Policy Changes and Clarifications Affecting Researchers and/or Zipline

• The IRB must approve this use; the Documents section below includes relevant changes to the IRB Protocol, Guidance and SOP documents, and Letter Templates

External IRB Submissions

• Allow the use of PI Proxies on External IRB submissions
• Allow Updates to External IRB submissions through the Zipline workflow, rather than logging changes as a comment

Financial Conflict of Interest

• HSD no longer receives Financial Conflict of Interest (FCOI) management plan letters from the Office of Research. Investigators have sole responsibility for providing the management plan to HSD and the IRB.

Non-UW Research Locations

• Require information about non-UW research locations and local context for all research; previously only required for IRB reviewed research
• Require confirmation of registration with UW Global Affairs for students conducting research in some international locations

System Release Highlights

• Upgrade IRB from version 7.7.1 to version 7.8.2. Changes include:
  • Allowing PI Proxies for External submissions
  • Adding a new Update Study activity for External submissions; functions similar to Modifications on Internal studies and can be used to notify HSD of a change in PI or reviewing IRB, or that the study is closed with the reviewing IRB.
  • Add a new required question on Continuing Reviews when the first four milestones are checked – when these milestones are checked, confirmation that the study will be closed must be included in order to submit the Continuing Review.
• Upgrade Global Common from version 7.4.1 to version 7.5.1. Changes include updating the Modification submission type to Modification/Update.
• Upgrade Portal from version 6.2.6 to version 6.2.8. Changes include fixing some issues with copying submissions and printing SmartForms.

Revise questions throughout the SmartForms. Revisions include:

• The addition of a required sub-question that appears when question 5 (“Is the Principal Investigator for this study a student, resident, fellow, or post doc?”) is answered affirmatively: Select the role under which the Principal Investigator will conduct the research: with options for undergraduate student, graduate student, resident, fellow, and post-doc.
• Revise the question from “Will an external IRB act as the IRB of record for this study?” to “Are you requesting authorization for an external IRB to review the study instead of the UW IRB?” to clarify the intent of the question.
• On the Add Funding SmartForm, all questions about funding other than the attachment are now required, and additional text was included to clarify that the Grants Office ID question is referring to the eGC1 number.
• Clarify that question 5 on the Additional Study Scope SmartForm (“Will you bill subjects, their health insurance, or the study sponsor for UW Medicine professional or facility services, items, or tests?”) is only about UW Medicine facilities, and remove the statement about ClinicalTrials.gov registration.
• Revise question 7 on the Additional Study Scope SmartForm from “Does this research involve any of the following: Check all that apply” to “Does this research involve exposing subjects to radiation through any of the following? Check all that apply.” to clarify the intent of the question.

Hide the External IRB Continued SmartForm

• The information gathered on this page will instead be gathered through the REQUEST: External IRB Review form.

Notification text updates, including:

• The Continuing Review Reminder now instructs investigators to submit the Continuing Review at least 4 weeks before the expiration date, rather than the previously stated 3 week to allow additional time for screening of submissions that will be reviewed by the convened IRB.
• External Submissions will now receive an annual reminder to submit an Update when the PI or reviewing IRB changes, or when the study is closed with the reviewing IRB.
• Notifications sent when a submission is determined to be not research or not human subjects, or when the UW is not engaged, no longer indicate a formal letter will be sent by email. Instead, investigators should check the study workspace for a copy of the letter.

Visual change to the Create Modification/CR button

• The button for the Create Modification/CR activity was revised to look like two separate buttons: one that says Create Modification, and another that says Renew or Close. Selecting either still takes the investigator to the same Modification/CR SmartForm the single button did.

Remove the Manage Study Team Activity from the Modification workspace

• Using the activity in workspace of a follow-on submission led to unexpected behavior: The added study team members could not access the study until after the follow-on was approved, and removing study team members did not remove them from the list of members in the follow-on submission. Now the Manage Study Team Activity will only be available in the Study workspace to avoid this behavior.

Add information to Workspaces

• The risk level and last day of approval for the Study was added to the workspaces for Modifications and Continuing Reviews. The risk level for the Study was added to the workspace of the approved (or otherwise review complete) Study.

Help Text enhancements

• Updates to help text throughout the SmartForms. Revisions include:
  • SmartForm: Add Funding Source, “Funding Organization”
    • Clarify that pass through funds should show the originating funding organization rather than the institution through which the funding is passing through
  • SmartForm: Study Scope, “Is this study intended…(FDA)”
    • Add instruction to select yes if FDA regulated even if there is no intention to submit data to the FDA
  • SmartForm: Reportable New Information
    • Add statement that modifications should not be reported as RNI and link to the HSD website about what does need to be reported

Updated Documents Highlights

Note: released to Zipline and website the evening of 08.24.2018
Changes have been made to enhance the following Zipline templates/forms/instructions. For instructions navigate to the Zipline Online Help Library and click on Help for Researchers.

• Add researcher date and version section to the footer
• Add instruction to only use the form for studies reviewed by the UW IRB
• Make section 3 on non-UW research locations required for all submissions
• Add a question to section 3 for students traveling outside the US for their research
• Add new questions about MRIs and gadolinium based contrast agents in section 5 (Procedures) and 10 (Risks)
• Update question 5.7 to allow for review of research with newborn dried bloodspots under two versions of the applicable regulation
• Add new questions about DocuSign and other forms of electronic consent to section 7 (Assent) and 8 (Consent)
• Revise question 10.5 with additional instruction for research involving anesthesia
• Revise question 10.10 to clarify when individual subjects results should be returned and when the SUPPLEMENT: Participant Results Sharing should be submitted
• Revise question 13.3 pertaining to Significant Financial Interest and Financial Interest
• Update UW Medicine Compliance links
• Fix other minor typos and formatting

• Add researcher date and version section to the footer
• Add instruction to only use the form for studies review by the UW IRB
• Make section 3 on non-UW research locations required for all submissions
• Add a question to section 3 for students traveling outside the US for their research
• Update question 5.8 to allow for review of research with newborn dried bloodspots under two versions of the applicable regulation
• Revise question 8.3 to clarify when the SUPPLEMENT: Participant Results Sharing should be submitted
• Revise question 10.2 pertaining to Significant Financial Interest and Financial Interest
• Update UW Medicine Compliance links
• Fix other minor typos and formatting

• Revise and re-order questions for clarity and to obtain information necessary for confirming reliance
• Add a question about data and safety monitoring activities that will occur
• Update names of some External IRBs

• Include information about contacting HSD prior to NIH funding expiration to obtain help from HSD in determining if an extension or consent revisions are needed. Note this revision was implemented 07.19.2018

• Add a note regarding researchers who will collect data beyond expiration of NIH funding. Note this revision was implemented 07.19.2018

• NEW A guidance document about all aspects of electronic consent. Based on the December 2016 joint guidance issued by FDA and OHRP. Note this document will be used with Zipline submissions, but it is not exclusive to Zipline.

• Remove statement that PI Proxies aren’t allowed for External IRB Studies

• Update instructions about Modification/CR button
• Include information about the need to confirm closure when the first four milestones are selected
• Add that radiation safety renewal should be attached to the continuing review, when applicable

• Add links to REQUEST: External IRB form
• Add information about using PI Proxies

• Add links to ZIPLINE APPLICATION: IRB Protocol
• Emphasize the need to submit the application

• Update to reflect changes to the Modification/CR button
• Update to reflect revised purpose of Modification/Update (previously only listed Modification)

• Update screenshots
• Add information that activity is only available in the parent study

• Add additional detail about linking related modifications

• Add note that advisor cannot be listed as a member of the study team

• Retire due to activity no longer being available

• NEW

• NEW

• Add a statement about renewing Certificate of Confidentiality when NIH funding expires as applicable
• Add a statement about approval to use DocuSign to Initial and Modification approval templates
• Update External IRB templates to allow for sending through Zipline
• Clarify the process for submitting responses in Modifications Required templates
• Remove references to “research” and “subjects” from Not Research and Not Human Subjects templates

• Add information about Study Updates
• Add previously missing states
• Add information about risk level and last day of approval being visible in workspaces

• Add a sentence about using electronic systems or processes to obtain consent, with reference to the Guidance document and the review Worksheet

• Add some information about using electronic systems, specially calling out the FDA requirements and DocuSign. References the Guidance document and review Worksheet

• Add information about e-consent requirements for FDA-regulated research, including references and links to the FDA Guidance, Part 11, the HSD Guidance, and the review Worksheet

• Add researcher date and version section to the footer
• Add statement that can be used for international studies with a Certificate of Confidentiality
• Update section about Social Security Numbers

• Add information about sending letters
• Add information about using PI Proxies

• Update to reflect revised Modification/CR button
• Add information about the need to confirm closure when the first four milestones are checked

• Update to reflect revised Modification/CR button

• Adjust audio about Modification/CR button

• Change wording to show the PI or a PI Proxy must submit the application

• Adjust audio about Modification/CR button
• Adjust audio about the need to confirm closure when the first four milestones are checked

• Add a question about status of NIH funding

• Add a definition of controlled substance to question 3

• Add a section for a description of the device
• Add request for confirmation that device will be disinfected between subjects, if applicable
• Add a question about safety testing
• Move question about FDA status to later in the form, and emphasize that it applies only to FDA regulated device studies

Policy Changes and Clarifications Affecting Researchers and/or Zipline

• Previously, studies relying on an external IRB did not need to create a record in Zipline, unless they were to be reviewed by WIRB or the Cancer Consortium IRB at the Hutch. Beginning January 12, 2018, all studies that wish to rely on an external IRB must submit a request through Zipline, regardless of the external IRB to be used or the reason for using an external IRB.
• IRBs with which HSD has a cooperative agreement (e.g., Seattle Children’s) will request a copy of the Acknowledgement of Ceding IRB Review Letter provided through Zipline before they will approve a study involving UW investigators. This change will take place over the next two months.
• Questions should be directed to the HSD Reliance Team at hsdrely@uw.edu

System Release Highlights

• Study Scope question 1: Are there any non-UW institutions, organizations, or individuals who will:
  • Obtain consent
  • Conduct non-recruitment research procedures through interaction with subjects
  • Collect identifiable data or specimens specifically for this research
  • Analyze identifiable data or specimens specifically for this research
• Study Scope question 2: Will any part of the study be conducted internationally? (Note: this question was previously on the External Sites SmartForm, and has been relocated to the Study Scope SmartForm. Studies for which an answer was already provided will not need to answer this again.)
• Drugs SmartForm and Devices SmartForm: Investigators will be asked to answer some new simple questions about drugs and devices in order to facilitate the IRB’s review of studies involving these items.
• Additional Study Scope question 2: Will your research require access to, or obtain identifiable information from, any medical records maintained in the State of Washington, without first obtaining the consent of the subjects? This will allow HSD to ensure applicable state laws are considered.
• Additional Study Scope question 3: Will you deliberately recruit subjects from any of the following patient populations? Options include UW Medicine facilities, Seattle Children’s, Northwest Kidney Centers, and other local sites with which UW investigators often collaborate.
• Additional Study Scope question 7: Does this research involve any of the following? (radiation)
• Additional Study Scope question 8: When do you estimate you will start enrolling subjects in your research? (Note: approved studies should select “Other” for this question.)

Some of these new questions will need to be answered before responses can be submitted for studies already under review, and when submitting modifications for studies approved before 6PM January 12, 2018. Additional required questions may appear when creating modifications for studies approved before prior Zipline changes.

• The text “To change the lead investigator (PI), select Other parts of the study, and describe the reason for this change in the summary box on the next page” now appears next to the Modification Scope question on the Modification/Continuing Review/Study Closure SmartForm.
• When the PI is changed in question 6 on the Basic Information SmartForm, the existing answers to questions 5 (Is the Principal Investigator for this study a student, resident, fellow, or post-doc?) and 7 (Do any study investigators have a Financial Conflict Interest related to this research?) will be removed. The questions will need to be answered again to ensure the answers are accurate given the change in study oversight.

• Question 1 on the Study Scope page is now clear about the criteria for answering “yes” to this question.
• When answering yes, investigators will now only need to list the sites that wish to rely on UW for IRB review, rather than being required to list all non-UW sites.

• Questions 7 and 8 are being combined to ask a single question about activities which require review from the UW Institutional Biosafety Committee (IBC).
• The combined question asks “Does this research involve giving the subject any of the following?” The revised wording is intended to help clarify when the options should be selected. For example, the option “Any infectious agent or bloodborne pathogen” should only be selected if you will actually give subjects infectious agents or bloodborne pathogens; it should not be selected if the only involvement is drawing blood from subjects with certain infectious diseases.

• Investigators will no longer be asked to indicate in the SmartForms if the study is requesting the Exception from Informed Consent (EFIC) waiver. This information is available through other information provided about the study.
• Investigators will no longer be asked in the SmartForms if they are planning to submit genomic data to an NIH-designated database. This information is gathered in the IRB Protocol and Genomic Data Sharing Supplement.
• Investigators will no longer be asked if the study will use the Clinical Research Center (CRC).

• The Basic Information SmartForm includes new text to help investigators understand when they should select yes to question 8 indicating an external IRB will act as the IRB of record for the study.
• The Consent SmartForm and Supporting Documents SmartForm include new text to help investigators understand what attachments are needed, including the draft consent form for studies that will be reviewed by an external IRB.

• Question 1 on the Basic Information page (Is this a conversion study?) can no longer be changed when a modification is being submitted. This answer should remain the same for the life of the study, regardless of other changes that are made.

• The RNI SmartForm is revised so that investigators no longer need to identify the categories that represent the new information.
• When completing a modification, investigators are reminded to notify HSD when the modification is submitted if the modification is related to an RNI.

• A new email notification has been added to remind investigators to submit their response to a Deferral.
• The Continuing Review reminders will now only be sent at 30 and 60 days before expiration, rather than 30, 60, and 90 days before expiration.

Updated Documents Highlights

Note: released to Zipline and website on 1.12.2018
Changes have been made to enhance the following Zipline templates/forms/instructions. For instructions navigate to the Zipline Online Help Library and click on Help for Researchers.

• Minor revisions to clarify the intent of various questions
• Updated links
• Revise questions 1.9 and 5.8 to clarify when information about genomic data sharing is needed
• Separate the questions about inclusion and exclusion criteria in section 2
• Clarify that section 3 does not need to be completed if all research activities will occur within UW and Harborview
• Revise section 4 to help elicit information specific to recruitment and screening procedures, rather than activities that occur after consent is obtained for full enrollment
• NEW question 5.9 asking if the research includes whole genome sequencing
• Revised instruction in question 9.5 to explain how to answer when NIH funded
• Revised 9.6 to specify that any protections within the chosen data security level that will not be followed must be listed

• Minor revisions to clarify the intent of various questions
• Updated links
• Revise questions 1.9 and 5.10 to clarify when information about genomic data sharing is needed
• Separate the questions about inclusion and exclusion criteria in section 2
• Clarify that section 3 does not need to be completed if all research activities will occur within UW and Harborview
• NEW question 5.11 asking if the research includes whole genome sequencing
• Revised instruction in question 7.4 to explain how to answer when NIH funded
• Revised 7.5 to specify that any protections within the chosen data security level that will not be followed must be listed

• The Financial Interest  section of the Consent form was significantly simplified

Due to significant changes and enhancements to the process by which HSD authorizes studies for review by an external IRB, most documents related to the external IRB authorization process have been retired or considerably revised.

Summary of enhanced process:

UW investigators must complete the form titled REQUEST: External IRB Review and follow the Zipline instructions on the HSD website to Ask for Non UW IRB review. HSD will assess whether the study qualifies for external review, confirm or establish needed reliance agreements with the reviewing IRB, and issue an acknowledgement letter documenting permission to use the external IRB. Researchers should include this letter in their submission to the reviewing IRB.  HSD’s Online Tutorial for Requesting Review from a Non-UW IRB in Zipline provides details about the forms and processes.

UW research involving cooperative partners such as Seattle Children’s, Hutch, Benaroya, and Kaiser/Group Health:

Cooperative partners will not approve UW research without an acknowledgement letter from HSD. This is a new process, which will support better coordination.

Research reviewed by a single IRB or other institution (not a UW cooperative partner):

The new forms and Zipline process replace a largely ad-hoc, email-based process.

WIRB and Cancer Consortium Studies:

The new forms replace previous WIRB and Cancer Consortium specific documents and processes. However HSD will continue to accept old versions of Authorization Request forms for a short period after January 12^th.

The information in these documents has been redistributed across the new documents in column 1, the HSD website, and materials that will be provided in Zipline for each study as part of the authorization process. Instructions for researchers on how to submit a request for non-UW IRB review are now on the Ask for non-UW IRB page on the HSD website.

• External IRB Checklist for UW Researchers
• UW Guide to Consent Elements for Externally Reviewed Studies

• ZIPLINE REVIEW AUTHORIZATION: External IRB revised to add new questions and instruction and renamed REQUEST: External IRB Review

• INSTRUCTIONS: Submitting to the CC-IRB
• INSTRUCTIONS: Submitting to WIRB
• ZIPLINE SOP External IRB (CC-IRB) Review – Researcher Procedures
• ZIPLINE SOP External IRB (WIRB) Review – Researcher Procedures
• ZIPLINE WIRB FAQ: REMOVED
• ZIPLINE WORKSHEET: External IRB (CC-IRB) Eligibility
• ZIPLINE WORKSHEET: External IRB (WIRB) Eligibility
• REQUEST TRANSFER: UW/CC-IRB
• WORKSHEET: Appropriate IRB, UW Affiliated

• Reorganized, and added information about linking modifications and RNI.

• Clarify that only the short title changes automatically when copying; the long title needs to be changed manually.

• Clarify the uses of the supplement.
• Include a question asking if UW will certify the information for submission to an NIH database.
• Revise the question about funding for clarity.

• Update instructions to include external studies.
• Update instructions to clarify who should be listed.

• All: Formatting and changes to improve clarity of information.
• Letters from the Full IRB requiring response: revised instructions as to how to prepare the response.
• Initial approval, Exempt, Not Human Subjects, and Not Research letters: include a reminder that other approvals or permissions may need to be obtained.

• Clarify the HSAP section about subject injury compensation.

Policy Changes and Clarifications Affecting Researchers and/or Zipline

System Release Highlights

• “Is this study intended to develop information about a drug, device, or biologic through its prospective use and assignment to subjects, which will then be submitted by you or someone else to the Food and Drug Administration (FDA)?”

This will allow HSD to more easily locate studies that are FDA regulated.

Updated Documents

Note: released to Zipline and website on 6.23.2017

• Removed the question asking about submitting to the FDA. (This question has been added to the Study Scope smart form)
• Typo fixes
• Fixed a link error in question 8

• Typo fixes

• Fixed broken link

• Removed reference to submitting a PAPER SUPPLEMENT: Waiver Request