HS IRBs News May 2018

Health Sciences and Minimal Risk IRBs, IRB News/Volume 10, Number 4, May 2018

HS IRBs Office Closure

The HS IRBs office will be closed Monday, May 28th, in observance of Memorial Day.

HS IRBs Staff Updates

  • Farewells: Staff reviewer Curtis Ryals had been working part-time for the HS-IRBs Office since his return in 2016, working mostly with full board changes of protocol reviewed by the Health Sciences IRB; he bid farewell to the office at the end of April. Tesha Zimmerman, the Quality Assurance and Operations Specialist (IRB Submission Manager), will be taking a new position as the Forestry Program Assistant for the City of Madison starting in June. We thank Curtis and Tesha for their work with us and wish them both the best!
  • Filling In: With Curtis' departure, Catherine Rogers will be the primary point person for HS IRB full board changes while Anna Martin will be handling most full board changes for the MR IRB. With Tesha's departure, Faye Lux will be handling administrative review.

Improving IRB Processes for Researchers - Updated ARROW Notifications

ARROW automatically sends email notifications to study teams at various points throughout the IRB review process. Email notifications are a convenient feature of the ARROW system that can assist study teams in navigating the IRB review process (see Working with Email Notifications for more details).

The format of these emails has remained largely unchanged since 2010, but starting in June, they will have a new, much improved look. The subject line will now refer to the specific protocol number and PI instead of generic language (e.g., "Application Not Yet Submitted"), and the email body has been rearranged to provide clarity.

For questions about this, or other ARROW improvements, please contact askarrowirb@medicine.wisc.edu.

Reminder: Selecting Secondary Use of Information as a Special Procedure

Study teams may have noticed new secondary use pages in the application that were added with the February update to ARROW. These pages appear when study teams select “Secondary use of information not included in health care records for research purposes (e.g., additional use of research data)” on the “Special Procedures” page. Study teams should select this box when they are conducting secondary analysis, or analyzing data that are being generated for another purpose than for what the research team completing the application will use the data. They will then be prompted to complete a couple pages with questions about what kind of information is included in the data set(s), the source(s) of the data, whether or not the data are directly or indirectly identifiable, and more.

There is guidance embedded within the application to help study teams answer these questions, but other resources that may be helpful are the HS IRBs Office’s Identifiability Guidance, and Sending or Receiving Specimens/Data/Images Guidance.

For questions about the secondary use pages or when to select them, please contact asktheirb@medicine.wisc.edu.

Updated Guidance Documents on Investigator's Drug Brochures (IDBs) and Package Inserts

The HS IRBs Office has recently updated guidance on when to submit new versions of IDBs or Package Inserts that were previously submitted to the IRB, as well as the IDB and Package Insert Log that must be used when study teams submit minor changes at the time of continuing review. The purpose of the edits were to clarify what information must be included in the IDB and Package Insert Log for package insert updates. The Principal Investigator may assess the revised package insert and confirm it does not meet any of the criteria noted above that would require submission prior to continuing review.

Introducing PREP: the Professional Research Education Program

A cross-campus education working group has been working to expand the educational offering to UW-Madison researchers. You may have completed a Needs Assessment Survey in late 2017 that was created to gauge the training needs of our research community. Your input helped us to prioritize the creation of these new opportunities when creating PREP.

PREP is a new education program open to all UW-Madison faculty, staff, and students who conduct human subjects research. PREP’s goal is to prepare the UW-Madison research community to conduct safe and compliant human subjects research by offering ongoing continuing education and professional development opportunities. Presentations will cover a variety of topics and be presented by subject matter experts from around campus. For a full list of upcoming events, go to the Upcoming Education Opportunities available on the Human Research Protection Program (HRPP) Education and Training webpage or to the "Professional Research Education Program (PREP)" category of the Office of Talent Management (OTM) Course Catalog.

For questions about PREP, please contact Travis Doran.

Keywords: staff updates, notifications, IDB, package inserts, PREP, education, secondary use, guidance, training   Doc ID:82167
Owner:Monica E.Group:Health Sciences IRBs
Created:2018-05-09 13:44 CSTUpdated:2018-08-23 03:36 CST
Sites:Health Sciences IRBs
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