91爆料

The 91爆料 does not typically rely on exempt determinations made by other institutions, nor does it usually allow other institutions to formally rely on 91爆料鈥檚 exempt determinations. Reliance for exempt research may be permitted only in very limited circumstances, as determined by HSD leadership.

If your research is exempt:

• Go to Apply for Review 鈥� 91爆料 Reviewing for 91爆料 Only ^[16]

Resources:

• Is Your Human Subjects Research Exempt from Regulations? ^[17]
• Contact hsdrely@uw.edu ^[18] with questions

In Zipline, selecting 鈥淢耻濒迟颈-蝉颈迟别/肠辞濒濒补产辞谤补迟颈惫别鈥� means that one or more non-91爆料 institutions are actively involved in conducting the research with human subjects.

This is not about where 91爆料 researchers travel or recruit participants. It only applies when non-91爆料 investigators or study teams are performing research activities such as obtaining consent, conducting study procedures, or collecting identifiable data.

Examples:

• 91爆料-only study: A 91爆料 researcher recruits participants at Seattle Pacific University, but only 91爆料 personnel obtain consent and conduct study activities. No SPU staff are involved in the research. This is a single-site (91爆料-only) study.
• Multi-site/collaborative study: 91爆料 researchers collaborate with investigators at UCLA and Johns Hopkins. Each institution has its own study team conducting research activities under a shared protocol. This is a multi-site/collaborative study.

For more help deciding, review our Engagement Guidance ^[19] or contact hsdrely@uw.edu ^[18].

91爆料 IRB review of multi-institutional research is not guaranteed unless HSD has been consulted in advance, or the collaboration is covered by an established cooperative agreement (for example, with Fred Hutch or Seattle Children鈥檚).

Before selecting this review path, consult HSD鈥檚 Reliance Team at hsdrely@uw.edu ^[18] to determine whether 91爆料 IRB review is appropriate for a collaborating institution.

For more information:

• 91爆料 IRB as a Single IRB ^[20]

91爆料 study team members who need access to the Zipline application must complete a one-time self-registration process in Zipline before they can be added to the application. Each person must be added to the application before they are able to access it.

Individuals from non-91爆料 institutions cannot access Zipline.

A 91爆料 NetID is required to register. For more information:

• Account Creation and Management ^[23]

All applications must include an IRB Protocol Form. Use the most recent version available on the HSD website or in Zipline and upload the form in Microsoft Word format. ^[24].

Two versions of the form are available:

• IRB Protocol Form ^[25]: Standard form for most studies.
• IRB Protocol Form, No Contact ^[26]: A shortened form for studies that involve no interaction with subjects in any format (for example, in person, email, or online).

Tips for multi-site and collaborative studies

• Indicate in Section 1.9 that 91爆料 IRB review is being requested on behalf of non-91爆料 individuals or institutions.
• Describe the overall study and research activities across all participating institutions.
• Where possible, describe the range of procedures across sites in the STUDY application.

For more guidance, go to Preparing and Submitting the sIRB Application ^[27].

We recommend preparing all other required study documents before creating your application in Zipline. Whenever possible, upload documents in Microsoft Word format.

Required Supplements

Your application must include one or both of the following supplements, as applicable:

• SUPPLEMENT Multi-site or Collaborative Research ^[28]:聽 Required for studies involving other institutions, including those with standing reliance agreements with 91爆料 (for example, Fred Hutch and Seattle Children鈥檚).
• SUPPLEMENT Non-91爆料 Individual Investigators ^[29]: Required for investigators who are unaffiliated with an institution, or who are affiliated with an institution that does not have a Federalwide Assurance (FWA).

Planning Consent Materials for Multi-site and Collaborative Studies

For multi-institutional research, consent materials are typically developed using a study-wide template created by the overall study team, which sites then adapt to local requirements. HSD does not create this template. You may need to coordinate with investigators at other institutions to develop it.

When submitting the STUDY application in Zipline, you will need:

• Template consent, assent, and parental permission forms (for multi-site studies where sites will create site specific versions based on a shared template)
• 91爆料 specific consent, assent, and parental permission forms

For more information, go to Designing the Consent Process: Considerations for Multi-institutional Research ^[30].

Other Required Documents

You may also need to prepare other required study documents and 91爆料 site specific documents, as applicable. A full list is included in the table under Step 4.

Keep documents specific to non-91爆料 sites for later. These materials will be submitted as part of the SITE application process.

Once your documents are ready, login to Zipline to create a new study record, complete the SmartForm application, and upload the study documents.

To create a new study record, select Create New Study from the menu:

General Tips

• Use the help bubbles throughout Zipline for additional context if you鈥檙e unsure how to answer a question.
  

  

• Navigate through the application sequentially by selecting Continue at the bottom of each page.
  

  

• Jump between pages using the left鈥慼and navigation menu when you need to review or update specific sections.
  

  

• Save your progress and return later by selecting Save and Edit Study if you need to complete the application in multiple sessions.
  

  

SmartForm Instructions for 91爆料 Reviewing for Other Institutions

The Manage Ancillary Review activity is used to obtain and document faculty advisor review when a student or medical resident is the principal investigator (PI) for the IRB application. Do not add the faculty advisor to the study team on the Zipline application before the faculty advisor has submitted the faculty advisor review. The system will not allow a member of the study team to submit an ancillary review for the study.

The faculty advisor review may occur concurrently with HSD or IRB review of an application. However, final IRB approval will not be issued until the required faculty advisor review is completed.

Your faculty advisor will receive an email notification when the application is submitted to HSD. For more information:

• FAQ: What are the additional requirements for student and medical resident researchers? ^[32]
• Add Faculty Advisor Review steps ^[33]

Checking the application for errors and omissions helps you to include all the relevant information, which is essential for receiving a timely review of your study. Automatic system error checking identifies any omitted answers to questions that are required for every application. A red asterisk (*) indicates required questions.

HSD also recommends looking over the forms to see what you may have missed, especially:

• Questions that are relevant to your study but are not required for all studies (no asterisks)
• Documents that should be attached

The Submit activity must be completed once the application is ready to go to HSD. This activity:

• Must be completed by the PI or the PI Proxy ^[34]
• Changes the application state from Pre-Submission to Pre-Review
• Sends the item to HSD for review
• Removes the study team鈥檚 ability to make edits while the study is in review unless HSD requests more information or a change to the study