June 29, 2020
For the Record – June 29, 2020
In this Issue:
- Expanding Allowed Research
- Restarting Research Involving UW Medicine Inpatients
- COVID-Related Resources
- Minor Changes to Zipline e-IRB System
- Zoom and Minors
- NIH Grant Applications and Single IRB
- Forms and Document Changes
- Reminder: Old Paper-Based IRB Applications
- Research Supported by the Office of Naval Research
Expanding Allowed Research
HSD knows that many study teams are eager to resume or begin research that has been halted because of COVID-19. We are actively working on identifying which additional types of studies can resume, and when, with input from public health and infectious disease experts. We hope to announce the next phase of human subjects research expansion before July 15th.
In the meantime, we strongly encourage study teams to complete the items on the CHECKLIST for Human Subjects Research during the COVID-19 Pandemic, so that they will be ready to start the research as soon as it is allowed.
Restarting Research Involving UW Medicine Inpatients
Effective June 18, 2020
Those wishing to restart allowed human subjects research, including clinical trials, within UWMC-Montlake or HMC inpatient and ED sites under current COVID conditions and restrictions must complete the brief RedCap form at https://redcap.iths.org/surveys/?s=WEYEH8FYLR.
The form includes a series of check boxes that score impact on the unit in which the research is to take place. If the impact is minimal on both nursing services and PPE, the researcher will receive an immediate reply by email that gives permission for the research to resume. If there is more than minimal impact, Hyacinth Lee (UWMC-ML) or Pat Klotz (HMC) will work with researchers to develop a plan to mitigate the impact so that the research can resume.
Research at UWMC-NW and Valley Medical Center can resume by following the respective process for initiating new research at the site.
UW’s Environmental Health & Safety has many resources useful to UW researchers, including specific recommendations and guidance about:
- Cleaning and Disinfection for Prevention
- Guidance on Facemask Use for Preventing the Spread of COVID-19
- UW Guidance for Symptom Monitoring for COVID-19
Minor Changes to Zipline e-IRB System
The Zipline e-IRB system was revised the evening of June 25th. Most of the changes are visible only to HSD staff. However, researchers will notice a few refinements.
- A new Help Text bubble has been added to assist in selecting the correct Modification Scope.
- Minor revisions were made to the approval letters to make more prominent the IRB’s approval of DocuSign for electronic documentation of consent.
- Small changes were made to the Funding SmartForm and Local Study Team Members SmartForm, but no new questions have been added.
List of all changes. The Release Notes describing all changes to Zipline have been posted at the bottom of the Zipline home webpage.
Zoom and Minors
Certain UW technology accounts (e.g., Zoom, Canvas and Panopto) cannot be used with youth under the age of 13, in any capacity. University recommendations for safe virtual use of technology with minors can be found here. For technology questions please contact UW IT. For questions about safe youth engagement in a virtual setting, you can consult with the Office for Youth Programs Development and Support.
NIH Grant Applications and Single IRB
NIH revised the Forms F General Instructions for NIH and Other PHS Agencies effective March 24, 2020. Though the Single IRB policy continues to apply to multi-institutional human subjects research, NIH no longer wants PIs to submit a Single IRB plan attachment as part of NIH SF424 (R&R) grant applications (unless explicitly requested in the funding announcement). However, applications to AHRQ that use the Forms F are still expected to include a Single IRB plan attachment. Some NIH resources, such as the NIH Single IRB website, will still describe the Single IRB Plan as a requirement until NIH can revise the materials. However, HSD has confirmed with NIH that a Plan is no longer required.
Forms and Document Changes
Implemented June 26, 2020
Many forms used by researchers have changed.
Form content. New questions have been added to the two forms listed here. Other forms have minor revisions to existing questions and/or help text. It is important to always use the current version of a form, as posted on HSD’s website.
- IRB Protocol form. Four COVID-related questions have been added: Questions 1.10, 2.8, 5.15, and 5.16. All applications must now include answers to these questions.
- Request External IRB Review form. New questions have been added; others have been significantly revised. These will improve HSD’s ability to efficiently review and authorize the request to use a non-UW IRB.
Form titles. The word “Zipline” has been removed from the name of all forms whose name contained that word. This means that bookmarks to the forms may need to be re-established.
Documents. Most SOPs and WORKSHEETs that address the basic aspects of IRB review have been re-organized, consolidated, and re-formatted. The policies and procedures themselves have not changed except for the SOP Appeal of IRB or HSD Determination.
Reminder: Old Paper-Based IRB Applications
By June 1, 2021, all remaining active paper-based IRB applications must be closed OR converted into a Zipline application. This applies to all remaining active studies that were approved prior to the 2016 implementation of the Zipline and that have not yet converted their IRB application into a Zipline application. This is because the database that supports these uses a 20-year-old software program that is prone to problems and that cannot be updated.
IRB approval will be terminated for all remaining, unconverted, paper-based applications on June 1, 2021. Contact Dolly Morse (firstname.lastname@example.org; 206.616.8042) to find out more about the conversion process and timeline. Also, see the Conversion webpage.
Research Supported by the Office of Naval Research
Effective June 30, 2020
The federal Office of Naval Research (ONR) is part of the Department of Navy (DON). It funds a variety of human subjects research, including some at the UW.
Researchers funded by ONR or DON are required to complete a DON-specific training module. They are encouraged to complete a refresher course every three years. Until now, this was accomplished at almost all institutions by completing the DON-specific online module in the national CITI Human Subjects Training Program.
The federal Office of Naval Research (ONR) has ended its contract with the online CITI Human Subjects Training Program that allowed extramural researchers to obtain DON-specific training through CITI.
HSD is working on finding an acceptable alternative. Until then, please contact email@example.com if you need to take DON-specific human subjects training.