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 email@example.com.
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 firstname.lastname@example.org for help.
- Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email email@example.com. These are the quickest ways to get help with general questions.
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.