August 9, 2018
For the Record – August 6, 2018
IN THIS ISSUE:
- Zipline Upgrade
- More Turnaround Times
- Confidentiality Agreements
- Job Opening
- Electronic Consent Signatures
- PI Proxy Study List
- NIH Requirements
- Did You Know?
Implementation date: August 24, 2018
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. At the same time, we will be making some additional helpful changes. The full list of changes will be available by clicking the link to the release notes at the bottom of HSD’s webpage about Zipline. Some of the most impactful changes are:
- 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.
- The REQUEST: External IRB Review form is being updated to gather additional information that is needed for many External studies.
- For studies reviewed by the UW IRB:
- The button to select to create a modification, or to renew or close your study wll be more obvious. The location of the button will not change, and can still be found in the approved Study workspace.
- Once approved, the risk level and last day of approval of a study will be visible in the upper left corner of the Study workspace.
- 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 ZIPLINE APPLICATION: IRB Protocol and ZIPLINE APPLICATION: IRB Protocol, No Contact with Subjects are being updated to reduce the number of screening questions needed for many studies, such as those involving MRIs, electronic consent, or international sites.
More Zipline Turnaround Time Information
HSD continues to explore the world of data available through Zipline. This month we’ve released a new analysis of turnaround time for different types of applications: looking at how much of the total turnaround time is due to HSD and IRB actions (such as writing review letters) and how much of the total turnaround time required to review new applications is due to researcher actions (such as writing a response to a review letter).
Interesting finding. The turnaround time for determinations (such as Not Research, or Not Human Subjects) and for Exemptions is almost 100% due to HSD activities. In other words, there is very little “back and forth” between HSD and the research team on these types of applications.
This indicates the success of the IRB application Streamlining project that was implemented at the same time as Zipline. The IRB application forms were consolidated and completely overhauled. The result: they are now providing the information that HSD and the IRBs need to make these determinations, usually without “back and forth”.
Confidentiality Agreements – Report Change Form
Emailing them is now allowed
Do you frequently add or remove study team members from a UW Confidentiality Agreement using the report change form? Wish there was a faster way to submit and keep track of these forms? HSD now allows Report Change Forms to be submitted via email instead of on paper. Follow the instructions on the form to send the PDF document via email to the HSD team reviewing the study. The team will add the documentation to the study in Zipline and send a confirmation back to you that the document has been received.
Payroll Title: Compliance Analyst, grade 9
Office Title: IRB Administrator
HSD is seeking interested individuals to fill an IRB Administrator position. They will be part of the HSD staff teams that support the four IRB committees. The position will:
- Conduct minimal risk reviews
- Make determinations about whether a study involves human subjects or qualifies for exempt status
- Assess applications that will be reviewed by a full convened IRB board and manage the applications through that process
- Provide help and guidance to researchers
Experience with human subjects research (e.g., as a study coordinator or researcher) or IRB experience is desirable but not necessary. HSD has a well-regarded on-the-job training program.
For more information, go to the UW Jobs main page, click on Find a Job, and enter the requisition number 158875.
Electronic Consent Signatures
Implementation Date: August 24, 2018
The UW eSignatures service utilizing DocuSign will be available for obtaining electronic signatures for consent beginning August 24, 2018. UW Information Technology (UW-IT) reached out to HSD to establish this availability, in response to requests that they have received.
Utilizing this service will require obtaining specific IRB approval. A new guidance document and a worksheet will be available, and questions about eSignatures for consent will be added to the IRB protocol form on August 24, 2018.
This service also requires an application and approval with UW-IT.
PI Proxy Study List is Now Available
HSD can now provide a report that lists all of the IRB applications for an individual who has the PI Proxy role in Zipline. PI Proxies manage most of the IRB application work for researchers. HSD sometimes receives requests for these lists when a research support group experiences staff turnover and needs this information during a transition or hand-off period. This report may also be useful in managing workload across individual PI Proxies within a research support group.
It is similar to the List of Department Active Studies report that we announced in our May 7th eNewsletter.
To request the list for a specific PI Proxy: Appropriate department or program staff should send an email to email@example.com. We will typically be able to provide the list within three business days. It will be accompanied by some explanatory information and definitions.
We regret that at this time we cannot customize the report to provide additional information nor can we schedule automatic generation and distribution of the report.
NIH Requirements for Human Subjects Research
Delayed enforcement and short term flexibility
We highly recommend that NIH-funded researchers review the July 20th NIH Notice about delayed enforcement and short-term flexibility for some human subjects research requirements.
Due to the advocacy of researchers, the Council on Governmental Relations (COGR), and other institutions, Congress has required NIH to delay and assess their initial approach to changes announced in 2016. Therefore:
- NIH is now defining “fundamental research” as equivalent to basic research.
- ClinicalTrials.gov registration and reporting policies for prospective basic science studies are delayed (but not eliminated) through September 24, 2019.
- There will be a period of leniency for grant applications submitted to NIH using an incorrect Funding Opportunity Announcement (FOA).
The delay and flexibility do not apply to these NIH changes implemented in 2016:
- The requirement for Good Clinical Practice training, for all personnel involved in the conduct, oversight, or management of any NIH-funded study involving human subjects;
- The NIH FORMS-E Human Subjects and Clinical Trials Information form must be submitted for all grant and contract applications involving human subjects.
Did You Know?
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