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Implementation of a Real-Time Psychosis Risk Detection and Alerting System Based on Electronic Health Records using CogStack
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Addressing risks to advance mental health research.

Ana S Iltis1, Sahana Misra, Laura B Dunn

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Effective risk communication and management are crucial for ethical mental health research. Practical strategies can help researchers navigate challenges, gain institutional review board approval, and facilitate vital psychiatric studies.

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Area of Science:

  • Psychiatric research ethics
  • Clinical trial risk management
  • Mental health research

Background:

  • Ethical research conduct necessitates robust risk communication and management.
  • Addressing research risks can be time-consuming and may lead to study design rejections by institutional review boards (IRBs).
  • Discouragement of needed research, particularly in high-risk or vulnerable populations, highlights the need for improved risk-handling mechanisms.

Purpose of the Study:

  • To offer mental health researchers practical approaches for identifying, defining, communicating, managing, and justifying research risks.
  • To enhance the ethical conduct and facilitate psychiatric research, especially in sensitive areas.

Main Methods:

  • A National Institute of Mental Health-funded scientific meeting series, including a public conference and expert panel.
  • Literature review focusing on empirical studies related to risk management and disclosure in mental health clinical trials.
  • Development of recommendations for best practices and future research.

Main Results:

  • Discussion of challenges, current data, and practical strategies for four key areas: risk identification/definition, risk communication, risk management during studies, and risk justification.
  • Identification of topics for future research in managing and disclosing risks in mental health clinical trials.

Conclusions:

  • Empirical data on risk communication and management can bolster the ethical conduct of mental health research.
  • Improved conceptualization and confrontation of risks can aid investigators in obtaining IRB approval.
  • Enhanced risk management strategies can facilitate essential psychiatric research.