Key Dates
Reissue of PAR-19-297 - Clinical Studies of Mental Illness (Collaborative R01 Clinical Trial Optional)
National Institute of Mental Health (NIMH)
The National Institute of Mental Health (NIMH) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for collaborative clinical studies not involving treatment development, efficacy, or effectiveness trials. The FOA will be a reissue of PAR-19-297, "Clinical Studies of Mental Illness (Collaborative R01 Clinical Trial Optional)".
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in Fall 2022 with an expected application due date of October 5, 2022.
This FOA will utilize the R01 activity code. Details of the planned FOA are provided below.
Consistent with the objectives of PAR-19-297, applicants will be expected to propose collaboartive projects for two or more sites. Primary areas of focus include mental health genetics, biomarker studies, and studies of mental illnesses (e.g., psychopathology, neurodevelopmental trajectories of psychopathology) including when associated with HIV/AIDS. Collaborating studies will share a specific protocol across the sites. In studies with a large number of sites, it is expected that one site will be submitted as a coordinating R01 for data management and/or other centralized administration. For a linked set of collaborative R01s, each application will have its own Program Director/Principal Investigator (PD/PI). The collaborative R01 program provides a mechanism for cross-R01 coordination, quality control, database management, statistical analysis, and reporting.
Across all mental health research areas, clinical studies that address research objectives outlined in the NIMH Strategic Plan are encouraged, with the exception of clinical trials that are for the development of a new intervention, efficacy and effectiveness studies. Potential applicants are encouraged to contact program staff as far in advance as possible to discuss the match between potential research interests and current NIMH priorities. The following are examples of the types of studies that can be supported under this mechanism.
Proposals may include but are not limited to:
- Large-scale human genetic/genomics studies, in which large-scale team science approaches are necessary for sufficiently powered analyses
- Studies that use clinical trial methodology not to study efficacy but to examine potential new biomarkers of treatment response
- Studies that require large sample sizes to identify neurobiological mechanisms underlying sex differences in risk for and development of mental illness
- Studies that develop, test, and validate biologically based markers for diagnosing or detecting risk/vulnerability, prodrome, onset, progress, and/or severity of mental disorders and functional domains
- Studies that develop large sample sizes to identify neurobiological mechanisms underlying sex differences in risk for and development of mental illness
- Studies that use clinical trial methodology not to study efficacy but to examine potential new biomarkers of treatment response
TBD
Application budgets are not limited but need to reflect the actual needs of the proposed project.
93.242
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Please direct all inquiries to:
Jonathan Pevsner (genomics studies)
National Institute of Mental Health
301-728-5618
Jonathan Pevsner (genomics studies)
National Institute of Mental Health (NIMH)
Telephone: 301-728-5618
Email: [email protected]
Christopher Sarampote (translational studies)
National Institute of Mental Health (NIMH)
Telephone: 301-443-1959
Email: [email protected]
Christopher Gordon (HIV/AIDS related studies)
National Institute of Mental Health (NIMH)
Telephone: 240-627-3867
Email: [email protected]
and Human Services (HHS)
