Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 2, February 2016
We are pleased to announce that Faye Levine, who has served as our Office Manager for the last few years and works with some study teams regarding funding issues, has been promoted to Departmental Administrator for the Health Sciences IRBs Office. Faye is available for consultation regarding funding issues and is happy to help study teams and research administrators get answers to questions they may have about IRB submissions.
Are you new to the HS-IRBs review process? Consider registering for one of our upcoming IRB for Beginners workshops. This two-hour session provides an introduction to the HS-IRBs review process, resources, and the ARROW online application system.
This workshop offers an introduction to the use of single IRB review for multisite and collaborative research. The goal is to familiarize researchers with single IRB review concepts and the resources offered by the HS IRBs to facilitate the use of single IRB review. Participants will be invited in advance to provide questions they wish to discuss at the workshop.
Update: Concurrent Changes of Protocols & Personnel Changes
ARROW currently allows study teams to submit a personnel change application and a change of protocol application at the same time. Beginning at the end March, submission of concurrent change of protocol and personnel change applications will no longer be permitted. Only one type of change application will be able to be submitted at a time. As is the case currently, study teams will still be able to make changes to personnel as part of a change of protocol application. This change to ARROW is being made eliminate inconsistencies in which study team members are listed in the approved IRB application. These inconsistencies are the result of technical limitations with ARROW and this is the most efficient solution to address the problem. If you have questions about this change to ARROW, please email firstname.lastname@example.org for help.
Update: ClinicalTrials.gov Required Question
In response to federal requirements, a new required question has been added to the Initial Review Application on the Clinicaltrials.gov registration page. All applications must now specify whether either the FDA or International Committee of Medical Journal Editors (ICMJE) require a study’s registration at clinicaltrials.gov. Since this change also affects existing studies, study teams will need to answer this new required question when submitting changes of protocol.
Tip: Uploading Updated Documents in ARROW
When submitting change of protocol that involve revisions to consent documents, please remember to upload versions of consent documents with only current changes tracked, using the ‘Upload Revision’ button. Changes in the consent documents that have already been reviewed and approved by the IRB should no longer be tracked as it leads to confusion between previously approved changes and those being newly proposed. When uploading revised documents in ARROW, please keep the following in mind:
We are in the process of updating the Quality Improvement/Program Evaluation Self-Certification tool (currently titled Research Decision Tool). These updates will incorporate researcher feedback, and make the tool easier to find and use. We will provide additional details in the coming months.
In the meantime, please note that this tool is intended for use with local, single-site projects. In cases of multi-site or collaborative research projects, please contact the HS IRBs Reliance Team for assistance rather than utilizing the tool. For more information, please see the Guidance on Research vs. Quality Improvement and Program Evaluation. For questions about the Research Decision Tool, contact Monica Esquibel.
A revised version of the campus Five Year Replacement/Renewal Policy has been posted. The policy has been revised to expand the types of studies for which a replacement application is not needed as well as to provide study teams with an additional year to qualify for an exception to the renewal policy. These changes are expected to decrease the number of studies for which a replacement application is required, which will reduce administrative burden for study teams and IRBs alike. Please contact Emily Jenner or Jessie Johnson if you have any questions about how the revised renewal policy applies to a particular study.