COVID-19 and Human Subjects Research
As part of an initiative by HSD to simplify COVID-related issues, the HSD Checklist for Human Subjects Research During the COVID-19 Pandemic has been eliminated. Though we hoped it would be a useful tool for researchers, it was ultimately found to be a significant source of confusion.
For international research locations where a local IRB has provided review: The research may proceed if it is allowed by the local IRB. If a local IRB has not provided review, contact firstname.lastname@example.org.
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: For domestic research locations (i.e., a U.S. location), only research allowed by HSD may resume or begin.
Non-UW institutions being reviewed by the UW IRB
These sites should follow the policies and requirements of their own institution. This means that the research may be allowed at some locations but not at others.
All ongoing or new exempt research must meet the same criteria.
Effect on new and pending IRB applications
New applications are still being accepted and reviewed. However, newly-approved research must also meet the COVID-related criteria in order to begin.
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 other allowed activities.
- All other new applications and modifications.
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.
Submit the requests via the form on the ITHS portal page. The requirement to go through the ITHS portal does not apply to research involving non-UW Medicine patients.
UW Medicine clinical specimens and residual clinical specimens. These can be obtained only through NorthWest Biospecimen. Contact Sarah Bowell email@example.com. 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 firstname.lastname@example.org if your COVID-19 research will involve other institutions. We can advise you about whether an IRB should review your research, whether the other institutions also need IRB review and (if yes) which IRB should provide review for those institutions.
Other Specific Issues
- Are HSD and the IRBs operating as usual? (updated 8.12.2020)
- How do I submit my paper-based materials? (updated 3.9.2020)
- Video Conferencing and Privacy Considerations (updated 09.08.2020)
- 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…