Expired PA-06-512: Mentored Clinical Scientist Research Career Development Award (K08)

Department of Health
and Human Services (HHS)

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EXPIRED

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 Institute on Aging (NIA) ( http://www.nia.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/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)(http://www.nibib.nih.gov/)
National Cancer Institute (NCI) (http://www.nci.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov/)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/index.aspx)

Title: Mentored Clinical Scientist Research Career Development Award (K08)

Announcement Type
This is a reissue of PA-00-003 which was previously released October 8, 1999.

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

December 12, 2008 - This PA has been reissued as (PA-09-042).
September 18, 2008 - See Notice (NOT-MH-08-017) NIMH Policy Update for Career Awards.
May 16, 2008 - See Notice (NOT-OD-08-069) Due to the upcoming receipt dates for several FOAs using these mechanisms, their expiration dates are being extended.
March 31, 2008 - See Notice (NOT-AI-08-039) NIAID Eligibility Requirements.
November 23, 2007 - Change in Research Development Support. See Notice NOT-DC-08-002.
September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.
February 1, 2007 - See Notice (NOT-AR-07-001) Effective with the February 12, 2007, application due date, the National Institute of Arthritis and Musculoskeletal and Skin Diseases is modifying its policies on required level of effort and salary for Career Development Awards for Physicians.
September 20, 2006 - See Notice NOT-DA-06-013 NIDA Policy Update Mentored and Career Development (K) Awards.
August 24, 2006 - See Notice NOT-EB-06-007 adding the National Institute for Biomedical Imaging and Bioengineering (NIBIB) as a participating institute.

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: PA-06-512

Catalog of Federal Domestic Assistance Number(s) 93.866; 93.271; 93.855, 93.856; 93.846; 93.286; 93.398; 93.865; 93.173; 93.121; 93.847, 93.848, 93.849; 93.279; 93.113, 93.114, 93.115; 93.361; 93.867; 93.233, 93.837, 93.838, 93.839; 93.281; 93.853; 93.213; 93.389; 93.859

Key Dates
Release Date: August 7, 2006
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(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission Dates(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS for guidance on dates.
Additional Information To Be Available (URL Activation Date): See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm
Expiration Date: January 8, 2009 (per PA-09-042) - Previously: January 8, 2010 (per NOT-OD-08-069) - Previously: September 8, 2009 (per NOT-OD-07-093) - Originally: September 2, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The Mentored Clinical Scientist Research Career Development Award (K08) represents the continuation of a long-standing NIH program that provides support and protected time to individuals with a clinical doctoral degree for an intensive, supervised research career development experience in the fields of biomedical and behavioral research, including translational research. Individuals with a clinical doctoral degree interested in pursuing a career in patient-oriented research should refer to the NIH Mentored Patient-Oriented Research Career Development Award (K23).
An award is for a period of 3 to 5 years and provides support for salary and research-related costs. The amount funded as salary for a career development award varies among the NIH participating Institutes and Centers (ICs). Therefore, the applicant is strongly advised to contact the relevant IC for any distinct guidelines, requirements, and allowable funds (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm).
Applications may be submitted on behalf of the candidate (principal investigator) by any domestic for-profit or non-profit institution/organization, or public or private institution, such as a university, colleges, hospital or laboratory. Foreign institutions are not eligible to apply.
Candidates for K08 award must have a clinical doctoral degree. They must also be U.S. citizens or non-citizen nationals, or must have lawfully been admitted to the U.S. for permanent residence at the time an offer of an award is made. Individuals on temporary visas are not eligible. Candidates must be able to commit at least 75% of full-time professional effort to the career development and research objectives of the application.
Applications must contain a career development plan as well as a research plan. The career development plan must justify the need for the requested period of support, be tailored to the prior research experience and career development needs of the candidate, and be designed to move the candidate from the mentored phase to the independent phase of their research career. The research plan must have intrinsic research importance as well as serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher.
Candidates may be principal investigators of NIH R03 and R21 grants or non-PHS equivalents at the time of application. They may also apply for, and be awarded an NIH investigator-initiated grant or non-PHS equivalent during the project period of a K08 award and retain the K08 award. However, the NIH will not accept any application in response to this Funding Opportunity Announcement (FOA) that is essentially the same as one currently pending initial 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 applications must include an Introduction addressing the previous critique.
Special Note: The participating NIH Institutes and Centers may have distinctive guidelines, requirements, and funding amounts for this announcement in order to accommodate the career needs of researchers working in fields related to their specific research missions. Candidates are therefore strongly encouraged to contact the staff person in the relevant Institute or Center listed in Section VII prior to preparing an application to discuss issues of eligibility and review the specific provisions of this award. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm.
See Section IV. for application submission information.
Telecommunications for the hearing impaired: TTY 301-451-5936

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Career 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. Submission, 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
A. Evaluation
B. Other Income
C. Special Leave
D. Changes in Research or Career Development Program
E. Change of Institution or Termination
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 objective of the Mentored Clinical Scientist Research Career Development Award (K08) is to continue the long standing NIH support of didactic study and mentored research for individuals with clinical doctoral degrees (e.g., M.D., D.D.S., D.M.D., D.O., D.C., O.D., N.D., D.V.M., Pharm.D., or Ph.D. in clinical disciplines). This award provides support and protected time for an intensive, supervised research career development experience in the fields of biomedical or behavioral research, including translational research. For the purpose of this award, translational research is defined as application of basic research discoveries toward the diagnosis, management, and prevention of disease. Clinically trained professionals who are interested in a career in patient-oriented research should apply for the Mentored Patient-Oriented Research Career Development Award (K23). A definition of "patient-oriented" research is provided in the K23 announcement.

The K08 award supports a three, four, or five year period of supervised research experience. The proposed research must have intrinsic research importance as well as serving as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for a well trained independent researcher.

The K08 award may be used by candidates with different levels of prior research training and at different stages in their career development. For example, a candidate with limited experience in a given field of research may use an award to support a career development experience that includes a designated period of didactic training followed by a period of closely supervised research experience. A candidate with previous research experience and training may not require extensive additional didactic preparation, and may use an award to support a career development experience that focuses on an intensive, supervised research experience.

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 K08 award mechanism. The candidate and his/her mentor will be jointly responsible for planning, directing, and executing the proposed project and career development activities.

This funding opportunity uses the just-in-time budget concept. 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). The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs for each year and for the entire proposed period of support and budget justification information.

Applicants may request 3 to 5 years of support. The actual duration of the award will depend upon the number of years of prior research experience and the need for additional experience to achieve independence, and the policy of the awarding Institute or Center (IC). Awards are not renewable and are not transferable from one principal investigator to another.

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.

Because the nature and scope of the proposed K08 award program will vary from application to application and the amounts provided by the participating ICs are not uniform, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs 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.

In order to accommodate the specific career needs of researchers working in fields related to their particular research missions, the participating NIH ICs have distinctive guidelines, requirements, and funding amounts for this announcement. Candidates are therefore strongly encouraged to contact the staff person in the relevant IC listed in Section VII prior to preparing an application to discuss issues of eligibility, level of salary and research support, and other specific provisions of this award. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm.

Allowable Costs

Salary: The component NIH ICs will provide salary and fringe benefits for the K08 award recipient. The total salary requested must be based on a full-time, 12 month staff appointment requiring the candidate to devote a minimum of 75% of full-time professional effort to conducting health-related research. The remaining effort may be devoted to clinical, teaching, or other research pursuits and activities consistent with the objectives of the award. For information regarding NIH policy on determining full-time professional effort for career awards, see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html

The salary must be consistent both with the established salary structure at the institution and 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. Confirmation of salary is required prior to the issuance of an award. Fringe benefits, based on the sponsoring institution’s rate and the percent of effort, are provided in addition to the salary.

The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. 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 PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K08 award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislatively mandated salary cap. See http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-023.html

Effective for all competing research project grant applications, mentored career award recipients in the last two years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent salary support from their career award and a competing NIH research grant if they are recognized as a Principal Investigator or Subproject Director of the research grant. This policy can be found at the following website: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

Research Development Support: NIH Institute and Centers provide varying levels of support per year for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm.

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

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 falls into one of the following categories:

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

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and career development activities is invited to work with his/her mentor and sponsoring institution to develop an application for support. Individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds are always encouraged to apply for NIH support.

Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who possess 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.

Candidates for this award must have a clinical doctoral degree or its equivalent. Such degrees include but are not limited to the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy). Individuals with the Ph.D. or other doctoral degree in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology or rehabilitation are also eligible. Individuals holding the Ph.D. in a non-clinical discipline who are certified to perform clinical duties should contact the appropriate Institute concerning their eligibility for a K08 award.

A candidate must identify a mentor with extensive and appropriate research experience, for the proposed Clinical Scientist Research Career Development Award plan.

Candidates must be able to commit a minimum of 75% of full-time professional effort conducting research career development activities associated with this award. The remaining 25% effort can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the K08 Award, i.e., the candidate’s development into an independent investigator. At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm.

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/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Individuals are eligible for a K08 award if they have been, or currently are the PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the provisions or research goals of an R03 or R21 grant.

Individuals are NOT eligible if they:

have pending an application for any other PHS career award (e.g., K01, K23, or another K08), an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00);
have been or are currently a PI on an NIH research grants (such as R01, R29, P01) or a subproject leader on a Program Project (P01) and Center Grant (P50), or a non-NIH equivalent to these grants/awards.

SPECIAL REQUIREMENTS

Environment: The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to serve as mentors. The candidate, mentor, and institution must describe a research career development program that will maximize the use of this environment.

Mentor(s): The candidate must name a primary sponsor/mentor, who, together with the applicant is responsible for the planning, direction, and execution of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training research scientists. The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. Candidates may also nominate co-mentors as appropriate to the goals of the program. Primary mentors (and if at all possible, co-mentors) should be full-time faculty at the sponsoring institution. If they are not (e.g., off-site mentors or co-mentors), strong justification for the appropriateness of the mentoring relationship must be provided in the application.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms. Applications must have a D &B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

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

Note that new and revised applications responding to this announcement must include at least three sealed letters of reference following the instructions and using the Career Development Award Reference Guidelines Format Page found in Part 1, Section III of the PHS 398 application. These letters must be 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 Submission Date: Not applicable.
Application Submission 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(s): http://grants.nih.gov/grants/funding/submissionschedule.htm

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity. However, applicants are encouraged to contact the scientific/research staff at the relevant awarding component (see Section 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 research grant application forms found in the PHS 398 instructions for preparing a career development award application (see Research Career Development Award Reference Guidelines ). 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 receipt/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.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. (See also Section VI.3. Reporting)

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

Concurrent Awards: Applicant must be aware of the NIH policies associated with other federally sponsored support (see: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).

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.

NIH policy allows NIH mentored career development award recipients in the final two years of their award, to receive salary support from both their K award and an NIH research grant or subproject (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html). The K-award recipient must be the named Principal Investigator on a competing NIH research project grant (R01, R03, R15, R21, R34, etc.), or be the sub-project director on a competing multi-component research or center grant or cooperative agreement (P01, P50, U01, etc.). See the Notice for full details.

Research Development Support: The research development support costs allowed for this program must be justified and be consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Salary for ancillary personnel support, such as mentors, secretarial and administrative assistants is not allowed.

Data and Safety Monitoring: Individual NIH institutes may have specific requirements for data and safety monitoring of clinical trials. Applicants proposing to conduct clinical trials should consult with relevant IC staff (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm).

Pre-Award Costs: 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 K08 award initial budget period of a new 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. Prior approval of the NIH funding component Institute or Center 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 NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

The following information must be included in the application in accordance with the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part 1, Section III).

CANDIDATE

Describe the candidate's commitment to a career in research. Include a description of all of the candidate’s professional responsibilities at the grantee institution and elsewhere and show their relation to the proposed activities on the career award.
Discuss prior training and how it relates to the immediate objectives and long-term career plans of the candidate.
Discuss the candidate’s research efforts to this point in his/her research career, including any publications, prior research interests and experience.
Provide evidence of the candidate’s potential to develop into an independent research investigator.
Include a statement that the candidate will commit at least 75% effort to the mentored clinical scientist development program and related career development activities.

CAREER DEVELOPMENT PLAN

Present a systematic plan that: (1) shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences that will occur during the K08 award period and then to independent investigator status; (2) justifies the need for further career development to become an independent research investigator; (3) includes didactic and research components; and (4) utilizes the relevant research and educational resources of the institution. The didactic and research components must be designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate s career goals. The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline including a publication plan is strongly encouraged. Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidate’s progress through the career development program.
Describe the professional responsibilities/activities including other research projects beyond the minimum required 75% effort commitment to the K08 award. Explain how these responsibilities/activities will help ensure career progression to an independent research investigator.

RESEARCH PLAN

A sound research project that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided. Organize the research plan as indicated in the Form PHS 398, following instructions for the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, and Research Design and Methods. The candidate should consult with the mentor(s) regarding the development of this section.
Training in the Responsible Conduct of Research: Document prior instruction in or propose plans to receive 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. Applications not providing documentation of prior instruction in the responsible conduct of research 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 instruction 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 regarding 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.
Plans for data and safety monitoring must be included in research plans involving Phase I or Phase II clinical trials (see Federal Citations in Section VIII): Generally, this requirement may be satisfied in the submitted application by providing documentation that the sponsoring institution has an approved plan in place and providing a brief description of the key elements of the plan.

MENTOR(S)/CONSULTANT(S)/COLLABORATOR(S)

The candidate must name a primary sponsor (or mentor), who, together with the applicant, is responsible for the planning, direction, monitoring, and execution of the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.
Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a mentoring plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for transitioning the candidate from the mentored phase of their careers to the independent research investigator phase during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and transition towards independence.
Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of personal meetings.
The mentor or department chair must agree and provide a statement in the application documenting that the candidate will be provided at least 75% of the full-time professional effort to devote to research and related activities in order to achieve the research objectives of the award.
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

The sponsoring institution must define and document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K08 award.

In addition, the statement should:

Describe the resources and facilities that will be available to the candidate.
Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
Provide assurances that the candidate will be able to devote a minimum of 75% professional effort to the development of a research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent clinician scientist, e.g. clinic responsibilities, teaching and administration, and/or additional research activities.
Candidates who will be using the resources within a General Clinical Research Center (GCRC) or Clinical and Translational Science Award (CTSA) during the course of the award are requested to include a letter of agreement from either the GCRC or CTSA program director or the principal investigator as part of the application.

LETTERS OF REFERENCE

Include with the application three sealed letters of reference from well-established scientists addressing the above areas and any other evidence that the candidate has a high potential for becoming an independent investigator. The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters. Revised applications must include new letters of reference. All sealed letters of reference should be attached to the face page of the application.

BUDGET FOR ENTIRE PROPOSED PERIOD OF SUPPORT

Allowable costs for the K08 award program are not uniform throughout the participating Institutes and Centers; therefore the salary amounts as well as the research development costs vary. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm.

Follow the application instructions, providing only the total direct costs for each year and the entire proposed period of support. Within the direct cost 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 award 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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.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 and 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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to a Scientific Review Group 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:

May undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Will receive a written critique.
Will receive a second level of review by an appropriate national advisory council or board.

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

Scientific merit and quality of the proposed project as determined by peer review.
Relevance of the proposed career development program, prior training, and commitment of the applicant to becoming an independent research scientist.
Relevance to the IC program priorities.
Availability of funds.

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. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application.

Candidate
Career Development Plan
Research Plan
Training in the Responsible Conduct of Research
Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)
Environment and Institutional Commitment to the Candidate

The application does not have to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority.

CANDIDATE

Potential to develop as an independent and productive researcher;
Quality of the candidate’s academic, clinical, and (if relevant) research record;
Commitment to meeting the program objectives to become an independent investigator in research;
Quality of the letters of reference from three well-established scientists evaluating the candidate’s potential to pursue an independent research career; and
Quality of letters of reference submitted by mentor(s)/co-mentor(s) which will be considered independent of and in addition to the three required reference letters.

CAREER DEVELOPMENT PLAN

Likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence, based on:

Appropriateness of the content, scope, phasing, and duration of the career development plan when considered in the context of prior training/research experience and the stated didactic and research objectives for achieving research independence; and
Plans for monitoring and evaluating the candidate’s research and career development progress.

RESEARCH PLAN

Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Nevertheless, a fundamentally sound research plan must be provided, addressing:

Scientific and technical merit of the research question, design, and methodology;
Relevance of the plan to the candidate’s research career objectives;
Adequacy of the plan for developing/enhancing the candidate’s research skills;
Quality and appropriateness of the prior or proposed training in the responsible conduct of research; and
If appropriate, adequacy of plans for data and safety monitoring of clinical trials.

TRAINING IN THE RESPONSIBLE CONDUCT OF RESEARCH

Quality and appropriateness of the proposed training or instruction in areas related to the responsible conduct of research.

STATEMENTS BY MENTOR/CO-MENTOR(S), CONSULTANT(S), AND COLLABORATOR(S)

Appropriateness of the mentor's research qualifications in the area of the proposed research;
Quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate;
Previous experience in fostering the development of independent investigators;
History of research productivity and peer-reviewed support;
Adequacy of active/pending support for the proposed research project; and
Strength of the mentor’s statement.

ENVIRONMENT AND INSTITUTIONAL COMMITMENT TO THE CANDIDATE

Clear commitment of the sponsoring institution to ensure that a minimum of 75% of the candidate s effort will be devoted directly to the research described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities;
Strength of the institutional commitment to the career development of the candidate;
Adequacy of research facilities and training opportunities, including faculty capable of productive collaboration with the candidate;
Quality and relevance of the environment for scientific and professional development of the candidate; and
Assurance that the institution intends the candidate to be an integral part of its research program.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will 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, adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research career development plan.

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/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131. 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 resources sharing plans with the principal investigator before recommending funding of an application. The final version of the resources sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resources 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 Principal Investigator will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the awarding Institute or Center grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

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

A. Evaluation:

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

B. Other Income:

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

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

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

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

C. Special Leave:

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K08 award will continue during such leave.

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

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

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

D. Changes in Research or Career Development Program:

Consultation with the applicable NIH funding Institute or Center Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered. See

http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_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 or Center. 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 funding Institute or Center program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered. See http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm.

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

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

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

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (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 awarding component 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, the effective date, and the right to appeal the decision.

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). See: 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 the 2590 instructions. Evaluation of the awardee’s progress will encompass the following:

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

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:

Scientific/Research Contacts:

Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm) for information regarding each IC’s scientific/research contact for this K08 program.

2. Peer Review Contacts:

Not applicable

3. Financial or Grants Management Contacts:

Applicants should refer to the NIH Web site (http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_contacts.htm) for information regarding each IC’s grants management contact for this K08 program.

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 (K08) by the participating NIH Institutes and Centers:

(http://grants.nih.gov/archive/grants/guide/contacts/pa-06-512_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/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://publicaccess.nih.gov/

Additional information regarding the submission process can be found in the Public Access Policy Author’s Manual found at: http://publicaccess.nih.gov/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. 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% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices