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 Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
Office of Dietary Supplements (ODS/OD/NIH), (http://dietary-supplements.info.nih.gov)

Title: International Clinical, Operational and Health Services Research Training Award (ICOHRTA) [D43]

Announcement Type
This is a reissue of RFA-TW-01-003, which was previously released February 13, 2001.

Update: The following update relating to this announcement has been issued:

• May 21, 2010 - See Notice NOT-TW-10-456 Notice of Intent to Publish a New Funding Opportunity that will Reconfigure and Consolidate The International Clinical, Operational, and Health Services Research and Training Award for Non-Communicable Diseases and Disorders (ICOHRTA-1).
• December 22, 2005 (NOT-TW-06-002) - The Fogarty International Center (FIC) announces a limited competition for HIV/AIDS-related competing applications.

Request For Applications (RFA) Number: RFA-TW-06-002

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.866, 93.279, 93.281, 93.853

Key Dates
Release Date: November 15, 2005
Letters of Intent Receipt Date(s): December 26, 2005
Application Receipt Dates(s): January 25, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: October 1, 2006
Additional Information To Be Available Date (Url Activation Date): http://www.fic.nih.gov/programs/ICOHRTA.html, October 28, 2005
Expiration Date: January 26, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

• Support for advanced training in collaborative, multidisciplinary, international clinical, operational, health services and prevention science research on non-communicable disorders and diseases for health researchers from low- and middle-income countries.
• Approximately eight to 12 institutional awards of up to $200,000 in direct costs for competing renewal applications and $150,000 in direct costs for new applications are anticipated for a total of about $2.5 million per year for up to five years.
• This support is available through the D43 mechanism.
• Eligible organizations are non-profit public or private research institutions in the U.S. in collaboration with institutions in eligible low- and middle-income countries.
• Eligible Principal Investigators include U.S. scientists with the skills, knowledge and resources necessary to carry out the proposed research training.
• Each applicant institution may submit not more than two applications. If two applications are submitted, they must propose clinical, operational, health services and prevention science research training in totally different fields of non-communicable disorders and diseases. Priority is given to research areas supported by or relevant to the participating NIH Institutes and Centers (ICs).
• HIV/AIDS-related research-training programs are not eligible for this Request for Applications (RFA); however, a limited competition for current HIV/AIDS-related ICOHRTA programs, originally awarded from RFA-TW-01-003, will be announced. Investigators and institutions interested in submitting a new proposal for an international training program focused on HIV/AIDS should consider the AIDS International Training and Research Program (AITRP, http://www.fic.nih.gov/programs/aitrp/aitrp.html) and the International Clinical, Operational and Health Services Research Training Award for HIV/AIDS and Tuberculosis (ICORHTA-AIDS/TB, http://www.fic.nih.gov/programs/ICOHRTA-AIDS-TB.html).
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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

1. Research Objectives

The Fogarty International Center (FIC), together with the National Institute on Aging (NIA), the National Institute of Dental and Craniofacial Research (NIDCR), the National Institute on Drug Abuse (NIDA), the National Institute on Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS) and the Office of Dietary Supplements, invites applications for research training programs in international clinical, operational, health services and prevention science which support the development and implementation of evidence-based interventions, for major global health problems on non-communicable disorders/diseases in low- to middle-income countries. Eligible topics must also be relevant to (a) major current or anticipated medical or public health problem(s) in the trainees home countries. The participating NIH ICs especially encourage research topics relevant to their missions. Ultimately, the goal is to address problems contributing to health disparities in the global burden of disease and disability not addressed through the FIC infectious disease-related research training programs. Consult the Disease Control Priorities Project website at http://www.fic.nih.gov/dcpp.

These awards are intended to strengthen the global capacity to conduct clinical, operational, health services and prevention science research necessary to measure incidence and prevalence of non-communicable disorders and diseases; characterize disease burdens; devise, evaluate and implement practical and affordable therapeutic or preventive interventions; and to help developing nations contribute to and benefit from international efforts to apply current knowledge and new discoveries to clinical and public health practice. To meet this goal, the objective is to develop a cadre of researchers in clinical, operational, health services and prevention science research at institutions in low- to middle-income countries that can respond to global health threats related to non-communicable disorders and diseases, particularly those that are priority health issues in their countries and regions. They will be prepared to build and take advantage of collaborative research efforts with partners globally, as well as within their countries and regions.

Broad objectives are to:

1. Support research training of low- and middle-income country scientists and clinicians with the long-term objective of strengthening low- and middle-income country research programs and institutions (referred to as foreign collaborating institutions in this RFA) related to clinical, operational, health services and prevention science research on non-communicable disorders and diseases.
2. Provide a variety of short-, medium- and long-term advanced training opportunities for scientists and clinicians from low- and middle-income country institutions within the context of ongoing U.S. research collaborations.
3. Strengthen ability of scientists from low- and middle-income countries to contribute to global and local clinical, operational, health services and prevention science research efforts related to non-communicable disorders and diseases and to communicate and disseminate knowledge in support of policies appropriate for their home countries and established international guidelines.
4. Help to build and maintain centers of research excellence with significant research resources in clinical, operational, health services and prevention science research efforts related to non-communicable disorders and diseases and to communicate and disseminate knowledge in support of policies appropriate for their home countries and established international guidelines.

This RFA follows an earlier RFA (TW-01-003), released February 13, 2001), the purpose of which was to support international research and training in clinical, operational, health services and prevention science research in developing countries and emerging democracies related to non-communicable disorders and diseases (and, unlike this RFA, included HIV/AIDS prevention as an eligible topic). This RFA represents a further evolution of this program to continue to create a cadre of such researchers at participating institutions in low- and middle-income countries.

HIV/AIDS-related research-training programs are not eligible for this RFA; however, a limited competition for current HIV/AIDS-related ICOHRTA programs awarded from RFA-TW-01-003 will be announced. Investigators and institutions interested in submitting a new proposal for an international training program focused on HIV/AIDS should consider the AIDS International Research Training Program (AITRP, http://www.fic.nih.gov/programs/aitrp/aitrp.html) and the International Clinical, Operation and Health Services Research Training Award for HIV/AIDS and Tuberculosis (ICOHRTA-AIDS/TB, http://www.fic.nih.gov/programs/ICOHRTA-AIDS-TB.html).

For the purposes of this RFA:

Clinical research is patient-oriented research in which an investigator directly interacts with human subjects. This area of research includes: therapeutic interventions, clinical trials, epidemiological, behavioral and demographic studies and the development of new technologies. For example, a program under this RFA might focus on preventive interventions in high-risk populations and/or to develop or adapt treatments (including pharmacological, other somatic, psychosocial or a combination) to enhance functional outcomes for individuals and families. In particular, programs are encouraged that train clinical investigators in the basic development, conduct and interpretation of intervention trials research in order that they may function effectively as independent researchers or collaboratively with their U.S. colleagues as part of multi-site networks.

Health services and outcomes research include studies that examine the organization, financing, management and delivery of health services and their impact on access to care and the utilization, quality, cost and outcomes of care.

Operational research encompasses translation of knowledge and technologies to field and clinic use, how to best implement existing and new prevention strategies, therapeutic tools and other interventions for broad-based field use, and the study of barriers to such translation and implementation. When interventions have been shown to be successful on a small scale or in limited situations, operations research will help determine how to best generalize such interventions for widespread and sustainable use. Operational research includes research that studies factors (such as economics, demographics and the characteristics of service delivery systems) that influence the effectiveness of interventions in real world settings.

The research subjects for all types of eligible research may be individuals, families, organizations, institutions, communities, populations or nations.

Excluded from consideration are:

• Projects that do not involve some component of research or evaluation (e.g., demonstration projects or health services delivery projects that do not involve evaluation are not eligible).
• Studies of animals.
• New programs directly involving HIV/AIDS or other infectious diseases.

BACKGROUND

By the year 2020, projections from the World Health Organization indicate that non-communicable diseases will contribute up to 60 percent of the world’s burden of disease (http://www.fic.nih.gov/dcpp/). Changing economic and demographic trends in low- to middle-income nations, including increasingly aging populations, will play a major role in this epidemiological shift. Increases in chronic, non-communicable conditions such as neuropsychiatric and neurological disorders, drug abuse/addiction, dementia, obesity, tobacco-related diseases including cancer, pulmonary and cardiovascular diseases, hypertension, diabetes and asthma, exacerbated by environmental factors and malnutrition, along with pre- and post-natal health issues, will add to the already unacceptable burden of illness caused by communicable infectious diseases such as HIV/AIDS, TB and malaria.

Lack of access to appropriate care for most of a country’s population, including the special needs of maternal and child health, along with outdated care when available, has been cited as contributing to mortality and morbidity, regardless of cause, in many resource-poor countries. Knowledge gained through new methods of research and current methods extended into new areas as appropriate, will profoundly influence the scope of clinical investigation and implementation of health services and prevention strategies in international health.

Unique opportunities exist for international partnerships to confront the changing and increasing burdens of disease and health disparities within low and middle-income nations. Along with implementation of proven interventions, many promising scientific advances, such as the development of new diagnostics, therapies and vaccines, could contribute to reductions in global health disparities. However, the health care systems in many countries, for a variety of reasons, have failed to implement even proven interventions or the most promising advances.

To be successful, a well-trained cadre of scientists in developing nations will be needed to plan, design and conduct clinical, operational, health services and prevention science investigations, including epidemiological, behavioral, demographic and economic studies, prevention research and investigations of complementary and alternative therapies. The training of international scientists alongside U.S. researchers will help to produce this cadre of experts and will facilitate collaborative clinical research and trials, and operational, health services and prevention science research for the benefit of populations in all countries.

This RFA seeks applications to build clinical, operational, health services and prevention science research capacity at foreign sites in response to global health threats of non-communicable disorders and diseases. The participating NIH institutes and centers (ICs) encourage applications in areas of emphasis that reflect their research missions. For more information, see the IC websites and contacts listed in this RFA. Some ICs have supplied additional information below:

NIMH: For global health concerns of NIMH also please refer to http://www.nimh.nih.gov/publicat/burden.cfm.

NINDS: The mission of NINDS is to reduce the burden of neurological disease a burden borne by every age group, by every segment of society, by people all over the world. The NINDS would be particularly interested in applications developing research-training programs related to clinical research and clinical trials in neurological disorders.

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 D43 award mechanism(s), which limits facilities and administrative (F & A) costs to eight percent of allowable direct costs. As an applicant, you will be solely responsible for planning, directing and executing the proposed project. The applicant organization’s administration must provide the necessary management for the transfer of funds and material to the collaborator(s) and any consortium agreements. Consortium institutions may only charge eight percent F & A costs of applicable direct costs.

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

The participating ICs, Fogarty International Center, the National Institute on Aging, the National Institute on Drug Abuse, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, and the Office of Dietary Supplements, intend to commit approximately $2.5 million in fiscal year (FY) 2006 to fund eight to 12 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $200,000 per year for competing renewal applications and direct costs up to $150,000 per year for new applications. Awards are expected to be made by September 30, 2006..

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.

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

Eligible institutions are non-profit U.S. institutions with scientific collaborations with institutions from low- and middle-income countries. See http://www.worldbank.org/data/countryclass.html for World Bank country classification tables to identify those countries considered low- or middle-income. Hong Kong-based institutions are not eligible as the primary low- to middle-income country partner institution. A second institution in Mainland China must be involved as the primary collaborating foreign institution if an institution in Hong Kong is included as a partner institution. Taiwan is not listed in the World Bank income classification list but is considered high-income and therefore is not eligible as a partner institution.

Applicant institutions may submit two applications, provided they are in totally different fields of research. Pre-approval from the FIC program officer is necessary for submission of two applications from the same institution.

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. FIC strongly encourages women, individuals from underrepresented racial and ethnic groups as well as individuals with disabilities to apply for NIH programs.

Applicants from U.S. institutions must propose collaborations with not more than two foreign institutions in a single low- to middle-income country and must name an individual at each foreign institution as the major foreign collaborator (MFC) for that institution.

Applicant investigators (PI or co-investigators) must be Principal Investigator (PI) or a Project Director of at least one NIH-sponsored research project grant (R series), a center grant, a program project grant (P series), a cooperative agreement (U series), or a research contract related to the proposed grant award period. Alternatively, applicant investigators may have a similar research award from a different funding source with written pre-approval of the FIC program director. If 18 months will not remain in the parent grant award period at the time of ICOHRTA award, applicants must provide documentation that a renewal of the parent grant(s) is expected, that a no-cost extension has been/will be requested for the parent grant(s) with sufficient remaining resources to continue the research project or that other research support will be available to complement this research training award.

2. Cost Sharing or Matching

FIC welcomes cost-sharing or other means of support from U.S. and foreign institutions. Such support, while not a prerequisite for an award, could include U.S. institution’s coverage of U.S. faculty participation, waiver or reduction of tuition for foreign trainees, donation of equipment to the foreign site, or, on the foreign side, waiver of custom duties for equipment.

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

The application, for new and competing renewal research training program awards, must demonstrate that the NIH-supported or other research grant(s) proposed as parent grant(s) for the research training award is/are relevant to and will enhance the activities of the proposed research-training program.

The proposed research training must be relevant to and must benefit the research needs of the host country or countries of the trainees. Such a demonstration may include addressing priority public health issues in the trainee’s country. Priority will be given to applicants with NIH research grants with foreign components at the collaborating low- and middle-income country institution(s).

With approval from the FIC program officer, research collaborations eligible for parent grant status can also include other industrialized nations linked to U.S. institutions if these collaborations will enhance the research-training program.

If the institution already has a D43 research training program, the proposed ICOHRTA research-training program must be demonstrably unique although they may make use of common resources and training, such as courses in grantsmanship and research ethics.

NOTE: While HIV/AIDS-related research-training programs are not eligible for this RFA, a limited competition for current HIV/AIDS-related ICOHRTA programs awarded from RFA-TW-01-003 will be announced. Investigators and institutions interested in submitting a proposal for an international training program focused on HIV/AIDS should consider the AIDS International Training and Research Program (AITRP, http://www.fic.nih.gov/programs/aitrp/aitrp.html) and the International Clinical, Operational and Health Services Research Training Award for HIV/AIDS and Tuberculosis (ICOHRTA-AIDS/TB, http://www.fic.nih.gov/programs/ICOHRTA-AIDS-TB.html).

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: GrantsInfo@nih.gov.

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.

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

Letter of Intent Receipt Date: December 26, 2005
Application Receipt Date(s): January 25, 2006
Peer Review Date: June/July 2006
Council Review Date: September 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:

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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.

The letter of intent should be sent to:

Kathleen Michels, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: ICOHRTA@nih.gov

When emailing the letter of intent, please include on the subject line your last name and ICOHRTA Letter of Intent.

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (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).

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

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, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the Fogarty International Center. Incomplete and 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.

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.

Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive low- and middle-income country training plan included in their application. The budgets may include costs to support the various types of training proposed (tuition, stipends, salary, travel, per diem) for trainees and faculty, and costs to support the administration of the program and grant. Adequate resources to meet U.S. government requirements for training and training-related research should be included in the budget.

All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages four and five) in the appropriate categories. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages four and five) in the appropriate categories. The total direct costs of the trainees budget should be identified on the PHS Form 398 (budget form pages four and five) in the Other category. The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Stipends

While involved in long-term training in the U.S., trainees (graduate students and post-degree participants) may be paid a stipend, comparable to their professional experience, not exceeding the NRSA stipend levels in accordance with the U.S. institutional policies. Applicants may wish to refer to http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html.

While involved in long-term training or conducting long-term training-related research in their home countries, trainees may be paid a stipend at levels comparable with the salary scales for similar professionals in that country in accordance with the collaborating foreign institution’s policies but not exceeding NRSA stipend levels.

Tuition, Fees and Insurance

Funds for tuition, academic fees and self-only or family medical insurance for trainees not exceeding 20% of direct costs may be requested. Institutions with multiple tuition levels should try to provide the lowest available level (e.g. in-state tuition) for enrolled trainees.

Training-Related Expenses

Training-related expenses (books, computers, courses for software, English language proficiency, etc.) may be included but must be described in the budget justification.

Travel

• Funds may be requested for round trip economy class airfare on U.S. carriers (to the maximum extent possible) and local ground transportation for long-term trainees travel, and trainees to participate in short courses or attend scientific conferences to present their research results.
• Funds may be requested for per diem and lodging for trainees to participate in short courses or attend scientific conferences to present their research results.
• Funds should be budgeted for an annual program network meeting, normally in the U.S., to coordinate program activities. Principal Investigators are expected to attend and applicants are encouraged to budget for grant administrators, other faculty , collaborators and trainees to attend.

Other Expenses

• One-time advanced in-country research-training support of up to $15,000 direct costs for mentored research to be undertaken by a long-term trainee upon completion of their training and return to his/her home country. The research should be relevant to his/her country and is subject to the same guidelines on human subjects as all NIH grants, including the need for IRB approval at the U.S. and foreign sites.
• Applicants are encouraged to budget adequate professional development (including but not limited to international scientific conference attendance) opportunities for trainees.
• Training-related expenses (books, computers, courses for software, English language proficiency, etc.) may be included but must be described in the budget justification.

Personnel

The PI, key personnel, faculty and coordinating staff who administer the program or provide extended training of trainees may receive salary and fringe benefits commensurate with the salary structure and benefits at their institution. The administrative or training and teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described.

Consultant Costs

Major collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles.

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

Proposed institutional and capacity-strengthening training programs should be designed to fill specific gaps in needed expertise and to establish a critical mass of trained biomedical and behavioral scientists and health professionals able to work cooperatively on clinical, operational, health services and prevention science research issues in the collaborating foreign institutions.

While research-related training for foreign scientists and clinicians may take place in either the U.S. or the foreign collaborating country institution, trainees must conduct research related to their training, and for terminal degree research projects, in their home country to the fullest extent possible. Applicants should provide the necessary resources for trainees to conduct the research related to their training in their home country and to provide support for advanced in-country training and research.

Applicants are encouraged to seek and develop training opportunities within the home country institutions with the goal of encouraging the foreign collaborating institutions to become full-fledged sites for research and training.

Each training proposal should incorporate a number of long-term (nine months or more), intermediate (three to nine months) and short-term (less than 3 months) training opportunities (including in-country research) in a wide range of relevant disciplines and skills necessary to advance research objectives while building sustainable clinical, operational, health services or prevention science research capacity at a center of research excellence at the proposed foreign institutions.

The types of training may include, but are not limited to:

• Long-term training including relevant academic courses that lead to a terminal degree may be undertaken in disciplines relevant to the proposed research training. Trainees should conduct research in their home country to the greatest extent possible;
• Post-degree training in advanced methods, tools, and data analysis, laboratory procedures, clinical trials research methodology and research projects and techniques related to clinical, operational, health services and prevention research;
• Short-term and medium-term training in focused research methodologies and procedures, including development of pilot studies and research instruments;
• Scientific skill-building activities. This could include, but is not limited to, courses in English for Science Professionals, grant proposal writing, the use of scientific literature, scientific article writing and publishing, scientific presentations, teaching skills, bio-informatics, bioethics, good clinical practice, bio-safety, data management, research administration, and the management of intellectual property.
• When a specific scientific course is given by one program, it is expected that this course may be widely publicized and open to trainees of other grantee institutions under this program.
• Additional institutional capacity-building efforts are encouraged including, but not limited to, in-country training workshops in advanced techniques, particularly aimed at a wider audience through the use of satellite and other electronic communication technology, distance learning, and interaction with other national and regional clinical, operational and health services research and communication efforts.

Use the NRSA substitute page for the Table of Contents. In place of the research plan requested in the PHS 398 application instructions, please describe the research-training program (25 page limit) that you are proposing and include information related to:

• A description of the priority proposal-related health issues in the low- or middle-income country named in the application.
• A description of the existing research capacity and research training in proposal-related clinical, operational, health services and prevention sciences research at the applicant institution and at the foreign collaborating institution(s). Include documentation by the applicant and foreign collaborating institutions of a long-term commitment to build the clinical, operational and health services research capacity of the foreign institution. Include a list of the potential mentors and their scientific areas of interest at the applicant and foreign collaborating institution(s). Pertinent research resources and the educational environment including the options available for distance learning for the proposed training at the U.S. and low- and middle-income country institutions should be described.
• A description of the training goals and objectives and the plan for meeting the objectives. Applicants are encouraged to describe their plans for dissemination of training materials, as well as other coordination efforts, to other FIC research training programs in low- and middle-income countries.
• A description of how the proposed research training plan will strengthen the research capacity at the foreign institution(s) to address the non-communicable disorder/disease health priorities in the country and of how the research training program will further strengthen that international research capacity at the U.S. institution (if applicable).
• A description of the background of the research and training collaborations between the key personnel at the applicant institution and the proposed collaborating institution(s).
• Descriptions of the PI’s and the MFC’s (s ) funded research and any other currently funded and future research that will serve as the research base for the proposed research-training program. Include a list of the research grants funded in the last five years in which the PI, MFC(s), key faculty at the applicant institution or relevant faculty at the foreign collaborating institution(s) have played a key role. Please include grant number (if applicable), title, PI, role played by key personnel, institution, funding period, funding amount and funding agency.
• A detailed description of the internal peer review for training-related and advanced in-country research. 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 responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.
• A plan for meeting the requirements related to the protection of human subjects in all training-related research. The definitions of research and human subjects are included in the Code of Federal Regulations, Title 45, Part 46 (45CFR46) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Please see http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm for decision trees to determine involvement of human subjects. All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, and have written evidence of documentation of education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at both the U.S. and foreign institutions and from the relevant government authority. Please see Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.
• Plans to provide education in the responsible conduct of research, including the protection of human subjects, to all long- and medium-term trainees and to short-term trainees involved in research. For more information on this provision, see the NIH Guide for Grants and Contracts under Institutional Research Training Grants at http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Applications must describe a program to provide formal or informal instruction in research integrity and/or the responsible conduct of research. Although NIH does not establish specific curricula or formal requirements, all programs are strongly encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it also is beneficial to discuss the mutual responsibilities of the institution and the trainees participating in the program. Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance requirements, and the frequency of instruction. The rationale for the proposed plan of instruction must be provided. Information on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must included in future competing continuation applications.
• A detailed description of the recruitment and selection procedures and criteria for the foreign doctoral and post-doctoral scientists and other beneficiaries of the training program (short- and intermediate-term trainees, workshop participants, etc.) as, for example, b a committee composed of investigators at participating institution(s). This should include a list of standards that will be used to ensure that trainees have appropriate prior training and experience, are likely to complete the program, and are likely to develop into productive independent researchers. The recruitment and selection process must be transparent and widely advertised within the appropriate countries. Applicants should describe strategies for recruiting and retaining women and socially and economically disadvantaged persons as trainees. Applications must identify a major role of the collaborators in the recruitment and selection plan. This plan should include procedures for retaining students in the program until completion. The application should include letters from participating U.S. and foreign collaborating institution faculty defining their specific roles (such as mentoring and teaching) and time commitments in the proposed training program. Degree candidates must meet all entrance requirements of the U.S. or foreign degree granting institution.
• 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, where appropriate, to allow trainees to make optimal use of their formal training period. Fees for such courses are allowable costs.
• A description of strategies that applicants will implement to encourage trainees to return to their home country. Encouragement and support to trainees to apply for awards under the Global Health Research Initiative Program for New Foreign Scientists (GRIP), the Fogarty International Research Collaboration Award (FIRCA), and other relevant NIH research grants are expected.
• A plan for self-evaluation of the program, including a plan to track long- and medium-term trainees for at least five years after completion of their training. Awardees will be required to track and document the long-term impact of this training program on the research capacity in clinical, operational, health services and prevention sciences research of the foreign institution(s). Among widely recognized and validated measures of success of trainees are the number and quality of publications, presentations, courses developed, professional awards, grant funding, career advancement and subsequent employment that demonstrates their sustained commitment to health research careers in their home countries; their contributions to future international research collaborations and research training; their influence on the development and use of research findings 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. Evaluation metrics should eventually encompass both the success of the individual trainees and the impact of the program on research capacity at the foreign institution(s) and the establishment or strengthening of multidisciplinary research training capability. The self-evaluation plan’s merits will be assessed based upon the awardee’s use of these or equivalent metrics. Applicants should establish some mechanism to periodically review the progress of the trainees and the effectiveness of the program. This may consist of regular meetings among faculty participating in the program or periodic review by an outside group of consultants.
• Plans to include education in the inclusion of children, women and individuals from underrepresented racial, ethnic, and disenfranchised groups in research in their country. Where appropriate, the design of training related research 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.

Competing renewal research training applications should include, in addition to the above, a description of the past experience and progress of the grantee’s ICOHRTA program (additional ten page limit) and include:

• A description of how the research training addressed the clinical, operational and health services research needs and priorities of the collaborating low- or middle-income country;
• A description of how the ICOHRTA grant has increased the research capacity of the institution(s) in the collaborating country;
• A description of how the applicant has been able to leverage other NIH or non-NIH program opportunities in the country;
• A description of the trainees, including country, training received, any degrees awarded, training-related research and post-training position;
• A list of publications in peer-reviewed journals, including local journals, in which a former or current trainee is listed as an author and which was supported through the ICOHRTA grant as evidenced by acknowledgment of support provided by the ICOHRTA grant in the publication;
• A description of how the previous ICOHRTA program addressed the recruitment and support for women and socially disadvantaged groups within the population of the country;
• A description of the success of the program for the return of long-term trainee (one year or more) to the country following completion of their training and a description of the strategies used by the program to maximize the number of trainees who return to their country of origin upon completing their training;
• A description of how the returning trainees are using their skills to strengthen the clinical, operational, health services or prevention science research capacity of their country;
• Prior performance through impact will be an important criterion in the recompetition of this program. Examples of such impact include how training received under the program has allowed participants to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in the funding of clinical, operational, health services and prevention science research investigators or co-investigators, publications authored or co-authored by trainees that were based upon support under this program, and health policies that were influenced or implemented by returning trainees in their home countries.

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

1. Criteria

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities, particularly the extent to which the proposed program complements other efforts in Global Health research sponsored by the FIC and participating NIH Institutes and Centers
• The interests of any co-funding partners
• Geographical balance

The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined b peer review and responsiveness to the review considerations. The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the Fogarty International Center Advisory Board and other co-sponsoring Advisory Councils.

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.

Significance: Does this research-training program address an important clinical, operational or health services research problem relevant to non-communicable diseases or disorders of relevance to the collaborating country? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the expected contribution of the research training program described in the application to the ability of the foreign institution(s) to conduct clinical, operational, health services and prevention sciences research? What is the expected potential of the training and the foreign institution(s) to contribute to addressing the priority health problems in the country? What is the expected ability of the proposed research training program to strengthen the capacity at the foreign institution over the life of the grant to provide opportunities for trainees and junior faculty to rise to scientific leadership positions in this or related programs? Is the proposed program likely to develop a cadre of researchers at the foreign institutions who can carry on research and training in clinical, operational and/or health services research?

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? Is the proposed research-training program able to provide breadth of training opportunities needed? Will the described research-training program provide the trainees with the necessary administrative and management skills to compete for future research support and conduct research?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? For applications to continue an existing program, please clearly indicate the ways in which the program has been innovative and any significant new measures that are considered innovative. How does the proposed research-training program take advantage of the research infrastructure of the applicant and foreign institution(s) and of previous and current investments and support from NIH or other organizations? How does the proposed research-training program take advantage of relevant research training opportunities outside the countries in which the participating institutions are located? Does the proposed mix of long-, medium- and short-term training achieve the goals of this RFA while taking into consideration existing conditions and existing capacity at the foreign institution(s)?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Are the applicant PI, the major collaborators, key personnel, and mentors named in the application appropriately trained and well-suited to achieve the goals and implement the activities of the proposed research training program? How strong and successful are the research collaborations between the PI and faculty at the applicant institution with major collaborator and faculty at the collaborating institution(s)?

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 subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there written commitment (agreement) among the institution(s) to cooperate to achieve the long-term goals and activities of the program? Are the mentoring resources and research-training environment at the applicant and at the collaborating institution(s) adequate to achieve the goals proposed in the application as evidenced by the quality of teaching and research facilities? Will the trainee recruiting and selection process capture the most qualified individuals and include an adequate representation of men, women and individuals from underrepresented racial, ethnic, or socially disadvantaged population groups of the countries among the trainees.

Additional Criteria to Be Considered for competing renewal Applications

How strong are the resources and training environment in-country as evidenced by past history of success of former trainees returning to their home countries and becoming independent researchers?

Do the former trainees remain committed and active in developing the field in their countries through advanced in-country research and as faculty and mentors for new trainees?

Does the past research training record demonstrate success in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development?

2.A. Additional Review Criteria:
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score.

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).

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).

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.

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
Not applicable

2.D. Sharing Research Resources
Not applicable

3. Anticipated Announcement and Award Dates

Applicants will be notified of the status of their application by e-mail from the FIC program officer after the funding plan is approved by the FIC Director.

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.

The applicant institution will be notified by email or postal mail as to when funding decisions are expected by the FIC program office.

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.

Grantees are also expected to maintain the trainee tracking system and impact criteria as described above. A summary and description of all research training projects, trainees recruited, active and graduated along with publications and other significant accomplishments of the program and trainees, must be reported in the annual progress report.

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:

FIC/NIH
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
FAX: (301) 402-0779
Email: ICOHRTA@nih.gov

FIC/NIH
AIDS-Related Program Information
Jeanne McDermott, CNM, MPH, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
FAX: (301) 402-0779
Email: mcdermoj@mail.nih.gov

NIA/NIH
John Haaga, Ph.D.
Deputy Associate Director
Behavioral and Social Research
National Institute on Aging
Gateway Bldg., Suite 533
7201 Wisconsin Avenue
Bethesda, MD 20892-
Telephone: (301) 496-3131
Email: haagaj@mail.nih.gov

NIDA/NIH
Steve Gust, Ph.D.
Acting Director, International Office
National Institute on Drug Abuse
6001 Executive Boulevard
Room 5274, MSC 9581
Bethesda, MD 20892-9581
Telephone: (301) 443-6480
FAX: (301) 443-9127
Email: sgust@nida.nih.gov

NIDCR/NIH
Kevin Hardwick, DDS, MPH
Extramural Training Officer
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AS-13
Bethesda, MD 20892
Telephone: (301) 594-2765
FAX: (301) 402-7033
Email: kevin.hardwick@nih.gov

NIMH/NIH
Enid Light, Ph.D.
Associate Director for Research Training and Career Development
National Institute on Mental Health
6001 Executive Boulevard
Room 7155, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-3599
FAX: (301) 443-4045
Email: elight@mail.nih.gov

NINDS/NIH
Yuan Liu, Ph.D.
Chief, Office of International Activities
National Institute of Neurological Disorders and Stroke
National Institutes of Health
Neuroscience Building, Room 2187
6001 Executive Boulevard, MSC 9523
Bethesda, MD 20892-9523
Telephone: (301) 496-3108
FAX: (301) 402-1501
Email: liuyuan@ninds.nih.gov

ODS/OD/NIH
Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3801
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
FAX: (301) 480-1845
Email: piccianm@od.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
MSC 7840, Room 3156
Bethesda , MD 20892
Telephone: (301) 435-1021
FAX: (301) 480-3567
Email: duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Andy Jones
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 402-9592
FAX: (301) 594-1211
Email: jonesan@mail.nih.gov

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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/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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NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
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