How to Add a New Site to an Approved Study

Version date: July 2017

The process for adding a new site to an already IRB-approved study varies depending on the type of site being added as well as whether the HS-IRBs will be serving as IRB of record for that site. The table below provides an overview of the most common types of site additions. If you do not see a scenario below that describes the change you wish to make to your study or you are unsure about what needs to be submitted to the IRB, please contact the Reliance Team (irbreliance@wisc.edu) for assistance.

NOTE: If your study or project was determined to be exempt or not human subjects research, no change of protocol will typically be needed to add a new site unless other changes are being made. Study teams should instead contact the IRB staff reviewer who originally reviewed the exemption application for guidance.

Type of Site to Be Added
What to Submit to the HS-IRBs
 Guidance
New location within UW-Madison  or UW Health
Expedited change

  • A new study site within the UW-Madison or UW Health can typically be added via an expedited change if no other substantial changes are being proposed.
  • The study location section of the modified application also will need to be revised to list the new study location.
  • If study activities at the new location will differ from those occurring at already approved locations, the modified application will need to be revised to reflect this.
  • If substantial changes are being made to the study (e.g., change in study design, eligibility criteria) in addition to adding a new location, a full change of protocol may need to be submitted.
  • If new personnel will be involved in the study as a result of the addition of the new site,select 'Changes to study team personnel' from the Expedited Change categories to describe the personnel changes.    
Madison VA
Contact the HS-IRBs office
  • The HS-IRBs require that study teams planning to conduct studies jointly with VA AND UW-Madison submit separate IRB applications for the VA and UW-Madison components when they are distinct (e.g., study procedures for UW subjects only occur at the UW and those for VA subjects only occur at the VA). As a result, the study team may need to submit a new application rather than a change of protocol.
  • Study teams should contact the HS-IRBs office for guidance on determining what type of application to submit.
  • Whether a new application or a change of protocol needs to be submitted, the application will need to be reviewed and approved by the VA R&D committee in addition to the HS-IRBs.
Site external to UW-Madison, UW Health, or the Madison VA
AND
HS-IRBs are NOT serving as IRB of record
Step 1: Expedited change
Step 2: Edit External Personnel Access
  • A new study site external to the UW-Madison or UW Health can typically be added via an expedited change if no other substantial changes are being proposed AND the HS-IRBs will NOT be serving as IRB of record for the new site.
  • As part of the expedited change, the modified application and study protocol must be revised to reflect all the study activities occurring at the new site, including who will be conducting study procedures and what their role is in the study.
  • The study location section of the modified application also will need to be revised to list the new study location. 
  • If substantial changes are being made to the study (e.g., change in study design, eligibility criteria) in addition to adding a new location, a full change of protocol may need to be submitted.
  • Personnel from the external site should NOT be listed on the study team member pages of the IRB application. Their role in the study, however, should be described elsewhere in the IRB application as well as in the study protocol.
  • If personnel from the external site need access to the IRB application in ARROW, the study team can grant them access using the Edit External Personnel Access activity. Please see Accessing ARROW for External Personnel Engaged in Research: UW-Madison is Not Serving as IRB of Record for more details.
Site external to UW-Madison, UW Health, or the Madison VA
AND
HS-IRBs have not yet agreed to serve as IRB of record
Full change

  • A new study site external to the UW-Madison or UW Health will need to be added via a full change of protocol if the HS-IRBs have not already agreed to serve as IRB of record for the new site.
  • As part of the full change, the modified application and study protocol must be revised to reflect all the study activities occurring at the new site, including who will be conducting study procedures and what their role is in the study.
  • The study team members pages and the study location section of the modified application also will need to be revised to list the new study team members and study location. 
  • As part of the change application, select 'Changes to study team personnel' from the Full Change categories to describe the personnel changes.  Please see Accessing ARROW for External Personnel Engaged in Research: UW-Madison is Serving as IRB of Record for more details.
  • NOTE: Anyone for whom the HS-IRBs are serving as IRB of record must complete CITI or comparable human subjects research training.
Site external to UW-Madison, UW Health, or the Madison VA AND HS-IRBs have already agreed to serve as IRB of Record
Expedited Change
  • A new study site external to the UW-Madison or UW Health will need to be added via an expedited change of protocol if the HS-IRBs have already agreed to serve as IRB of record for the new site.
  • As part of the expedited change, the modified application and study protocol must be revised to reflect all the study activities occurring at the new site, including who will be conducting study procedures and what their role is in the study.
  • The study team members pages and the study location section of the modified application also will need to be revised to list the new study team members and study location.
  • As part of the change application, select 'Changes to study team personnel' from the Expedited Change categories to describe the personnel changes. Please see Accessing ARROW for External Personnel Engaged in Research: UW-Madison is Serving as IRB of Record for more details.
  • NOTE: Anyone for whom the HS-IRBs are serving as IRB of record must complete CITI or comparable human subjects research training.

What information about the new site(s) should be provided in the change of protocol?

When adding a new site via a change of protocol, the change form, modified application, and IRB protocol 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);
  • List the personnel who will be conducting study procedures at the new site(s) and their specific role in the study (e.g., data analysis, subject recruitment);
  •  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; and
  • Identify who will provide IRB oversight for the new site(s) and, if applicable, indicate whether the HS-IRBs are being asked to serve as IRB of record for the new site.
Study teams should keep in mind that, depending on the nature of the study, several sections of the modified IRB application may need to be revised to fully reflect the role of the new site(s). Study teams are advised to review the modified application carefully to ensure that the revisions have

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. Making this determination can be difficult and 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 and does not have an IRB to oversee its study activities or if its IRB is willing to cede IRB review to the HS-IRBs, 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?

If the currently approved IRB application specifies that specimens/data/images collected for the study will be shared with another site or researchers at another institution, no change or notification to the IRB is required if the scope of what the samples will be used for falls within those described within the UW IRB application. If the currently approved IRB application does not specifically state that specimens/data/images will be shared with a site and/or personnel external to the UW-Madison/UWHC/Madison VA, a change of protocol must be submitted to the HS-IRBs before specimens/data/images are sent to that site/researcher. 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 18:00 CSTUpdated:2017-07-21 08:25 CST
Sites:Health Sciences IRBs
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