National Institute of Mental Health (NIMH)

Purpose

Suicide is the 10th leading cause of death, with rates increasing over several decades for all age groups, even while rates of many other major causes of premature mortality have declined. Suicide prevention is a research priority at NIMH (see https://theactionalliance.org/resource/prioritized-research-agenda-suicide-prevention-action-plan-save-lives). This administrative supplement seeks to expand the number of mental health researchers both established scientists, as well as early career scientists who engage in suicide research. NIMH will prioritize those applications that currently do not include a suicide research aim. If suicide measures are proposed to be added, NIMH encourages applicants to use common data elements (see https://grants.nih.gov/grants/guide/notice-files/NOT-MH-15-009.html; https://www.phenxtoolkit.org/). The supplement can include various approaches that align within the range of NIMH science. Administrative supplements can be sought through all non-trainin grant mechanisms, including small business innovation research and technology transfer applications. NIMH has developed some safety and ethical issues and resources for suicide research (see https://www.nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers.shtml) that may be of interest to applicants. Examples of administrative supplement application requests could include, but are not limited to the following:

1. Addition of measures/assessments and analyses to study co-occurring suicide risk in studies of etiology, pathophysiology, and trajectory of mental disorders. Applicants could consider potential ‘mechanisms of action’ in the suicidal process through the Research Domain Criteria (RDoC) framework (see https://www.nimh.nih.gov/news/events/2016/mechanisms-underlying-suicide-risk/index.shtml).
2. Addition of measures to explore potential ‘mechanisms of action’ in the suicidal process through the Research Domain Criteria (RDoC) framework (see https://www.nimh.nih.gov/news/events/2016/mechanisms-underlying-suicide-risk/index.shtml).
3. Among existing mental health intervention studies (prevention and treatment intervention and services), expansion of study inclusion to accommodate at risk participants (individuals with current ideation; past attempts) with appropriate safety procedures and/or add suicide-related outcomes (see https://www.phenxtoolkit.org/sub-collections/view/3), including linkage to medical records (e.g., suicide attempts) and suicide mortality.
4. Addition of measures of suicide event outcomes to treatment trials to explore potential suicide risk reduction benefits. Benefits of rapid treatments (e.g., ketamine, brexanolone) are of particular interest.
5. Development of approaches to monitoring and addressing suicidal side effects (https://www.fda.gov/downloads/drugs/guidances/ucm225130.pdf) and understanding why certain subgroups may have higher risk for side effects.
6. Development or assessment of approaches to identifying suicide risk (e.g., screening; predictive analytics) in settings (e.g., health care; justice; education; workplace; congregate housing such as assisted living or group homes; community outreach programs); or processes related to increased risk (e.g., bankruptcy or disability determinations) where referral and early intervention could be supported and tested.
7. In ongoing studies that include data on defined populations, conducting simulation modeling of the impact of risk identification and intervention for various settings and/or populations, to project benefits of types of program implementation.
8. Testing approaches to augment studies of mental health and social media to include suicide risk detection.
9. In ongoing studies of just-in-time telephone and/or on-line referral and/or interventions, exploring potential approaches to identify and mitigate suicide risk.
10. Determining potential ‘cross-over’ effects (e.g., unanticipated beneficial effects) of prevention interventions (universal, selective, indicated, tiered) in reducing risk for suicide ideation and behaviors (e.g., substance abuse prevention programs that also reduce suicide risk; see https://onlinelibrary.wiley.com/toc/1943278x/2016/46/S1). This could include addition of measures of suicide risk in ongoing prevention trials to enhance understanding of suicide course and suicide outcomes, and/or effects of prevention interventions on suicide ideation and behaviors.
11. Propose supplements to NIMH Centers that typically have broader scope than other funding mechanisms, and often support a range of opportunities, including infrastructure (e.g., cohort registries; tissue collections) as well as high-risk/high-reward pilot studies. Requests for supplemental funds for Centers should specify how the support will be used (e.g., to support additional suicide subject matter experts, to provide support for early career scientists pursuing suicide-relevant research) and should specify how the funds will be used to pursue suicide-relevant questions consistent with the focus and ongoing research of the Center.

Administrative supplement work that is proposed needs to be within the scope of the research or training that is already supported. Active awards with project end dates in FY 2020 or later are eligible. The award may not be in terminal no cost extension or going into a no cost extension in FY2019.

Requests may be for one year of support only. Before submitting an administrative supplement request, principal investigators are strongly encouraged to contact their program officers supporting their award to discuss whether the proposed supplement is within its scope.

Applications that propose supplemental data collection in on-going studies should clearly address the following: study progress, including enrollment, to date, the anticipated number of data points that can be captured with the proposed supplemental assessments, and a plan for how the newly collected data will be analyzed.

Applications that propose new measures and assessment of suicide-related outcomes should

• propose assessment measures and strategies that can facilitate integration and sharing of data (e.g., see NOT-MH-15-009 ;
• provide the rationale for the selection of suicide-related constructs and corresponding assessment instruments (e.g., measures of ideation, attempts), the time periods assessed (e.g., lifetime history, current), and the assessment schedule for administration (e.g., baseline, during intervention, post-intervention, follow up);
• address provisions for clinical management when suicidal risk or behavior is reported, as appropriate.
• where appropriate, consider opportunities for later follow-up of suicide events through self-report and/of medical records/vital statistics (ideation, attempts, deaths, crisis-related services such as emergency care) through informed consent.

In some cases, a supplement could propose to recruit participants in a separate pilot arm or sample to determine feasibility of research methods and hypotheses.

Investigators should submit applications as responses to the parent active administrative supplement PA: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html

Indicate the title of this Notice, Administrative Supplements for NIMH Grants to Expand Suicide Research, in the abstract. Applicants are encouraged to apply through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.

As part of the application investigators should submit an abstract of the proposed research that shows the relevance to suicide and suicide prevention research.

Requests must be received by June 1, 2019 for funding in FY 2019.

Review process

NIMH will conduct administrative reviews of applications that include these criteria:

1. Is the work proposed within the scope of the active award?
2. Is the work proposed relevant to enhancing our understanding of suicide and suicide prevention?
3. Is the work likely to stimulate additional activity leading to progress on suicide prevention?

Inquiries

Please direct all inquiries to:

Jane Pearson, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3598
Email:[email protected]