To determine that the risk to human subjects is reasonable in terms of the outcomes expected from the clinical trial, the IRB may need to begin reviewing proposals for quality and likelihood of outcomes. USDA inspections of teaching and research animals are expected to be expanded to cover rats, mice, and birds. MSU is separating compliance from care functions and determining the cost to meet compliance. An organizational meeting of about 10 institutions interested in forming a Community IRB met in March and began working out details of procedures. It hopes to be reviewing proposals before the end of the year.
Many details remain to be settled, including signatures of hospital CEOs.