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