Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (

Components of Participating Organizations
Fogarty International Center (FIC), (
National Institute of Child Health and Human Development (NICHD), (
Office of Dietary Supplements (ODS), (

Title: Global Research Training in Population Health

Announcement Type
This is a modification of RFA-TW-00-004 that was previously released December 20, 1999.

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

Request For Applications (RFA) Number: RFA-TW-05-002

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.865

Key Dates
Release Date: August 26, 2005
Letters of Intent Receipt Date(s): December 13, 2005
Application Receipt Date(s): January 13, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s) : September 12, 2006
Earliest Anticipated Start Date: September 30, 2006
Additional Information To Be Available Date (URL Activation Date): N/A
Expiration Date: January 14, 2006

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
4. Intergovernmental Review
5. Funding Restrictions

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement
Section I. Funding Opportunity Description

1. Research Objectives

The Fogarty International Center (FIC), in collaboration with the National Institute of Child Health and Human Development (NICHD) and the Office of Dietary Supplements (ODS) of the National Institutes of Health, invites applications from non-profit public or private institutions in the U.S. and low- and middle-income countries, as defined using the World Bank classification system at, to support advanced international research training in population health sciences.

Broad objectives are to:

1. Support research training of low- and middle-income country scientists with the long-term objective of strengthening low- and middle-income country research programs and institutions (referred to as foreign institutions in this RFA) related to population health, including the study of: a) demographic processes, including: aging, child health, adult health, mortality, morbidity, fertility, migration, urbanization, population dynamics and environment, nutrition, sex and gender, and other social, behavioral, and economic factors that influence population dynamics; and b) reproductive processes (including biology, immunology, genetics, endocrinology), fertility and infertility, contraceptive development, contraceptive clinical trials, contraceptive and reproductive health evaluation.

2. Provide a variety of short-, medium- and long-term advanced training opportunities for participants from low- and middle-income country institutions within the context of ongoing U.S. research collaborations. Emphasis is on research training for doctoral and post-doctoral level scientists and clinicians.

3. Strengthen ability of scientists from low- and middle-income countries to contribute to global population research efforts and to communicate and disseminate knowledge in support of population 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 population health sciences to serve as loci in low- and middle-income countries and regions for research training.

This RFA follows an earlier RFA (TW-00-004), International Training and Research in Population and Health (ITRPH) Program, the purpose of which was to support international research and training in population-related sciences in developing countries and emerging democracies. This RFA represents a further evolution of this program to provide population health research training to create a cadre of researchers at foreign institutions in low- and middle-income countries named in the successful applications.


According to projections by the United Nations, world population will increase from 6.3 billion in 2004 to over 7.8 billion by 2025, to 8.9 billion by 2050. Human population growth is driven largely by the world's less developed countries (LDCs). Ninety-eight percent of world population increase occurs in the LDCs of Africa, Asia, and Latin America, and this percentage will rise over the course of the next quarter century. Indeed, 99 percent of global natural population increase the difference between numbers of births and deaths occurs in the developing world. The regions of Sub-Saharan Africa and the Middle East are expected to continue to have the highest fertility rates and need priority attention.

This trend has important ramifications for global health. In some low- and middle-income nations, high birth rates and poor health may impede sustainable economic development that, in turn, affects a population's health. Population growth and changes in population distribution and household structure may negatively affect maternal and child mortality rates, pollution levels, sanitation, the spread and emergence of infectious diseases, exploitation of land, destruction of natural ecosystems, unemployment, and inadequate access to health care and education. With declines in population growth rates in some countries, there has been increased economic productivity, improved health and cultural changes, including acceptance of and access to a wide choice of birth control methods, sustained improvements in child survival, and improvements in the education and societal status of women. Research is needed to better understand the relationships, including direction of causality, of these variables.

Emphasis will be placed on collaborative activities in countries and regions where population growth adversely impacts public health, the environment and economic progress. Interdisciplinary and translational research approaches are especially encouraged. Examples of research and training topics include, but are not limited to, the following:

The emphasis is on training doctoral and post-doctoral level scientists from the low- and middle-income countries identified in the application (referred to as Trainees in this RFA), but other types of training may also be included, as appropriate. The types of training include:

While research-related training programs for foreign scientists may take place in either the U.S. or the low- and middle-income country of the collaborating institution, applicants are strongly encouraged to provide the necessary resources for trainees to conduct research related to their training in the host low- and middle-income country and to seek and develop training opportunities within the low- and middle-income country institution.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the D43 award mechanism, 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.

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 A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The applicant organization's administration must provide the necessary management for the transfer of funds and material to the collaborator(s) and any sub-contracts (consortium). Subcontracts (consortiums) may only charge eight percent F & A costs of applicable direct costs.

2. Funds Available

The FIC, NICHD, and ODS intend to commit approximately $1.5 million in FY 06 to fund six to eight 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 $185,000 per year for re-competing applications (competing continuation) and costs up to $139,000 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Eligible institutions are non-profit U.S. institutions or foreign institutions in low- and middle-income countries. U.S. institutions must demonstrate scientific collaborations with institutions from low- and middle-income countries. Foreign institutions from one of the low- or middle-income countries must demonstrate scientific collaborations with a U.S. institution. See for World Bank country classification tables to identify those countries considered low- or middle-income. Applications are encouraged with research-training programs proposed for countries in Africa and the Middle East. This announcement does not encourage HIV-related applications. Applications that are HIV-related will be considered non-responsive and will be returned without review.

Each applicant institution may submit up to two applications, but only one application proposing research training in reproductive biology and one application proposing research training in demography-related population studies are allowed per 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. Individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH programs.

Applicants from U.S. institutions must propose collaborations with not more than two foreign institutions in low- and middle-income countries and must name an individual at each foreign institution as the major foreign collaborator for that country. Individuals chosen as major foreign collaborators should be scientists with whom the Principal Investigator or key personnel named in the application have had prior successful research collaborations. Applicants from low- or middle-income countries should apply in collaboration with U.S. institutions capable of enhancing their proposed training opportunities, and may propose collaboration with one other institution in their country and must name an individual at the proposed collaborating institution as major collaborator. The PI and collaborators will be responsible for the overall conduct of the grant. A significant and specific role of the collaborators in setting the research agenda, conceptualizing and mentoring research projects should be described in the application.

Applicant investigators must be a Principal Investigator (PI) or a Project Director of at least one NIH-sponsored research project grant (R series), a center grant (such as NIA Demography of Aging Centers), a program project grant (such as an NICHD Population Research Infrastructure Program (R24) grant), a cooperative agreement (U series), or a research contract related to population health studies that will be funded during at least three years of the proposed grant award period. Alternatively, applicant investigators may have a similar research award from a different funding source with advance permission of the FIC program officer. Investigators may request five years of support in anticipation that a renewal application for the parent grant(s) will be submitted and awarded or that other research support will be available to complement this training award. Under certain circumstances, an NIH research contract will be considered as meeting the eligibility requirements. Institutions are encouraged to collaborate with NICHD Population Research Infrastructure Programs at their own or other institutions.

FIC strongly encourages women and individuals from underrepresented racial, ethnic and socially disadvantaged groups to submit an application. 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 and intervention strategies.

Applicants must address the ability of the trainee recruiting and selection process to capture the most qualified individuals and to include an adequate representation of men, women and ethnic minorities or socially disadvantaged population groups among the developing country trainees.

2. Cost Sharing

The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria

The application must demonstrate that the research training award is relevant to and will enhance the activities of the NIH-supported or other research grant(s), and benefit the research needs of the host country or countries of participating scientists and health professionals. Such a demonstration may include addressing priority public health and population health issues in the country(ies) addressed by the proposed research training. Priority will be given to applicants with NIH research grants with foreign components at the collaborating low- and middle-income country institution(s) or to foreign low- and middle-income country applicants directly supported by NIH research awards.

With approval from the FIC program officer, research collaborations can also include other industrialized nations linked to U.S. institutions if these collaborations enhance the research training capacity of low- and middle-income countries.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at 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:

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 The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.


Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

3. Submission Dates and Times
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 13, 2005
Application Receipt Date(s): January 13, 2006
Peer Review Date: June/July 2006
Council Review Date: September 12, 2006
Earliest Anticipated Start Date: September 30, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to.

Jeanne M. McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Dr., MSC 2220
Bethesda, MD 20892
Telephone: (301) 496-1492
FAX: (301) 402-0779

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions as described above. 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

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:

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the Fogarty International Center. Incomplete and non-responsive applications will not be reviewed.

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

Allowable Costs

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 coordination 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 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 & 5) in the appropriate categories. The total direct costs of the trainees budget should be identified on PHS Form 398 (budget form pages 4 & 5) in the "Other" category. The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.


Tuition and Fees

Trainee Travel

Training Related Expenses




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

6. Other Submission Requirements

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:

In addition to the above, re-competing research training applications should also include, in the main application, a description of the past experience of the grantee in the ITRPH program (additional ten-page limit) and include:

Plan for Sharing Research Data
Not applicable

Sharing Research Resources
Not applicable

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

The most important factor to be considered in making funding decisions will be the quality of the proposed project, as determined by 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.

In addition, FIC, in consultation with NICHD and ODS, will attempt to ensure a reasonable balance of population health research training, as well as geographic balance.

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. This announcement does not encourage HIV-related applications. Applications that are HIV-related will be considered non-responsive and will be returned without review.

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

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 study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of 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 population health research?

What is the expected potential of the foreign institution(s) to contribute to addressing the priority population health problems in the country?

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 including clinical, lab-based, applied, survey design and implementation, and product-related training where relevant?

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?

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?

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 FIC, NICHD, ODS, other NIH Institutes, Centers and Offices, CDC, USAID 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)?

Will the proposed program develop a cadre of population health researchers at the foreign institutions?

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 institutions(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 country(ies) among the trainees?

Additional criteria to be considered for re-competing applications are:

How strong are 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?

Have former trainees been successful in completing the program and returning to their home country?

2.A. Additional Review Criteria:
Not applicable

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 decisions are made by the FIC Director.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

3. Reporting

Awardees are also expected to maintain the trainee tracking system and impact criteria as described above. Publications and other significant accomplishments of the program and trainees must be reported and described to the FIC program officer in a timely manner.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually ( and financial statements as required in the NIH Grants Policy Statement.

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:

Jeanne McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Rm. B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
FAX: (301) 402-0779

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive
MSC 7840, Room 5136
Bethesda, MD 20892
Telephone: (301) 435-1021
FAX: (301) 480-3567

3. Financial or Grants Management Contacts:

Andy Jones
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 402-9592
FAX: 301-594-1211

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 ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations (, 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 (

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,

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 (

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.

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 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 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 (; a complete copy of the updated Guidelines is available at 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 (

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( 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 ( 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 and view the Policy or other Resources and Tools including the Authors' Manual (

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 ( 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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at 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

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:

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