HS IRBs News August 2018

Health Sciences and Minimal Risk IRBs, IRB News/Volume 10, Number 5, August 2018

HS IRBs Office Closure

Our office will be closed Labor Day, Monday September 3rd. 

Coming Soon: Improvements to the ARROW Initial Review Application

At the end of September, ARROW will be updated with the following improvements:
The September newsletter will include more information about these and other changes. Please email askarrow@medicine.wisc.edu if you have any questions about these upcoming improvements. 

Delay in Revised Common Rule Implementation

The Office for Human Research Protections (OHRP) announced that implementation of the proposed revisions to the Common Rule would be delayed until January 20, 2019. Until the revisions then, the addition of federal support to human subjects research that was not previously federally funded will affect whether the IRB can determine a project to qualify for exemption under additional institutional policies or excuse it from continuing review. The revised Common Rule will not yet affect studies that fall under FDA regulations. 

When to Add a Federal Grant to Your IRB Application and Congruency Reviews

Whether a study is supported by federal funding can affect the regulations that the IRB must apply to a study. Federal regulations can be stricter than institutional policies and some federal agencies (e.g. the VA or the Department of Defense) have additional specific requirements. It is therefore important for study teams to promptly update their applications to inform the IRB of any new federal awards, including for research that had been determined to qualify as exempt human subjects research. 

If an investigator has applied for funding and received a Just In Time request that would support a project already approved or determined by the IRB to be exempt, the study team should contact our office to request a "congruency review." During this review, our office will compare the grant application and the IRB application and, when they are a complete or close match, provide documentation for the study team to submit to RSP to indicate that the activities described in the funding proposal have been approved by the IRB (or fall under an exempt application). Once the grant has been awarded, study teams should add the grant to an approved or exempt IRB study by submitting a change of protocol.

To request a congruency review, please email irbadmin@medicine.wisc.edu and provide the following: 
For more information, please see [Link for document 21528 is unavailable at this time.] or contact Faye Lux (flevine@medicine.wisc.edu or 608-263-4922). 

New Resources for Research Teams

We have recently put together new guidance documents to help study teams get started and navigate human subjects research requirements. These include:
These resources are now grouped with the New Investigators Guide, which provides an overview of the IRB review process, to provide a toolkit for both new and experienced study teams.