Site Visits

Federal Regulations grant IRBs the authority to observe the consent process and the research (21 CFR 56.109(f) and 45 CFR 46.109(g). 

WCG IRB conducts the following types of site visits:

• For-Cause – WCG IRB staff initiate “for-cause” site visits in response to concerns raised about the site, investigator, etc. These visits are usually carried out by WCG IRB Regional Representatives, Board members or WCG IRB management.
• Board-Directed – The Board directs site visits in response to concerns raised about the site, investigator, etc. These visits are usually carried out by WCG IRB Regional Representatives, Board members, or WCG IRB management.

Sites receive a site visit confirmation notice soon after the site visit has been scheduled. 

The notice provides the time of the visit, the basis for the visit, and the agenda for the visit. For the fees associated with a WCG IRB site visit, please consult the current fee schedule.

WCG IRB reviews all site visit reports. If any follow-up is required, the investigator will be informed about the Board’s decision. WCG IRB does not release copies of site visit reports to sites or sponsors.