Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Research Resources (NCRR) (No Longer participating per NOT-OD-12-093)
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)

Funding Opportunity Title

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

Activity Code

R25 Education Projects

Announcement Type

Reissue of RFA-RR-07-005

Related Notices

  • March 19, 2012 - See Notice NOT-OD-12-093. Notice of Change in Participation of NIH Institutes and Centers.

Funding Opportunity Announcement (FOA) Number

PAR-11-325

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.389, 93.866, 93.846, 93.279, 93.865, 93.398, 93.307

FOA Purpose

The purpose of the Clinical Research Education and Career Development (CRECD) Program is to expand the national capability to improve diversity for research in the health sciences by developing the research workforce in clinical and translational sciences though providing grant support to minority institutions that offer doctorate degrees in the health professions or in a health-related science. These institutions historically have trained professionals from diverse backgrounds who provide health care to minority populations and are uniquely positioned to engage these populations in research and in the translation of research advances into culturally appropriate, measurable and sustained improvements in health outcomes. 

The primary goals of the CRECD program are to (1) support development and implementation of curriculum-dependent programs to train selected doctoral and postdoctoral participants in clinical research leading to a Master of Science in Clinical Research or Master of Public Health in a clinically relevant area; (2) develop a diverse group of clinical researchers who have the necessary knowledge and skills to pursue clinical research and can become part of translational and/or patient-oriented research, particularly on diseases that disproportionately impact minority populations.

Key Dates
Posted Date

September 1, 2011

Open Date (Earliest Submission Date)

October 2, 2011, October 2, 2012

Letter of Intent Due Date

October 2, 2011, October 2, 2012

Application Due Date(s)

November 2, 2011, November 2, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2012, February 2013

Advisory Council Review

May 2012, May 2013

Earliest Start Date(s)

June/July 2012, June/July 2013

Expiration Date

November 3, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background:

The NIH recognizes a unique and compelling need to promote diversity in the NIH-funded 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; improve the quality of the educational and training environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and improve the Nation’s capacity to address and eliminate health disparities.

The National Center for Research Resources (NCRR) provides laboratory scientists and clinical researchers with the environments, tools and training they need to understand, detect, treat and prevent a wide range of diseases with the goal of building capacity to bring effective prevention and treatment strategies more quickly into practice. NCRR programs accelerate and enhance research along the entire continuum of biomedical science. NCRR’s mission also includes developing a diverse research workforce that includes minorities who are underrepresented in the biomedical, behavioral and clinical sciences. The institutes and centers (ICs) participating in this FOA have also corresponding interest in the mission in developing more clinical researchers who are underrepresented in clinical research, that is why they have also joined in this initiative to address clinical research workforce diversity needs in the nation.

Minority institutions historically have trained professionals who provide health care to minority populations and are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes. These institutions provide high quality educational programs and they possess a rich resource of talent with cultural sensitivity, community engagement and perspectives needed in clinical research.

There is a critical need for trained clinical researchers in several health areas that disproportionately affect minority and underserved populations that minority institutions can readily address. Published reports from AAMC, NSF, National Academy of Sciences, American Federation For Medical Research (http://www.afmr.org), and others (J. National Medical Association 97, 1063 (2005)) provide evidence that there is a need to replenish and diversify the U.S. workforce, especially the clinical research community, whose small numbers are insufficient to meet the increasing needs for clinical research (http://www.nap.edu) and the situation for underrepresented minorities is worse. Minority institutions, however, have had difficulties in developing and sustaining independent clinical research, and there is a paucity of clinical researchers from these institutions who are pursuing successful clinical research careers. NCRR and the ICs participating in this FOA recognize this need and realize that through the development of programs in minority institutions that include training specific to the knowledge and skills needed to conduct clinical and translational research, their potential to contribute to research advances that are necessary to eliminate disparities in health and disease experienced by members of minority communities is greatly enhanced.

Program Goals:

Purpose

The purpose of the Clinical Research Education and Career Development (CRECD) program is to expand the national capability for research in the health sciences by developing the research workforce in clinical and translational science though providing grant support to minority institutions that offer doctorate degrees in the health professions or in a health-related science. These institutions historically have trained professionals from diverse backgrounds who provide health care to minority populations and are uniquely positioned to engage these populations in research and in the translation of research advances into culturally appropriate, measurable and sustained improvements in health outcomes.

The primary goals of the CRECD program are to (1) support development and implementation of curriculum-dependent programs to train selected doctoral and postdoctoral participants in clinical research leading to a Master of Science in Clinical Research or Master of Public Health in a clinically relevant area; (2) develop a diverse group of clinical researchers who have the necessary knowledge and skills to pursue clinical research and can become part of translational and/or patient-oriented research, particularly on diseases that disproportionately impact minority populations.

The nature and scope of the CRECD Program may vary in different institutional settings. However, the CRECD program must be focused on clinical and translational sciences. Each applicant must assess and plan a program to address its own research education and career development needs and strategic vision. The applicant must describe and justify how requested resources will be utilized and leveraged to implement the institutional plan to develop, expand, and maintain an environment and framework suitable for achieving the objectives of their CRECD program. Moreover, plans for enhancement of clinical research education and career development capacity must include an evaluation plan to determine the extent to which program goals are achieved. The CRECD program must provide opportunities to:

The most important criterion for inclusion of any component in the proposed CRECD program is the extent to which the activity or resource will enable the institution to achieve the stated goals.

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.

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 (ICs) (e.g., health disparities, HIV/AIDS, cancer, cardiovascular disease, diabetes, aging, arthritis, musculoskeletal diseases, skin diseases, reproductive medicine, mental health/psychiatric disorders, drug abuse and addiction, etc.) are strongly encouraged. The overall goal of the IC’s research education programs is to ensure that a diverse group of trained scientists will be available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, clinical and translational research needs in the participating ICs.

Programmatic Approach:

The CRECD award will provide up to five years of support consisting of two components referred to as Phase I and Phase II: (1) Phase I to design and develop new or improve existing courses; and offer structured didactic curricula and mentored clinical research project leading to a Master of Science in Clinical Research or Master of Public Health for qualified and selected participants; (2) Phase II of the program will provide continued mentoring and career development to the selected CRECD Phase I graduates for up to three years in clinical research as part of their training and skill development to become independent clinical and translational 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.

An institution with already established curriculum for an accredited Master of Science in Clinical Research degree or an accredited Master of Public Health degree, may recruit either Phase I, Phase II or both Phase I and Phase II participants in the program.

The Program Director/Principal Investigator (PD/PI) leads a multi-disciplinary 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 Phase I participants and the CRECD graduates who are continuing through Phase II of the clinical research training.

Phase I (Didactic program and clinical research experiences):

Phase II (Mentored clinical research and career development):

Research Scope for Phase I and Phase II:

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

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

The National Institute on Aging will support CRECD participants 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.

This FOA encourages applications from organizations that propose creative and innovative research education programs in the mission area(s) of the participating ICs. The NIH Research Education (R25) grant mechanism is designed to support the development of creative and innovative research education programs for the development of biomedical, behavioral, and clinical researchers. Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine their effectiveness. Plans must be provided both for program evaluation and dissemination.

The application must also include appropriate training in the responsible conduct of research (see Section IV.2 for details).

Evaluation Metrics:

Applicants must include a detailed process and outcome evaluation plan. The plan should be designed to determine the effectiveness of various career development components, and the extent to which program goals are achieved. It must include milestones for each key activity, and milestones for the overall program in terms of the career outcomes of participating scholars (see Section IV.2 for details).

Applicants should note that this career development program will undergo evaluation and assessment. The evaluation of the overall CRECD program is distinct from each individual award’s outcome evaluation (Section IV.2).  While both address “success”, they differ in scope (individual award vs. national program, different timelines) and metrics (PD/PI defined vs. programmatic goals specified below).  The evaluation of the overall CRECD program will be carried out seven years after the release of this FOA.  Common Assessment will be developed by participating ICs and will be based on the metrics that will include, but are not limited to:

The findings of this evaluation will determine whether the CRECD program is continued as configured, continued with modifications or discontinued.  Should the findings indicate that the program is no longer needed or is ineffective, then NCRR and participating ICs may consider terminating the program.

The proposed research education program may complement ongoing 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 Administration:

The participating institution(s) must have well-established clinical research programs and qualified faculty in curriculum development and implementation, and in program evaluation to serve as faculty for the program. The institution must have a pool of highly trained and experienced faculty investigators who have productive track records in clinical and translational research, and who have the commitment and capability to provide mentoring and career development guidance to promising participants who aspire to become independent clinical research scientists.

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 or other activities as defined by the applicant.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission (Resubmission (A1) applications may only be submitted for those applications that are not successful from the November 2, 2011 due date. Resubmissions from the 2007 RFA-RR-07-005 are not allowed.

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

NIH intends to fund 2-3 awards for fiscal year 2012. Future year amounts will depend on annual appropriations.

Award Budget

New first-time applicants and continuation (renewal) applications may request 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..

Award Project Period

Up to five years

Other Award Budget Information
Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds). The Program Directors/Principal Investigators 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 1.20 person months or ten percent effort. Faculty critical to the design, development, implementation and refinement of the specialized curriculum essential to the didactic needs of the CRECD program may be provided salary support in accordance with the proposed level of effort.

Salary support for CRECD Advisory Committee members must be justified by their specific contributions to program development (see Section IV). 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 current salary cap (current salary cap levels can be found at the following URL:http://grants.nih.gov/grants/policy/salcap_summary.htm) and the effort on all awards does not exceed 12 person months or 100 percent.

Typically, there will be one Lead Mentor per participant. 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.

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% of direct costs may also be requested for evaluation of the CRECD program.

Participant Costs

Participants may be paid if specifically required for the proposed research education program and sufficiently justified. Participant costs must be itemized in the proposed budget

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

Participants may also receive tuition remission and other education-related expenses if in accordance with the provisions of the NIH Grants Policy Statement.

Allowable costs for Phase I participants:

Up to two years of support can be provided for the master's degree participants.

Doctoral candidates can be provided up to $40,000 in direct costs per year per participant for the following types of expenditures:(a) salaries up to $20,000 adjusted to the actual percent effort; (b) research expenses, such as supplies, and technical personnel; (c) tuition remission and fees related to courses fulfilling requirements for the master's degree; (d) travel to research meetings; and (e) statistical services including personnel and computer time. These costs must be specifically documented for each individual participant and must be directly related to the participant's research activities.

Postdoctoral/Faculty appointees can be provided up to $95,000 in direct costs per year per participant for the following types of expenditures: (a) salaries up to $75,000 adjusted to the actual percent effort; (b) research expenses, such as supplies, and technical personnel; (c) tuition remission and fees related to courses fulfilling requirements for the master's degree; (d) travel to research meetings; and (e) statistical services including personnel and computer time. These costs must be specifically documented for each individual participant and must be directly related to the participant's research activities.

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.

Allowable costs for Phase II participants: 

For Phase II award, the total cost for the mentored clinical research investigator may not exceed $130,000 total costs per year per participant. 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 participants to devote a minimum of 75% (i.e. 9.0 person months) 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 participants are strongly encouraged to submit applications for K08, K23 and/or R series awards.

Expenses for foreign travel must be exceptionally well justified.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the R25 mechanism, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 mechanism is not intended as a substitute for an NRSA institutional training program (T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. 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. 

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

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

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

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. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD/PI must be actively engaged in research and/or teaching in an area related to the goals of the CRECD program.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

 Eligible applicant organizations may submit only one application.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.  

Preceptors/Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award and provide an annual evaluation of the mentee’s progress on career development activities.

CRECD Advisory Committee: 

Members of the CAC, which may include external advisors, must adequately represent the disciplines, departments and schools. CAC members recommend the recruitment and selection of participants, the establishment and effectiveness of the curriculum, the approval of the education and research plans and interim monitoring of the program.

Participants

Applications must describe the intended participants, and the eligibility and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels essential for participation in the planned program.

The program can include as participants junior faculty, postdoctoral trainees such as interns and residents, and doctoral candidates who seek to combine their clinical doctorate degree with a Masters of Science in Clinical Research or a Masters 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., O.D., N.D. (Doctor of Naturopathy), Ph.D. with clinical responsibilities, or Pharm.D. Postdoctoral appointees may include junior faculty (those within seven years of their first faculty appointment). Those individuals with a Ph.D. in nursing, clinical psychology or those who want to become involved in clinical research also may participate..

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Krishan K. Arora, Ph.D. 
Program Officer
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 

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.  

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

SF 424(R&R) Cover Component, SF 424(R&R) Project/Performance Site Locations Component

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.

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

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.

Advisory Committee (Uploaded via the Other Attachments section)

A plan must be provided for the appointment of an Advisory Committee to monitor progress. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of participants should be included. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of participants, and the evaluation of the overall effectiveness of the program.

The established Advisory Committee members should be identified and named in the application. However, new members may not be contacted or named.

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF 424(R&R) Senior/Key Person Profile Expanded Component

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, 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, mentors, and other participating faculty.

R&R Budget Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following modifications:

PHS398 Cover Letter Component, PHS398 Cover Page Supplement

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the additional instructions described below:

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below: Proposed Research Education Program, Institutional Environment and Commitment, Program Director/Principal Investigator, Program Faculty/Staff, Program Participants, Diversity Recruitment and Retention Plan, Plan for Instruction in the Responsible Conduct of Research, Evaluation Plan, Dissemination Plan.

Proposed Research Education Program (Component of Research Education Program Plan)

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

Preliminary Studies/Progress Report should contain information on steps that have led to the proposed research education program.

For Renewal applications, a Progress Report must include:

Proposed Research Education Program:

Provide programmatic detail on the special activities proposed, e.g., courses, curricula, seminars, workshops.

For Phase I (didactic and clinical research experiences), the Education and Career Development Plan must include:

For mentored Phase II:

Institutional Environment and Commitment (Component of Research Education Program Plan)

Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. If the letter of institutional commitment is not included, the application will not be reviewed.

Program Director/Principal Investigator (Component of Research Education Program Plan)

Describe arrangements for administration of the program, provide evidence that the Program Director is actively engaged in research and/or teaching in an area related to the mission of NIH, 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. S/he must be actively engaged in research and/or teaching in an area related to the goals of the CRECD program.

When multiple PD/PIs are proposed, all individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system. Applications proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the program should be delineated for each of the PD/PIs.

Program Faculty/Staff (Component of Research Education Program Plan)

Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other scholarly activities related to the mission of NIH.

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 must have a productive track record and be involved in clinical research or research methodologies important to the clinical research and objectives of the proposed CRECD program.

The participating institution(s) must have well-established clinical research programs and qualified faculty in curriculum development and implementation, and in program evaluation to serve as faculty for the program. The institution must have a pool of highly trained and experienced faculty investigators who have productive track records in clinical and translational research, and who have the commitment and capability to provide mentoring and career development guidance to promising participants who aspire to become independent clinical investigators.

Include a description of how the PD/PI will assemble and chair a multidisciplinary CRECD Advisory Committee (CAC) representing the disciplines, departments, schools, institutions, etc. involved in this education and training program. The CAC may include external advisors. Provide a description of how the CAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies; process for recommending recruitment and selection of participants 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 participant's progress, including a determination of when a participant 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 participant 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 participants and mentors.

Program Participants (Component of Research Education Program Plan)

Where the proposed program involves participants, provide details about the pool of expected 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, 3. Additional Information on Eligibility).

Recruitment and Retention Plan to Enhance Diveristy(Component of Research Education Program Plan)

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 the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

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

C. Individuals from disadvantaged backgrounds who are defined as:

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

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

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

New applications must include a description of plans to enhance recruitment of a diverse participant pool and may wish to include data in support of past accomplishments.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

For those individuals who were enrolled in the program, the report should include information about the duration of education and whether those individuals finished the program in good standing. Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment and retention plan may be delayed or not accepted for review. An award cannot be made if an application lacks this component.

Plan for Instruction in the Responsible Conduct of Research (Component of Research Education Program Plan)

Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. All applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019. Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will be delayed or not accepted for review. An award cannot be made if an application lacks this component. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Evaluation Plan (Component of Research Education Program Plan)

A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report short or long-term outcome measures that would determine the success of the research education program in achieving its objectives. Where appropriate, applicants are encouraged to include plans to obtain feedback from participants to help identify weaknesses and to provide suggestions for program improvements.

Applicants must describe an evaluation plan to review and determine the effectiveness of the program. This should include a detailed formative and summative evaluation plan. The application must describe a proposed process evaluation plan to examine the program operations to determine if they are being conducted as planned, whether output is being produced or how processes can be improved. The plan must include milestones for each key activity.

Include the parameters and criteria, timeline, and benchmarks to be used in evaluating the success of the CRECD program.The plan must include milestones for the overall program in terms of the career outcomes of scholars. The outcome measures for the participating scholars should include, but are not limited to: development of new and unique curriculum courses and pedagogy; an increased awareness and use of new teaching tools such as intranet or internet-based tools; progression of Phase I participants towards completion of degree program; progress of the Phase I and Phase II participants toward a productive research career, journal papers written/published, grant proposals submitted/funded; increase in the number of collaborations established between CRECD, RCMI and CTSA institutions; and how the CRECD program supports and enhances the professional development activities in the RCMI and other training/career development programs at the institution.

Annual progress reports and renewal applications must include a report on the program's ongoing evaluation. Evaluation results should also be included as part of the Final Progress Report.

Dissemination Plan (Component of Research Education Program Plan)

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

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R Application Guide), with the following modifications:

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:

Appendix

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.     

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the NCRR, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the proposed research education program address an important problem or critical question in research education or other critical issues?  How will implementation of the proposed program advance the objectives of the proposed program?  Is the proposed program adequate in meeting the NIH's intent of supporting education and career development programs that prepare participants to participate as independent investigators in clinical and translational research?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, or in the early stages of an independent career, does the PD/PI have appropriate experience to lead the program?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?  Is the faculty responsible for the specialized CRECD curriculum adequate?  Are program faculty research mentors available for the duration of the program? Are all mentors involved in clinical research or research methods?

Innovation

Is the proposed research education program characterized by innovation and scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere?  Adaptations of existing research education programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program?  Is the CRECD curriculum unique relative to other curricula available at the institution(s)? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If called for, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program?  Is there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? 

If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Does the curriculum provide the participants a basis to enhance their research skills?  Are the proposed research activities and experiences adequate? Will continuation and/or expansion of an existing program enhance clinical research training at the institution? Is a qualified pool of participants for Phase I and/or Phase II who would like to pursue careers in clinical research available? Are the criteria used for selecting these participants appropriate?  Are the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?  Does the evaluation plan obtain feedback from participants to help identify weaknesses and provide suggestions for program improvements?

Environment

Will the scientific/educational environment in which the proposed research education program will be conducted contribute to the probability of success?  Are the institutional commitment and support, equipment and other physical resources available to the investigators adequate for the program proposed?  Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?  Is there evidence of appropriate collaboration among participating programs, departments, and institutions?  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)?  Are the institution, the, PD/PI, and the faculty and mentors supportive and committed to meet the training and career development objectives of the CRECD program?  Is the CRECD Advisory Committee (CAC) membership appropriate and experienced? Are the criteria for selection of CAC members appropriate?  Is the CAC's involvement adequate in recommending selection of Phase I and Phase II participants for the program?  Are plans for monitoring the progress of Phase I and Phase II participants by CAC and the PD/PI adequate?  Are plans for CAC oversight of the program adequate?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Inclusion of Women, Minorities, and Children 

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.  

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research.

For renewal applications only, Past Performance: 

Has the research education program successfully achieved its stated objectives during the prior project period? Has the level of success been satisfactory?

Revisions

 Not Applicable.

Additional Review Considerations

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

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The review panel’s evaluation will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the research education program, level of participant experience, and the particular circumstances of the participants, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g. lectures and/or real-time discussion groups?  Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Do the plans ensure participants will receive instruction (or in the case of more senior level participants, provide instruction) for an appropriate amount of time given the length of the research education experience?  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCRR , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Resources Council . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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 eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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, participants are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590) and financial statements (Financial Status Report) as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards.

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 participant. These annual reports will be closely monitored by the NCRR and CRECD participating ICs Program Staff to ensure that the grant is achieving the goals of the Program. Progress reports must contain the following information:

What were the significant unexpected outcomes (positive or negative) of your CRECD Program’s activities? 2) What were the challenges or obstacles your Program encountered in reaching its goals and what are your plans to overcome these challenges? 3) What has been the impact of the program on the institutional culture toward clinical research? 4) What were the best products of your CRECD (new courses, techniques, scientific findings, other)?

The progress on Phase II participants should include the following:

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 _______ (list names of the participating ICs). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NIH."

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

Other Reporting Requirements

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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

John Ojeifo, M.D., Ph.D., M.B.A.
Program Director
Center to Reduce Cancer Health Disparities
National Cancer Institute
6116 Executive Blvd., Suite 602
Bethesda, MD 20892-8350
Telephone: (301) 443-0542
Email: ojeifojo@mail.nih.gov

Lyndon Joseph, Ph.D
Health Scientist Administrator
Division of Geriatrics and Clinical Gerontology
National Institute on Aging, NIH, DHHS
7201 Wisconsin Avenue, Suite 3C307
Bethesda, MD 20892-9205
Telephone: 301-496-5278
Email: Josephlj@nia.nih.gov 

Marie Mancini, Ph.D.
Program Director
Systemic Autoimmune Diseases Biology
Division of Skin and Rheumatic Diseases
NIAMS/NIH/DHHS
6701 Democracy Blvd., Suite 882
Bethesda, MD 20892
Telephone:  (301) 594-5032
Email:  mancinim2@mail.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
Email: ep61h@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
Email: lbeatty@nida.nih.gov

Peer Review Contact(s)

Steven Birken, Ph.D.
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Boulevard
Bethesda, MD  20892-4874
Bethesda, MD  20817-4874 (for express/courier service)
Telephone: (301) 435-0811
FAX: (301) 480-3660
E-mail: birkens@mail.nih.gov

Financial/Grants Management Contact(s)

Patience Musikikongo 
Office for Grants Management
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd.
Democracy I, Room 1036
Bethesda, MD 20817
Telephone: (301) 594-6268
Email: patience.musikikongo@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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.


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