91爆料

External IRB Reliance Process

Applying for HSD Authorization

What is an External IRB and when should you ask for one?

The term external IRB refers to any non-91爆料 IRB that reviews 91爆料 research. The 91爆料 is willing to rely on an external IRB for many types of studies, but the review must be authorized by HSD in advance on a study by study basis.

Consult Identify the Correct IRB for a list of types of research that must be reviewed by an external IRB instead of the 91爆料 IRB. External IRBs not listed on that page may also be used, with the permission of HSD.

91爆料 can rely on a large variety of different IRBs, however HSD must grant permission for the use of any external IRB for each study, even under pre-established cooperative agreements (like the Fred Hutch or Seattle Children鈥檚) or other agreements. Whether or not the 91爆料 can rely on a particular IRB depends on a number of factors such as accreditation status, what kind of institution it is operated by, and whether or not the IRB has the expertise to review the proposed research project.

Not allowed. The 91爆料 does not rely on:

• International IRBs or Ethics Review Committees (ERCs).
• IRBs of the U.S. Veteran鈥檚 Health Administration 鈥� for example, the VA Puget Sound Health Care System. This is VA policy.

Contact hsdrely@uw.edu with any questions about which IRB should review.

When should you submit your authorization request in Zipline?

Submit your request to use the external IRB when you are ready to start applying for IRB review and when you have enough information to complete the application.

To complete the request in Zipline you will typically need:

• The final protocol and any template consent forms that have been approved by the reviewing IRB
• A plan for how the study will be carried out at 91爆料 (e.g. will you need access to PHI for recruitment)
• Any instructions from the reviewing IRB or coordinating center about what documents they require

Submitting a request in Zipline before you have this information will not speed up the request process.

You may submit your request at the same time you submit to all other necessary compliance/administrative offices. This allows for concurrent review.

For industry research, budget approval and a finalized contract (Clinical Trials Agreement) are not necessary before asking for (and receiving) authorization for use of an external IRB from HSD. However, you will need to provide a Worktag for HSD to charge its administrative fee. Review Industry Sponsored Research for more information.

How do you submit your application?

Follow these step by step instructions for submitting an application in the 91爆料鈥檚 Zipline e-IRB system.

The application process is similar to the standard IRB application process but the system branches on the first webpage when you indicate you are requesting authorization for an external IRB to review the study instead of the 91爆料 IRB. Be sure to upload any materials already provided by the external IRB, lead site, or coordinating center. The REQUEST External IRB Review form is always required. Pre-requisite: The 91爆料 researcher and the person preparing the Zipline application must already be registered in the Zipline system.

Three common, high-impact mistakes (and how to prevent them)

• Beginning the request process too soon or without having enough information.
  • Prevention: Check with the lead study team, coordinating center or reviewing IRB to make sure you have all the necessary documents and understand the reviewing IRB’s timeline for executing reliance agreements and reviewing site submissions.
• Providing a study title in Zipline that is inconsistent with the protocol title.
  • Prevention: Provide the full, complete title that is the same as the title on the protocol document and on any funding.
• Not providing the e-GC1 number for a grant that is supporting the research. This information makes it much easier and faster for OSP to allow the release of your grant funds for human subjects research.
  • Prevention: Provide the e-GC1 number where it is requested on the Zipline Funding SmartForm, or add the word 鈥減ending鈥� if the number is not yet available.

What is HSD鈥檚 role in the external authorization process?

HSD will:

• Ensure that the proposed external IRB is appropriate and qualified.
  • This step is minimal if the researcher already obtained a Letter of Support about the external IRB for a grant application or if there is an already-established review arrangement.
  • If the external IRB is not appropriate, HSD will work with the 91爆料 PI to select another external IRB or obtain review from the 91爆料 IRB.
• Confirm or establish any necessary reliance agreements.
  • Reliance agreements are legally-binding written agreements where one institution or individual gives permission for an IRB to review research on their behalf. Reliance agreements are required by federal human subjects regulations.
  • HSD is the only entity authorized to sign on behalf of 91爆料.聽 91爆料 has already established several standing agreements and will use them whenever possible instead of negotiating a new agreement.
• Provide local context information to the external IRB, if required.
  • IRBs must consider any applicable state or local laws, or institutional policies that apply to the 91爆料 research. External IRBs request this information through questionnaires, worksheets, or webforms.
  • Requests for local context information should be fulfilled in collaboration with HSD to ensure completeness and accuracy.
• Provide documentation authorizing the use of the external IRB.
  • HSD鈥檚 authorization will be documented in an Authorization Letter. An automatic email notification is sent to the 91爆料 researcher when authorization is granted and the letter is available in the Zipline study record.
  • After receiving the Authorization Letter, the researcher can now apply to the external IRB. The letter should be provided to the external IRB with the IRB application.

How long do reliance requests take?

Authorization can take one day to several weeks, depending on:

• Whether a new reliance agreement must be established
• The complexity of the reliance agreement
• The need for a Diversity in Clinical Trials Plan
• Whether HSD needs to provide local context information to the external IRB.

Applying for External IRB Approval

What should you expect when submitting to the External IRB?

This process can be highly variable due to operational and policy differences among IRBs outside of HSD’s control. Do not hesitate to ask questions as you navigate the process!

91爆料 researchers must use the system, forms, and processes of the external IRB when seeking approval for the 91爆料 site activities. Consult the external IRB鈥檚 webpage or office for information or assistance.

91爆料 researchers participating in collaborative or multi-site research should consult with the lead researcher or coordinating center to find out who will be responsible for submitting the 91爆料 application to the external IRB.

What are the 91爆料 investigator鈥檚 responsibilities?

91爆料 PIs are responsible for:

• Including a copy of the Authorization Letter provided by HSD to the external IRB. Some IRBs (such as Seattle Children鈥檚 and Fred Hutch) will not review 91爆料 research without the letter.
• Following the policies of the external IRB. This includes submitting to the reviewing IRB using their forms and processes (or assisting the lead site with that process), following their reporting requirements for unanticipated problems and new information about the study, and complying with the stipulations of the IRB鈥檚 approval.
• Ensuring that any relevant financial conflicts of interest are disclosed to the external IRB and that conflict of interest management plans issued by the Office of Research are given to the external IRB.
• Obtaining any required ancillary review and approvals and providing the results of these reviews to the external IRB if requested.
• Making copies of IRB approvals available for inspection by monitors and auditors.

Consult the CHECKLIST External IRB, 91爆料 Researchers for a detailed list of responsibilities.

What do you do once you receive approval from the reviewing IRB?

When you have received documentation of the external IRB鈥檚 approval for 91爆料, send the approval documentation to HSD by emailing hsdrely@uw.edu. Until HSD receives these documents, the status of the study in Zipline will be 鈥淧ending sIRB Review鈥� and the PI will receive a reminder every 6 months that approval documents have not been received.

The documentation of IRB approval for the 91爆料 site can be variable. Examples of common processes and associated approval documents:

• 91爆料 is formally onboarded as a participating site (e.g., a pSite) and receives a site-specific approval letter;
• 91爆料 is approved as a participating site via Modification and the 91爆料 site approval is noted in the Modification approval letter;
• 91爆料 investigators are added as collaborators on the research via Modification, documentation of 91爆料 approval may not be explicit in an approval letter.

If you are not sure what documentation to provide, please contact hsdrely@uw.edu for instructions.

HSD will upload approval documents to the study record in Zipline and change the study status to 鈥淎ctive鈥�. You do not typically need to send approval documents from WCG IRB or Advarra to HSD. WCG IRB and Advarra automatically send approval documents to HSD when hsdrely@uw.edu is listed as a study contact in either Connexus or CIRBI.

Will HSD review your consent forms?

In most cases, HSD will not separately review consent forms for studies that are reviewed by an external IRB. It is the researcher鈥檚 responsibility to ensure that HSD鈥檚 consent requirements are met.

However, for all studies reviewed by Advarra and WCG IRB and all industry-initiated clinical trials reviewed by any other non-91爆料 IRB (except Jaeb IRB and Fred Hutch IRB), HSD will perform a post-IRB approval audit of consent forms to ensure that they meet HSD鈥檚 consent requirements. The authorization letter provided by HSD for each study contains specific instructions and expectations about this review.

During the Research

When do you need to submit a Modification?

The Zipline application requesting authorization to use an external IRB should be updated/modified only when:

• There is a change in 91爆料 PI.
• There is a need to allow new members of the study team access to the study in Zipline.
• There is a change from one external IRB to a different external IRB.
• The study will use an e-consent platform to obtain documentation of consent and you have not already obtained HSD鈥檚 acknowledgement that the platform is acceptable for use in the study. HSD must assess whether the e-consent platform is acceptable under 91爆料 policy and WA state requirements before you can use it.

For information about how to submit a study update or Modification, visit instructions on changing external IRB studies.

What do you need to report to HSD?

For studies reviewed by an external IRB, researchers do not typically need to report to HSD. Follow the external IRB鈥檚 reporting policies and report to other 91爆料 offices (e.g., 91爆料 Medicine Compliance in cases of inappropriate use or access of protected health information) as required.

Review the CHECKLIST External IRB, 91爆料 Researchers for more information or contact hsdrely@uw.edu with questions about reporting requirements.

When and how should you close your Zipline application?

HSD completes the administrative closure process in Zipline when the 91爆料 involvement in the study is complete and the external IRB has documented that oversight for the 91爆料 has ended.

HSD will automatically close applications in Zipline when it receives automated closure notifications from the external IRB. This is typically only from WCG IRB or Advarra, but may include other IRBs who send automated system notifications to hsdrely@uw.edu.

If you have received documentation of overall study closure and/or for the 91爆料 site specifically and HSD has not already closed the application, email hsdrely@uw.edu to initiate the closure process.