HS-IRBs News June 2016

Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 6, June 2016

HS IRBs Office Closure

The HS IRBs office will be closed Monday, July 4th, in observance of Independence Day.

NIH Single IRB Review Policy Now Final

NIH recently issued its final policy requiring single IRB review for multisite research funded by NIH. The effective date for this policy is May 25, 2017. This policy will apply only to studies where the same research protocol is conducted at all study sites. Multsite studies currently ongoing will not need to comply with this policy until a competing renewal applicatin is submitted. Guidance from NIH regarding key questions such as costs for single IRB review and what information about single IRB review needs to be included in grant applications and proposals is pending. The HS IRBs Office is very involved in the national discussions about implementation of this new policy, and we will provide further information when available. In the meantime, researchers are encouraged to contact the HS IRBs Reliance Team with any questions regarding IRB oversight for collaborative and multisite projects.

Improving IRB Processes for Researchers

As part of our continuing series on how the HS IRBs Office is working to improve IRB processes for researchers, we want to highlight improvements in handling funding deadlines. In the last month, the HS IRBs Office has seen many Just-in-Time (JIT) requests as well as other tight timelines to fulfill grant requirements. While the HS IRBs Office has always made every effort to address funding constraints, we have started a new, comprehensive process for tracking funding time-frames for newly submitted applications, both initial reviews and changes. We are implementing this process to better support researchers who are faced with tight funding deadlines and to help ensure timely IRB approval for such projects.

To assist us in these efforts, we ask that study teams please provide detailed information about any funding deadlines or other time constraints when submitting their applications. This information should be included in the comment box that is available in ARROW when an application is submitted. If you have a funding deadline that has arisen while you are still working on an IRB application, please contact Faye Levine, the IRB Fee/Funding Point of Contact, for assistance.

ARROW Updates

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 and recent improvements include:

  • Earlier and More Frequent Pre-Submission Notifications: ARROW currently sends an email notification to study teams to remind them that an application has been in pre-submission for 90 days and has not yet been submitted to the IRB office. Later this summer, this notification will be sent to study teams twice - at 14 and 30 days - to help researchers better manage pending IRB submissions
  • Concurrent Changes Reminder: ARROW has been updated to now allow only one type of change of application (either a personnel or regular change of protocol) to be submitted at a time. This change eliminates inconsistencies between change forms in ARROW and will reduce the potential for noncompliance when listing study team members in ARROW. Study teams are still able to make changes to personnel as part of a change of protocol application and may submit a continuing review at the same time as a change application.
  • Coming Soon: The HS IRBs and ED/SBS IRB offices are currently discussing ways to improve navigation for exiting and submitting applications to make it easier for study teams to know what steps to take to submit an application to the IRBs.

If you have questions about these changes to ARROW, please e-mail askarrowirb@medicine.wisc.edu.

Tips for Managing Study Team Transitions

With the end of one academic year upon us, study teams may be undergoing transitions with personnel either leaving or joining the UW. Here are a couple tips for managing these changes:

  • Submit a Personnel Change to Update List of the Study Team Members: Whether personnel are leaving or joining the UW, a personnel change must be submitted to keep the list of study team members current. For additional information, see our Personnel Change Guidance or contact us for assistance.
  • Clarify IRB of Record Issues: UW-Madison IRB review does NOT automatically cover someone who leaves the UW but who continues to be involved in the conduct of a study open at the UW. Study teams who wish to keep someone on the study team after they leave the UW should contact the Reliance Team for assistance.
  • Consider Whether a PI Change or Study Transfer Is Needed: Study teams may need to submit a change in PI if the current PI is leaving the UW or make arrangements for the PI to retain PI status at the UW for up to one year in order to complete the study. PIs leaving the UW also may wish to consider transferring IRB oversight for their study to another institution. To discuss options for transferring IRB oversight, please contact the Reliance Team.

Good Clinical Practice Training Reminder

In response to a recent NIH mandate, UW-Madison now requires Good Clinical Practices (GCP) training every 3 years for all members of a study team engaged in research involving drugs, devices, biologics, or radiation. The effective date for this training requirement is August 1, 2016. The human subjects training snapshot activity in ARROW will include GCP training data starting July 30th. The HS IRBs Office will begin monitoring for GCP training starting August 1st. For more information about GCP training, please visit this page. If you have any questions about this requirement, please contact the Office of Research Policy at hrpp@research.wisc.edu or 608-890-4399.

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, Good Clinical Practice, GCP, NIH, single IRB, JIT   Doc ID:64110
Owner:Carol P.Group:Health Sciences IRBs
Created:2016-06-14 15:13 CDTUpdated:2016-07-26 10:55 CDT
Sites:Health Sciences IRBs
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