HS-IRBs News March 2016

Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 3, March 2016

Coming Soon: New and Improved Consultation Request Form

Our office is creating a more user-friendly method to request consultations with HS IRBs staff. Our [Link for document 18204 is unavailable at this time] page will be updated with the new version soon, but you can continue to use the current version in the meantime.

Consultations provide an opportunity for study teams to meet with an experienced HS IRBs staff reviewer to discuss substantive issues in the development and implementation of research projects. Study teams may find consultations especially helpful when planning multisite or complex projects, or when considering making major changes to IRB-approved studies. Researchers new to the HS IRBs review process also are encouraged to schedule a consultation before submitting their first IRB application.

Engagement in Human Subjects Research Questions

Whether IRB oversight is required for a project, person, or site involved in human subjects research often hinges on a determination about what federal guidance calls engagement. These determinations can be complex and IRBs may differ in their interpretation of the federal guidance. As a result, study teams conducting collaborative research may receive requests from HS IRBs staff to confirm that the non-UW-Madison sites or personnel involved in the project have consulted with their own IRBs regarding whether they are engaged in human subjects research. With more collaborative research occurring across the country as well as an increase in scrutiny by federal regulators about engagement determinations, it is important the HS IRBs to help researchers appropriately navigate these complex issues. If you have questions about engagement in human subjects research and collaborative projects, please contact the HS IRBs Reliance Team.

Data Use Agreements (DUAs) & IRB Review

We would like to remind study teams that copies of signed data use agreements for research use of a Limited Data Set (LDS) must be submitted to the IRB before applications can be approved. Although the IRB does not approve data use agreements, it needs to maintain copies for its files in its role as the HIPAA privacy board. If the purpose of the LDS involves a collaboration or a subcontract with another institution, the application must be approved by a UW-Madison IRB and the data use agreement must be signed by the appropriate UW-Madison signatory prior to disclosure of the LDS. For more information, see this page on the UW HIPAA website.

Opportunity to the Join the HS IRBs Staff

The HS IRBs Office has an opening for an IRB reliance facilitator. The person in this role will provide support for the Greater Plains Collaborative IRB consortium and serve as a member of the HS IRBs' Office Reliance Team, which manages studies ceded to other IRBs as well as IRB of record agreements. This person will work closely with study teams at the UW and across the country. The deadline for applications is March 22nd. If you have questions about the position, please email the IRB Reliance Team for more information.

Upcoming ARROW Outage (4/9/16 - 10am-6pm) **Updated

ARROW will be unavailable Saturday, April 9 from 10 AM - 6 PM for upgrades and maintenance. If you have questions please email askarrowirb@medicine.wisc.edu.

Important ARROW Reminder: End of Concurrent Personnel Changes and Changes of Protocol

ARROW currently allows study teams to submit a personnel change application and a change of protocol application at the same time. Beginning at the end of this month, submission of concurrent change of protocol and personnel change applications will no longer be permitted. Only one type of change application will be able to be submitted at a time. As is the case currently, study teams will still be able to make changes to personnel as part of a change of protocol application. This change to ARROW is being made eliminate inconsistencies in which study team members are listed in the approved IRB application. These inconsistencies are the result of technical limitations with ARROW and this is the most efficient solution to address the problem. If you have questions about this change to ARROW, please email askarrowirb@medicine.wisc.edu for help.

Information previously provided on this page has been relocated to our new IRB website.

Please visit this page for information about connecting with the IRBs.

Keywords:newsletter, listserv,   Doc ID:61496
Owner:Monica E.Group:Health Sciences IRBs
Created:2016-03-03 12:30 CSTUpdated:2016-04-19 15:34 CST
Sites:Health Sciences IRBs
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