HS-IRBs News July 2017

Health Sciences and Minimal Risk IRBs, IRB News/Volume 9, Number 7, July 2017

New Informed Consent Tools and Knowledge Base Orientation Session

The Health Sciences IRBs Office is excited to announce that newly developed Informed Consent Templates and Additional Model Language are now available for use in new research studies. An orientation session has been planned to provide an overview of the new materials, including when and how researchers submitting to the HS IRBs can use the documents as well as addressing any questions you might have.

The session will be held on:

If you have questions, please contact Jake Rome at jarome@medicine.wisc.edu.

WIC Transitioning to SMART IRB

Effective August 1st, the Wisconsin IRB Consortium (WIC) will transition to SMART IRB. Each WIC institution has signed on to the SMART IRB agreement, along with over 240 institutions across the United States. The WIC institutions have agreed that transitioning to the SMART IRB agreement now would ensure the IRB reliance process continues to go as smoothly as possible for researchers and IRBs alike. Using the SMART IRB agreement also will allow researchers to more easily work with sites outside of WIC.

Any WIC requests still under review or received in early August can use the WIC agreement and procedures. Studies currently approved under the WIC agreement will NOT be affected by this transition. After early August, the process for submitting a request to cede IRB oversight or to have the UW serve as IRB of record will be the same as other such requests submitted to the HS IRBS.

For more information on this transition, please see WIC Transition to SMART IRB FAQ or contact the HS IRBs Reliance Team (irbreliance@wisc.edu) with any questions.

Upcoming IRBs for 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. The August date and registration link can be found below; the next training will not be held for another six weeks.

  • Thursday, August 10th - 2PM to 4PM, HSLC 2121 - Registration available here.

If you have questions, please contact Jake Rome at jarome@medicine.wisc.edu.

Revised Scientific Review Guidelines

The categories of new submissions that do NOT require review by the ICTR Scientific Review Committees have been updated and now include studies that solely involve:

  • Wearable devices, such as accelerometers and fitbits, or tests that use external sensors that do not otherwise result in physical stimulation (e.g. EEGs)
  • Walking tests
  • Imaging (MRIs, ultrasounds) with FDA-approved devices (hardware and software) when the imaging is performed within the FDA indications and evaluation of the device is not the focus of the research (NOTE: PET-MRI does not fall under this category.)

In addition, if peer review has already been conducted, study teams may be asked to provide the criteria used to evaluate the project. This information should be uploaded in the Supplemental Section of the application.

For questions about the ICTR SRC processes, please contact Danielle Gale, Administrative Coordinator, UW-ICTR Scientific Review Committee, at dgale@uwhealth.org.

Coming Soon: ARROW Newsletter

A special edition of the newsletter focused on upcoming improvements and enhancements to ARROW will be sent out by the end of July. We will highlight specific items you will see as a result of the ARROW patch at the end of this month as well as coming attractions for this fall.

New and Updated Guidance

The Guidance and SOP Working Group (GSWG) and Reportable Events Team have new and updated documents for study teams.

  • Communicable Disease Guidance: This document has been updated to clearly define a communicable disease, distinguish between testing performed for research versus clinical results used for research, and outline IRB considerations for communicable disease research, including communicable diseases requiring contact precautions.
  • HIV Testing in Research Guidance: This new document provides guidance for researchers on testing and reporting for HIV within the context of a research study, or for use of HIV test results for research purposes.
  • Events Requiring Reporting to the IRB: Notable changes include: 1) Serious Adverse Events (SAEs) generally do not require reporting to the IRB unless they also potentially meet the definition of an unanticipated problem and 2) events unrelated to the research no longer need to be reported for VA studies.

If you have any questions or suggestions for GSWG, please contact Tesha Zimmerman at tmzimmer@medicine.wisc.edu.

For questions about reportable event updates, please contact Catherine Rogers at csr@medicine.wisc.edu.

Keywords:news, newsletter, consent, workshop, training, WIC, reportable events, RE, scientific review   Doc ID:74481
Owner:Monica E.Group:Health Sciences IRBs
Created:2017-07-06 09:58 CSTUpdated:2017-07-27 08:20 CST
Sites:Health Sciences IRBs
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