Notice Number: NOT-MH-10-021
Update: The following update relating to this announcement has been issued:
- June 24, 2010 - See Notice NOT-MH-10-026, Amends this Notice to include P20 and P30 grants among the selected active NIMH grants eligible for competitive revision applications.
Key Dates
Release Date: June 17, 2010
Receipt Date: August 31, 2010
Earliest Anticipated Start Date: April 1, 2011
Issued by
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
Purpose
The National Institute of Mental Health (NIMH) announces the opportunity for investigators and United States institutions/organizations with selected active NIMH-supported grants to submit revision applications (formerly termed competitive supplements) to support an expansion of the scope or research protocol to conduct secondary analyses to target research questions addressing mental health disparities.
NIMH is seeking innovative, multidisciplinary research that uses existing data sources to increase knowledge of: (1) methods for measuring and tracking mental health disparities; (2) epidemiology of cardiovascular disease (CVD) risk factors among members of racial/ethnic/sex groups with serious mental illness (SMI); and (3) identification of differences in engagement, outcomes, or mediators for diverse groups in clinical trials. An application may focus on one or more of the three areas.
Background and Scientific Areas of Interest
A. Methods for Measuring and Tracking Mental Health Disparities
Over the last decade, the literature on the detection of mental health disparities has been enriched substantially. However, the field does not appear to have validated measures to track changes in racial/ethnic, sex, socioeconomic, and geographic disparities over time. These types of measures are important for research, clinical work, and policymakers. This notice seeks to encourage the use of existing data sources to develop methods and measures for quantitatively characterizing mental health disparities over time.
Scientific areas of interest include, but are not limited to, the following:
- Development of preliminary methods for characterizing mental health disparities;
- Development, testing, and validation of a mental health disparities index or set of indices to measure disparities in the domains of race/ethnicity, sex, socioeconomic status, and/or geography;
- Analyses of specific cultural variables that might impact measures of mental health disparities.
B. Epidemiology of Cardiovascular Risk among Members of Racial/Ethnic Groups with SMI
Compared with the general population in the United States, people with SMI experience, on average, a twenty-five year reduction in life expectancy. This reduction is largely attributable largely to CVD, which is the leading cause of death among people with SMI. Similarly, compared to non-Hispanic Whites in the United States, African Americans, Native Americans, and Hispanics have shorter life expectancies and higher rates of CVD. Despite strikingly similar patterns in morbidity and mortality, a paucity of research exists regarding the intersections of race/ethnicity, SMI, and CVD mortality. Whereas differences in the onset, course, and outcome of CVD by racial/ethnic group membership are well characterized, less is known about the contribution of sex differences or racial or ethnic group membership to elevated CVD mortality in the context of SMI. This notice seeks to encourage the analysis of existing data sets to increase the understanding of the intersections among SMI, race/ethnicity, and CVD morbidity and mortality.
Examples of research congruent with the intent of this notice include, but are not limited to, the following:
- Analyses of the prevalence and correlates of CVD risk factors across racial/ethnic groups among people with SMI;
- Analyses of the potential modification of CVD morbidity and mortality risk by race/ethnicity among people with SMI.
C. Identification of Differences in Engagement, Outcomes, or Mediators for Diverse Groups in Clinical Trials
Disparities in access, availability, and use of mental health services are well established. However, published efficacy and effectiveness studies often do not report findings specific to participants from diverse racial/ethnic populations, sex, socioeconomic groups, or geographic locations. Establishing an evidence base for effective mental health interventions for diverse groups requires inclusion of adequate numbers of women and members of racial/ethnic and other underrepresented groups in clinical trials. Secondary analysis of existing data sources that will deepen the evidence base for intervention effectiveness in diverse groups is encouraged.
Scientific areas of interest include, but are not limited to, the following:
- Subgroup analyses of treatment engagement and outcomes in intervention studies;
- Analyses of potential mediators of treatment efficacy and effectiveness within or across racial/ethnic, sex, socioeconomic, or geographically diverse groups.
Eligibility
This notice calls for competitive revision applications to selected active NIMH grants, including, R01, R21, R34, R37, P50, U01, and U19.
To be eligible, the parent grant on which the revision application is based must be active at the time the revision application is submitted and the research proposed in the revision must be accomplished within the current competitive segment. The project period of the competitive supplement may not exceed 1 year (12 months). If a no-cost extension is needed to complete the work proposed in the revision, the no-cost extension must be in place before the revision application is submitted. Only one revision request may be submitted per NIMH-funded parent grant.
NIMH encourages the participation of individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and individuals from disadvantaged backgrounds.
Budget and Funding Information
The NIMH intends to commit up to $3 million in total costs per year in FY 2011 to fund up to 14 competitive revisions in response to this announcement. Funding for competitive revisions to existing parent awards will be available in FY 2011. Due to the limited, one-year nature of these funds, competitive revision applications may be requested for no more than one year (12 months); therefore the scope and budget of the requested revision application must reflect aims and goals that can be accomplished within that limited timeframe.
An applicant may request a budget of up to $125,000 for direct costs associated with the proposed new work (excluding consortium F&A). The maximum duration of each award will be limited to one year. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate. The budget format (modular or detailed) should follow the format of the parent application.
Although the budget plans of the NIMH provide support for this program, awards pursuant to this solicitation are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Application Review Process
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Applications that are complete will be evaluated for scientific and technical merit by appropriate scientific review group(s) convened by the NIMH in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applicants will be notified regarding the review outcome.
As part of the scientific peer review, all applications will:
- Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an overall impact/priority score;
- Receive a written critique; and
- Receive a second level of review by the National Advisory Mental Health Council.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the standard review criteria, and additional review criteria (as applicable for the project proposed). The review committee will consider the overall scientific merit of the new work proposed, the appropriateness of the match between the parent project and the proposed work, and the likelihood for the project to achieve the goal of increasing knowledge in the three targeted areas of mental health disparity research.
If the revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. Additionally, the committee will consider the feasibility of accomplishing the specific aims of the revision application within the requested project period.
Scored Review Criteria. The standard review criteria for research grant applications and cooperative agreements will be used by reviewers for evaluating the scientific and technical merit of all applications as outlined in this Notice: NOT-OD-09-025.
Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items: Protections for Human Subjects; Inclusion of Women, Children, and Minorities; Vertebrate Animals; and Biohazards.
Additional Review Considerations. As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score: Budget and Period Support; Select Agent Research; and Resource Sharing Plans.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review;
- Availability of funds; and
- Translational impact and relevance of the proposed project to program priorities.
Award Notices
If the application is considered for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
Terms of Award
All awards will be subject to the standard NIH terms of award. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., Funding Restrictions.
A Program Official from NIMH will be assigned to each funded application and will assume responsibility for normal stewardship of the awards.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy StatementPart II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
How to Apply
The receipt date for revision applications is August 31, 2010.
Applicants interested in applying for revision support must submit the application through Grants.gov, using the Funding Opportunity Announcement (FOA) that was used for the parent grant. Or, if this FOA is no longer active, use the Parent FOA that matches the program (activity code) of the award.
- The activity code of the prior submission (referenced by the Federal Identifier on the SF 424 RR Cover page) must match the activity code of the FOA used for the revision
- Competitive revisions applications to grants using the activity code R37 (Method to Extend Research in Time (MERIT) Awards) should use the Parent R01 FOA (PA-10-067).
NOTE: Applicants submitting an R37 revision in response to the R01 Parent FOA will receive the following warning from eSubmission: The mechanism of the prior submission (referenced by the Federal Identifier on the SF 424 RR Cover page) does not match the mechanism of the Funding Opportunity Announcement (FOA). Please check the Federal Identifier provided for your application to ensure you are including the correct prior information and the FOA to ensure you are submitting to the correct opportunity. This application will be processed but there may be a delay in referral. Please ignore this warning.
For ALL applications:
Follow the instructions as noted below. NOTE: Font size restrictions apply as designated within the applicable SF424 (R&R) Application or the PHS398 application instructions. The current NIH guidelines on page limitations should be followed.
- Include a Cover Letter and cite the Notice Number (NOT-MH-10-021) and title [NIMH Announces Availability of Funds for Competitive Revision Applications for Targeted Research on Mental Health Disparities] in the first sentence.
- Provide a one-page Introduction that describes the nature of the revision and how it relates to the scope of the specific aims, research design, and methods of the current grant. Use Item 2.1, Introduction to application, of the PHS 398 Research Plan component to provide this information.
- The body of the application should contain sufficient information from the original grant application to allow evaluation of the proposed revision in relation to the expertise and approach of the original application.
- Applicants must submit a budget using the same budget format as was used for the parent award. Any budgetary changes for the remainder of the project period of the current grant must be discussed in the Budget Justification.
- Any significant budgetary changes for the remainder of the project period of the current grant must be discussed in the Budget Justification.
- Include the following additional information in the revision application:
a) Specific Aims. Summarize the activities that were included in the parent grant that encompass those proposed in the revision request. This section should include a description of the revision’s specific aims, including research design and methods and data analysis. Describe the relationship of the revision request to the parent grant and the impact that the proposed work will have on the research field(s) involved.
b) Research Strategy. The research strategy section should discuss how the expertise and the existing research resource from the current parent grant can be leveraged to address scientific and technical issues in three areas of mental health disparity research: (1) methods for measuring and tracking mental health disparities; (2) the epidemiology of cardiovascular disease risk factors among members of racial/ethnic groups with serious mental illness (SMI); and (3) identification of differences in engagement, outcomes, or mediators for diverse groups in clinical trials. The page limits for the research strategy should parallel the current requirements for the parent grant.
c) Budget. The budget format must be the same as that of the parent grant. Budget for the revision with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role in this project. The budget provided for the revision application must match the budget provided in the parent application. For instance, if the parent application was submitted using the Modular budget component, then the revision application must also use the Modular budget component.
d) Biographical Sketch for PD/PI and all new Senior/Key Personnel (those who are additions on the revision project). You will need to include an updated biographical Sketch for the PD/PI and new Senior/Key Personnel, using the forms, which are available as MS Word (http://grants.nih.gov/grants/funding/phs398/biosketch.doc) or PDF (http://grants.nih.gov/grants/funding/phs398/biosketch.pdf). There is no need to repeat information previously provided for other Senior/Key Personnel.
e) Human Subjects/Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a revision award being made. Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative revision activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html).
For electronic applications: Use the SF424 (R&R) Application Guide available at: http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.doc (MS Word [3.5 MB]) or http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf (PDF [4.5 MB]).
Inquiries
Applicants are encouraged to discuss their plans for responding to this Notice by phone or email to the NIMH Program Official listed below. Scientific inquiries can also be directed to the NIMH Program Official who oversees the parent grant associated with the competitive revision request.
Program Contact:
LeShawndra N. Price, Ph.D.
Office for Research on Disparities and Global Mental Health
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd., Rm. 8130, MSC 9659
Bethesda, MD 20892-9689
EXPRESS/COURIER: Rockville, MD 20852
Phone: (301) 594-7963 Fax: (301) 443-8552
Email: [email protected]
Grants Management Contact:
Joy R. Knipple
Grants Management Branch
National Institute of Mental Health
National Institutes of Health
6001 Executive Blvd., Rm. 6115, MSC 9605
Bethesda, MD 20892-9689
EXPRESS/COURIER: Rockville, MD 20852
Phone: (301) 443-8811 Fax: (301) 443-6885
Email: [email protected]
and Human Services (HHS)
