Children).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described in the PHS 398 research grant application instructions, Research Plan, section 5.5., item 12 will be assessed.

Biohazards:  If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2B. 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 score.

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.

Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

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 12 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 NoA. 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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

At the time each progress report is submitted and in the final year of the award, awardees will be required to update trainee data in CareerTrac, a trainee tracking database that will be provided by FIC.

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.

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:

Flora Katz, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31C, Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 402-9591
Fax:  (301) 402-0779
Email:  katzf@mail.nih.gov

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 3216, MSC 7808
Bethesda, MD  20892-7808
For express/courier service use ZIP 20817
Telephone:  (301) 435-1021
Fax:  (301) 594-6363
Email:  duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Angela L. Smith
Grants Management Specialist
OD, Fogarty International Center, NIH
Building 31, Room B2C29
31 Center Drive
Bethesda, MD  20892-2220
Phone# 301-402-9592
Fax# 301-594-1211
Email: smitha2@mail.nih.gov

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.

Policy 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 http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) 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 http://publicaccess.nih.gov/.

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. 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. 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER) 		  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892 		  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) 		  USA.gov - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.