Notice of Clarification in Application Materials for PA-09-075 (Collaborative R34) and PAR-09-153 (Collaborative R01)

Notice Number: NOT-MH-10-027

Key Dates
Release Date:  July 20, 2010

Issued by
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)

Purpose

The purpose of this notice is to clarify how the OVERVIEW section, required for Collaborative R34 and Collaborative R01 applications may be addressed within the recently changed grant application package (see NOT-OD-09-149). Announcements to which this notice applies include PA-09-075 - Collaborative R34s for Pilot Studies of Innovative Treatments in Mental Disorders (Collaborative R34) and PAR-09-153 - Collaborative R01s for Clinical and Services Studies of Mental Disorders, AIDS and Alcohol Use Disorders (Collaborative R01).

The collaborative mechanisms currently require an OVERVIEW section that is part of the one-page specific aims attachment to the SF424 application form.  This OVERVIEW section should be identical for all applications that are linked together for the collaborative R34 or R01 mechanism. The requirements of the OVERVIEW are as follows:

The overview should provide an overall rationale for applying as a collaborative study; the role of each site; the approach to project management; and elements unique to any of the sites.

This information is required in order to address the sixth review criterion, COLLABORATION, as noted in the funding opportunity announcements. This criterion is not scored separately but is incorporated within the Overall Impact and is described as follows:

Collaboration:  Are sufficient and feasible mechanisms in place to ensure collaboration across sites to achieve scientific integration of research procedures, overall managerial and administrative responsibilities, appropriate quality control and reliability assurance, and planning for data management, analysis and reporting of results? Are there adequate plans for shared decision making among PIs with regard to personnel, clinical decisions, changes in study protocol, and authorship?

Effective for the May 2011 Council (application receipt dates from October 5, 2011 and later), applicants are advised that the Resources section, which should address not only physical resources, but also the intellectual and collaborative resources for executing the project (see Section 4.4, Item 9 of the SF 424 [R & R]) can be utilized to address relevant Resource-related collaborative issues. Instructions for this section include the following language:

  • Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements.
  • If there are multiple performance sites, describe the resources available at each site.

Thus, per the instructions (Section IV.6 of each FOA), the one-page Specific Aims should provide a brief Overview regarding the overall rationale for applying as a collaborative study, role of each site, approach to project management, and elements unique to the sites.  Elaboration regarding collaborative resources and project management may be provided in the Resources section, as appropriate to address scientific Environment. Elaboration may also be provided in the section “ELEMENTS UNIQUE TO THIS SITE” within the Research Strategy section, as per FOA instructions (Section IV.6).

Inquiries

Applicants are encouraged to discuss the implications of this notice and receive technical assistance from the appropriate program contacts, as listed in Section VII.1 of the FOA.

PA-09-075Scientific/Research Contacts

PAR-09-153Scientific/Research Contacts