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 Complementary and Alternative Medicine (NCCAM)

Funding Opportunity Title

Interdisciplinary Complementary and Integrative Health Clinical Research Training Award (T90/R90)

Activity Code

T90/R90 Interdisciplinary Research Training Award/Interdisciplinary Regular Research Training Award

Announcement Type

New

Related Notices

  • November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.

Funding Opportunity Announcement (FOA) Number

PAR-13-065

Companion Funding Opportunity

None

Number of Applications

Only one application per partnership is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

93.213    

Funding Opportunity Purpose

The National Center for Complementary and Alternative Medicine (NCCAM) is establishing this clinical research training program aimed at improving the capacity of the integrative health field to carry out rigorous research. This Funding Opportunity Announcement (FOA) will fund coherent and unified partnerships between institutions with research intensive environments (e.g., T32 and CTSA institutions) and institutions with curricula focused on clinical training of practitioners in complementary modalities and disciplines that also have faculty with a substantial interest in rigorous clinical research. The program will support mentored research training and hands-on experiences in clinical research, as well as trainee-focused developmental efforts including didactic activities in clinical research methodology, integrative health, and trainee-initiated pilot clinical research projects within NCCAM's research priority areas. The funded institutional programs are expected to generate a cadre of research clinicians who are able to participate fully in multi-disciplinary teams engaged in complementary and integrative health research.

Key Dates
Posted Date

December 20, 2012

Open Date (Earliest Submission Date)

February 4, 2013

Letter of Intent Due Date(s)

February 4, 2013, December 28, 2014, December 28, 2015

Application Due Date(s)

March 4, 2013, January 28, 2014, January 28, 2015, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June - July, 2013, 2014, 2015

Advisory Council Review

 October 2013, 2014, 2015

Earliest Start Date

December, 2013, 2014, 2015

Expiration Date

January 29, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, 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.


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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

Two National Health Interview Surveys (NHIS), conducted by the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention (CDC) in 2002 and 2007, showed that nearly 40 percent of adult Americans reported using some form of alternative and/or complementary medicine (CAM). The 2007 survey also showed that 12 percent of children are using some form of CAM. Despite this increase in CAM use and integration with conventional remedies and treatments, we still need to strengthen the evidence base for many CAM approaches through basic and clinical research. In addition, there is a dearth of clinical researchers who possess CAM scientific content as well as a limited pool of CAM practitioners with clinical research expertise. In order to remedy this situation, the National Center for Alternative and Complementary Medicine (NCCAM) of the National Institutes of Health (NIH) supports a variety of high-quality research training and career development opportunities aimed at increasing the number, quality, and diversity of well-prepared and skilled clinical investigators with knowledge and expertise in complementary health practices (https://nccam.nih.gov/training). The Center's long-standing commitment to research training and the development of a well-prepared diverse biomedical workforce continues in NCCAM's Third Strategic Plan and is specifically delineated in Strategic Objective Four Improve the Capacity of the Field to Carry Out Rigorous Research. As the Center moves forward with implementation of this plan NCCAM is establishing the Interdisciplinary Complementary and Integrative Health Clinical Research Training Award (T90/R90) program to support its research capacity building goals by furthering the development of a research workforce with the combination of scientific skills and clinical research experience needed for competitive, collaborative integrative health research.

NCCAM recognizes that developing a clinical research workforce with training and expertise in complementary and integrative health medicine will require a multi-institutional and interdisciplinary approach. Thus, this initiative will support research training at the postdoctoral level because of the expertise, skills and scientific content needed in areas of integrative health medicine. This program will bring together institutions with research intensive environments (e.g., Clinical and Translational Science Award (CTSA) institutions and National Research Service Award (NRSA) T32 institutions) that have the clinical research expertise, infrastructure and potential participant pool (i.e., Ph.D. and M.D.) for integrative health-related research training and institutions focused in complementary health practice that have the expertise, the curriculum and faculty, as well as the potential participants (i.e., Ph.D., N.D., D.A.O.M., D.C., D.O., D.N.P., etc.) for clinical research training. NCCAM has been supporting both types of institutions for the last decade using individual institutional research-training programs (i.e., NRSA T35 and T32; and R25 research education grant mechanisms). Thus, the next logical step in NCCAM’s research-training and workforce development efforts is to formalize collaborations between these institutions through a single joint-program.

The Interdisciplinary Complementary and Integrative Health Clinical Research Training Award (T90/R90) program will support coherent, cohesive and unified partnerships between institutions with research intensive environments (e.g., CTSA and T32 institutions) and institutions with curricula focused on clinical training of practitioners in complementary modalities and disciplines that also have faculty with a substantial experience in rigorous clinical research. The proposed T90/R90 partnership must provide evidence of successful collaborative efforts and demonstrated institutional synergy. Participating institutions must be committed to creating a comprehensive interdisciplinary complementary and integrative health clinical research training program that builds on the existing strengths, expertise, and infrastructure at all partnering institutions. It is expected that the proposed partnership will create a clinical research workforce development exchange where clinical researchers go to the institution focused on integrative health practice for training and hands-on experiences, and integrative health practitioners go to the institutions with research intensive environments for clinical research training and hands-on clinical methodology experiences. The proposed program administration will use a team-science approach that creates and secures cross-talk, cross-training, and cross-activities between the participating institutions.

NCCAM will use the NIH T90/R90 mechanism to fund the Interdisciplinary Complementary and Integrative Health Clinical Research Training Award (T90/R90) and the proposed program must have a T90 and a R90 component with supported activities aligned with the goals of the program. The expected outcomes of the program are:

a)  strong, established, stable, and sustainable long lasting research collaborations between the participating institutions;

b)  the creation of cadre of biomedical researchers with training, expertise, and practice in  complementary and integrative health who are qualified to apply for and complete competitive  clinical research projects and to participate fully in multi-disciplinary research teams; and

c)  the development of a cadre of complementary medicine practitioners with training, expertise,  and practice in complementary and integrative health who are qualified to apply for and     complete competitive clinical research projects and to participate fully in multi-disciplinary research teams.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution, but the proposed research training experiences must be distinct from those research training programs currently receiving Federal support.

Within the framework of NIH and NCCAM longstanding commitment to excellence, NCCAM's Third Strategic Plan, as well as the projected need for investigators in particular areas of research, attention must be given to recruiting trainees from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences, individuals with disabilities, and individuals from disadvantaged backgrounds.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (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.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Grantees are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Award Project Period

The maximum period is 5 years.

Other Award Budget Information
Stipends, Tuition, and Fees (R90) and Participant Costs (R90)

Program-supported Trainees (T90) and Participants (R90) will be appointed to the program following the guidance provided in Section III. Item 3. Additional Information on Eligibility: T90/R90 Program-Supported Trainees/Participants. This section also provides guidance and information on Trainee stipends and Participant salaries.

NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award.

The most recent stipend, tuition, and fee levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Trainee (T90) and Participant (R90) Travel

Trainee/Participant travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense. 

Training Related Expenses (T90) and Other Program Related Expenses (R90)

NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. The most recent levels of training related expenses are described on the Ruth L. Kirschstein National Research Service Award (NRSA) site.  Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Other Trainee/Participant-associated costs must be justified as specifically required for the proposed research-training developmental activities. These expenses must be itemized in the proposed budget.

Personnel Costs: Individuals designing, directing, and implementing the research-training and 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 Trainees and Participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with Trainees and Participants are non-reimbursable from grant funds.

Limited program-related administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when they are in accordance with applicable cost principles.  For institutions covered by OMB Circular A-21, this type of training program may qualify as a “major project” where administrative salaries are allowable as a direct cost.  When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

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.

Travel costs for the program PD(s)/PI(s) to attend the annual T90/R90 meeting should be included in the budget.

Indirect Costs

For both T90 and R90 components, 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

Governments

Other

Applicants must propose a T90/R90 partnership consisting of one institution with research-intensive environment (e.g. CTSA and/or T32 institution) and one institution focused in complementary health practice. Partnerships defined by departments/schools within the same institution as single entities are not allowed. Participating institutions must have their own separate DUNS number or NIH IPF number. Since only one institution can receive a notice of award for the T90/R90 mechanism, at the time of submitting an application the partnership must decide which institution will be the applicant institution that will submit the application on behalf of the partnership. This decision must be based in available infrastructure and resources to support and sustain rigorous scientific clinical research and history of receiving and managing external research funds. At the time of award, the applicant institution will administratively manage the program and will make a sub award/contract to the PARTNERING institution. It is expected that both institutions have the appropriate management and financial infrastructure and support to comply with the management of federal funds.

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.

Foreign Institutions

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (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(s)/PI(s)) 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 6 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(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), 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.

Since the T90/R90 program consists of a partnership and collaborative effort, applicants are strongly encouraged to use a team-science approach and include a multiple PD(s)/PI(s) administrative/management model. If the applicant selects the multiple PD(s)/PI(s) administrative/management model, these individuals should be part of the collaborative implementation team or committee (CIT) that will be responsible for the implementation of the proposed 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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) Application Guide.

Mentors

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as 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 award. Mentors in the proposed T90/R90 program must be established independent research investigators with externally-funded research projects in areas pertinent and aligned to NCCAM's mission and research priorities.

T90/R90 Program-Supported Trainees (T90) and Participants (R90)

The proposed T90/R90 program will provide support to Trainees (T90) and Participants (R90) actively engaged in research-training activities. The collaborative implementation team or committee (CIT) will select and appoint individuals to each of the program components as follows: T90 Trainees – these are individuals appointed to the T90 component of the program and who receive a stipend following NRSA policy guidelines; and R90 Participants – these are individuals appointed to the R90 component of the program and who receive salary commensurate with their active participation in this component of the research-training program. Salary rates must be established using institutional policies for individuals in similar positions, regardless of the source of funds, and their level should be comparable to the stipend levels defined in the NRSA policy guidelines.

Training Appointment Duration: Appointments should be at least one year in length. Trainees and Participants may be reappointed for up to two additional years (on either T90 or R90 component or combined).

Academic Degree/Credentials: The research-training program is aimed at the postdoctoral level only, thus trainees must have received, as of the beginning date of the appointment to the program, a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable.

Kirschstein-NRSA institutional research training grant must be used to support a program of full-time research training. Within the full-time training period, research Trainees/Participants who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. The program may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training except when those studies are part of a formal, combined research degree program, such as the MD/PhD. Similarly, Trainees/Participants may not accept NRSA stipend (T90) or salary (R90) support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Citizenship: Details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement. In brief, Trainees (T90) and Participants (R90) must be U.S. citizens or non-citizen nationals or permanent residents of the United States.

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:

Alberto L. Rivera-Rentas, Ph.D.
Program Officer, Training Portfolio
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Blvd., Ste. 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: 301-443-8372
Email: riverara@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 SF424 (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. with the following additional page limits:

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following modifications:

Applicants are strongly encouraged to clearly delineate the R90 component and its elements accordingly by substituting all references to “trainees” in the SF 424 (R&R) Application Guide with “participants” and all references to “training” in the SF 424 (R&R) Application Guide with “participants' research-training development” as needed.

Project Summary /Abstract

Provide an abstract of the entire application, including the long-term goals and objectives of the program. Include the rationale and design of the program, the planned duration of the program and the projected number of trainees/participants, including their levels (i.e., predoctoral, postdoctoral).

Other Attachments

Use the "Other Attachments" to upload a single attachments called "Program Overseeing Committees.pdf"

The Program Overseeing Committees” must have three (3) overseeing components:

a)    Advisory Board.  The Advisory Board should include members with significant expertise in the areas related to the proposed program

b)    Collaborative Implementation Team or Committee (CIT). The Collaborative Implementation Team or Committee (CIT) should include equal representation from the participating institutions and their members should have the authority to make both institutional and programmatic decisions. The CIT will be responsible for the implementation phase of the proposed program including the selection of program-supported participants.

c)    Assessment and Evaluation Team. The Assessment and Evaluation Team will be responsible for the evaluation component that must use quantitative and qualitative methods to assess program outcomes at the participant and the institutional levels. Applications without an evaluation plan will not be reviewed.

Advisory Board: Describe the composition of the advisory board, identifying the role and the desired expertise of members. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Note that proposed advisory board members should NOT be named in the application, particularly if they include individuals from outside the institution. However, renewal applications with advisory board should include names of existing external advisors.

Collaborative Implementation Team or Committee (CIT):  Describe the composition of the CIT, include the names of the representatives of each institution, identifying the role and the desired expertise of members. Composition, responsibilities, frequency of meetings, and other relevant information should be included. A plan for CIT approval and selection of program-supported participants should be included. Describe how the CIT will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program.

Assessment and Evaluation Team: The proposed program must select either an individual or a team to complete this task. Describe how evaluator(s) will function in implementing the proposed program evaluation/assessment plan and the evaluation of the overall effectiveness of the program. In general, evaluators must have formal training and experience in evaluation methodology and statistics demonstrated by publications and/or reports in the field. Responsibilities usually include preparing reports and recommendations for the PD(s)/PI(s) and institutional administrators; interacting with program staff and staff from other campus-wide student academic preparation and educational collaboration and research training programs; making recommendations of new administrative structures, policies and procedures; establishing and maintaining contact with institutional officials for the collection and exchange of information; gathering data and information; finding and evaluating alternative solutions; and making recommendations for program direction. The evaluator(s) may also provide the conceptual framework for institutional change and suggest ways of reducing the resistance to change. He/she/they will provide training and technical assistance, as necessary, to staff and to collaborators to insure integrity and adequacy of data capture and reporting.

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

Senior/Key Person Profile

Members of the Collaborative Implementation Team or Committee (CIT) and the Assessment and Evaluation Team should be considered key personnel and should include biosketches.

Training and Research & Related (R&R) Budget Component

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

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the additional instructions described below:

Particular attention must be given to the required Training Data Tables. Applications without the required Training Data Tables will not be reviewed.

Applicants are strongly encouraged to clearly delineate each T90/R90 component and its elements accordingly. For the R90 component, please substitute all references to “trainees” in the SF 424 (R&R) Application Guide with “participants” and all references to “training” in the SF 424 (R&R) Application Guide with “participants' research-training development” as needed.

Program Administration (Component of Program Plan)

Describe the strengths, leadership and administrative skills, and scientific expertise of the Training PD/PI. Include the planned strategy and administrative structure to be used to oversee and monitor the program. For applications with multiple PDs/PIs, address the Leadership Plan and how the combined knowledge, skills and experience of the individual PDs/PIs will enhance the likelihood of success of the program. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application. The PI(s)/PD(s) of the awarded T90/R90 grants are expected to attend an annual meeting organized by the grantee institutions on a rotating basis.

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise and experiences of the proposed mentors. Provide an overview of their active research and other scholarly activities, as well as track records of mentoring and training.

Proposed Training (Component of Program Plan)

Provide an overview of the proposed program and describe the immediate and long-term objectives of the proposed T90/R90 program. The activities supported by the T90 component of the program will occur at the institutions with research-intensive environments using the NRSA Training guidelines. It must include a clinical research training postdoctoral practicum consisting of:

a)mentored clinical research training;

b)career development and scientific activities in clinical research;

c)hands-on experiences in clinical research; and

The R90 component of the program will occur at the institutions with demonstrated expertise in training complementary medicine practitioners. It must be focused in participants' development in interdisciplinary complementary and integrative health clinical research. This component must include:

a)didactic activities in clinical research methodology;

b)scientific and professional career development activities (e.g., technical workshops, research seminar series, grantsmanship);

c)  integrative health scientific  development activities;

d)  seed funds to program-supported participants for the development of competitive complementary and integrative health clinical research pilot projects within; and NCCAM's research priority areas.

Applicants may include additional activities in any of the components that they deem appropriate to address participant-specific academic and research needs and that will significantly contribute to their development as successful independent investigators. In addition, applicants may include didactic and curricular development activities designed to improve the institutional capacity and participants' skills in clinical research such as courses and/or certifications in integrative health clinical research. Include information about planned courses, curricula, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. In order for the trainees and participants to fully benefit from the proposed program, applicants are strongly encouraged to design and develop programs where trainees and participants experience activities implemented at each of the partnering institutions. Institutional program-supported activities (i.e., seminars, conferences, workshops) should not be confined to trainees or participants of the T90/R90 programs, but rather should be open to anyone interested.

Both participating institutions must have a strong and high quality curriculum and research program in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs occurring at the partnering institutions and that a substantial number of program faculty will have active research projects in which program-supported participants may gain relevant experiences consistent with their research interests and goals. Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential Trainees/Participants, and resources are robust enough to support additional programs.

The PD(s)/PI(s) should also describe past research career development activities/experiences including those of mentors, documenting the success of former trainees in establishing independent productive scientific careers. Programs should provide all Trainees/Participants with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future fellowships as eligible and career development and independent research support. Thus, applicants should provide detailed plans to transition Trainees /Participants to other research and/or career opportunities. All postdoctoral Trainees/Participants should also be provided with instruction in laboratory and project management.

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine the effectiveness of the program. This should include plans to obtain feedback from current and former Trainees (T90) and Participants (R90) to help identify weaknesses and to provide suggestions for program improvements, as well as plans for assessing Trainees’ and Participants’ career development and progression. Evaluation results should be included in future competing continuation (renewal) applications and in the Final Progress Report.

Specified evaluation metrics should be tied to the goals of the program. The evaluation plan must be based on appropriate literature and cited methodology. Benchmarks should be specified and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the program in achieving its objectives. The plan should be designed to assess and evaluate how the proposed program progresses toward meeting its specific aims, measurable objectives, goals, and outcomes. Some examples of outcomes metrics for programs involving postdoctorates and early career investigators include (but are not limited to):

a)subsequent participation in a formal research training or career development program in complementary and integrative health clinical research;

b)subsequent participation in basic, clinical or translational research as independent investigator; authorship of scientific publications;

c)subsequent independent research grant support from NIH or another source.

The evaluation must provide useful information to the PD(s)/PI(s) and the institutions for improving the program. Thus, the emphasis of the evaluation activities in the plan should be on:

a)assessment of the overall impact of the program both at the individual and institutional level;

b)improvement of the overall program outcomes;

c)informing the senior leadership in deciding which elements of the program should be institutionalized; and

d)assessing the effectiveness of the partnership as well as the team-science approach.

Trainee (T90) and Participant (R90) Candidates (Component of Program Plan)

Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training and the expected career level required for the program. Do not name prospective Trainees and Participants. Describe plans to recruit and select candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the evaluation criteria to be used in the selection of Trainees and Participants. Provide brief summaries of training plans that the program will employ. The application should contain a description of how training plans will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences.

Institutional Environment and Commitment to the Program (Component of Program Plan)

The application must include a statement from the applicant institution describing the commitment to the planned program. The institution must assure that essential time will be allowed for the PD(s)/PI(s), other faculty and mentors, and the required protected time for Trainees/Participants selected for the program.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide. 

Letters of Suport

Include Letters of Support for all members of the Collaborative Implementation Team or Committee (CIT) and the Assessment and Evaluation Team.

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 and NIH Guide Notice NOT-OD-11-100

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before 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 before the deadline 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. The National Research Service Award (NRSA) policies apply to this program. A T90/R90 appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the T90/R90 program.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a Trainee/Participant has actually been appointed and the appropriate paperwork submitted to the NIH awarding component.

Rebudgeting between the T90 (NRSA) and R90 (non-NRSA) components of the award is not allowed.

6. Other Submission Requirements and Information

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.

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 by the Office of Scientific Review of the National Center for Complementary and Alternative Medicine (NCCAM), NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Applicants are advised to refer to Agency Contacts for exceptions.

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 score to reflect their assessment of the likelihood for the program 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.

Training Program and Environment

Partnership: Are the partnership arrangements reasonable for the scope of the proposed program? Have the participating institutions established a cohesive, coherent and unified partnership that will secure strong, stable, sustainable, and long lasting research and research-training collaborations? Are the research facilities and research environment conducive to preparing Trainees/Participants for successful careers as biomedical scientists? How well and in what ways does this program interact with other research education and research training programs at the participating institutions?

Institutional Commitment: Is a significant level of institutional commitment to the program evident? Is the institutional commitment to the proposed program appropriate? Is there sufficient assurance that the required effort of the PD(s)/PI(s), mentors, Trainees (T90) and Participants (R90) will be devoted directly to the research training, career development, and related activities?

Program Management: When applicable, is there adequate documentation describing the responsibilities of the advisory committee, collaborative implementation team or committee (CIT), and, assessment and evaluation team with regard to the provision of input, guidance and oversight of the program?

Program Design: Are the objectives, design, direction, and quality of the proposed research training program appropriate? Do the objectives, design and direction of the proposed research program ensure effective training? Does the proposed program provide suitable training for the levels of Trainees/Participants being proposed and the area of science to be supported by the program? Is the proposed program of training likely to ensure that Trainees/Participants will be prepared for successful and productive scientific careers? Do the proposed program-supported activities and research training experiences address state-of-the-art science relevant to the aims of the program? Is the quality of proposed developmental activities and training experience appropriate for all levels of Trainees/Participants to be included in the program? Does the program provide training in inter- or multi-disciplinary research and/or provide training in state-of-the-art or novel methodologies and techniques? Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate? Does the proposed program clearly outline a plan to recruit and develop well-qualified Trainees/Participants for successful careers as biomedical or clinical researchers? Does the application include a detailed plan to transition Trainees/Participants to other research and/or career opportunities after participation in the proposed program?

Applicant Pool: Is there evidence of an adequate pool of potential Trainees/Participants who could benefit from receiving career development support? Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD(s)/PI(s) have the scientific background, expertise, and experience to provide strong leadership, direction, management, and administration of the proposed research training program? Do the PD(s)/PI(s) plan to commit sufficient time to the program to ensure its success? Is there evidence that an appropriate level of effort will be devoted by the PD(s)/PI(s) to ensure program objectives? Do the PD(s)/PI(s) bring complementary and integrated expertise to the program? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

For applications designating multiple PD/PIs: Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the Trainees/Participants? Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and with the complementary expertise of each of the PD(s)/PI(s)? Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program? Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

Mentors

Are sufficient numbers of experienced mentors with appropriate expertise and funding available to support the number and level of Trainees/Participants proposed in the application? Do the mentors have strong records as researchers, including successful competition for research support in areas directly related to the proposed research training program? Do the mentors have expertise and experience, as well as track records of past mentoring and training? Are the quality and extent of the mentors’ roles in providing guidance and scientific advice to the Trainees/Participants acceptable? Are the mentors currently engaged in relevant research? Is there evidence of a successful past training record of the PD(s)/PI(s) and mentors, including the success of former Trainees/Participants in seeking independent support and establishing productive scientific careers?

Trainees/Participants

Is a recruitment plan proposed with strategies to attract high quality Trainees/Participants? Are there well-defined and justified selection criteria and retention strategies? Is a competitive applicant pool in sufficient numbers to warrant the proposed size and level of the training program in evidence?

Training Record

How successful are the Trainees/Participants (or for new applications, other past students/fellows in similar training) in completing the program? How productive are Trainees/Participants (or for new applications, other past students/fellows) in terms of research accomplishments and publications? How successful are Trainees/Participants (or other past students/fellows) in obtaining further training appointments, fellowships, and career development awards? How successful are the Trainees/Participants in achieving productive scientific careers, as evidenced by successful competition for research grants, receipt of honors or awards, high-impact publications, receipt of patents, promotion to scientific leadership positions, and/or other such measures of success? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former Trainees/Participants and monitoring Trainees’/Participants' subsequent career development?

Is there a record of retaining health professionals in research training or other research activities for at least two years?

Are plans presented to follow the careers of Trainees/Participants and to assess the effect of the training program on subsequent career choices?   

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

Evaluation

Are the evaluation plan and timeline adequate for assessing the effectiveness of the program in achieving its goals and objectives? If applicable, are the plans for obtaining feedback from participants adequate to measure the quality and effectiveness of the partnership and team-science approach? Is the evaluation plan based on appropriate literature and cited methodology? Does the plan adequately describe how the program outcomes will be determined and evaluated? Will the planned evaluation appropriately assess how the proposed activities will enhance the academic preparation and competitiveness of the Trainees /Participants? Does the proposed evaluator(s) have the appropriate background and credentials to complete the proposed evaluation plan?

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 and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical and behavioral science. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the training experience? Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program's evaluation?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 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. Plans and past record 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 training program, level of trainee experience, and the particular circumstances of the Trainees/Participants, the reviewers will address the following questions.  Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework 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, and laboratory safety?  Do the plans adequately describe how faculty will participate in the instruction?  Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? If this is a renewal, is there a report describing past instruction in the five components described above? Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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).

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 NCCAM, 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:

Applications will be assigned on the basis of established PHS referral guidelines to the National Center for Complementary and Alternative Medicine (NCCAM). 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 National Advisory Council for Complementary and Alternative Medicine (NACCAM). 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.

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 the DUNS, SAM 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.

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.

Inventions and Copyrights

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements 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. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

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.

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. 

Other Reporting Requirements

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. Evaluation results should be included as part of the final Progress Report.

4. 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 from databases and from participants themselves. Participants 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.

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)

Alberto L. Rivera-Rentas, Ph.D.
Program Officer, Training Portfolio
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: (301) 443-8372
Email: riverara@mail.nih.gov

Peer Review Contact(s)

Dale Birkle Dreer, Ph.D.
Chief, Office of Scientific Review
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: (301) 451-6570
Email: birkled@mail.nih.gov

Financial/Grants Management Contact(s)

George Tucker, M.B.A.
Chief Grants Management Officer
National Center for Complementary and Alternative Medicine (NCCAM)
Telephone: (301) 594-9102
Email: tuckerg@mail.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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.


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