It’s not unusual for a study to require subjects to be fasting before a certain study procedure, such as a blood draw. What is unusual, we’ve noticed here at the IRB, is a new submission that adequately describes what is meant by “fasting” on the first go-around. Addressing the following items in the consent form and protocol will help you avoid some contingencies related to the fasting requirement:
–What, exactly, is meant by “fasting”? No food or drink after a certain time the night before? Can subjects have water or black coffee or tea and still be considered fasting?
–How should subjects handle any of their usual oral medications? Can they take those with water before the study visit? Or should they bring them with them to the visit to take after study procedures are completed?
–How will study appointments be scheduled? Ideally, if you’re going to require subjects to fast overnight, we’d like to see you attempt to make morning appointments for everybody so they’re not fasting until the afternoon. Also, if your study population involves young children or another population that, you know, may not be readily compliant with the idea of fasting, please specify how closely they must hew to the fasting requirement. Can they eat dry toast or something like that if they’re really hungry? Or is there some way the procedure that requires fasting can be done at a more convenient time for the subject?