Part I Overview Information


Department of Health and Human Services

Issuing Organization
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/)

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

Components of Participating Organizations
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD) (
http://www.ncmhd.nih.gov/)
National Institute on Aging (NIA) (
http://www.nia.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH) (
http://www.niams.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (
http://www.niddk.nih.gov/)                                                  
National Heart, Lung and Blood Institute (NHLBI) (
http://www.nhlbi.nih.gov/)
National Institute on Drug Abuse (NIDA) (
http://www.nida.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

Title:  Clinical Research Education and Career Development (CRECD) in Minority Institutions (R25)

Announcement Type
This is a reissue of RFA-RR-03-007 which was previously released February 12, 2003.

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the 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 weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-RR-06-003

Catalog of Federal Domestic Assistance Number(s)
93.389, 93.307, 93.866, 93.846, 93.847, 93.837, 93.279, 93.865

Key Dates
Release/Posted Date: August 18, 2006
Opening Date: September 29, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 29, 2006
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): November 29, 2006
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s):  February 22, 2007
Council Review Date(s): May 17, 2007
Earliest Anticipated Start Date(s): June/July 2007
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: November 30, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism 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. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives
PURPOSE                                                                                                         

The National Center for Research Resources joins National Center on Minority Health and Health Disparities, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Drug Abuse, National Institute of Diabetes and Digestive and Kidney Diseases and National Institute of Child Health and Human Development in inviting minority institutions with professional schools offering doctoral degrees in one or more health care disciplines to apply for a Clinical Research Education and Career Development (CRECD) grant. This FOA is intended to encourage both current CRECD awardee institutions in the final year of funding and eligible institutions that have not received previous CRECD award to apply.

CRECD awards support development and implementation of curriculum-dependent programs in minority institutions to train selected doctoral and postdoctoral candidates in clinical research leading to a Master of Science in Clinical Research or Master of Public Health in a clinically relevant area. A successful program will result in an accredited master's degree program to produce trained and independent clinical researchers who can become engaged in conducting  translational and/or patient-oriented research projects.

RESEARCH OBJECTIVES

As part of the Federal effort to eliminate racial and ethnic disparities in health, a need is identified to expand training of clinical researchers at minority institutions as an important approach to fostering careers in clinical research, and address health disparities. Minority institutions conduct high quality programs for educating racial and ethnic minorities. They represent a rich resource of talent with appropriate cultural sensitivity and perspectives needed in clinical research.  Minority institutions, however, have had difficulties in developing and sustaining independent clinical research, and there is a paucity of racial and ethnic minority clinical researchers who are pursuing successful clinical research careers. There is a critical need for trained clinical researchers in several health areas that disproportionately affect minority and underserved populations. Programs that include training specific to the knowledge and skills needed to conduct clinical research in areas of interest to the participating NIH Institutes and Centers (e.g., health disparities, cardiovascular disease, diabetes, aging, reproductive medicine, mental health/psychiatric disorders, drug abuse and addiction, etc.) are strongly encouraged.

The National Institute of Child Health and Human Development is particularly interested in supporting candidates whose research focus and career development activities are in the area of reproductive medicine.                                                         

The National Institute on Aging will support CRECD candidates conducting research on issues related to aging confined to areas such as: (1) disability, physical and cognitive functioning, causes of activity limitation, and high vulnerability to adverse outcomes from illness, injury, or other stressors; (2) relationship of age and comorbidity to the effects of disease risk factors, or on the clinical course of disease, and effects of one disease for others; (3) clinical and functional effects of interactions of comorbid conditions, and of interactions of therapies for these conditions, and the efficacy of interventions to prevent or treat adverse interactions; (4) major diseases affecting older persons such as cardiovascular diseases, cancer, diabetes and Alzheimer’s; (5) geriatric syndromes such as urinary incontinence, falls prevention, hip fracture; areas of mobility, and polypharmacy. Topics that do not fit with this broad array may be identified and discussed with the NIA’s Program contact for consideration.

The scope of clinical research is broad. "NIH defines human clinical research as: (1) Patient-oriented research: Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.  Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies.  (3) Outcomes research and health services research."

The proposed research education program may complement other, ongoing clinical research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. The R25 is not a substitute for an institutional research training program (T32) and can not be used to circumvent or supplement Ruth L. Kirschstein National Research Service Award (NRSA) mechanisms.

PROGRAM

The CRECD award provides up to five years of support to a minority institution. The Principal Investigator leads a CRECD Advisory Committee (CAC) to design, develop, implement and evaluate a curriculum for an accredited Master of Science in Clinical Research or an accredited Master of Public Health in a clinically relevant area, and to evaluate the progress of CRECD graduates who are continuing through Phase II of the mentored clinical research training. The function, size, composition and term of the CAC should be clearly stated. The application should describe the types of research being proposed, the qualifications and selection criteria for members of the proposed CAC, and the duties and responsibilities of this committee as indicated in Section IV.6., Special Requirements.

The CRECD award will provide up to five years of support consisting of Phase I and Phase II: (1) an initial two-year Phase I to develop and offer a structured didactic course work and mentored clinical research training leading to a degree in Master of Science in Clinical Research or Master of Public Health for qualified and selected candidates; (2) Phase II of the CRECD program will provide continued mentoring and career development to the selected CRECD graduates for up to three years in clinical research as part of their training and skill development to become independent clinical investigators. The goal is to promote the development of trained and independent clinical researchers who can conduct clinical research activities in areas that are in accordance with NIH co-funding entities and also, addressing health disparities among the American people.

Phase I (Didactic program and clinical research experiences):

Phase II (Mentored clinical research training):

The primary intent of Phase II is to develop researchers who will pursue careers as independently-funded clinician scientists.

Candidates approved for the Phase II will be required to submit their progress through the annual progress report on the CRECD program to receive continued support. Each Phase II candidate will be evaluated for progress by the mentor, and the NIH program staff on an annual basis. Evaluation of the candidates progress will depend on the following:

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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. 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.  Up to two resubmissions (formerly “revisions/amendments”) of a previously reviewed research education grant application may be submitted.  See NOT-OD-03-041, May 7, 2003.  

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 NCRR and NIH participating Institutes and Centers provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of award may vary with the scope of the research education program proposed, it is expected that applications will stay within the following budgetary guidelines: total direct costs are limited to $500,000 annually.

New first-time applicants and competing continuation (renewal) applications may request up to five years of support with no more than $500,000 in direct costs per year. Both the duration and amount of support are subject to peer review and NIH policy considerations. Funding in subsequent years is contingent upon satisfactory progress during the preceding year and availability of funds.

It is anticipated that an estimated total of $ 2 million dollars, including direct, and facilities and administrative (F&A) costs will be available in FY 2007. Support for the program is contingent upon availability of funds. The anticipated number of total awards (new and renewal) will be 3-5.  

The participating organization(s) National Center for Research Resources, National Center on Minority Health and Health Disparities, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Drug Abuse, National Institute of Diabetes and Digestive and Kidney Diseases, and National Institute of Child Health and Human Development intends to commit approximately $ 2 million dollars in FY2007 to fund 3-5 new and competing renewal grant applications. At this time, it is not known if this RFA will be reissued.

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

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

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 $ 2 million dollars for fiscal year 2007. Future year amounts will depend on annual appropriations.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has all of the following characteristics:

The institution must be accredited to award Master in Clinical Research or Master of Public Health in a clinically relevant area or demonstrate the commitment and capability to develop a core curriculum leading to an accredited Master of Science in Clinical Research degree or an accredited Master of Public Health degree in a clinically relevant area. Eligible minority-serving institution may submit only one application. Applicants are encouraged to develop consortia in common geographic locations to enhance the depth of their faculty, mentors and participant pools and to improve the quality of the educational experience. Institutions that already hold a CRECD grant and are in their final year of funding are eligible to apply under this FOA.

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 with the skills, knowledge, and resources necessary to carry out the proposed research education program as the Project Director/Principal Investigator (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. The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., “Reporting.”)

The PD/PI should be an established investigator who is capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program.  He/she must be actively engaged in research and/or teaching in an area related to the goals of the CRECD program.

The program can include as students junior faculty, postdoctoral trainees such as interns and residents, and doctoral candidates who seek to combine their clinical doctorate degree with a Master of Science in Clinical Research or a Master of Public Health in a clinically relevant area and who want to become independent clinical investigators. Relevant clinical doctorate degrees include:  M.D., D.D.S., D.M.D., D.O., D.C., O.D., N.D. (Doctor of Naturopathy), Ph.D. with clinical responsibilities, or Pharm.D. Those individuals with a Ph.D. in nursing or those who want to become involved in clinical research also may participate.

Candidates must be citizens or non-citizen nationals of the United States (U.S.) or must have been lawfully admitted to the U.S. for permanent residence.  Individual on temporary or student visas are not eligible. Phase II candidates must devote a minimum of 75% effort to the program.

2. Cost Sharing or Matching

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

Cost sharing or matching for institutional eligibility is not required. However, significant institutional commitment is required by the applicant institution(s). This may take the form of office, laboratory, or clinical space, personnel, equipment, other resources or dollars, release time for candidates, tuition rebates etc. and will be considered as a strength in the review of these applications.  

3. Other-Special Eligibility Criteria

Mentors:  Mentors must have track records of funded research and be involved in clinical research or research methodologies clearly important to the clinical research focus and objectives of the proposed CRECD program.  The faculty mentors must be available and committed to the mentorship role for the duration of the candidate’s program and provide an annual evaluation of the candidate’s progress on career development activities.

CRECD Advisory Committee:  Members of the CAC, which may include external advisors,  must adequately represent the disciplines, departments, schools, and CAC members must accept responsibility for the recruitment and selection of candidates, the establishment and effectiveness of the curriculum, the approval of the education and training plans, interim monitoring and program evaluation.

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

Applications must contain an evaluation plan.  Applications submitted without these sections may be delayed in the review process or not reviewed.

An eligible minority-serving institution may submit only one application.

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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

PD/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 Started

2) Organizational/Institutional Registration in the eRA Commons

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

·         This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the Commons.

·         Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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 “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

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

Foreign Organizations (Non-domestic (non-U.S.) Entity): Not Applicable

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.

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 the degree of success or failure. 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 outcome measures that would determine the success of the research education program in achieving its objectives. 

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. No application may exceed $500,000 per year in direct costs.

Personnel: Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program.  These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget.  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 mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. The PD/PI may request salary support for leadership, management, coordination, and evaluation of the CRECD program, in accordance with the percent effort commitment. This commitment should be at least a ten-percent effort. Faculty critical to the design, development, implementation and refinement of the specialized curriculum essential to the training and didactic needs of the CRECD program may be provided salary support in accordance with the percent effort of commitment.

Salary support for CRECD Advisory Committee members must be justified by their specific contributions to program development (see Special Requirements – Section IV.6 Other Submission Requirements). However, in general, it is assumed that many of these activities are within the normal scope expected of academic faculty and are supported by the applicant institution. The PD/PI and CRECD program faculty may derive additional compensation from other Federal sources or awards, provided the additional compensation does not exceed the maximum annual salary level for Federal employees and their total percent effort on all awards does not exceed 100 percent.

 Typically, there will be one Lead Mentor per candidate. While mentors may not receive salary compensation from the grant, moderate expenses associated with the mentor’s laboratory or didactic activities that are directly attributable to the CRECD program may be charged to the grant program.

Limited administrative and clerical salary costs associated distinctly with the CRECD program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified. Funds up to 5-10% of direct costs may also be requested for evaluation of the CRECD program.

Other Program-Related Expenses: 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. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget. While salary compensation may not be provided to faculty mentors, compensation and expenses can be provided for external consultants and advisors in accordance with the policies of the sponsoring institution.

Participant Costs: Participants/candidates 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. 

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, requests for participation of non-U.S. citizens under the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or supplement NRSA training mechanisms. Unless strongly justified on the basis of exceptional relevance to the NIH/IC mission, research education programs should be used primarily for the education of U.S. citizens.  Applicants are strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate utilization of this mechanism with respect to the eligibility, appointment, and participation of non-U.S. citizens.

Allowable costs for Phase I candidates: 
Doctoral candidates can be provided salaries
of up to $20,000 per year plus fringe benefits commensurate with the institution's full-time salary scale for persons of equivalent qualifications, experience, and rank. Up to two years of support can be provided for the master's degree. Salary and tuition may be applied only to those courses fulfilling requirements for the master's degree.

Postdoctoral/Faculty appointees during the Phase I can be provided salaries of up to $75,000 per year plus fringe benefits commensurate with the institution's full-time salary scale for persons of equivalent qualifications, experience, and rank. Postdoctoral appointees may include junior faculty (those within seven years of their first faculty appointment). Up to two years of support can be provided for the master's degree.

The institution may supplement the NIH contribution to an appointee's salary up to a level that is consistent with the institution's salary scale. Institutional supplementation of a salary must not require extra duties or responsibilities that would interfere with the purpose of the award.

Up to $20,000 in direct costs per year per candidate adjusted to the actual percent effort can be provided for the following types of expenditures:(a) research expenses, such as supplies, and technical personnel; (b) tuition and fees related to career development; (c) travel to research meetings or training; and (d) statistical services including personnel and computer time. These costs must be specifically documented for each individual candidate and must be specifically and directly related to the candidate's research activities.

Allowable costs for Phase II candidates:                                                                                                             
For Phase II award, t
he total cost for the mentored clinical research investigator may not exceed $130,000 per year per candidate. This amount includes salary, fringe benefits, research support allowance and applicable F&A costs. The total salary requested must be based on a full-time, 12-month staff appointment and requires candidates to devote a minimum of 75% of full-time professional effort to conducting health-related clinical and/or patient-oriented research with the remaining effort being devoted to activities related to the development of a successful research career. During the Phase II, the candidates are strongly encouraged to submit applications for K08, K23 and/or other R series awards.

Institutional Commitment: Evidence of institutional commitment to the R25 educational program is strongly encouraged. This may take the form of office, laboratory, or clinical space, personnel, equipment, other resources or dollars, release time for candidates, tuition rebates etc. and will be considered as a strength in the review of these applications.

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.  

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: September 29, 2006 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): October 29, 2006
Application Submission/Receipt Date(s): November 29, 2006
AIDS Application Submission/Receipt Date(s): Not Applicable
Peer Review Date(s): February 22, 2007
Council Review Date(s):  May 17, 2007   
Earliest Anticipated Start Date(s): June/July 2007   

3.A.1. Letter of Intent

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

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:

Krishan K. Arora, Ph.D. 
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Blvd.
Democracy I, Room 938
Bethesda, MD 20892
Telephone: (301) 435-0760
FAX: (301) 480-3770
Email: arorak@mail.nih.gov

3.B. Sending an Application 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. 
 
3.C. Application Processing

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 submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. 

Once an application package has been successfully submitted through Grants.gov, any 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 business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

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: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. 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
The NIH requires the PD/PI 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. 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 “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

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:

Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.   

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.   

Special Requirements                

Supplementary Research Education Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.  Applications that do not conform to the specific instructions detailed below will be returned. Applicants are strongly encouraged to contact NIH Program Staff early in the application process and they should have a clear understanding of the intent and expectations of this FOA before developing an application.  

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.  Provide a description of the research infrastructure; and the facilities that are available and accessible to the CRECD program; as well as a discussion of how an active research environment will be sustained to meet the needs and objectives of the CRECD program.

3.  SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.  Include the PD/PI, Curriculum Advisory Committee members, mentors and other faculty participating in the CRECD program.  Make sure that you include each individual's degree and departmental affiliation (or equivalent) and, if a consortia of institutions, each person’s institutional affiliation. Provide biographical sketches for the PD/PI, CRECD Advisory Committee members, mentors, and other participating faculty.  

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 must be included here.

B.  Other Personnel: complete for all other personnel including candidates, associated with the research education program. Include doctoral candidates by name or position (when position is to be filled); and postdoctoral/junior faculty candidates by name or position (when position is to be filled). Provide biographical sketches for candidates (for those that are available).

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. Include funds for the PD/PI and another staff person to attend an annual meeting in Bethesda, Maryland.

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.  For Research and Development Costs, maintain a separation between doctoral and postdoctoral candidates. For the budget categories other than salary, specifically identify the requested costs under each budget category (e.g., supplies, travel) for each candidate by name or position (if the position is to be filled), and the total for each individual cannot exceed $20,000.

F.  Other Direct Costs: itemize as appropriate and allowed for the R25 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:

Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed research education program. A Progress Report must be included in renewal applications. List accomplishments and successes of the overall CRECD program. Provide in a text or table format, who and how many candidates attended and graduated from the program; provide their current status and career plans and publications.

List curriculum courses that are already in place and those that need to be developed/adapted to address the needs of the candidates and meet the objectives of the program. Describe any novel courses developed that are critical to the training of clinical investigators working in the area of health disparities. If proposing substantial changes in the CRECD curriculum developed, provide adequate justification.

Part 5 of this section (Research Design and Methods) should be retitled "Research Education Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director(s): 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 goals and objectives of the CRECD program, 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. Provide a description of the qualifications and role of the PD/PI in providing scientific leadership, and administrative management and coordination of the CRECD program (A minimum of ten percent effort is required); Include a STATEMENT OF ELIGIBILITY of the applicant institution as a minority institution eligible for the CRECD Program.

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 goals and objectives of the CRECD program. Provide a description of the qualifications of the faculty research mentors, including information on their qualifications related to the conduct of clinical research. Provide evidence of the availability and commitment of the faculty mentors for the duration of the program. All the mentors should be involved in clinical research or research methodologies clearly important to the clinical research focus and objectives of the proposed CRECD program.

Include a description of how the CRECD Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies; process for recruitment and selection of candidates for the CRECD program; establishment, implementation, and evaluation of the core/specialized curriculum; approval of individual education and career development plans (e.g., curriculum, research/methodology experiences, mentors); interim monitoring and evaluation of each candidate's progress, including a determination of when a candidate has successfully completed the program (for Phase I, award of the degree; and Phase II, abstracts, publications and demonstration of the efforts to seek external grant support to become independent clinical investigators), with recommendations for changes in the plan and, if necessary, termination of a candidate not making adequate progress; and monitoring of the overall effectiveness of the CRECD program. Include plans for periodic research meetings and networking for all Phase I and Phase II candidates and mentors.

Proposed Research Education Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).

For didactic and training Phase I, the Education and Career Development Plan must include:

For mentored Phase II,

Research Scope for Phase I and Phase II:

The applicant should describe the focus of its curriculum or the clinical research training program available to candidates and how it relates to one or more of the areas of interest to the participating NIH Institutes and Centers (e.g., health disparities, cardiovascular disease, diabetes, aging, reproductive medicine, mental health/psychiatric disorders, drug abuse and addiction, etc.).

The National Institute of Child Health and Human Development is particularly interested in supporting candidates whose research focus and career development activities are in the area of reproductive medicine. 

The National Institute on Aging will support CRECD candidates conducting research on issues related to aging confined to areas such as: (1) disability, physical and cognitive functioning, causes of activity limitation, and high vulnerability to adverse outcomes from illness, injury, or other stressors; (2) relationship of age and comorbidity to the effects of disease risk factors, or on the clinical course of disease, and effects of one disease for others; (3) clinical and functional effects of interactions of comorbid conditions, and of interactions of therapies for these conditions, and the efficacy of interventions to prevent or treat adverse interactions; (4) major diseases affecting older persons such as cardiovascular diseases, cancer, diabetes and Alzheimers; (5) geriatric syndromes such as urinary incontinence, falls prevention, hip fracture; areas of mobility, and polypharmacy. Topics that do not fit with this broad array may be identified and discussed with the NIA’s Program contact for consideration.

The National Institute of Diabetes and Digestive and Kidney Diseases will support up to two CRECD graduates (i.e. those who have completed CRECD Phase I degree requirements), for Phase II like  mentored clinical research training though the institute-funded “Mentored Clinical Scientist Award to Promote Diversity in Health-Related Research” using the K08 mechanism. This award provides an intensive, supervised research experience for individuals from groups that are underrepresented in health-related science and, who are committed to pursuing clinical research careers in areas of relevance to the mission of NIDDK. Applicants must hold health professional degrees (e.g., M.D., D.D.S., D.O., O.D., D.V.M., N.D. [Doctor of Naturopathy], Pharm.D. degrees) or their equivalents and a recently acquired (less than 3 years) Master of Science in Clinical Research or Master of Public Health in a clinically relevant area. Individuals with the Ph.D. or other doctoral degrees in clinical disciplines such as clinical psychology, nursing, clinical genetics, speech-language pathology, audiology, and rehabilitation are also eligible as long as they have graduated from the CRECD program. Individuals who graduated from the CRECD program will receive special consideration. Individuals holding the Ph.D. in a non-clinical discipline are not eligible to apply for this NIDDK K08 award.

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.

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

Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.  Document the presence of a suitable group of 4-6 doctorally-qualified individuals to matriculate in the proposed program and become independent clinical investigators (see section III, 1.A. and 1.B. Eligible Institutions). Doctorally-qualified individuals are those who have completed a doctoral degree or are in the final phase of completing a doctoral degree. The program can include as candidates junior faculty, postdoctoral trainees such as interns and residents, and doctoral candidates who seek to combine their clinical doctorate degree with a Master of Science in Clinical Research or a Master of Public Health in a clinically relevant area.

Diversity Recruitment and Retention Plan:  Provide a detailed diversity recruitment and retention plan for the research education program.  Renewal applications must detail experiences in recruiting and retaining individuals from underrepresented groups during the previous award period.  Include, in a table, the total numbers of individuals who applied, were interviewed, admitted, and participated in the research education program as well as the total number of individuals from the three classes defined below.  For those programs where individuals are not participating, e.g. a program requesting support to develop a curriculum, the PD/PI must explain why this information is not appropriate. 

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. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

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

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

C. Individuals from disadvantaged backgrounds who are defined as:

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

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.  Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement.

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.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the NCRR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

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 outcome measures that would determine the success of the research education program in achieving its objectives. The inclusion of evaluation instruments is encouraged.  Applications that lack an evaluation plan will be returned. Include the parameters and criteria, time-line, and benchmarks to be used in evaluating the success of the CRECD program.

Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the research education program, e.g., Web postings, presentations at scientific meetings, workshops, etc. 

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Research education 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:

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 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.”

Section V. Application Review Information


1. Criteria 

See Section III Eligibility Information 1.A., and 1.B.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCRR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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:  

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, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. 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 NCRR and participating NIH Institutes and Centers in meeting their objectives.  Applicants are strongly encouraged to contact NCRR program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

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

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?

For renewal applications only:

Innovation: Is the research education 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? 

Investigators: 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 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?

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? 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)?

For renewal applications only:

Past Performance: 

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research:
The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research education program will be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims, methods, educational opportunities, and participant activities?

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 priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge 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. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the NCRR, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
 
3. Anticipated Announcement and Award Dates

The earliest anticipated award date is June/July 2007.

 
Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the NCRR to the grantee business official.

2. Administrative and National Policy Requirements

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. 

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.

3. Reporting

Awards made in response to this FOA are not subject to the Streamlined Non-competing Application Process (SNAP). In general, this means that all reporting of budgetary information and CRECD program progress is provided in greater detail. This R25 grant is subject to Expanded Authorities except for changes in key personnel and the carryover of funds from one fiscal year to the next, which must be approved by Program and Grants Management staff.

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 annual progress report should provide information about changes in the Program, a summary report of the evaluation of the CRECD Advisory Committee, and a description of the research and career progress of each candidate. These annual reports will be closely monitored by the NCRR and CRECD funding Institute/Centers Program Staff to ensure that the grant is achieving the goals of the Program. Progress reports must contain the following information:

All publications from CRECD activities supported entirely or in substantial part by NIH should include the following or comparable acknowledgment of support:  "The project/study described was supported by Grant Number R25 RR _______, which is co-funded by National Center for Research Resources, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Center on Minority Health and Health Disparities, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, and National Institute of Child Health and Human Development of the National Institutes of Health.” “Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NIH."

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Any carryover of funds from one fiscal year to the next will be considered only after the FSR has been approved by the NIH Office of Financial Management.   

Evaluation:  In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, award recipients are hereby notified that they may be contacted during and 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.

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Krishan K. Arora, Ph.D.
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Blvd.
Democracy I, Room 938
Bethesda, MD 20892
Telephone: (301) 435-0760
FAX: (301) 480-3770
Email: arorak@mail.nih.gov

Madeline Turkeltaub, R.N., Ph.D., C.R.N.P., F.A.A.N.
Deputy Director, Extramural Program
NIAMS,
Democracy One
6701 Democracy Blvd., Suite 800 MSC 4872
Bethesda, MD 20892-4872 Telephone: 301-594-2463
FAX: 301-480-4543
Email: mturkeltaub@mail.nih.gov

Roger J. Bulger, M.D.
Medical Officer
National Center on Minority Health and Health Disparities
National Institutes of Health
6707 Democracy Blvd, Suite 800
Bethesda, MD 20892-5465
Telephone: (301) 402-1366
Fax: (301) 480-4049
Email: bulgerr@mail.nih.gov

Frances E. Ferguson, M.D., M.P.H.
Program Director
Office of Minority Health Research Coordination
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy, Room 902
6707 Democracy Blvd.
Bethesda, MD 20892-5454
Telephone: (301) 594-9652
Fax: (301) 594-9358
Email: FF54t@nih.gov

Lula Beatty, Ph.D.
Chief, Special Populations Office
National Institute of Drug Abuse
6001 Executive Blvd. MSC 9567
Bethesda, MD 20892-9567
Telephone: (301) 443-0441
Fax: (301) 480-8179
Email: lbeatty@nida.nih.gov

Traci Mondoro, Ph.D. National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10182
Bethesda, MD 20892-7965
Telephone: (301) 435-0052
Fax: (301) 402-1056
Email: mondorot@nhlbi.nih.gov

Rosemary Yancik, Ph.D.
National Institute on Aging
Gateway Building, Suite 3C307
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-5278
Fax:: (301) 402-1784
Email: yancikr@nia.nih.gov

Estella Parrott, M.D., M.P.H.
Program Director
Reproductive Medicine Gynecology Program
Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development, NIH
6100 Executive Boulevard, Room 8B-01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-6515
Fax:: (301) 496-0962
Email: ep61h@nih.gov

2. Peer Review Contacts:

Mahadev Murthy, Ph.D., M.B.A.
Office of Review
National
Center for Research Resources
6701 Democracy Blvd.
Democracy I, Room 1072
Bethesda, MD 20892
Telephone: (301) 435-0813
FAX: (301 480-3660
Email:
mmurthy@mail.nih.gov

3. Financial or Grants Management Contacts:

Irene H. Grissom
Office for Grants Management

National
Center for Research Resources
6701 Democracy Blvd.

Democracy I, Room 1036
Bethesda, MD 20892
Telephone: (301) 435-0836
FAX: (301) 480-3777

Email: ig3y@nih.gov

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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

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-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

Authority and Regulations:                                                                            
This program is described in
the Catalog of Federal Domestic Assistance 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Bethesda, Maryland 20892
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