Opportunity Information: Apply for RFA MH 09 130

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Studies of Induced Pluripotent Stem (iPS) Cells from Healthy and Mental Health Patient Populations (R21/R33)" 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 Nov 14, 2008 and posted on Nov 14, 2008.
  • Applicants must submit their applications by Feb 27, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,250,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • The number of recipients for this funding is limited to 10 candidate(s).
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) .
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Opportunity Summary:

The grant opportunity "Exploratory Studies of Induced Pluripotent Stem (iPS) Cells from Healthy and Mental Health Patient Populations (R21/R33)" (Funding Opportunity Number RFA MH 09-130) is a National Institute of Mental Health (NIMH), National Institutes of Health (NIH) funding announcement designed to push early-stage, high-impact work using induced pluripotent stem cells to study mental health and brain-related disorders. The core goal is to support projects that generate iPS cell lines from human participants and then carefully characterize those cells and their derivatives in ways that make them useful for research into how brain disorders develop and function at the cellular level. The program is framed around exploratory and developmental studies, meaning it is meant to help researchers establish feasibility, build foundational resources, and develop or validate approaches that can later scale into larger, more definitive investigations.

A central emphasis of the announcement is the use of iPS cells derived from either healthy control subjects, patient populations, or both, specifically focusing on conditions tied to cognitive, affective, social, sleep, and developmental brain disorders. Importantly, the FOA does not restrict applicants only to disorders with well-established genetic links. Projects may certainly involve disorders where genetic linkage has already been suggested, but that is not a requirement. This makes the opportunity broadly relevant across a wide range of psychiatric and neurodevelopmental conditions, including those where the biological basis is still unclear and where iPS-based cellular models could help reveal disease-relevant pathways, developmental differences, or cellular phenotypes.

The mechanism used is the R21/R33 Exploratory/Developmental Phased Innovation award. In practical terms, this is intended to support a phased project structure where the early phase (R21) is used to establish key proof-of-concept milestones such as deriving iPS cells from selected donors, confirming quality and pluripotency, and demonstrating that downstream differentiation and assays are workable and meaningful. If the initial milestones are met, the project can transition into the later phase (R33), which supports more expanded development, characterization, and application of the cell models and assays. This structure reflects NIMH's intent to encourage innovative but rigorously validated work, while also reducing risk by tying progression to demonstrated feasibility.

The FOA strongly encourages multidisciplinary teams that combine expertise in stem cell biology, cortical development, and the clinical study or treatment of mental disorders. The underlying idea is that iPS cell modeling in psychiatry is inherently cross-cutting: success depends on strong cell reprogramming and differentiation methods, deep knowledge of neural development and relevant neural cell types, and careful clinical characterization of patient cohorts and phenotypes. Because these projects often require multiple specialized skill sets, the FOA explicitly encourages the use of multiple principal investigators (multiple PIs), making it easier to assemble collaborative leadership across basic science and clinical domains.

Scientifically, the announcement highlights several priorities that go beyond simply making iPS lines. NIMH is looking for applications that place a clear emphasis on validating iPS cells and any derivatives used in experiments, which typically includes demonstrating pluripotency, genomic integrity, stable growth characteristics, and reliable differentiation potential. The FOA also stresses evaluating the heterogeneity or homogeneity of cell populations intended for screening or downstream assays, reflecting awareness that mixed or poorly defined neural cultures can confound results and make comparisons between patient and control lines unreliable. Finally, applicants are expected to use cellular assays that are relevant to brain function and to the biology of mental disorders, meaning assays should connect to neural activity, synaptic function, developmental trajectories, network properties, stress responses, or other mechanisms plausibly tied to psychiatric or neurodevelopmental phenotypes rather than generic cell health readouts.

Another practical requirement addresses biospecimen stewardship and sharing. For studies that involve acquiring tissue from new subjects, the FOA asks applicants to include provisions to archive and distribute non-induced primary cells (for example, fibroblasts or other starting tissue-derived cell populations). This is meant to increase the long-term value of the collected samples, support reproducibility, and enable broader community use. It also reflects the reality that primary cells can be useful for alternative reprogramming approaches, validation comparisons, or future technologies that may not rely on the same induced state.

From an administrative and funding standpoint, this was a discretionary grant opportunity in the health category under CFDA 93.242 (Mental Health Research Grants). NIMH anticipated approximately 10 awards, with an estimated total funding level of about $2.25 million and an award ceiling listed at $200,000. The announcement indicated no cost sharing or matching requirement. Key dates show it was posted on November 14, 2008, with an original and current closing date of February 27, 2009, and an archive date of March 30, 2009, indicating it was a time-limited call for proposals tied to the early surge of interest in iPS technologies.

Eligibility was broad and included public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities other than universities), for-profit organizations, small businesses, and additional categories 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 even non-U.S. (foreign) entities and regional organizations. This wide eligibility scope aligns with the FOA's emphasis on assembling the right mix of technical and clinical expertise, regardless of institutional type or geography, as long as the proposed work meets NIMH priorities and NIH requirements.

Overall, the opportunity is best understood as an NIMH effort to accelerate the creation of well-validated, disease-relevant human cellular models for psychiatric and neurodevelopmental research. It supports teams that can bridge clinical cohorts and stem cell platforms, generate high-quality iPS resources from healthy and patient donors, rigorously characterize derived neural cell types, and apply assays that meaningfully connect cellular phenotypes to brain function and mental disorder biology, while also building in archiving and distribution practices that increase the usefulness of the resulting biological materials for the broader research community.

Frequently Asked Questions (FAQs)

What is the name of this grant opportunity?

The opportunity is titled "Exploratory Studies of Induced Pluripotent Stem (iPS) Cells from Healthy and Mental Health Patient Populations (R21/R33)" (Funding Opportunity Number RFA MH 09-130).

Which agency is offering this funding opportunity?

This funding announcement is offered by the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH).

What is the main purpose of this FOA?

The main purpose is to support early-stage, high-impact exploratory work using induced pluripotent stem (iPS) cells to study mental health and brain-related disorders. The program is designed to help researchers generate iPS cell lines from human participants and characterize those cells and their derivatives so they become useful tools for investigating how brain disorders develop and function at the cellular level.

What kind of research projects does this program aim to support?

The FOA is framed around exploratory and developmental studies. It is intended to help teams establish feasibility, create foundational resources (such as well-characterized iPS lines), and develop or validate approaches that can later scale into larger and more definitive investigations.

What human populations can iPS cells be derived from under this FOA?

The FOA emphasizes iPS cells derived from healthy control subjects, patient populations, or both.

Which disorders or symptom domains are relevant to this announcement?

The announcement specifically highlights conditions tied to cognitive, affective, social, sleep, and developmental brain disorders, broadly across psychiatric and neurodevelopmental conditions.

Do proposed disorders need to have well-established genetic links to be eligible?

No. The FOA explicitly notes that projects are not restricted to disorders with well-established genetic links. Studies may involve disorders where genetic linkage has been suggested, but it is not required.

What funding mechanism is used for this opportunity?

The mechanism is the R21/R33 Exploratory/Developmental Phased Innovation award.

How does the phased R21/R33 structure work in this FOA?

The early phase (R21) is intended for key proof-of-concept milestones such as deriving iPS cells from selected donors, confirming quality and pluripotency, and demonstrating workable downstream differentiation and meaningful assays. If those milestones are met, the project may transition to the later phase (R33), which supports expanded development, characterization, and application of the cell models and assays.

What types of teams does NIMH encourage for this program?

The FOA strongly encourages multidisciplinary teams that combine expertise in stem cell biology, cortical development, and the clinical study or treatment of mental disorders.

Are multiple principal investigators (multiple PIs) allowed or encouraged?

Yes. The FOA explicitly encourages the use of multiple PIs to support collaborative leadership across basic science and clinical domains.

Is simply creating iPS cell lines sufficient for this FOA?

The scientific priorities go beyond creating iPS lines. Applications are expected to emphasize validation of iPS cells and their derivatives, assess the heterogeneity or homogeneity of cell populations intended for assays, and use cellular assays that are relevant to brain function and the biology of mental disorders.

What kinds of validation and characterization does the FOA emphasize?

The FOA highlights validating iPS cells and derivatives in ways that typically include demonstrating pluripotency, genomic integrity, stable growth characteristics, and reliable differentiation potential.

Why does the FOA emphasize heterogeneity or homogeneity of cell populations?

The FOA stresses evaluating whether neural or other derived cell populations are heterogeneous or homogeneous because mixed or poorly defined cultures can confound results and make comparisons between patient and control lines unreliable, particularly for screening or downstream assays.

What does the FOA mean by "assays relevant to brain function"?

It means assays should connect to neural activity, synaptic function, developmental trajectories, network properties, stress responses, or other mechanisms plausibly tied to psychiatric or neurodevelopmental phenotypes, rather than relying only on generic cell health readouts.

Are there expectations related to biospecimen stewardship or sharing?

Yes. For studies acquiring tissue from new subjects, the FOA asks applicants to include provisions to archive and distribute non-induced primary cells (for example, fibroblasts or other starting tissue-derived populations). This is intended to increase long-term value, support reproducibility, and enable broader research community use.

What is the CFDA number and category associated with this opportunity?

This was described as a discretionary grant opportunity in the health category under CFDA 93.242 (Mental Health Research Grants).

How many awards were anticipated and what was the estimated total funding?

NIMH anticipated approximately 10 awards, with an estimated total funding level of about $2.25 million.

What was the award ceiling listed in the announcement?

The award ceiling listed was $200,000.

Is cost sharing or matching required?

No. The announcement indicated there was no cost sharing or matching requirement.

What were the key dates for this FOA?

The FOA was posted on November 14, 2008. The original and current closing date was February 27, 2009, and the archive date was March 30, 2009.

Is this a time-limited/archived funding opportunity?

Yes. The listed closing date and archive date indicate it was a time-limited call for proposals tied to early interest in iPS technologies.

Who was eligible to apply?

Eligibility was broad and included public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities other than universities), for-profit organizations, small businesses, and additional categories such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, as well as non-U.S. (foreign) entities and regional organizations.

Does this FOA allow applications from non-U.S. (foreign) entities?

Yes. The eligibility list includes non-U.S. (foreign) entities and regional organizations.

What is the overall program intent in plain terms?

The FOA represents an NIMH effort to accelerate the creation of well-validated, disease-relevant human cellular models for psychiatric and neurodevelopmental research by linking clinically characterized cohorts to stem cell platforms, producing high-quality iPS resources, rigorously characterizing derived neural cell types, using meaningful assays tied to brain function, and building in archiving/distribution practices that increase value for the broader research community.

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