August 12, 2020
For the Record – August 12, 2020
In this Issue:
- Identification of Allowed Human Subjects Research
- Expectations for All Research Involving In-Person Interactions
- All Research MRI Facilities Are Now Open
- Elimination of HSD Checklist for Human Subjects Research During the COVID-19 Pandemic
Identification of Allowed Human Subjects Research
Effective August 12, 2020
The Human Subjects Division (HSD) is now identifying the research that can occur during the pandemic by drawing upon improved knowledge about how to effectively manage the risk of COVID-19 infection and severe disease. The HSD webpage describing allowed research has been revised to incorporate these changes.
Summary of the changes
- No already-active research is being halted. Already-started research that met the July 13, 2020 criteria for being conducted during the COVID-19 pandemic continues to be allowed.
- Revised criteria for allowed research. All other research should be assessed against the revised criteria.
- Requirements for all allowed in-person research. All research involving in-person interaction with participants, whether new or ongoing, must meet the basic, common-sense infection and risk control requirements described below.
- The HSD Checklist for Human Subjects Research During the COVID-19 Pandemic has been eliminated.
COVID-19 Relative Risk self-assessment tool. HSD’s guidelines for describing allowed research have, until now, been based on research methods and types of research. That was the best approach in the first few months of the pandemic when so much was uncertain about COVID-19 and the virus. Unfortunately, this required crude categorizations. Also, it has been a difficult approach for researchers to use, because of the near-infinite variety of research methods and procedures. Now we are adopting an evidence-based approach to more directly identifying and managing the risks of COVID-19 infection.
This approach retains the easiest-to-apply existing categories of allowed research but supplements them with a COVID Relative Risk self-assessment tool to use with all other research. The advantages of the risk tool are:
- Captures the major known risks associated with COVID infection and severity
- Easier for researchers to apply
- Allows researchers to easily see what changes might significantly lower the COVID risk profile of a study
- Can be easily adjusted/revised as new information about COVID risks and current pandemic status becomes known, though HSD intends to revise the scores and threshold infrequently and only when there is significant, reliable new information.
Expectations for All Research with In-Person Interactions with Participants
Effective August 12, 2020
This information is likely self-evident but is important enough to highlight. All human subjects research involving in-person interactions with the participants must meet these basic common-sense infection and risk control requirements. If any of them are not possible for your research but you believe your research has sufficient other protections in place, contact email@example.com to discuss a possible exception.
- Essential in-person interactions. The only in-person interactions are those that cannot be adequately accomplished through a remote method such as a phone call, video conference (e.g., Zoom), email, etc.
- Face coverings. Study team members and participants wear face coverings throughout all procedures. Study team members who are not able to wear a face covering should not interact with participants. HSD and UW infection control experts strongly recommend the use of surgical, medical/procedure, or N95 masks, instead of cloth coverings, during participant interactions. If cloth coverings are used, they should meet the requirements described by UW EH&S for effectiveness. Good fit of face coverings is vital.
- COVID-19 screening. All study staff and participants are screened for COVID-19 just prior to each research visit. This means: (1) questions about symptoms and/or attestation that symptoms have not been experienced recently or currently and (2) they are not under self-isolation for COVID-19, self-quarantine for COVID-19 exposure, or have pending testing for the SARS-CoV-2 virus. Temperature measurement alone is not considered an adequate screening method. Just prior to means upon arrival or in the preceding 24 hours.
- Participant age. No participants over the age of 85 years will be enrolled.
All Research MRI Facilities Are Now Open
Effective August 5, 2020
The Department of Radiology has approved the resumption of research MRI scans at the Health Sciences 4.7 Tesla NMR Spectometry facility, with the concurrence of the Human Subjects Division. This means that all three UW research MRI facilities are now operational (DISC, BMIC, 4.7 T).
Elimination of HSD Checklist for Human Subjects Research During the COVID-19 Pandemic
Effective August 12, 2020
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 by summarizing a wide variety of issues, it was ultimately found to be a significant source of confusion. We apologize. We appreciate the feedback we receive that helps us do the best we can at providing support for UW researchers.