What information will WIRB need regarding the study staff, sub-investigators and the sites?
WIRB will need the name and title of each person involved in the conduct of the research (those members of the study team who have contact with subjects or distribute study articles), a description of the role of each study member, and a curriculum vitae. WIRB’s initial review submission forms provide a space for sites to list the names, titles and duties of the study staff. WIRB must be assured that the investigator can personally oversee the conduct of the research and the protection of human subjects. 21 CFR 50.3(d). WIRB will need to know the number of sub-investigators. Possible relevant information includes whether all of the sub-investigators are on rotation at a clinic, whether multiple specialties, and if written procedures exist for the conduct of research. WIRB will need to know the number of sites. Possible relevant information includes the physical distance between the sites, the number of regularly scheduled visits by the PI to the sites, written procedures explaining how
Related Questions
- Can the staff find out more detail about the alternative study sites? For example, when other libraries will be open, and whether they offer wireless?
- What information will WIRB need regarding the study staff, sub-investigators and the sites?
- Do the notification requirements also apply to staff at non-school administrative sites?
