The basic suggested safeguard for subjects enrolled in a no greater than minimal risk study includes a written plan describing methods to assess decision-making capacity. Which of the following should be added to this assessment of decision-making capacity for subjects enrolled in a greater than minimal risk study offering the prospect of direct benefit to the subject? Approval of the study by a federal agency Review of the study by a representative from the organization's risk management team A second research coordinator to sign the consent form A participation monitor (such as a LAR) to monitor the subject's involvement in the study