COVID-19 and Human Subjects Research
Effective May 22, some temporarily-halted human subjects research may now resume, or begin. See this page for a description of the research that is now allowed.
All active human subjects research (ongoing or that will be resumed) must meet the requirements described in the HSD Checklist for Human Subjects Research During the COVID-19 Pandemic.
Mandatory Pause Considerations
Checklist with mandatory requirements
The CHECKLIST for Human Subjects Research During the COVID-19 Pandemic describes the mandatory requirements for conducting human subjects research as well as for UW research in general. This includes recent new items such as the requirement for a COVID Supervisor at any campus location where study staff will return to work. The Checklist was created as a tool to help researchers keep track of rapidly evolving information. HSD will update it in near-real-time as new or revised HSD or campus-wide requirements are implemented. It is not intended to be a part of IRB applications, so please do not submit it with IRB applications.
This Checklist applies to all ongoing as well as all new or resuming human subjects research.
The halt continues to apply to UW-conducted research in all settings (including international locations), unless the study meets the criteria for continuing. Note that some locations and facilities may have their own restrictions and requirements. Research that is allowable in Washington State may not be appropriate in other locations. UW researchers should consider the local public health and pandemic context as well as local requirements. If local requirements are more relaxed than UW requirements, the UW requirements about what is allowable should nonetheless be followed.
UW Medicine clinical facilities and settings. Researchers should review communications from UW Medicine and School of Medicine leadership for information about resuming research in clinical facilities and settings, and/or check with specific clinic managers.
Research reviewed by a non-UW IRB
When the external IRB is a local non-commercial IRB (e.g., Fred Hutch, Seattle Children’s): Follow the requirements and policies of that IRB as to which research can resume and under what conditions.
For all other external IRBs: Only research allowed by HSD may resume or begin. Follow the requirements of the UW Human Subjects Division in addition to any requirements of the external IRB.
Non-UW sites being reviewed by the UW IRB
These sites should follow the policies and requirements of their own institution. Example scenarios:
- UW IRB is acting as the Single IRB for a UW-led multi-site clinical trial
- UW IRB is reviewing the non-UW sites that are collaborating with the UW (main) site
All ongoing or new exempt research is also required to pause, unless it meets the criteria for continuing.
Effect on new and pending IRB applications
New applications are still being accepted and reviewed. However, newly-approved research is subject to the temporary pause unless they meet one or more of the criteria for continuing.
Priorities. New applications and modifications will be prioritized as follows:
- All new applications and modifications that involve COVID-19 or SARS-CoV-2, or their impact on ongoing research.
- All new applications and modifications for activities that are allowable under the temporary halt.
- All other new applications and modifications. These reviews may be somewhat delayed, depending on workload and staffing.
Information for UW Researchers Planning COVID-19 Research
Portal for UW COVID-19 and SARS-CoV-2 Research
In this time of unprecedented research need, the Institute of Translational Health Sciences (ITHS) at the University of Washington is coordinating researchers who are requesting COVID-19 biospecimens, medical records information and/or proposing clinical research with UW Medicine patients with or at risk for COVID-19, or convalescing or recovered from COVID-19.
To manage the volume of requests, all interested parties must submit requests via the form on the ITHS portal page. Only official requests submitted through this form will be considered. The requirement to go through the ITHS portal does not apply to research involving non-UW Medicine patients.
HSD will coordinate IRB reviews, external IRB authorizations, and determinations with this mandatory ITHS review. This applies to all new Zipline applications intentionally involving interactions with UW Medicine COVID-19 patients, their biospecimens, and/or their medical records information, as well as modifications to non-COVID-related studies that will involve such interactions. This is regardless of:
- Current COVID-19 status (positive, presumptive positive, exposed and self-isolated, convalescing, or recovered)
- Location (hospitalized, outpatients at clinics, home)
- Identifiability of the specimens or medical records information
- Which IRB will conduct the review (UW or an External IRB or any Single IRB)
Researchers may submit their Zipline application and their ITHS Review Work Group application at the same time, or in any order they wish. The ITHS Review Work Group will provide the researcher with an Approval Letter, which should be uploaded to the Other Attachments section of the Zipline application. HSD and the IRB will begin review of the Zipline application as usual, with or without the Approval Letter. However, final IRB approval, exempt status, or authorization to use an External IRB will not be granted until the ITHS Review Work Group Approval Letter has been received.
UW Medicine clinical specimens and residual clinical specimens. These can be obtained only through NorthWest Biospecimen. Contact Sarah Bowell firstname.lastname@example.org. Note it is likely that not all researchers will be able to obtain these specimens, and NorthWest Biospecimen is not robustly staffed. Do not contact clinicians directly, as hospital regulations (driven by accreditation compliance requirements) are not authorized to provide specimens to researchers.
Specimens obtained for research purposes. This includes specimens that may be obtained by “piggybacking” onto collection done for clinical purposes. You must have prospective IRB approval before collecting the specimens, even if they will be de-identified or anonymized. Obtaining specimens from UW Medicine patients while they are in clinics or hospitals requires advance approval through the ITHS Research Portal.
Returning results to participants
Results cannot be returned to individual research participants if the information is about the diagnosis, prevention, or treatment of any disease unless the laboratory is certified by the Washington State Department of Health or by the federal CLIA program. This is not an IRB policy; it is due to the federal CLIA regulations and Washington State law.
This means that COVID-19 test results cannot shared with participants unless the testing is done by a certified lab.
Collaborations with other institutions
Contact HSD at email@example.com if your COVID-19 research will involve other institutions. We can advise you which IRB should review your research, whether the other institutions also need IRB review and (if yes) which IRB should provide review for those institutions. Additional information is available at:
Other Specific Issues
- Are HSD and the IRBs operating as usual? (updated 3.25.2020)
- How do I submit my paper-based materials? (updated 3.9.2020)
- Video Conferencing and Privacy Considerations (added 06.25.2020)
- What about in-person monitoring of patient safety? (updated 3.12.2020)
- What are the considerations with respect to study monitoring and/or…
- What changes require a Modification or a Report of New…
- When participants cannot come to study locations for continuing studies…