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 of Nursing Research (NINR), (http://www.ninr.nih.gov/)

Title: Ruth L. Kirschstein National Research Service Award (NRSA) for Individual Predoctoral Fellows (F31) in Nursing Research

Announcement Type
This is a replacement of program announcement PAR-02-019, which was published in the NIH Guide on November 26, 2001. For more information (see, http://grants.nih.gov/grants/guide/pa-files/PAR-02-019.html).

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

Program Announcement (PAR) Number: PAR-05-091

Catalog of Federal Domestic Assistance Number(s)
93.361

Key Dates
Release Date: April 22, 2005
Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details
Letters of Intent Receipt Date(s): Not applicable.
Application Receipt Dates(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Expiration Date: New Date July 3, 2009 (per issuance of PAR-09-227) Original Date: April 4, 2008 - (Changed to January 8, 2010 per NOT-OD-08-069)
(now May 8, 2008 per NOT-OD-07-093)

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

NINR is committed to increasing the number of doctorally-prepared nurses in order to meet the demands for adequately trained behavioral, biological, and biobehavioral scientists. NINR is particularly interested in facilitating the progress of students who are in research training programs for recent nursing graduates and students in BSN to PhD programs.

This grant program will provide predoctoral training support for doctoral students. The applicant must propose a research training program and dissertation research that is consistent with the scientific mission of the NINR. Research topics and skills that will serve as a foundation for an ongoing program of research are of particular interest. The research training experience must enhance the applicant's conceptualization of research problems and research skills, under the guidance and supervision of a committed mentor who is an active and established investigator in the area of the applicant's proposed research. The research training program should be carried out in a research environment that includes appropriate human and technical resources and is demonstrably committed to the research training of the applicant in the program he/she proposes in the application.

The mechanism of support is the Ruth L. Kirschstein National Research Service Award (NRSA) for individual predoctoral fellowship (F31) which is intended to provide biomedical and/or behavioral research training experiences to individuals committed to pursuing a career in research within the scientific mission of the National Institute of Nursing Research.

Individuals encouraged to apply include:

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 and individuals from any racial or ethnic group that can be convincingly demonstrated to be underrepresented by the grantee institution are encouraged to apply.

Individuals with disabilities, which are defined as those with a physical or mental impairment that substantially limits one or more major life activities, but does not impair their capacity to function as an independent investigator are encouraged to apply.

Up to five years of aggregate NRSA support may be provided. Fellowship awardees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the training program.

Awards will be administered under the National Institutes of Health (NIH) Grants Policy Statement, which includes the Kirschstein-NRSA Guidelines for Individual Awards found at http://grants.nih.gov/grants/policy/policy.htm.

Eligible sponsoring institutions include for-profit and non-profit organizations, public or private institutions such as universities, colleges, hospitals, and laboratories that issue doctorate degrees.

Citizenship: By the time of award, candidates for the predoctoral Kirschstein-NRSA fellowship award must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the F31 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.

An F31 may not be held concurrently with another Federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. An individual may not have two or more competing NIH fellowship applications pending review concurrently. In addition, CSR will not accept for review any application that is essentially the same as one already reviewed.

The Kirschstein-NRSA Guidelines for Individual Awards and Institutional Grants is available on the NIH Website at: http://grants.nih.gov/training/nrsa.htm.

Applications may be submitted by any individual with the skills, knowledge, and resources necessary to carry out the proposed research. Application materials are available at http://grants.nih.gov/grants/funding/416/phs416.htm.

Telecommunications services for the hearing-impaired are available at: TTY 301-451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

 Section I. Funding Opportunity Description
   1. Research Objectives

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

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

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

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

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

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

 Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

NINR is committed to increasing the number of doctorally-prepared nurses in order to meet the demands for adequately trained behavioral, biological, and biobehavioral scientists. NINR is particularly interested in facilitating the progress of students who are in research training programs for recent nursing graduates and students in BSN to PhD programs.

This program will provide predoctoral training support for doctoral students. The applicant must propose a research training program and dissertation research that is consistent with the scientific mission of the NINR. Research topics and skills that will serve as a foundation for an ongoing program of research are of particular interest. The research training experience must enhance the applicant's conceptualization of research problems and research skills, under the guidance and supervision of a committed mentor who is an active and established investigator in the area of the applicant's proposed research. The research training program should be carried out in a research environment that includes appropriate human and technical resources and is demonstrably committed to the research training of the applicant in the program he/she proposes in the application.

NIH recognizes the critical importance of training nurse clinicians to become researchers and encourages them to apply. Individuals encouraged to apply include:

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 and individuals from any racial or ethnic group that can be convincingly demonstrated to be underrepresented by the grantee institution are encouraged to apply.

Individuals with disabilities, which are defined as those with a physical or mental impairment that substantially limits one or more major life activities, but does not impair their capacity to function as an independent investigator are encouraged to apply.

An NRSA Award may not be used to support studies leading to the M.D., D.O., D.D.S., D.V.M., PhD-MD, or other similar health-professional degrees. Neither may this award be used to support the clinical years of residency training.

It is critical that all applicants consult the appropriate Program Officer at NINR, prior to submission, to address questions of eligibility. See http://www.ninr.nih.gov/ResearchAndFunding/DEA/OEP/AreasofscienceFile.htm for a list of Program Directors.

Background

Public Health Need

The Congress of the United States enacted the National Research Service Act (NRSA) Program in 1974 to help ensure that highly trained scientists would be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda.

Under this congressional authority, the National Institute of Nursing Research (NINR) awards NRSA Individual Predoctoral Fellowships (F31) to promising nursing applicants enrolled in doctoral programs and with the potential to become productive, independent investigators in the scientific mission areas of NINR. The proposed NRSA training must be within the scope of biobehavioral, behavioral, or biomedical research relevant to the NINR mission and must offer an opportunity for research training.

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 Ruth L. Kirschstein National Research Service Award (NRSA) individual predoctoral fellowship (F31) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 416-1 application instructions (see http://grants.nih.gov/grants/funding/416/phs416.htm). A detailed categorical budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application.

2. Funds Available

Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level, including any combination of support from institutional training grants (T32) and individual fellowship awards (F31). However, it is not possible to have concurrent NRSA support (e.g., F31 and T32) during the same time period. Applicants must consider any prior NRSA predoctoral research training in determining the duration of fellowship support requested. Accurate information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at time of award. Requests for support and recommendations of review committees are generally for two or three years of support for individual fellows conducting dissertation research and training. Training beyond the 5-year aggregate limit may be possible under rare and exceptional circumstances, but a waiver from the NIH awarding component, NINR, is required. Individuals seeking additional Kirschstein-NRSA support beyond the fifth year are strongly advised to consult with relevant NINR staff before preparing a justification. Any waiver will require a detailed justification of the need for additional research training. Waiver requests should be made to program officials at NINR prior to the termination date of the fellowship.

Continuation of the fellowship award for each subsequent year beyond the first award year is based upon evidence of satisfactory progress in a graduate program and the availability of funds.

Because the nature and scope of the proposed research 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 NINR 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.

This NRSA mechanism provides a stipend to predoctoral fellows to apply for the research training experience. The awards are not provided as a condition of employment with either the Federal government or the sponsoring institution. For information on current stipend levels, see the NIH website at http://grants.nih.gov/training/nrsa.htm). The awards are made on the anniversary date of the fellowships to ensure consistency with stipend levels in effect at that time. For fellows sponsored by domestic non-federal institutions, the stipend will be paid through the sponsoring institution.

Tuition, Fees, and Health Insurance. NINR will offset the combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the fellowship. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm.

Institutional Allowance. An institutional allowance of $2,500 per 12-month period will be awarded to non-Federal, non-profit sponsoring institutions to help defray such awardee expenses as research supplies, equipment, travel to scientific meetings, and related items. This allowance is intended to cover training-related expenses for the individual awardee and is not available until the fellow officially activates the award. If the fellow is not enrolled or engaged in training for more than 6 months of the award year, only one-half of that year's allowance may be charged to the grant. The Notice of Research Fellowship Award will be revised, and the balance must be refunded to NINR.

Funds are not available to cover the cost of travel between the fellow's place of residence and a training institution.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

Citizenship. By the time of award, candidates for the predoctoral Kirschstein-NRSA fellowship award must be citizens or non-citizen nationals of the United States, or must have been lawfully admitted to the United States for Permanent Residence (i.e., possess a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Individuals may apply for the F31 in advance of admission to the United States as a Permanent Resident recognizing that no award will be made until legal verification of Permanent Resident status is provided.

Applicants must have a baccalaureate or higher degree in nursing and be enrolled in doctoral programs or have been accepted by and agreed to enroll in such a graduate program in the academic year in which funds are awarded.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Fellowships must be administered in accordance with the current NRSA section of the Grants Policy Statement at http://grants.nih.gov/grants/policy/policy.htm, and any terms and conditions specified on the award notice.

Certification and Reporting Procedures: No application will be accepted without the applicant signing the certification block on the face page of the application. Individuals admitted to the United States as permanent residents must submit notarized evidence of legal admission prior to the award. When support ends, the fellow must submit a Termination Notice (PHS 416-7) to the NIH. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

Inventions and Publications: Fellowships made primarily for educational purposes are exempted from the PHS invention requirements. F31 awards will not contain any provision giving the PHS rights to inventions made by the awardee.

Sponsor: Before submitting a fellowship application, the applicant must identify a sponsoring institution and an individual who will serve as a sponsor (also called mentor) and will guide and supervise the training and research experience. The applicant's sponsor should be an active investigator in the area of the proposed research who will directly supervise the candidate's research. The sponsor must document the availability of research support and facilities for high-quality research training. The applicant must work with his/her sponsor in preparing the application.

As part of the fellowship application process, certification by an authorized official of the degree-granting institution that the R.N. applicant is enrolled in the sponsoring institution's doctoral program is required.

Co-Sponsor: It may be desirable to identify a co-sponsor who brings expertise that will compliment that of the primary sponsor and that provides an essential component to the training experience. The co-sponsor should be an active investigator in the complementary area of the proposed research who will directly supervise the specified component of the candidate's research.

An individual may not have two or more competing NIH fellowship applications pending review concurrently.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 416-1 application instructions are available at http://grants.nih.gov/grants/funding/416/phs416.htm#forms in an interactive format. 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

Individuals must submit the application using the Ruth L. Kirschstein National Research Service Award Individual Fellowship Form (PHS 416-1, rev. 06/02).

Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The DUNS number should be entered on line 12 of the face page of the PHS 416-1 form. For further assistance contact GrantsInfo, telephone (301) 435-0714, email: GrantsInfo@nih.gov.

The title and number of this funding opportunity must be typed on line 3 of the face page of the application form.

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not applicable
Application Receipt Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Dates: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: December 1, 2005

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 416 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and one signed photocopy 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)

At the time of submission, one additional copy of the application must be sent to:

Weiqun Li, M.D.
Scientific Review Officer
National Institute of Nursing Research
National Institutes of Health
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892
Phone: 301-594-5966
Fax: 301-480-8260
E-Mail: wli@mail.nih.gov

3.C. Application Processing

Applications must be submitted on or before the application receipt 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.

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

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

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

5. Funding Restrictions

All 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).

These awards are also subject to the NRSA Policies. There are no payback requirements for predoctoral NRSA support. For more information see: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

Pre-Award Costs are not allowed.

6. Other Submission Requirements

Plan for Sharing Research Data
Not applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/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 any related data sharing plans 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 the NINR on the basis of established PHS referral guidelines.

Applications that are complete and responsive to the PAR will be evaluated for scientific training and research merit by appropriate peer review group convened by NINR in accordance with the review criteria stated below.

Applications receive two sequential levels of review. The first level is an assessment of the merit of the research training by an SRG, composed primarily of non-government scientists selected for their competence in research and research training in a scientific area related to the applications. After the SRG meeting, the Scientific Review Administrator (SRA), a designated Federal official, who coordinates the review of applications for the SRG, prepares a written summary of the review of each application and forwards it to the appropriate NIH Institute. Staff within the assigned funding Institute or Center provides a second level of review.

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Review Criteria:

The F31 individual predoctoral fellowship is a research training award designed to prepare future generations of outstanding scientists for research careers relevant to the NINR scientific and public health mission. Major considerations in the review of each application include the candidate's potential for a productive career, the candidate's need for the proposed training, and the degree to which the research training proposal, the sponsor, and the environment will satisfy those needs. Reviewers are instructed to consider the following factors in evaluating the overall merit of each application:

Applicant:

Research Training Plan:

Research Proposal:

Sponsor:

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (See the criteria included in the section on Federal Citations, below).

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 Inclusion Criteria in the sections on Federal Citations, below).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described on page 21 of the PHS 416-1 fellowship application instructions will be assessed. (see http://grants.nih.gov/grants/forms.htm).

2.B. Additional Review Considerations
Not applicable

2.C. Sharing Research Data
Not applicable

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://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 Grant Fellowship Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

The Notice of Grant Fellowship Award will be sent electronically to the designated institutional business official listed on the face page of the application or may be retrieved by the institution through its NIH eRA Commons account. If the grantee is not email enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form PHS 416-9 annually (http://grants.nih.gov/grants/funding/416-9/phs416-9.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

Potential applicants are STRONGLY ENCOURAGED to consult with one the scientific contact of NINR prior to submitting an application. 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:

David Banks, Ph.D., M.P.H., M.S.S.W., RN
Program Director, Office of Extramural Programs
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 496-9558
Fax: 301-480-8260 
Email: banksd@mail.nih.gov 

2. Peer Review Contacts:

Weiqun Li, M.D.
Scientific Review Officer
National Institute of Nursing Research
National Institutes of Health
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892
Phone: 301-594-5966
Fax: 301-480-8260
E-Mail: wli@mail.nih.gov

3. Financial or Grants Management Contacts:

Lawrence Haller
Grants Management Specialist
Office of Grants/Contract Management
National Institute of Nursing Research, NIH
6701 Democracy Blvd. Rm. 710
One Democracy Plaza
Bethesda, Maryland 20892 (courier use 20817)
Telephone: (301) 402-1878
FAX: (301) 451-5652
E-mail: hallerl@mail.nih.gov

Section VIII. Other Information

Required Federal Citations

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

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

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

Sharing 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.

Public 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 public 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 PAR in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

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

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

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PAR 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 66 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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