PHS 398 Research Training Program Plan

PHS SF 424 (R&R) Forms Version C Application Guide

8.7 Research Training Program Plan Form

 

Before preparing the Research Training Program Plan, be sure to check the specific instructions in the Funding Opportunity Announcement (FOA) to which you are responding. Contact the appropriate PHS awarding component, which may have further advice or suggestions on completing your application, including the data tables mentioned below.

Note that there are page limits for certain sections. Follow the page limits for the Institutional Research Training and Career Development Applicants, Including Ruth L. Kirschstein NRSA Application in the Table of Page Limits at http://grants.nih.gov/grants/forms_page_limits.htm, unless specified otherwise in the FOA. Please see NOT-OD-11-039 and NOT-OD-11-076.

The information provided in required data tables (Data Tables 1-8, described below) will not be counted toward the page limitation. These tables should be numbered consecutively and titled as shown. Additional tables required by the FOA or generated by the applicant may be included in the Research Training Program Plan; however, these tables will count as part of the page limit. Additional tables not specified in these instructions should be identified by letter, rather than number to avoid confusion with the sequentially numbered required tables.

The instructions for Data Tables 1-8 are located on the OER website at http://grants.nih.gov/grants/funding/424/index.htm#datatables. Please read the Introduction to the Data Tables before beginning to prepare your application. This section includes important definitions that should be used consistently both in the Data Tables and in all other parts of the application. The Data Tables should be included in the application at the point indicated and should not be inserted in the narrative.

The Research Training Program Plan should include sufficient information needed to evaluate the proposed program, independent of any other document (e.g., previous application). Be specific and informative, and avoid redundancies.

Research Training Program Plan Attachments

(See also Section 2.3.2 Creating PDFs for Text Attachments.)

Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.

Text attachments should be generated using word processing software and then converted to PDF using PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems for the agency handling the application. In addition, be sure to save files with descriptive file names.

Do not include any information in a header or footer of the attachments. A header will be system-generated that references the name of the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered.

Since a number of reviewers will be reviewing applications as an electronic document and not a paper version, applicants are strongly encouraged to use only a standard, single-column format for the text. Avoid using a two-column format since it can cause difficulties when reviewing the document electronically.

Full-sized glossy photographs must only be included within the page limitations of the Research Training Plan. The maximum size of images to be included should be approximately 1200 x 1500 pixels using 256 colors. Figures must be readable as printed on an 8.5 x 11 inch page at normal (100%) scale.

Investigators must use image compression such as JPEG or PNG. Do not include figures or photographs as separate attachments either in the Appendix or elsewhere in the application.

Separate Attachments

Separate attachments have been designed for the Research Training Program Plan sections to maximize automatic validations conducted by the eRA system. When the application is received by the agency, all of the Research Training Program Plan sections will be concatenated in the appropriate order so that reviewers and agency staff will see a single cohesive Research Plan.

When attaching a PDF document to the actual forms, please note you are attaching an actual document, not just pointing to the location of an externally stored document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised document to the application form. Use the “View Attachment” button to determine if the correct version has been attached.

Follow page limitations as specified in Funding Opportunity Announcements.

All applications and proposals for NIH funding must be self-contained within specified page limitations. Agency validations will include checks for page limits. Note that while these computer validations will help minimize incomplete and/or non-compliant applications, they do not replace the validations conducted by NIH staff. Applications found not to comply with the requirements may be delayed in the review process. Unless otherwise specified in an NIH solicitation, internet website addresses (URLs) may not be used to provide information necessary to the review because reviewers are under no obligation to view the internet sites. Moreover, reviewers are cautioned that they should not directly access an internet site as it could compromise their anonymity.

Notice of Proprietary Information

Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. However, when the application contains information that constitutes trade secrets, or information that is commercial or financial, or information that is confidential or privileged, make sure you have checked “Yes” in the “Other Project Information” form.

When information in the application constitutes trade secrets or information that is commercial or financial, or information that is confidential or privileged, it is furnished to the Government in confidence with the understanding that the information shall be used or disclosed only for evaluation of this application. However, if a grant is awarded as a result of or in connection with the submission of this application, the Government shall have the right to use or disclose the information to the extent authorized by law. This restriction does not limit the Government’s right to use the information if it is obtained without restriction from another source.

Although the grantee institution and the PD/PI will be consulted about any such release, the PHS will make the final determination. Any indication by the applicant that the application contains proprietary or privileged information does not automatically shield the information from release in response to a Freedom of Information Act (FOIA) request should the application result in an award (see 45 CFR Part 5). If an applicant fails to identify proprietary information at the time of submission as instructed in the application guide, a significant substantive justification will be required to withhold the information if requested under FOIA.

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program

• Faculty, Trainees, and Training Record

• Other Training Program Sections

• Appendix

Begin each text section of the Program Plan with a section header (e.g., Background, Program Plan, etc).

Introduction

Field Name

Instructions

1. Introduction to Application (for Resubmission or Revision only)

Use only if Type of Application is Resubmission or Revision The Introduction must fit within the page limits for Institutional Research Training and Career Development Applications in the Table of Page Limits at http://grants.nih.gov/grants/forms_page_limits.htm. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.

Training Program Section

Field Name	Instructions
2. Program Plan	The Program Plan must fit within the page limits for Institutional Research Training and Career Development Applicants, Including Ruth L. Kirschstein NRSA Application in the Table of Page Limits at http://grants.nih.gov/grants/forms_page_limits.htm, unless specified otherwise in the FOA. Please see NOT-OD-11-039 and NOT-OD-11-076. Background: Provide the rationale for the proposed research training program, relevant background history, and the need for the research training proposed. Indicate how the proposed program relates to current training activities at the applicant institution. Summarize the research training activities of the major participating unit(s) and department(s) represented in the proposed program. Use these data to document the environment in which the proposed training program will take place. If required by the FOA, complete Tables 1-3 and summarize those data here. Table 1. Census of Participating Departments and Interdepartmental Programs. Describe the organization of the proposed training program, the participating departments and interdepartmental programs, and the extent to which faculty, graduate students, and/or postdoctorates from those departments/interdepartmental programs participate in the programmatic activities to be supported by the training grant. Table 2. Participating Faculty Members Describe the distribution of participating faculty by academic rank, department or interdepartmental program, areas of research emphasis, and the rationale for the faculty selected to participate in the training grant. Analyze the data in terms of the overall experience of the faculty in training predoctorates and/or postdoctorates. Comment on the inclusion of faculty whose mentoring records may suggest limited, recent training experience at either training level (predoctoral or postdoctoral). Table 3. Federal Institutional Research Training Grant and Related Support Available to Participating Faculty Members Summarize the level of research training support at the institution. Comment on instances where the tabular data indicate that there may be substantial overlap of participating faculty. Program Plan: Utilize the appropriate Training Tables to summarize and describe the Program Plan according to the following instructions. NOTE: Applicants for institutional career development awards (e.g., K12s) must complete a Research Career Development Program Plan instead of the Training Program Plan. Refer to specific instructions in the FOA. Please see NOT-OD-11-039 and NOT-OD-11-076. a. Program Administration. Describe the Program Director's qualifications for providing leadership of the program, including relevant scientific background, current research areas, experience in research training and administrative experience. Indicate the Program Director's percent effort devoted to the proposed program. Describe the administrative structure of the program and the distribution of responsibilities within it, including the means by which the Program Director will obtain continuing advice with respect to the operation of the program. If multiple PD/PIs are proposed, explain in this section your rationale for how this will facilitate program administration. In addition, you must complete the Multiple PD/PI Leadership Plan. b. Program Faculty. Describe each faculty member's research that is relevant to the program and indicate how trainees will participate in the research. Provide information on the extent to which participating faculty members have cooperated, interacted, and collaborated in the past, including joint publications and joint sponsorship of student research. Use this section to document the ability of the faculty to support the research activities of the proposed trainees, the training record of the faculty members, and the success of their trainees in generating publishable research results. If required by the FOA, complete Tables 4-5 and summarize this data, as well as data previously provided in Table 2, here. Table 4. Research Support of Participating Faculty Members Analyze the data in terms of total and average grant support. Additionally, comment on the inclusion of faculty without research grant support in the proposed training program and explain how the research of trainees who may work with these faculty members would be supported. Table 5A. Publications of Those in Training: Predoctoral Summarize these data, including, for example, the average number of publications, how many students published as first author, and how many students completed doctoral training without any first-author publication resulting from their graduate research. Table 5B. Publications of Those in Training: Postdoctoral Summarize these data, including, for example, the average number of papers published by postdoctorates, the number as first author, and the number of postdoctorates who completed training without any peer-reviewed publications. Table 5C. Publications of Those in Training: Undergraduate Summarize these data, including, for example, the average number of publications and how many students published their work. For new applications, and if required by the FOA, see the instructions for Table 5A, 5B and/or 5C, as applicable, and list publications for trainees who are representative of those who would be appointed if the grant is awarded. For Renewal applications, these data constitute part of the Progress Report (see Progress Report below). c. Proposed Training. Describe the proposed training program. Indicate the training level and number of trainees. For postdoctoral trainees, indicate the proposed distribution by degree (e.g., M.D., Ph.D.). Describe course work, research opportunities, professional development that is part of the proposed training, the extent to which trainees will participate directly in research, and the duration of training, i.e., usual period of time required to complete the training offered. For multi-disciplinary and/or multi-departmental programs, indicate how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how they will relate to an individual trainee's experience. For training programs that emphasize research training for clinicians, describe the interactions with basic science departments and scientists. Include plans for ensuring that the training of these individuals will provide a substantive foundation for a competitive research career. Generally, a minimum of 2 years of research training is required for all postdoctoral trainees with health professional degrees. Describe fully any trainee’s access to and responsibility for patients, including time commitment. Provide representative examples of programs for individual trainees. Include curricula, degree requirements, didactic courses, laboratory experiences, qualifying examinations, and other training activities, such as seminars, journal clubs, etc. Describe how the mentor and research problems are chosen, how each trainee's program will be guided, and how the trainee's performance will be monitored and evaluated, including the use of individual development plans, if applicable. If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line from the NIH hESC Registry cannot be identified, provide a strong justification for why an appropriate cell line cannot be chosen from the Registry at this time d. Training Program Evaluation. Describe an evaluation plan to review and determine the quality and effectiveness of the training program. This should include plans to obtain feedback from current and former trainees to help identify weaknesses in the training program and to provide suggestions for program improvements. In addition, describe plans for assessing trainee’s career development and progression, including publications, degree completion, and post-training positions. Evaluation results are to be included in renewal (competing continuation) applications and as part of the Final Progress Report. e. Trainee Candidates. Describe recruitment plans, including the sources and availability of trainees; the qualifications of prospective trainees; and the criteria and procedures by which trainees will be initially selected and reappointed to the program. If required by the FOA, complete Tables 6A and/or 6B Applicants, Entrants, and their Characteristics for the Past Five Years, and summarize the data in terms of the overall numbers of potential trainees, their credentials, characteristics, and eligibility for support, and enrollment trends. f. Institutional Environment and Commitment to Training. Include information in the application that documents the support and commitment of the applicant institution and participating units and departments to the goals of the proposed program. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for additional trainees in the program, or any other creative ways to improve the environment for the establishment and growth of the research training program. Qualifications of Trainee Candidates and Admissions and Completion Records Describe the ability of the participating departments/programs to recruit and retain trainees through the completion of their training, the selectivity of the admissions process, and the success of the departments/programs in recruiting individuals from diverse backgrounds. Discuss the quality and depth of the applicant pools, including both training grant eligible and non-training-grant eligible individuals; and the competitiveness of the program. Report the number and characteristics of current program participants and their distribution by department and mentor. For renewal/revision applications, describe the selectivity of appointments to the training grant, as represented by the current program participants. Use all of this information to justify the number of positions requested. If required by the FOA, complete Tables 6-8 and summarize this data here. Recruitment Plan to Enhance Diversity: A Recruitment Plan to Enhance Diversity is required for all training grant activity codes except T34, T36, U2R, and all D-series activity codes. The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. (NOT-OD-15-053). Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as: Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf. Individuals from disadvantaged backgrounds, defined as: Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. The disadvantaged background category (C1 and C2) is applicable only to programs focused on high school and undergraduate candidates. Note: this group is generally NOT part of the recruitment plan for predoctoral and postdoctoral trainees on institutional training grants (e.g., T32). New applications must include a description of plans to enhance recruitment including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments. Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information should be included on both successful and unsuccessful recruitment strategies. History and Achievements. Describe efforts to recruit trainees from Diversity groups A and B, as well as group C (when applicable), into the existing training program. For competing continuation/renewal applications, also describe past efforts to recruit underrepresented minority students and individuals with disabilities into training grant funded positions. If required by the FOA, refer to the data presented in Tables 6 and 7, as applicable. Use these data to document the success of the program in recruiting trainees who are under-represented and provide information on their support. Proposed plans. Describe steps to be taken during the proposed award period regarding the identification, recruitment, and retention of graduate students and postdoctorates from Diversity groups A and B, as well as group C (when applicable). Consider the success and/or failures of recruitment strategies used in the past. In particular, describe the specific efforts to be undertaken by the training program and how these might relate to the recruitment efforts of the medical school, graduate school, and/or the university at large. In most cases, institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Applications without a Recruitment Plan to Enhance Diversity will be considered incomplete and will not be reviewed. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
3. Plan for Instruction in the Responsible Conduct of Research	A plan for Instruction in the Responsible Conduct of Research (RCR) is required for all training grant activity codes except T36. Every trainee must receive instruction in the responsible conduct of research. See Supplemental Instructions Part III Section 1.16 for information on the NIH Policy on Training in the Responsible Conduct of Research (RCR). Please see NOT-OD-11-039. New applications must include a plan for instruction in the responsible conduct of research. The plan should address how applicants plan to incorporate the five instructional parts outlined in the NIH Policy on Training in the Responsible Conduct of Research: format, subject matter, faculty participation, duration, and frequency. In addition, the plan must describe how participation in RCR instruction will be monitored. In addition, Renewal applications must describe any changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current RCR instruction. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
4. Plan for Instruction in Methods for Enhancing Reproducibility	New and Renewal applications must include a plan for instruction in methods for enhancing reproducibility through scientific rigor and transparency. The plan should address how applicants plan to incorporate the areas outlined in the NIH Guide Notice on “Enhancing Reproducibility through Rigor and Transparency” (NOT-OD-15-xxx). Scientific rigor is the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. This includes full transparency in reporting experimental details so that others may reproduce and extend the findings. In addition, the plan must describe how participation in rigor and transparency instruction will be monitored. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
5. Multiple PD/PI Leadership Plan	If you wish to submit a multiple PD/PI application, you must provide a Leadership Plan. Do not submit a leadership plan if you are not submitting a Multiple PD/PI application. For applications designating multiple PD/PIs, all such individuals must be assigned the PD/PI role on the Senior/Key Profile form, even those at organizations other than the applicant organization. Refer to the instructions in Section 5.5 (Research Plan Form), Multiple PD/PI Leadership Plan. However, the emphasis in a training grant multiple PD leadership plan should be on how it will benefit the program and the trainees. A single Contact PD must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD when necessary. Because training programs are intended to be coherent, NIH will not allocate the budget or training positions between multiple PDs. A single award will be made. Multiple PD plans should include reasonable numbers of PDs and each should be included for a specific purpose. Multiple-PD applications should not include all mentors of the training grant as PDs, except in unusual cases. For background information on the Multi-PD/PI initiative, see: http://grants.nih.gov/grants/multi_pi/index.htm. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
6. Progress Report (Renewal Applications Only)	Indicate the period covered and briefly describe the accomplishments of the training program. Describe any specific effects of this training program on curriculum and/or research directions. Describe how the funds provided under Training Related Expenses were used to benefit the program. For each trainee supported during the period covered, describe their activities and progress, including the following information, as applicable: Mentor(s) Description of the trainee/scholar’s research project and progress Coursework Honors Workshops attended Career development activities If required by the FOA, complete required Data Tables, with the following additional instructions, below: For current trainees and previous trainees appointed to the training grant and still in training, complete Table 5, Publications of Those in Training, and summarize the data presented in this table in the application. Note that a MyBibliography report of publications arising from work conducted by trainees while supported by the training grant is not required at the time of submission, but will be requested as Just-in-time (JIT) information prior to award. Referring to Table 7, describe the utilization of awarded training positions. If any trainee positions were not filled, provide an explanation. Referring to relevant versions of Table 8 (e.g. 8A, 8B, 8C and/or 8D as appropriate), describe how training positions are used (i.e., distribution by mentor, year in program, years of support per trainee) and the success of the program in achieving the training objectives of the prior award period(s). If any postdoctoral trainee with a health professional degree was appointed to a Kirschstein-NRSA training grant for less than 2 years of research training, explain why. For past trainees, describe the extent of their current involvement in research, including research grant support received subsequent to completion of the training program. Use the progress report narrative to provide information that is not readily presented in the required tables. Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information should be included on both successful and unsuccessful recruitment strategies. Renewal applications must describe the type of instructions provided in the current project period, the degree of student participation, the results of any assessments, and other relevant information. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.

Faculty, Trainees, and Training Record Section

Field Name	Instructions
7. Participating Faculty Biosketches	Faculty Biosketches for participating faculty should follow the Additional NIH and other PHS Agencies Instructions for a Biographical Sketch, except that a personal statement is not required for participating faculty. These should be attached as a single document to avoid having to upload large numbers of separate documents. However, the Biosketches of the Program Director and other Senior/Key Personnel should also be entered as described under SF424 (R&R) Section 4.5 Senior/Key Person Profile (Expanded) Form. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
8. Letters Of Support	Attach appropriate letters here from all individuals confirming their roles in the project. Letters documenting any agreements between the Program Director(s) and senior administration officials or other institutional officials are not required but may be included. For consultants, letters should include rate/charge for consulting services. The Program Director should check the FOA (particularly for non-NRSA programs) to determine if any program-specific letters of support are required. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
9. Data Tables	Instructions for Data Tables 1-8 mentioned above are located on the OER website at the following URL http://grants.nih.gov/grants/funding/424/index.htm#datatables. These instructions include an Introduction to the Data Tables that provides instructions applicable to all tables, information about where to find specific instructions for each table, and Sample Data Tables. The Sample Data Tables illustrate the kind of data to include in each table for Kirschstein-NRSA training grant applications. Be sure to choose the Instruction and Blank Data Table set that corresponds to the type of application you are submitting, e.g., New, Renewal, or Revision Application, and the kind of training to be provided, e.g., predoctoral only, postdoctoral only, pre and postdoctoral mixed, postdoctoral and short-term mixed. Instructions for use in other training grant, institutional career development, and research education grant applications will be included in relevant FOAs. Save this information in a single file in a location you remember. Start each numbered table on a new page. Click Add Attachment, browse to where you saved the file, select the file, and then click Open. User-defined bookmarks in the Data Tables attachment will be retained in the assembled application image after submission to facilitate easy navigation between tables. Start each numbered table on a new page, and separately bookmark each table in the PDF attachment. Many PDF generators will automatically create bookmarks from text formatted using predefined Heading styles in Word.

Other Training Program Sections

Field Name	Instructions
10. Human Subjects	Complete this section if you answered “yes” to the question “are human subjects involved?” on the R&R Other Project Information Form. If trainee participation in research involving human subjects is solely as part of other research projects and no portion of the Training Grant Award will be used to support this research; describe how the institution will ensure that trainees only participate in (a) exempt human subjects research or (b) non-exempt human subjects research that has IRB approval. In training programs where trainees will design and conduct their own independent human subjects research, follow the instructions in Supplemental Instructions Part II, Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
11. Data Safety Monitoring Plan	Refer to Part II, Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan. Complete this section if you answered “yes” to Item 2 Clinical Trial of the Cover Page Supplement Form. Follow the instructions provided in the Application guide and the FOA regarding the attachment
12. Vertebrate Animals	Complete this section if you answered “yes” to the question “are Vertebrate Animals Used?” on the R&R Other Project Information Form. If the training program involves the use of live vertebrate animals solely as part of other research project grants, and no portion of the Training Grant Award will be used to support the purchase, use, or husbandry of live vertebrate animals in this research; , describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval In training programs where trainees will design and conduct their own independent vertebrate animal research, follow the instructions in Part I, 5.5, (Research Plan Form), Vertebrate Animals. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
13. Select Agent Research	If participating faculty proposed in the training program are conducting or plan to conduct research involving select agents in which trainees may participate, follow the instructions in Section 5.5, (Research Plan Form), Select Agent Research. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
14. Consortium and Contractual Arrangements	Describe any programmatic, fiscal, or administrative arrangements between the applicant organization and other participating organizations. See Section 5.5, Consortium/Contractual Arrangements for additional guidance. Save this information in a single file in a location you remember. Click Add Attachment, browse to where you saved the file, select the file, and then click Open.
15. Appendix	Do not use the appendix to circumvent the page limitations of the Training Plan. All appendix material must be submitted as PDF attachments. A summary listing all of the items included in the appendix is required, and should be the first PDF file of the Appendix. Applications that do not follow the appendix requirements will not be reviewed. Research publications of trainees and mentors are not normally included as part of the Training Grant applications, but are allowed. Note that only publications reflecting on the activities of the program as a whole may be included. When publications are allowed, appendix materials should be limited to those which are not publicly available, such as: Manuscripts and/or abstracts accepted for publication but not yet published. Published manuscripts and/or abstracts where a free, online, publicly available journal link is not available. Patents directly relevant to the project. Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Biographical Sketch. Note that for renewal applications, a My NCBI report of publications arising from work conducted by trainees while supported by the training grant is not required at the time of submission, but will be requested as Just-in-time (JIT) information prior to award. Do not include unpublished theses or abstracts/manuscripts submitted but not yet accepted for publication. Some materials other than publications that are unique to training grant applications (but not typically included in research grant applications) may be included as appendices. In general, the appendix may be used to provide samples of materials that are referred to in the body of the application, but are too cumbersome to include in the Research Training Program Plan without disrupting the narrative flow. Examples include: Syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, etc.; Retreat, seminar series, and other program activity agendas and schedules; Examples of forms used to document trainee progress and monitoring by the program; Examples of materials used in recruitment and particularly recruitment to enhance diversity of the applicant pool; As a reminder, tables other than the required Data Tables 1-8, must be incorporated into the Research Training Program Plan. Follow the page limits for the Institutional Research Training and Career Development Applicants, Including Ruth L. Kirschstein NRSA Application in the Table of Page Limits at http://grants.nih.gov/grants/forms_page_limits.htm, unless specified otherwise in the FOA. These additional tables must not be included in the appendix materials.

8.8 Training Grant Peer Review Process

The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of criteria below in assigning the application’s overall score, weighting them as appropriate for each application. Reviewers will first determine the quality of the proposed research training program, including information presented in the data tables and appendix, and then consider whether the requested number of trainee positions is appropriate for the program.

The general process information (Overview, Streamlining, and Dual-Level Peer Review) found in Part I.6 applies to training grant applications as well. However, the actual review criteria and other review considerations are different.

Review Criteria:

• Training Program and Environment

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

• Preceptors/Mentors

• Trainees

• Training Record

Review Criteria for Institutional Career Development Awards (e.g. K12):

• Career Development Program and Environment

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

• Mentors

• Candidate/Scholars

• Training Record

Additional Review Criteria:

• Protection of Human Subjects from Research Risk

• Inclusion of Women, Minorities and Children in Research

• Care and Use of Vertebrate Animals in Research

• Biohazards

• Resubmission Applications

• Renewal Applications

Additional Review Considerations:

• Training in the Responsible Conduct of Research

• Training in Methods for Enhancing Reproducibility

• Recruitment Plan to Enhance Diversity

• Budget and Period of Support

Applicants should carefully review the applicable FOA for complete information associated with the peer review process. The FOA will describe essential information to be submitted for each of the above elements.

Part I: Instructions for Preparing and Submitting an Application