RFA-RR-06-003: Clinical Research Education and Career Development (CRECD) in Minority Institutions (R25)

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:

Grants.gov (http://www.grants.gov/GetStarted) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.

· 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 301-451-0088.

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, the 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:

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

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

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

The letter of intent should be sent to:

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.

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.

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).

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.

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:

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 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. A