On behalf of a client, I have a question about wehere to file documents related to an IBC in a gene therapy study. (From Adverra, IBC vs IRB):
While both committees focus on risk, they have contrasting responsibilities. IRBs are tasked with protecting the rights and welfare of research subjects. IBCs, however, seek to protect study personnel, the community and the environment from exposure to engineered genetic material and other biohazardous agents. An IBC may also advise the IRB in assessing potential risks to the study subjects.
I suspect that these would be filed under the same sections as IRB documents, and distinguished by name/title. Does anyone have any experience with this?
I think that is also a good possiblity. Will check with them on which way is more clear, the eTMF includes committee name in placeholders so it should be clear to users I think no matter which is chosen.