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