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Frequently Asked Questions (FAQs): NIH PAR-15-307 (U01)

What is PAR-15-307?

PAR-15-307 is an NIH funding opportunity titled "Translational Studies on Adducts for Cancer Risk Identification and Prevention (U01)." It supported clinically relevant translational and epidemiological research using macromolecular adducts as measurable indicators of exposure to cancer-related risk factors in people.

What are "adducts" in the context of this funding opportunity?

In this program, "adducts" are chemical modifications formed when reactive compounds bind to cellular macromolecules such as DNA, RNA, or proteins. The premise is that adducts can serve as biological records of real-world exposures.

What was the main scientific goal of the program?

The central goal was to strengthen the ability to connect environmental, lifestyle, occupational, or other external exposures to downstream cancer risk in specific populations and subgroups by measuring exposure-related adducts in human biospecimens.

What types of research did PAR-15-307 prioritize?

The announcement prioritized clinically relevant translational and epidemiological studies that use human biospecimens linked to detailed clinical or medical information. The intent was to produce findings that meaningfully relate to human cancer risk and real-world health outcomes.

What does "adductomics" mean, and why was it a priority?

"Adductomics" refers to approaches that look beyond single, one-off adduct measurements and instead assess broader patterns or a more comprehensive spectrum of adducts. It was a priority because it pushes exposure assessment toward more informative signatures that may better support cancer risk estimation, earlier detection strategies, and prevention decisions.

Did projects have to measure a single adduct or multiple adducts?

The FOA encouraged moving beyond measuring a single suspected marker and favored broader characterization of adduct burdens in human samples, consistent with an adductomics emphasis.

Were human biospecimens required?

Yes. The FOA strongly emphasized the use of well-annotated human biospecimens linked to detailed clinical or medical information. Projects were expected to leverage high-quality specimen collections where robust health, demographic, and outcome data already exist.

What does "well-annotated" biospecimens mean here?

In this context, "well-annotated" means biospecimens are linked to detailed clinical or medical information and associated data such as health status, demographic characteristics, and outcomes, enabling credible clinical and epidemiological interpretation.

Were NCI-supported cohort studies specifically encouraged?

Yes. NCI-supported cohort studies were provided as a prominent example of the kind of high-quality specimen collections and data resources the program expected applicants to leverage.

Was the program limited only to prevention and risk assessment, or could it include etiology studies?

While the main focus was cancer detection, prevention, and risk assessment in human populations, the announcement also allowed studies examining how adducts may contribute to cancer etiology, including gene-environment interaction research, as long as the work remained grounded in appropriate sets of human biospecimens.

Could gene-environment interaction research be supported under this FOA?

Yes. Gene-environment interaction research was allowed, with the key condition that the project be grounded in suitable human biospecimens (for example, from NIH-supported cohort studies) so results could be interpreted in a clinically and epidemiologically credible way.

What was the intended translational impact of the funded research?

The program aimed to advance exposure assessment tools and evidence that could improve cancer risk estimation, support earlier detection strategies, and inform prevention interventions by identifying which exposures matter most and in which groups they have the greatest consequences.

What funding mechanism did PAR-15-307 use?

This opportunity used a cooperative agreement (U01) mechanism. A U01 typically implies closer scientific involvement and collaboration with NIH program staff than a standard research project grant, aligning with the program's translational and coordination-intensive goals.

Why does a U01 cooperative agreement matter for applicants?

Because the U01 mechanism generally involves more NIH program staff scientific involvement, it is often used when coordination is important, such as when working with complex biospecimen resources, analytical platforms, and data integration needed for translational adduct research.

What NIH activity areas did the program fall under?

The program spanned NIH activity areas related to environmental health and multiple cancer research categories, including cause and prevention, detection and diagnosis, and treatment research. This reflected the cross-cutting nature of adduct-based exposure science.

When was PAR-15-307 posted, and what were the key dates?

The FOA was posted on July 24, 2015. The original and final closing date was July 11, 2018. It was archived on August 11, 2018.

Is this funding opportunity still open?

No. Based on the provided information, the FOA had a final closing date of July 11, 2018, and it was archived on August 11, 2018.

Did the FOA require cost sharing or matching funds?

No. The opportunity did not require cost sharing or matching.

Who was eligible to apply?

Eligibility was broad and included public and private institutions of higher education, nonprofit organizations (with and without 501(c)(3) status), for-profit organizations (including small businesses), state and local governments, tribal governments and organizations, public housing authorities, and other specialized entities.

Were minority-serving institutions explicitly included?

Yes. The eligibility list explicitly included a range of minority-serving institutions, as well as community-based and faith-based organizations.

Could for-profit organizations and small businesses apply?

Yes. For-profit organizations, including small businesses, were included in the eligibility list.

Could government entities apply?

Yes. State and local governments, tribal governments and organizations, and public housing authorities were among the eligible entities listed.

Were non-U.S. (foreign) organizations allowed to apply?

Yes. The eligibility list allowed non-U.S. (foreign) entities and regional organizations, as well as U.S. territories or possessions.

What kinds of exposures was the program interested in linking to cancer risk?

The program emphasized connecting real-world exposures to cancer risk, including environmental, lifestyle, occupational, or other external risk factors, using adducts as measurable indicators of those exposures in people.

Why was the program so focused on biospecimen-driven research rather than only laboratory or method development?

The FOA focused on producing findings tied to human cancer risk and real-world outcomes. That emphasis meant projects needed a clear path to population-level relevance through annotated human biospecimens and associated clinical and epidemiological data, rather than being purely methodological or discovery-oriented without such linkage.

What was the expected overall payoff of the program?

The expected payoff was stronger tools and evidence for identifying exposure-related cancer risks in diverse populations, improving the scientific basis for linking environmental and behavioral risk factors to cancer outcomes, and supporting prevention-focused decision-making.