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:

  • Thursday, November 16th: 1:30pm - 3:00 pm, 1325 HSLC, register here
  • Thursday, December 14th: 11:30am - 1:00 pm, REGISTRATION FULL
  • January Sessions: Dates for additional information sessions in January will be announced soon.

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:

  • November 23rd: The office will be closed in observance of the Thanksgiving holiday with no coverage, including for ARROW.
  • November 24th: The office will be closed. Limited coverage for urgent HS-IRBs and ARROW issues will be provided from 9am to 3pm only by email.
  • WIRB offices are closed both November 23rd and 24th. No WIRB coverage will be provided by the HS-IRBs those days.

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:

  • Updated User Interface: Significant changes to the user interface (UI) for study teams will be implemented in December. The HS IRBs Office will be updating its help documents in preparation for these changes.

Forthcoming in 2018:

  • Updated Ceded Review Form and Workflow: Applications in which the UW-Madison is ceding review to an external IRB or institution will have a revised form and workflow within ARROW. Highlights of these changes include:
    • Single ceded review form that will be used for all requests to rely on an external IRB, including independent IRBs such as WIRB.
    • Official IRB correspondence regarding reliance decisions made by the HS IRBs Office.
    • Annual reminders to research teams about ongoing responsibilities for studies ceded to an external IRB.
    • Ability to submit changes of protocol (including personnel) for ceded studies.
    • More information about how these and other related updates will affect study teams will be announced via our listserv and newsletter. If you have questions about the ceded review changes, please email the Reliance Team (irbreliance@wisc.edu).

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.

  • 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 asktheirb@medicine.wisc.edu. 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 irbreliance.wisc.edu.

  • Assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
  • 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.



Keywords:news, Common Rule, office, ARROW, ceded review, WIRB, UI Revolution   Doc ID:78174
Owner:Tesha Z.Group:Health Sciences IRBs
Created:2017-11-09 12:43 CSTUpdated:2017-11-16 15:57 CST
Sites:Health Sciences IRBs
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