Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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 will not be reviewed

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

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) enhance the diversity of the biomedical, behavioral and clinical research workforce; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The over-arching goal of this NIMHD R25 program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce. To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

• Couses for Skills Development: CRECD awards will provide opportunities to support implementation of courses designed to develop knowledge and skills for postdoctoral participants in clinical research leading to a Master of Science in Clinical Research or Master of Public Health or Master in Population Health.
• Research Experiences: CRECD awards will provide research experiences for postdoctorates, clinical and research fellows and early stage investigators to develop a diverse cadre of clinical and translational investigators who will pursue clinical and/or population health research as part of the translational, patient-oriented and/or population health research workforce, particularly on diseases that disproportionately impact health disparity populations.

Background

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. This program is to support educational activities that enhance the diversity of the biomedical, behavioral and clinical research workforce. This program encourages institutions to diversify their student and faculty populations and thus to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral and social sciences research enterprise, as described in NOT-OD-15-053. Since the program does not support high school or undergraduate participants, the disadvantaged background category (C1 and C2) is not applicable.

NIMHD Interest In Diversity

The NIMHD’s mission is to conduct and support research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to facilitate the education of participants from diverse backgrounds underrepresented in biomedical research to pursue clinical research, translational and/or patient-oriented research, particularly on diseases that disproportionately impact minority and health disparity populations.

By increasing the number of students from underrepresented groups pursuing advanced training in the clinical research, NIMHD strives to ensure that the future generation of minority health and health disparities researchers draws from the entire pool of talented individuals, bringing different aptitudes, perspectives, creativity, and experiences to address complex scientific problems.

Need for the Program

There is a critical need for trained clinical researchers in several health areas that disproportionately affect health disparities and underserved populations. Published reports from AAMC, the National Academy of Sciences, the American Federation For Medical Research, NSF and others 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.nsf.gov/statistics/wmpd/2013/race.cfm

(see Ginther et al., http://science.sciencemag.org/content/333/6045/1015.full and http://sites.nationalacademies.org/cs/groups/pgasite/documents/webpage/pga_057621.pdf).

NIMHD and the ICs participating in this FOA recognize this need and realize that through the development of programs in institutions whose historical mission is educating and training individuals from groups underrepresented in the biomedical sciences, that include education and 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 diverse underserved communities is greatly enhanced.

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 through providing grant support to institutions that offer doctorate degrees in the health professions or in a health-related science . These institutions historically have educated and trained professionals from diverse backgrounds who provide health care to health disparities 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 courses for skill development to educate postdoctoral participants in clinical research leading to a Master of Science in Clinical Research or Master of Public Health or Masters in Population Health; and (2) support research experiences to develop a group of clinical researchers who have the necessary knowledge and skills to pursue clinical research and can become part of translational, population health and/or patient-oriented research, particularly on diseases that disproportionately impact minority and health disparity populations.

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 improve existing courses and offer structured didactic programand mentored clinical research project leading to a degree in Master of Science in Clinical Research or Master of Public Health or Masters in Population Health for participants; (2) Phase II of the program will provide continued research experiences to the CRECD Phase I graduates for up to three years in clinical research as part of their education and skill development to become independent clinical, translational and population health 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 underserved Americans.

The Program Director/Principal Investigator (PD/PI) leads a multi-disciplinary CRECD Advisory Committee (CAC) to design, develop, implement and evaluate the progress of Phase I participants and the CRECD graduates who are continuing through Phase II of the clinical research education and training.

Phase I (Didactic program courses for skill development in clinical research):

• Phase I will allow the selected participants who are junior faculty, postdoctoral candidates, clincial or research fellows; and candidates with health professional doctoral degrees in clinical research areas such as medical, dental, nursing, pharmacy and other health profession to complete requirements including course work and a mentored research project that will lead to either aMaster of Science in Clinical Research degree or aMaster of Public Health or Masters in Population Health degree.
• The program must include multi-disciplinary, didactic course work and collaborative project in clinical and translational research for participants to enhance their research skills.

Phase II (Mentored clinical research experiences):

• The primary intent of Phase II is to develop researchers who will pursue careers as independent clinical research scientists.
• Phase II of the award will provide up to three years of support for clinical/translational research experience to the graduates of CRECD program. This additional research experience should allow the participant to continue working toward establishing his/her own independent research program as clinical research scientists leading to applications for individual mentored career development (K) or research grant (R series) awards.
• The participants should propose a research project in an area(s) that is in accordance with the research interests of the NIH co-funding partners. Each participant should be assigned at least one lead mentor.
• Support for the Phase II participants is contingent upon review and recommendation by the mentor, institutional CAC and the PD/PI. It is expected that participants who completed Phase I should transition to Phase II without any delays. Delays in transition will be considered only in circumstances such as personal or family situations involving child or elder care, medical conditions, military service or disability.
• For programs with already established courses, recently graduated Phase I participants are eligible to participate in the Phase II of the award, however, support for these scholars may not exceed a total of three years.
• The participant, mentor(s) and the PD/PI will be responsible for all aspects of the program.

Research Scope:

CRECD applications are intended to reflect the plans and priorities of the participating NIH Institutes and Centers as well as the clinical research education program available to participants and how it relates to one or more of the areas of interest.

The National Institute on Minority Health and Health Disparities (NIMHD) supports research on the many aspects of minority health and health disparities from genetic, molecular, and biologic science to clinical, behavioral, and translational research, as well as research on health systems, workforce development, and environmental justice. NIMHD is interested in the full continum of causes of health disparities and the interrelation of these causes.

The National Institute on Drug Abuse (NIDA) is the lead federal agency supporting scientific research on drug use and its consequences. Our mission is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. NIDA is interested in supporting CRECD participants conducting research on issues related to drug abuse and addiction such as: (1) understanding the complex interactions of factors influencing drug use trajectories; (2) accelerating development of treatments; (3) addressing real-world complexities; and (4) advancing bidirectional translation.

The National Cancer Institute is particularly interested in supporting participants whose research focus and career development activities are in the area of cancer or cancer health disparities research.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

See Section VIII. Other Information for award authorities and regulations.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-Serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Additional information regarding the eligibility of applicant organizations:

• To be eligible for this FOA, applicant institutions must be institutions in the United States or its territories which award doctorate degrees in the health professions or the sciences related to health and have a historical mission of educating and training individuals groups that have been shown by the National Science Foundation (see http://www.nsf.gov/statistics/wmpd/) to be underrepresented in biomedical research enrolled in their graduate or professional programs.
• The applicant institution must have received less than an average of $50 million/year in support from the NIH for the past three fiscal years;
• Institutions that have a documented track record of recruiting, retaining, training, and graduating underrepresented students as defined by NSF (see above), which has resulted in the demonstrable outcome of increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers.
• The institution must be accredited to award a Masters in Clinical Research or Masters of Public Health or Masters in Population Health.
• Institutions that already hold a CRECD grant and are in their final year of funding are eligible to apply under this FOA. Eligible institutions that have not received previous CRECD awards may also apply under this FOA.

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (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.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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.

CRECD participants are those who will receive support in the form of salaries/wages under this program. Participants must be U.S. citizens or permanent residents.

The program can include as participants junior faculty and postdoctoral candidates who seek to combine their clinical doctorate degree with a Masters of Science in Clinical Research or a Masters of Public Health or Masters in Population Health 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

Applicants must obtain 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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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 will not be reviewed.

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

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Thomas Vollberg, Sr., PhD
Telephone: 301-594-8770
Email: [email protected]

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional 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.

Other Attachments. Provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

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 courses, the approval of the education and research plans and interim monitoring of the program.

Provide a description of how the CAC will function in providing oversight of the CRECD program including 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.

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

Follow all instructions provided in the SF424 (R&R) Application Guide.

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. Include each individual's degree and departmental affiliation (or equivalent) and, if a consortium of institutions, each person s institutional affiliation. Provide biographical sketches for the PD/PI, mentors, and other participating faculty.

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

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Use the section on Participant/Trainee Support Costs to include allowable categories of funds requested to support participants in the program.
• Include any travel funds requested for senior/key persons and other personnel associated with the research education program. Include funds participants to attend an annual meeting in Bethesda, Maryland.
• For Participant Costs, include 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 form are needed, describe in Other. State the number of Participants to be supported by the proposed research education program. For the budget categories other than salary, specifically identify the requested costs under each budget category (e.g., supplies, travel) for each participant by name or position (if the position is to be filled), and the total for each individual cannot exceed $20,000.

Follow all instructions provided in the SF424 (R&R) Application Guide.

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

Research Strategy

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
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Diversity Recruitment Plan
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. 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 distinguish between the activities in the proposed research education program and the research training supported by the training program.

Provide a brief description of the following to address the anticipated value-added of the CRECD program to participating institutions

Rationale that led to identification of areas selected for improvement at the participating institutions and for incorporating particular courses for skills development and research experiences into the proposed CRECD program;

Proposed Research Education Program:

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

For Phase I (didactic courses for skill development in clinical research), the Education and Research Experience Plan must include:

• the background, purpose and objectives of the CRECD program;
• a description of the requirements that participants willcomplete that will lead to either a degreein Master of Science in Clinical Research or Master of Public Health or Master in Population Health;
• a description of the proposed courses that includes an explanation of how the courses for skill development are linked to the purpose and objectives of the CRECD program and to the research career development of participants, Describe how CRECD courses are innovative relative to other courses available at the institution(s).
• a description of other didactic opportunities utilizing any existing courses or curricula within the institution(s);
• a description of the research activity and experiences that will be offered by the mentors to the participants in the program;
• a description of plans that provide examples of education and researchexperiences for participants that will prepare them to design, implement, and participate in multidisciplinary clinical research projects;
• plans for monitoring participants' progress.

For mentored Phase II:

• provide a description of the process for selection of participants and mentors, requirements of mentors; and their research plans, and mentoring and research experience activities;
• provide a description of the process CAC will use for recommending the selection and evaluation of the participants who are continuing the mentored training through the CRECD award.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator 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. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs; their leadership approach, and governance appropriate for the planned project.

Provide a description of the 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.

Provide evidence that appropriate level of effort will be devoted by the program leadership to ensure the program's objectives

Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.

Provide a description of the faculty research mentors, related to the conduct of clinical research. Provide evidence of the availability and commitment of the faculty mentors for the duration of the proposed CRECD program.

Program Participants.

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

Describe the criteria and procedures for identification, selection and retention of CRECD students into the program. Provide description of recruiting strategies, the size of the participant pool expected, and any other institutional programs that might compete for this pool (include strategies for addressing this competition);

Institutional Environment and Commitment. 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 (see below). 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 be considered incomplete and administratively withdrawn .

Progress Report (For Renewal applications only):

For renewal applications, a detailed Progress Report must be included. Applications with more than one previous funding cycle must provide information on the past consecutive funding cycles. In the report, state the original goals and specific aims, anticipated milestones and outcomes, as well as a summary of the specific accomplishments of the CRECD program.

• Accomplishments and successes of the overall CRECD program in increasing diversity;
• Information highlighting Phase I participants who attended and graduated from the program;
• Current status and career plans, grants awarded with source and publications for both Phase I and Phase II participants;
• Courses that are already in place and those that need to be developed/adapted to address the needs of the participants and meet the objectives of the program;
• Any novel courses developed that are critical to the education and training of clinical investigators working in the area of health disparities. If proposing substantial changes in the CRECD courses developed, provide adequate justification.

Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

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 data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

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

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double

Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds 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:

• Individuals who applied for admission to the research education program,
• Individuals who were offered admission to the research education program,
• Individuals who participated in the research education program.

For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who 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 will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to 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 not be reviewed.

Evaluation Plan. Applicants must describe a detailed process and outcome evaluation plan to review and determine the effectiveness of the program. This should include a detailed formative and summative evaluation plan. The application must also 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. The evaluation plan should describe a process for receiving feedback from participants to help identify weaknesses and provide suggestions for program improvements.

The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

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 participants. The outcome measures for the participatants should include, 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.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment.

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following Guide:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

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

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide with the following modifications . An Appendix is not permitted. Applications that submit an appendix will not be reviewed.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Add Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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 System for Award Management (SAM). 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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, behavioral, and clinical research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: The goal of this R25 program is to support educational activities to improve diversity for research in the health sciences by developing the research workforce in clinical and translational sciences through providing grant support to institutions whose historical mission is educating and training individuals from groups underrepresented in the biomedical sciences that offer doctorate degrees in the health professions or in a health-related science.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

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 program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program? How well does the proposed program address the NIH's intent of supporting education programs and enhance research experiences that prepare diverse underrepresented participants as independent investigators in clinical and translational minority health and health disparities research?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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? How strong is the 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 courses adequate? ? How are the mentors involved in clinical research or research methods?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience? Is the CRECD courses considered innovative relative to other curricula available at the institution(s)?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Does the courses provide the participants a basis to enhance their research skills? Are the proposed research activities and experiences adequate for increasing the knowledge and skill of diverse participants? 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 in clinical research available? Are the criteria used for selecting these participants appropriate to meet the proposed goals of the program? 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 and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions? Are the institution, the PD/PI, and the faculty and mentors supportive and committed to meet the education 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?

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 score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.

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

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 score.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019. The review panel’s evaluation will be included in the summary statement. Plans 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

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

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) Genomic Data Sharing Plan..

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.

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 . Following initial peer review, recommended applications will receive a second level of review by the NIMHD National Advisory Council. The following will be considered in making funding decisions:

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

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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.

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’s 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) 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 RPPR Instruction Guide.

In addition, the annual progress report should provide 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 NIMHD 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:

• Progress of individual participants: A brief paragraph for each participant describing the research and didactic training experiences completed and ongoing, as well as the specific future plans for satisfying the Core Requirements of the Program;
• A report from the CAC summarizing the recommendations of the CAC during the last year, evaluating the performance of the program in meeting its objectives and the intent of the CRECD program, evaluating the effectiveness of recruitment strategies, and providing recommendations for improving the program (e.g., new mentors, changes in Core Requirements, changes in recruitment strategies etc.) (3-5 page limit).
• Describe what has been learned through the program evaluation and any changes made in the program as a result of the evaluation. You may append your assessment tools (i.e., questionnaires) to the Progress Report. Include answers to the following questions in your update (3-5 page limit):
• 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)?
• Success of the participants who have completed the CRECD program: This information is essential for assessing the effectiveness of this program and must be provided in the progress report. The participants should be tracked after the completion of this program for periodic updates on various aspects of their employment history, publications, support for research grants or contracts, honors and awards related to scholarly activity, and other information helpful in evaluating the impact of the program. Applications with more than one previous funding cycle should provide information on a minimum of past two consecutive funding cycles.

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 MD _______ (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.

A final progress report 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.

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

The evaluation of the overall CRECD program is distinct from each individual award’s outcome evaluation. 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). Common Assessment will be developed by participating ICs.

In evaluating this research education program NIMHD expects to use the following evaluation measures that will include, but are not limited to:

• Career outcomes of CRECD participants in terms of publications that impact health disparities;;
• Contributions made in the field of clinical research impacting areas in health disparities,drug abuse, cancer, among others;
• Does the CRECD program develop a diverse group of clinical research scientists?
• Are these institutions able to create a stable environment for education and training underrepresented clinical researchers who can address health disparities ?
• Does participation in CRECD affect the career outcomes of participants do they pursue clinical research?
• What are the best practices and noteworthy outcomes in educating and mentoring participants to become clinical research investigators?
• Aggregate number and demographic characteristics of participants
• Subsequent educational/career progress of participants, including:

  Successful completion of Phase I and Phase II CRECD program

  New knowledge or skills acquired in clinical/translational research

  Subsequent participation in a formal research training or career development program

  Subsequent participation of underrepresented (UR) students in clinical research

  Subsequent employment of UR participants in a research or research-related field

  Subsequent independent research grant support from NIH or another source

  Enhanced student engagement in research as reflected by authorship on peer-reviewed papers and presentations at scientific conferences

  Number and percentages of CRECD alumni who enter the biomedical workforce and at what stage in their academic career

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Rina Das, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-496-3996
Email: [email protected]

Albert Avila, Ph.D.
National Institute on Drug Abuse, NIH/DHHS
Telephone: 301-496-8804
Email: [email protected]

John O. Ojeifo, MD, PhD, MBA.
National Cancer Institute
Telephone: 240-276-6186
Email: [email protected]

Thomas M. Vollberg, Sr., PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8770
Email: [email protected].

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Pam Fleming
National Institute on Drug Abuse NIDA
Telephone:301-253-8729
Email: [email protected]

Carol Perry
National Cancer Institute NCI
Telephone:240-276-6282
Email: [email protected]

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.

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 Part 75.