International Research Scientist Development Award (IRSDA) (K01) - Independent Clinical Trial Not Allowed | PAR 18 539

Opportunity Information: Apply for PAR 18 539

The International Research Scientist Development Award (IRSDA) (K01) is an NIH career development grant meant to help early-career U.S. scientists build a long-term, independent research career in global health. It is structured to provide substantial protected time and support for an intensive mentored research experience lasting three to five years in a low- or middle-income country (LMIC), using the World Bank country classifications (low-income, lower-middle-income, and upper-middle-income). The core idea is to give advanced postdoctoral researchers and newly appointed junior faculty a sustained period to develop skills, produce strong research outputs, and position themselves to compete successfully for future independent funding focused on global health priorities.

This opportunity targets investigators who are already beyond the most basic training stage: applicants must be at least two years past the date their doctoral degree was awarded. NIH is looking for early-career investigators from any health-related field, so the program is not limited to a particular disease area, methodology, or discipline. What matters is that the proposed research and career development plan are directly relevant to the health needs and priorities of the LMIC setting where the work will be carried out, and that the applicant will receive strong, structured mentorship from both an LMIC-based mentor and a U.S.-based mentor. The expectation is that the LMIC environment is central to the applicant's development, not a short add-on, and that the training experience will clearly build expertise in conducting rigorous global health research in real-world international contexts.

A defining feature of this specific FOA (PAR-18-539) is how it treats clinical trials. Despite the title line stating "Independent Clinical Trial Not Allowed," the description indicates that this announcement is intended for applicants who plan to be the lead investigator of an independent clinical trial, a clinical trial feasibility study, or an ancillary study linked to an existing clinical trial, as part of their overall research and career development plan. In practice, NIH K awards often separate FOAs based on whether the applicant will lead a clinical trial or not, and they direct applicants to the correct companion announcement depending on their role. This FOA explicitly notes that applicants who are not planning an independent clinical trial, or who simply want experience working on a trial led by someone else, should apply to a separate companion FOA (listed as PAR-18-MMM in the provided text). Because the wording in the title and description can appear contradictory, applicants typically need to confirm the clinical trial policy details in the full announcement and NIH definitions to ensure they are submitting under the correct FOA for their proposed study design and leadership role.

Eligibility is centered on U.S. institutions and U.S.-based investigators. Eligible applicant organizations include public and state-controlled institutions of higher education, private institutions of higher education, and certain other eligible organizations. The FOA also explicitly recognizes and encourages applications involving institutions that serve historically underrepresented groups, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs). At the same time, non-U.S. entities (foreign institutions) are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components are allowed under NIH policy, meaning the research and training activities can take place in the LMIC and include LMIC partners and sites consistent with NIH Grants Policy Statement rules.

Administratively, this is a discretionary grant mechanism administered by the National Institutes of Health, categorized under education and health funding activities. The CFDA numbers associated with the opportunity are 93.398 and 93.989. The opportunity was created on December 21, 2017, and the original closing date listed is March 6, 2020. The provided source text does not specify an award ceiling or expected number of awards, so applicants would need to consult the full FOA for budget and programmatic details, including allowable costs, salary support levels, effort requirements, and any institute- or center-specific priorities that may shape competitiveness.

Overall, the IRSDA (K01) is best understood as a structured pathway for promising U.S. early-career researchers to develop into independent global health investigators through a multi-year mentored experience embedded in an LMIC, supported by a dual-mentor team and a research project aligned with local health priorities. The main strategic decision point for applicants is choosing the correct FOA based on whether they will lead a clinical trial (or related feasibility/ancillary trial work) versus pursuing non-trial research or participating in a trial led by another investigator.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "International Research Scientist Development Award (IRSDA) (K01) - Independent Clinical Trial Not Allowed" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.398, 93.989.
• This funding opportunity was created on 2017-12-21.
• Applicants must submit their applications by 2020-03-06. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education, Private institutions of higher education, Others.

Apply for PAR 18 539

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