July 1, 2019
For the Record – July 1, 2019
- Paper-Based IRB Applications
- No More Confidentiality Agreements
- Medical Records Reviews: Exempt?
- Campus Satisfaction Survey Results
- Help Us Improve the Zipline Online Help Library
- Major Zipline Upgrade
Paper-Based IRB Applications
Notice to Researchers
All remaining paper-based IRB applications must be closed or “converted” into a Zipline e-IRB application before June 1, 2021 (about 2 years from now).
In addition, no new paper-based Modifications will be accepted after June 1, 2020 (11 months from now). After that date, paper-based studies must first be converted into a Zipline application in order for a modification to be submitted for review.
Rationale. A few paper-based IRB applications have been allowed to continue as paper, instead of being converted into a Zipline e-IRB application. However, the paper and Zipline processes have diverged to an unsustainable point. The database for paper applications is based on 16-year-old software that cannot be updated and that is showing clear signs of a limited life.
What you should do:
- If your IRB application can be closed now: Your application can be closed if you have completed all data collection and all analysis of identifiable data described in your application. Contact your HSD staff team or firstname.lastname@example.org if you want assistance with this determination.
- If your application can be closed before June 1, 2021: You do not need to do anything. However, note that no new paper-based Modifications will be accepted after June 1, 2020 (11 months from now). No exceptions will be allowed for continuing paper-based applications after the June 1, 2021 deadline (about 2 years from now).
- If you will need to convert your application into Zipline: Contact your HSD staff team or email@example.com to discuss the timing and process for converting the application, and other possible options (such as possibly qualifying for exemption under the revised Common Rule regulations implemented last January).
We will provide occasional reminders in this newsletter throughout the next two years.
No More Confidentiality Agreements
After July 28, 2019
The legal change. Washington State law RCW 42.48 was revised in the just-completed legislative session. This is the law that requires researchers and the UW Human Subjects Division to complete Confidentiality Agreements before accessing identifiable UW records for research purposes – for example, UW medical records, dental records, and student records.
Beginning on July 28, 2019, this law will no longer apply to the records of Washington State public institutions of higher education. The legislature recognized that federal laws such as HIPAA and FERPA provide equivalent protections to the Washington State law, making the state-mandated Confidentiality Agreements an unnecessary and burdensome requirement.
This legislative change was the result of a successful collaboration between the UW State Relations office (especially the UW Medicine group), the UW Human Subjects Division, Washington State University, the Washington State Council of Presidents, and the Fred Hutchinson Cancer Research Center (FHCRC).
How it affects researchers. This will affect a very large number of UW researchers, as well as many researchers at FHCRC and Seattle Children’s. HSD typically receives about three new Confidentiality Agreements and twelve revisions (Report Personnel Change) every work day. The specific changes effective on July 28 are:
- No new Confidentiality Agreements will be required or accepted.
- No revisions to existing Confidentiality Agreements will be required or accepted.
- Researchers should keep any existing Confidentiality Agreements as part of their research records.
All other requirements for accessing identifiable records will continue – for example, the requirement for IRB approval and (if appropriate) waivers of consent and/or HIPAA authorization.
Questions? Send them to firstname.lastname@example.org
Medical Records Reviews: Exempt?
Effective July 28, 2019
The above-mentioned change in state law RCW 42.48 means that the UW will now be able to implement the provision of the federal Revised Common Rule that allows Exempt status to be granted to these types of research:
- Medical records reviews, when identifiable Protected Health Information (PHI) will not be shared with anyone outside the UW covered entity; and
- Secondary analysis of biological specimens obtained originally for clinical purposes by a UW healthcare entity such as UW Medicine or the UW Dental Clinics.
What you need to do: Nothing.
- If you have an existing paper-based application that qualifies for this change: HSD staff will grant Exempt status to your application and contact you about this change. This means that your research can continue as described in your application, but it will allow us to close your application.
- If you have an existing Zipline application that qualifies for this change: HSD will likely not make any changes, as it will not affect the amount or type of work you need to do during the life of the study.
- New Zipline applications approved after July 28, 2019: Applications will be granted Exempt status if they qualify.
The Common Rule regulatory justification for this change is that all of the protections of HIPAA still apply to these uses.
Campus Satisfaction Survey Results
Thank you for participating!
The Office of Research conducts a Campus Satisfaction Survey about every three years. The most recent survey was conducted in late 2018. The confidential survey was emailed to all individuals on the HSD eNewsletter subscription list.
Results. Numerical rating questions and textbox “comment” questions showed general high satisfaction with HSD and the Institutional Review Boards (IRBs).
HSD is particularly pleased at the success of the comment-type questions at eliciting specific, actionable feedback – which was the primary goal we had in mind when designing those questions. We plan to repeat those questions in future surveys.
Themes that emerged from the Comments were:
- Request for specific features in the Zipline e-IRB system.
- Difficulties in searching and navigating Zipline Instructions.
- Requests for some changes to the organization and navigation of HSD’s website.
- Confusion about: data security protections; returning results to research participants; subject payment; and data and safety monitoring plans.
Actions. We have already implemented some of the requests (e.g., specific Zipline features; guidance about returning participant results; see the next news item about Zipline Instructions). The other themes have been incorporated into HSD’s annual goals for the upcoming fiscal year. Stay tuned to this newsletter for updates.
Thank you for participating. Your feedback makes a difference!
Help Us Improve the Zipline Online Help Library
Very Short Survey
HSD is planning to revamp the Zipline Online Help Library sometime in late 2019. We are considering two options to make the Zipline instructions easier to navigate by dramatically changing their structure. To learn more and provide your feedback, please take our user survey.
Major Zipline Upgrade
In Late 2019
Sometime in late 2019, HSD and the Office of Research Information Services (ORIS) will be upgrading the Zipline software to the most recent version provided by the software vendor. This is Huron’s IRB 9.0 version.
Why. The newest version offers several improvements and features not available in our current version. In addition, the current UW version will no longer be supported by the vendor.
Overview. The big changes are focused in a few specific areas. They include:
- Involvement of other institutions. There will be major changes in how information is requested about the involvement of other institutions. This is necessary to handle the growing use of single IRBs for multi-site and collaborative research.
- Study roles addendum. The UW’s current Study Roles Addendum form will no longer be needed. Instead, there will be a simple “Smart Form” process for identifying and changing the members of the study team.
- Expanded help. The existing “help bubbles” will be augmented with a second type of on-screen help, which will not require navigating away from Zipline.
- Scrolling the entire application. It will no longer be necessary to jump or navigate from Smart Form to Smart Form. Instead, researchers will be able to scroll the entire application as if it were a single “page”.
Communication plans. We will provide additional details and educational resources in each month’s eNewsletter.
User testing. We will ask for some volunteers to do a short session or two helping us to test the new system before it is implemented by trying out specific types of application scenarios. This is a great opportunity to get an early look at the new system. The user testing sessions will likely be during the fall academic quarter. Contact email@example.com if you are interested or would like details.