Opportunity Information: Apply for RFA MH 19 200
The NIH funding opportunity titled "Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (U01 Clinical Trial Not Allowed)" (RFA-MH-19-200) supports research that uses rare genetic disorders as a powerful lens for understanding how genetics contributes to mental and neuropsychiatric conditions more broadly. The central aim is to clarify the genetic architecture underlying a wide range of neuropsychiatric phenotypes observed in rare syndromes, and to determine how that genetic risk overlaps with the risk for more common, idiopathic psychiatric disorders. In practical terms, the initiative is looking for projects that can move beyond single-gene explanations and instead use genome-wide approaches to explain why people with the same rare syndrome can show very different psychiatric or behavioral outcomes, including variable expressivity (differences in severity or presentation) and incomplete penetrance (some individuals with a risk variant not showing the expected phenotype).
A key expectation is that funded teams will integrate rich phenotypic characterization with high-quality genome-wide data. Projects are intended to comprehensively evaluate how different types of genetic variation contribute to neuropsychiatric outcomes in rare disorders, including the possibility that additional variants elsewhere in the genome modify the clinical presentation of a primary syndrome. Because inconsistent or shallow phenotyping is a major barrier in rare disease research, the FOA places strong emphasis on improving the quality, consistency, and usefulness of phenotype data. Applicants are encouraged to develop or apply phenotyping methods that can be standardized and used across multiple rare genetic disorders, and that can track neuropsychiatric features across developmental time points rather than treating them as static traits. The goal is to create assessment pipelines that allow meaningful cross-disorder comparisons and improve the ability to map genotype-to-phenotype relationships.
The opportunity also explicitly promotes leveraging what already exists. Projects are encouraged to build on established cohorts, biobanks, and collaborative networks that already have infrastructure for reliable clinical data collection and genomic data generation. This reflects an intent to accelerate progress by using proven pipelines and reducing fragmentation in small, hard-to-ascertain populations. Even though this particular FOA is meant for applications that are not multi-site collaborative submissions, awardees are still expected to participate in a broader coordinated effort through a formal network structure.
All funded projects under this FOA, along with those funded under the companion collaborative U01 mechanism (RFA-MH-19-201), will operate under the Mental Health Rare Genetic Disease Network (MHRGDN). Through this network, investigators will harmonize and share clinical and genetic data across studies, helping to ensure that datasets can be combined or compared rather than remaining siloed. A major deliverable is the creation of a widely usable resource for the broader scientific community, including biospecimens and linked phenotypic and genetic datasets. The overarching idea is that the network will not only support individual projects, but will also build an enduring, standardized data and sample resource that enables future discovery and replication.
From an administrative and structural standpoint, this is a discretionary NIH cooperative agreement (U01), meaning NIH will have substantial programmatic involvement compared to a standard research grant. Clinical trials are not allowed under this specific FOA. It is also important that applicants choose the correct submission path: this announcement (RFA-MH-19-200) is for projects that can be completed without requiring two or more collaborating sites under a linked application structure. If the research requires multiple collaborating sites to complete the aims, the applicant should instead use the companion collaborative U01 FOA (RFA-MH-19-201) and submit as a linked set.
Eligibility is broad and includes many types of U.S. organizations and governmental units, such as state, county, and city governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; as well as other eligible entities. The FOA also highlights inclusion of a wide range of institution types, including Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions, along with faith-based or community-based organizations and certain non-U.S. entities. The listed CFDA numbers are 93.242 and 93.865, and the original closing date provided in the source is 2018-08-09.Apply for RFA MH 19 200
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (U01 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): 93.242, 93.865.
- This funding opportunity was created on 2018-06-07.
- Applicants must submit their applications by 2018-08-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the NIH funding opportunity RFA-MH-19-200 about?
This NIH opportunity, titled "Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (U01 Clinical Trial Not Allowed)" (RFA-MH-19-200), supports research that uses rare genetic syndromes to better understand how genetics contributes to mental and neuropsychiatric conditions more broadly. The focus is on clarifying the genetic architecture underlying neuropsychiatric phenotypes observed in rare syndromes and determining how that genetic risk overlaps with risk for more common, idiopathic psychiatric disorders.
What is the central scientific aim of this FOA?
The central aim is to explain the wide range of neuropsychiatric outcomes seen in people with rare genetic syndromes and to identify how genetic risk in these syndromes overlaps with genetic risk for more common psychiatric disorders. A major emphasis is moving beyond single-gene explanations to genome-wide approaches that can account for differences in psychiatric or behavioral outcomes among individuals who share the same syndrome.
Why does this FOA emphasize genome-wide approaches instead of single-gene explanations?
The FOA is looking for work that can explain why people with the same rare syndrome can have very different neuropsychiatric presentations. This includes studying variable expressivity (differences in severity or presentation) and incomplete penetrance (some individuals with a risk variant not showing the expected phenotype). Genome-wide approaches are expected to help identify additional variants elsewhere in the genome that may modify the clinical presentation of the primary syndrome.
What kinds of neuropsychiatric outcomes or traits are relevant to this opportunity?
The opportunity is broadly focused on neuropsychiatric phenotypes observed in rare genetic syndromes, including psychiatric, behavioral, and neuropsychiatric features. The FOA emphasizes that these features may vary substantially across individuals with the same syndrome and may change over developmental time points.
What does the FOA mean by variable expressivity and incomplete penetrance?
In this FOA's context, variable expressivity refers to differences in severity or presentation of psychiatric/behavioral outcomes among individuals with the same rare syndrome. Incomplete penetrance refers to situations where some individuals carry a risk variant but do not show the expected neuropsychiatric phenotype.
What is expected regarding phenotyping and clinical characterization?
A key expectation is the integration of rich phenotypic characterization with high-quality genome-wide data. The FOA places strong emphasis on improving the quality, consistency, and usefulness of phenotype data, recognizing that inconsistent or shallow phenotyping is a major barrier in rare disease research.
Does the FOA encourage standardized phenotyping methods?
Yes. Applicants are encouraged to develop or apply phenotyping methods that can be standardized and used across multiple rare genetic disorders. The intent is to enable meaningful cross-disorder comparisons and improve mapping from genotype to phenotype.
Is tracking developmental change in neuropsychiatric features important for this FOA?
Yes. The FOA encourages phenotyping approaches that can track neuropsychiatric features across developmental time points rather than treating them as static traits.
What kinds of genetic data are expected in proposed projects?
Projects are expected to integrate high-quality genome-wide data with deep phenotypic characterization. The FOA also anticipates comprehensive evaluation of how different types of genetic variation contribute to neuropsychiatric outcomes in rare disorders, including the possibility that additional variants elsewhere in the genome modify clinical presentation.
Does the opportunity encourage use of existing cohorts, biobanks, or networks?
Yes. The FOA explicitly promotes leveraging existing resources, including established cohorts, biobanks, and collaborative networks with infrastructure for reliable clinical data collection and genomic data generation. The intent is to accelerate progress by using proven pipelines and reducing fragmentation in small, hard-to-ascertain populations.
If this FOA is not for multi-site collaborative submissions, do awardees still have to coordinate with others?
Yes. Even though RFA-MH-19-200 is intended for applications that can be completed without requiring two or more collaborating sites under a linked application structure, awardees are still expected to participate in a broader coordinated effort through a formal network structure.
What is the Mental Health Rare Genetic Disease Network (MHRGDN)?
All projects funded under this FOA (RFA-MH-19-200) and the companion collaborative U01 mechanism (RFA-MH-19-201) will operate under the Mental Health Rare Genetic Disease Network (MHRGDN). Through this network, investigators will harmonize and share clinical and genetic data across studies.
What does participation in the MHRGDN involve?
Participation involves harmonizing and sharing clinical and genetic data across studies so that datasets can be combined or compared rather than remaining siloed. The network structure is intended to support coordinated, standardized resource building across funded projects.
What major deliverables are expected from this networked effort?
A major deliverable is a widely usable resource for the broader scientific community, including biospecimens and linked phenotypic and genetic datasets. The overarching intent is to build an enduring, standardized data and sample resource that enables future discovery and replication.
What funding mechanism is used for RFA-MH-19-200?
This opportunity uses a U01 cooperative agreement mechanism. As a cooperative agreement, it is a discretionary NIH funding mechanism with substantial NIH programmatic involvement compared to a standard research grant.
Are clinical trials allowed under this FOA?
No. Clinical trials are not allowed under RFA-MH-19-200, as indicated by the title "(U01 Clinical Trial Not Allowed)."
How do applicants know whether to apply to RFA-MH-19-200 versus the companion FOA?
Applicants should use RFA-MH-19-200 when the project can be completed without requiring two or more collaborating sites under a linked application structure. If the research requires multiple collaborating sites to complete the aims, the applicant should instead apply to the companion collaborative U01 FOA (RFA-MH-19-201) and submit as a linked set.
What is the companion collaborative FOA mentioned in the announcement?
The companion collaborative U01 FOA is RFA-MH-19-201. It is intended for projects that require multiple collaborating sites to complete the research aims under a linked application structure.
Who is eligible to apply for this funding opportunity?
Eligibility is broad and includes many types of U.S. organizations and governmental units. Examples listed include state, county, and city governments; public and private institutions of higher education; tribal governments and tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other eligible entities.
Does the FOA mention specific institution types as eligible or encouraged?
Yes. The FOA highlights inclusion of a wide range of institution types, including Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISI institutions. It also mentions faith-based or community-based organizations and certain non-U.S. entities.
Are non-U.S. entities mentioned in the eligibility description?
Yes. The eligibility description includes mention of certain non-U.S. entities.
What are the CFDA numbers associated with this opportunity?
The listed CFDA numbers are 93.242 and 93.865.
What is the closing date provided in the source information?
The original closing date provided in the source is 2018-08-09.
What is the overall purpose of harmonizing data across projects?
The purpose is to ensure that clinical and genetic datasets can be combined or compared across studies rather than remaining siloed. This supports broader discovery, replication, and the creation of a standardized community resource.
What is the practical research strategy encouraged by the FOA?
In practical terms, projects are expected to pair deep, consistent phenotyping with genome-wide data and to evaluate multiple types of genetic variation that may shape neuropsychiatric outcomes in rare syndromes. The FOA also encourages building on established cohorts, biobanks, and networks to speed progress and improve consistency.
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