Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Neurological Disorders and Stroke (NINDS)

National Library of Medicine (NLM)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Funding Opportunity Title
Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional)
Activity Code

Si2/R00 Intramural Clinical Research Scholar Transition Award

Announcement Type
Reissue of PAR-20-167
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-22-078
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.213, 93.398, 93.837, 93.838, 93.839, 93.840, 93.233, 93.866, 93.279, 93.855, 93.846, 93.173, 93.121, 93.847, 93.853, 93.879, 93.113
Funding Opportunity Purpose

This FOA encourages applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers.

The program offers the opportunity for a unique bridge between the NIH intramural and extramural research communities and contains two phases. In the first phase, Lasker Scholars will receive appointments for up to 5-7 years as tenure-track investigators within the NIH Intramural Research Program with independent research budgets. In the second phase, successful scholars will receive up to 3 years of NIH support for their research at an extramural research facility; or, the Scholar can be considered to remain as an investigator within the intramural program.

Key Dates

Posted Date
January 26, 2022
Open Date (Earliest Submission Date)
May 24, 2022
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
June 24, 2022 Not Applicable Not Applicable October 2022 January 2023 February 2023

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
June 25, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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

This is a career development program to foster the development of early stage, independent clinical investigators. The NIH funds research and research training at extramural institutions, as well as within the NIH Intramural Research Program (IRP) to support the development of clinical treatments for disease and to improve human health. However, these efforts can be hindered by barriers to clinical and translational research. Such barriers include limited research time for clinical investigators, increases in the length of time to independent careers, and access to hospital facilities and patient enrollments.

In an effort to address those barriers, the NIH has created the Lasker Clinical Research Scholars (Lasker Scholars) program that will offer applicants the opportunity to compete for a unique combination of intramural and extramural resources for clinical research. The program will support a small number of exceptional clinical researchers in the early stages of their independent careers to promote their development as fully independent scientists. The program combines a period of research experience as a tenure-track Investigator in the IRP with additional years of independent financial support, either within the IRP or at an extramural research institution. The Scholar must meet the conditions described below, including fulfilling milestones and an agreement with IRP, in order to receive the additional years of funding.

The program honors the contributions of Mary and Albert Lasker to the NIH and to the overall biomedical community.

The Lasker Scholars program aims to support successful candidates in two phases. Applicants will respond to this Funding Opportunity Announcement (FOA) for an initial period of support through a position in the NIH IRP. Selected scholars who successfully complete the initial phase and internal review, and who meet the criteria described below, will be able to either remain within the IRP or receive up to 3 years of extramural grant funding in the second phase.

First Phase: The first phase will support scholars in the IRP for up to 5 years, with the possibility of an extension for an additional 2 years. NIH may grant additional extensions, as needed, on a case by case basis. Successful applicants for the Lasker Scholars Program will be appointed as independent tenure-track investigators within an NIH Institute or Center, a process that includes being hired as a full-time employee at the NIH and completing the procedures required of new Federal government employees. As Federal employees, Lasker Scholars will be subject to certain regulations and policies that will govern their relationships with outside organizations. Nonetheless, in certain cases, Lasker Scholars may be able to maintain relationships with their previous institution. The IRP will provide space, research expenses, full salary, and Federal employee benefits. Scholars will develop independent research activities over the course of their stay in the IRP and will be formally reviewed by a panel of senior extramural investigators every 2-4 years to evaluate their research progress. More information about the IRP can be found at http://irp.nih.gov/

Second Phase: Upon successfully completing the initial IRP phase of the program, the Lasker Scholar will be eligible for two options in the second phase:

Option 1. Remain in the IRP with continued intramural funding and progression to tenured senior investigator status, if consistent with formal reviews and assessments. Retention in the IRP will be dependent on the development of a mutual agreement between the Scholar and the IRP. Tenure at the NIH requires evaluation and approval by the NIH Deputy Director for Intramural Research.

Option 2. Scholars who successfully complete at least five years in the first phase of the program will be considered for up to 3 years of support to continue their research as independent clinician scientists at an extramural institution. This support is contingent upon obtaining an appropriate full-time tenure-track or tenured extramural position at an eligible institution, and the successful NIH programmatic review of the scholar's progress during the intramural phase of the award. Scholars who choose to leave the Lasker program before completing 5 years of research in the IRP will not be eligible for the Lasker Scholars Grant but may be eligible to compete for other extramural NIH research grants as announced in the NIH Guide for Grants and Contracts.

The NIH recognizes seeks to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce. 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 research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. (See NOT-OD-20-031 and NOT-OD-22-019 for details) 

RESEARCH AREAS OF INTEREST

Participating NIH Institutes and Centers, and their preferred areas of clinical research interest, are provided below. Applicants are strongly encouraged to discuss their proposed research with a Scientific/Research Contact listed in Section VII, Agency Contacts.

National Cancer Institute:

  • Medical oncology, medical hematology-oncology, pediatric hematology/oncology, radiation oncology, surgical oncology, pathology, neuro-oncology, urology, myeloid malignancies, health disparities, data science and artificial intelligence. Specific areas within these categories include genitourinary oncology, lymphoid malignancies, neuro-oncology, immunotherapy (including cell therapy and transplant), women's cancers, aeoro-digestive cancers, molecular diagnostics, functional imaging.
  • Translational and clinical epidemiology, genetics of cancer.

National Center for Complementary and Integrative Health:

  • Epidemiological, clinical, and translational research focusing on the role of the nervous system, other physiological systems, and psychosocial factors in perceiving, modifying, and managing pain, including approaches that apply to the concept of whole person health and health restoration.

National Heart, Lung, and Blood Institute

  • Population sciences/epidemiology and community health
  • Pulmonology research and lung disease

National Institute on Aging

  • The NIA Intramural Research Program is looking to hire a Physician Scientist with outstating clinical skills and a strong interest in developing a research program that examine biological, environmental and social factors that perpetuate health inequities, with special emphasis on aging and accelerated aging.

National Institute of Allergy and Infectious Diseases:

  • Clinical allergy/immunology, Clinical infectious diseases, Virology.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

  • Rheumatology, dermatology, bone, joint, and skin research

National Institute on Deafness and Other Communication Disorders:

  • Normal and disordered processes of hearing, balance, taste, smell, and voice.

National Institute of Dental and Craniofacial Research:

  • Craniofacial anomalies, including genetics, pathophysiology, and surgical therapies
  • Craniofacial and salivary gland regenerative medicine, tissue engineering, stem cell biology
  • Craniofacial and dental developmental biology and human genetics
  • Metabolic bone disease

National Institute of Diabetes and Digestive and Kidney Diseases:

  • Gastroenterology
  • Nephrology
  • Endocrinology

National Institute on Drug Abuse:

  • Bench-to-bedside translational human laboratory approaches to better understand the biological and behavioral factors contributing to initiation, maintenance, and treatment of substance use disorders and associated/comorbid diseases.
  • Translational innovative approaches aimed at developing new medications, approaches and methods for the treatment of individuals suffering from substance use disorders.

National Institute of Environmental Health Sciences:

  • Endocrinology
  • Reproduction
  • Inflammation
  • Environmental health

National Institute of Neurological Disorders and Stroke:

  • Neurological disorders
  • Neurosurgery

National Library of Medicine

  • Computational approaches to integrating, mining and tracking data relevant to public health surveillance
  • Natural language processing and understanding of consumer/patient health information needs and uses
  • Artificial intelligence and machine learning to support automated decision making, genome-phenome data linking, bias reduction and image-based diagnostics for health care

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

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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

It is anticipated that up to 5 awards will be made in FY 2023.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Intramural Phase (Si2)

Allowable Costs:

Scholars will be supported by intramural funds provided by the NIH Institute/Center in which they are conducting their research. Budget details for the intramural phase will be negotiated with the sponsoring Institute/Center. Salary will be consistent with that offered scientists in similar, intramural NIH positions.

Extramural Phase (R00)

Allowable Costs:

For the extramural phase (R00) applicants can request direct costs of up to $499,000 per year. This amount includes salaries, fringe benefits, and research costs.

Indirect Costs:

Indirect costs will be reimbursed at the extramural sponsoring institution's indirect cost rate.

Award Project Period

The initial phase of research in the IRP is for 5 years with the possibility of a 2 year extension. Additional extensions, as needed, may be approved on a case by case basis. The extramural phase of the program is for up to 3 years.

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)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

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.

  • 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.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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)

Eligible applicants include physicians, dentists and nurses (including MD, MD/PhD, DO, DDS, DMD, RN/PhD, or equivalent clinical doctoral degree from an accredited domestic or foreign institution) who have a professional license to practice clinically in the U.S. The program is intended for investigators at the early stages of their careers. Applicants will generally have completed or be completing a post-residency clinical fellowship, and will have demonstrated sufficient patient-oriented research experience to qualify for a tenure-track level appointment. Tenured applicants are not eligible. Applicants do not have to be U.S. citizens or permanent residents, although selected Scholars must qualify for and maintain appropriate visa/residency status throughout the program. An application can be submitted on behalf of the candidate by the candidate's current institution, even if that is not the institution where the candidate would be affiliated if selected as a Lasker Scholar. Individuals not affiliated with an organization, or who want to submit an application independently of their current organization, may apply (specific informationis available for unaffiliated candidates.) Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, e.g., Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

To prevent a lapse in funding, an applicant can submit a Lasker Scholar application in which the research is similar to that in an NIH award already held by the applicant. Should the applicant be selected for and accept a Lasker Scholar award, the previous NIH award must be relinquished prior to accepting the Lasker appointment. Applicants can also submit an R01 application and a related Lasker Scholar application in parallel. Should both applications be selected for funding, the applicant will be permitted to accept only one of the awards.

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 instructions in the Research (R) 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.

 

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.

Facilities and Other Resources: Rather than indicate the resources available, describe the resources that the proposed research will need. Also indicate the specific resources and environmental features that will be needed for research in Phase 2 of the program, should that be conducted in an extramural institution, including subject populations, collaborative arrangements, and/or equipment.

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Although itemized budget information for the R00 phase is not required at time of application, applications that include itemized information will be accepted.

The following instructions may be used to submit the R&R Budget without itemized information.

A $0 budget can be provided for the intramural (Si2) phase, usually project years 1-5. A few required form fields must be completed to move from one budget period to the next even if the budget period requests $0.

For each budget period of the Si2 phase:

- Select the appropriate Budget Type.

- Provide the Budget Period Start Date and End Date.

- In Section A: Senior/Key Persons provide an entry for the PD/PI, including 0.01 calendar months as the level of effort, $0 for Requested Salary and $0 for Fringe Benefits.

For each budget period of the R00 phase, usually project years 6-8, a total requested amount up to $499,000 is allowed. Itemized budget information is not required at the time of application. If awarded, the R00 applicant institution (at the time of transition to the R00 phase) will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution.

For each budget period of the R00 phase:

Provide the Budget Period Start Date and End Date.

In Section A: Senior/Key Persons provide an entry for the PD/PI, including 0.01 person-months as the level of effort, $0 for Requested Salary and $0 for Fringe Benefits.

In Section F: Other Direct Costs add a line item titled 'R00 Independent Phase' and provide the total request for that period (up to $499,000).

In Section H. Indirect Costs: leave this field blank.

Budget Justification: Applicants should indicate they are requesting no more than the allowed R00 budget.

At the time of transition to the R00 phase, the R00 applicant institution will submit a detailed budget for each budget period of the R00 project period that reflects the direct and indirect costs at the R00 applicant institution.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on human health. List succinctly the specific objectives of the research proposed, e.g., to challenge an existing paradigm or clinical practice, create a novel design, solve a specific problem, test a stated hypothesis, address a critical barrier to progress in the field, or develop new technology.

Research Strategy:

(a) Significance – Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. Explain how the proposed project will improve the field, as well as the effect on human health. Describe how the field will be changed if the proposed aims are achieved.

(b) Innovation – Explain how the application challenges and seeks to shift current clinical practice or research paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation, or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions.

(c) Approach – Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed and interpreted. Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. Include preliminary data, if appropriate. Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. Include a prospective timeline for the project. For human subjects research, provide a brief explanation of human subjects protection and inclusion plans.

(d) Milestones - List specific "go/no-go" milestones that the applicant plans to achieve during the Phase I, intramural phase of the research. The milestones are not a reiteration of the Specific Aims, but are measurable, specific endpoints for the Phase I research that will allow NIH extramural staff to assess research progress and appropriateness for Phase 2 support. The milestones should include a timeline for achieving the goals, and may include alternative goals should the original approaches not succeed.

Vertebrate Animals: Successful scholars will submit their proposed research to review boards in the intramural research program upon being selected. Applicants need to follow the SF424 (R&R) Application Guide to complete this section for the extramural portion of the proposed work.

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

Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

.

Do not complete. Indicate that for For the Si2 phase, successful scholars will submit their proposed research to review boards in the intramural research program upon being selected. Applicants proposing human subjects and or clinical trials for the extramural (R00) portion of the proposed work should create a delayed onset study record.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Justification Attachment

Applicants proposing human subjects or clinical trials for the extramural (R00) portion of the proposed work should indicate these will not begin until after 5 years of research, and the study information is not yet available. The information will be provided in the R00 application

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions.

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 form. 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. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify Dr. Charles Dearolf, NIH Office of Intramural Research by email at dearolfc@od.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 

Letters of Reference

Letters of reference are an important component of the Lasker Clinical Research Scholar application. Applicants should arrange to have four letters of reference submitted on their behalf. Applications that are missing letters of reference will not be reviewed. Late letters will not be accepted. Applicants are responsible for monitoring the submission of letters to ensure that the letters have been submitted prior to the submission deadline. Applicants are encouraged to check the status of their letters in their eRA Commons accounts.

To submit a letter of reference, the referee will need the following information:

Funding Opportunity Number (FOA) for this announcement: PAR-22-078

The applicant's Commons User Name (Note: Referees do not need to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name of the applicant is required);

The applicant's first and last name (note – the name must match exactly the applicant's name in the Commons);

The URL to the letter submission page (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new);

The letter of reference submission dates – May 24, 2022 – June 24, 2022. Deadline for receipt of letters is 5:00 p.m. (ET).

Letters of reference are confidential to the extent permitted by law. Email confirmations will be sent to both the applicant and the referee. Note: Since email can be unreliable, it is the applicant's responsibility to check the status of letters of reference periodically in the Commons.

Instructions for Referees:

Letters may be submitted to the Commons at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) beginning May 24, 2022, and must be submitted no later than 5:00 p.m. (ET), June 24, 2022.

Late letters will not be accepted and applications missing letters of reference may not be reviewed.

The applicant's name should be placed at the top of the letter. Although signatures are not required, the letter must include a signature block with the referee's full name, title, institution, and contact information.

In two pages or less, describe the applicant's qualities that support the applicant's claim to possess the scientific, leadership and management skills necessary to conduct successful, independent clinical research. When possible, give specific examples that illustrate these qualities.

Note: The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons. Referees must provide the applicant's Commons User Name (User ID) and the other information below:

Referee Information (the individual providing the letter of reference):
Referee's First and Last Name (Required)
Referee's Middle Initial (MI) (Not Required)
Referee's Email Address (Required)
Referee's Institution/Affiliation (Required)
Referee's Department (Required)

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.

For this particular announcement, note the following:

The goal of the Lasker Clinical Research Scholars Program is to support a small number of exceptional clinical researchers in the early stages of their careers, and to promote their development to fully independent scientists. Therefore, the review will emphasize the accomplishments and potential of the applicant, as well as the research project.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Has the candidate demonstrated appropriate experience, training, and the skills to conduct innovative research? Do the letters of reference indicate that the candidate has the research and leadership skills to conduct independent research? Is the researcher well suited to the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Has the applicant identified the scientific environment, subject populations, or collaborative arrangements that will be needed to conduct the proposed Phase I research? Assuming successful completion of the proposed milestones, has the candidate identified appropriate and sufficient institutional resources, such as subject populations, collaborations, and equipment, that will be needed for the Phase 2 portion of the research?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable.

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).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 the Center for Scientific Review (CSR) , 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 be discussed and assigned an overall impact score, and will receive a written critique.

Select candidates may be invited to the NIH campus for an employment interview, based upon the results of the initial peer review, and selected by the intramural NIH Scientific Director. Applicants who are identified to progress to the interview process will be asked to provide additional information that will be used to establish the candidates' eligibility and suitability for hire. The applicant will receive a package of additional documents to complete if selected to proceed to this phase of the interview process.

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.

Recipients 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.

 Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

For the R00 award, individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

INTRAMURAL PHASE Selected Scholars will be notified by the Scientific Director of the host NIH Institute or Center, and will receive a formal Notice of Employment from the NIH Human Resources Office. Lasker Scholars are appointed under excepted service. These appointments will be made under time-limited Title 42 (g) or (f). For more details on the hiring process, pay scales, and benefits, see http://hr.od.nih.gov/benefits/default.htm. Selected Scholars will be appointed as tenure-track investigators in the NIH Intramural Research Program. Tenure-track investigators receive independent resources (staff, space, and budget), and receive mentoring from their Lab or Branch Chief, and from other senior leaders in the IRP. Additional information concerning the philosophy and practices for IRP tenure-track investigators can be found at http://sourcebook.od.nih.gov/prof-desig/ttiphilosophy.htm and at http://sourcebook.od.nih.gov/prof-desig/investigator.

TRANSITION TO THE R00 PHASE To be eligible for the extramural funding award of the program, Scholars must have:

• Successfully completed at least five years in the NIH intramural research;

• Been offered, and have accepted, a full-time tenure-track or tenured position at an extramural sponsoring institution/organization.

This support is contingent upon the successful NIH programmatic review of the scholar's progress during the intramural phase of the award. To avoid potential problems in activating the R00 phase, applicants are strongly encouraged to contact their NIH program official as soon as plans to apply for and assume a position outside of the NIH Intramural Research Program. At that time, individuals should discuss plans for transition to, and application for, the R00 phase with their NIH program official. The application for the R00 phase of the award should be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization. The R00 phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398 Application. The R00 application must include:

• A new face page signed by the R00 phase institutional representative;

• A new project description page (the project summary or abstract should be updated to reflect current plans for the R00 phase);

• Detailed budget pages for a non-modular budget;

• Biographical sketches for the PD/PI and any other Key Personnel;

• A new Resources page;

• A brief description of progress made during the intramural phase, including an assessment of progress toward achieving the stated milestones, that will serve as the Final Progress Report for the intramural phase;

• An updated research plan (the specific aims should be updated to reflect current plans for the R00 phase and the updated research plan should be briefly described in less than 5 pages);

• Updated Protections for Human Subjects and Inclusion of Women, Minorities and Individuals Across the Lifespan (as appropriate);

• Updated Vertebrate Animals (as appropriate);

• Updated Biohazards (as appropriate); and

• A new checklist.

These materials should be sent directly to the awarding Institute or Center (IC). The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) to the Financial or Grants Management contact person of the awarding NIH Institute or Center listed in the Notice of Award. The R00 application will be evaluated by extramural Program staff of the awarding component for completeness and appropriateness to the program.

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, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR Part 200.206 “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

For the R00 phase: When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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.

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 submission by the due date, 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 instructions, 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)

Charles R. Dearolf, Ph.D.
Director, Program Development and Support
Office of Intramural Research
National Institutes of Health
Telephone: 301-402-1225
Email: LaskerScholar@nih.gov

Sharon Savage (epidemiology)
National Cancer Institute (NCI)
Telephone: 240-276-7241
Email: savagesh@mail.nih.gov

David Shurtleff
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-435-0891
Email: David.Shurtleff@nih.gov

Kat Miller
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-2441
Email: kat.miller@nih.gov

Valerie Florance
National Library of Medicine (NLM)
Telephone: 301-496-4621
Email: florancev@mail.nlm.nih.gov

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: lanay.mudd@nih.gov

William Dahut (oncology)
National Cancer Institute (NCI)
Telephone:  301-496-4251
Email: dahutw@mail.nih.gov

Stephen J. Chanock (epidemiology)
National Cancer Institute (NCI)
Telephone: 240-276-7150
Email: chanocks@mail.nih.gov

Robert Balaban, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone:  301-496-2116
Email: balabanr@nhlbi.nih.gov

Luigi Ferrucci, MD, Ph.D.
National Institute on Aging (NIA)
Telephone: 410-558-8110
Email: ferruccilu@grc.nia.nih.gov

Karyl S. Barron
National Institute of Allergy and Infectious Disease (NIAID)
Telephone: 301-402-2208
Email: Kbarron@nih.gov

John O'Shea
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-2612
Email: osheajo@mail.nih.gov

Lorenzo Leggio
National Institute on Drug Abuse (NIDA)
Telephone: 443-740-2801
Email: lorenzo.leggio@nih.gov

Lisa Cunningham, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-443-2766
Email: cunninghamll@mail.nih.gov

Jamie Kugler
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-0320
Email: Jamie.kugler@nih.gov

Michael Krause
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-4633
Email: michaelkr@niddk.nih.gov

Janet Hall, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3647
Email: janet.hall@nih.gov

Nina Schor, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9746
Email: nina.schor@nih.gov

Avindra Nath, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1561
Email: avindra.nath@nih.gov

Richard C. Palmer
National Library Of Medicine (NLM)
Phone: 301-496-4254
E-mail: richard.palmer@nih.gov

Peer Review Contact(s)

Center for Scientific Review

Emai: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Shelley Headley
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: shelley.headley@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: (301) 435-0713
E-mail: myersc@nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

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

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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