HS-IRBs News November 2017

Health Sciences and Minimal Risk IRBs, IRB News/Volume 9, Number 11, November 2017

Revised Common Rule Webpage and Presentations

Some revisions to the Common Rule (aka the Federal Policy for the Protection of Human Subjects) are expected to go into effect January 19, 2018 and the UW-Madison IRBs are proactively preparing for these changes. The revised Common Rule reduces IRB and other oversight for many research studies involving human subjects that can be classified as minimal risk. Of note, the Food and Drug Administration (FDA) has not issued revised regulations and thus any FDA-regulated research will not be affected by the revisions to the Common Rule.

The Department of Health and Human Services requested a delay in implementation of some of the proposed revisions to the Common Rule, but has not identified which aspects of the revised Common Rule would go into effect in 2018 and which would be delayed, if the request is approved, until 2019. The UW-Madison IRBs will begin applying those components of the revised Common Rule that will go into effect in 2018 to new studies approved on or after January 19, 2018 and that are not FDA-regulated. IRB staff will work closely with study teams to identify the best implementation strategy for each initial review submission.

To learn more about these changes, please sign up for one of our upcoming information sessions:

The HS IRBs' website also includes a new page dedicated to revisions to the Common Rule. We will regularly update this page to help study teams to stay informed about the impact the revised rule may have on their research.

HS IRBs Office Closures

The HS IRBs will be closed or have limited coverage the following days in November:

HS IRBs Office Staff Update

The HS IRBs Office is pleased to welcome Lara Curkeet to our office as a full-time staff reviewer! Lara previously worked for the Wisconsin State Laboratory of Hygiene, and she will be supporting both the HS and MR IRBs. We're excited for Lara to join us!

Upcoming Changes to ARROW Application

In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned improvements for the December update include:

Forthcoming in 2018:

For more information about this and other ARROW updates, please see Vice Chancellor for Research and Graduate Education's ARROW updates page.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.