July 8, 2021
For the Record – July 8, 2021: Revisions to COVID Restrictions
- Revisions to COVID-Related Restrictions
- Mobile Version of REDCap Doesn’t Meet Requirements
- Humanitarian Use Devices
- Change at the Human Subjects Division
Significant Revision to COVID-Related Restrictions on Human Subjects Research
COVID-related restrictions on human subjects research have been significantly revised and are described on HSD’s COVID webpage, in parallel with the more general changes in Washington State and at the University of Washington.
The remaining restrictions depend on:
- The location where interactions will occur with participants, and
- The vaccination status of researchers and participants.
These are the minimum requirements. Individuals, investigators, or study teams may voluntarily choose to adopt additional safety measures, such as wearing face coverings and observing social distancing even when vaccinated.
Should you submit a modification to your IRB application before you return to pre-pandemic study procedures?
This is not required if any COVID-related modifications to your study procedures were described as additions to the study and the discontinuation of pre-pandemic procedures was described as temporary (i.e., not permanent) due to COVID-related restrictions on research.
See the HSD COVID webpage for many more questions and answers. New Q&A will be added as issues arise, so be sure to check the page frequently during the rest of this month.
Contact HSD at firstname.lastname@example.org if you have any questions.
Consent and e-Signatures with REDCap Mobile Version
Not legally valid
HSD has learned that e-signatures obtained using the mobile version of REDCap do not meet the requirements of Washington State law or federal law for e-signatures. Therefore, they are not considered legally valid signatures.
If you wish to use REDCap to obtain e-signatures for consent and/or HIPAA authorization, you must use the non-mobile version of REDCap.
For studies where e-signature is captured outside the U.S., use of REDCap Mobile may be acceptable, if it meets applicable local law(s) regarding a legally valid electronic signature. HSD and the UW cannot advise on this and you will be required to provide supporting information as part of your application before approval to use REDCap Mobile is granted.
Humanitarian Use Devices (HUDs)
HSD maintains a website on its Special Topics page about the Humanitarian Use Devices (HUDs) that have been approved by the UW IRB for use at the UW. The purpose of the website is to assist UW Medicine physicians who wish to use a HUD for clinical care (not research).
The table of approved HUDs has been significantly revised because the U.S. Food and Drug Administration (FDA) has changed the status of several HUDs from “HUD” to “fully approved”. This means that they are now considered standard, approved medical devices that are routinely available for clinical care.
Change at the Human Subjects Division
Karen Moe, Director of the Human Subjects Division, has decided to retire from the University as of January 14, 2022.
Dr. Moe became the HSD Director almost 15 years ago, in January 2007, after two years as its first Assistant Director. Prior to that she was a faculty member with a sleep research program in the UW’s Department of Psychiatry and Behavioral Sciences. She successfully led HSD through many profound changes, including a complete re-organization and multiple moves. She identified and developed key infra-structure elements and process improvements essential for improving the protection of human research subjects, promoting ethical considerations, and making it easier to accomplish research compliance. Some of her accomplishments include: the e-IRB online system called Zipline; implementation of the revised Common Rule; successful elimination of a burdensome but no-longer-necessary state law; and significantly improved HSD and IRB effectiveness, efficiency, transparency, and approachability despite a steadily increasing workload. She has enjoyed her many interactions with UW researchers and study teams and has found it richly satisfying to play a role in supporting the University’s research mission.
The search for a new HSD Director will begin soon. In the meantime, Dr. Moe will remain fully engaged working with the IRBs, HSD staff, and other campus offices through the end of this calendar year, to ensure a smooth transition that paves the way for the success of the next Director.