Find below answers to frequently asked questions for applicants to International Research Scientist Development Award (IRSDA) (K01) Independent Clinical Trial Not Allowed (PAR-18-539) and International Research Scientist Development Award (IRSDA) (K01) Independent Clinical Trial Required (PAR-18-540).
Learn more about the International Research Scientist Development Award (IRSDA).
Please check this page for updates.
Updated July 11, 2018
Eligibility | Program features | Budget | How to apply | Reporting | Funding partners
- Where can I find more information if my question isn't addressed in these FAQs?
Find more extensive policies and information on NIH Career Development Awards, also known as "K awards," from the NIH Office of Extramural Research.
Be sure to read the FOAs and any related NIH Guide Notices carefully. NIH Guide Notices provide important information about policies for extramural grants and may include eligibility updates, deadline changes, participation of new partners, etc.
- How do I find out what countries are classified as LMIC?
LMICs are defined by the World Bank Country Classification system according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income.
- I am an LMIC citizen. Am I eligible for the International Research Scientist Development Award (K01)?
Only U.S. citizens and individuals who are permanent residents of the U.S. are eligible for the IRSDA. LMIC citizens may apply for the Fogarty Emerging Global Leader Award (K43).
- Are LMIC institutions eligible to apply to this IRSDA (K01)?
No. Only eligible U.S. institutions may apply.
- I have independent research funding. Am I eligible for the IRSDA K01?
It depends. One of the primary objectives of the mentored K awards is to provide the training necessary for candidates to become independent investigators. Research independence is typically defined as having obtained an R01 or equivalent major grant.
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 career development awards (K awards), 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. A candidate for this award may not concurrently apply for or have an award pending for any other NIH career development award.
When listing research support in the Biographical Sketch, clarify PD/PI status on award(s).
- Is there a degree requirement for these FOAs?
Yes. 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 his/her doctoral training. Evidence of research experience includes lead authorship and/or significant contribution to research publications in peer reviewed journals, presentations at international meetings, and research fellowships.
- Is there an age limit to apply for an IRSDA K01?
There is no age limit or upper limit on the number of years beyond the doctoral degree, however the IRSDA program is intended to support advanced postdoctoral research scientists and junior faculty.
- Must I be within a certain number of years of finishing my degree?
Applicants must have received their doctoral degree at least two years prior to the application deadline. In addition applicants must have research experience beyond their doctoral training. Evidence of research experience includes lead authorship and/or significant contribution to research publications in peer reviewed journals, presentations at international meetings, and research fellowships.
- If I do not meet the eligibility requirements for Fogarty Emerging Global Leader Award or the International Research Scientist Development Award (IRSDA), are there other career awards that I can apply for?
You may be eligible for other NIH career development awards offered through other NIH Institutes and Centers. Please visit the Research Career Development page for information on other NIH Career Development Awards. Note that for most NIH K awards, eligibility is limited to U.S. citizens and permanent residents.
- Can the applicant institution submit more than one application?
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
- May an individual candidate apply for two Ks simultaneously?
No. NIH allows you to have only one career development application pending peer review at any time. That means you may not apply for two career development grants simultaneously or apply for a career development award while another career development application awaits review.
In the latter case, you have to wait until the review is complete or withdraw the first application before you can submit your next one.
- Where can I find more information about the program?
Interested individuals should carefully review the Funding Opportunity Announcements, which contain details about eligibility, instructions for submitting an application, and details about the review process and review criteria.
Also see the IRSDA program page, which includes a list of recent awards.
- Are there any restrictions on research topics?
As stated in the FOAs, Fogarty has no restrictions on research topics. However, the topic should be relevant to the priority health needs of the LMIC. The interests of participating funding partners are noted in the FOAs.
- What is the effort required on this award?
Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research training. 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 may get paid for those activities during the remaining 25% time, but may not get paid from U.S. government funds.
- How many mentors are required?
Applicants are required to have two primary mentors: one primary mentor at the LMIC applicant institution and one primary mentor at the collaborating U.S. institution. However, additional mentors may be included to form a “mentoring team”.
Both primary mentors (U.S. and LMIC) are required to have eRA Commons Usernames (NOT-OD-16-082). As stated in the FOAs, 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.
For funded IRSDAs, both primary mentors must submit mentor statements with the annual progress report
- Can the LMIC primary mentor be a U.S. citizen?
No. The LMIC primary mentor should not be a U.S. citizen who holds a joint appointment at the LMIC institution. The LMIC primary mentor should be a LMIC citizen whose primary appointment is at the LMIC collaborating institution.
- Can I propose a mentoring team?
Yes. Provided that the requirement for two primary mentors (one U.S. and one LMIC mentor) is met, candidates may propose a mentoring team to contribute additional appropriate expertise. Additional mentors can be from other LMIC or non-U.S. high income countries.
- Can the IRSDA K01 award support advanced degrees?
The K01 is not intended to support extensive coursework for the purpose of obtaining an advanced degree. Recipients may enroll in some advanced scientific specialty classes that are part of a PhD track provided those courses are relevant to the research and career development of the individual.
- How much time am I required to spend at the LMIC institution?
Awardees must 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 any given year of the award, awardees must spend a minimum of three months conducting research in the LMIC. For example, a candidate with 75% effort on a 5-year K01 must spend 22.5 months at the LMIC institution. Plans for spending time in the LMIC should be detailed in the application and a timeline is strongly encouraged. Candidates are required to report annual, cumulative and planned time in-country in their annual progress reports.
- How much support can I get through the grant?
Salary support: The NIH will contribute up to $75,000 per year toward the salary of the career award recipient. The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff of equivalent qualifications, rank, and responsibilities in the department concerned. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.
Research support: The NIH will contribute up to $30,000 per year toward the research development costs of the award recipient.
- Can mentors receive salary on this award?
No. Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
- Can I pay for a technician on a career award?
Yes. These expenses are allowed from the research development support costs.
- What are the allowable costs for the research development funds?
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. These items should be described in the budget justification.
- How many years of support will be covered?
Applicants can request three to five years of support.
- What indirect cost rate should be used in preparing the budget?
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
- How many awards will be issued each year?
The total number of awards will depend upon the quality and merit of applications received and contingent upon availability of funds.
How to apply
- Which of the two IRSDA K01 FOAs should I apply to?
In December 2017, the IRSDA K01 FOA was reissued as two FOAs because of the NIH clinical trials policy. IRSDA PAR-17-002 expired and was replaced by two FOAs. One is for individuals proposing independent clinical trials (PAR-18-540). The other is for individuals who are not conducting independent clinical trials (PAR-18-539), although research experiences on a mentor's clinical trial are allowed.
It is essential that applicants apply to the appropriate FOA.
If the proposed study involves human subjects, it may meet the NIH definition of a clinical trial. You should use the clinical trial tool to determine whether NIH considers any of your studies a clinical trial. If any study (or component) of your IRSDA K01 application is an independent clinical trial (even if your application includes other studies that are not clinical trials), you must respond to the IRSDA K01 FOA that requires independent clinical trials. If none of your specific aims include studies that are independent clinical trials, you must respond to the IRSDA K01 FOA that does not allow clinical trials (research experiences on a mentor's clinical trial are allowed under this FOA). Check section II of the FOA to confirm you are applying to the appropriate FOA.
More information on NIH Clinical Trials Requirements and Fogarty information on human subjects research and clinical trials.
- Is the candidate or one of the mentors considered the PI on the application?
The candidate is the PI.
- Where can I find instructions and guidance for submitting an application?
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in the FOAs or in a Notice from the NIH Guide for Grants and Contracts). Applications that do not comply with these instructions may be delayed or not accepted for review. Be aware that the instructions in the FOAs supersede those found in the SF424 application guide.
See the Annotated Forms for tips on how to fill in the SF424 forms.
- What is the timeframe for submission of applications?
The application can be submitted any time between the “Open Date” and the ‘Application Due Date” noted in the FOAs. Applicants and their institutions should familiarize themselves with the requirements of electronic submission through grants.gov, including registration of the applicant and the institution through NIH Commons. The registration process can take several weeks and applications cannot be submitted before all registrations are completed.
It is strongly suggested that you submit your application electronically a few days BEFORE the actual deadline. Remember, you must check for error messages to your email address after submission to Grants.gov AND subsequently when the application is transferred automatically to eRA Commons (error messages go to your eRA Commons Account). You must correct any Grants.gov and eRA-identified errors BEFORE the submission deadline or your application will NOT be accepted by NIH. Verify that your application is viewable in your eRA Commons account. If you cannot view the application in eRA Commons, NIH has not yet accepted it! Do not wait until the last day. References letters must be submitted by the application deadline in order for the application to be considered. See the NIH Policy for Late Application Submission (NOT-OD-15-039) for more information.
Check your application for common errors before you submit. See "Avoiding Common Errors."
- Should I submit a letter of intent?
No. Letters of intent will not be considered for these FOAs. Applicants are encouraged to carefully review all the application materials and read through all the FAQs. If you have additional questions or would like to discuss the program further, please contact the Program Officer named in the FOAs (email preferred).
- Who submits my reference letters to the eRA Commons?
Reference letters are different from Mentor Statements. Reference letters are required. People writing your reference letters submit them to the eRA Commons. As the applicant, you can check the status of letters, but you may not read them since they are confidential. The letters should be from individuals not directly involved in the application.
For further details, including information you should give to those writing your reference letters, read the supplemental instructions for K awards in part 7 of the SF 424 Application Guide.
Individuals submitting letters of reference do not need to have an eRA Commons account but must have the applicant's eRA Commons username and other information detailed in the SF424 (R&R) Application Guide Supplemental Instructions for Individual Career Development Award (CDA) series applications.
Applications that have fewer than the required numbers of qualifying reference letters will not be reviewed.
- Will NIH accept paper applications for these FOAs?
No. The NIH requires electronic applications in response to these FOAs and it is critical that applicants complete all required registrations well in advance of the application deadline as the registration process can take several weeks or longer.
- Do I need to have an eRA Commons Username?
Yes. Failure to register in the Commons and to include a valid PD/PI Commons Username in the credential field will prevent the successful submission of an electronic application to NIH. For additional information, see the eRA Commons Registration FAQs.
- Do my mentors need to have eRA Commons Usernames?
Yes. Per NOT-OD-16-082, eRA Commons Usernames are required for primary mentors. This means that both the U.S. primary mentor AND the LMIC primary mentor must have eRA Commons Usernames. Including eRA Commons usernames for individuals designated as co-mentors remains optional.
- Do I list my mentors as Key Personnel?
Yes. As stated in the FOAs, 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.
- The FOAs state that applicants must have and maintain a System for Award Management (SAM) registration. Where can I find more information about this?
The submitting institution and the PI are required to register in order to submit an application using the online systems. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations:
- System for Award Management (SAM) – Applicants must complete and maintain an active entity registration (formerly CCR registration), which requires renewal at least annually. The renewal process may require as much time as the initial registration. Use the Sam.gov "Manage Entity" function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
- eRA Commons - Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.
Find detailed instructions about this multiple step SAM registration process.
- Do I include the LMIC institution as a performance site?
Yes. The U.S. applicant institution and all of the collaborating institutions, including the LMIC institution, must be listed as performance sites.
- Where do I include information about the U.S. institutional environment?
Provide information about the U.S. institutional environment in the Facilities & Other Resources section, which must describe the resources available at each site. This should describe how the necessary facilities and other resources will be made available for career enhancement as well as the research proposed, including opportunities for intellectual interactions, relevant courses offered, journal clubs, seminars, and presentations.
- The IRSDA requires two letters of Institutional Commitment. Where do I include these?
The U.S. applicant institution's Institutional Commitment letter should be submitted under Item 11 as instructed in the SF424 R&R Application Guide. The LMIC collaborating institution's Institutional Commitment letter should be submitted in the Letters of Support from Collaborators, Contributors, and Consultants attachment, following the page limits for this section.
- Is the Candidates Plan to Provide Mentoring section required for these FOAs?
No. Do not include this section.
- Where can I find clarification of page limits for application form sections?
The page limits for most sections are listed by Activity Code in the Table of Page Limits. Follow the page limits for Individual Career Development Award applications (K) applications. Do not use the Appendix or any other sections to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
- How should I allocate the 12 pages for Candidate Information and Goals for Career Development and Research Strategy in the application?
As explained in the SF424 instructions, the total number of pages for the Candidate Section (Candidate's Background, Career Goals and Objectives, and Candidates Plan for Career Development/Training Activities During Award Period) and the Research Plan Section combined may not exceed 12 pages.
You can allocate the space however you think best portrays your background, career objectives, and training plan. All of these sections are scored by reviewers and will be taken into consideration in the overall Impact/Priority Score.
The general strategy is to explain your background and training plan in the context of your overall career goals and the research project itself. The training plan is very important. It should add to what you have learned already during past research experiences and prepare you for an independent research career. The Research Strategy is important too, obviously. It must be of high quality scientifically and within your capabilities, as acquired either in the past or as part of the mentored training plan. Do not propose any experiments in areas with which you and your mentors have no documented experience.
What you need to include in all of these sections is described in Section K.410 of the SF424 instructions. The Program Announcement includes under "Review Considerations" lists of items the reviewers will specifically evaluate. Be sure you provide information relevant to each of these items.
- The page limits for Plans and Statements of Mentors and Co-Mentors and for Letters of Support from Collaborators, Contributors, and Consultants are each 6 pages. Is this really the limit? Can I put letters in the Appendix?
The SF424 instructions state the following: Letters from the mentor(s), co-mentor(s), consultant(s), advisory committee members (if applicable), and contributor(s) documenting their role and willingness to participate in the project must be included in this section of the application. Do not place these letters in the Appendix.
The instructions do not offer any flexibility with respect to the six-page limit for this section. Letters on letterhead take up considerably more space than needed to describe the roles and commitments of the mentors or collaborators. However, reviewers tend to expect letterhead from mentors and other key participants. For a typical one- to three-mentor application, six pages may be enough to describe the training, resources, and commitments. If there are more individuals associated with the project, the applicant should include letters on letterhead from the mentors and any other collaborators who are absolutely essential to the training plan. Other less important collaborators may summarize what they intend to provide in terms of expertise, resources, or time in the personal statement section of the biosketches. Another alternative is to place any letters that might be considered resources under Facilities and Other Resources. Statements and letters of collaboration should absolutely not be included in the Appendix. The instructions are clear about this, and the application may be rejected or withdrawn later if applicants take that route.
See the NIH Notice on the appendix policy for NIH applications NOT-OD-17-035.
- What should be included in the Training in Responsible Conduct of Research section?
In addition to the guidance provided in the application instructions for this section, applicants are strongly encouraged to include courses and activities offered at the LMIC site to get a perspective of the issues involved in RCR where they will be engaged in research.
- To which NIH Institute, Center or Office will my application be assigned?
Upon receipt, applications are assigned to the Fogarty International Center. Applicants should not request assignment to any other NIH component.
- The application form invites requests for assignment to a Scientific Review Group. What should I enter?
IRSDA (K01) applications will be reviewed by Fogarty's chartered study section International and Cooperative Projects-1 [ICP1] within NIH's Center for Scientific Review (CSR).
- When will review results be sent to applicants?
Scores can be accessed from the PI's NIH eRA Commons account 1-2 days after the review. The NIH summary statement with the critiques of the initial peer reviewers will be available in the NIH eRA Commons (in the account of the PI, linked to the application number) approximately four to six weeks after the review meeting. The review will be held in July of each year. The results of the review will be presented to the FIC Advisory Board in October.
- If my initial application is unsuccessful, can I reapply?
Yes, you can. Please see the NIH resubmission policy NOT-OD-14-074.
- If my application is awarded, where can I find information about progress reporting?
Fogarty and NIH require grantees to submit annual progress reports to document grantee accomplishments and compliance with the terms of the award. Guidance can be found at RPPR guidance for Fogarty career awards.
Both primary mentors (U.S. and LMIC) must include an annual evaluation statement of the candidate's progress in the submitted progress report.
The awardee must provide a statement of amount of time at the LMIC site (annual, cumulative and planned) in each year's progress report.
- Which NIH components are partnering on the International Research Scientist Development Award (IRSDA)?
Partners at this time include the Fogarty International Center (FIC) and the National Cancer Institute (NCI). Additional NIH partners may join this initiative in the future and will be announced through at Notice in the NIH Guide and will be added to this site.