Part I Overview Information

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)
Office of Dietary Supplements, Office of the Director (ODS/OD) (http://dietary-supplements.info.nih.gov/)

Title: International Research Scientist Development Award (IRSDA) [K01]

Announcement Type
This is a reissue of PAR-04-058, which was previously released February 5, 2004.

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

• December 17, 2009 - This PA has been reissued as (PAR-10-066).

• This program supports U.S. postdoctoral biomedical, epidemiological, clinical, social and behavioral scientists in the formative stages of their careers to conduct research in developing countries. These awards will provide the successful candidates with a three- to four-year period of intensive mentored research, leading to an independent research career focused on global health. This research must be directly linked to an established collaboration between a U.S. mentor/sponsor and a leading developing country scientist at an internationally recognized research institution in a developing country. Collaborations are expected to lead to advances that will reduce the impact of global health problems and narrow the gap in health disparities between developed and developing countries. Awardees who obtain a tenure track position may submit a competitive renewal application for up to three years of additional mentored career development support.
• The total amount to be awarded is expected to be $250,000 - $500,000 and the anticipated number of awards is two to five.
• Applicants may request salary and fringe benefits for the Principal Investigator and support for travel and research development.
• This program will use the NIH career development (K01) award mechanism.
• The application may be submitted on behalf of the candidate (Principal Investigator) by any domestic non-profit, public or private institution, such as a university, college, hospital, or laboratory. Foreign institutions are not eligible to apply.
• Candidates must be U.S. citizens, non-citizen nationals, or individuals lawfully admitted for U.S. permanent residence, who have earned a doctoral, dental or medical degree within seven years of the application receipt date.
• A candidate for the K01 award may not have pending nor concurrently apply for any other career development award.
• See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is available at: TTY 301-451-5936

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 of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The International Research Scientist Development Award (IRSDA) provides research opportunities, as well as cutting-edge technical training, in leading developing country institutions for U.S. postdoctoral biomedical, epidemiological, clinical, social and behavioral scientists who are committed to careers in international health research. The award supports the recipient for a three- to four-year period of collaboration with a U.S. mentor and an established developing country mentor. This collaboration should be based on a research project of mutual interest in the context of an ongoing research relationship between the U.S. and foreign mentors. It is expected that this experience will prepare scientists to pursue an independently-funded global health research career involving ongoing collaboration with developing country scientists.

The IRSDA is part of the FIC strategy to support research collaborations in developing countries in order to build research capacity to address global health research priorities. The role of the IRSDA is to:

• attract new research talent to global health research and enhance research collaboration between the U.S. and foreign sites;
• advance the career paths of exceptional junior U.S. scientists with mentored training in health issues of developing country populations;
• extend the impact and scope of existing career research and training support for U.S. scientists committed to international research; and
• stimulate a more effective translation of the results of research on global health problems into public health practice.

With IRSDA support, the investigator will have the opportunity to work closely with an established foreign scientist in the developing world and a U.S. investigator, who are involved in collaborative research. The applicant will conduct research and receive training at both the U.S. and developing country institutions. It is expected that these awards will serve to forge collaborative relationships between established, developing country researchers and outstanding U.S. junior scientists who are potential leaders of basic, clinical and behavioral/social health research programs in the U.S. Collaborations are expected to lead to advances that will reduce the impact of global health problems and narrow the gap in health disparities between developed and developing countries.

All career development proposals must be tailored to meet the individual needs of the candidate. The specific career development and research training activities proposed in the application may be new to the candidate or an extension of the candidate’s prior research, but should focus on global health concerns which include, but are not limited to, infectious diseases, nutrition, chronic/degenerative conditions, trauma/injury and mental health disorders. Basic laboratory, behavioral/social and clinical biomedical research will be supported in clinical, field or laboratory settings.

The candidate must devote a minimum of 75% of full professional effort to the goals of this award, including significant time devoted to research in the chosen developing country. Applicants for initial awards must agree to spend a minimum of 50% of the project period of the grant at the foreign research site for at least three months per year. Applicants for a competitive three-year renewal mentored career development award must agree to spend a minimum of one year of the total project period at the foreign research site for at least three months per year.

The candidate and the U.S. and foreign mentors are jointly responsible for the preparation of the plan for career development. The applicant must justify the need for this award and provide a convincing case that the proposed period of support will substantially enhance his or her career as an independent investigator in global health research. The sponsoring institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. FIC recognizes that there will be significant differences in the applicants, U.S. and foreign institutional environments, U.S. and foreign mentors backgrounds, and approaches to international research collaboration among applications. Therefore, applicants should clearly define specific research and training goals related to each mentor and each institution, methods to achieve the goal of an independent research career in global health and specific measurable objectives to enable assessment of the proposed project.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH career development (K01) award mechanism (PA-06-001). Please note that this K01 award has some important differences from the K01 award described in PA-06-001. These include:

• The original award period is for three to four years;
• A competitive renewal mentored career development award is possible for up to three years;
• Both a U.S. and a foreign mentor are required and must share a research collaboration; and
• Requirement of significant time spent in the foreign country.

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.

Initial awards are for three to four years. Competitive renewal awards are allowable for awardees who have obtained a tenure track position and additional mentored support can be for up to three years. Awards are not transferable from one Principal Investigator to another.

2. Funds Available

The total amount to be awarded and the number of awards will depend on the quality and merit of the applications received and the availability of funds. Because the nature and scope of the proposed research career development program will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Awards include funds for salary, fringe benefits and travel, and research development costs.

Allowable Costs:

Salary: The IRSDA will provide direct costs for salary for the Principal Investigator up to $75,000 (based on the established salary scale at his/her institution) plus applicable fringe benefits. The total salary requested must be based on a full time, 12-month staff appointment. Applications must be submitted on behalf of the candidate by the U.S. mentor's institution, which must be a U.S. research institution. The candidate must have a full-time appointment at a domestic research institution, and, while in most cases the applicant will be at the same U.S. institution as his/her mentor, s/he need not hold a position at the U.S. mentor's institution.

Research Development Support: In addition to the candidate’s salary and fringe benefits, an additional $20,000 per year may be requested for travel and research development support each year for up to four years. All expenses must be directly related to the proposed research career development program. These funds may be used for expenses such as: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; (c) language training; (d) statistical and computational services, including personnel and computer time; and (e) in-country travel required for research, research meetings or training (round trip economy class airfare on a U.S. carrier and necessary ground transportation for the candidate’s travel to and from the foreign site over the duration of the project and roundtrip economy airfare for each dependent accompanying the candidate for four months or more abroad).

Competitive Renewal: Current IRSDA grantees who have obtained a tenure-track position at a domestic institution (or a developing country institution with prior approval from the IRSDA FIC program official) may submit a competitive renewal application at the same direct cost level described above in the case of an appointment at assistant professor level. In the event that the candidate is at the associate professor level, he/she can request a salary of up to $100,000 per year for three years.

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

Facilities and administrative (F & A) costs: F&A costs of eight percent of modified total direct costs should be used for IRSDA applications.

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:

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

Foreign Institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities 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 support.

FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups. Where appropriate, the design of projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

To be eligible for the award, the applicant must:

1. Be a U.S. citizen, a non-citizen national or a permanent resident in possession of an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Non-citizen nationals are usually born in areas that are not states but are under U.S. sovereignty, jurisdiction or administration. Individuals on temporary or student visas are not eligible.

2. Have earned a doctoral, dental or medical degree or the equivalent in a health, social or behavioral science field within seven years of the application receipt date, except as noted below. Exceptions must be approved by the FIC Program Officer.

o Time spent in clinical or other related training that is not research (such as policy training), or time spent obtaining another degree (e.g., M.P.H.), does not count toward the seven-year limit.

o Candidates who are more than seven years beyond the eligible degree, but who have interrupted their careers because of illness or family commitments, may also apply. They must clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific re-entry.

3. Have demonstrated a commitment and competence in health and health-related research, as well as the potential to engage in independent and productive biomedical, social, behavioral or epidemiological/clinical research in the period following the award.

4. Have mentors in the United States and in the eligible developing country where the proposed research will be performed who are committed to both the research and career development/training requirements of the candidate.

5. Submit a research plan related to, but not overlapping with, the collaborative research project of the U.S. and foreign site mentors.

Applicants awarded an initial competitive IRSDA grant agree to spend a minimum of 50 percent of the period of the grant at the foreign research site, with at least three months per year at the site. Applicants who already have a faculty position need a letter of support from their institution that shows they will be released from clinical and teaching duties to conduct research at the foreign site for the required minimum time.

Current IRSDA grantees who have obtained a tenure-track position at a domestic institution may submit a competitive renewal mentored career development application. Applicants awarded a competitive renewal grant agree to spend a minimum of one year of total time at the foreign site and a minimum of three months per year at the foreign site.

2. Cost Sharing or Matching

Cost sharing is not required.

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 U.S. mentor must be at a U.S. institution of higher learning or non-profit research institution.
• The developing country mentor must be in an internationally-recognized developing country research institution addressing one or more of that country's major health problems. Eligible countries include those in the following regions: Africa, Asia (except Japan, Singapore, South Korea and Taiwan), Russia and countries of the Former Soviet Union, Central and Eastern Europe, Latin America and the Caribbean, the Middle East (except Israel) and the Pacific Ocean Islands (except Australia and New Zealand). Applications for work in institutions in sub-Saharan Africa are especially encouraged. Awards may be delayed or denied by any State Department restrictions in effect at the time of award.
• The two mentors for the IRSDA applicant must have a recent or on-going collaboration on a relevant research program or project. An enhancing factor for consideration is a funded collaboration between the mentors. Funding may include, but is not limited to, sources such as NIH R01 grants with a foreign component, Fogarty International Research Collaboration Awards, World Health Organization grants, Burroughs-Wellcome Foundation grants or other U.S. or international agency funding.
• U.S. and foreign mentor statements must be included in the application and provide information from the U.S. and foreign mentors about their research collaboration, their research qualifications and previous experience, and their record in supervising research training (number of Ph.D. and post-docs mentored and their current career status). Both the U.S. and foreign mentors should submit Biographical Sketches, Other Support and Resources Forms. The application must also include a detailed plan for the supervision of the Fellow, by both mentors, at each institution, during the proposed award period.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: 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.

Supplementary Instructions for Career Development Awards are located in the PHS 398, Section III..

The application must:

• Establish the candidate's commitment to a career in international biomedical, clinical, social or behavioral research addressing a major global health problem.
• Establish the candidate's potential to develop into a successful independent investigator.
• Summarize the candidate's immediate and long-term career objectives, explaining how the award will contribute to their attainment.
• Provide a career development plan. The plan should incorporate a detailed description of Ph.D. and other previous research experiences, as well as an explanation of long-term career goals of the applicant and the role of this award in achieving them, including intentions to establish future foreign collaborations. It should delineate a systematic approach to achieving the necessary basic biomedical, social or behavioral science background and research experience to launch an independent international research career addressing a major global health problem.
• Provide a research plan using form PHS 398 and the use of a sound research approach to a biomedical, social or behavioral problem including the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods sections. It should include an annual schedule of planned research activities at the U.S. and foreign sites during that period. The research plan should serve as a justification for conducting research abroad and provide a clear description of the relationship between the proposed research and current research efforts at U.S. and foreign labs.
• For renewal mentored career development applications, the research plan must describe progress made under the original K01 and how the research proposed in the renewal continues or extends the original research.

Support Letters

• For the original K01 application, three sealed letters of recommendation from senior research scientists, addressing the candidate's potential for an international research career, must be included as part of the application. One of the three letters should be from the applicant's thesis advisor, research supervisor, chief of staff or department head. Letters of recommendation should not be submitted from either the U.S. or foreign mentor.
• For renewal mentored career development applications, a letter from the applicant's U.S. institution must be submitted indicating commitment to provide the candidate with the necessary support and time, free from clinical and teaching duties, to continue the international work proposed in the application.

Training in Responsible Conduct of Research

• Candidates must describe evidence of previous training, or plans to receive instruction, in the responsible conduct of research in an international context. The topics, format, frequency and duration of instruction, as well as the amount and nature of faculty participation, should be detailed. No award will be made if an application lacks this component.

U.S. and Foreign Institutional Commitments

• The extent and quality of the research environment, relevant to the candidate's research focus, should be described for the U.S. and foreign institutions. The research environment includes faculty and staff capable of productive collaboration with the candidate, seminars and opportunities for interactions with other research groups and scientists and available research facilities and equipment.
• A detailed description of overall research funding at the foreign institution (government, non-government and international sources), specific for the proposed research area, should be included to support its status as an existing or potential center of research excellence.

Budget

• Budget requests must be provided according to instructions in form PHS 398 (rev. 9/2004, Interim revision 4/2006)

Concurrent Applications

• A candidate for the K01 award may not have pending nor concurrently apply for any other career development award.

Subsequent Applications for NIH Research Support

• After receiving the K01 award, incumbents are encouraged to apply for independent research support (e.g., R01, etc.). K01 recipients who are successful in obtaining NIH research grant support may receive salary support from the research grant under the policy described in NOT-OD-04-007.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): December 15, 2006; December 14, 2007, December 16, 2008
Application Receipt Date(s): January 16, 2007; January 16, 2008; January 16, 2009
Peer Review Date(s): June/July 2007; June/July 2008; June/July 2009
Council Review Date(s): September 2007; September 2008; September 2009
Earliest Anticipated Start Date(s): October 2007; October 2008; October 2009

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

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

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

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

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

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

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

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Plan for Sharing Research Data

Not applicable

Sharing Research Resources

Not applicable

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the FIC.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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 FIC Advisory Board.

The following will be considered in making funding decisions:

• Scientific, technical and educational merit of the proposed project as determined by peer review
• Availability of funds
• Likelihood that the proposal will contribute to the achievement of FIC’s objectives.

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.

Candidate:

• Commitment to an independent international research career including potential to contribute to knowledge that will address a major global health problem;
• Potential to develop (or evidence of the capacity to develop) as an independent investigator pursuing international research;
• Quality and relevance of prior scientific training and experience, including detailed description of previous research, record of previous research support and publications.

Career Development Plan:

• Likelihood that the research and training in the plan will contribute substantially to the scientific development of the candidate, the achievement of scientific independence and ongoing involvement in collaborative international research;
• Appropriateness of the plan to the career goals of the candidate;
• Appropriateness of the plan to increase conceptual and theoretical knowledge in the research area proposed;
• Consistency of the plan with the candidate's prior training, research and academic experience, and the stated career goals;
• Clarity of the goals, scope of the plan and the need for the proposed research and training experience at the foreign site;
• Adequacy of the proposed training for responsible conduct of research in an international context;
• Clear description of the roles of the U.S. and foreign mentors in the training and research planned.

Research Plan:

• Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan;
• Scientific and technical merit of the research question, design and methodology judged in the context of the candidate's previous training and experience;
• Relevance of the proposed research to a major global health problem;
• Relevance of the proposed research to the candidate's career objectives.

Training in the Responsible Conduct of Research:

• Quality and appropriateness of the proposed training in the responsible conduct of research.

U.S. and Foreign Mentors:

• Appropriateness of U.S. and foreign mentors' collaborative research and their other research and training qualifications for the proposed project;
• The extent of the commitment of each mentor to supervising and guiding the candidate throughout the award period;
• Adequacy of each mentor's previous experience in fostering the development of independent researchers, highlighting persons involved in international research;
• Adequacy of each mentor's research productivity and grant support related to the proposed project.

U.S. and Foreign Institutional Environment and Commitment:

• Adequacy of the research facilities at the U.S. and foreign institutions;
• Adequacy of the training opportunities and quality of the environment for scientific and professional development at the U.S. and foreign institutions;

If applying for a K01 award renewal, the adequacy of:

• Soundness of the rationale for an extended mentored career development award rather than a research grant (R01, etc.) award;
• Candidate;
• Career Development Plan;
• Research Plan;
• Training in the Responsible Conduct of Research;
• Mentoring plan; and
• Institutional Environment and Commitment:

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 career development plan. 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 PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following related administrative policies apply to NIH Research Career Award ( K ) programs:

A. Evaluation:

In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income:

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

• The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
• The funds may be used for health-related research purposes.
• The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH awarding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.)

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K01 award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

D. Changes in Research or Career Development Program:

(http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm)

Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

E. Change of Institution or Termination

Consultation with the applicable NIH program staff is strongly encouraged when either termination or a change of institution is being considered. See (http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm).

A change of grantee request normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the grantee is moving to another eligible institution, career award support may be continued provided:

• A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NIH awarding institute.
• The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new sponsor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
• All conditions of the award are met at the new institution.
• The period of support requested is no more than the time remaining within the existing award

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

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.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the2590 instructions. Evaluation of the awardee's progress will encompass the following:

• A demonstration of scientific progress toward the aims of the research as described in a brief summary of the studies and results obtained during the prior funding period;
• A description of career development and research-related activities undertaken during the prior funding period.
• A list of accomplishments such as publications, scientific presentation, new collaborations, inventions, or project- generated resources made during the prior funding period;
• A brief explanation of plans to address the specific aims during the next year of support;
• A description of proposed career development and research-related activities for the next year of support with a clear indication of percent effort devoted to research/research training and other activities.
• An annual evaluation statement of the candidate's progress, as required in the PHS 2590 continuation application instructions (item J. Sponsor's Report).

Final Reports: A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 402-0779
Email: sinab@mail.nih.gov

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, MSC 7840, Room 5136
Bethesda, MD 20892-7840 (Courier: 20817)
Telephone: (301) 435-1021
Fax: (301) 480-3567
Email: duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
Email: butrumb@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 287b) 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

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