HS-IRBs News May 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 5, May 2013

HS-IRBs Staff Update

The HS IRBs Office has had the privilege of counting Gemma Gliori amongst its staff since she joined the office in 2008 as a staff reviewer. Gemma has accepted a position in the Department of Radiology as their regulatory specialist. The good news for us is that we will be able to continue working with her and will benefit from the application of her knowledge and skills to IRB submissions from that department. The sad news for us and the wider research community that works with the HS IRBs is that we are losing a wonderful colleague who took the mission of customer service seriously and went out of her way to assist study teams, IRB members, and her co-workers. Gemma, we will miss especially your intelligence, humor and kindness. Please join us in wishing Gemma the best in her new position.

Tips for Completing Continuing Review Applications

To help ensure the continuing review process goes as smoothly as possible, please keep the following tips in mind when preparing a continuing review application:

If you have any questions about the continuing review process, please contact Jessica Johnson or Carol Pech.

Improved Training Snapshot Activity in ARROW

The Record Human Subjects Training activity in ARROW now displays the names of anyone on the study team who has not completed human subjects research training, has expired training certification, or has taken the required training without using a netID. The names will display in the history tab after the snapshot activity is used.

Study teams must use the snapshot activity when submitting a new application or a personnel change. All study team members must have current human subjects research training certification before a new application or personnel change can be approved.

Update: Submitting IDBs at Continuing Review

Per HS-IRBs guidance, study teams may submit IDBs (investigator's drug brochures) at continuing review if the IDB does not contain new risk information. As a result, these revised IDBs are uploaded only in the continuing review application and not in the initial review application. In some cases, sponsors have requested that the study team “move” these IDBs from the continuing review application to the initial review application, which requires the study team to submit a change of protocol.  

Rather than submit changes of protocols that are otherwise not needed, study teams are advised to direct sponsors to the appropriate continuing review application for documentation that the IDB was reviewed by the IRB. If the sponsor requests additional documentation after being directed to the appropriate continuing review application, please contact the IRB for further assistance. 

Updates to VA Template Consent and Authorization Forms

Updates were made to VA Template Documents . The VA HIPAA authorization template was revised to change the title from “VA Consent Form” to “VA Authorization Form” and now contains highlights to better direct study teams to the sections that require either revision or insertion of language.

The VA consent template also has been revised to address the following:

The template also was recently revised to reference language that should be included if study teams are paying subjects or if they are using the UW’s OnCore system to manage the study and store subject data.

Reminder: ARROW Helpline Voicemail Support Ended

As previously announced, voicemail support for the HS-IRBs' ARROW helpline has been phased out. We will continue to provide email support for ARROW through askarrowirb@medicine.wisc.edu. ARROW guidance documents also are available on the Health Sciences IRBs ARROW Help page.

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.

  • 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 asktheirb@medicine.wisc.edu. 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 irbreliance.wisc.edu.

  • Assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • WIRB updates, 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.