Does anyone have a clearly defined policy on who should be included on a protocol as research staff?
Comments & Events
Joni Koenig
We use the following definition for study personnel and have separate definitions for "investigator", sub-investigator, and "Principal Investigator". This definition comes from the OHRP Investigator Responsibilities FAQ
Study Personnel: an individual performing various tasks related to the conduct of human subjects research activities, such as interacting and/or intervening with human subjects or handling, providing, performing data linkage or data management (when done in addition to other research activities), studying, interpreting, or analyzing individually-identifiable data
Notified 97 people
Robin Krause
Thank you Joni for responding. One of our researchers was questioning whether or not someone should be added to the study. We do not have anything in our local SOP, but I gave her the definition similar to the one you have (based on OHRP as well) and I just wanted to put it out there to see what other institutions may have.
Notified 97 people
Craig Conover,Medical advisor, Chicago DPH, IRB Chair IL DPH
For our IRB applications, we require that anyone who will be interacting with subjects or have access to identifiable data be listed.
Study Personnel: an individual performing various tasks related to the conduct of human subjects research activities, such as interacting and/or intervening with human subjects or handling, providing, performing data linkage or data management (when done in addition to other research activities), studying, interpreting, or analyzing individually-identifiable data