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Table 1 Risk levels and essential safeguards for research studies involving critically ill patients

From: Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards

Risk level Proposed safeguards
Level I: Procedures do not involve greater than minimal risk for any research. • A written plan describing methods to assess decision making capacity
If subjects do not have capacity to provide consent, then:
• Proxy consent;
• A process to respect assent and dissent of the subjects;
• A process to obtain re-consent from the subjects if and when subjects regain capacity
Level II: Procedures of the research involve greater than minimal risk and offer the prospect of direct benefits. • Level I safeguards
• Participation monitor: availability of an independent person to monitor the subject's involvement in the study, e.g., the subject's legal authorized representative.
Level III: Procedures of the research do not involve greater than a minor increment above minimal risk and do not offer the prospect of direct benefits. • Level I and II safeguards
• Necessity requirement
• Subject condition requirement
Level IV: Procedures of the research involve greater than minimal risk and do not offer the prospect of direct benefits. • Level I, II, and III safeguards
• Independent consent monitor
• Evidence of the subject's preferences and interests.