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 Eye Institute (NEI) (http://www.nei.nih.gov)

Title: The NEI Mentored Clinical Scientist Development Program Award (K12)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of  PAR-09-083.

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

Program Announcement (PA) Number: PAR-10-166

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.867

Key Dates
Release/Posted Date:
April 13, 2010
Opening Date; May 3, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):  Not applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization)
Application Due Date(s):June 3, 2010, and May 13, 2011  
Peer Review Date(s):  Oct/Nov 2010, and 2011
Earliest Anticipated Start Date(s):  April 2011, and 2012
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date:  May 14, 2011

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The goal of this Funding Opportunity Announcement is to support the development of a diverse pool of highly trained clinician scientists and patient oriented investigators in adequate numbers and in appropriate research areas to address the Nation's biomedical, behavioral, and clinical research needs in vision research.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Institutional Research Career Development Program Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting 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 
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


Institutional Career Development Program Objectives

Purpose:  The NEI Mentored Clinician Scientist Development Award (K12) is an award to an educational institution or professional organization to facilitate and support career development experiences which lead clinician scientists to research independence.  It is expected that scholars appointed to the program will subsequently apply for their own individual research support.

Program Objectives:  The program should be designed to accommodate candidates with varying levels of research experience who require an individualized career development program ranging from two to five years.  Applications for this award should propose a structured, phased development plan overseen by a Program Director and a Program Advisory Committee.  A designated period of didactic training should be followed by a period of supervised research experience.  Candidates should be exposed to both research that is typically undertaken with a few investigators and to research approaches that require a multidisciplinary team to address complex research questions as appropriate.  It is expected that at the end of the career development period, appointees will transition successfully into positions as independent investigators.

This award provides five years of potentially renewable support.  The subsequent continuation will depend in part on the progress made by the Scholars in achieving independent research support.  Renewal applications must contain a progress report documenting the accomplishments and current career activities of former Scholars.

Program Components

Career Development Program Plan: Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including strategies and career development activities that will be used to ensure that the objectives of the FOA are met.  Include information about planned courses, curricula, seminars, workshops, or tutorials which will be incorporated into the career development program and mentored research experiences and activities. Institutions with existing K12 or other institutional career development training programs must explain what distinguishes this proposal from the others, how the programs will synergize, if applicable, and make it clear that the faculty, potential scholars, and resources are robust enough to support additional programs.  The description should include planned strategies to be used to ensure that the objectives are met.

Institutional Environment and Commitment to the Program: The sponsoring institution must have well-established research programs and highly qualified faculty mentors and be the site for the institutional -program.  Describe the research infrastructure, facilities, etc., that are available and accessible to this Program. This includes the existence of funded laboratories and research space and activities that will meet and sustain the needs of the Program. Provide information establishing the commitment of the applicant institution, the Project Director/Principal Investigator (PD/PI), the Research Administrator, if any, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, and/or clinical research relevant to the mission of the NEI.  The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PDs/PIs, other faculty and mentors, and the required protected time for scholars (9 person months, equivalent to 75%) selected for the program.

1.  Program Director/Principal Investigator (PD/PI):  The proposed PD/PI should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary career development program relevant to vision research.  The Program Director should also be experienced in the design and management of programs for developing investigators, and should be able to demonstrate a superior record of preparation of scientists for independent research careers (see Section III. 1B).

2.  Program Advisory Committee: A committee with representatives from the appropriate academic and or clinical departments should be established to advise the Program Director and to monitor the progress of participants.  Committee composition, responsibilities, frequency of meetings, and other relevant information should be included in the application.  An annual evaluation of the program by the Program Advisory Committee is recommended.  This on-going evaluation should include an assessment of the curriculum, active mentors, and program staff; general recruitment and retention goals, including a plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women; completion success; and overall outcome.

3.  Mentors: The application should identify mentors capable of guiding the research candidates admitted to the program.  Each candidate appointed in the program must have a primary mentor who is recognized as an accomplished investigator, is actively involved in basic or clinical research, and has a successful record of providing the type of training required under this award.  This Lead Mentor must be committed to continue this involvement throughout the candidate's total period of development under this award.  The Lead Mentor will assist the appointee in developing an individualized career plan based on the candidate's research experience.  For example, a candidate with limited research experience would require a structured, phased developmental program, including a block of time devoted to didactic training followed by a period of mentored research.  Because a critically important aspect of the training should include mentoring in grant writing, and because Scholars are expected to apply for independent grants, the Lead Mentor should also have a strong track record in obtaining NIH funding for research.  If the Lead Mentor’s research funds come primarily from outside the NIH system, Scholars should have a co-mentor with a strong history of NIH support.

4.  Scholar Candidates:  Appointees must hold a clinical doctorate (such as DO, DVM, MD, MD/PhD, OD, or PhD) and must have completed their clinical training (i.e., completed residency/fellowship and are board-eligible).  At least 75% of the candidate's full-time professional effort must be devoted to the program, with the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award.  The recruitment and retention of underrepresented minorities, individuals with disabilities, and women into the program should be a continuing program goal.

5.  Recruitment Plan:  Applicants should include a plan describing selection procedures for recruiting the best possible Scholars. These plans must include recruiting efforts to enhance diversity.

6.  Research Environment/Institutional Commitment:  Beyond the research activities described in the Research Plan, the institution must describe current and future resources that are or will be used to encourage research by junior faculty and facilitate development of their research careers.   It should document equipment, facilities, and resources that will be made available to Scholar candidates (See Resource Format Page in PHS 398).  In addition, for candidates described in the application and for future appointments to the K12 program, the institution must submit the institutional commitment agreement to support the candidate as described in the PHS 398 form, with signatures as described in that section. 

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH K12 Mentored Clinical Scientist Development Program Award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  This FOA uses “just-in-time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format.  Applicants must complete and submit detailed categorical budget requests using the SF24 Research and Related (R&R) Budget Component found in the application package for this FOA.

Institutional career development grant support is renewable. Institutional career development grant support is for new and renewal (formerly “competing continuation”) applications.   It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a renewal (formerly “competing continuation”) application.  Only one resubmission (formerly “revision/amendments”) of a previously reviewed grant application may be submitted.  See NOT-OD-09-003, NOT-OD-09-016.

2. Funds Available

Because the nature and scope of the proposed institutional career development program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NEI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed five years. Although the size of award may vary with the scope of the institutional research career development program proposed, it is expected that applications will stay within the following budgetary guidelines: total direct costs are limited to $1,125.000 per year.

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation.  See NOT-OD-05-004.  

Allowable Costs

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the institutional career development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.  Note that instructions for completing the budget information in the SF 424 (R&R) application, using the Research & Related (R&R) budget, are included in Section IV, “Selecting the Appropriate Budget Component.”

Personnel: Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.  These expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

PD/PI: Salary support for up to 5% effort for the Program Director may be provided.

Scholar Costs: Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in Section B (scholar salaries) and F (other program-related expenses) as appropriate.

Candidates/Scholars: Clinician research candidates may be provided salary support plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank.  It should be noted that the NEI does not impose any salary restriction beyond that imposed legislatively.  The institution may supplement the NEI contribution; however, supplementation may not be from Public Health Service funds.  Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award.  The total salary required must be based on a full-time,12 month staff appointment for at least 75% effort.

Up to $30,000 per candidate may be requested for the following types of expenses:  research supplies, equipment, and technical personnel; tuition, fees, and books related to didactic courses or career development; travel to research meetings or training; and statistical services including personnel and computer time.  These costs must be specifically documented for each proposed candidate and must be specifically and directly related to the candidate's research activities and individualized career development program.  Costs cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees.

Items that may NOT be supported with K12 funds include: Salaries for support of ancillary personnel, i.e. mentors, secretarial, and administrative assistance, etc.

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs (excluding tuition, fees, and equipment).  

NIH Grants Policy: NIH grants policies as described in the NIH Grants Policy Statement.

3. Other - Special Eligibility Criteria

Sponsoring Institution: The sponsoring institution must assure support for the proposed institutional career development program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and relevant resources that can contribute to the planned program. Applicant institutions must also guarantee the required protected time for the scholars selected for support. The application must include a letter explaining the institutional commitment to the proposed institutional research career development program (see Section IV.6, item 14).

Scholars: Individuals to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Appointees must hold a clinical doctorate (such as DO, DVM, MD, MD/PhD, OD, or PhD) and must have completed their clinical training (i.e., completed residency/fellowship and are board-eligible).  At least 75% of the candidate's full-time professional effort must be devoted to the program, with the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award. 

Scholar Citizenship and Residency Requirement: Only U.S. citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program.  Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S.  They are usually persons 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.

Mentors: Mentors will interact closely with the scholar, and should have research expertise and experience in vision research relevant to the proposed career development program. Mentors must be committed to continue their involvement throughout the total period of the scholar’s career development under this award. Describe the eligibility criteria and responsibilities of program mentors.

Each candidate appointed in the program must have a primary mentor who is recognized as an accomplished investigator, is actively involved in basic or clinical research, and has a successful record of providing the type of training required under this award.  This Lead Mentor must be committed to continue this involvement throughout the candidate's total period of development under this award.  The Lead Mentor will assist the appointee in developing an individualized career plan based on the candidate's research experience.  For example, a candidate with limited research experience would require a structured, phased developmental program, including a block of time devoted to didactic training followed by a period of mentored research.  Because a critically important aspect of the training should include mentoring in grant writing, and because Scholars are expected to apply for independent grants, the Lead Mentor should also have a strong track record in obtaining NIH funding for research.  If the Lead Mentor’s research funds come primarily from outside the NIH system, Scholars should have a co-mentor with a strong history of NIH support.

Program Advisory Committee: An advisory committee is encouraged to provide input, guidance, and oversight of the program.   A committee with representatives from the appropriate academic and or clinical departments should be established to advise the Program Director and to monitor the progress of participants.  Committee composition, responsibilities, frequency of meetings, and other relevant information should be included in the application.  An annual evaluation of the program by the Program Advisory Committee is recommended.  This on-going evaluation should include an assessment of the curriculum, active mentors, and program staff; general recruitment and retention goals, including a plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women; completion success; and overall outcome.

Number of Applications: Applicants may submit only one application.

Resubmissions: Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement).Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals: Renewal applications are allowed for this institutional NEI Mentored Clinical Scientist Development Program  research career development (K12) program. 

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Training Program Plan Component (for Institutional Research Career Development Program)
PHS398 Checklist
SF 424 Research & Related Budget (R&R)

Optional Components:
PHS398 Cover Letter

Research and Related Subaward Budget Attachment(s) Form

Evaluation Plan

The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program.  This should include plans to obtain feedback from current and former scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing scholars’ career development and progression, including publications, and subsequent positions.  Evaluation results should be included in future renewal applications and as part of the Final Progress Report.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date:  May 3, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s):   June 3, 2010, May 13, 2011
Peer Review Date(s):  October/Nov 2010, Oct/Nov 2011
Council Review Date(s): January 2011, January 2012
Earliest Anticipated Start Date(s): April 2011, April 2012

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1. Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2. Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3. Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

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

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

 Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this FOA 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS 398 Research Training Program Plan Component Sections

Page limitations of the Research Career Development Program Plan (uploaded using the PHS398 Research Training Program Plan) component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, Supplemental Instructions for the Institutional NRSA Application.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for K12 applications:

Course offerings should be relevant to diverse areas of clinical and patient-oriented vision research and should provide opportunities in more than one discipline (e.g., genetics, neuroscience, biostatistics, psychology, bioethics, and epidemiology).  Particular developmental activities mentioned such as seminars, scientific meetings, training in responsible conduct of research, and presentations should be linked to the overall theme and goals of the program.  Opportunities to learn how to communicate research results and develop coherent research applications that are essential to future success in an independent research career should be provided.  Skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, drug development, etc., are indispensable to a research program and therefore candidates must be provided the opportunity to participate in such activities.

Accordingly the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as:  individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.  The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/sbe/srs/women/start.htm). In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.     Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.     Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

SF424 R&R Cover Component

Project/Performance Site Locations Component

Indicate where the career development program described in the Research and Career Development Plans will be conducted. Include collaborating sites, if appropriate.

Research and Related (R&R) Other Project Information Component

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

Data Sharing Plan: Not Applicable.

Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.  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). See Section VI.3., “Reporting.”

Senior/Key Person Profile(s) Component

The PD/PI: The PD/PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2 which provides information regarding required registration in the eRA Commons.

Key Personnel must include the PD/PI as well as any other key persons,involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to and have key roles in the proposed institutional research career development program.

See Section 4.5 of the Grants.gov Application Guide SF424 (R&R)

Complete the Profile for the PD/PI according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R).

Multiple-Program Directors may be proposed only if the FOA to which you are responding indicated the multiple PD/PIs will be accepted. If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration.  If your application involves Multiple PD/PIs, follow the directions in Section 4.5 to designate the Contact PI and to assign the PD/PI role to other Senior/Key Persons.  Additionally, the application must include a Multi-PD/PI Leadership Plan.

Complete the Profiles for Other Senior/Key Persons according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R)

The PD/PI, applicable faculty and any other individuals whose contributions are critical to the development, management and execution of the Institutional Career Development Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as Senior/Key Persons. These would include the multiple PDs/PIs, if applicable, and other program staff.  Since these efforts are not project related research endeavors, they should not be identified in Other Support information.

Other Personnel: See “R&R Budget Component Research & Related Budget,” Item “B” below.

Budget Component

Institutional Research Career Development Program applications will use the non-modular budget format (Research & Related Budget component) and "Just-in-Time" concepts.  See Sections II and Section IV for budgetary guidance.  Instructions for completing the R&R Budget Component are provided below. Information regarding allowable costs is provided in the specific FOA. The R&R Budget component includes three separate data entry screens (1) Sections A and B; (2) Sections C through E; and (3) Sections F through K.  Applicants must complete a separate detailed budget for each year of support requested.

R&R Budget Component Research & Related Budget: Complete for each budget period requested.

A.    Senior/Key Person: complete for all senior/key persons associated with the institutional career development   program.  The PD/PI must be included here.

B.    Other Personnel: complete for all other personnel (including clerical and program administrative staff) associated with the institutional career development program. Include here the salary costs proposed for the planned scholars, identifying as the Project Role “Scholar”.

C.    Equipment: self-explanatory.

D.    Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the program.

E.    Participant/Trainee Support Costs: Do not complete this budget category (does not apply to K12 programs).

F.    Other Direct Costs: Include the funds requested for research development costs allowed for the scholars in the program, using lines 8-10 (when necessary), and itemize as appropriate and allowed for institutional career development program.

G.    Indirect Costs: Indirect costs are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis of a negotiated rate agreement.

K.    Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section F, itemize each category of support costs per scholar and justify. Provide an explanation for all scholar research and development costs in the Budget Justification.  

Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.

Text attachments should be generated using word processing software and then converted to PDF using PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems for the agency handling the application. In addition, be sure to save files with descriptive file names.

When attaching a PDF document to the actual forms, please note you are attaching an actual document, not just pointing to the location of an externally stored document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised document to the application form. Use the “View Attachment” button to determine if the correct version has been attached.

Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1)     Contact the IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study;

2)     Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and,

3)     Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new, renewal, revision, or resubmission applications. See NOT-OD-02-004.

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Review Process

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NEI and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the initial merit review, all applications:

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.

The NIH K12 grant mechanism is a specialized mechanism designed to foster the development of biomedical, behavioral, and clinical researchers through creative and innovative institutional career development programs.  The NEI Mentored Clinical Scientist Development Program Award (K12) is to facilitate and support the career development of clinical vision scientists who have made a commitment to independent research careers.

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the institutional research career development  program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

Scored Review Criteria: Reviewers will consider each of the five review criteria below in the determination of scientific merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Career Development Program Plan and Environment:

Program Director(s)/Principal Investigator(s) (PD/PIs):

Mentors:

Candidates/Scholars:

Training Record:

Does the training program have a rigorous evaluation plan to assess its quality and effectiveness?  ?

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the program.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.  In addition, the committee will consider the following:

Additional Review Considerations  

As applicable for the program proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds. 

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.  Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

Select Agents Research: Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans:

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Budget and Period of Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed institutional career development program and the number of proposed scholars.  

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates
Not Applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH 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.

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

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 NEI to the grantee business official. 

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The institutional career development program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NEI, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

Leave policies:  In general, appointees may receive salary during the normal periods of vacation and holidays observed by individuals in comparable positions at the grantee institution.  For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and is not considered to be a vacation or holiday.  Appointees may receive salary from annual and sick leave, according to the institution's policy.  Appointees also may receive salaries for up to 30 calendar days of parental leave per year for the adoption or birth of a child when those in comparable positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the PD/PI.

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 of such leave does not exceed three months.  For longer periods, prior written approval of the NEI 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/archive/grants/policy/nihgps_2003/index.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 K12 will continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the prior approval of the NEI and will only be granted in unusual circumstances.  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.

A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken.  Individuals requiring periods of time away from their research career development experience longer than specified here must seek prior approval from the NEI for an unpaid leave of absence.

Termination:  When a grantee institution plans to terminate an award, the NEI 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 thereof, the effective date, and the right to appeal the decision.

Carryover of Unobligated Balances:  The carryover of funds from one budget period to the next requires prior written approval of NEI.  When required, such requests must include compelling justification, including the status of candidates/scholar appointments to the program.

3. Reporting

Complete applications with detailed budgets and progress reports are required annually.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed career development program (including training and education in the responsible conduct of research), any modifications to the career development program as originally proposed, details about the applicant pool and the participating scholars including their career level(s), gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the program, and a list of any publications and/or other materials arising from the program.

This report should provide information about changes in the Program, a summary of any ongoing evaluation results , a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program and to confirm that the institution is continuing to meet its goal of recruiting promising investigators, and facilitating their career development

Examples:

3.A. Additional Reporting Requirements

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The K12 program is not subject to the Streamlined Non-competing Application process (SNAP).  In general, this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report.  The following topics must be addressed:

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period.  Continuation support will not be provided until the required form is submitted and accepted.

Progress of Individual Candidates/Scholars:  Provide a brief paragraph for each selected Scholar describing the research and didactic training experiences completed and ongoing, as well as the specific future plans for satisfying the requirements of the program.  Provide a list of publications for each Scholar resulting from their work in the program.  Provide information on each Scholar’s progression to research independence, including grant applications, and grant awards.

Mentors: Information should be included describing any mentors who have left the program or any who have been added.  For new mentors, biographical sketches should be included in the application. Also include any recommended changes to improve the program for the continuation years.

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, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.  Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.  Evaluation results should be included as part of the Final Progress Report.

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:

Neeraj Agarwal, Ph.D.
Training Director
National Eye Institute   
5635 Fishers Lane, Suite 1300
Rockville, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528    
E-mail: agarwalnee@mail.nih.gov

2. Peer Review Contacts:

Samuel C. Rawlings, Ph.D.
Division of Extramural Research
National Eye Institute 
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 402-0528
Email: rawlings@mail.nih.gov

3. Financial or Grants Management Contacts:

William W. Darby 
Division of Extramural Research
National Eye Institute 
5635 Fishers Lane, Suite 1300, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 402-0528
Email: darbyw@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) 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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

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.

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 SF424 (R&R) application; 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-09-116 .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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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

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


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NIH Funding Opportunities and Notices


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