Site Visiting Program

Your investigative site may be contacted by a representative of New England IRB, requesting that a site visit be scheduled. New England IRB has the authority to observe the conduct of the research New England IRB has approved. New England IRB may also verify that the study is being conducted as stipulated by New England IRB and may verify information in any interim or continuing review submissions. The intent of the site visit is to provide your site with additional information and resources regarding clinical research. It should not be perceived as an audit.

New England IRB Site Visitors

New England IRB utilizes consultants to conduct the site visits. Site visitors have been trained by New England IRB on the conduct of the visit and New England IRB Policies and Procedures. Site visitors have also reviewed New England IRB's regulatory files for the studies that will be reviewed during the New England visit.

Conduct of the Site Visit

The site visitor will contact the principal investigator to schedule the visit during a mutually convenient time. During the visit, the site visitor will review the regulatory files and meet with the principal investigator, study coordinator and/or other research staff. The visit usually takes about 1-2 hours. 

Determination of Sites to Visit

New England IRB conducts site visits based on several criteria:

• The nature of the research (investigators conducting higher risk studies are more likely to be visited by New England IRB).

• The intended study population (investigators enrolling vulnerable subjects are more likely to be visited by New England IRB).

• Investigators that have had previous issues of non-compliance are more likely to be site-visited.

• Investigators that have a high volume of studies with New England IRB are more likely to be site-visited by New England IRB.

In addition, New England IRB conducts "for-cause" site visits.

Lastly, if the study involves an investigational drug and is in being conducted in the state of Massachusetts, New England IRB will conduct a site visit, in accordance with New England IRB's Affiliation Agreement with the Massachusetts's Department of Public Health. 

Following the visit, the site visitor will send a written report to the principal investigator. 
If the site visitor requires that corrective action be taken in response to a finding, you will receive further communication from New England IRB to ensure that the action has been taken. In addition, New England IRB may require that additional
action(s) are taken.