PAR-27-025-Full-Announcement.html
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- Paul Calabresi Career Development Award for Clinical Oncology (K12 Clinical Trial Not Allowed)
- Opportunity number
- PAR-27-025
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PAR-27-025-Full-Announcement.html
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Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations
National Cancer Institute (NCI)
Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.
Funding Opportunity Title
Paul Calabresi Career Development Award for Clinical Oncology (K12 Clinical Trial Not Allowed)
Activity Code
K12 Clinical Scientist Institutional Career Development Program Award
Announcement Type
Reissue of
PAR-22-136
Related Notices
Check for any recent Notices of NIH Policy Changes that may impact application requirements.
Funding Opportunity Number (FON)
PAR-27-025
Companion Funding Opportunity
None
Number of Applications
See Section III. 3. Additional Information on Eligibility.
Assistance Listing Number(s)
93.398
Funding Opportunity Purpose
The goal of the Paul Calabresi Career Development Award for Clinical Oncology (PCACO) is to increase the number of clinician-scientists trained in clinical and translational cancer research, and to promote their career development as cancer researchers.
This Notice of Funding Opportunity (NOFO) does not allow Scholars to propose to lead an independent clinical trial, but does allow Scholars to propose research experience in a clinical trial led by a mentor or co-mentor.
Funding Opportunity Announcement Goal(s)
To make available support to nonprofit and for-profit institutions interested in providing biomedical training opportunities for individuals interested in careers in basic, clinical, and prevention research important to the National Cancer Program.
Key Dates
Posted Date
June 03, 2026
Open Date (Earliest Submission Date)
September 12, 2026
The following table includes NIH standard due dates marked with an asterisk.
| Application Due Dates |
| Review and Award Cycles |
| New |
| Renewal / Resubmission / Revision (as allowed) |
| AIDS - New/Renewal/Resubmission/Revision, as allowed |
| Scientific Merit Review |
| Advisory Council Review |
| Earliest Start Date |
October 12, 2026 *
November 12, 2026 *
Not Applicable
| March 2027 | |
| May 2027 |
July 2027
February 12, 2027 *
March 12, 2027 *
Not Applicable
| July 2027 | |
| October 2027 |
December 2027
June 12, 2027 *
July 12, 2027 *
Not Applicable
| November 2027 | |
| January 2028 |
April 2028
February 12, 2028 *
March 12, 2028 *
Not Applicable
| July 2028 | |
| October 2028 |
December 2028
June 12, 2028 *
July 12, 2028 *
Not Applicable
| November 2028 | |
| January 2029 |
April 2029
February 12, 2029 *
March 12, 2029 *
Not Applicable
| July 2029 | |
| October 2029 |
December 2029
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
March 13, 2029
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the Training (T) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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. | |
| Use the NIH ASSIST system to prepare, submit and track your application online. | |
| 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. | |
| Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application. |
Table of Contents
Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Other Award Budget Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
The overall goal of the NIH Research Career Development programs is to help ensure that a pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. More information about career programs may be found at the NIH Research Training and Career Development website.
This NOFO encourages applications from organizations that propose well-designed, rigorous institutional research career development programs in the mission area(s) of the NIH. The applicant organization must have the requisite faculty, staff, potential scholars and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.
The proposed institutional research career development program may complement other ongoing research training and career development activities at the applicant institution; however, its career development components must be clearly distinct from those of any programs currently supported by Federal funds.
Note: This Notice of Funding Opportunity (NOFO) does not allow Scholars to propose to lead an independent clinical trial, but does allow Scholars to propose research experience in a clinical trial led by a mentor or co-mentor.
This Notice of Funding Opportunity (NOFO) does not allow appointed scholars to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.
See Section VIII. Other Information for award authorities and regulations.
Section II. Award Information
Funding Instrument
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed
New
Renewal
Resubmission
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Clinical Trial?
Not Allowed: Only accepting applications that do not propose clinical trials.
Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.
Need help determining whether you are doing a clinical trial?
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget
Direct costs are limited to $50,000 in the initial year of new (Type 1) programs and may be used for curriculum planning and development, advertising, and recruiting of the first class of scholars. K12 scholars will begin work in the second year of the grant, where costs are limited to $750,000 direct costs annually. For renewal (Type 2) applications, the program may request up to $750,000 direct costs annually in each of the 5 years.
Funds may be used only for those expenses that are directly related to and necessary for the career development of K12 scholars and must be expended in conformance with OMB Cost Principles and the NIH Grants Policy Statement.
The award budget includes salary support for the PD(s)/PI(s) and scholars, research and development support, and administrative support costs.
Award Project Period
The project award duration for this funding opportunity may not exceed 5 years.
Other Award Budget Information
Personnel Costs
Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.
Salary support for individuals involved in program administration and management must be substantially justified. Salary support for ancillary personnel (e.g. administrative assistance or secretarial support) on career development awards is not allowable.
Scholar Costs
Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.
Scholar salaries can be requested up to $110,000, in accordance with K-recipient salary guidelines, along with associated fringe benefits.
The total salary requested for scholars must be established on the base salary of a full-time, 12-month staff appointment. Scholars are required to devote a minimum of 9 person-months (75%) of full-time professional effort to conducting health-related research with the remaining effort devoted to activities related to the development of a successful research career.
Surgeon-scientists with surgical duties may request a minimum of 6 person-months (50% full-time professional effort) to the K12. A clear justification must be provided in the application when requesting less than 75% full-time professional effort (less than 9 person-months). The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from federal funds unless specifically authorized by the federal program from which such funds are derived. (https://grants.nih.gov/grants/policy/nihgps/HTML5/section_12/12.8_allowable_and_unallowable_costs.htm#Salaries) Scholar appointments are up to two (2) years in length, with the option of an extra year for scholars who would benefit. The application must clearly indicate the number of scholar appointments proposed for each year. Candidates must have a full-time appointment at the applicant institution or a partnering institution. Scholar support is provided for a minimum of two years and a maximum of three years of consecutive funding for each scholar, consisting of 12-month appointments, provided their progress towards an independent academic career is on track and satisfactory.
Scholar Research and Development Support: Up to $30,000 per individual scholar may be provided for the following types of research-related expenses: (a) research expenses, such as supplies, equipment, and technical personnel; (b) tuition and fees related to required career development courses and activities; (c) travel to scientific meetings or training that the institution determines to be necessary for the individual's career development experience; and (d) statistical services including personnel and computer time. These funds may be pooled for program-wide activities only if such activities support the career development of all scholars. It is expected that the K12 scholars will be working in a funded research environment and that support provided by the K12 grant will augment existing research support to the scholar. These expenses must be itemized in Section F of the R&R Budget.
For information regarding NIH policy on determining full-time professional effort for career awards, see: NIH Grants Policy Statement.
Other Program Related Expenses
Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses (including expenses for mentor training activities) may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
In years other than year 1 of a new award, if applicable and justified, up to $26,000 per year may be requested to defray the costs of a consultant, program administrator, and/or program assistant with responsibilities directly associated with the institutional career development program; salaries must be commensurate with institutional policy for similar positions and specifically identified and justified. When applicable, this expense must be itemized in Section B of the R&R Budget.
Travel for key persons and Advisory Committee members must be justified as specifically required by the proposed program and must not duplicate items generally available for similar programs at the applicant institution. These expenses must be itemized in Section D of the R&R Budget.
Travel funds at the rate of $1,500 per person will be provided to defray the travel costs to attend a K12 community conference (a regular conference voluntarily organized by an institution(s) with an NCI K12 award for the purpose of gathering K12 scholars and mentors for exchange of knowledge, career development and networking). Each year, one mentor and about half the total scholars will be supported. It is anticipated that a scholar will attend this conference in their first year of support, and if applicable again in their third year. Each program would decide who would receive this funding giving priority to scholars who have not previously received it and based on the scholar's ability to travel at the time of the conference as well as standing in the program. Other scholars/mentors/program leaders could attend using funds from their institution as available.
Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations
| Higher Education Institutions - Includes all types | |
| Public/State Controlled Institutions of Higher Education | |
| Private Institutions of Higher Education |
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) |
Local Governments
| Indian/Native American Tribal Governments (Federally Recognized) |
| Indian/Native American Tribal Governments (Other than Federally Recognized) |
| U.S. Territory or Possession |
Other
| Native American Tribal Organizations (other than Federally recognized tribal governments) |
| Faith-based or Community-based Organizations |
Federal Governments
Eligible Agencies of the Federal Government
U.S. Territory or Possession
The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.
Foreign Organizations/International Collaborations
Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Required Registrations
Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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 failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
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. Foreign organizations must obtain a NATO Commercial and Government Entity (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. The same UEI must be used for all registrations, as well as on the grant application.
| eRA Commons – Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed career development program as the Program Director/Principal Investigator (Training PD/PI) is invited to work with their organization to develop an application for 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 How to Apply - Application Guide.
The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be responsible for the selection and appointment of scholars to the approved career development program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day-to-day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.
The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.
The PD(s)/PI(s) are expected to have independent R01 and/or R01-equivalent cancer-focused grant support at the time of application and award. For the NCI K12, R01 or R01-equivalent awards (https://grants.nih.gov/grants/glossary.htm#R01EquivalentGrant) are defined as grants or contracts of at least 3 years in duration and $150,000 per year in direct costs, including those supporting clinical trials.
2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is programmatically distinct.
NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Preceptors/Mentors
Program faculty should be active researchers in the biomedical sciences, as demonstrated by recent publications and research support in the area of the proposed research career development program.. When building a training team, programs should include faculty who are committed to training, mentoring, and providing safe, accessible, and supportive research career environments. All program faculty should have a mentoring philosophy appropriately tailored to the needs of potential Scholars that ensures scholars will receive the tailored mentorship needed to develop skills and advance their career. Program faculty should also have sufficient time to commit to training scholars in the career development program given their other professional obligations.
Scholars The applicant organization will select the scholars to be supported by the institutional career development program and is responsible for establishing eligibility and selection criteria that are consistent with applicable law.
Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.
Surgeon-scientists with surgical duties may request a minimum of 6 person-months (50% full-time professional effort) to the K12. A clear justification must be provided in the application when requesting less than 75% full-time professional effort (less than 9 person-months).
Scholars must be citizens or non-citizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.
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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission It is critical that applicants follow the Training (T) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - 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 How to Apply - Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.
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 How to Apply - Application Guide must be followed.
SF424 (R&R) Other Project Information
Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., predoctoral, postdoctoral), and intended scholar outcomes.
Other Attachments. An Advisory Committee is not a required, but a highly recommended component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file “Advisory_Committee.pdf”.
The filename provided for each "Other Attachment" will be the name used for the bookmark in the electronic application in eRA Commons.
SF424(R&R) Senior/Key Person Profile Expanded Follow all instructions provided in the How to Apply - Application Guide.
PHS 398 Cover Page Supplement
PHS 398 Training Subaward Budget Attachment(s)
Research and Related (R&R) Budget Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:
| Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars. |
| Do not complete the section on Participant/Trainee Support Costs. |
PHS 398 Research Training Program Plan The PHS 398 Research Training Program Plan Form is comprised of the following sections:
| Training Program Section | |
| Faculty, Scholars, and Training Record Section | |
| Other Training Program Section | |
| Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the NOFO specifically instructs applicants to do so. |
Follow all instructions provided in the How to Apply - Application Guide.
Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the prospective trainee candidate pool, faculty mentors, the educational and career outcomes of past participants, and other factors that contribute to the overall environment of the program.
Training Program Section Program Plan Program Administration.
Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.
In the event that a Scholar would propose to gain research experience in a clinical trial, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study.
Proposed Training.
The PD/PI should describe program activities intended to develop the working knowledge needed for proposed scholars to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all proposed scholars with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral scholars should also be provided with instruction in laboratory and project management.
In the event that a Scholar would propose to gain research experience in a clinical trial, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study.
Program Faculty.
If any mentors will supervise a scholar proposing to gain research experience in a clinical trial, provide documentation of their expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.
Institutional Environment and Commitment to the Program The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.
Other Plan(s):
A Data Management and Sharing Plan (DMS Plan) is not applicable for this NOFO.
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide (https://grants.nih.gov/grants/policy/appendix_policy.htm#5070).
PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed, with the following additional modifications:
Study Record: PHS Human Subjects and Clinical Trials Information DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.
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).
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must complete a Delayed Onset Study.
PHS Assignment Request Form
3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply - 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. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.
7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - 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 field of 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.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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.
Mandatory Disclosure
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described 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.
While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex of program candidates, scholars, or faculty may not, be used as factors in the evaluation of applications.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed career development program will prepare individuals for successful, productive scientific research careers, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of the merit of the institutional career development and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major career development impact.
Career Development Program and Environment
| Does the application provide a compelling rationale for the proposed career development program and propose appropriate training goals and objectives relevant to the rationale? | |
| Are the content and duration of any proposed didactic, career development, and research-related activities of the program appropriate to achieve the program's goals and objectives? Do the program activities foster the development of scholar skill and expertise in transparent, rigorous, reproducible, and relevant research methodologies tools applicable to the goals of the career development program? | |
| Are appropriate timelines indicated for scholar career progression and transition to independence? What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars? | |
| Is there an effective mechanism to monitor mentoring and to promote the development, retention and success of all scholars throughout their training? | |
| Does the environment have adequate and appropriate facilities to support the proposed career development program? | |
| Is the level of institutional commitment to the career development program, including administrative and research training support, sufficient to promote the success of the program? | |
| Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research, career development, and related activities? | |
| When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of appropriate and helpful input and guidance to the program? |
Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
| Do the PD/PI and Research Administrator (if applicable) have the appropriate experience to develop, direct and administer the proposed program? | ||
| Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives? | ||
| Have the PD(s)/PI(s) demonstrated a strong commitment to training future researchers? | ||
| Does the application describe how the PD(s)/PI(s) will receive appropriate training on effective mentoring practices to promote scholars' success? | ||
| Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program? | ||
| For applications designating multiple PDs/PIs: | Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars? | |
| Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs? |
Mentors
| Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training? | |
| Are the quality and extent of the mentors' roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research? | |
| Is there a strong plan to ensure mentors receive appropriate training in the use of evidence-informed mentoring practices that promote the development of all scholars? |
Scholars
| Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support? As applicable, does the proposed program clearly outline a plan to recruit and develop junior investigators for successful careers as biomedical or clinical researchers? | |
| Is a recruitment plan proposed with strategies likely to identify candidates with the potential to strongly benefit from, and with proper support, succeed in the career development program? | |
| Are there well-defined and justified selection and re-appointment criteria? |
Training Record
| How successful are the scholars (or, for new applications, recent graduates in similar training) in completing the program? | |
| Does the application provide evidence that scholars (or, for new applications, other recent graduates in similar training) conducted rigorous research that advanced scientific knowledge and/or technologies with increasing self-direction (such as peer-reviewed publications and other accomplishments appropriate to the field)? | |
| How successful are the scholars (or, for new applications, recent graduates in similar training) in transitioning to appropriate careers in the biomedical research workforce that utilize their training and directly benefit the broader biomedical research enterprise? | |
| Does the program have a rigorous evaluation plan to assess the and effectiveness of the career development program and the extent to which it is meeting its overall goals and objectives? Are effective mechanisms in place for obtaining feedback from current and former scholars, and appropriate plans to respond to feedback? |
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Inclusion of Human Subjects Policies
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Vertebrate Animals
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Biohazards
Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.
Instruction in the Responsible Conduct of Research
All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?
For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?
Instructions in Methods for Enhancing Reproducibility
Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development related to scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?
For renewal applications, does the progress report document appropriate changes in the plan for Methods for Enhancing Reproducibility in response to feedback and to evolving issues related to the conduct of rigorous and reproducible research?
Resubmissions
For Resubmissions (as applicable), 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.
Renewals
| For Renewals (as applicable), the committee will consider the progress made in the last funding period. | |
| Does the application describe the program's accomplishments over the past funding period(s)? | |
| To what extent have the program goals and objectives been achieved since the last cycle? If certain goals were not met, did the program provide reasonable explanations and describe appropriate alternative approaches taken? | |
| Has the program evaluated its effectiveness, and is there evidence that the evaluation outcomes and feedback from scholars have been acted upon? | |
| Are appropriate changes proposed that would improve or strengthen the career development experience? | |
| Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers? | |
| Does the program use current, evidence-informed career development and mentoring approaches, and continue to evolve and reflect changes in the research area in which the career development occurs? |
| For Renewals, the committee will consider the progress made in the last funding period. Has the career development program successfully achieved its stated objectives during the prior project period? | |
| Has the Program been of high quality and effective in developing new independent investigators? | |
| Has the program been innovative in the past and does it continue to demonstrate innovation? | |
| Has the program been adequately evaluated and has the level of success been satisfactory? | |
| Do the results of the evaluation document show a continued need for support for this program? | |
| Is the approach for the next project period responsive to the results of the program's evaluation? |
Revisions
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific aspect of the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous…
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