Opportunity Information: Apply for PAR 14 165
Apply for PAR 14 165
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Studies of Mental Illness Not Involving Treatment Development, Efficacy, or Effectiveness Trials (Collaborative R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants.
- This funding opportunity was created on Mar 27, 2014 and posted on Mar 27, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Special district governments Public and State controlled institutions of higher education County governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity PAR 14-165, titled "Clinical Studies of Mental Illness Not Involving Treatment Development, Efficacy, or Effectiveness Trials (Collaborative R01)," supports multi-site, collaborative clinical research projects in mental health that are not designed to test treatments. The intent is to fund studies that deepen understanding of mental illnesses through clinical investigation rather than through intervention trials. It is aimed at situations where a single site cannot reasonably achieve the scientific goals on its own, especially when larger sample sizes, faster enrollment, or broader representation across populations and settings are necessary to answer the research questions convincingly.
The scientific scope emphasizes areas such as mental health genetics, biomarker research, and studies focused on the nature and development of mental illness. Examples of the types of topics that fit include research on psychopathology, the course and expression of symptoms across time, and neurodevelopmental trajectories that may help explain how mental disorders emerge or change from childhood through adulthood. In practice, this could include work that links genetic variation to clinical phenotypes, studies that identify biological or behavioral markers associated with risk or prognosis, or carefully characterized observational and mechanistic clinical studies that clarify underlying processes in mental illness. What the FOA does not support are projects framed as treatment development, efficacy, or effectiveness trials, meaning it is not intended for testing whether a therapy works, comparing interventions, or establishing clinical effectiveness in real-world settings.
A defining feature of this opportunity is the requirement for two or more collaborating sites using a shared, common protocol. The sites are expected to be organized around the same study design, eligibility criteria, assessment methods, and data collection procedures, so that data can be pooled and interpreted as part of a single coordinated project. The collaborative structure is meant to strengthen the science by increasing statistical power, improving recruitment efficiency, and ensuring that study samples include diverse participants who better represent the populations affected by mental illness. For projects that involve many sites, the FOA anticipates that one site will function as a coordinating site, taking primary responsibility for centralized activities such as data management and other administrative functions that keep the collaboration consistent and on track.
The mechanism is a collaborative R01 structure, described as a linked set of R01 applications where each participating site submits its own application and has its own Program Director/Principal Investigator. Although each site is funded through its own award, the overall program is expected to operate as a coordinated network. The FOA highlights the need for cross-site coordination and infrastructure that supports quality control, database management, statistical analysis, and reporting. In other words, applicants are expected to plan not only the scientific aims at each site, but also the operational systems that ensure data integrity, harmonized procedures, and timely shared outputs across the collaboration.
From an administrative standpoint, this is a discretionary grant opportunity in the health category under CFDA 93.242 (Mental Health Research Grants). The announcement was posted and created on March 27, 2014, with an original and final closing date of May 7, 2017, and an archive date of June 7, 2017. Cost sharing or matching is not required, which generally means applicants are not expected to contribute non-federal funds as a condition of the award.
Eligibility is broad and includes many U.S.-based organization types such as public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, with specific notes excluding the non-501(c)(3) category when it functions as an institution of higher education), small businesses, for-profit organizations other than small businesses, and various government entities (state, county, city or township, special district, and independent school districts). It also includes public housing authorities/Indian housing authorities and tribal governments and tribal organizations, including federally recognized tribal governments. The FOA also lists additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based and community-based organizations and eligible federal agencies.
Notably, the FOA allows participation by non-U.S. entities and components. Non-domestic (non-U.S.) organizations and foreign institutions are eligible to apply, non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. This flexibility supports international collaboration when it strengthens recruitment, increases diversity, or enables access to unique populations or specialized expertise, as long as the overall project remains aligned with NIH policy and the FOA requirements.
The sponsoring agency is the National Institutes of Health. The full announcement was made available through the NIH Grants Guide at the link provided in the source text (http://grants.nih.gov/grants/guide/pa-files/PAR-14-165.html). For technical issues accessing the announcement or linking to it, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: NIH PAR-14-165 (Collaborative R01)
What is PAR-14-165?
PAR-14-165 is an NIH funding opportunity titled "Clinical Studies of Mental Illness Not Involving Treatment Development, Efficacy, or Effectiveness Trials (Collaborative R01)." It supports multi-site, collaborative clinical research projects in mental health that are designed to deepen understanding of mental illnesses through clinical investigation, not by testing treatments.
What kind of research is this opportunity meant to support?
This FOA supports collaborative clinical studies that improve understanding of mental illness through approaches such as mental health genetics, biomarker research, and studies focused on the nature and development of mental illness. It is intended for projects where a single site cannot reasonably achieve the scientific goals alone, particularly when larger sample sizes, faster enrollment, or broader representation across populations and settings is needed.
What research topics are within the scientific scope described?
The scope emphasizes areas such as mental health genetics, biomarker research, and clinical studies examining the nature and development of mental illness. Examples mentioned include research on psychopathology, the course and expression of symptoms across time, and neurodevelopmental trajectories that may help explain how mental disorders emerge or change from childhood through adulthood.
Does this FOA support genetics-related clinical research?
Yes. The described scientific scope includes mental health genetics and examples such as studies that link genetic variation to clinical phenotypes.
Does this FOA support biomarker studies?
Yes. Biomarker research is explicitly highlighted, including studies that identify biological or behavioral markers associated with risk or prognosis.
Are observational or mechanistic clinical studies allowed?
Yes. The FOA describes support for carefully characterized observational and mechanistic clinical studies that clarify underlying processes in mental illness, as long as they are not treatment development, efficacy, or effectiveness trials.
What types of projects are not supported under PAR-14-165?
This FOA does not support projects framed as treatment development, efficacy, or effectiveness trials. It is not intended for testing whether a therapy works, comparing interventions, or establishing clinical effectiveness in real-world settings.
Is a multi-site design required?
Yes. A defining feature of this opportunity is the requirement for two or more collaborating sites using a shared, common protocol.
What does "shared, common protocol" mean in this FOA?
It means the collaborating sites are expected to use the same study design, eligibility criteria, assessment methods, and data collection procedures so that data can be pooled and interpreted as a single coordinated project.
Why does NIH require multiple collaborating sites for this FOA?
The collaborative structure is intended to strengthen the science by increasing statistical power, improving recruitment efficiency, and ensuring study samples include diverse participants who better represent populations affected by mental illness.
Can one site act as a coordinating site?
Yes. For projects involving many sites, the FOA anticipates that one site will function as a coordinating site and take primary responsibility for centralized activities such as data management and administrative functions that keep the collaboration consistent.
What grant mechanism is used for PAR-14-165?
The FOA uses a collaborative R01 structure described as a linked set of R01 applications, where each participating site submits its own application and has its own Program Director/Principal Investigator.
Does each site receive its own award?
Yes. Although the overall program is expected to operate as a coordinated network, each site is funded through its own award.
What kinds of cross-site infrastructure are expected in applications?
The FOA emphasizes the need for cross-site coordination and infrastructure supporting quality control, database management, statistical analysis, and reporting. Applicants are expected to plan both scientific aims and operational systems that support data integrity, harmonized procedures, and timely shared outputs across the collaboration.
What agency sponsors this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the CFDA number and program category?
This is a discretionary grant opportunity in the health category under CFDA 93.242 (Mental Health Research Grants).
Is cost sharing or matching required?
No. The FOA states that cost sharing or matching is not required.
Who is eligible to apply?
Eligibility is broad. The FOA includes many U.S.-based organization types such as public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status, with specific notes excluding the non-501(c)(3) category when it functions as an institution of higher education); small businesses; for-profit organizations other than small businesses; and multiple government entities (state, county, city or township, special district, and independent school districts).
Are tribal and housing authorities eligible?
Yes. The FOA includes public housing authorities/Indian housing authorities, tribal governments (including federally recognized tribal governments), and tribal organizations.
Are minority-serving institutions specifically included as eligible applicants?
Yes. The FOA lists eligibility for organizations including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Are faith-based or community-based organizations eligible?
Yes. The FOA includes faith-based and community-based organizations among eligible applicants.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA allows participation by non-U.S. entities and components, stating that non-domestic (non-U.S.) organizations and foreign institutions are eligible to apply.
Are foreign components of U.S. organizations allowed?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed.
What is the rationale for allowing international participation?
The FOA describes flexibility for international collaboration when it strengthens recruitment, increases diversity, or enables access to unique populations or specialized expertise, as long as the project aligns with NIH policy and FOA requirements.
When was this opportunity posted, and when did it close?
The announcement was posted and created on March 27, 2014. The original and final closing date was May 7, 2017. The archive date was June 7, 2017.
Where can the full FOA announcement be found?
The full announcement is available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-14-165.html.
Who should be contacted for technical issues accessing the announcement link?
For technical issues accessing the announcement or linking to it, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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