HS-IRBs News November 2014

Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 11, November 2014

HS-IRBs Office Closures

The HS IRBs office will be closed or have limited coverage the following days in November:

New Outreach Event: Reportable Events Refresher

The HS IRBs office is offering a new outreach event for study teams, a one-hour Reportable Events Refresher session. This event will be held on Tuesday, November 25th from 11AM to noon in CSC G5/119. Topics will include:

Registration is required for this session. To register or to let us know that you would like to participate but are unable to attend the November 25th session, please complete this short form: http://tinyurl.com/od7go24/.

Important New Guidance on Use of X-Ray Radiation in Research Studies

New guidance has been posted on the HS IRBs’ website regarding a Wisconsin Department of Health Services (DHS) regulation that applies to some human subjects research studies using x-ray.  Under DHS regulations, deliberate exposure of an individual to useful beam radiation without prior medical examination indicating a need for an x-ray procedure and prescription for such a procedure by a practitioner of the healing arts is prohibited without a formal variance from DHS.  Research studies that expose subjects to x-ray radiation as part of standard clinical imaging or which are therapeutic in nature (i.e. those which present the prospect of direct benefit to subjects), do NOT presently require a variance from DHS.  However, if a research study is non-therapeutic in nature or enrolls healthy volunteers, a variance must be requested.  The new Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes provides more information about the DHS statute and describes the process UW-Madison researchers should follow to request a variance for new or previously-approved human subjects protocols to which the statute applies.

Reminder about Regulatory Documents

Study teams are responsible for maintaining a record of regulatory documents. One of the benefits of the transition to the ARROW system is a better means for tracking which documents the IRB has approved and any changes made to those documents. Study teams should use ARROW to ensure they are working with the most current versions of IRB-approved documents, including protocols, recruitment materials, and consent and HIPAA documents. Study teams are expected to be able to easily ascertain the correct (approved) version of documents that have been reviewed by the IRB.  Failure to use the approved version of documents that have been reviewed by the IRB can result in noncompliance.

Minimum documentation study teams are responsible for keeping related to IRB review of human subjects research includes the following:

For further guidance on materials that require IRB review and approval, please see Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval .

Study teams are required to keep other documentation related to the conduct of human subjects research beyond those related to the IRB review and approval process. The UW Institute for Clinical and Translational Research (ICTR) has developed a Clinical Research Toolkit  to assist study teams throughout the study process; including a “Regulatory Binder Guidance” that provides additional information on what materials should be kept.

Last Call for 2014: IRB for Beginners Workshops

The HS IRBs office is offering IRB for Beginners Workshops. The 90-minute workshops will be held in the HSLC computer lab and will give participants a first-hand view of the resources available on the HS-IRBs website as well as basic tools and tips for the ARROW electronic application submission system. The workshop will also introduce participants to the IRB’s review process and procedures. This workshop is designed to help people who are new to the HS-IRBs review process.

This workshop is scheduled for the following dates:

Tuesday, December 9th 9:30-11:00 AM (HSLC Room 2121)
Wednesday, December 10th 2:00-3:30 PM (HSLC Room 2121)

Registration is required. Please email Brooke Mechelke at bmechelke@medicine.wisc.edu to reserve your spot in one of the future sessions. Space is limited.

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.