University of Wisconsin KnowledgeBase

HS-IRBs News April 2017

Upcoming Beginners Workshop

The Health Sciences IRBs for Beginners Workshop provides training on the HS IRB's processes, regulatory approval process, resources, and ARROW online application system. The two-hour workshop is held several times each year in the HSLC computer lab (room 2121), and is meant for individuals new to the HS IRBs processes or for those looking for help on how to effectively submit an IRB application. The workshop consists of two sections meant to provide the regulatory framework and technical skills to submit an application. Upcoming dates and registration links, when available, can be found below.

• Tuesday, May 9th - 2PM to 4PM, HSLC 2121 - Registration available here.

Updated WIRB Eligibility Form

The HS-IRBs Reliance Team has posted an updated WIRB Eligibility worksheet, effective 4/11/17. The updated form is posted on the Eligibility page under the step-by-step process. Changes of note include updated conflict of interest language, a removal of the multi-site requirement, and an alteration of the form format. Please contact submitwirb@medicine.wisc.edu with any questions.

New Informed Consent Templates

The HS IRBs Informed Consent Working Group (ICWG) is excited to announce that, after a successful pilot, they will be rolling out new informed consent templates and additional model consent form language. Thank you to all our pilot participants, who provided critical and helpful feedback on the new forms! The documents are expected to be available on the IRB website in early summer, so stay tuned.

If you have any questions about the new templates, please email ICWGquestions@medicine.wisc.edu.

Updated Reportable Event Form and Guidance

Study teams may have encountered the changes to the reportable event form after the March ARROW update. Information within the form has been reorganized, new questions have been added, and the Serious Adverse Event (SAE) event type has been removed, as SAEs only require report if they are also an Unanticipated Problem (see updated guidance on when SAEs qualify as an unanticipated problem).

Accompanying these changes to the form, the Noncompliance guidance page has also been revised, and new guidance on Presenting Noncompliance Reports to the IRB is now available. The goal with the change to the reportable event form and revised guidance is to make the process for reporting these events easier and less time-consuming for the research community.

Questions about these changes can be directed to Catherine Rogers, HS IRBs Reportable Event Team, at csr@medicine.wisc.edu.

New Reliance Team Pilot Projects

The Reliance Team has initiated two new pilot projects to proactively reach out to study teams regarding applications in that have not yet been submitted to the HS IRBs office and that may benefit from assistance from the Reliance Team. The two projects focus on the following types of situations:

• Studies that are multi-site with a non-UW-Madison coordinating center since these may may qualify for review by a non-UW IRB. The goal of this project is to help streamline the IRB review process for researchers by potentially utilizing a single IRB review model.
• Applications that include a request for the UW to serve as IRB of Record for external personnel. The goal of this project is to help mitigate the administrative burden to researchers and delays in the review process that can result from these kinds of requests.
  

These pilot projects will run through June and be evaluated for implementation at that time. If you have any questions about these pilot projects, single IRB review, or multi-site research in general, please contact the Reliance Team at IRBReliance@medicine.wisc.edu.

Improving IRB Processes for Researchers: New Training Matrix

The Human Research Protection Program (HRPP) has developed new resources for the research community regarding the minimum training requirements to conduct human subjects research at the UW-Madison. High quality research starts with the proper training, and researchers are encouraged to use new webpage as a guide to help determine which training, compliance, and oversight mechanisms at UW apply to their research. This new page also includes information on campus resources that may be helpful for researchers, organized by the stage of a study and topic.

For additional information about this page, please contact Travis Doran, Human Research Protection Program, at travis.doran@wisc.edu.

Changes to Informed Consent Document Stamp Have Commenced

As of February 2017, the IRB approval stamp for consent forms, information sheets, and assent forms no longer include an expiration date or the UW's federalwide (FWA) number. Consent and assent documents no longer expire and, following a transition period, study teams will no longer need to request reapproval of their consent documents at continuing review. Additional guidance is available here.

• New Studies: For studies approved after 2/11/17, consent documents will receive the new stamp. The only time the consent documents will be stamped again is when revisions are made to the consent documents via a change in protocol.
• Ongoing Studies: For studies approved before 2/11/17, consent documents will receive the new stamp with either the next continuing review or change of protocol if the change includes revisions to any consent document. If a study has multiple consent documents and a change revises any consent documents, all of the consent documents will receive the new stamp at that time for consistency's sake.

For any questions or concerns about this change to the approval stamp, please contact Peter Johnson in the Office of Research Policy at 608-890-1241 or peter.johnson3@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.

• 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.