HS-IRBs News March 2015

Important Reminder: Understanding Expedited Versus Full Changes of Protocol

The HS-IRBs office has recently received a large number of changes submitted for expedited review that in fact required full IRB review. Here are a few things to keep in mind when considering whether to submit a change for expedited or full review:

• Whether a change qualifies for expedited review depends on the type and not the number of changes being proposed.  For example, a single change to study procedures - even though it may appear minor -  can have significant implications that could affect the IRB's assessment of the study, such as addition of a blood draw to monitor subject health status, which likely requires full IRB review as defined by federal regulations.
• Selecting the wrong review type for a change can result in delays in the review process, particularly for VA studies.
• Examples of common changes of protocols and the type of review required for such changes can be found in the recently updated Expedited Changes Examples Table.
• Expedited Change of Protocol Guidance includes specific criteria for expedited changes of protocol.

If you are unsure whether a change may qualify for expedited review, please contact the HS-IRBs office for assistance.  

Coming Soon: Moving from Multisite Research to IRB Reliance

Over the coming weeks, significant changes will be made to the multisite research resources on the HS-IRBs website. These changes are being made to reflect the growing number of IRB reliance agreements in which the HS-IRBs participate as well as updated resources regarding all aspects of IRB reliance. Part of this change will be renaming the main multisite research page, which will soon be called IRB Reliance Basics. This name change is occurring to keep the HS-IRBs website in step with national trends regarding how agreements among IRBs are described. More information about these changes will be forthcoming in the April newsletter and a future workshop. If you have questions about these changes or any IRB reliance issues, please contact the HS-IRBs Reliance Team (irbreliance@medicine.wisc.edu).

Revised Personnel Change Guidance

The Principal Investigator Changes and Personnel Updates Guidance has been revised for clarity only (no major revisions were made) and has been posted.

Reminder: Unanticipated Problem and Adverse Event Reporting for non-VA Studies

If an adverse event occurs on a non-VA study and the study team needs to determine if the event requires reporting to the IRB please first consult our unanticipated problem/adverse event decision tree. Also keep in mind the general principle that if an adverse event is probably related to study participation and unexpected in any way, it most likely requires reporting to the IRB. If you need further assistance in determining whether an event requires reporting to the IRB, please contact Jessie Johnson or Emily Jenner. Note: Reporting requirements for VA studies are more stringent than those for non-VA studies. Please see the HS-IRBs Reporting and Submission Timeframes for more information about VA reporting requirements.

Update on Apple ResearchKit

Apple recently launched its ResearchKit platform, designed to assist researchers with data collection, subject recruitment, and diagnostics. Since UW-Madison’s human research protection program has not yet had the opportunity to review ResearchKit in detail, study teams should not plan on using it for studies approved by a UW-Madison IRB at this time. Updates about the use of ResearchKit will be provided in future newsletters.