Steps in the Single IRB Review Process for Initial Applications

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This page describes

• How the UW IRB reviews single IRB applications and the activities of relying institutions
• The steps to obtain sIRB review from the UW IRB
• Who is responsible for completing what tasks during the review process

For information about what to do before you submit a funding application to a funding agency which will require sIRB review, review UW is the Lead or Coordinating Site or UW is a Participating Site.

Overview of the sIRB process

The UW IRB reviews sIRB studies in a sequential manner, meaning that it first reviews and approves the overall protocol and any generic materials to be used across all sites. After that, it begins the reliance process and review of relying sites. UW’s experience is that sequential review is typically more efficient and leads to less confusion than concurrent review of sites along with the protocol. For example, if relying sites create and submit their consent materials based off of a consent template that has not been fully approved by the IRB, the sites will need to redraft and resubmit their site specific consent forms if the IRB requests significant changes to the template during its review of the protocol.

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 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.

The INFORMATION SHEET Single IRB Initial Review Process Flow Diagram provides a visual overview of the key steps and roles in the process.

The sIRB application structure

The study application provides the primary description of the overall study as it will be carried out across all institutions 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
• The UW PI’s CV
• The UW-specific consent form, if applicable
• Any appropriate supplements (e.g., the drug or device supplement)

A site application is opened up separately for each non-UW institution (“site”) involved in the research. These are linked to the study application. The site application is very short and will be created in Zipline by HSD staff after the overall study is approved. 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.

View our short tutorial video which illustrates this structure in Zipline:

Preparing and submitting the sIRB application

Confirm that the UW IRB Can Serve as the sIRB for the Research

The UW IRB serves as the sIRB in limited circumstances. Read the webpage UW IRB as a Single IRB for more information on the situations in which UW can serve as the sIRB and which institutions and individuals can rely on the UW IRB. If you have not already confirmed with HSD that UW can serve as the sIRB, contact hsdrely@uw.edu before you prepare and submit an application in order to avoid unnecessary work.

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 you are requesting that the UW IRB review on behalf of. This information is communicated to the IRB by completing and submitting the following supplements with your application:

• SUPPLEMENT Multi-site or Collaborative Research for institutions, including those with a standing reliance agreement with UW, such as Fred Hutch and Seattle Children’s
• SUPPLEMENT Non-UW Individual Investigators for individuals who are unaffiliated with an institution or affiliated with an institution without a Federalwide Assurance (FWA)

Preparing the IRB Protocol and Application for sIRB Review

Efficient sIRB review depends on a well-prepared application. HSD suggests that research teams consider the following when preparing the IRB protocol for a sIRB submission:

1. Indicate in section 1.9 that the IRB is being asked to review on behalf of non-UW individuals and/or institutions.
2. Describe the overall 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.
   Examples

   • 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.
3. Describe the range of options across all sites. Although sites may specify site-specific procedures during the site approval phase, it is typically more administratively efficient to address these differences in the overall study application.
   Examples

   • If sites may employ a range of recruitment strategies, describe all of the potential strategies in the IRB Protocol
   • If only some sites may enroll children, describe the children as a study population in the IRB Protocol
   • If only some sites will require access to PHI in order to identify potential subjects, describe the PHI access in the IRB Protocol
4. Consider how you will develop site-specific consent materials. For most multi-institutional research, each relying institution has an institution-specific consent form. This is because there are minor differences in some elements of consent across institution, for example, what options for compensation for injury will be provided to subjects. For multi-institutional research, a template is typically generated by the overall study team which will allow sites to customize to the local requirements. HSD will not generate this template for you. You may need to work with the investigators at the other institutions in order to decide how you will accomplish this. For guidance, contact hsdrely@uw.edu.
5. 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.
6. 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 Team S, which specializes in review of multi-institutional research. Because sIRB review can be complex, HSD will assess every non-exempt incoming application 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 IRB begins its review. It is important for the IRB 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 typically be assigned to a Reliance Administrator, who will manage the IRB review of the overall study as well as manage the reliance arrangements and the review of non-UW sites after the overall application is approved.

The IRB reviews the protocol and the UW involvement

Once HSD has confirmed that the UW IRB will review for the non-UW institutions and/or individuals, the IRB will review the overall application, any template materials to be used to create site-specific materials, and the activities of the UW, including UW-specific consent form, if there is one.

The IRB reviews the non-UW institutions and individuals

After the overall protocol is approved, the IRB can review and approve the non-UW institutions and individuals. In most cases, this will be done through the expedited review process. The process consists of two parts:

Part One: Establishing the Reliance Agreement

To facilitate sIRB arrangements, UW has established standing reliance agreements with several other regional institutions. Additionally, UW is a SMART IRB Participating Institution. However, this does not necessarily mean that the reliance process for each study is complete. In most cases, each non-UW institution must formally agree to rely on the UW IRB for each study. Additionally, if the relying institution does not have a standing agreement or is not a SMART IRB Participating Institution, HSD will need to negotiate a study-specific reliance agreement with the institution.

For the following “Silent” Cooperative Partners, under the terms of the established agreements, there is no need to obtain the agreement of the relying institution. HSD staff will record the reliance of the institution, and there is no further action required on the part of the study teams.

• Public Health – Seattle and King County
• Northwest Kidney Centers
• WA State DSHS IRB (only for L&I records and Gary Franklin)

For the following Cooperative Partners, the study team must reach out to the institution’s IRB, IRO, or Regulatory Contact to obtain their agreement to rely. This agreement is typically documented in the form of a letter. The UW study team should upload the letter in Zipline, or return the letter to hsdrely@uw.edu.

• Seattle Children’s
• Fred Hutchinson Cancer Center
• Kaiser Permanente of WA
• Benaroya Institute at Virginia Mason
• Bloodworks Northwest
• Washington Center for Bleeding Disorders aka Washington Institute for Coagulation

The study team must reach out to the institution’s IRB, IRO, or Regulatory Contact to obtain their agreement to rely. This agreement is typically documented in the form of a letter. The UW study team should upload the letter in the site application in Zipline, or return the letter to hsdrely@uw.edu.

For all other institutions and individuals, the HSD Reliance Administrator will reach out directly to the institution and/or individuals to propose which reliance agreement will be used, provide them with template documents, and negotiate and document the terms of reliance. In addition, if not already collected HSD will collect an Institutional Profile with important regulatory information about the relying institution to facilitate compliance and reporting obligations. Institutional Profiles are collected at the time of the initial reliance with a new site and are updated at the time of a new reliance request if it has been more than 3 years since the most recent update. The collection, processing, and tracking of Institutional Profiles is managed by HSD staff, not UW study teams. Updates to Institutional Profiles are generally not retroactively applied to previous studies.

HSD primarily makes use of the following agreements:

• The SMART IRB Agreement. HSD will use this agreement when the other institution is a SMART Participating Institution. HSD typically requires that the flexible terms of this agreement are negotiated prior to the IRB reviewing for the site.
• UW Template Reliance Agreements. HSD will use these agreements with any institution.

Part Two: Reviewing on Behalf of the Relying Institution

After the overall study is approved, the assigned HSD Reliance Administrator will set up shell site applications in Zipline for the study and provide specific instructions to the UW study team for how to collect and submit site materials for IRB review. The UW study team must provide the relying site study teams with copies of approved materials from Zipline before the relying sites can complete their site materials. The UW IRB will typically require:

• A completed SUPPLEMENT Site Application (No Contact) or SUPPLEMENT Site Application (Contact) depending on the activities to be conducted by the relying institution. This supplement should be completed by the relying institution study teams in coordination with their IRB or HRPP office.
• Site-specific consent forms and other materials.

NOTE: Under the terms of the standing reliance agreements with Seattle Children’s and Fred Hutch, a SUPPLEMENT Site Application is not typically required for these institutions. HSD only requires the documented agreement of the IRB or IRO as described in part one above.

Once all of the site materials are complete, the UW study team must submit them to the IRB using the Zipline site submission instructions.

For studies with an approval period and that require continuing review, the approval period applies to the overall study and applies to all sites. Separate approval periods or renewal processes are not required for the non-UW sites. This will be noted in the approval letter for the relying institution.

UW study team delivers approval materials to relying study teams

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. The relying institution study team is responsible for providing these to their institution’s IRB or HRPP office depending on their local requirements.

Responsibilities after initial approval

All institutions and their study teams relying on the UW IRB must conduct the research as it has been approved by the UW IRB. They must follow HSD’s requirements for modifying the study, submitting for continuing review, and for reporting problems and other information that may impact the IRB’s determinations. They are also responsible for following their institution’s reporting requirements, for example for reporting breaches of confidentiality under HIPAA.

Consult Steps in the Single IRB Review Process for Follow-on Submissions for more information.

Related Materials

INFORMATION SHEET Single IRB Initial Review Process Flow Diagram
GLOSSARY Engagement
RESEARCHER MANUAL UW Reviewing for Other Institutions
RESEARCHER MANUAL Submitting New Sites
SUPPLEMENT Non-UW Individual Investigators
SUPPLEMENT Multi-site and Collaborative Research
SUPPLEMENT Site Application, Contact
SUPPLEMENT Site Application, No Contact
WEBPAGE Identify the Correct IRB
WEBPAGE Is the UW IRB the Right IRB?
WEBPAGE Guide to Reporting New Information
WEBPAGE Single IRB
WEBPAGE UW IRB as a Single IRB
WEBPAGE UW is a Participating Site
WEBPAGE UW is the Lead or Coordinating Site

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Keywords: Internal reliance; Multi-site; Single IRB