TABLE 3

Criteria for the Approvability of Human Research (Checklist)

Physical, psychological, legal, and economic risks are minimized by using procedures consistent with sound research and do not subject participants to unnecessary risks
Risks are minimized by using procedures, when appropriate, already being performed for diagnostic or treatment purposes
Risks are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge expected to result from the study
The selection of participants is equitable
The research plan makes provisions for monitoring the data collected to ensure the safety of participants
Privacy of participants is protected
Confidentiality of the data collected is protected
Additional safety measures are in place
  • Adapted from the Nemours IRB initial IRB review checklist.