How to Add a New External Site or Individual to an Approved Study

Version date: August 2018

The process for adding a new external site or individuals to an already IRB-approved study varies depending on the type of site or personnel as well as whether the HS-IRBs will be serving as IRB of record for that site. Generally, the following types of changes should be used when adding external sites or personnel:

  • Expedited change
    • External sites or collaborators for which the HS IRBs will not be serving as IRB of record
    • External sites or collaborators for which the HS IRBs have already agreed to serve as IRB of record
  • Full change
    • External sites or collaborators for which the HS IRBs have NOT yet agreed to serve as IRB of record
  • Exempt change
    • Depending on the involvement of external sties or collaborators in projects already determined by the HS IRBs may or may not require submission of change. Please contact the HS IRBs office for guidance on your particular situation.

What information about the new external site(s) or personnel should the study team provide in the change of protocol?

When adding a new external site or personnel via a change of protocol, the change form, modified application, and IRB protocol (if applicable) all must address the following:

  • Identify the new site(s) being added;
  • Describe all of the study procedures that will be occurring at the new site(s);
  •  If the study procedures at the new site(s) will differ from those being conducted at sites already under the purview of the HS-IRBs, explain why; 
  • Identify who will provide IRB oversight for the new site(s) and, if applicable, indicate whether the study team is requesting the HS-IRBs serve as IRB of record for the new site; and
  • If the HS IRBs will be serving as the reviewing IRB for new external sites, upload site-specific documents as applicable, such as recruitment materials and consent and authorization documents.

Do all sites outside the UW-Madison, UW Health, or Madison VA require IRB oversight for their involvement in a study approved by the HS-IRBs?

An external site requires IRB oversight if it is engaged in human subjects research as defined by federal guidance. Study teams are encouraged to consult with the Reliance Team (irbreliance @wisc.edu) when making this assessment.

Will the HS-IRBs serve as IRB of record for a site engaged in human subjects research?

If an external site is engaged in human subjects research, the HS-IRBs may consider serving as IRB of record for that site. Please see HS-IRBs Guidelines for Serving as IRB of Record for more information.

What do I need to do if I want to send specimens/data/images to a site outside UW-Madison, UW Health, or the Madison VA?

For additional information, please see Sending or Receiving Specimens/Data/Images Guidance.




Keywords:IRB of record, adding, add site, Madison VA,oversight, change,   Doc ID:17732
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-03-29 19:00 CDTUpdated:2018-09-25 08:50 CDT
Sites:Health Sciences IRBs
Feedback:  1   0