HS-IRBs News May 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 5, May 2015

HS IRBs Office Closure

The HS IRBs Office will be closed Monday, May 25th in observance of Memorial Day.

June Dates for IRB for Beginners

Are you new to the HS-IRBs review process? Consider signing up for one of the Summer 2015 IRB for Beginners Workshops.

The 90-minute workshops are held in the HSLC computer lab and are designed to give participants a first-hand view of the resources available on the HS-IRBs website as well as basic tools and tips for the ARROW electronic application submission system. The workshop will also introduce participants to the IRB’s review process and procedures.

There are workshop openings on the following dates:

Monday, June 1st 10:00-11:30 AM (HSLC Room 2121)
Thursday, June 4th 3:00-4:30 PM (HSLC Room 2121)

Space is limited and registration is required. Please email Jake Rome at jarome@medicine.wisc.edu to reserve your spot in one of the future sessions.

Exemptions and Five Year Extensions

UW-Madison has a five year renewal policy for non-exempt human subjects research protocols. A similar but much simplified process for exempt projects has been developed. ARROW will send five year extension notifications to study teams for exempt projects that have been open for five years. 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 email asktheirb@medicine.wisc.edu.

Reminder: HS IRBs Reliance Team Formed to Support Collaborative Research

Along with the changes to multisite and IRB reliance resources on the website, the HS IRBs offices has a team of people to support study teams with IRB reliance issues. The team includes Mike Bingham, Molly Lumley, Carol Pech, and Brandy Stoffel. The Reliance Team is able to assist study teams with issues such as:

  • Identifying what IRB oversight requirements may apply to studies involving multiple sites or personnel outside the UW, including community partners.
  • Assisting study teams with navigating the review process for different IRB reliance partnerships (e.g., WIC, Meriter).
  • Facilitating the processing of IRB authorization and independent investigator agreements.
  • Fostering collaborative research by coordinating communication with other institutions regarding IRB oversight issues.

The Reliance Team encourages study teams to contact them with any questions about IRB reliance or multisite and collaborative research issues.

Training Reminders

Please see below for some reminders regarding training requirements for human subjects researchers:

  • Per campus policy, all personnel listed as study team members on an IRB application must complete human subjects research training.
  • The HS and MR IRBs will accept biomedical and social-behavioral training courses completed via UW-Madison's CITI module as well as VA human subjects training.
  • Only VA training can be accepted for study team members listed on VA human subjects protocols unless a waiver is granted by the VA.
  • Personnel outside the UW for whom the HS IRBs are serving as IRB of record also must complete human subjects research training. The HS IRBs will accept CITI or equivalent training completed elsewhere in lieu of completion of UW-Madison CITI training. Please contact the HS IRBs' Reliance Team if you have questions about training requirements for non-UW personnel.
  • Personnel transferring to UW-Madison may receive credit for CITI training completed elsewhere by following these instructions on the HRPP website.
  • Study team members also may need to complete HIPAA training if they are members of the UW-Madison's health care component or if other criteria apply. Please see the HIPAA training page for more information.

ARROW Outage in June

Due to upgrades and maintenance, ARROW will be unavailable June 27th from 1PM to 5PM. We apologize for any inconvenience.

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.

  • For 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.
  • For 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.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, 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:newsletter, listserv, reliance, multisite, exemption, exempt, extension, workshop, beginners, training   Doc ID:51161
Owner:Carol P.Group:Health Sciences IRBs
Created:2015-05-07 09:10 CDTUpdated:2015-06-16 12:55 CDT
Sites:Health Sciences IRBs
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