- How do I know if a single IRB is needed? [2]
- How do I know when the UW IRB can be the Single IRB, and who decides? [3]
- What is the process for determining which IRB should review, and when it should occur? [4]
- What does applying for UW Single IRB (sIRB) review look like in Zipline? [5]
- What is the Correspond with Site activity that shows up for SITE applications? [6]
- How do I change my application from internal to external review, or vice versa? [8]
- What is the Correspond with sIRB activity? [9]
Single IRB Studies
How do I know if a single IRB is needed?
A Single IRB is required when ALL of the following are true for the research:
- The research is federally funded by any agency except the Department of Justice.
- The research involves more than one domestic (United States) institution.
- The research receives its initial IRB approval on or after January 20, 2020.
- There are no laws requiring a separate IRB review or federal agency exceptions.
Examples of exceptions:
- International sites and tribal locations.
- Many Veteran Affairs (VA) sites due to strict VA policy. For each study you must check with the VA site to understand whether or not they qualify for exception.
- Washington State law requires the Washington State IRB to review studies involving certain state agencies, employees, and clients even if another IRB is already reviewing the study.
- Federal agencies are allowed to grant exceptions to the Single IRB requirement for specific studies they fund.
The Single IRB requirement applies to all studies meeting the criteria listed in the bullet points, even if the federal funding Request for Applications (RFA or RFP) doesn’t mention the Single IRB requirement. However, a RFA or RFP may specifically state that the Single IRB requirement does not apply to the RFA or RFP. This is an example of the authority of the federal agencies to grant exceptions to the requirement.
How do I know when the UW IRB can be the Single IRB, and who decides?
HSD is the only entity authorized at the UW to approve the use of the UW IRB as a Single IRB. In general, the UW IRB will be the Single IRB when the UW is a primary awardee of the funding and the lead principal investigator (PI) for the overall study is UW faculty, staff or student.
Exceptions:
- The federal RFA or RFP may require the use of a specific non-UW IRB.
- The UW Lead PI and co-investigators may prefer to use a different IRB.
- Another IRB should conduct the review under the terms of an existing cooperative agreement with another institution. Example: The Hutch IRB reviews almost all greater-than-minimal-risk research involving Cancer Consortium sites, regardless of which institution is the primary funding recipient and lead PI.
- The UW IRB may not have the capacity to serve as the Single IRB if the study is complex, there are many non-UW institutions, or the UW IRB lacks appropriate expertise. This is especially true if the need for the UW Single IRB is identified after a grant is awarded.
What is the process for determining which IRB should review, and when it should occur?
Who, how: The lead PI should assess the criteria listed above and then consult with hsdrely@uw.edu [10].
Outcome: The consultation will:
- Confirm the applicability of the requirement and the UW IRB’s availability to be the Single IRB (or identify a mutually-acceptable alternative)
- Provide information about any budget and personnel implications
- Provide a Letter of Support from HSD as needed
- Provide information about next steps
Timing:
Optimal: When a federal grant or contract proposal is being prepared
This allows all parties (including the UW IRB) to plan ahead of time so that there are no unpleasant budget surprises or last-minute delays for study start-up. Because this time frame allows HSD time to build and/or ensure staff and IRB capacity, the UW IRB is likely to be available for most multi-institutional research except possibly very large and complex studies.
OK in some circumstances: When there is reason to think a grant or contract will be awarded
This timing is fine if the other institutions are frequent regional partners (e.g., Hutch, Seattle Children’s). It will also likely be acceptable for uncomplicated studies involving only one or two non-UW institutions. For all other studies, this timing is associated with risks that there will be (1) budget impacts that were not built into the grant application; (2) delays in study start-up (due to IRB capacity building); and (3) a somewhat greater possibility that the UW will not be able to serve as the Single IRB.
Potentially problematic: After an award, when the UW IRB application is submitted in the Zipline e-IRB system
If the lead PI does not consult with HSD prior to submission and instead submits a Zipline application requesting that the UW be the single IRB, HSD staff will refer the application to the HSD Reliance Team for consultation before the review can occur.
This timing is fine if the other institutions are frequent regional partners (e.g., Hutch, Seattle Children’s). It may also be acceptable for uncomplicated studies involving only one or two non-UW institutions. But for all studies except those involving only our regional partners: This timing will cause delays in obtaining IRB approval and therefore study start-up, due to agreement negotiations with the non-UW institutions. It also has risks: (1) budget impacts that were not built into the grant application; and (2) the highest probability of the three timing scenarios that the UW will not be able to serve as the Single IRB, despite what the PI may have told the funding agency or the other institutions.
What does applying for UW Single IRB (sIRB) review look like in Zipline?
The Study application [11] provides the primary description of the study and of the local (i.e., 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 generic consent form; the new Supplement for Multi-site or Collaborative Research; a grant application; and any appropriate Supplements (e.g., the Drug or Device supplement).
A Site application [12] is opened up separately for each institution (“site”) involved in the research. These are linked to the study application. The Site application SmartForm is very short and will be filled out by HSD staff, for the researchers to submit. To do this, HSD staff will request specific materials from the UW team such as a completed Site-Specific Questionnaire and other documents such as a site-specific consent form. 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.
What is the Correspond with Site activity that shows up for SITE applications?
The Correspond with Site activity is built in by our system vendor and is meant to facilitate communication between the lead institution (UW) and any relying institutions. However, at this time, we do not recommend using the Correspond with Site activity to communicate with contacts at other institutions.
External IRB Studies
How do I change my application from internal to external review, or vice versa?
If the initial application (STUDY) is in Pre-Submission or Clarification Requested (Pre-Review) state, the application can be changed from internal (UW IRB) review to external IRB, or vice versa, simply by updating the question about external IRB review on the Basic Information page of the study SmartForm. If the application is in Pre-Review state, contact the assigned IRB Coordinator and ask them to push the application to Clarification (Pre-Review) state so that you are able to edit the external IRB review question.
After the initial application (STUDY) is past the Pre-Review state, the application cannot be changed from internal to external review, or vice versa. Instead, the PI or a designated PI proxy may use the Copy Submission [13] activity to create a new application and update the external IRB question on the Basic Information page of the copy. After it is updated, the new application must be submitted and reviewed, and the original application may be closed or discarded.
What is the Correspond with sIRB activity?
The Correspond with sIRB activity is built in by our system vendor and is meant to facilitate communication between the reviewing IRB and UW. However, at this time, we do not recommend using the Correspond with sIRB activity to communicate with contacts at other institutions.
