HS-IRBs News November 2014

HS-IRBs Office Closures

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

• November 27th: The office will be closed in observance of the Thanksgiving holiday with no coverage, including for ARROW.
• November 28th: The office will be closed. Limited coverage for urgent HS-IRBs and ARROW issues will be provided from 9AM to 3PM and ONLY by email via asktheirb@medicine.wisc.edu.
  
• WIRB offices are closed both November 27th and 28th and no WIRB coverage will be provided by the HS-IRBs those days.
  

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:

• What types of events need reporting and when 
• What determinations the IRB makes regarding unanticipated problems and noncompliance
• Understanding corrective action plans
• Tips for what to include in your reports
• We also will have plenty of time for your questions.

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:

• All versions of approved submissions (initial approved application, approved change of protocol forms and modified applications, approved continuing reviews, and approved/acknowledged reportable events)
• All versions of formal protocols submitted to and approved by the IRB, including tracked change versions to assist in determining what has changed
• All official correspondence to and from the IRB, including approval letters, requests for modifications, and other board determinations
• Funding documentation, including grant applications and award letters
• Stamped, approved consent documents, including consent forms, assent forms, information sheets, and other documents regarding the informed consent process
• Recruitment materials
• Study instruments
• HIPAA authorization forms reviewed and accepted by the IRB
• HIPAA waivers granted by the IRB
• Closure reports

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.