July 9, 2018
For the Record – July 9, 2018
IN THIS ISSUE:
On June 18, 2018, the implementation of the revised “Common Rule” human subjects regulations was again postponed for another 6 months. With this announcement, the implementation date is now January 21, 2019. It is widely expected that this will be the last delay – that is, the revisions to this important set of human subjects regulations will in fact be implemented on January 21, 2019. HSD is refining its communication and implementation plan to make sure that researchers will know what is changing and how it affects them. Look for details in this newsletter and on the HSD website during the summer and fall. Contact firstname.lastname@example.org if you have any questions.
Since the roll-out of Zipline in 2016, HSD has made some relatively minor changes to the system to improve the user experience and gather additional necessary data. These have all been changes initiated by HSD to meet the needs and requests of our users. For the first time, we will soon be upgrading the Zipline software to a newer version, which will also bring some helpful changes. The full list of changes will be available the week of the upgrade and include:
- For studies reviewed by an External IRB:
- The PI will be able to designate a PI Proxy, similar to studies reviewed by the UW IRB.
- A new activity will be available called Update Study. With this activity, investigators will be able to change the PI of an External IRB study, and will be able to report that the study
has been closed.
- For studies reviewed by the UW IRB:
- When investigators prepare a Continuing Review and check the first four milestones (which indicate that the study should be closed), they will be required to check a box acknowledging that the study will be closed before submitting. This will prevent a common inadvertent mistake.
The UW eSignatures service utilizing DocuSign will soon be available for obtaining electronic signatures for consent. HSD has been working with UW Information Technology (UW-IT) to make DocuSign available for this purpose beginning August 24, 2018. Utilizing this service will require obtaining IRB approval specifically for electronic signatures for consent forms; there will be a new question about this on the IRB Protocol form. It will also require an application to UW-IT, a trial session, and approval process through UW-IT. A guidance document and more details will be available in early August. Contact email@example.com if you have any questions.
The UW IRB cooperative reliance agreements with Kaiser Permanente Washington (formerly Group Health) and Benaroya Research Institute at Virginia Mason have been revised. These agreements allow research that involves the UW and one of these institutions to be reviewed by only one IRB instead of two. The agreements have been revised for clarity and enhanced information about roles and responsibilities. Each page has a flow chart to help researchers identify which IRB will do the review. Contact firstname.lastname@example.org if you have any questions.
Federal Certificates of Confidentiality (CoCs) protect identifiable subject information against subpoena, public records requests, and other legal proceedings. Most grants from the National Institutes of Health (NIH) automatically confer a CoC on the funded human subjects research. CoCs have an expiration date, which is usually tied to the end of the federal grant, although the protections for data gathered under an active CoC are permanent.
HSD has recently obtained some clarifying information from NIH about the impact of the CoC expiration date on study data that are collected after the expiration. See the revised GUIDANCE: Certificate of Confidentiality. This new information has also been added to the Acknowledgement of Federal Certificate of Confidentiality. This document is placed on the Documents tab of Zipline for new studies with a CoC when they receive IRB approval. Contact email@example.com if you have any questions.
When a member of the study team leaves, you should remove that person’s access to the Zipline application using the Manage Study Team activity in the main study workspace.