HS-IRBs News October 2016

Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 10, October 2016

Upcoming Beginners Workshop

The Health Sciences IRBs for Beginners Workshop provides training on the HS IRB's processes, regulatory approval process, resources, and ARROW online application system. The two-hour workshop is held several times each year in the HSLC computer lab (room 2121), and is meant for individuals new to the UW IRB process or for those looking for help on how to effectively submit an IRB application. The workshop consists of two sections meant to provide the regulatory framework and technical skills to submit an application. This will be the last workshop held in 2016, so please register soon to reserve your spot!

  • Tuesday, November 1st - 2 PM to 4 PM, HSLC 2121 - Registration available here

Seeking Pilot Studies for SMART IRB

In partnership with Harvard University, the Health Sciences IRBs office is leading the NIH-funded SMART IRB initiative to enable single IRB review for multisite studies. SMART IRB is a flexible, national IRB reliance agreement as well as complementary tools and resources to help streamline the IRB review process. UW-Madison has already signed the SMART IRB agreement and many other academic medical centers are in the process of doing so.

SMART IRB is currently seeking studies to pilot its process and tools. By participating in the pilot phase, researchers will gain early access to the system, provide input to guide future development, and ensure SMART IRB meets the needs of the nation. Studies eligible for the pilot phase must:

  • Involve 2-5 sites that hold a federalwide assurance (FWA)
  • Be not yet reviewed or approved by any IRB
  • Have a PI with experience conducting multisite research
  • Be ready for IRB submission no later than November 25, 2016

If you have a study that meets these criteria and you are interested in piloting SMART IRB, please email irbreliance@medicine.wisc.edu.

New Repository and Registry Guidance

The Health Sciences IRBs Office has released new guidance materials on creating, maintaining, and contributing to research repositories and recruitment registries. Several new documents have been developed to assist study teams, including a general overview guide, as well as an application guide for investigators planning to submit a research repository or recruitment registry application to the IRB. Finally, a Repository-Registry table outlines IRB-review requirements for various scenarios related to creating or contributing to a research repository or registry. Please contact the HS IRBs Office at 608-263-2362 or AsktheIRB@medicine.wisc.edu with any questions.

ARROW Email Sync and Listserv Update

Coming soon: the Vice Chancellor for Research and Graduate Education's IT will be conducting an email sync to link the email addresses in ARROW with those listed in the Human Resources System (HRS). Those affected will be contacted via email from the ARROW Support Team, and there will be further updates posted on the ARROW homepage. Following the sync, study teams will no longer be able to edit their email addresses within ARROW, and notifications will be sent to the email on file in HRS. If study teams wish to change their contact information, please follow the guidance available here to change a business email address. 

After the email sync, the HS IRBs Office will update its general announcements listserv. Key regulatory personnel as well as PIs and points of contact on current, active ARROW applications will remain on the list. All other email addresses will be removed so as to improve deliverability rate and reduce unwanted messages. If removed in error, study teams can email join-hs_irbs_announcements@lists.wisc.edu to receive the newsletter and other IRB updates. After this first update, it is expected that further updates will occur on a semi-annual basis. 

Please contact the ARROW Help Desk Team at askarrowirb@medicine.wisc.edu with any questions about this process. 

Improving IRB Processes for Researchers

As part of our continuing efforts to improve processes within the HS IRBs Office, we would like to inform you about a new FDA Liaison position being established within the office. The position, which is being developed by Jacob Rome, will focus on building greater expertise on FDA human subjects regulations within the office to improve the application of FDA regulations to IRB submissions. Working with members of the research community, Jake will develop FDA-related policies and guidance for the Health Sciences IRBs and research teams conducting FDA-regulated research. Jake will also work with the ICTR IND/IDE support and study monitoring services to bring IRB expertise to the FDA regulatory process. For IRB-FDA related questions, feel free to contact Jake at jarome@medicine.wisc.edu.

Exemptions and Five Year Extensions Reminder

ARROW sends five year extension notifications to study teams for exempt projects that have been open for five years. Just a reminder: if you receive an email notification that an exempt project has been open for five years, you may extend the project or close it as follows.

  • If you wish to keep an exempt project open, please complete the Extend Exemption activity in the exempt project workspace. This activity is NOT reviewed by the IRB office and no replacement application is required. Completing the activity simply indicates in ARROW that the study team is keeping the exempt project open.

  • If you wish to close an exempt project, please complete the Submit Study Completion Report activity in the exempt project workspace. The study completion report will be reviewed by the IRB office as with any other study completion report.

If you have any questions about the five year notifications for exempt projects and the extension or closure process, please refer to the available guidance or email askarrowirb@medicine.wisc.edu.

Keywords:newsletter, listserv, exemption, extension, registry, repository, guidance, SMART IRB   Doc ID:67465
Owner:Monica E.Group:Health Sciences IRBs
Created:2016-10-04 07:57 CSTUpdated:2016-11-17 10:29 CST
Sites:Health Sciences IRBs
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