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Steps in the Single IRB Review Process for Follow-on Submissions

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Contents

Overview of responsibilities

Relying institution Study Teams are responsible for following UW IRB’s policies, procedures and guidance [9] as long as the UW IRB is overseeing the activities at the institution. This includes, but is not limited to:

Relying institution Study Teams are also responsible for following their institution’s policies and procedures regarding relying on the UW IRB review, which may include obtaining other reviews and sign-offs and delivering IRB review outcome documents to their institution.

HSD’s Zipline system is only accessible by members of the UW Study Team who have a UW NetID. This means that relying institutions cannot submit materials directly to the IRB. Instead, the UW Study Team will need to collect submission materials from relying institutions and submit them to the IRB in Zipline. Additionally, the UW Study Team is responsible for delivering all IRB communications and outcome documents to the relying institution study teams.

Successfully conducting multi-institutional research under sIRB review requires careful planning. HSD strongly recommends that study teams develop clear plans for communication among study sites and with the IRB. For more information about the typical communication responsibilities for sIRB, consult the Template Communication Plan for SMART IRB [10].

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Continuing review

For sIRB applications with an approval period, the approval period applies across all relying institutions. There is no separate approval period for each site. The UW Study Team is responsible for communicating this approval period and any changes or lapses in approval to relying institution study teams. In the case of a lapse in approval, all relying institution study teams are responsible for halting activities with human subjects according to the SOP IRB Review [12].

sIRB applications with an approval period are required to obtain continuing review according to the SOP IRB Review [12].

The UW Study Team is responsible for:

The relying institution study team is responsible for:

HSD strongly recommends that studies with multiple relying institutions develop a plan ahead of time for how they will coordinate the sharing of this information between relying sites and the UW Study Team.

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Study-level modifications

All changes to the approved research, with a few exceptions described in the SOP IRB Review [12], must be approved by the IRB prior to implementation.

The UW Study Team is responsible for identifying the need to submit a study-level modification and for submitting the modification in Zipline [14]. This may require communicating with the relying institutions in order to collect information about the changes being proposed. The UW Study Team is also responsible for responding to any requests for additional information from the IRB and delivering approved materials and outcome documents to the relying institution study teams.

The relying institution study teams are responsible for implementing the changes to the research as applicable to their institution and delivering any outcome documents from study-level modifications to their IRB or HRPP office as required under their local policies.

Considerations when submitting study level modifications:

Whether the study-level changes may implicate changes to site-level documents. For example, if there is a major change to study procedures or risks that must then be described in each of the site-specific consent forms. In this case, both a study level modification and a site level modification will be required. HSD reviewers may assist study teams in identifying whether or not site-level modifications may be required in these circumstances, however the UW Study Team remains responsible for identifying this need.

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Site-level modifications

All changes to the information provided by relying institution study teams and approved by the IRB must be approved by the IRB prior to implementation.

The relying institution study team is responsible for identifying the need to submit a site-level modification and for providing revised information to the UW Study Team for submission to the IRB.

The UW Study Team is responsible for submitting the modification in Zipline [15], responding to any requests for additional information from the IRB (which may require communication with relying institutions), and for delivering approved materials and outcome documents to the relying institution study teams.

The relying institution study teams are responsible for implementing the changes to the research at their institution and delivering any outcome documents from site-level modifications to their IRB or HRPP office as required under their local policies.

When reviewing any site-level modifications, the UW IRB will refer to the Institutional Profile provided by the relying institution in order to determine if there are any additional local context considerations (e.g., laws or consent requirements provided by the institution) that apply to the changes. If the UW IRB is unable to understand how the local context information applies to the changes, it will request that the relying institution study team contact their institution’s IRB or HRPP for guidance prior to approving the changes.

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Reports of new information

The UW Study Team is responsible for identifying and reporting any new information across the overall study that meets the UW requirements for reporting new information [16].

Relying institution study teams are responsible for identifying and reporting any new information at their site that meets UW requirements for reporting new information from relying institutions [17]. They are responsible for promptly communicating this information to the UW study team for reporting to the IRB.

The UW Study Team is responsible for submitting any reports in Zipline [18] on behalf of the overall study or an individual relying institution and for delivering IRB communications and outcome documents to all impacted relying study teams. The relying study teams are responsible for delivering any outcome documents to their institution’s IRB or HRPP office according to their local policies.

If the new information is determined to be serious or continuing non-compliance or results in a suspension or termination of study activities, the UW will communicate this outcome to the UW PI, the site PI and any impacted relying institution’s IRB or HRPP office according to the terms of the applicable reliance agreement.

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Site or study closure

HSD does not require that relying sites be closed in Zipline upon the cessation of site activities, however Individual relying sites can be closed when the activities of the employees or agents of the relying institution are no longer considered research with human subjects.

The overall study can be closed when all research with human subjects has been completed across UW and all relying sites, including any coordinating centers as described in the SOP IRB Review [12].

The UW Study Team is responsible for submitting all closure requests to the UW IRB [13] on behalf of the overall study and all relying site study teams and for delivering all outcome documents to the relying site study teams. Relying site study teams are responsible for providing any information required by the UW IRB through the UW Study Team and for delivering outcome documents to their IRB or HRPP according to their local policies.

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RELYING SITES Reporting of New Information [17]
RESEARCHER GUIDE Continuing Review and Closure [13]
RESEARCHER GUIDE Multi-site Modifications [15]
RESEARCHER GUIDE Reports of New Information [18]
RESEARCHER GUIDE Study Modifications [14]
SOP IRB Review [12]
WEBPAGE Guide to Reporting New Information [16]

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Version Information

Open the accordion below for version changes to this guidance.

Version History

Version Number Posted Date Implementation Date Change Notes
1.1 02.08.2024 02.08.2024 Revised for DEI language, minor revisions
1.0 06.30.2022 06.30.2022 Newly posted webpage

Keywords: Internal reliance; Multi-site; Single IRB