Ms. Ward is responsible for maintaining records for the study and for taking routine blood samples, blood pressure readings, weight, and so on. The protocol calls for these measurements to be taken weekly, at which time the patients are expected to come to the hospital. Ms. Ward is used to such procedures. She has worked on research protocols for several years. Many of them have involved patients receiving medications on an out-patient basis and coming to the hospital regularly for data monitoring.
She is troubled by the present protocol, however. She knows how difficult it is for her patients, being seriously ill, to come to the hospital. She realises that they have to make the trip weekly and that most of the visits are solely for the purpose of the research. She also knows that Dr. Hanson, the principal investigator for the study, has never considered any variations in the protocol that would ease the burden on these men. She wonders how much the study would be compromised if the data were gathered only when the men needed to come to the hospital for therapeutic reasons. Alternatively, she wonders whether nurses could visit the men in their homes to get the blood samples and other data.