IRB Member Newsletter--Volume 4 (Winter 2011/2012)

Updates for IRB Members

• New IRB Members
• New Guidance Available for Primary Reviewers
• Other New Guidance Documents Available
• Updated IRB Members Responsibilities Document
• 2012 IRB Member Schedules
• IRB Member Evaluations

Welcome to New HS IRB Members! (And good-bye to another)

Two new community members (i.e. unaffiliated with the UW, UWHC, UWMF, or VA) have joined the HS IRB.   Both are practicing attorneys in the Madison area and come to us to with prior experience with research oversight.  

Stuart Mondschein is an attorney with Wheeler, Van Sickle & Anderson, S.C. and practices in the area of commercial and personal litigation and consultation.  Notably, he served as a member of both the UW School of Letters and Sciences Animal Care and Use Committee and the All-Campus Animal Care and Use Committee until 2005.

Joe Hanes is an attorney with Quarles & Brady, LLP in their Health Law Group.  Mr. Hanes has served as a legal consult to various IRBs, specializing in regulatory compliance with particular interest in FDA regulations.

We are excited to have such experienced community members join the Board! 

On another note, one of the HS IRB’s long-serving community members, Dave Sugar, departed the committee in September 2011 as part of his decision to retire. We want to express our sincerest gratitude to Dave for his service on the committee, especially for his dedication, the unique professional and personal experience he brought to his reviews, his kindness and a wonderful sense of humor. Enjoy your retirement, Dave!

New Document Available: Guidance for Primary Reviewers for Summarizing Initial Review Applications

The HS IRBs assign a primary and secondary reviewer to each initial review submission. At IRB meetings, these reviewers are responsible for providing a brief but sufficiently detailed summary of the submission and analysis as to whether the protocol meets the criteria for IRB approval.  We have created guidance to help primary reviewers determine what details should be included in this summary, and what issues, comments, or concern may warrant special attention.   The new guidance can be reviewed here:  Guidance for UW Madison Health Sciences IRB & Minimal Risk IRB Primary Reviewers for Summarizing Initial Review Applications

Additional Guidance Documents Available

In addition to the Primary Reviewer Guidance, we have also added several other new documents to the website directed at IRB members.  These include:

• How to Conduct a Deferral Response Review in ARROW: Shows how to review an assigned deferral response, including how to determine what has changed in an application.
  
• How to Conduct a Modification Response Review in ARROW: Shows how to review an assigned modification response, including how to view the IRB requests and the study teams response.
  
• How to Conduct PRS Review: Shows how to complete Preliminary Review Session duties in ARROW, including where to find reviewer checklists and how to submit PRS notes.
• IRB Member Workspace Navigation Guide: Shows how to navigate between different roles (e.g. study team member, IRB member), and describes the tabs available to IRB members, including the inbox tabs.
• Meeting Workspace Navigation Guide: Shows how to find an agenda and access items for a specific IRB meeting.

To access these, and many other helpful materials created specifically for IRB members, please remember to visit the IRB Member page of the IRB website regularly: For IRB Members

Updated IRB Members Responsibilities Document

All IRB members are provided with a document outlining IRB Member Responsibilities at the time of their orientation.  The document addresses overall expectations of IRB members and includes detailed information on meeting logistics and review process.  Given the numerous changes the MR and HS IRBs have undergone over the course of the past three years, this document has been significantly updated.  Please review the updated documents here:

For HS IRB Members: Brief Responsibilities of an HS-IRB Member

For MR IRB Members: Brief Responsibilities of an MR-IRB Member

2012 IRB Member Schedules

The HS IRBs Office set the 2012 IRB meeting dates and has been trying to confirm schedules for IRB members since October. We try to set the schedule for the entire year beginning in late fall of the preceding year. If you have not responded to email requests from Molly Lumley to confirm your assigned meetings, please do so as soon as possible in order to allow the IRB Office to set up the Preliminary Review Session schedule for 2012. Thank you to all of the IRB members who have already confirmed their schedules.

IRB Member Evaluations

Due in part to recommendations made during the recent Association for the Accreditation of Human Research Protection Programs (AAHRP) accreditation site visit in September, the IRB Office in conjunction with the IRB chairs is rolling out a process for formally evaluating IRB member performance at regular intervals during the course of an appointment.  Recognizing the voluntary nature of IRB membership, as well as the significant time commitment involved in serving on the committee, this evaluation plan is intended to be a collaborative process, serving as both a way to provide feedback to IRB members as well as to offer members the opportunity to share their views on the functioning of the board.  Details on the rollout of this process will be provided as they become available.