HRPP Newsletter November 2022
Research Data in Healthlink and Consent Form Language
With the implementation of phase 2 of the 21st Century Cures Act in October, Health Link users should be aware that more data previously available only in Health Link or via Release of Information request is now visible to subjects via the patient portal, MyChart. This includes research data documented in Health Link. As before, any research data that is recorded in Health Link must be approved by the IRB and described in consent documents- this is not changing. However, this data is now more easily accessible to subjects. Although the details of what research data may be viewable in MyChart is not generally included in consent forms, study teams are encouraged to review language in the consent form to confirm that it accurately reflects research data that will be placed in Health Link. If revisions are necessary, study teams should submit a change of protocol for review and approval by the IRB before making changes to the types of data recorded in Health Link.
For questions related to Health Link documentation and research data, please reach out to Ann Wieben, firstname.lastname@example.org and review guidance on clinical research documentation requirements: https://uconnect.wisc.edu/clinical/tools-resources/ehr/health-link/research/documentation/resources/name-20960-en.file
For questions related to whether or not a change in consent form language may be necessary, please email email@example.com.
With the November 12th ARROW patch, the PI appointment page in IRB ARROW has been streamlined. If you have a joint appointment (such as with the Madison VA and UW-Madison) select the SINGLE appointment under which you will be conducting the research in that application. Per the PI status for human subjects research policy, UW-Madison investigators with the following appointments can automatically serve as PIs for IRB applications: tenured or tenure track faculty, CHS appointments, research professor track and UW-Madison staff with permanent PI status for grants. Those with other appointment types will be directed to the Request to Serve as PI page in ARROW. If you have any questions, contact IRBdirector@hsirb.wisc.edu
Introducing New Staff
Welcome to Nathan Putman-Buehler and Sarah Dietz, who are joining both the RELIANT and HS IRB teams. Nathan joined us on November 18th, transitioning from a role as a Project Manager in the Department of Biochemistry. Sarah will join us on November 28th, transitioning from a role as a Clinical Research Project Coordinator of multi-site infectious disease studies in the Department of Medicine.