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/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)

Title: Career Enhancement Award for Stem Cell Research (K18)

Announcement Type
This is a reissue of PAR-02-069, which was previously released March 1, 2002.

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PAR-06-115

Catalog of Federal Domestic Assistance Number(s)
93.233, 93.837, 93.838, 93.839, 93.271, 93.855, 93.856, 93.847, 93.848, 93.849

Key Dates
Release Date: December 30, 2005
Letters Of Intent Receipt Date(s): Not applicable
Application Receipt Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Additional Information To Be Available (URL Activation Date): Not applicable
Expiration Date: January 3, 2007

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this funding opportunity announcement is to encourage investigators to obtain the training they need to appropriately use stem cells in their research.  The use of stem cells in biomedical research offers the potential for significant advances in the next decades, provided investigators not only understand this potential, but are equipped to take advantage of it.  Human embryonic stem cells (hESC) have only recently become available and most investigators are not prepared to handle, maintain, or properly study hESCs. Likewise, the potential of human adult or cord blood, and even animal, stem cells for understanding, treating, and curing human disease is great.

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

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

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

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description


1. Research Career Objectives

The use of stem cells in biomedical research offers the potential for significant advances in the next decades, provided investigators not only understand this potential, but are equipped to take advantage of it.  Human embryonic stem cells (hESC) have only recently become available and most investigators are not prepared to handle, maintain, or properly study hESCs. Likewise, the potential of human adult or cord blood, and even animal, stem cells for understanding, treating, and curing human disease is great. This Career Enhancement Award is meant to provide the opportunity and necessary protected time for investigators to gain experiences that will enable them to take full advantage of stem cells in their research. Applicants must propose a training program suitable for their level of experience and scientific interests, and seek an environment where the training can occur. All training should be carefully tailored to meet the individual needs of the applicant and should, usually, include a description of a research project involving stem cells. The proposed training may include both didactic as well as laboratory-based instruction in the growth, management, and application of human, or animal, embryonic stem cells or adult stem cells for the broad areas of interest supported by the NIH. These areas, for each participating IC, are listed under INQUIRIES. 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 uses the NIH K18 award mechanism.  As an applicant, the candidate and his/her sponsor will be jointly responsible for planning, directing and executing the proposed project and career development and enhancement activities.

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.

The project period will typically be six months to one year, although up to two years may be appropriate in some situations. Prospective applicants are advised to discuss the length of the training period they are proposing with the appropriate contact listed under "INQUIRIES". Awards are not renewable.

2. Funds Available  

The total amount to be awarded by the participating ICs and the number of awards will depend upon the quality and merit of applications received and the availability of funds.

The total amount awarded under the K18 program and the number of awards will depend upon the number, scientific merit, overall quality, and costs of the applications received, as well as on the funds available at the participating NIH Institutes/Centers.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Allowable Costs:

Salary: All applicants must devote a minimum of 50 percent effort to the stem cell training and research activities, although a full time commitment for the six to 12 month period of time is encouraged and up to 24 months is allowable. For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The actual salary provided by the award will be based on your full-time, 12-month institutional salary and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award.  For example, in Fiscal Year 2005, the maximum allowable annual salary on an NIH award was $180,100 for a full-time position.  In all cases, the salary requested must be consistent with the level of effort and with the established salary structure at your institution as well as with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.  If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure.  The award will also provide fringe benefits on the calculated base salary at the established institutional rate.

For K18 awards used to support a sabbatical period, the NIH award will take into account concurrent sabbatical salary support provided by the home institution and any other supplemental support.

K18 award applicants may not concurrently apply for any other PHS award that duplicates the provisions of this award.

K18 award recipients may hold independent research support, either Federal or private, concurrently with this award and may derive additional compensation for effort from other Federal sources or awards.  However, the total salary derived from all Federal sources may not exceed the maximum legislated salary rate and the total percent effort cannot exceed 100 percent. 

Research Development Support: Research Development support of up to $50,000 may be requested to pay for the cost of tuition and fees for courses, allowable research expenses, consultant fees for the sponsor, and travel to scientific meetings or to training courses.

Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

Section III. Eligibility information

1. Eligible Applicants

1.A. Eligible Institutions

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

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 research training is invited to work with their institution to develop an application for support.  All applicants for this award must have a clinical or research doctoral degree and be actively engaged in research of interest to the NIH.  Applicants should have completed at least three years of post-doctoral work prior to applying for this K18. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Only U.S. citizens or non-citizen nationals, or an individual lawfully admitted for permanent residence who possesses an Alien Registration Receipt Card (I-151 or I-551), or some other verification of legal admission as a permanent resident prior to the time of award, are eligible for this award.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration.  Individuals on temporary or student visas are not eligible.

As a K18 award applicant, you must be able to devote at least 50 percent effort to your proposed program of didactic and/or research training in stem cell research. You may devote your full time effort to the award, however.

All applicants must identify a stem cell expert with a record of providing the type of supervision required by this award who is willing to sponsor the training experience.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

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

A candidate for an NIH K18 Award may not simultaneously submit or have an application pending for any other PHS career award (e.g., K01, K07, K08, K22, K23) or any PHS or award that duplicates any of the provisions of the K18 award. Current principal investigators on NIH career awards are not eligible.

Candidates for the K18, under some circumstances, may have been principal investigators on NIH research or career development awards, provided the research experience proposed in the K18 application is in a fundamentally new field of study or there has been a significant hiatus in their research career because of family or other personal obligations. Candidates are therefore strongly encouraged to contact the staff person in the relevant IC listed under Section VII prior to preparing an application to discuss issues of eligibility, program relevance, and review the specific provisions of this award.

Special Requirements:

Candidate’s Background: Describe your commitment to a biomedical research career in an area of interest to the NIH, your immediate and long-term career objectives, and how training in the use of stem cells will further those objectives. Provide evidence that you have the capabilities and support to continue your research career and/or provide leadership as a stem cell researcher. You must include three letters of reference with your application from individuals familiar with your research.

Key elements for the award, in addition to information about the applicant candidate, include:

Career Development Activities: You must provide details of your overall plan for developing expertise with stem cell research techniques, tailoring the plan to your own goals, prior experience, and career level as well as to the intent of the K18 award.  Provide details of any coursework to be taken, including any laboratory courses.

Research Plan: As part of your research training experience, you are encouraged to pursue a research project that will make use of stem cells and thus provide practical experience in the required techniques. The research plan must be described as outlined in form PHS 398 including sections on Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods.  You should consult with your sponsor to develop this section because the proposed project should reflect the expertise of the stem cell expert as well as your own interests and research needs.

Training in the Responsible Conduct of Research: Describe your plans for training in the Responsible Conduct or Research or describe training that has already been completed. You must have already completed training in the Responsible Conduct of Research by the time the award begins.  No award will be issued without confirmation of the completion of this requirement, or of confirmation that the intent of the requirement has been met (e.g. you are the person who teaches the Responsible Conduct course at your institution). 

Sponsor’s Statement: Your application must include a statement from the stem cell expert describing his/her research qualifications as well as previous experience as a research mentor.  The sponsor must provide a description of the nature and extent of supervision that will occur during the proposed award period. You should also describe any plans for future, ongoing collaborations with the stem cell expert once the K18 award is completed.

Environment and Institutional Commitment:  Your own institution must agree to your plan to obtain additional research training in the techniques necessary for stem cell research either at another institution or your current location.  Release time from administrative, clinical, teaching, and research duties is critical and must be documented.  In addition, your institution must demonstrate a commitment to the development of a research program related to stem cell research.

The institution "hosting" your stem cell research training must provide assurance that their facilities and the time of the stem cell expert are available to you.  If the “host” institution is not your own institution, the application must include a Resources Format page (PHS 398) in the application.

Biographical Sketches: You must submit Biographical Sketches for yourself, your sponsor, and any other key personnel, following the Biographical Sketch Format page in the PHS 398.

Section IV. Application and Submission Information

1. 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 Grants Info, Telephone (301) 435-0714, 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 Dun and Bradstreet (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.

See also Section VI.2. for additional information.

SUPPLEMENTARY INSTRUCTIONS for Career Development awards are located in the PHS 398, Section III, starting on page 44.

Note that new and revised applications responding to this announcement must include at least three sealed letter of reference following the instructions and using the CDA Reference Guidelines Format Page found in Section III of the PHS 398 application attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

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

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not applicable.
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required for this funding opportunity. However, applicants are encouraged to contact the scientific/research contact at the relevant awarding component (listed in Sec. VII) prior to submitting an application, to discuss issues of eligibility and review the specific provisions of the award.

3. B. Sending an Application to the NIH

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

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

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

3. C. Application Processing

Applications must be submitted on or before the application submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

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

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

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

5. Funding Restrictions

All 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 (See also Section VI.3. Reporting).

Citizenship: Applicants must meet the citizenship requirements as described in the Eligibility section of this announcement prior to award (Section III).

Concurrent Awards: Applicant must be aware of the NIH policies associated with other federally sponsored support.

Salary Support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the applicable department. All applicants must devote a minimum of 50 percent effort to the stem cell training and research activities, although a full time commitment for the six to 12 month period of time is encouraged and up to 24 months is allowable. Confirmation of the actual salary is required prior to the issuance of an award. 

Research Development Support: Research Development support of up to $50,000 may be requested to pay for the cost of tuition and fees for courses, allowable research expenses, consultant fees for the sponsor, and travel to scientific meetings or to training courses. Facilities and Administration costs will be reimbursed at 8% of modified total direct costs to the applicant institution.

6. Other Submission Requirements

Using the Supplemental Instructions in the PHS 398 for Research Career Awards (Instructions, Part III, starting on page 44), the following information must be included in the application.

CANDIDATE

CAREER DEVELOPMENT ACTIVITIES

RESEARCH PLAN

As part of your research training experience, you are encouraged to pursue a research project that will make use of stem cells and thus provide practical experience in the required techniques.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. 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, policies regard the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in or propose plans for instruction in the responsible conduct of research in terms of subject matter and duration of instruction.  An award cannot be made if an application lacks this component.

SPONSOR’S STATEMENT

Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles.  Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

BIOGRAPHICAL SKETCHES

You must submit Biographical Sketches for yourself, your sponsor, and any other key personnel, following the Biographical Sketch Format page in the PHS 398.

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. Within the direct costs limitation for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award. 

Plan for Sharing Research Data
A plan for sharing research data is not required.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria
Not applicable

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

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:

Applications will compete for available funds with all other approved career development award applications. The following will be considered in making funding decisions:

Review Criteria

The goals of NIH-supported career development programs are to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs.  In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed training will have a substantial impact on the pursuit of these goals:

Applicant

Stem Cell Expert (Sponsor)

Research Training Plan

Research Plan

Environment and Institutional Commitment

Training in the Responsible Conduct of Research

Quality of the proposed training in the responsible conduct of research that has been, or will be, completed.

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:  Justification of the requested budget in both time and amount, relevant to your research career goals and interests 

2. C. Sharing Research Data
A data sharing plan is not required.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plan with the principal investigator before recommending funding of an application. The final version of the resource sharing plan negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

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

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

2. Administrative and National Policy Requirements

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

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:

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, is permitted if the leave is directly related to the purpose of the award (e.g. the proposed stem cell research training is to occur at another institution).  You must obtain a letter, countersigned by your department head and the appropriate institutional official, indicating that your institution approves the leave.  A letter from the sponsor and the host institution, where the training is to take place, must be submitted with the application to document that satisfactory arrangements have been made. Your own institution will pay your salary from the K18 award, while you are training at the host institution. 

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:

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:  Note that the instructions for Research Career Development applications must be followed for this program 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 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:

NHLBI supports research in the areas of heart, vascular, and lung diseases, hematological disorders such as bone marrow suppression syndromes, anemias and sickle cell disease, thrombosis and homeostasis, blood resources and transfusion medicine , sleep disorders, organ transplantation, and stem cell research including blood, marrow, and cord blood stem cell transplantation, immune reconstitution, graft vs. host disease, gene therapy, stem cell plasticity, and embryonic stem cell developmental biology. 

Ellen M. Werner, Ph.D.
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, MSC 7950
Bethesda, MD 20892-7950
Telephone: (301) 435-0077
Email: wernere@nhlbi.nih.gov

NIAAA supports research in the areas of the mechanisms of alcohol addiction, alcohol-induced organ and system injury, and fetal alcohol syndrome.

Laurie Foudin, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd., Room 402, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0912
Email: lf29z@nih.gov

NIAID supports research in the areas of immune cell/system development, strategies to alleviate graft vs. host disease and chronic graft rejection, cell and organ transplantation, including beta islet cells for the treatment of type 1 diabetes, immune cell/system reconstitution, including gene therapy approaches, for treatment of HIV-infection and amelioration of drug side effects, and for the treatment or cure of primary immunodeficiencies and autoimmune diseases.           

Milton Hernandez, Ph.D.
National Institute of Allergy and Infectious Diseases
6700 B Rockledge Drive, Room 2133 MSC 7610
Bethesda, MD 20892-7610
Telephone: (301) 496-3775
Email: mh35c@nih.gov

NIDDK supports research in the areas of diabetes, metabolic diseases, endocrinology, gastrointestinal disorders, liver diseases, obesity, nutrition, urologic disorders, kidney diseases, and hematological disorders.

Judith Podskalny, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 667, MSC 5450
Bethesda, MD  20892-5450
Telephone:  (301) 594-8876
Email: jp53s@nih.gov

2. Peer Review Contacts:
Not applicable

3. Financial or Grants Management Contacts:

Marsha Mathis
Grants Operations Branch
National Heart, Lung, and Blood Institute
Rockledge II, Room 7158
6701 Rockledge Drive
Bethesda, MD 20892
Telephone: (301) 435-0170
FAX: (301) 480-3310
Email: mathismd@mail.nih.gov

Section VIII. Other Information

Applicants are strongly encouraged to visit the following NIH Web site to gain a better understanding of the use of this program (K01) by the participating NIH Institutes and Centers: (http://grants.nih.gov/grants/guide/contacts/pa-06-001_contacts.htm).

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.

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/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: 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.

Additional information regarding the NIH Public Access Policy can be found at: http://www.nih.gov/about/publicaccess/index.htm

Additional information regarding the submission process can be found in the Public Access Policy Author's Manual found at: http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm.

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.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: (Be sure to cite any additional appropriate authorizations, regulations or policies below)
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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