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Health Services Research & Development

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Risk Management Resources for Working with VA Research Participants

Research teams often have questions related to safely conducting VA research with participants at risk for suicide. It is recommended that patients who have less-than-imminent and/or high acute suicide risk not be excluded from research studies due to concerns about risk management.  Past practices of excluding such patients from some studies have limited the evidence base around suicidal risk.  Newer approaches emphasize the importance of including potentially at-risk individuals in research. In fact, research participants often receive a higher level of oversight and monitoring than usual care – which can be beneficial for the individual in addition to the importance of this work to the science of suicide prevention. 

Thus, any exclusions based on risk should be minimized and those that are utilized should be carefully justified.

The table below provides: (a) resource guides and (b) templates for managing suicide risk in research participants. While the resources included aim to address various research study types (e.g., surveys, qualitative methods, interventions, etc.), and to address safety in various stages of the research process (e.g., participant risk assessment, participant correspondence, tracking, language for IRB and DSMP), study teams may have additional questions related to a specific population or study protocol. SPRINT Core Investigators are happy to meet with study teams to help clarify the attached materials or to discuss any specific concerns about risk that come up when conducting suicide-related research in Veterans. For questions or additional information, please contact suicidepreventionres@va.gov. The following documents are examples of tools that study teams may adapt to their particular study’s needs. Investigators/facilities may choose to utilize different procedures for assessing and tracking research participant risk. For the most appropriate and effective application of research participant risk protocols, we highly recommend that you discuss protocols for working with research participants with your facility Suicide Prevention Coordinator.

Risk Management Protocols and Flow charts

Suicide Risk Flowchart Example 1

Assists research personnel in the determination of risk level. This document includes instructions and a flowchart for making step-by-step decisions with action steps.

Suicide Risk Flowchart Example 2

Assists research personnel in the determination of risk level. This document includes instructions and a flowchart for making step-by-step decisions with action steps.

Intoxicated Participants Flowchart

Outlines potential signs of intoxication, steps for determining cognitive awareness, and steps for working with participants.

Risk Management - Qualitative Interviews

Example of a contact list and steps for risk assessments that take place in the course of a qualitative interview.

Risk Management – Surveys

Provides rational for not providing individual feedback or follow-up for most cases in response to survey responses as well as the risk management activities in these instances.

Risk Management Detailed Protocol

In-depth protocol that can be used for internal staff training or to help develop protocols to submit to the IRB/regulatory boards. Detailed explanation of the specific items used to measure risk in each assessment, the threshold for risk assessment, multiple ways to respond in different situations (in person, via phone, etc.). Also includes information regarding contacting the crisis line from a VA phone, and a risk assessment template for notes.

Risk Documentation

Risk Documentation Excel Spreadsheet

Efficient spreadsheet template for documenting participant risk assessments and action steps.

Risk Documentation Decision Guide and Template

Detailed template/checklist for helping research personnel determine if risk decisions need to be elevated to clinical supervisors and for documenting actions steps.

Risk Documentation - Clinical Involvement Template

Detailed template/checklist for clinical supervisors to document decisions and action steps to take for high-risk participants.

Risk Management Training

Remote Risk Management Training

Provides tips for the remote management of risk, including information related to contacting emergency services/911

Training Sample Dialogue for Role Plays

Vignettes and sample dialogue for research personnel to use when creating training role plays.

Participant Resources

Participant Information Sheet

For Veterans with information on the study and activities that will occur. Highlighted on the bottom of page 1 is information regarding risk assessments and potential risk.

Risk Resource Brochure Example

Sample brochure with resources for getting help related to substance use and suicide to be given to high-risk participants.

DSMB/Regulatory

DSMP - Participant Safety

Sample language related to participant safety to include in Data Safety Monitoring Plans.


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Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.