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
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Career Development Program in the Genetics and Genomics of Lung Diseases (K12)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-HL-07-004

Catalog of Federal Domestic Assistance Number(s)
93.838

Key Dates
Release Date: July 3, 2006
Letters of Intent Receipt Date (s): October 30, 2006
Application Receipt Date(s): November 30, 2006
Peer Review Date(s): May/June 2007
Council Review Date(s): September 2007
Earliest Anticipated Start Date(s): September 30, 2007
Additional Information To Be Available: Go to http://www.nhlbi.nih.gov/funding/inits/hl06006-faq.htm
Expiration Date: December 1, 2006

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

The purpose of this funding opportunity announcement (FOA) is to develop multidisciplinary career development programs in genetics and genomics of lung diseases that will equip new investigators with the knowledge and skills [to elucidate their role in the etiology and pathogenesis of such diseases. Through this program, the NHLBI will support the early career development of researchers who are expected to become independent investigators and assume academic leadership roles in this rapidly evolving field. To accomplish this goal, NHLBI invites any eligible institution with the appropriate established infrastructure and expertise in genetics and genomics to submit an application. Programs supported under this RFA should provide comprehensive, multidisciplinary career development opportunities, which includes training in research methodologies, such as genome variation and genome-wide screening, expression profiling technologies as well as informatics and data analysis, in the area of lung diseases. Programs should include a core curriculum, didactics, and a short-term research project for each Scholar.

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 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

Background:

Lung diseases are genetically complex diseases in which many genes and many environmental factors interact. Identification of gene variants associated with such diseases will greatly facilitate the characterization of the contribution that genes and environment play in the development of pathological conditions like asthma and chronic obstructive lung disease. We recognize that, in the pulmonary community, genetic and genomic approaches are not sufficiently well utilized, and this deficiency has limited pulmonary investigators in taking full advantage of the tools and information that have been generated by the human genome project. We believe that this is due in part to the lack of a critical mass of junior investigators properly trained and interested in applying their knowledge to the diseases of the lung.

This new program will utilize the K12 NIH Institutional Mentored Research Scientist Development Program to give M.D. and Ph.D. scientists, who are already committed to the study of lung diseases and who have completed their M.D. or Ph.D. degree within the last 5 years, opportunities to obtain additional career development and training in the genetic bases and genomic analysis of such diseases. They will accomplish this by being part of interdisciplinary research groups in which several different genetic and genomic techniques are being applied to the study of lung diseases.

We encourage applications that propose, at least in part, a specific lung disease-related research theme where each Scholar/Faculties team would be in charge of a different aspect of the research, such as clinical phenotyping, human sample selection, genotyping and SNPs analysis, expression profile analysis, and the selection and application of the right software for data analysis. This approach to career development would give each scholar an appreciation of the complexity of the issues surrounding a complex lung disease and the need for integration and interaction of the various components.

K12 Institutional Mentored Research Scientist development programs are awards to organizations which include domestic, for-profit and non-profit, public and private institutions, such as universities, colleges, and hospital to support career development experiences for new investigators leading to research independence. Under this award, newly trained investigators are to be selected and appointed to this program by the grantee institution.

Individuals who wish to apply as Principal Investigators (PIs) should be senior funded investigators who are well established in their areas of research and who will recruit and mentor new Scholars. The participating institutions will be encouraged to also develop a formal training curriculum that includes course and hands-on activities.

Research Career Development and Training Objectives

The primary goal of this RFA is to promote comprehensive genetic and genomic research career development activities, including training for senior postdoctoral fellows and junior faculty-level health professionals who want to pursue academic careers in pulmonary medicine. Through this initiative, the National Heart, Lung, and Blood Institute (NHLBI) will support several multidisciplinary career development programs to prepare these individuals for academic research careers in the genetics and genomics of pulmonary diseases.

Research Career Development Objectives

The specific research career development objectives of this RFA, which is focused on the areas of genetics and genomics of lung diseases, are to:

These objectives stem from the fact that, despite very substantial progress made in the area of genetics and genomics in the last 10 years, the lung research community has been lagging behind other organ-focused research communities in the ability to take advantage of the tools and information generated by the human genome project and other related programs that followed it.

It is important to note that the proposed programs are distinct from traditional clinical fellowships or career development programs. Programs funded by this NHLBI initiative require a 1-year multidisciplinary core curriculum and didactics, and 1 year or more of mentored research to foster careers in genetics and genomics of lung diseases.

Through this program, NHLBI will provide awards to organizations that include domestic, for-profit and non-profit, public and private institutions, such as universities, colleges, and hospitals, in order to develop a core curriculum and a didactic component, and provide the participating researchers with an opportunity to conduct a mentored research project. With this award, Scholars should develop the skills, knowledge, and experience to pursue additional grants (e.g., K08, K23, R01), and to become independent investigators and leaders in academic research programs in genetics and genomics of lung diseases. Under the current policy, recipients of K12 support may subsequently apply for NHLBI-supported individual mentored K-series awards (K01, K08, K23) provided that they had no more than 3 years of K-12 support by the time the individual K-series award is issued. The combined total of K12 support plus individual mentored K-series support must not exceed 6 years. Therefore, if an investigator has been supported by a K12 for 3 years, he/she will be able to receive no more than 3 years of mentored individual career award (K01, K08, K23, etc.).

Programs should emphasize the multifaceted nature of the required career development program which includes training.

The Program Director (PD) should draw on the strengths of his/her institution, its faculty, and resources to develop a specialized core curriculum in genetics and genomics of lung diseases. The Program Director, as the scientific and administrative leader of the Program, should obtain guidance from a multi-disciplinary Advisory Committee responsible for program oversight and evaluation.

Faculty with expertise in multiple specialties should serve as Mentors. They should be responsible for:

The core curriculum for the first year should provide:

Didactics and hands-on activities in genetics and genomics should expose Scholars to:

Scholars entering the Program should have completed their M.D. or Ph.D degree within the past 5 years and be interested in applying genetic and genomic techniques to lung diseases. Some individuals may not need to participate in the entire core curriculum or didactics. These Scholars may elect additional career development and training in areas of interest, such as bioinformatics, pharmacogenomics, epidemiologic methods, advanced biostatistics, and proteomics. Applicants are encouraged to submit plans to accommodate these potential Scholars and to individualize their career development and training experiences.

Late in year 1 and early in year 2, Scholars, with guidance and input from both Mentors, should design a research project that can be implemented and the data analyzed in the remaining period of support. Applications that focus mainly on lung cancer will not considered responsive to this RFA.

The applicant institution and affiliated organizations should:

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 NIH Institutional Mentored Research Scientist Development Program (K12) grant award mechanism. 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 http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

The issuing Institute, NHLBI, intends to commit approximately $2,000,000 in FY2007 to fund 5 new grants in response to this RFA.

An applicant may request a project period of up to 5 years and a budget for direct costs up to $370,000 per year.

Although the financial plans of NHLBI 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:

Although foreign institutions are not eligible to apply, foreign collaborators may participate in this program through subcontract(s) with eligible domestic institutions.

Applicant institutions must have established research infrastructures and expertise in genetic and genomics and lung diseases and related disciplines. See Section III.3. Other-Specialty Eligibility Criteria.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and training 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.

The proposed Program Director (i.e., Principal Investigator [PI]) should be a senior faculty member, or director of a research or training center who possesses scientific expertise in genetics/genomics and/or pulmonary diseases, and the leadership and administrative capabilities required to coordinate and supervise a multidisciplinary research and career development program of this scope. Exceptionally qualified associate professors may apply as the Program Director if they meet all other eligibility requirements. Program Directors should have:

The Program Director’s effort devoted to program leadership and administration must be no less than 10 percent.

K12 Scholars must be citizens or non-citizen nationals of the United States (U.S.), or must be lawfully admitted to the U.S. for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-155 or other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the U.S. (i.e., American Samoa and Swains Island). Individuals on temporary visas are not eligible.

At least 75 percent of the Scholar’s full-time professional effort must be devoted to the Program and the remainder devoted to clinical and teaching pursuits consonant with the objectives of the award. The Scholar must not be or have been a Principal Investigator on an R01 or R21 award or on a component project of a Program Project (P01), Center grant (P50, P60, or U54), mentored career development (K-series) grant, or other equivalent research grant award. Candidate Scholars may have had support on a NRSA grant (F or T) or NIH small grant (R03).

2. Cost Sharing or Matching

Cost sharing is not required under this program.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Special Programmatic Requirements

1. Institutional Environment: The applicant institution must show commitment to the Program's goals, and provide assurances that the institution intends the Program and the supported Scholars to be an integral part of its research endeavor. Research facilities as well as career development and training opportunities will be critical parts of the environment. Applicant institutions should provide a guarantee of 75 percent protected time for the Scholars’ participation in Program activities. Applicant institutions should demonstrate commitment to recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds.

An eligible institution may submit only one application in response to this RFA. Multiple applications from different divisions, faculties, centers, etc., at the same institution will be returned without further consideration by the NIH.

Applications focusing on lung cancer are not acceptable under this RFA.

2. Genetic Research Capability and Infrastructure:

The institution must have a strong program in pulmonary research, a well-funded genetic/genomic research base, and the infrastructure and facilities to support genetics/genomics research (for example, a DNA sequencing and microarray facility, biostatistics and bioinformatic expertise, etc.). If other institutions are involved, each must provide written commitments of resources that they will provide to the Program.

3. Advisory Committee:

The Advisory Committee will be a group of scientists from the sponsoring department, and other departments or institutions as appropriate, with interests relevant to the Program's career development and research focus. The committee may use institutional or outside consultants if needed. Plans to include members or consultants from outside institutions should be described in the application, but such individuals should not be named in the application.

4. Mentors: Each Scholar appointed under this K12 award must be supervised by at least two Mentors, including one primary and one or more secondary, from different disciplines relevant to the Scholar’s career goals and research project. The primary mentor should be recognized as an independent investigator (i.e., has R01 or similar funding) who is actively involved in genetics/genomics and/or lung diseases and has a successful track record of mentoring. The Mentors must be committed to continue their involvement with the Scholar for the duration of his/her selection to this Career Development Program. Each Program should have a minimum of four mentors, each devoting a minimum of 5 percent effort. Mentors should be specifically identified in the application. Mentors that are not included in the application must be approved by NHLBI Program Staff before being assigned a Scholar.

In general, to facilitate access and communication with Scholars, Mentors should be members of the faculty of the grantee institution. Proposed exceptions should be well justified.

5. Candidate Scholar Positions:

In addition to the citizenship requirement and effort commitment required (Section III.1.B. scholars should be research fellows, clinical or research instructors, or recently-appointed assistant professors who have completed their M.D. or Ph.D. degrees within the past 5 years.

Under all circumstances, Scholars should commit to a minimum of 2 years of career development in the K12 Program.

6. Allowable Costs:

a. Direct cost cap: Direct costs for a single application may not exceed $370,000 in any year. Facilities and Administrative (F&A) costs will be reimbursed at 8 percent of modified total direct costs. Indirect costs for consortia are not included in the direct cost ceiling.

b. Scholars' Salaries: Scholars will receive salary support of up to $75,000 each year, plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. At least 75% of the Scholar’s full-time professional effort must be devoted to the program and the remainder devoted to clinical and teaching pursuits consonant with the objectives of the award. The K12 award will provide for 2 to 3 years of funding for each Scholar. The institution may supplement the NHLBI contribution; however, supplementation may not be from Federal funds unless specifically authorized by the federal program from which such funds are derived. In no case, may U.S. Public Health Service (PHS) funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary requested must be based on a full-time, 12-month staff appointment.

c. Personnel Costs for Program Director and Program Faculty: Up to 10 percent of the Program Director's salary and fringe benefits may be requested. Program Director’s responsibilities throughout the award include program coordination, leadership, outreach and recruitment of Scholars, curriculum evaluation and revisions, and dissemination of curricula, innovative methods and tools.

Current NIH policy prohibits program faculty from receiving salary as mentors from career development awards, including the K12. However, because of the special features of this RFA initiative, some program faculty must be recruited from outside of the usual community of lung researchers. For these and other relevant program faculties who will be involved in developing, updating, enhancing, evaluating, and revising curricula and innovative teaching methods and tools, up to 5% of program faculty members’ salary and fringes may be requested. Such funding must be in accordance with the formal institutional policy of the sponsoring institution and the faculty’s parent institution.

The costs of travel for the Program Director, active Mentors, and active Scholars to the annual grantees' meeting in Bethesda, MD, should be included in the budget.

d. The Advisory Committee chair and members may be paid a maximum of $5,000 per year to defray costs for their participation in this Program.

e. Research and Development Support: This Program will provide $25,000 per Scholar per year for the following types of expenses: (1) research expenses, such as supplies, equipment and technical personnel; (2) tuition and fees related to career development; and (3) travel to research meetings, training, and NHLBI-sponsored annual grantees' meetings. These costs must be specifically documented for each individual Scholar and must be specifically and directly related to the Scholar’s research activities. These costs may not be used for Program advertising or recruiting.

f. Ancillary Personnel Support: Up to 25 percent effort may be budgeted for an administrative assistant; expenses for this administrative effort must be for actions and responsibilities distinctly associated with this K12 Program.

g. Facilities and Administrative (F&A) Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs.

h. Other Income: Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient, i.e., Scholar. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Scholars may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

i. Funds budgeted in an NHLBI-supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a K12 award, may not be re-budgeted without prior approval of the NHLBI.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo; Telephone: (301) 435-0714, Email: GrantsInfo@nih.gov.

Modified instructions for this particular type of grant application (K12) must be followed and are found in Section IV.2., Content and Form of Application Submission, of this announcement.

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.

The instructions in the Form PHS 398 do not fully apply to the special needs of this K12 grant application. Therefore, please follow the modified instructions below in preparing an application for a Institutional mentored Research Scientist Development Program (K12) in Genetics and Genomics of Lung diseases.

1. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Career Development Program. On Line 2, provide the number of this Request for Applications, RFA-HL-07-004, the RFA title, “Career Development Program in the Genetics and Genomics of Lung Diseases" and check the YES box. The Program Director will be the Principal Investigator (PI) of the grant application.

2. Description/Performance Site(s)/Key personnel (Form Page 2 of PHS 398): Complete as directed in the PHS 398 instructions. Information should be provided for the Program Director, Mentors, and other faculty participating in the Program. The Description should state specifically which pulmonary disease(s) will be the focus of the Program.

3. The application should be organized as per PHS 398 with specific additional information as detailed below (if questions arise when following this format, applicants should refer regularly to those sections of this announcement that delineate “Other-Special Eligibility Criteria” and “Merit Review Criteria”):

Budget for Entire Proposed Period of Support to fully train 6 to 7 Candidate scholars over 5 years. Biographical Sketches in the standard NIH format for the Program Director, Mentors, and other Faculty of, and Consultants to, this Program.

Other Support for the Program Director, Mentors, other Faculty of, and Consultants to, this Program. Any changes in Other Support will be requested just prior to award.

Career Development Program in the Genetic and Genomics of Chronic Lung Diseases (not to exceed 40 pages):

(1) Overall Aims

(2) Major Program Elements

(3) Candidate Scholar Pool and Recruitment Plans

(4) Evaluation and Tracking

(5) Planning Phase and Milestones

(6) Participation in NHLBI Activities for Grantees

Appendices and Tables: Suggested tabular formats for this information can be discussed with the Program office (see Section VII.1., Scientific/Research Contacts). The following information should be included:

1. Funded Training and Career Development Programs and Investigator Initiated Research Projects Relevant to This Program (Pulmonary Research, Genetics/Genomics). This section should include all programs within the institution that are relevant to the purpose and objectives of the Program (e.g., R01s, K01s, K08s, K23s, K24s, R25s, T15s, T32s, T35s, SCCORs, Degree Programs, etc.). The table should be organized using the following headings: Principal Investigator, Source of Support (e.g., institutional, NIH, other Federal, non-Federal, industry), Project/Program Title, Pulmonary Disease Focus [if applicable], Number of Scholars, and Description (no more than two sentences).

2. Infrastructure and facilities available to the Scholars.

3. Expertise and Training Track Records of Program Director, Mentors, and Other Faculty. This section should include name, rank, department/division, area of expertise, and other relevant information. For each person, please include a list of mentored Scholars within the past 10 years (name, degree, research project, current position, and current research area).

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review, and Anticipated Start Dates

Letters of Intent Receipt(s): October 30, 2006
Application Receipt Date(s): November 30, 2006
Peer Review Date(s): May/June 2007
Council Review Date(s): September 2007
Earliest Anticipated Start Date(s): September 30, 2007

3.A.1. Letter of Intent

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

The letter of intent is not binding, and does not enter into the review of a subsequent application. The information that it contains allows NHLBI 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:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge Building, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (for U.S. Postal Service express or regular mail)
Bethesda. MD 20817 (for express/courier delivery; non-USPS service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
E-mail: nhlbichiefreviewbranch@nhlbi.nih.gov


3.B. Sending an Application to the NIH

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

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

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Rockledge Building, Room 7214, MSC 7924
Bethesda, MD 20892-7924 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
E-mail: nhlbichiefreviewbranch@nhlbi.nih.gov


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

3.C. Application Processing


Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by staff at NHLBI. Incomplete and non-responsive applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Project Director/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 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 award.

The incurrence of pre-award costs in anticipation of a 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 the NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

Scholars selected for this K12 award must receive support for 2 years, but may not receive support for more than 3 years. Applicants/grantees cannot receive more than 6 years of combined K12/ Individual Mentored Career Development Award (K01, K08, K23, K25, K99).

NIH support beyond the initial 5-year project period is not guaranteed and is dependent upon a later decision to issue another RFA, the availability of appropriated funds, and success in any competition for renewed support. In the event that there is no further support, no phase-out funds will be provided. Thus, the applicant institution must have plans in place to provide continued support to remaining scholars in the event that funding from the NIH is not available.

6. Other Submission Requirements

1. Institutional Environment: Applicant institutions should demonstrate their commitment to the Program's goals. Applications should include letters from appropriate institute officials addressing the following issues:

Collaborations/consortia are allowed in order to include a specific expertise not available at the granting institution.

In these cases, applicants should describe how sites will coordinate activities, share resources, communicate and otherwise address logistical issues.

An eligible institution may submit only one application in response to this RFA. Multiple applications from different divisions, faculties, centers, etc., at the same institution will be returned without further consideration by the NIH.

2. Genetics/Genomics Research Capability and Infrastructure: The institution must demonstrate that it has a well-funded research base, the infrastructure to support research in genetics and genomics, lung disease, and access to patient resources. If other institutions are involved, each must provide written commitments of resources that they will provide to the Program.

3. Advisory Committee: A multidisciplinary Advisory Committee of three or four members appointed by the Program Director will be responsible for general oversight and evaluation of the Program. The Chair of the Advisory Committee will be appointed by the Program Director. Members of the Advisory Committee may be faculty from within and outside the institution. Advisory Committee members will be compensated for their Program-related activities (see 14.c. below). Proposed external Advisory Committee members should not be specifically identified in the application, because doing so limits availability of qualified peer reviewers not in conflict. However, the types of expertise expected for the Advisory Committee should be described.

Additional duties that may be assigned to the Advisory Committee, at the discretion of the Program Director, include: reviewing Candidate Scholars’ applications; reviewing the core clinical curriculum; approving Scholars’ education, career development plans, and research projects; providing interim monitoring and evaluation of each Scholar’s progress with recommendations for modifications, if necessary, or termination of a scholar who is not making adequate progress; and establishing criteria for awarding a certificate of completion of the Program.

The Advisory Committee should meet regularly and keep written minutes, which may be reviewed in an NHLBI site visit, and/or as part of competing or non-competing continuation applications. The Advisory Committee will provide the Program Director with a summary annual progress report of the Program's developments, including an evaluation of its strengths and weaknesses.

4. Mentors: Each Scholar appointed under this K12 award must be supervised by at least two Mentors, including one primary and one or more secondary, from different disciplines relevant to the scholar’s research project. The primary mentor should be recognized as an independent investigator (i.e., has R01 or similar funding) who is actively involved in genetic/genomic research and has a successful track record of mentoring. The Mentors must be committed to continue their involvement with the Scholar for the duration of his/her selection to this Career Development Program. Each Program should have a minimum of four mentors, each devoting no less then 5 percent effort. Mentors should be specifically identified in the application. In general, to facilitate access and communication with Scholars, Mentors should be members of the faculty of the grantee institution. Proposed exceptions should be well justified.

5. Candidate Scholar Positions:

Applicants should propose to provide career development and training for six to seven Scholars over the 5 years of support. No more than three scholars may be supported each year.

Scholars must commit to a minimum of 2 years of training, and may be supported for a maximum of 3 years.

The final selection of Scholars will be made by the Program Director and/or the Advisory Committee. To be certain that individuals meet eligibility requirements, Program Directors will be required to submit Candidate Scholars’ biosketches/CVs and supporting documentation to the NHLBI Program Official after approval by the Advisory Committee, and before Scholars’ admission to the Program.

6. Didactic Research Curriculum: While participating in the Program, preferably in the first and second years, each Scholar should receive didactic instruction in research design and methods, biostatistics, bioethics, responsible conduct of research, manuscript preparation, and grantsmanship.

The curriculum can be individualized, depending upon the level of experience of the Scholar. For example, Scholars who can demonstrate mastery or who have a doctorate in a specific area (e.g., biostatistics) may be exempted from that aspect of the research curriculum. Course work may be obtained through affiliated schools of public health or other educational institutions or sources. Programs, in addition, should propose regularly scheduled career development opportunities such as journal clubs, seminars, grand rounds, and other forums. Scholars should be encouraged and funded to attend national scientific meetings and present their research.

7. Mentored Research Project: The mentored research project, designed by the Scholar, should be completed within the second or third year, and allow sufficient time for analyzing data, writing a manuscript, and planning additional research suitable for a K08, K23, R01, or similar grant application. This short-term research project should be reviewed by the Program Director and Advisory Committee. This project should provide a suitable experience for the Scholar to generate preliminary data, present preliminary results, and develop an independent grant application.

8. Recruitment Plan: Applicants must submit a recruitment plan that includes strategies for: recruiting Scholars from both outside and inside their institution(s); and recruiting Scholars from under-served and under-represented racial and ethnic groups, individuals with disabilities and individuals from disadvantaged backgrounds. Programs are encouraged to collaborate with minority-serving institutions.

9. Evaluation and Tracking Plan: The applicant should describe a strong evaluation and tracking plan that will determine effectiveness of all aspects of the Program (including courses, Mentors, Advisory Committee members, Program Director), and a system for tracking graduates throughout their career to determine the success rate of applying for and obtaining federal and nonfederal research grant support. Tracking should include Scholar selection information (diversity of backgrounds, disciplines and specialties) and outcome measures (academic placement, clinical vs. basic science research).

10. Participation in the NHLBI Program: Programs will be expected to interact with the other NHLBI Career Development Programs in the Genetic and Genomics of Lung Diseases funded by the NHLBI Division of Lung Disease. NHLBI will host a grantees' meeting in Bethesda, MD, within the first few months after awards are made and annually thereafter. Program Directors, Scholars, and Mentors will be invited to attend for the purposes of sharing information and making midcourse corrections that will improve Programs. Travel for these meetings should be budgeted. NHLBI Program Staff may conduct periodic site visits to review each site's progress in meeting its overall goals.

11. Training in the Responsible Conduct of Research: Every Scholar supported in this K12 award must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see http://grants.nih.gov/grants/guide/notice-files/not92-236.html.) Applications must include a description of a program to provide formal or informal instruction in scientific integrity and ethical principles in research.

Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the Scholars appointed to the program.

Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will not be reviewed.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Applications should include a statement that curricula, innovative teaching methods and tools will be shared by dissemination at national meetings, through publications, and/or Web sites.

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review, and responsiveness by the NHLBI. Incomplete and/or non-responsive applications will not be reviewed.

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

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

The goal of this Career Development Program is to increase the number of highly trained genetic/genomics researchers and assure their availability in adequate numbers and in appropriate research areas to forward our knowledge in the genetic bases of lung diseases. 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 this goal. 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 program address an important need? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field?

Approach: Are the career development and research training framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Is the overall Program strategy adequate to satisfy the intent of this initiative to develop and sustain a high-quality career development program in genetics and genomics of lung diseases? Does the Program provide comprehensive career development and research training in the design and conduct of genetics and genomics of lung diseases? Will Scholars acquire the appropriate skills? Does the Program take maximum advantage of existing didactic capabilities, clinical infrastructure, and faculty strengths? Does this Program integrate all genetic/genomics resources (faculty, clinical departments, centers, laboratories, educational opportunities and infrastructure) to enhance Candidate scholars' training?

Innovation: Is the Program original and innovative? For example: Does the Program challenge existing paradigms; address an innovative approach or critical barrier to progress in the field? Does the Program develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

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 Program Director, Mentors, and other researchers? Does the team bring complementary and integrated career development and research training expertise to the project?

Does the Program Director have the necessary research background and administrative qualifications and experience to provide scientific leadership, manage, and coordinate a genetic/genomics career development program of this size and complexity? Has the Program Director committed sufficient time to devote to this Program? Will the Advisory Committee have sufficient and appropriate expertise to oversee this multidisciplinary career development program? Will the Advisory Committee operational procedures provide adequate monitoring and evaluation of the Scholars and the overall Program? Will the process and review criteria for evaluating the Scholar’s clinical research projects meet the high scientific standards of an NIH review? Will the projects comply with all applicable federal rules and regulations?

Are the Mentors who will participate in this Program identified? Do they have the experience, skills, and track records in mentoring necessary to provide Scholars with high-quality research training, and do they broadly represent the disciplines, specialties, and subspecialties necessary to make this Program work effectively? Will the Mentors commit sufficient time to ensure the success of the Program? Are the proposed plans for mentoring likely to nurture development of good research skills and independence on the part of the Scholars?

Candidate Scholars Pool and Recruitment Plans: Does the application indicate an adequate potential pool of Scholars? Does the application adequately describe recruitment procedures, potential sources and numbers of high-quality Scholars, Scholars selection criteria, and retention strategies? Does the Program seek to recruit Scholars from outside the institution? Are there adequate plans to recruit scholars from under-served and underrepresented racial, ethnic, and disadvantaged populations and individuals with disabilities?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed program benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Institutional Commitment: Is the institutional leadership committed to this Program and its goals? Does the institution provide assurances that research facilities and training opportunities will be available to the Program? Are there adequate cooperative arrangements between consortium institutions, if applicable, to ensure that the Program performs effectively as one activity across institutional boundaries? Is there adequate commitment from the institution(s) to protect 75 percent professional effort of each Scholar, and to actively promote each Scholar’s research career? Will there be ample protected time for the Program Director and Mentors?

Research Capability and Infrastructure: Is the overall research, career development and research training environment adequate for conducting multidisciplinary, peer-reviewed research in genetic/genomics of lung diseases? Are the existing infrastructures of the institution(s) and other sources adequate? Are there sufficient plans to improve and complement the existing infrastructure, if needed, e.g., by collaborations with other institutions?

Curriculum: Does the 1-year core curriculum cover essential topics/skills needed for conducting research in genetics/genomics of lung diseases? Are the didactic requirements sufficient to train physicians and doctorally-prepared health professionals to lead, design, and conduct research and work effectively in collaborative multidisciplinary teams? Are these elements timed properly to maximize opportunities for Scholars to apply new skills in their own research? Does the Program have adequate flexibility to accommodate Scholars from different disciplines or with different levels of experience?

Evaluation and Tracking: Are plans adequate for the Advisory Committee and/or other procedures to evaluate the performance of the Program as a whole (e.g., quality of the didactic training, adequacy of the performance of mentors, adequacy of faculty participation), to set benchmarks, and to make changes that improve performance and outcomes? Are plans adequate to track career outcomes of Scholars, including positions held, papers published, grants and awards submitted/obtained, and other relevant information?

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.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant’s plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Following initial peer review, the NHLBI Advisory Council also reviews applications. These advisory groups will consider the assessment of the scientific and educational merit of the career development and research training application as well as the initial review group’s comments on the recruitment of individuals from underrepresented minority groups and the plan for instruction in the responsible conduct of research.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

Applications should include a statement that curricula, innovative teaching methods and tools will be shared by dissemination at national meetings, through publications, and/or Web sites.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

Special Administrative Requirements

1. Special Leave: Leave to another institution of a Scholar, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of NHLBI staff is required. To obtain prior approval, the Scholar must submit a letter to NHLBI Program Staff describing the plan, countersigned by his or her department head and the appropriate institutional official. 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 award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NHLBI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Parental leave will be granted consistent with the policies of the NHLBI and the grantee institution.

2. Termination: When a grantee institution plans to terminate an award, the NHLBI must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination.

3. Change of Institution: The Program cannot be transferred from one institution to another.

4. Change of Program Director: If the Program Director moves to another institution or resigns from the position, support of the award may be continued with NHLBI prior approval, provided:

The current Program Director or the awardee institution has submitted a written request for change of Program Director, countersigned by the appropriate institutional business official, to NHLBI Program Staff describing the reasons for the change. The Biographical Sketch of the proposed new Program Director, including a complete listing of active research grant support and history of mentorship for the past 10 years, is provided. The information in the request establishes that the specific aims of the original peer-reviewed program to be conducted under the direction of the new Program Director will remain unchanged, and that the new Program Director has the appropriate research and administrative expertise to lead the Program.

The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.

5. Changes of Program: Awards are made for a specific Program under the guidance of a particular Program Director. Changes in any of these parameters require prior approval by NHLBI Program Staff. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed Program. The new Program will be evaluated by NHLBI Program Staff to ensure that the Program remains within the scope of the original peer-reviewed Program. If the new Program does not satisfy this requirement, the award could be terminated.

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. Forms are also available at most institutional offices of sponsored research.

The K12 grant, as administered by the NHLBI, is not subject to the Streamlined Noncompeting Application Process (SNAP). In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. This report should provide information about changes in the Program, the evaluation summary of the Advisory Committee, and a description of the research and career progress of each Scholar. These Annual Reports will be closely monitored by NHLBI staff to ensure that the grant is achieving the goals of this Career Development Program in Genetics and Genomics of Lung Diseases.

Special Reporting Requirements

1. Progress Reports: An Annual Progress Report is required. This report should provide information about changes in the Program, a summary report of the evaluation of the Advisory Committee, a description of the efforts to recruit women, racial and ethnic minorities, individuals with disabilities, and individuals from disadvantaged backgrounds (including the results of such recruiting efforts), and the research and career progress of each Scholar. These Annual Progress Reports will be closely monitored by NHLBI staff to ensure that the grant is achieving the goals of the Program.

Since the Form PHS 2590 does not apply easily to the K12 program, adapt the application for continuation to contain the following information:

2. Final Reports: A final progress report, invention statement, and Financial Status Report are required upon termination of an award or relinquishment of an award.

3. Evaluation: In carrying out its stewardship of human resource-related programs, the NHLBI may request 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.

Section VII. Agency Contacts


We encourage 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:

Sandra Colombini Hatch, M.D.
Lung Biology and Disease Program
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Rockledge ll Suite 10124, MSC 7952
Bethesda, MD 20892-7952 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)
Telephone: (301) 435-0222
Fax: (301) 480-3557
E-mail hatchs@nhlbi.nih.gov

2. Peer Review Contacts:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Rockledge ll Room 7214, MSC 7924
Bethesda, MD 20892-7924 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)
Telephone: (301) 435-0270
Fax: (301) 480-0730
E-mail: nhlbichiefreviewbranch@nhlbi.nih.gov

Roy L. White, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Rockledge ll, Room 7202, MSC 7924
Bethesda, MD 20892-7924 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)
Telephone: (301) 435-0310
Fax: (301) 480-4755
E-mail: rlwhite@mail.nih.gov

3. Financial or Grants Management Contacts:

Mr. Robert Pike
NHLBI Grants Operations Branch
6701 Rockledge Drive, Rockledge II Room 7154, MSC 7926
Bethesda, MD 20892-7926 (for U.S. Postal Service express or regular mail)
Bethesda, MD 20817 (for express/courier delivery; non-USPS service)
Telephone: (301) 435-0166
Fax: (301) 451-5462
E-mail: piker@nhlbi.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); and 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 institutional review board (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 at http://grants.nih.gov/archive/archive/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: (1) 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 (2) 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 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50 percent of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov.


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and Human Services (HHS)
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