Funding Opportunity PAR-21-132 from the NIH Guide for Grants and Contracts. This is a reissue of RFA-MH-18-707: Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline FOAs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.

Funding Opportunity PAR-21-134 from the NIH Guide for Grants and Contracts. This is a reissue of RFA-MH-18-705: Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required). As part of NIMH's clinical trials pipeline, this FOA encourages pilot research developing and testing novel psychosocial interventions and/or targets. Consistent with NIMH's emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. This RFA will provide up to three years of support to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s).

Funding Opportunity PAR-21-130 from the NIH Guide for Grants and Contracts. This is a reissue of RFA-MH-18-701: Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This FOA is a key element of NIMHs set of FOAs to support clinical trials research across the intervention development and testing pipeline. The FOA supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This FOA is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this FOA is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).

Funding Opportunity PAR-21-131 from the NIH Guide for Grants and Contracts. This is a reissue of RFA-MH-18-706: Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34- Clinical Trial Required). As part of NIMH's clinical trials pipeline FOAs, this announcement encourages pilot effectiveness studies focused on 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this FOA is intended to support pilot studies of intervention effectiveness or service delivery approaches that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.).

Activists fault agency for not directly addressing funding disparity for Black researchers

Funding Opportunity PAR-21-133 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

Notice NOT-MH-21-090 from the NIH Guide for Grants and Contracts

In this installment of Your Unicorn Career, our columnist encourages making a habit of helping others

Notice NOT-OD-21-070 from the NIH Guide for Grants and Contracts

Notice NOT-OD-21-069 from the NIH Guide for Grants and Contracts

Notice NOT-HG-21-023 from the NIH Guide for Grants and Contracts

Notice NOT-OD-21-066 from the NIH Guide for Grants and Contracts

Notice NOT-GM-21-021 from the NIH Guide for Grants and Contracts

Notice NOT-NS-21-045 from the NIH Guide for Grants and Contracts

Funding Opportunity RFA-DA-22-010 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity is to develop technologies to improve the delivery of pharmacological, gene editing, or other cargoes for HIV and SUD mechanistic research.

Notice NOT-GM-21-028 from the NIH Guide for Grants and Contracts

Notice NOT-GM-21-027 from the NIH Guide for Grants and Contracts

Notice NOT-GM-21-030 from the NIH Guide for Grants and Contracts

Notice NOT-GM-21-025 from the NIH Guide for Grants and Contracts

Notice NOT-AG-21-016 from the NIH Guide for Grants and Contracts