Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
K01 Research Scientist Development Award - Research & Training
Reissue of PAR-18-540 - International Research Scientist Development Award (IRSDA) (K01) Independent Clinical Trial Required
See Notices of Special Interest associated with this funding opportunity
PAR-21-104 - International Research Scientist Development Award (IRSDA) (K01) Independent Clinical Trial Not Allowed
93.989, 93.398
The purpose of the International Research Scientist Development Award (IRSDA) is to provide support and protected time (three to five years) to advanced postdoctoral U.S. research scientists and recently-appointed U.S. junior faculty (applicants must be at least two years beyond conferral of doctoral degree) for an intensive, mentored research career development experience in a low- or middle-income country (LMIC), as defined by the World Bank (http://data.worldbank.org/about/country-classifications/country-and-lending-groups), including "low-income," "lower-middle-income," and "upper-middle-income" countries) leading to an independently-funded research career focused on global health. This Funding Opportunity Announcement (FOA) invites applications from postdoctoral research scientists and junior faculty from any health-related discipline who propose career development activities and a research project that is relevant to the health priorities of the LMIC under the mentorship of LMIC and U.S. mentors.
This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (PAR-21-104).
Not Applicable
March 9, 2021; March 9, 2022; March 8 2023 by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
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.
March 9, 2021; March 9, 2022; March 8 2023 by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.
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.
July 2021; July 2022; July 2023
October 2021; October 2022; October 2023
October 2021; October 2022; October 2023
Not Applicable
The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, awardees will launch independent research careers and become competitive for new research project grant (e.g., R01) funding.
Program Description
Opportunities to advance global health research careers are central to building a robust global health workforce, yet it remains a challenge for researchers to establish independent international research careers given the requisite time spent away from their home institutions. Prolonged field experience is critical for global health research and for establishing sustained research partnerships, but gaining this field experience can be difficult for junior faculty, who are balancing administrative and teaching requirements, or for individuals in standard postdoctoral positions. The International Research Scientist Development Award (IRSDA) program addresses this need and fills an important global health career development gap. The IRSDA program provides opportunities to conduct mentored global health research in low- and middle-income country (LMIC) settings and to foster long-term research collaborations that strengthen global health research.
The objective of the IRSDA program is to prepare qualified advanced postdoctoral research scientists and recently-appointed junior faculty (see Eligible Individuals) for research careers that will have a significant impact on the health-related research needs of LMICs. IRSDA awardees will conduct their research and career development activities under the guidance of experienced U.S.-based and LMIC-based mentors, in any health-related discipline that is relevant to the health priorities of the LMIC.
Awardees must spend a minimum of 50% of the cumulative effort over the project period (all years) physically in-country conducting collaborative research at the LMIC institution. In addition, in each year of the award, the recipient must spend a minimum of three months in the LMIC (see In-country requirement under Eligible Individuals in Section III). Awardees are expected to gain increased capabilities in collaborative research (i.e. team science) skills in low-resource settings, advanced research methodology, analysis and data management, research administrative skills, responsible conduct of research, scientific presentation, and manuscript and grant writing. Through this program, it is expected that awardees will launch independent global health research careers, continue to collaborate with LMIC scientists on research that addresses the health needs of their countries, and become competitive for new research project grant (e.g., R01) funding in global health.
LMICs are defined by the World Bank classification system (according to Gross National Income (GNI) per capita as "low-income," "lower-middle-income," and "upper-middle-income" (http://data.worldbank.org/about/country-classifications/country-and-lending-groups).
Interests of Participating NIH Institutes and Centers
The Fogarty International Center (FIC) is interested in applications from individuals seeking to become independent investigators and global health research leaders in any therapeutic or scientific area of health priority and scientific importance to the LMIC. FIC is dedicated to advancing the mission of the NIH by supporting and facilitating global health research conducted by U.S. and international investigators, building partnerships between health research institutions in the U.S. and abroad, and training the next generation of scientists to address global health needs. FIC supports a diversity of research and research training grants that advance basic to implementation science with a particular focus on LMICs. The IRSDA is responsive to the FIC Strategic Plan to build research capacity through individuals, institutions and networks by building future research leaders in the U.S. and in LMICs.
The National Cancer Institute (NCI) is interested in applications from individuals committed to an independent career in global cancer research, who propose mentored research projects in topics relevant to the LMIC where the research will be conducted. NCI is interested in applications that include, but not limited to, studies in cancer biology and genetics, cancer epidemiology, research in cancer primary and secondary prevention, clinical and translational research, implementation science and health systems research, health surveillance and cancer informatics research, studies in integrative oncology and cancer survivorship as well as investigations that employ technology (including mhealth and ehealth) to address cancer control. Applications that propose capacity development in research methods across disciplines that might be relevant to LMIC setting including, but not limited to, clinical and translational research, behavioral and social sciences research, patient reported outcomes research, are encouraged. The career development plan should include training in advanced scientific skills, research methodology, data management and analysis, grant and manuscript writing, and research administration skills that are appropriate for the LMIC. The proposed career development and mentoring must be focused on developing independent researchers in the field of cancer in a manner that increases the research capacity at the LMIC institution. Mentors should have a track record of research in cancer.
Additional Information
For applications proposing HIV/AIDS research projects, applicants are encouraged to review the NIH HIV/AIDS Research Priorities, and the NIH Plan for HIV-Related Research for the year they are applying.
Candidates are encouraged to review answers to frequently asked questions about the IRSDA K01 program at IRSDA FAQs, which will be updated on a regular basis.
Individuals who are unable to meet the requirement to spend a minimum of 50% of the cumulative effort over the total project period (all years) and the additional requirement to spend a minimum of three months each year conducting research physically in the LMIC are encouraged to consider other NIH career development awards (see https://researchtraining.nih.gov/programs/career-development), many of which support global health research in LMICs.
Individuals from LMICs (individuals who are not U.S. citizens, non-citizen nationals or permanent residents) are not eligible for the IRSDA but may be eligible for the Fogarty Emerging Global Leader Award (K43).
Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion FOA (FOA #PAR-21-104).
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Required: Only accepting applications that propose an independent clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The total project period should be a minimum of 3 years and may not exceed 5 years.
NIH will contribute up to $100,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.
The total NIH contribution to salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
NIH will contribute up to $40,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. Research development costs include, but are not limited to, supplies, equipment, technical personnel, non-degree related tuition or registration fees for activities related to the proposed career development plan, fees for statistical and computational services, and travel to research sites, research meetings, or training, as detailed in Section IV.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
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.
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.
Mentors
The primary mentor at the U.S. institution and the primary LMIC mentor must have eRA Commons accounts. Obtaining an eRA Commons account can take up to 2 weeks.
Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and 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. Multiple PDs/PIs are not allowed.
Current and former PDs/PIs (including Multiple PDs/PIs) on NIH research project (R01), program project (P01), research training (D43), or center (P50) grants, sub-projects of program project (P01) or center (P50) grants, other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), or the equivalent to these grants/awards (including non-NIH equivalent grants/awards from other research funding organizations) are not eligible. Current and former PDs/PIs (including Multiple PDs/PIs) of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36), or SBIR/STTR (R41, R42, R43, R44) remain eligible. Individuals supported by institutional K awards (K12 or KL2) remain eligible but cannot exceed 6 years of combined institutional K plus individual K01 funding.
Candidates for this award must have a research or health-professional doctoral degree (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD or equivalent doctoral degrees) received at least two years prior to the application deadline and have research experience beyond their doctoral training.
By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
At the time of award, the candidate must have a full-time appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.
Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.
After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.
In-country requirement: Awardees must be able to spend a minimum of 50% of their cumulative effort over the total project period (all years) physically in-country conducting research at the LMIC institution. In addition, in each year of the award, awardees must spend a minimum of three months at the LMIC institution. For example, a candidate with 75% effort on a 5-year IRSDA K01 must spend 22.5 months at the LMIC institution.
Mentor(s)
Before submitting the application, the candidate must identify a primary mentor based at the U.S. applicant institution and a primary mentor based at the collaborating LMIC institution who are accomplished investigators in the research area proposed and have experience in successful development of independent investigators. Together, the two primary mentors will supervise the proposed career development and research experience. The LMIC primary mentor should hold a primary appointment at the collaborating LMIC institution and should not be a U.S. citizen who holds a joint appointment at the LMIC institution. The institutional affiliations of the mentors should be clear from the biosketches, mentor support letters, and institutional letters. The mentors should be active investigators in the area of the proposed research and committed both to the career development of the candidate and direct supervision of the candidate's research. The primary mentors must document the availability of sufficient research support and facilities for the candidate's research. Candidates are encouraged to identify additional co-mentors to form a mentoring team if this is deemed advantageous for providing expert advice in all aspects of the research career development plan. Additional mentors can be from other LMIC or high income countries. The candidate must work with all mentors (primary and co-mentors) in preparing the application.
The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.
The U.S. and LMIC institutions must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.
Buttons to access the online ASSIST system or to download application forms 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following additional instruction applies:
Include the applicant institution and all of the collaborating institutions, both U.S. and LMIC, as performance sites.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following additional instructions apply:
Both the primary US and primary LMIC mentor must insert "Other" or "Other Professional" in the Project Role field, and enter "Mentor" in the Other Project Role Category field.
When listing other individuals with a substantive role in the project, clearly label roles to distinguish "Co-Mentor", "Consultant", "Collaborator", etc.
When listing the applicant's research support in the Biographical Sketch, clarify PD/PI status (direct recipient) of awards.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following additional instructions apply:
Applicants should identify specific expenses such as: (a) non-degree related tuition or registration fees for specific PD/PI career development activities; (b) research expenses such as supplies, equipment and technical personnel; (c) statistical and computational services, including technical personnel and computer time; (d) mentor and grantee communication costs; and (e) PD/PI travel and per diem expenses to field research sites, collaborating institutions, research or networking meetings, or research skills workshops or courses in the appropriate budget form category.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix
All instructions in the SF424 (R&R) Application Guide must be followed.
Candidate Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Candidate’s Background
Career Goals and Objectives?
Candidate’s Plan for Career Development/Training Activities During Award Period
Research Plan Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Training in the Responsible Conduct of Research
Mentor, Co-Mentor, Consultant, Collaborators Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Plans and Statements of Mentor and Co-mentor(s)
Letters of Support from Collaborators, Contributors and Consultant
Signed statements must be provided by all additional collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches unless also listed as senior/key personnel. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent researcher.
The LMIC Institutional Commitment letter should also be included in this section, following page limit requirements for this section. It should provide a statement of commitment to the candidate's development into a productive, independent researcher and provide assurances that appropriate time and support for the proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
All letters should be combined and submitted as a single PDF
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
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 the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or 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 Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters
Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.
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
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) using ASSIST or other electronic submission systems. 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.
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.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
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. 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.
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.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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:
Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.
In addition, for applications involving clinical trials:
The reviewers will consider that the clinical trial may include study design, methods, and interventions that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the
possibility that research support provided through K awards may be sufficient to support only small feasibility studies.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
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.
Candidate
Career Development Plan
Research Plan
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
Study Timeline for 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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
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).
Training in the Responsible Conduct of Research
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 level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.
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).
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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.
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.
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.
Specific to applications proposing clinical trials, ancillary or feasibility studies
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, or a new ancillary study to an ongoing clinical trial. By law (Title VIII, Section 801 of Public Law 110-85), the lead investigator 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 of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee 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).
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. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
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 theFederal 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.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
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.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Christine Jessup, PhD
Fogarty International Center (FIC)
Telephone: 301-496-1653
Email: Christine.Jessup@nih.gov
Sudha Sivaram, DrPH, MPH
National Cancer Institute (NCI)
Telephone: 240-276-5804
Email: sivarams@mail.nih.gov
Seetha Bhagavan, PhD
Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: bhagavas@csr.nih.gov
Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-496-9750
Email: Mollie.Shea@.nih.gov
Dawn M Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dm437a@nih.gov
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.
Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.
Awards are made under the authorization of Sections 301, 307, and 405 of the Public Health Service Act as amended (42 USC 241, 284, and 287(b)) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.