Health Sciences and Minimal Risk IRBs, IRB News / Volume 6, Number 11, November 2014
The HS IRBs office will be closed or have limited coverage the following days in November:
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:
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.
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.
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:
Registration is required. Please email Brooke Mechelke at firstname.lastname@example.org to reserve your spot in one of the future sessions. Space is limited.
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.