Notice of Correction to PAR-15-304 "Clinical and Translational Science Award (U54)"

Notice Number: NOT-TR-16-009

Key Dates
Release Date:   February 12, 2016

Related Announcements
PAR-15-304
NOT-OD-16-007    

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

This Notice amends PAR-15-304 "Clinical and Translational Science Award (U54)" with updates to the Institutional Career Development Core and the Training Core component instructions effective for due dates on and after May 25, 2016:

  • The research training data table formats have changed and the new required tables are specified for the Institutional Career Development Core and the Training Core (see NOT-OD-16-007).
  • There are changes to the PHS 398 Research Training Program Plan form. The Program Plan attachment has been restructured to include  the Background, Program Plan, and Recruitment Plan to Enhance Diversity under one attachment. Previously, the form allowed for submission of three separate attachments for the Program Plan, Background, and Recruitment Plan.

Additionally, the FY15 NIH Prior Year Award link has been updated directly in the PAR-15-304 funding opportunity announcement.

Part 2. Section IV.2. Instructions for the Submission of Multi-Component Applications

Institutional Career Development Core

PHS 398 Research Training Program Plan (Institutional Career Development Core)

Current Language:

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Institutional Career Development Core.

Background: Provide the rationale for the proposed program, relevant background history, and the need for the research career development proposed. Indicate how the proposed program relates to current career development activities at the applicant institution.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Program Administration: Describe the acknowledged strengths, leadership and administrative skills, mentoring experience, scientific expertise, and active research of the Core Leader. Relate these strengths to the proposed management of the career development core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

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 scholars, and resources are robust enough to support additional programs. 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.

Program Faculty: The application must include information about the faculty who will be available to serve as mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stage(s). For any proposed faculty lacking mentoring experience, describe a plan to ensure successful scholar guidance by these individuals. Describe the criteria used to appoint and remove faculty and to evaluate their participation.

Proposed Career Development Program: Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the career development program is intended, including the training level(s) of the scholars, the academic and research background needed to pursue the proposed career development, and, as appropriate, plans to accommodate differences in preparation among scholars. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed career development. Describe how scholars will be educated in the human health- and disease-related aspects of their research career development.

Instruction in grant writing, the peer review process, and novel career development  opportunities (e.g., optional experiences in industry, community health centers, other CTSA hubs or research institutions, non-governmental organizations) is also encouraged, so that scholars obtain a working knowledge of career options and the steps required to transition successfully to the next stage of their chosen career.  Describe how knowledge will be fostered in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting.  Describe how flexibility to adapt to individual education needs will be provided.

Applicants should present a broad vision of the workforce needed to drive future innovation and implement effective clinical and translational research. Describe ideas for integrating a team science approach into career development, and for offering a research curriculum aligned to core competencies in translational research. Early exposure to collaboration leveraging disparate areas of expertise may enhance efforts to cultivate a team approach to tackle current challenges facing clinical research. The Institutional Career Development component will provide formal coursework, research experiences, and career guidance to postdoctoral scholars. The CTSA career development environment should serve as a hub for fostering high-impact research careers in translational research.

Harmonizing career development across a CTSA hub requires integrating clinical and translational science across multiple departments, schools, and clinical research institutes in a team science approach to research collaboration. Support for a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics or bioengineering) should be offered.

Distance training, sharing resources, and reciprocal exchanges of scholars/mentors are encouraged but not required.  They can address the research and career guidance needs of scholars and introduce interactive and innovative programs that include “real-world” exposure to different areas of translational research. 

Describe any plans to collaborate with other CTSA hubs. Collaboration in career development and research training initiatives is encouraged. Taking advantage of modern information technology, CTSA hubs should seek opportunities to share methods or online resources, and to disseminate tools.  

Program Evaluation: Describe a plan to review and determine the quality and effectiveness of the career development program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements. Applicants are expected to work with a CTSA program-wide initiative establishing common metrics across the CTSA network.

Candidates/Scholars: Describe, in general terms, the size and qualifications of the pool of candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective scholars. Describe specific plans to recruit candidates from underrepresented backgrounds and explain how these plans will be implemented (see also section on Recruitment Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for scholars’ reappointment to the program.

Institutional Environment and Commitment to the Program: Describe the environment for career development, emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from, quoting any historical data from the previous 5 years (as applicable). The sponsoring institution must assure support for the proposed core including assurance that sufficient time will be allowed for the Core Leader and other faculty to contribute to the proposed program and that there will be protected time for scholars (generally 9 person months, equivalent to 75%) selected for the program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed core from existing career development programs at the same scholar level, how the programs will synergize, if applicable, whether scholars are expected to transition from one support program to another, and how the faculty, pool of candidates, and resources are sufficiently robust to support the proposed career development in addition to existing ones.
In demonstrating their institutional commitment, applicants should describe any existing career development activities in translational research currently supported by the institution.

Modified language:
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Institutional Career Development Core.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Background: Provide the rationale for the proposed program, relevant background history, and the need for the research career development proposed. Indicate how the proposed program relates to current career development activities at the applicant institution.

Program Administration: Describe the acknowledged strengths, leadership and administrative skills, mentoring experience, scientific expertise, and active research of the Core Leader. Relate these strengths to the proposed management of the career development core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

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 scholars, and resources are robust enough to support additional programs. 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.

Program Faculty: The application must include information about the faculty who will be available to serve as mentors and provide guidance and expertise appropriate to the level of scholars proposed in the application. Describe the complementary expertise and experiences of the proposed faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stage(s). For any proposed faculty lacking mentoring experience, describe a plan to ensure successful scholar guidance by these individuals. Describe the criteria used to appoint and remove faculty and to evaluate their participation.

Proposed Career Development Program: Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the career development program is intended, including the training level(s) of the scholars, the academic and research background needed to pursue the proposed career development, and, as appropriate, plans to accommodate differences in preparation among scholars. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed career development. Describe how scholars will be educated in the human health- and disease-related aspects of their research career development.

Instruction in grant writing, the peer review process, and novel career development  opportunities (e.g., optional experiences in industry, community health centers, other CTSA hubs or research institutions, non-governmental organizations) is also encouraged, so that scholars obtain a working knowledge of career options and the steps required to transition successfully to the next stage of their chosen career.  Describe how knowledge will be fostered in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting.  Describe how flexibility to adapt to individual education needs will be provided.

Applicants should present a broad vision of the workforce needed to drive future innovation and implement effective clinical and translational research. Describe ideas for integrating a team science approach into career development, and for offering a research curriculum aligned to core competencies in translational research. Early exposure to collaboration leveraging disparate areas of expertise may enhance efforts to cultivate a team approach to tackle current challenges facing clinical research. The Institutional Career Development component will provide formal coursework, research experiences, and career guidance to postdoctoral scholars. The CTSA career development environment should serve as a hub for fostering high-impact research careers in translational research.

Harmonizing career development across a CTSA hub requires integrating clinical and translational science across multiple departments, schools, and clinical research institutes in a team science approach to research collaboration. Support for a range of disciplines (including medicine, dentistry, nursing, pharmacy, public health, epidemiology, biostatistics, bioinformatics or bioengineering) should be offered.

Distance training, sharing resources, and reciprocal exchanges of scholars/mentors are encouraged but not required.  They can address the research and career guidance needs of scholars and introduce interactive and innovative programs that include “real-world” exposure to different areas of translational research. 

Describe any plans to collaborate with other CTSA hubs. Collaboration in career development and research training initiatives is encouraged. Taking advantage of modern information technology, CTSA hubs should seek opportunities to share methods or online resources, and to disseminate tools.  

Program Evaluation: Describe a plan to review and determine the quality and effectiveness of the career development program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former scholars to help identify weaknesses and to provide suggestions for program improvements. Applicants are expected to work with a CTSA program-wide initiative establishing common metrics across the CTSA network.

Candidates/Scholars: Describe, in general terms, the size and qualifications of the pool of candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective scholars. Describe specific plans to recruit candidates from underrepresented backgrounds and explain how these plans will be implemented (see also section on Recruitment Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for scholars’ reappointment to the program.

Institutional Environment and Commitment to the Program: Describe the environment for career development, emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from, quoting any historical data from the previous 5 years (as applicable). The sponsoring institution must assure support for the proposed core including assurance that sufficient time will be allowed for the Core Leader and other faculty to contribute to the proposed program and that there will be protected time for scholars (generally 9 person months, equivalent to 75%) selected for the program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed core from existing career development programs at the same scholar level, how the programs will synergize, if applicable, whether scholars are expected to transition from one support program to another, and how the faculty, pool of candidates, and resources are sufficiently robust to support the proposed career development in addition to existing ones.
In demonstrating their institutional commitment, applicants should describe any existing career development activities in translational research currently supported by the institution.

Recruitment Plan to Enhance Diversity: Applicants are required to comply with the instructions for the Recruitment Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. Applications must include a description of their recruitment plans, 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. Information should be included on both successful and unsuccessful recruitment strategies. 

Current language:
Data Tables: The SF424 instructions provide a detailed description of required data tables. The Introduction to the Data Tables linked from the SF424 instructions specifies the tables that should be included for each type of application (new or renewal) and program.  Tables 2, 5B (Postdoctoral Trainees of Participating Faculty Members), 10 and 12B (Postdoctoral Trainees Supported by this Training Grant (Renewal Applications Only)) are required. Tables can be found at the following link:  http://grants.nih.gov/grants/funding/424/index.htm#data

Modified language:
Data Tables: The SF424 instructions provide a detailed description of the research training tables. The Introduction to the Data Tables linked under the SF424 instructions provides an overview of the tables, their contents, and the templates. Tables 2 and 8C are required for new, renewal, and revision applications, and the tables are posted in the following link: http://grants.nih.gov/grants/funding/424/datatables.htm

Part 2. Section IV.2. Instructions for the Submission of Multi-Component Applications

Training Core

PHS 398 Research Training Program Plan (Training Core)

Current language:
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Training Core.

Background: Provide the rationale for the Training Core and the need for the cross-training proposed. Indicate how the Training Core will relate to current training activities at the applicant institution.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Program Administration: Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Training Core Leader. Relate these strengths to the proposed management of the training core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

Program Faculty: The application must include information about the faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty and to evaluate their participation. For faculty proposed as mentors, describe available programs to enhance mentor skills or mentor coaching as needed.

Proposed Training: Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among trainees. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how trainees will be educated in the human health, disease related, and translational aspects of their research training.  Describe how training will be fostered in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting.   Evidence should be provided that the CTSA supported activities are synergistic (not duplicative) with other funded NIH T32 programs (as applicable).

Recognizing the scope of career opportunities, NCATS strongly encourages the use of Individual Development Plans for trainees, including for example areas such as problem solving, communication, team science, time management, and leadership skills, as well as career guidance.  See NOT-OD-14-113 .

Describe ideas for implementing training in team science, and for offering training options that are flexibly adapted to the individual trainee's needs and may include short-term training, dual-degree training, year-off training, and for postdoctoral trainees master’s level training.  Curricula should be aligned to translational research core competencies, and career guidance should be provided to trainees. Describe how flexibility to adapt to individual training needs will be provided. Advanced degree offering programs should be described including recruitment and plans for inter-disciplinary exposure.

Program Evaluation: NCATS is developing common metrics to measure the impact of the CTSA program, and will work with successful applicants on their implementation. Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program. This should include plans to engage faculty, professional staff, and trainees in educational efforts and obtain feedback from them to help identify weaknesses and to provide suggestions for program improvements (i.e., retention, diversity, and outcomes). Describe plans for tracking career progress among trainees.  Identify tools to assess program performance including evaluation of the curriculum, mentors, research training opportunities, and trainees.

Trainee Candidates: Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for trainees’ reappointment to the program.  Describe a plan to recruit across multiple disciplines including basic science, medicine, social science and allied health.

Institutional Environment and Commitment to the Program: The sponsoring institution must assure support for the proposed Training Core including assurance that sufficient time will be allowed for the Training Core Leader and other Faculty to contribute to the proposed training. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed Training Core from existing training programs at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed training in addition to existing ones.

Describe the training environment emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from quoting any historical data from the past 5 years (as applicable). Describe new areas of recruitment leveraging expertise from faculty.

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. Applications must include a description of plans to recruit a diverse trainee pool and may wish to include data in support of past accomplishments. Information should be included on both successful and unsuccessful recruitment strategies. 

Modified language:
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Training Core.

Program Plan: The Program Plan should be saved as a single pdf file and should consist of the following elements:

Background: Provide the rationale for the Training Core and the need for the cross-training proposed. Indicate how the Training Core will relate to current training activities at the applicant institution.

Program Administration: Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the Training Core Leader. Relate these strengths to the proposed management of the training core. Describe the planned strategy and administrative structure to be used to oversee and monitor the core.

Program Faculty: The application must include information about the faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty and to evaluate their participation. For faculty proposed as mentors, describe available programs to enhance mentor skills or mentor coaching as needed.

Proposed Training: Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among trainees. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how trainees will be educated in the human health, disease related, and translational aspects of their research training.  Describe how training will be fostered in rigorous research methodology that would help promote best practices among the next generation of researchers for minimizing bias in experimental design and reporting.   Evidence should be provided that the CTSA supported activities are synergistic (not duplicative) with other funded NIH T32 programs (as applicable).

Recognizing the scope of career opportunities, NCATS strongly encourages the use of Individual Development Plans for trainees, including for example areas such as problem solving, communication, team science, time management, and leadership skills, as well as career guidance.  See NOT-OD-14-113 .

Describe ideas for implementing training in team science, and for offering training options that are flexibly adapted to the individual trainee's needs and may include short-term training, dual-degree training, year-off training, and for postdoctoral trainees master’s level training.  Curricula should be aligned to translational research core competencies, and career guidance should be provided to trainees. Describe how flexibility to adapt to individual training needs will be provided. Advanced degree offering programs should be described including recruitment and plans for inter-disciplinary exposure.

Program Evaluation: NCATS is developing common metrics to measure the impact of the CTSA program, and will work with successful applicants on their implementation. Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program. This should include plans to engage faculty, professional staff, and trainees in educational efforts and obtain feedback from them to help identify weaknesses and to provide suggestions for program improvements (i.e., retention, diversity, and outcomes). Describe plans for tracking career progress among trainees.  Identify tools to assess program performance including evaluation of the curriculum, mentors, research training opportunities, and trainees.

Trainee Candidates: Describe, in general terms, the size and qualifications of the pool of trainee candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective Trainees. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for trainees’ reappointment to the program.  Describe a plan to recruit across multiple disciplines including basic science, medicine, social science and allied health.

Institutional Environment and Commitment to the Program: The sponsoring institution must assure support for the proposed Training Core including assurance that sufficient time will be allowed for the Training Core Leader and other Faculty to contribute to the proposed training. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed Training Core from existing training programs at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed training in addition to existing ones.

Describe the training environment emphasizing institutional strengths; broadly indicate which disciplines/departments candidates may apply from quoting any historical data from the past 5 years (as applicable). Describe new areas of recruitment leveraging expertise from faculty.

Recruitment Plan to Enhance Diversity: Applicants are required to comply with the instructions for the Recruitment Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide. Applications must include a description of their recruitment plans, 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.  Information should be included on both successful and unsuccessful recruitment strategies. 

Current language:
Data Tables: The required NRSA tables will differ depending on the type of application (new or renewal) and training focus [e.g., predoctoral, postdoctoral, or a combined (mixed) pre- and postdoctoral program]. The SF424 instructions provide a detailed description of required data tables. Tables can be found at the following link: http://grants.nih.gov/grants/funding/424/index.htm#data

Modified language:
Data Tables: The required data tables will differ depending on the type of application (i.e., new versus renewal/revision) and whether the program includes predoctoral training, postdoctoral training, short-term training, or mixed variations of these categories. Read the new category variations carefully and submit the appropriate set of data tables. The SF424 instructions provide a detailed description of the required data tables posted in the following link: http://grants.nih.gov/grants/funding/424/datatables.htm

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Petra Kaufmann, M.D., M.Sc.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0178
Email:  CTSAFOAQuestions@mail.nih.gov

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