Notice Number: NOT-MH-11-005
Key Dates
Release Date: March 23, 2011
Issued by
National Institute of Mental Health (NIMH)
Purpose
The NIMH Strategic Plan calls for clarification of the underlying causes of mental disorders with efforts towards integrating genetic, neurobiological, imaging, behavioral and clinical data. Specially, Strategy 1.4 of the plan calls upon researchers to “Develop, for research purposes, new ways of classifying mental disorders based upon dimensions of observable behavior and neurobiological functioning.” NIMH has begun the implementation of this strategy via the Research Domain Criteria Project (RDoC) (http://www.nimh.nih.gov/research-funding/rdoc.shtml). To achieve the goal of developing a research classification system informed by genetics, neuroscience, and behavioral science, NIMH will conduct a series of workshops over the next two years to develop consensus regarding basic broad domains of functioning and specific dimensional constructs within the domains (draft description and domain/construct listing can be found at http://www.nimh.nih.gov/research-funding/nimh-research-domain-criteria-rdoc.shtml). The goal of the workshop series is to document for each construct: (1) a consensus definition and (2) an annotated listing of state-of-the-art measures or elements at various units of analysis (e.g., genes, circuits, behavior) that could be used as variables to classify participants in clinical research studies. NIMH aims to shape its funding portfolio to give priority to applications that employ RDoC criteria for research classification.
During the interim period until the RDoC workshops are completed and the information disseminated, NIMH encourages the submission of applications that examine patient populations across diagnostic groups in order to explicate genetic factors or neurobehavioral dimensions that cut across DSM/ICD disorder categories. Studies exploring such dimensions within a single disorder category are also of interest. When appropriate, NIMH encourages the inclusion of two additional types of patient populations to speed the acquisition of information regarding dimensional aspects of psychopathology:
• those with relevant Not Otherwise Specified (NOS) diagnoses, often excluded from trials;
• those who experience significant symptoms of a disorder but do not quite meet the usual diagnostic criteria
Although the draft RDoC domain/construct list provides ready illustrations of dimensions that are of interest to NIMH, other constructs might also be proposed. It is incumbent upon the Principal Investigator to specify the scientific rationale for the particular construct(s) and diagnostic categories in the context of the specific aims of the application. An appropriate approach in grant applications would be to list the anticipated number of patients with each primary DSM/ICD diagnosis in the study. Publications resulting from NIMH-funded grants should specify the actual numbers for primary diagnoses, a listing of the total number of occurrences for each DSM/ICD category occurring in the sample (i.e., including co-morbidity), and the number of patients with NOS and/or forme fruste diagnoses, as above, who are included in (or excluded from) the study. This process is intended to facilitate the transition from traditional clinical categories to the dimensional and mechanism-based approach embodied by RDoC to select subjects for clinical research.
The appropriate analytic strategy for these interim studies might vary depending upon the number of different primary DSM/ICD diagnoses included and the sample size in each category. A typical strategy might be to conduct one analysis in terms of the constructs of interest, and a second in terms of DSM/ICD disorder categories. Where the sample size permits, a multi-factorial design that includes both these factors would be useful; if the sample size in each of the DSM/ICD categories is too small to use diagnostic group as a factor, it would be desirable to provide measures of central tendency and variability for each diagnosis.
Applications that employ the sample selection and analysis strategies of this Notice will receive particular attention during the funding process for each application cycle. Program staff may seek High Program Priority designation for noteworthy applications provided that they are in accord with existing program goals of the Institute, such as including measures at multiple units of analysis (e.g., genes, circuits, behavior). As with the main goals of the RDoC project, the intent of this Notice is to accelerate the process of applying new knowledge regarding genetics, brain functioning, and behavior to understand disorders and develop novel interventions to relieve the burden of suffering of people with mental disorders.
Grant activities under which applications can be submitted include, but are not limited to:
PA-10-067 Research Project Grant (Parent R01)
PAR-09-153 Collaborative R01s for Clinical and Services Studies of Mental Disorders, AIDS and Alcohol Use Disorders (Collaborative R01)
PAR-09-173 Pilot Intervention and Services Research Grants (R34)
PA-09-075 Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative R34)
Other activities of currently active FOAs may be applicable and may be used.
Inquiries
Interested applicants are encouraged to contact NIMH program staff about further information with respect to this Notice. See http://www.nimh.nih.gov/about/organization/nimh-extramural-research-programs.shtml for links to program staff in the NIMH funding divisions.
General questions regarding RDoC may be addressed to: [email protected].
and Human Services (HHS)
