June 3, 2019
For the Record – June 3, 2019
- No More Confidentiality Agreements
- Revised Agreement with Seattle Children’s
- Help Improve the Zipline Help Library
- Modifying Exempt Research
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
Revised Agreement with Seattle Children’s
The longstanding cooperative agreement with Seattle Children’s has been revised. This agreement applies to research studies that involve both the UW and Seattle Children’s. The purpose of the revised agreement is to:
- Avoid dual IRB review whenever possible, by having only the UW IRB or the Seattle Children’s IRB conduct the review on behalf of both organizations;
- Clarify which IRB does the review for which types of studies;
- Revise and clarify the process that researchers follow for obtaining IRB review for these collaborative studies.
See this new HSD webpage for more information. You can also navigate to it from the main HSD right-hand navigation menu by selecting External IRB Review of UW Research and then Existing Reliance Agreements.
Additional help. The Seattle Children’s IRB office has prepared materials, which are available from them upon request; email email@example.com. For an example scenario, see HSD’s online tutorial on using an external IRB.
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.
Reminder about Modifying Exempt Research
What does, or does not, need advance consultation with HSD
Some modifications of exempt research require advance HSD review and approval, to ensure that the change doesn’t disqualify the research from being considered exempt. For example, if you plan to reduce the level of data security protections for your exempt study, you should contact HSD first for instructions. The GUIDANCE: Exempt Research provides more information about what types of modification do, or do not, require advance consultation with HSD.