Steps in the Single IRB Review Process for Initial Applications
This page describe the steps to obtain single IRB (sIRB) review from the UW IRB at the time a study has been funded. For information about what to do before you submit a funding application to a funding agency, see UW is the Lead or Coordinating Site or UW is a Participating Site.
The sIRB application structure
The study application provides the primary description of the study and of the UW involvement in the research. It includes several SmartForms and the IRB Protocol form, which should describe the overall or generic study. Other study documents that might be uploaded include:
- Questionnaires used at all sites;
- A template consent form to be used to create site consent forms;
- A grant application that funds the overall study;
- Any appropriate supplements (e.g., the drug or device supplement).
A site application is opened up separately for each institution (“site”) involved in the research. These are linked to the study application. The site application is very short and will be created by HSD staff. The documents submitted in the study application (such as the IRB Protocol form) are automatically displayed in the site application and do not need to be completed or submitted again. The site applications can be accessed from within the study application.
See our short tutorial video which illustrates this structure in Zipline:
Preparing and submitting the sIRB application
Follow the Correct Zipline Instructions
When submitting the initial application, make sure that you are following the application pathway for UW Reviewing for Other Institutions. If you are adding institutions to an already approved study, follow the instructions for Submitting New Sites.
Identify the Institutions and Individuals the UW Will Review For
The IRB will need to know which non-UW institutions or individuals will rely on the UW’s review. UW will only review for institutions or individuals who are engaged in the research. Complete the SUPPLEMENT Multi-site or Collaborative Research and/or the SUPPLEMENT Non-UW Individual Investigators and upload them to the Zipline SmartForms indicated on the supplements.
Key principle for initial applications: Submit only information and materials that apply across the whole study and for the UW site.
HSD will collect site-specific information and materials after you have submitted the initial application.
- Describe the study in the IRB Protocol. The IRB protocol should describe all of the activities across all of the sites for which the UW will review.
A multi-site clinical trial where each site will recruit and enroll subjects and complete the study procedures. The application should describe how the overall protocol will be conducted by all of the sites including: how potential subjects will be identified, and approached, how consent and/or assent will be obtained, what procedures subjects will undergo, how data confidentiality will be maintained, etc.
A collaborative study where site A will identify and recruit subjects, site B will perform study interventions and obtain data, and site C will analyze identifiable data and specimens. Procedures across all sites should be described, including: how subjects will be identified and recruited, how consent will be obtained, what interventions will be performed, how data will be obtained, analyzed and stored, etc.
- Provide template consent forms and other materials. If the study is a multi-site study for which the sites will create site-specific materials off of a study-wide template, make sure to upload the template to the Study-Related Documents SmartForm.
- Provide UW specific materials. If there are materials that will be specific to the UW site (such as consent forms or assent materials), make sure to upload those to the Local Site Documents SmartForm.
HSD assesses the application
The application will be assigned to HSD’s new Team S, which specializes in review of multi-institutional research. Because sIRB review can be complex, HSD will assess every incoming study that involves another institution to identify:
- Whether the Common Rule or NIH sIRB review requirements apply
- Whether the UW IRB is the right IRB
- Whether UW can review for the non-UW institutions and individuals
- Whether the non-UW sites are engaged in the research
- Whether the application is ready for sIRB review
You may be asked to provide more information about the non-UW sites before the study is assigned to a Review Administrator. Before the IRB begins its review, it is important for HSD to have a clear understanding of the general study, the involvement of the non-UW sites and whether UW will review for those sites. Although this may involve an extra step for multi-institutional research, proceeding with IRB review without having this understanding is likely to lead to delays and require substantive revisions to the IRB submission after the IRB has approved the study.
The application will be assigned to a Review Administrator, who will manage the IRB review of the overall study, and to a Reliance Administrator, who will manage the reliance arrangements and the addition of non-UW sites after the overall protocol is approved.
The IRB reviews the protocol and the UW
Once HSD has confirmed that the IRB should review for the non-UW institutions, the IRB will review the overall protocol, the template materials, and the UW site.
In some cases, HSD can proceed with setting up reliance agreements and obtaining site-specific information in tandem with the IRB’s review of the overall protocol. In other cases, it will be important to wait until the overall protocol is approved. This depends on:
- The complexity of the study
- The role of the non-UW institutions
- Whether the UW has an established agreement with the non-UW institutions
- The amount of information to be collected about site-specific activities
- Whether the non-UW institution requires a copy of the fully approved protocol in order to begin its part of the reliance process
The IRB reviews the non-UW institutions and individuals
After the overall protocol is approved, the IRB can approve the non-UW institutions and individuals. In most cases, this will be done through the expedited review process. To complete this review, HSD staff will request site-specific materials from such as a completed Site-Specific Questionnaire and any site-specific documents such as a site-specific consent form. HSD staff may work directly with the non-UW institutions to obtain this information, or may request that the UW study team facilitate obtaining this information from the non-UW institutions.
When HSD has obtained this information, HSD staff will create the site application in Zipline. The site application will be linked to the study application. HSD staff will send a request to the UW study team to confirm the accuracy of the information before the IRB approves the addition of the site.
With the approval of the site, the UW PI will receive an approval letter specific to the non-UW institution.
For studies with an approval period and that require continuing review, the approval period applies to the overall study and includes all sites. Separate approval periods or renewal processes are not required for the non-UW sites.
UW study team delivers approval materials
HSD’s Zipline system is only accessible to the UW study team. Notifications from the Zipline system, including notification of the availability of approvals for the non-UW sites, will only be sent to the UW study team. The UW study team is responsible for providing the non-UW institutions and individuals with approved study materials and approval materials for the site.