Identification of Suicidality or Major Depression Guidance

Version: November 6, 2019

This document guides research teams on how to handle findings of depression or suicidal thoughts, taking into account situations that commonly occur in human subjects research. If study teams use instruments that collect information about depression or suicidality, they should use this guidance to determine if a plan is necessary, and describe their plan in their IRB application. The plans outlined below represent the minimum requirements that apply and should be tailored to the research project.

Findings of Suicidal Thoughts or Acts

When a research study uses diagnostic or symptom severity tools that can identify suicidal thoughts, or uses instruments that ask specific questions about suicidal thoughts or behaviors, the Health Sciences IRBs expect the study team to have a plan for prompt review and follow-up of participants’ responses:

Findings of Depression

When there is a potential to discover depression in subjects during research activities, the need for a follow-up plan depends on the circumstances.

Follow-up plan required

When a study uses diagnostic or symptom severity tools that can identify depression, the Health Sciences IRBs expect a plan for review and follow-up of participants’ responses. Diagnostic tools could include the Structured Clinical Interview for the DSM (SCID) or the Mini-International Neuropsychiatric Inventory (MINI). Examples of symptom severity tools include the Patient Health Questionnaire (PHQ), Quick Inventory of Depressive Symptoms (QIDS), Beck Depression Inventory (BDI), Geriatric Depression Scale (GDS), or the Hamilton Depression Rating Scale (HDRS).

All of the diagnostic and symptom severity tools noted include descriptions of when a diagnosis can be established, and typical scores reflecting depression severity (mild, moderate, severe). Tools that can identify depression should be evaluated/scored by qualified personnel. The study team should articulate and justify the method and timeframe of their follow-up plan based on the subject population and test results.

Findings of moderate and severe depression (as defined by the diagnostic or symptom severity tool) should prompt referrals:

When a follow-up plan may not be required

There are two situations in which a follow-up plan for handling depression findings may not be required:

  1. The study uses non-diagnostic tools asking questions such as “Are you feeling blue?” Generally, such tools do not require a follow-up plan. However, a plan may be required when the research population includes subjects at higher risk for depression or suicidal thoughts (e.g., subjects receiving mental health treatment for depression, mood, or anxiety disorders), and responses reveal severe or prolonged low mood. The Health Sciences IRBs evaluate these situations on a case-by-case basis.
  2. The study does not enroll high risk subjects and a follow-up plan is not feasible, such as:

    1. Data are collected anonymously;
    2. The study team cannot reasonably assess the findings in time to provide adequate follow-up (e.g. when there are large numbers of subjects participating at the same time or multiple assessments over the course of the study);
    3. The data are sent directly to an external coordinating site that does not have a plan for review and follow-up of depression findings.

If the study team believes, based on the guidance above, that a follow-up plan is not feasible or is not required, explain why no review and follow-up plan should be required for the study. Situations where the study team is not able to follow up are expected to be rare.

Information to Include in the Protocol and IRB Application

Include the information below in the IRB submission when a study uses instruments that require a plan for review and follow-up:

  1. Specify the questions and scores/responses that will lead to implementation of the follow-up plan. If multiple findings are possible, such as moderate depression, severe depression, and suicidal thought, specify a score/response for each level of findings.
  2. Describe who will assess the findings and their qualifications (e.g., training in scoring responses) and who will be contacted (e.g., PI, licensed physician) for further evaluation when needed.
  3. Describe the timeline for reviewing responses and assessing potential findings.
  4. Describe what will happen should a concern be identified:

    1. Referral or intervention procedures (e.g. contacting 911), including variations of the plan if instruments are completed in different settings (e.g., study lab, subject’s home, hospital setting, telephone).
    2. How and when information is communicated to the subject.
    3. If the study includes children, whether and how parents/guardians will be informed.

Consent Form Language

The consent form should inform participants that a study involves questions about depression or suicidal thought and describe how their responses will be handled. Use the instructions and model consent form language for psychological assessments available here.

Unexpected Identification of Depression or Suicidal Thought

Even in studies that do not assess or ask about depression or suicidal thoughts or acts, study personnel may become aware that a study participant has symptoms of moderate to severe depression or has suicidal thoughts. In cases where unexpected findings are made, local policies should be followed (e.g. hospital policy if the research visit is in a hospital space). A qualified study team member should review the findings and determine appropriate next steps. This may include referral for treatment, or in the case of an emergency, contacting 911 or transporting the subject to a local emergency department.

In all cases, report unexpected identification of depression or suicidal thoughts to the Health Sciences IRBs as a reportable event (potential unanticipated problem).

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