Leveraging Electronic Medical Records for Psychiatric Genetic Research (R01 (Collab) Clinical Trial Not Allowed) | PAR 18 905

Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The funding opportunity is titled "Leveraging Electronic Medical Records for Psychiatric Genetic Research (R01 (Collab) Clinical Trial Not Allowed)."

What is the Funding Opportunity Number (FON) and CFDA number?

The Funding Opportunity Number is PAR 18 905, and the CFDA number listed is 93.242.

What is the main purpose of this grant opportunity?

The opportunity supports collaborative, multi-site research that uses electronic medical records (EMRs) and other large-scale health data resources to strengthen psychiatric genetic research. The central goal is to better explain how genetic liability (including polygenic risk and specific risk variants/loci) interacts with environmental and other non-genetic factors to shape the development and course of serious mental disorders.

What long-term impact is this program trying to achieve?

By clarifying genetic and non-genetic causes in real-world human populations, the long-term goal is to improve how mental disorders are understood, diagnosed, and eventually treated.

What NIH activity code does this opportunity use?

This is a discretionary grant mechanism under the NIH R01 activity code, tailored for multi-site collaboration.

Is this a single-project R01, or is it designed for multi-site collaboration?

This announcement is specifically structured for a linked set of collaborative R01 applications. Multiple sites submit connected R01 proposals, and each site names its own Program Director(s)/Principal Investigator(s).

What does a "linked set of collaborative R01 applications" mean in practice?

It means the research is submitted as multiple connected R01 applications from participating sites, with built-in cross-site coordination. The design emphasizes regular communication so teams can align methods, harmonize data elements, and integrate findings across different settings.

Why does NIH emphasize a collaborative format for this FOA?

The collaborative format is intended for research questions that are too large, complex, or multidisciplinary for a single institution to address alone, especially when complementary expertise is needed across areas like psychiatric genetics, epidemiology, informatics, biostatistics, molecular biology, and health system data science.

What types of data are applicants expected to use?

Applicants are expected to leverage electronic medical records (EMRs) and other large-scale health data resources, particularly where EMR data can be linked to genetic information at the individual level.

Does the FOA encourage building new cohorts?

No. The FOA encourages molecular epidemiology carried out efficiently and creatively within existing resources rather than building entirely new cohorts from scratch.

What kinds of existing resources does the FOA expect applicants to leverage?

The FOA expects the use of established, population-based cohorts, registries, and/or health systems where EMR data can be linked to genetics at the individual level.

What kinds of genetic components are specifically mentioned?

The FOA mentions genetic components such as polygenic scores, specific genetic variants, risk loci, and biologically meaningful networks.

What kinds of research questions or analyses are emphasized?

The emphasis is on analyses that use scale, diversity of data, and real-world clinical information captured through routine care to test hypotheses about etiology, risk pathways, and gene-environment interplay.

Is gene-environment interplay a focus of this program?

Yes. A core aim is to understand how genetic liability works together with environmental and other non-genetic factors to influence serious mental disorders.

Are clinical trials allowed under this FOA?

No. Clinical trials are not allowed under this FOA.

If clinical trials are not allowed, what kinds of study designs fit this FOA?

The FOA indicates that proposed studies should focus on observational research, secondary analyses, methodological development for EMR-linked genetic studies, and related non-interventional designs.

Does the FOA support prospective testing of treatments or interventions?

No. The intent is to draw stronger causal and mechanistic inferences from existing data sources and linked datasets rather than to test treatments or interventions prospectively in a trial framework.

What types of expertise are highlighted as relevant for teams?

The FOA highlights the value of complementary expertise, including psychiatric genetics, epidemiology, informatics, biostatistics, molecular biology, and health system data science.

Can a single institution apply without collaboration?

This FOA is designed for collaborative, linked R01 submissions. The announcement notes that applicants seeking non-collaborative, single-project R01 applications should use a companion FOA rather than this collaborative mechanism.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S. organizations, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are minority-serving and other special categories of institutions included as eligible applicants?

Yes. The FOA highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, Historically Black Colleges and Universities, and Tribally Controlled Colleges and Universities.

Are federal agencies eligible to apply?

Yes. The FOA includes eligible federal agencies among the eligible applicant categories.

Are faith-based or community-based organizations eligible?

Yes. The FOA explicitly includes faith-based or community-based organizations among eligible applicants.

Are U.S. territories or possessions included in eligibility?

Yes. The FOA lists U.S. territories or possessions as eligible applicants.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The FOA indicates that non-U.S. entities (foreign organizations) are included, reflecting interest in inclusive participation and, where appropriate, broader population representation.

Does the FOA specify an award ceiling or the expected number of awards?

No. The provided information does not specify an award ceiling or expected number of awards. It notes that budgets and award counts typically depend on NIH institute priorities, available appropriations, and the scientific merit and feasibility of the applications received.

When was this funding opportunity originally created, and what was the original closing date?

The original posting indicates a creation date of August 16, 2018, and an original closing date of September 7, 2021.

What makes EMR-based research especially relevant to the goals of this FOA?

The FOA emphasizes using real-world clinical information captured through routine care, combined with individual-level genetic information, to strengthen psychiatric genetic research and improve understanding of serious mental disorders across people and environments.

What is the overall "big picture" objective of the collaborative structure?

The collaborative structure is intended to support scale and methodological consistency across sites, including coordination, harmonization of data elements, and integrated findings that can have broader validity and utility for psychiatric research.