Do the federal statutes apply to all human subjects, even those that participate in privately funded studies?
No. Only if you have a grant funded by NIH or another federal agency will the federal Human Subjects policy apply. What is a concrete example of a project that will need a Data Safety and Monitoring Board (DSMB)? Phase I Trials Phase I trials are initial evaluations of safety in human volunteers or in patients affected by a condition/disease. They are usually small studies that focus on the following types of outcomes: the safety and tolerability of a new drug; dosing range studies to find the maximum tolerated dose; pharmacokinetic studies of a new drug; feasibility of a behavioral intervention. Although these studies may enroll fewer than 30 subjects, they often require intense monitoring of subjects because of safety and design issues. Repetitive, intense monitoring is difficult in the setting of a DSMB/C; however, oversight by a small group of independent investigators with relevant expertise is recommended. Phase II Trials Phase II trials are pilot trials of safety and efficacy of
