Site Visits
Federal Regulations grant IRBs the authority to observe the consent process and
the research (21 CFR 56.109(f); 45 CFR 46.109(e)).
During site visits, the WIRB representative will focus on subject safety as well
as regulatory compliance. The visits also offer an opportunity to the site to address
research-related issues and ask questions of the WIRB visitor.
In preparation for the visit, WIRB asks the sites to set out the following review
materials in a suitable work area, to allow for the visit to be conducted efficiently
and with minimal disruption to the site's work:
- The site's organization's informed consent policies, and the process by which consent
is routinely obtained.
- The site's document files for WIRB-approved studies, including:
- Protocol and amendments,
- FDA form 1572 (if applicable),
- IRB correspondence and approved consent form(s),
- Participant charts or source documents and the consent form(s) for each study,
- Investigator Brochure(s),
- Curriculum Vitae (CV) for all research staff, and
- The Principal investigator's CV and medical license.
WIRB may also ask to see the site's drug storage areas and emergency equipment.
WIRB conducts the following types of site visits:
- Routine (Site Assessment) - Routine site visits are generally brief and simple.
However, some "routine" visits to sites at institutions with which WIRB has a contract
are dictated by the terms of the contract, and those visits' length and depth will
vary depending on the terms in the contract.
- For-Cause - WIRB staff initiate "for-cause" site visits in response to concerns
raised about the site, investigator, etc. These visits are usually carried out by
WIRB Regional Representatives, Board members or WIRB 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 WIRB Regional
Representatives, Board members or WIRB 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, the
name of the visitor and the agenda for the visit.
The Board reviews all site visit reports. If any follow-up is required, the investigator
will be informed about the Board’s decision. WIRB does not release copies of site
visit reports to sites or sponsors.
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