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 study team member pages will be streamlined to reduce the amount of information study teams need to enter into the application.
- The existing study location will be replaced with a new, shortened section to better focus on IRB reliance issues (i.e., when UW-Madison will serve as the reviewing IRB).
- As a result of the above changes, where and how external personnel are listed in the application will also be changing. The most significant of these changes is that study teams will no longer need to obtain NetIDs to list external personnel in the application. Study teams will either enter external personnel manually one time in the application or list them in a delegation log.
The September newsletter will include more information about these and other changes. Please email email@example.com 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 firstname.lastname@example.org and provide the following:
- a copy of the entire grant application
- the IRB number(s) of the study that the grant would be added to if awarded
- the grant number
- a description of which components match IRB protocols, if the grant spans multiple IRB protocols
- whether any component of the grant was reviewed by an external IRB
- the deadline by which the review should be completed
For more information, please see Guidance Regarding Federal Requirements for IRB Review of Grants or contact Faye Lux (email@example.com 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:
- An Operations Manual, which organizes HS IRBs guidance and policy by topics (e.g. how to identify activities subject to IRB review, preparing to submit an application, etc.).
- Top 25 Searches, which lists the most popular searches and related documents on our website.
- Tips for Making IRB Review as Smooth as Possible, which highlights key information for each step of the submission and review process.
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.