HS-IRBs News March 2012

Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 3, March 2012

New: Quick Check Pre-Review Pilot Project

Beginning in mid-April 2012, the Health Sciences IRBs will be piloting a new quick check pre-review process for investigator-initiated and/or trainee studies undergoing full IRB review. Quick check pre-review is a brief form of pre-review that will focus only on certain sections of the IRB application. Quick check pre-review is designed to help study teams by providing them with feedback on key sections of the IRB application early in the review process. This will allow study teams to address major concerns as soon as possible and hopefully shorten the overall time an application spends in pre-review.

For applications that qualify, quick check pre-review will be conducted within 2 weeks of the application being assigned to an IRB staff reviewer for pre-review. Study teams will be notified via reviewer notes in ARROW of any significant issues with a protocol or certain areas of the application that are identified during the quick check pre-review. The quick check process will NOT replace the current pre-review process and study teams should still expect to address issues during the regular pre-review process.

This pilot quality improvement project will last approximately 3 months and will then be evaluated. Time from receipt of an application to approval will be reviewed as well as study team feedback to determine whether the quick check process will continue.

For a full description of this pilot project (including what types of studies qualify for quick check pre-review), please see Document 22914 is unavailable at this time. . If you have any questions about this pilot project, please contact Carol Pech at cap@medicine.wisc.edu.

Introducing HS-IRBs' Community Research Specialist

In response to the growing volume and complexity of community-based research studies reviewed by the HS-IRBs, we are proud to announce that Staci Taylor Lowe is now serving as the community research specialist for the office. Staci holds a PhD in social policy from Cornell University and has worked on numerous research and evaluation studies based in community settings. She has worked in the SMPH for eight years in both research and administrative capacities.

In her new role, Staci will serve as the IRB staff reviewer for most community-based research applications submitted to the HS and MR IRBs. Staci also can assist community-based researchers by:
  • Providing consultations about the IRB review process
  • Assisting researchers in identifying and addressing IRB issues most salient to CBR studies before an application is submitted the IRB
  • Developing educational resources useful to the CBR community
  • Serving as a liaison between research teams and the IRB
To arrange a consultation, community-based researchers are strongly encouraged to contact Staci directly at stlowe@medicine.wisc.edu or 262-4501.

New ARROW Activity: Using the Record Human Subjects Training Snapshot

By mid-April, a new activity will be available in ARROW that will allow study teams to check human subjects training status and dates for all study team members listed on an IRB application. The new activity is called Record Human Subjects Training Snapshot. The new activity will list training expiration dates for all study team members listed in the IRB application. It also will display in the History tab whether any study team members do not have the required training or have expired human subjects research training certification. Study teams should use this activity before submitting new initial review applications or personnel changes to ensure that study team members have current human subjects research training certification. For more information on how this new activity works and how to use it, please see Using the Record Human Subjects Training Snapshot Activity in ARROW .

Coming Soon: Resource Page for New Investigators

We are working on a new resource page on the HS-IRBs website for new investigators. This page will include a step-by-step guide to the IRB process, including determining whether a project requires IRB review, what do if a project requires IRB review, and information about submitting applications to the HS or MR IRB. If you have suggestions for information that should be included for new investigators, please contact Chelsea Dahmen at cmdahmen@medicine.wisc.edu.

New Initial Review Application Guidance

New FAQs have been posted for a few areas of the initial review application that can be challenging to complete:

Study teams - particularly those new to the IRB review process - are encouraged to review these and other FAQs when preparing their IRB applications to help the review process go as smoothly as possible.

Reminder: No Deadlines for Submitting Initial Reviews or Changes to the HS-IRBs

We have recently received several questions about deadlines for submitting new initial review applications or changes of protocol to the HS-IRBs. This is just a reminder that the HS-IRBs no longer have any deadlines for submitting new applications or changes. All applications submitted to the HS-IRBs must first undergo scientific review, if applicable, and pre-review before being scheduled for an IRB meeting or approved by an IRB member. Exemptions also undergo the same pre-review process. Study teams are reminded that continuing reviews should be submitted 6 weeks prior to the study's expiration date.

Update: Logging Out of ARROW

UW-Madison is moving its campus netID and password service to a different platform. The only change that ARROW users should experience is to the log off  process. In order to completely log off of ARROW, users will need to both log off using the log off link in the right corner of their personal workspace and close the browser. Closing the browser without logging off also will completely log users off ARROW. If you encounter any problems with this process, please contact the ARROW helpline at askarrowirb@medicine.wisc.edu.

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, quick check pre-review,community based research, CBR, recruitment, research design and procedures, deadline, deadlines, new investigator, training, record human subjects training snapshot,   Doc ID:23190
Owner:Carol P.Group:Health Sciences IRBs
Created:2012-03-15 10:48 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
Feedback:  1   0