Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

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

Title: Coordination Core for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE) (R25)

Announcement Type
Funding Opportunity Announcement

Update: The following updates relating to this announcement have been issued:

• August 14, 2013 - See Notice NOT-HL-13-186. Notice of Intent to Publish a Funding Opportunity Announcement for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE II) - (R25).
• August 9, 2013 - Notice of Intent to Publish a Funding Opportunity Announcement for a Coordination Core for Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE II). See Notice NOT-HL-13-185.
• August 16, 2010 - 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.

Request for Applications (RFA) Number: RFA-HL-10-028

(FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (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)
93.837, 93.838, 93.233

Key Dates
Release/Posted Date: December 14, 2009
Opening Date: January 4, 2010 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): January 5, 2010
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 Submission/Receipt Date(s): February 4, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): September 30, 2010
Additional Information To Be Available Date (Activation Date): http://www.nhlbi.nih.gov/funding/inits/faq-hl-10-019andhl-10-028.htm
Expiration/Closing Date: February 5, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, solicits Research Education (R25) grant applications from institutions/organizations to serve as the Coordination Core (CC) for the Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE). This FOA runs parallel with a separate FOA that solicits the applications for five Summer Institutes (See RFA-HL-10-019). The Institutes are designed to enable faculty and scientists from diverse backgrounds to further develop their research skills and knowledge, enhancing their career development as faculty members or scientists. The primary goal of PRIDE is to encourage scientists and research-oriented faculty from diverse backgrounds to further develop their research skills and gain experience in advanced methods and experimental approaches in basic and applied sciences relevant to heart, lung, blood, and sleep disorders. Ultimately, these enhanced skills will allow them to compete for external funding for scientific research in the biomedical and behavioral sciences. Among other tasks, the CC solicited by this FOA (RFA HL-10-028) will facilitate coordination of education and evaluation activities between and among Summer Institute awardees and the NHLBI and provide support for candidate selection, program-wide organization, and identification and training of mentors. In addition the CC will plan, arrange, and support annual meetings and PD/PI meetings for the program.
• Mechanism of Support. This FOA will use the NIH Research Education (R25) grant mechanism. Research education programs may not be transferred from one institution to another, unless strongly justified (see Section VI.2).
• Funds Available and Anticipated Number of Awards. The NHLBI intends to commit up to $270,000 in total costs in FY2010 to fund one Coordination Core in response to this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. The total project period for an application submitted in response to this FOA may not exceed four years. The total costs for the Coordination Core (CC) are limited to $270,000 in Year 1 and $325,000 in Years 2-4.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry out the proposed research education program are invited to work with their institution/ organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
• Number of PDs/PIs: More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application.
• Number of Applications: Applicants may submit more than one application, provided each application is scientifically distinct.
• Resubmissions. Resubmission applications are not permitted in response to this FOA. Unsuccessful applicants from a previous version of this FOA must submit a new application to this FOA.
• Renewals. Renewal applications are allowed for this research education program.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials: See Section IV.1 for application materials.
  All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the most current forms and instructions.
• General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
  • SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
  • General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
• Hearing Impaired: Telecommunications 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 Education 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 Electronically 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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Education Objectives

This Funding Opportunity Announcement (FOA) issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, solicits Research Education (R25) grant applications from institutions/organizations to serve as the Coordination Core (CC) for the Programs to Increase Diversity Among Individuals Engaged in Health-Related Research (PRIDE). This FOA runs parallel with a separate FOA that solicits the applications for five Summer Institutes (See RFA HL-10-019). The Institutes are designed to enable faculty and scientists from diverse backgrounds to further develop their research skills and knowledge, enhancing their career development as faculty members or scientists. The primary goal of PRIDE is to encourage scientists and research-oriented faculty from diverse backgrounds to further develop their research skills and gain experience in advanced methods and experimental approaches in basic and applied sciences relevant to heart, lung, blood, and sleep (HLBS) disorders. Ultimately, these enhanced skills will allow them to compete for external funding for scientific research in the biomedical and behavioral sciences. Among other tasks, the CC solicited by this FOA (RFA HL-10-028) will facilitate coordination of education and evaluation activities between and among Summer Institute awardees and the NHLBI and provide support for candidate selection, program-wide organization, and identification and training of mentors. In addition the CC will plan, arrange, and support annual meetings and PD/PI meetings for the program.

Background

The National Heart, Lung, and Blood Institute (NHLBI) recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NHLBI expects efforts to diversify the workforce to lead to:

• The recruitment of the most talented researchers from all groups.
• An improvement in the quality of the educational and training environment.
• A balanced perspective in the determination of research priorities.
• An improved capacity to recruit subjects from diverse backgrounds into clinical research protocols.
• An improved capacity to address and eliminate health disparities.

Although the NHLBI currently provides multiple opportunities to develop research careers and to improve participation in research from groups with low representation in the biomedical and behavioral sciences, reports from the National Science Foundation (see http://www.nsf.gov/statistics/wmpd/) and others provide strong evidence that participation of individuals from diverse backgrounds remains an important challenge that the entire research enterprise must actively address.

Program Organization and Coordination

Summer Institutes

Each Summer Institute will provide an intensive mentorship and research skills-enhancing experience in an area relevant to HLBS disorders to promote the mentorship and scientific career development of selected mentees from diverse backgrounds, across a breadth of academic institutions. The goal of the Summer Institute program will be to enhance and develop research careers by providing mentorship and advice on research design appropriate to study questions, skills and methodologies, strategies to prepare research grants, and tips for success in obtaining external funding in research related to applicable disorders.

The specifics of the Summer Institute program will be left to the applicants, but we envision a program consisting of three components (See RFA HL-10-019 for full details):

The first component will be an initial summer session lasting from 10-28 days in duration. The first summer program may be divided into more than one session, and mentees may attend multiple sessions. Training may involve both classroom and laboratory and/or field research activities. The program must also include instruction on unique issues faced by mentees in conducting research and obtaining funding, from an instructor who has been successful in a similar environment(s). Other topics for consideration include sessions on reviewing manuscripts or participating on grant review committees.

The second component will be mentoring and networking activities throughout the following academic year, which is expected to require a minimum commitment of 5% time for both mentees and mentors. It is anticipated that, with the assistance of the Coordination Core, a mentorship committee will be developed for each Summer Institute enrollee. The mentorship committee should be tailored to the research pursuits of the mentee with an array of areas of expertise pertinent to the mentee s career development. This committee should consist of experienced or senior faculty from the mentee’s institution, the Summer Institute, and/or other thought leaders nationally with appropriate expertise. Mentoring could be online, by telephone, and/or in-person. Mentoring activities could include areas such as assistance with career goals, research design and statistical analysis, external funding, and proposal development. At least one mid-year meeting must be held either during intervals between semesters, in conjunction with a conference, on a three-day weekend during the winter, or at another appropriate time and location. At the mid-year meeting, additional mentoring activities will occur, such as identification of appropriate grant mechanism and funding agencies, and/or review and feedback on draft research concepts or applications. Mentoring activities may also include a visit to the laboratory or research site of a mentor during the academic year.

The third component of the program is the second summer session, which may be of a different duration than the first summer session. The second summer session could be held either at one location for all mentors and mentees, or each mentee could attend a summer session at the laboratory of their mentor(s). Activities could include developing and writing a grant application, holding a mock study section meeting, additional coursework on relevant topic areas, and/or focused mentoring.

Each year, Summer Institute awardees may matriculate up to 12 eligible candidates as mentees in their program, called a cohort. Each awardee will hold programs for three cohorts. Program Directors must recruit mentors nationally who are experts in their respective areas and who are exceptional mentors.

Time Line for PRIDE

Summer Institute grantees will develop their program during the last quarter of 2010 and early part of 2011 and implement their program during the summers of 2011, 2012, 2013, and 2014 with appropriate modifications or refinements following each of the first two years.

Year 01: During the first three months of the award (October-December 2010), Summer Institute investigators will plan the training and mentoring program, and initiate the recruitment of mentees. In conjunction with the Institutes, the Coordination Core will develop and implement a plan to outreach for Institute candidates; to coordinate common application procedures; and to establish meeting schedules. During the next four months (January-April 2011), Institute grantees must complete recruitment and select the mentees. The initial Summer Institute for the first cohort of mentees will occur during the summer of 2011.

Year 02: From October 2011-April 2012, the investigators will plan for the second summer, hold a mid-year meeting of the first cohort, and recruit and select the second cohort. During the summer of 2012, the first cohort will return for their second Summer Institute and the second cohort will attend their first Summer Institute.

Year 03: From October 2012-April 2013, the investigators will plan for the third summer, hold a mid-year meeting of the second cohort, and recruit and select the third cohort. During the summer of 2013, the second cohort will return for their second Summer Institute, and the third cohort will attend their first Summer Institute.

Year 04: From October 2013-April 2014, the investigators will plan for the fourth summer, and hold a mid-year meeting of the third cohort. During the summer of 2014, the third cohort will return for their second Summer Institute. During the final two months of the program (August-September 2014), the Program Directors will prepare the final project report.

Coordination Core

The primary goal of the CC is to facilitate coordination of education and evaluation activities among and between awardees and the NHLBI. The CC will be responsible for conducting a number of tasks, including the following:

Outreach

• Develop and coordinate outreach efforts to recruit Summer Institute program candidates.

Mentorship and Networking

• Coordinate the identification, development, conduct and evaluation of each mentee s mentorship committee.
• Develop and conduct training programs for mentors.
• Identify and disseminate information on additional training and networking opportunities for mentees throughout the academic year. For example, applicants may suggest ways that linkages can be made with existing NHLBI programs of research, such as the Jackson Heart Study or Strong Heart Study, and may propose using elements from existing mentoring/networking programs (e.g., the Sarnoff fellowship program) in order to increase applicants' long-term opportunities for learning, networking and funding success.

Meetings

• Summer Institute programs are extended face-to-face meetings. Summer Institute awardees will arrange and budget for travel, lodging, and meals for all mentees from their home institution to the Institute program; necessities of meeting logistics including meeting space; and travel, lodging and meals for mentors. CC applicants should budget for their key personnel to travel to Summer Institute programs as needed.
• In addition to the meeting during the Summer Institute program, Summer Institute Directors and staff, mentees, mentors, the Coordination Core Director, and NHLBI program staff will meet annually in the Washington, D.C. metro area. Coordination Core applicants will be responsible for planning the agenda and handling the logistics of this annual conference. CC applicants should budget for travel for their Director and staff as well as any experts to conduct mentorship and mentee training during the meetings.
• Plan the agenda and handle the logistics of at least one additional in-person meeting of Program Directors and NHLBI staff per year in the Washington, D.C. metro area. CC applicants should budget for their Director to travel to this meeting annually.

Communications

• Coordinate all conference calls, including monthly calls between Summer Institute directors/staff and NHLBI staff.
• Create web-based resources for Summer Institute faculty, mentees, and mentors, including a program-wide website addressing such areas as NIH policies; procedures and application information and materials (e.g., application timelines and templates); web-based courses; and email systems for group communication.
• Facilitate information exchange across the sites and NHLBI.
• Post minutes of the conference calls and in-person meetings on a program website.

Evaluation

• Coordinate an evaluation protocol across the entire program. Each Summer Institute must propose an evaluation protocol. The CC will work to coordinate these protocols across the Institutes for common measures and reporting. The proposed evaluation protocol for the program should include specific detailed plans for evaluation from both the mentees and mentors. The evaluation plan should include plans to assess the effectiveness of the program in terms of the mentees' perceptions of the curriculum and conduct of the program, as well as the longer-term impact, as measured by mentees' success in receipt of external funding from government agencies or private foundations. The desired outcome of the PRIDE program is that each mentee would submit a grant application focusing on a HLBS disorder within 2 years of completing the program. Evaluation must be ongoing to permit evidence-based modification of the program or specific activities of the program (e.g., changing recruitment strategies). Annual evaluation data must be provided with the non-competing continuation application (progress report) and a summary of the final evaluations must be provided to the NHLBI as part of the final report.
• In addition to the evaluation plan described above, the CC applicants should submit an evaluation proposal to track the mentees from the first three cohorts funded via the previous FOA related to this program (http://www.biostat.wustl.edu/sipid/sipid.html) to assess their success in obtaining external funding, in publishing their research in refereed journals, and in career progression. The evaluation plan must describe the organization and operation of a five-year follow-up of the original three cohorts from the original three Summer Institute sites. This evaluation plan must describe how the applicant would subcontract with the previous awardees to provide the resources needed to participate in the follow-up. This evaluation plan should also describe contents of an annual report on new and old mentees.

Applicant institutions are strongly encouraged to apply for both the Summer Institute and CC components of this program. The PD/PI for the CC must not be the same PD/PI for the Institute application, but can be from the same institution. Applicants proposing to perform the functions of a Summer Institute should describe how these activities will be performed in a separate application responsive to RFA HL-10-019.

Please Note: The evaluation of the Summer Institute applications will be separate from the overall review of the scientific merit of the CC applications (see Section IV. 2.B). Institutions may apply for a Summer Institute award, CC, or both. Applicants should include in the budget for the CC the cost of meeting rooms and equipment for in-person meetings. The budget and budget narrative should include the direct and facility and administrative (F&A) costs for the CC component not to exceed the funding levels provided in Section II.2.

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 Research Education Grant (R25) award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed research education program.

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

Research education grant support is renewable. It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a competing renewal (formerly competing continuation ) application. Only one resubmission (formerly revisions/amendments ) of a previously reviewed research education grant application may be submitted. See NOT-OD-09-003 and NOT-OD-09-016.

2. Funds Available

Because the nature and scope of the proposed research education 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 NHLBI 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 NHLBI intends to commit up to $270,000 in total costs in FY2010 to fund one Coordination Core in response to this FOA. The total costs for the Coordination Core (CC) are limited to $270,000 in Year1 and $325,000 in Years 2-4. Facilities and Administrative costs will be reimbursed at 8% of modified total direct costs (exclusive of equipment).

Funds for CC staff to attend the face-to-face meetings must be included in the application. All meeting costs (meeting rooms, refreshments, etc.) for the annual conference and the annual meeting of Program Directors and NHLBI staff must be included in the application.

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

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement is about $270,000 for fiscal year 2010. Awards issued under this FOA are contingent upon both the availability of funds and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution, nor can they be used to circumvent or supplement funds provided to individuals supported by Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Individuals (PD/PIs) designing, directing, and implementing the research education 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 students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

Other Program-Related Expenses: These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget. Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution

Participant Costs: Participants are those individuals who benefit from the proposed research education program. Participant costs must be justified as specifically required for the proposed research education program. Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program. For example, Undergraduate Students are allowed to receive salary and fringe benefits consistent with the institutional salary policies for employees in similar positions. Institutional rates for undergraduate salary should be no more than $10.00 per hour plus fringe benefits, only when such benefits are provided to other employees in similar positions. Graduate students, including health professional students, may receive compensation in accordance with the NIH policy for graduate student compensation (see: NOT-OD-02-017). Amounts for all participants must conform to the established, consistently applied salary and wage policies of the institution and reflect the percentage of time/effort devoted to the program.

Participants in the research education program may receive partial costs of meals unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition, other education-related, and travel expenses.

Expenses for foreign travel must be exceptionally well justified.

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 (exclusive of tuition, fees, and equipment).

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Foreign institutions are not eligible to apply in response to this FOA.

In many cases, it is anticipated that the proposed research education program will complement other ongoing research training occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving NIH support. Moreover, the R25 mechanism is not intended to support long-term training by NRSA-eligible individuals and may not be used to circumvent or supplement Ruth L. Kirschstein NRSA research training mechanisms.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research education program as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the research education program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. The application must have a strong research program in the area(s) proposed for research education and should include a letter explaining the institutional commitment to the proposed research education program.

Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Evaluation Plan: Applications must contain an evaluation plan in order to determine their effectiveness. Applications submitted without an Evaluation Plan section may be delayed in the review process or not reviewed.

Number of Applications: Each PD/PI may submit only one application. An applicant institution may submit more than one application, provided each application is scientifically distinct and has a different PD/PI. In addition, an institution can submit an application for both the Summer Institutes and Coordination Core, but the PD/PI must be different for each component.

Resubmissions: Resubmission applications are not permitted in response to this FOA. Applicants who unsuccessfully applied for a previous version of this FOA must submit a new application.

Renewals: Renewal applications are allowed for this research education 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, go to http://www.grants.gov/applicants/apply_for_grants.jsp 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 application. Several 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:

• Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
• Direct questions regarding the Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
  Email [email protected]

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

• The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.
• Each PD/PI must hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
• When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
• This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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 301-710-0267, Email: [email protected].

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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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 Plan
PHS398 Checklist
SF 424 Research & Related Budget
(See Special Instructions, below, regarding required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs: When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Plan section, Multiple PD/PI Leadership Plan , must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the Research Plan should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the program or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Research Education Program: While the proposed research education program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program. The information should include a description of the education and/or career levels of the planned participants.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements,

A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Application Due, Review and Anticipated Start Dates
Opening Date: January 4, 2010 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): January 5, 2010
Application Due Date(s): February 4, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): September 30, 2010

3.A.1. Letter of Intent

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

• Descriptive title of proposed research education program.
• Name, address, and telephone number of the PD(s)/PI(s).
• Names of other key personnel.
• Participating institutions.
• Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

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 :

• All registrations must be complete prior to the submission deadline
• The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
• Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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:

• Initial application submission must be on-time.
• The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
• Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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.

• If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
• Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process, the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12 of the SF 424 (R&R) application guide, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
• If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
• If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
• Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

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

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.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

Facilities and Environment

All applicants must provide evidence that the institution or institutions in which the coordination will take place have the infrastructure, resources and institutional support needed to achieve the goals outlined above. Applicants must demonstrate the availability of adequate office and other facilities needed to carry out the objectives of the CC. To the extent possible it is desirable for the CC to have a commitment for sufficient contiguous space so that the CC has a high degree of cohesion and visibility. Internet access to scientific literature and other information must be readily available. Relevant support services, including for example adequate data management and analytic support, must also be readily accessible and documented in the proposal.

Coordination Core for the Research Education Program

In lieu of a section in the application on the Proposed Research Education Program, the following items should be addressed satisfactorily by the applicant:

Evidence of Leadership and Performance Experience:

The PD/PI should demonstrate leadership and experience in conducting the following coordinating functions.

• Promoting collaboration across studies/sites and among investigators.
• Providing expert assistance in supporting the development of an evaluation protocol and common evaluation measures.
• Promoting collaboration across studies or sites to promote common constructs and instruments and to standardize procedures, such as application procedures for Institute candidates.
• Establishing partnerships with other institutions/agencies to outreach for potential Institute candidates and mentors for mentorship committees.
• Harnessing the skills of staff with various expertise and work collaboratively in building teams across Institutes.

Capacity and Ability to Manage Data and Communications:

• In their applications, applicants must indicate their capability to utilize electronic technology to meet the goal for coordination of Institutes.
• Applicants should have experience in developing and maintaining data management systems for collection of evaluation data.
• Applicants should propose methods to be employed to facilitate communication between CC staff and investigators as well as with external partners for outreach and mentorship.

Academic and Management Capabilities:

• Evidence of scholarship as PI of a coordinating unit or similar research education collaborative, or evidence of scholarship in mentorship or research education/training.
• Applicants should demonstrate skills as a manager for a CC.
• Evidence of knowledge in HLBS-related research.

Staffing Expertise and Capabilities:

• Applicants must propose an operational structure for coordinating functions at the CC, including lines of responsibility for professional staff at the CC.
• The PD/PI of the CC must have at least 15% effort.

Evidence of Communication Capabilities:

• The CC is responsible for supporting infrastructure for meetings and teleconferences. Applicants should have experience arranging logistical services for multiple sites, such as assuring meetings are held and minutes are recorded and communicated to investigators and NHLBI in a timely manner.

Evidence of Expertise in Evaluation of Education/Training or Research Programs

• The CC is responsible for coordinating the evaluation protocol across the five Summer Institutes. Applicants should have experience developing, conducting and supporting common evaluation measures

Departmental and/or Institutional Commitment:

• Applicants must demonstrate departmental and/or institutional commitment to participate in research education and must provide letters of support from appropriate individuals. Support in areas of secure transfer of data, information technology, equipment, and general support of research education, should be described along with evidence of previous research education support.

All applicants should include specific plans for how the CC will work to coordinate the evaluation protocols across the Institutes for common measures. Applicants should propose metrics and benchmarks appropriate for the CC.

The evaluation protocol can include metrics such as the effectiveness of the didactic portions of the program in terms of the mentees perceptions of the material and conduct of the program, as well as the longer-term impact, as measured by mentee success in receipt of external funding from government agencies or private foundations, in publishing articles in refereed scientific journals, and in tracking career progression. Of the primary metrics for evaluation, submission of a grant application is the primary goal, and publications in scientific journals and career advancement are secondary goals.

Applicants are encouraged to describe special or unique strengths that may be relevant to research education such as that described in RFA HL-10-019.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. The need for and use of multiple sites must be justified.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget. Individuals (PD/PIs) designing, directing, and implementing the research education 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 students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

Applications should contain four budget periods of 12 months each.

Limited program-related 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.

Normally, all personnel costs (including program-related and clerical costs) associated with directing, coordinating, and administering the program are not expected to exceed 50% of the total direct cost over the four years of the program (not including consultant fees associated with mentors outside of the grantee institution).

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged.

A letter of institutional commitment may be attached at line item 16 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

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 Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

• The Research Education Program Plan must be attached using the Research Strategy section (Item 3 of the Research Plan). This section may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
• Research Education Program applications will use the non-modular budget format and "Just-in-Time" concepts. See Sections II.2 and IV.2 for budgetary guidance.

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, October 16, 2001.

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.

2. SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources): Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

3. SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI (or multiple PDs/PIs, if applicable) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.

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

A. Senior/Key Person: complete for all senior/key persons associated with the research education program. The PD/PI (or multiple PDs/PIs, if applicable) must be included here.

B. Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.

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 research education program (e.g. funds for travel to the site of the Summer Institute, to the mid-year meeting as appropriate, to the annual conference; per diem costs; reimbursement for university-provided room and board; and travel for the PD/PI to the Directors meeting in the Washington, D.C. metro area).

E. Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the research education program. If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed research education program. Refer back to Section IV.2 for this information.

F. Other Direct Costs: itemize as appropriate and allowed for the research education program.

K. Budget Justification: provide a detailed justification for each category for which funds are requested. For Section E, itemize each category of support costs per participant and justify.

5. PHS 398 Research Plan Attachments

The Research Education Program Plan (attached using the Research Strategy section) should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program:

Proposed Coordination of Research Education Programs: Applicants may request funds for coordination and evaluation activities as outlined above and to pay experts to participate as consultants to lead mentor and mentee training at annual meetings. Travel funds may be requested for CC investigators, necessary CC staff, and expert consultants leading any training to travel to summer programs and the annual meeting in the Washington, D.C. metro area. Travel funds may also be requested for any CC investigators and necessary staff to attend an additional annual meeting of Program Directors and NHLBI staff in the Washington, D.C. metro area.

Institutional Environment: Describe the institutional environment, including facilities and educational resources, that can contribute to the planned Research Education Program.

Program Director/Principal Investigator (for multiple PD/PI Leadership Plan, see instructions for the Multiple PD/PI Leadership Plan section of the Research Plan): Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of the NHLBI, and can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program. Include a description of plans for the CC collaborating with program participants and other institutions for purposes of outreach. Provide a biosketch for the PD/PI(s) and key personnel.

Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of the NHLBI. Provide a biosketch and a letter of cooperation from each faculty/mentor who has agreed to participate in the program and indicate the exact role of each faculty/mentor.

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed research education program. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction. Applicants may wish to consult the NIH website (http://bioethics.od.nih.gov/) for additional guidance. An award cannot be made if an application lacks this component.

If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements. The inclusion of evaluation instruments is encouraged. Applications that lack an evaluation plan will not be reviewed. All applicants should include specific plans for how the CC will work collaboratively to evaluate the effectiveness of the Institute program. Applicants should propose metrics and benchmarks appropriate. The CC should include plans to work to coordinate the evaluation protocols across the Institutes for common measures.

Dissemination Plan: A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program, e.g., sample curricula, web postings, presentations at scientific meetings, workshops, etc. Applications that lack a dissemination plan will not be reviewed.

Institutional Commitment: Evidence of institutional commitment is strongly encouraged.

A letter of institutional commitment may be attached at line item 14 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to program.

Resource Sharing Plan(s):

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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 the Resource Sharing section of the application (N/A.)

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact (N/A)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which 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.)

(c) 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 (e.g., 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 (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

(d) Research education programs: These programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

The initial review group will comment on the appropriateness of the proposed software dissemination plan. Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

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 any related data sharing plans (if applicable) 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.

Appendix Materials

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.

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.

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

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NHLBI 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 will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score;
• Receive a written critique; and
• Receive a second level of review by the NHLBI advisory council.

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:

• Scientific merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed Education Program to program priorities.

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 goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. 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 education program 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, and weighted 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 impact/priority score. These criteria are not listed in any order of priority.

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs of the NHLBI in meeting its objectives. Applicants are strongly encouraged to contact NHLBI program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

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

Core 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.

Significance: Does the proposed research education program address scientific/education areas and/or topics important to the mission of the NHLBI? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the NHLBI?

Investigator(s): Are the investigators appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI (or multiple PDs/PIs, if applicable) and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Does the PD/PI demonstrate the ability to work as part of a multi-disciplinary team through significant prior experience in coordinating collaborative scientific research? Is the level of effort that will be devoted to direction and leadership adequate for a successful coordinating program? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the project/program and the expertise of each of the PD/PIs?

Innovation: Is the program original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does this program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is there evidence that the program is based on sound research concepts and educational principles? Is the approach feasible and appropriate to achieve the stated research education goals? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? What is the quality of the plans for coordinating research efforts and training, including logistical support for meetings and calls, data management systems, and the development and archiving of reports and other documents? What is the quality of the plans for dissemination, such as the development of web sites for research and training programs, communication of program results to other scientists, and communicating program results and scientific principles to the lay public?

Environment: Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? Are the facilities, environment, and resources adequate and appropriate for the proposed research education program? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)?

2.A. Additional Review Criteria:

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

Evaluation Plan Are the collaborative evaluation plan for the program and the proposed timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? Does the application contain an adequate description of analytic and personnel plans and methods for monitoring mentee progress? Does the application contain an adequate description of plans for evaluating the effectiveness of the PRIDE program?

Are the five year follow-up evaluation plan and timeline adequate for tracking the success of the mentees from the original three cohorts of Summer Institute programs in obtaining grant applications, publishing in scientific journals, and career progress adequate?

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.

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:

• Has the research education program successfully achieved its stated objectives during the prior project period?
• Has the research education program successfully recruited a diverse pool of participants (if applicable)? Has the PD/PI effectively shaped the recruitment plan in response to recruitment outcomes?
• Has the program been innovative in the past and does it continue to demonstrate innovation?

Evaluation Plan: Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives? If applicable, are the plans for obtaining feedback from participants adequate to measure the quality and effectiveness of the research education program?

For Renewal applications: Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program’s evaluation?

Dissemination Plan: Is the dissemination plan strong and of high quality?

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.

2.B. Additional Review Considerations

As applicable for the project 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.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the overall impact/priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in the summary statement. Regardless of the overall impact/priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will determine the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the Nation s capacity to address and eliminate health disparities.

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.

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.

Budget and Period Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research education program.

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).

Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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:

• Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm).
• Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html).
• Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Research education programs: The initial review group will comment on the appropriateness of the proposed software dissemination plan.

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 allowable costs incurred 90 days before the beginning (or start) date 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 Institute 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 research education 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 NIH funding component, 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 Specific Aims of the original peer-reviewed research education 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.

3. Reporting

Awards made in response to this FOA are not subject to SNAP.

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 research education program (including education in the responsible conduct of research), modifications to the research education program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program.

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 participants are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, 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.

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:

Nakela L. Cook, M.D., M.P.H.
Division of Prevention and Population Sciences
National Heart, Lung, and Blood Institute
Rockledge 2, Suite 10018
6701 Rockledge Drive
Bethesda, MD 20892-7936
Telephone: (301) 435-0383
Fax: (301) 443-0945
Email: [email protected]

2. Peer Review Contacts:

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Tawana McKeither
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7159
Bethesda, MD 20892-7924
Bethesda, MD 20817
Telephone: (301) 435-0166
Fax: 301-451-5462
Email: [email protected]

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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the impact/priority score.

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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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/.