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 Cancer Institute (NCI), (
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (
National Institute of Dental and Craniofacial Research (NIDCR), (
National Institute of Mental Health (NIMH), (
National Institute on Drug Abuse (NIDA), (
National Institute on Nursing Research (NINR), (
Office of Dietary Supplements, Office of the Director (ODS/OD), (
Office of Research on Women's Health, Office of the Director (ORWH/OD), (

Title: AIDS International Training and Research Program

Announcement Type
This is a reissue of PA-03-018, which was previously released October 31, 2002.

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

Program Announcement (PA) Number: PAR-05-140

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.398, 93.273, 93.121, 93.242, 93.279, 93.361

Key Dates
Release Date: July 14, 2005
Letter of Intent Receipt Date: November 21, 2005; November 21, 2006; November 21, 2007
Application Receipt Date: December 21, 2005; December 21, 2006; December 21, 2007
AIDS Application Receipt Dates(s): N/A
Peer Review Date: February/March 2006; February/March 2007; February/March 2008
Council Review Date: May 2006; May 2007; May 2008
Earliest Anticipated Start Date: July 1, 2006; July 1, 2007; July 1, 2008
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: April 2, 2007

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

As the global HIV/AIDS epidemic enters its third decade, the toll it has taken on individuals' lives is felt around the world. While currently the affected populations are primarily in sub-Saharan Africa, HIV epidemics in China, India and other south Asian countries, and Russia and the Newly Independent States, are increasing. The capacity of institutions in low- and middle-income countries to conduct integrated prevention and care research across the full range of conditions and issues that relate to care of adult and pediatric patients with HIV/AIDS in their country (e.g., opportunistic infections, HIV malignancies, neurological and mental health consequences, behavioral issues, issues related to mother-to-child transmission, hematological and cardiovascular conditions, blood safety issues, nutritional issues, pulmonary manifestations, ophthalmologic manifestations, gastrointestinal conditions, drug and alcohol usage, sex/gender-related science and issues, and oral health manifestations) need to continue to be strengthened and expanded. In addition to the identification of effective interventions, the ability to evaluate the economic and social impacts of these interventions will be crucial to guide policy makers as they develop policies and programs to address the HIV/AIDS epidemic in low- and middle-income countries. Applicants are encouraged to review the annual NIH Plan for HIV-Related Research available at: to review the research interests of NIH.

The purpose of this announcement is to invite applications from eligible institutions for innovative, collaborative training programs that would contribute to the long-term goal of building sustainable research capacity in HIV/AIDS and HIV-related conditions at institutions with which they have ongoing research collaborations, in low- and middle-income countries, (as defined using the World Bank classification system at These research-training programs will strengthen scientific knowledge and skills to enhance prevention of, and treatment and care for, HIV/AIDS and HIV-related conditions in these countries.

The Fogarty International Center (FIC), together with partner Institutes and Offices from the National Institutes of Health (NIH), has supported long-term research capacity-strengthening efforts in low- and middle-income country institutions for over 15 years through a series of competing five-year awards for the AIDS International Training and Research Program (AITRP). At this time, the FIC, with its partners, will solicit new and competing renewal applications under this program announcement (PA). These awards will increase research training across the span of biomedical, behavioral and social sciences, clinical science, epidemiology, bio-statistics, and public health practice. The research-training program should continue to emphasize prevention research and expand to include research to identify appropriate interventions to provide care to those adults and children infected with HIV. It should involve a wide range of professionals (e.g., nurses, midwives, physicians, dentists, health care administrators and public health workers), and should be multidisciplinary, including training across the span of sciences and disciplines listed above.

The applicants should describe research-training programs that provide a variety of short-, medium- and long-term training opportunities for participants from their proposed collaborating foreign institution in low- and middle-income countries (referred to as foreign collaborating institutions in this PA) within the context of ongoing research collaborations. Training may occur in either the U.S. or foreign collaborating institution, however, applicants are strongly encouraged to provide support and mentoring for trainees to conduct the research related to their training in their country to the greatest extent possible. Applicants should include a plan that demonstrates the increasing research training options and responsibilities to the collaborating foreign institution during the course of the five-year award. Applicants should present an assessment of the specific needs for HIV/AIDS and HIV-related research training at their foreign collaborating institution(s) and a proposed training plan to address those needs during the course of a five-year award. It is expected that each research-training program award supported will:

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

2. Funds Available

Because the nature and scope of the proposed research training will vary from application to application, and the number and funding level of re-competing applications varies from year to year, it is anticipated that the size of each award will also vary. See guidelines for levels of funding below. The total amount awarded and the number of awards each year will depend upon the number of applications, the quality of those applications, and the previous duration of re-competing applications.

FIC expects to award from $300,000 to $5.6 million to fund one to eight awards annually through this announcement, depending on how many awards are re-competing in a given year. An applicant for an AITRP award may request a project period of up to five years and a budget for direct costs, according to the following guidelines:

Awards are expected to be made by July 1, 2006, July 1, 2007, and July 1, 2008. 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 if your organization has any of the following characteristics:

Eligible domestic institutions must demonstrate active research collaborations with institutions in the low- and middle-income countries named in their application. See for World Bank country classification tables to identify the countries considered to be of low- or middle-income.

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. However, applicants must have a strong HIV/AIDS and HIV-related research and research-training program and the requisite faculty and facilities to carry out the proposed training activities. The Principal Investigator and/or key personnel listed on the application must be designated as the Principal Investigator of at least one active (with at least 18 months of support remaining at the time of application) HIV/AIDS or HIV-related research award, directly relevant to the research training proposed. The research grants may be funded by the NIH or by other national or international organizations. The research award needs to involve the foreign collaborating institutions named in the AITRP application and the applicants need to document this existing research support in their application. Applicants should explain in detail how their relevant research grant support and activities are related to the proposed training plan. Priority will be given to applicants associated with NIH-funded direct research grants to the proposed foreign collaborating institution(s) or with NIH-funded research grants with foreign components at the foreign collaborating institution(s).

Women and individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH programs.

2. Cost Sharing or Matching

The most current Grants Policy Statement can be found at:

3. Other-Special Eligibility Criteria

Only one application for an award may be submitted from an institution. Only one AITRP award will be made to an institution at any given time.

The application must demonstrate that the proposed research training will be relevant to and will benefit the HIV-related research needs of the foreign collaborating country or countries.

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 Dun &Bradstreet 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.

3. Submission Dates and Times
See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: November 21, 2005; November 21, 2006; November 21, 2007
Application Receipt Date: December 21, 2005; December 21, 2006; December 21, 2007
Peer Review Date: February/March 2006; February/March 2007; February/March 2008
Council Review Date: May 2006; May 2007; May 2008
Earliest Anticipated Start Date: July 1, 2006; July 1, 2007; July 1, 2008

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 McDermott
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
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 application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at

Applicants proposing training that will incur tuition expenses to a U.S. academic institution should try to arrange the lowest (e.g. in-state) possible tuition scale to be paid.

Allowable Costs

Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive research-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 award. 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 and 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 and 5) in the appropriate categories. The total direct costs of the trainee participation budget should be identified on the PHS Form 398 (budget form pages 4 and 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

Personnel Costs


Pre-Award Costs are allowable. A grantee may, at its own risk and without prior NIH 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 AITRP 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.

2. Review and Selection Process

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit.

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

The following will be considered in making funding decisions:

The most important factors 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 its partners, will attempt to ensure a reasonable balance of HIV-related scientific issues of the research training, as well as geographic balance.

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 proposed research training 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 the proposed research training on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

What is the expected contribution of the proposed research training to the ability of the foreign institution(s) to conduct HIV-related research? What is the expected potential of the foreign institution(s) to contribute to addressing the priority HIV-related 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?

Will the proposed research training provide the breadth of training opportunities in biomedical, behavioral and social sciences to develop true multidisciplinary research teams at the foreign institution(s)?

Will the proposed research training strengthen the necessary administrative and management skills at the foreign institution(s) and of the trainees to compete for future research support and conduct research?

What is the expected ability of the proposed research training 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?

What is the expected ability of the proposed research training to strengthen the capacity to conduct research independently at the foreign institution over the life of the grant?

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?

How does the proposed research training take advantage of the research infrastructure of the applicant and foreign institutions and of previous and current investments and support from FIC; other NIH Institutes, Centers and Offices; CDC; USAID; or other organizations?

How does the proposed research-training program take advantage of relevant opportunities in other countries?

Does the proposed mix of long-, medium- and short-term training achieve the goals of this PA, while taking into consideration existing conditions and existing capacity at the foreign institution(s)?

Will the proposed program develop a cadre of multidisciplinary (biomedical, behavioral and social sciences) 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) amongst the institutions to cooperate to achieve the long-term goals and activities of the program?

Are the mentoring resources and research-training environment at the applicant institution and 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 groups of the country(ies) among the trainees?

What is the expected ability of the proposed training plan to maximize the return and integration of trainees into HIV/AIDS and HIV-related research at the foreign collaborating country institution(s) to build sustainable research capacity?

How adequate is the proposed method to monitor the long-term impact of the HIV/AIDS and HIV-related research training experience on the subsequent careers of the trainees, the HIV/AIDS and HIV-related research capacity at the foreign institution(s), and public health in the collaborating country(ies)?

How adequate are the proposed systems for scientific peer review of training-related research, protection of human subjects, education in the responsible conduct of research, and inclusion of women and disadvantaged groups in research?

How well has the Training Advisory Group been constructed to serve the functions defined in the PA?

Is there evidence of foreign government and institution support among the relevant institutions for the proposed research training?

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

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

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
Not applicable

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 (; selected tables with the PHS 2590, as requested by the Program Officer; 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
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892
Telephone: (301) 496-1492
FAX: (301) 401-0779

2. Peer Review Contacts:

Sherry L. Dupere, PhD
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 Specialist
Office of the Director
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892
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,

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 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 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 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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NIH Funding Opportunities and Notices

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