HS-IRBs News February 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 2, February 2016
Office Staff Updates
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.
1) Health Sciences IRBs for Beginners Workshops
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.
- February 24th, 9-11 am, HSLC 2121 - Registration available here
- February 29th, 2-4 pm, HSLC 2121 - Registration available here
2) Single IRB Review Workshop (Basics)
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.
- Thursday, February 25th, 1-2 pm, HSLC 1244 - Registration available here
ARROW Updates & Tips
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:
- Always use the Upload Revisions button to upload revised documents. Do NOT delete the current version of the document and/or upload new documents. Please see [Link for document 17339 is unavailable at this time.] for more information.
- Always accept all previous changes and then ensure that proposed updates to the documents are tracked.
- Always upload ONLY a tracked changes version of the revised documents. Do NOT upload a clean copy in addition to the tracked changes copy and do NOT upload a copy of the previous version of the document.
Coming Soon: Updates to the Research Decision Tool
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.
Reminder: Important Updates to the Five Year Renewal Policy
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.
- 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.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email email@example.com. These are the quickest ways to get help with general questions.
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.