Identification of Suicidality or Major Depression Guidance
Follow-up requirements associated with the identification of suicidality or major depression
Version Date: August 4, 2011
For studies involving assessments (including surveys, questionnaires, interviews) that may identify subjects with major depression or suicidality, the HS-IRBs require that a follow-up plan be in place. The HS-IRBs determine whether follow-up plans provide sufficient protections for subjects based on several factors, including the likelihood that the specific research interventions will identify majorly depressed or suicidal subjects and the nature of the subject population itself. For all studies, the protocol and consent form should describe any research assessments that may identify depression or suicidality. The protocol and consent form must also describe what actions the study team will take should a subject be identified as having clinically-concerning depression or being suicidal, including whether report outside the study team will be made.
Additional examples of potentially acceptable follow-up plans include:
- For studies which may discover that subjects are at imminent risk of harm (e.g., suicidal): If a study assessment indicates a subject is in immediate danger and the research is conducted in a clinical setting where appropriate assistance can be provided, researchers must describe how they will ensure that subjects receive the appropriate services (e.g., subjects will be escorted to the ER for a psychiatric consultation). If researchers believe that a subject is in immediate danger and the research is NOT conducted in a setting where immediate appropriate assistance can be provided, researchers must plan to call 911 for assistance. In either case, the protocol and consent form would indicate that subjects identified as at risk for suicide would have this reported to a study psychiatrist and undergo further evaluation, or researchers would contact local emergency services.
- For studies involving assessments, surveys, questionnaires, or other interventions that may identify subjects with clinically-concerning depression: Follow-up plans should describe how subjects will be informed of the potential concern as well as how recommendations to seek further clinical care will be provided, including referral to available clinical care. If the subject population is likely to have a diagnosis of depression (or the study drug includes a known risk of depression), the protocol's list of key personnel may need to include a psychologist/psychiatrist who is able to evaluate subjects and take any necessary actions minimize risks to subjects.