ASSIP is provided by licensed mental health professionals following routine clinic protocols for in-person, over the phone, or video conference crises. Therapists are accustomed to treating high-risk individuals. Study staff followed an IRB-approved risk management protocol and received supervision from investigators on all clinical interviews.
Given the nature of this study, suicide attempts and psychiatric hospitalisations are expected to occur and to be non-study related in most cases. As such, these serious adverse events (SAEs) are reported in summary reports to the Data and Safety Monitoring Board (DSMB), with annual reports to the National Institute of Mental Health (NIMH) and IRB. Suicide deaths are reported to the DSMB within 48 hours of discovery, with investigators’ judgments as to whether a relationship to the study can be ruled out. The DSMB members either concur or request additional investigation as an SAE. Suicide deaths are reported to the IRB and NIMH within 5 business days of discovery with the investigators’ and DSMB’s determination regarding whether a relationship to the study can/cannot be ruled out and any recommendations made by the DSMB.
After reviewing the circumstances and consulting with coinvestigators, a designated unblinded coinvestigator can reclassify an adverse event as an SAE. SAEs deemed unexpected and study related are reported to the IRB and NIMH within 5–7 working days of discovery. If considered related to the study, unanticipated adverse events involving risks to participants or others are reported by the principal investigator and/or DSMB to the IRB, and the IRB promptly informs the NIMH. The DSMB, IRB, and NIMH can recommend corrective actions to be taken by the investigators.
Given the nature of this study, suicide attempts and psychiatric hospitalisations are expected to occur and to be non-study related in most cases. As such, these serious adverse events (SAEs) are reported in summary reports to the Data and Safety Monitoring Board (DSMB), with annual reports to the National Institute of Mental Health (NIMH) and IRB. Suicide deaths are reported to the DSMB within 48 hours of discovery, with investigators’ judgments as to whether a relationship to the study can be ruled out. The DSMB members either concur or request additional investigation as an SAE. Suicide deaths are reported to the IRB and NIMH within 5 business days of discovery with the investigators’ and DSMB’s determination regarding whether a relationship to the study can/cannot be ruled out and any recommendations made by the DSMB.
After reviewing the circumstances and consulting with coinvestigators, a designated unblinded coinvestigator can reclassify an adverse event as an SAE. SAEs deemed unexpected and study related are reported to the IRB and NIMH within 5–7 working days of discovery. If considered related to the study, unanticipated adverse events involving risks to participants or others are reported by the principal investigator and/or DSMB to the IRB, and the IRB promptly informs the NIMH. The DSMB, IRB, and NIMH can recommend corrective actions to be taken by the investigators.
