Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Library of Medicine (NLM)

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title
NLM Institutional Grants for Research Training in Biomedical Informatics and Data Science (T15 Clinical Trial Not Allowed)
Activity Code

T15 Continuing Education Training Grants

Announcement Type
Reissue of RFA-LM-16-001
Related Notices
  • April 15, 2021 Notice of Correction for RFA-LM-21-001. See Notice NOT-LM-21-007.
Funding Opportunity Announcement (FOA) Number
RFA-LM-21-001
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.879, 93.855
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites training grant applications for support of predoctoral and postdoctoral training for research careers in biomedical informatics and data science. Applications may be for the creation of entirely new programs or for the renewal of existing NLM training programs. Such training helps meet the growing need for investigators trained in biomedical computing, data science and related information fields as they directly relate to application domains in health and biomedicine, including health care delivery, basic biomedical research, clinical and translational research, public health surveillance, consumer health and similar areas.

This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

Key Dates

Posted Date
March 25, 2021
Open Date (Earliest Submission Date)
April 14, 2021
Letter of Intent Due Date(s)

April 14, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 14, 2021 May 14, 2021 Not Applicable July 2021 October 2021 July 2022
Expiration Date
May 15, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Training (T) Instructionsin the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of the National Library of Medicine (NLM) Institutional Training Program in Biomedical Informatics and Data Science is to support pre-doctoral and post-doctoral training for research careers in biomedical informatics and data science. Applications may be for the creation of entirely new training programs or for the renewal of existing NLM training program grants. NLM's training programs help meet the growing need for investigators trained in biomedical computing, data science and related information fields as they directly relate to application domains in health and biomedicine, including health care delivery, basic biomedical research, clinical and translational research, public health and similar areas. Biomedical informatics and data science training is, by its nature, interdisciplinary. Trainees will come to these programs with a range of educational and professional backgrounds and receive the training they need to prepare them for research careers in biomedical informatics and data science. More information about NLM's existing training programs is available at http://www.nlm.nih.gov/ep/GrantTrainInstitute.html.

Graduates of the NLM-supported programs should be able to conduct original basic or applied research at the intersection of computer, statistical and information sciences with one or more biomedical application domains. Successful graduates of these programs will be prepared for research-oriented roles in academic institutions, not-for-profit research institutes, governmental and public health agencies, pharmaceutical and software companies, and health care organizations. This initiative is not intended to prepare trainees for careers emphasizing planning, deployment, maintenance, or administration of computer systems in health care, public health, medical education or research. The emphasis in this program is on the development of new knowledge that advances the scientific disciplines of biomedical informatics and data science.

Program Considerations

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

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

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all.

This program encourages institutions to diversify their student and faculty populations and thus to enhance the participation of individuals currently underrepresented in the biomedical, clinical, behavioral and social sciences research enterprise, as described in NOT-OD-20-031.

Institutional research training grants must be used to support a program of full-time research training. Within the full-time training period, research trainees 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.

NLM has not endorsed a single approach or curriculum for research training in biomedical informatics, or a preferred career path after training. The proposed training in a required core curriculum should include informatics and data science principles and concepts, quantitative methods, such as biostatistics and applied mathematics, concepts of computer science, engineering, information sciences and/or other relevant fields, and instruction on the design of rigorous, reproducible research studies in biomedical informatics and data science. This core curriculum should be supplemented by other courses and research experience in one or more biomedical application domains so that trainees acquire an appropriate depth of knowledge to pursue meaningful research. They should have experiences specifically designed to promote the integration of basic informatics/data science methods and the relevant application domain(s). Beyond the core curriculum, trainees should have opportunities for advanced training in those fields basic to informatics (computer, statistical, information, social/behavioral sciences and other fields) that prepares them for their research projects and their thesis or dissertation work. Throughout their training, they should have meaningful, supervised research experiences of gradually increasing sophistication—culminating in an independent research project that may be a thesis or dissertation pursuant to an academic degree. It is expected that trainees will disseminate the results of their research at national meetings and in peer-reviewed publications during and after the training period. Graduates of these programs are expected to be capable of carrying out independent research at a level of sophistication compatible with publication of results and competition for research grants and contracts.

The training offered by a program must lead to one or more of the following educational end-points, depending on the educational background of the trainee. The first end-point is pertinent to predoctoral trainees; the other two end-points are pertinent to postdoctoral trainees:

  • For individuals entering training without any type of doctoral degree, the end-point must be a PhD or other doctoral degree in informatics or a related field. Trainees who are, at the time of application for informatics training, matriculated in programs leading to a doctoral-level health professional degree (i.e., an MD/PhD program), may be supported as predoctoral trainees for their informatics PhD training.
  • For individuals entering training with a doctoral degree in a health profession or an area of science other than informatics, the end-point of post-doctoral training must be either a research-oriented masters or a doctoral degree in biomedical informatics (or related field).
  • For individuals entering the program with doctoral training in informatics or a closely related information field, the end-point of post-doctoral training must be enhanced preparation for a research career in biomedical informatics resulting from a research-intensive non-degree program.

Applicants may propose training programs in one or more of the four basic areas for research training in informatics and data science listed below. Special tracks that emphasize informatics and data science training may also be proposed within this general framework. The basic informatics and data science training areas are:

  • Health care/clinical informatics (HC): Applications of informatics and data science principles and methods to direct patient care, such as advanced clinical decision support systems and multimedia electronic health records, to the provision of informational support to health care consumers. Special tracks may be offered for nursing informatics, dental informatics, imaging informatics, or other appropriate clinical themes.
  • Translational bioinformatics (TB): Applications of informatics and data science principles and methods to support 'bench to bedside to practice' translational research, such as genome-phenome relationships, pharmacogenomics, or personalized medicine. Special tracks might be offered in health effects of environmental factors, genome-wide association studies (GWAS), intelligent tools for curation, visualization and analysis of biomedical big data, precision medicine or other similar areas.
  • Clinical research informatics (CR): Applications of informatics and data science principles and methods to support basic clinical trials and comparative effectiveness research. Special tracks might be offered in areas such as big data integration and analytics, biostatistics, in-silico trials, merging and mining large disparate data sets that mix images, text and data, reducing and eliminating bias in clinical and genomic data sets.
  • Public health informatics (PH): Applications of informatics and data science principles and methods to build integrated resources for population research, for decision support in public health agencies, to support regional or global health research, or syndromic surveillance. Special tracks might be offered in areas such as health effects of climate change; environmental surveillance for indicators of potential pandemic agents
  • Consumer health informatics (CH): Applications of informatics and data science principles and methods to address and support the needs of individuals to gather, manage, understand and use data and published information about their personal health. Special tracks might be offered in areas such as health literacy, tailored information design for patients, design of personal health libraries.

In addition to full-time training, NLM supports short-term trainee positions (STTPs) to develop or enhance interest in research careers in biomedical informatics and data science among pre-doctoral health professions or veterinary students, graduate students who are interested in careers in biomedical informatics and data science, and for postdoctoral fellows interested in a research career in this area. In conjunction with institutions' regular recruiting strategies, NLM encourages its institutional training programs to recruit a diverse pool of prospective candidates for STTPs, including individuals from under-represented racial and ethnic groups; individuals with disabilities, individuals from disadvantaged backgrounds, and women, who are still under-represented in scientific and technical fields such as biomedical informatics and data science. See, Notice of NIH's Interest in Diversity. All applicants are expected to present a rigorous recruitment plan to enhance the diversity of the pool of trainee candidates; if STTP slots are requested, those should be addressed in the overall recruitment plan. Applications requesting STTP slots without an effective recruitment plan will not be considered for STTP funding. The STTP program provides short-term support for a period of at least 8, but no more than 12, weeks in a grant year for full-time training experiences under the supervision of experienced researchers. Trainees are exposed to individuals with active research careers and learn about further research training opportunities and research career options. The STTP program should be of sufficient depth to enable selected trainees, upon completion of the program, to have a thorough exposure to the principles underlying the conduct of research in biomedical informatics and data science.

Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training. Short-term positions should be requested at the time of application as described in the NIH Grants Policy Statement.

Research training programs solely for short-term research training should not apply to this announcement.

An applicant may request any combination of predoctoral and postdoctoral positions. However, applicants are advised that NLM expects that most training programs will support a balanced combination of predoctoral and postdoctoral trainees. It is generally expected that predoctoral trainees will constitute three-fifths of the training program, the rest being postdoctoral trainees. NLM will take this goal into account in award decisions and will monitor the balance throughout the life of the grant.

  • Applicants proposing training in one or more basic informatics training areas, or a combination of basic and specialized training areas, may request NLM funding for up to 15 full-time trainees for a combination of predoctoral and postdoctoral trainees.
  • An applicant that wishes to offer basic informatics training but restrict its trainee pool to only predoctoral or only postdoctoral trainees may request up to 10 full time trainee positions.
  • An applicant that wishes to offer a Short-term Training Program (STTP) positions may request NLM funding for up to 4 STTPs positions each year.

Informatics/Data Science Training Addressing HIV

NIAID seeks to support and advance research training in graduate education and post-doctoral research in biomedical informatics and data science addressing infection with the Human Immunodeficiency Virus (HIV).The NIAID funds will add an additional track to the NLM training program with a focus on one or more areas of HIV research including but not limited to epidemiology, basic science, clinical research, viral phylogenetics, genomics, immunology, and public health. Data simulations, cluster and network analyses, and prediction methodology are encouraged. The HIV activities will be a component of a larger core curriculum within a training program in the fundamentals of quantitative and computational methods relevant to healthcare informatics, statistics, and computer science. The goal is to increase the pool of young researchers with skills to interrogate basic, clinical, and observational data and the capacity to build tools to understand the complex multifactorial causal pathways of HIV susceptibility and transmission and the structural and cultural barriers to HIV prevention, linkage to care and long-term viral suppression. To the extent that programs request positions for this special training track, they may exceed by two slots the full-time slot maximums described above.

Technical Assistance Meeting:

April 15, 2021 at 2:00pm EDT. NLM will hold a Technical Assistance webinar to provide information and answer questions from interested parties. Details and a web link to join the meeting will be provided on the NLM Extramural Programs website, www.nlm.nih.gov/ep/ no later than COB April 8, 2021.

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

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NLM intends to commit $12,000,000 in FY 2022 to fund up to 16 awards.

Award Budget

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

Recipients are expected to be familiar with and comply with applicable cost policies. 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 regulations, policies, guidelines, and conditions set forth in this document.

Award Project Period

The expected project period is five years, beginning July 1, 2022.

Other Award Budget Information

Stipends, Tuition, and Fees

NLM Institutional training awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience. NLM will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Support for stipends, tuition and fees will be based on the most recent levels for the Ruth L. Kirschstein National Research Service Award (NRSA). For short-term trainees, stipend will be provided at the appropriate predoctoral or postdoctoral level and prorated according to the length of the appointment.

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

Trainee Travel

Trainee 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 for predoctoral and postdoctoral trainees. Applicants may request $2,000 per year per full-time trainee to support trainee travel to scientific meetings and workshops, one of which must be the annual NLM Informatics Training Conference. Trainees must be appointed to the training grant at the time of the actual travel for this to be an allowable cost. Short-term trainees do not receive travel support.

Training Related Expenses

NLM 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. Applicants may request training related expenses (TRE) for each predoctoral or postdoctoral trainee.

NLM will provide TRE at a rate of $6,500 per year for each full-time predoctoral trainee. For postdoctoral trainees, NLM will provide TRE of $11,850 per year. For each short-term trainee, applicants may request TRE at the appropriate predoctoral or postdoctoral level, prorated according to the length of the appointment.

Additionally, applicants may request $2,500 in funds each year to support curriculum development that incorporates new material and activities that enhance scope of course content that were developed in partnership with an HBCU or Tribal College and Universities. .

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, consortium costs in excess of $25,000, 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 from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession

Other

  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations

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.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees 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 applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

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.
Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) 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 PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

A PD/PI must, at the time of application, be a senior-level (at the rank of associate professor or higher), full-time faculty member at the applicant institution.

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

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

Preceptors/Mentors

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Trainees

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.

Predoctoral trainees must have received a baccalaureate degree by the beginning date of their appointment and must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Postdoctoral trainees must have received, as of the beginning date of the appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., 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. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Trainees selected for short-term training are required to pursue research training for 2-3 months on a full-time basis devoting at least 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Within the full-time training period, trainees 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. Successful trainees may be appointed for additional periods of short-term training or, if appropriate to their career level, they should be encouraged to apply for an extended period of full-time training supported by an NLM or NRSA training grant or fellowship, or an NIH career development award.

Short-term training is not intended, and may not be used, to support activities that would ordinarily be part of a research degree program, nor for any undergraduate-level training.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) 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.

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:

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

The letter of intent should be sent to:

Leonid V. Tsap, PhD
Telephone: 301-827-7077
Email: Leonid.Tsap@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral, short-term ), and intended trainee outcomes.

Other Attachments. An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file “Advisory_Committee.pdf”.

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

SF424(R&R) Senior/Key Person Profile Expanded

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Training Budget

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

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
PHS 398 Research Training Program Plan

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- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

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

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

Training Program

Program Plan

Program Administration.

Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the “Multiple PD/PI Leadership Plan” section of the application.

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.

When a program director position is planned, in addition to the PD/PI, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application. Each application must describe in detail the organizational entity in which the program will be based. This may be a department, center, division, institute, or other organization as appropriate. If the home organization for the program is not authorized to confer academic degrees and the proposed training is to be degree-granting, the application should contain appropriate certifications from the leadership of the degree-granting unit(s) to the effect that the proposed curricula have been approved to enable students to earn the stipulated academic degrees. Applicants should not predicate their training plans on any degree-granting programs that are pending approval at the time of submission.

Program Faculty. The application must include information about the program 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 Program 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 Program 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 as Program Faculty and to evaluate their participation.

Each program must list separately a core faculty and any additional faculty members who will directly support the program as teachers of important courses or advisors to trainees.

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- and disease-related aspects of their research training.

Describe how trainees will be taught the principles of rigorous, reproducible research in biomedical informatics and data science. Give examples of research rotations and projects trainees would likely undertake.

Acceptable applications must be clear that the primary intent of the program is preparation for research careers in biomedical informatics and data science. Applicants must also, in this section, specify the application domain(s) of informatics that will be addressed by their training program, with specific reference to the list introduced in Part 2, Section I.

Applicants may describe their proposed training domain-by-domain, or they may describe an overall program that spans domains and then specify how training in each domain varies from the general theme. All proposed training descriptions must include details regarding a core curriculum that includes required coursework in informatics and data science concepts and principles, quantitative methods, and techniques of computer science/engineering or other information fields; elective options providing opportunity for advanced training in fields basic to informatics; trainee research experience, with emphasis on the process by which students are assisted in selecting research projects.

For degree-granting programs, tables specifying the proposed programs of studies are highly recommended. Applicants are also encouraged to describe experiences that seek to integrate informatics methods and the application domain, including details about how these experiences will be structured. For all courses listed as part of the program that are not under the direct control of the principal investigator’s home academic unit (e.g. his/her home department), applicants must document through appropriate letters that their trainees will have routine access to these courses.

The application must specify a core curriculum addressing informatics concepts and methods that supports the entire program, spanning all application domains that are addressed. While the proposed core curriculum may include variations that customize it to specific domains, the preponderance of courses and other educational elements comprising the core must apply to all application domains.

The description of the core curriculum should include details about all required components such as courses and other experiences, including the specific goals and objectives of each component.

The application should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical informatics/data science workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All trainees should also be provided with instruction in laboratory and project management.

For programs that propose short-term training, any didactic training must be well structured and appropriately justified for the duration of the training experience. Short-term trainees must have the opportunity to carry out supervised biomedical, behavioral, or clinical research with the primary objective of developing or enhancing their research skills and knowledge in preparation for a health-related research career.

Recruitment Plan to Enhance Diversity

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:

  1. 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, Native Hawaiians and other Pacific Islanders.  In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).

  2. 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, https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.

  3. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:

    Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (see https://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/https://nces.ed.gov/programs/coe/indicator_tva.asphttps://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

    1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
    2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);
    3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
    4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
    5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
    6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
    7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas  (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.
  4. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/ ).

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 of graduate students 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.

Program Evaluation. 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, diversity recruitment, 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.

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 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.

The application should contain a description of how the individual development plan for each trainee will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences. Applicants must describe any prerequisites that apply to all trainee candidates.

To request the full number (15) of full-time informatics trainees, a program must request a combination of predoctoral and postdoctoral positions. Generally speaking, NLM expects that predoctoral trainees will account for no more than three-fifths of the total requested training slots. NLM may adjust the requested number of slots to achieve/preserve this balance.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

Institutional Environment and Commitment to the Program.

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program. The application must include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful training program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed program from existing ones 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 program in addition to existing ones.

 

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 the SF424 (R&R) Application Guide.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

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 has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

7. 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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile Component of the SF424(R&R) Application Package.Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and for responsiveness by NLM staff. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NLM Referral Office by email at Leonid.Tsap@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission 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 that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained 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 the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

  • Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?
  • Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
  • Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire skill and expertise in transparent, rigorous, and reproducible research methodologies and state-of-the-art scientific methods and tools applicable to the goals of the training program, including relevant areas of data science?
  • Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related careers?
  • Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
  • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
  • 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 topics addressed by the informatics and data science core curriculum well integrated, and is the core curriculum relevant to all application domains it is intended to cover? • Are the plans for educational experiences that tie the study of informatics and data science principles and methods to the relevant application domains well developed?
  • For programs that provide research training to doctoral-level health-professionals: is there a record of retaining previous health professional trainees in research fields?

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

  • Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
  • Does the PD/PI plan to commit sufficient effort to ensure the program’s success?
  • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
    • 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 the complementary expertise of the PDs/PIs?

Preceptors/Mentors

  • Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
  • Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
  • Do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
  • If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

Trainees

  • Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program?
  • Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?
  • Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?

Training Record

  • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program?
  • Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
  • How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
  • To what extent do trainees’ subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?
  • Does the program propose 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?
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.

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 Individuals Across the Lifespan

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.

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees?

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

Has the program recruited trainees in sufficient numbers and of high quality?

  • Do the core faculty receive outside funding to support their work and are they disseminating their findings in peer-reviewed publications?
  • Do trainees complete their degrees in the allotted time?
  • Have trainees generated peer-reviewed presentations and publications from their research projects?
  • What has been the success of program graduates in their subsequent careers, and have they been productive in generating peer-reviewed research?
  • If the applicant proposes significant changes in scope or direction from the previous program, are they well-justified and adequately documented?

Revisions

Not Applicable

Additional Review Considerations

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years? For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

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 NLM 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 will receive a written critique.

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

Appeals for initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities
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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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 recipient’s business official.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the recipient 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 agreementsare 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

The institution must submit a completed Statement of Appointment(PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support. Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each trainee appointed for eight weeks or more.

A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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.

Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

For programs involving graduate students:

  • Successful completion of a STEM graduate program
  • Subsequent participation in a formal research training or career development program in a STEM field
  • Subsequent participation in research or employment in a STEM field
  • Authorship of scientific publications in a STEM field
  • Subsequent independent research grant support from NIH or another source

For programs involving postdoctorates and early career investigators:

  • Subsequent participation in a formal research training or career development program in a STEM field
  • Subsequent participation in research or employment in a STEM field
  • Authorship of scientific publications in a STEM field
  • Subsequent independent research grant support from NIH or another source 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

For Informatics/Data Science Training Addressing HIV:

Rosemary McKaig, PhD, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-627-3214
E-mail: rmckaig@niaid.nih.gov

For the overall Training Program:

Jane Ye, PhD
National Library Of Medicine (NLM)
Phone: (301) 594-4927
E-mail: yej@mail.nih.gov

Alan Vanbiervliet, PhD
National Library Of Medicine (NLM)
Phone: 301-594-1297
E-mail: vanbiervlietag@mail.nih.gov

Yanli Wang, PhD
National Library Of Medicine (NLM)
Phone: 301-594-4933
E-mail: yawang@mail.nih.gov

Peer Review Contact(s)

Leonid V. Tsap, PhD
National Library of Medicine (NLM)
Telephone: 301-827-7077
Email: Leonid.Tsap@nih.gov

Financial/Grants Management Contact(s)

For Informatics/Data Science Training Addressing HIV:

Regina Kitsoulis
National Institute Of Allergy And Infectious Diseases (NIAID)
Phone: 240-669-2946
E-mail: regina.kitsoulis@nih.gov

For the overall Training Program:

Samantha J Tempchin
National Library Of Medicine (NLM)
Phone: 301-496-4222
E-mail: tempchins@mail.nih.gov

Section VIII. Other Information

Authority and Regulations

Awards are made under the authorization of 42 USC 286b-3.


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