HS-IRBs News - October 2010

Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 10, October 2010

Printer Friendly Newsletter October 2010

REMINDER: All study teams will begin using ARROW (the new electronic submission and review system for the HS and MR IRBs) on November 17, 2010.

ARROW Mini Quick-Start Training and Open Lab Sessions

The HS-IRBs will be offering brief introductions to ARROW for those who did not attend training earlier this fall. These sessions will be held in the HSLC computer lab, with open lab time to follow for those who want assistance with using ARROW or just want to try out the system.

Mini quick-start sessions will be offered in HSLC 2121 on:

  • December 13th from 10-11:30AM
  • January 12th from 2-3:30PM
  • January 17th from 10-11:30AM

Space is limited, so registration for these sessions is required. To register, please email your request to askarrowirb@medicine.wisc.edu. Be sure to include the date for the session you wish to attend.

ARROW Small-Group Demonstrations Will Resume in 2011  Research groups wanting a more detailed introduction to ARROW may request a small-group demonstration. NOTE: No small-group demonstrations will be offered for the remainder of 2010.  Slots for small-group demos will again be available in January 2011. Requests for demonstrations should be emailed to askarrowirb@medicine.wisc.edu.

Questions about Going Live with ARROW?

For more information on what going live with ARROW means, please see the Document 17172 is unavailable at this time. For more information about ARROW – including brief training videos as well as FAQs – check out Health Sciences IRBs ARROW Help of the HS-IRBs website.

Tips for Current ARROW Users

  • Submit Legacy Applications 2 months prior to expiration of IRB approval: Study teams should allow additional time to prepare legacy applications and for the IRB to review these applications. The HS-IRBs Office will work to ensure that legacy applications are approved before IRB approval for a study expires. Legacy application submitted less than 1 month prior to expiration of IRB approval, however, will NOT be prioritized over legacy applications already received.
  • Do NOT Add New Key Personnel to Legacy Applications: When creating legacy applications in ARROW, do NOT add personnel who are not already on the list of key personnel in the currently approved version of the IRB application. A personnel change can be submitted after the continuing review and legacy applications have been approved. For the list of currently approved key personnel, please review the last continuing review or initial review application, whichever is most recent.
  • Cut and Paste Information from Currently IRB Approved Documents: When completing the legacy application, copy and paste information directly from the most recently IRB approved versions of the paper IRB application, consent documents, and study protocol. NOTE: If you completed a non-exempt medical records application or an initial review application form with the version date of 5/27/2008, please see the Document 17435 is unavailable at this time. document for a detailed list of where to find answers in the paper applications to match the questions in the legacy application in ARROW.

    Videos from the WIRB On Campus Symposium Now Available

    Videos for the panel presentations on accessing PHI and HIPAA from the WIRB On Campus Symposium are now available:

    • How to Gain Access to Protected Health Information (PHI)/Medical Records for Research and How to Protect Research PHIHIPAA Research Authorizations

      Feedback from researchers attending these sessions was very positive, so please take a look if you were unable to attend.

      REMINDER: Human Subjects Protection Training Requirements

      UW-Madison requires all personnel engaged in human subjects research to complete human subjects protection training before they can be added to a protocol or a protocol can be approved.  The following trainings are generally required:

      • For all UW-Madison faculty, staff, and students engaged in human subjects research, human subjects training must be completed every three years and generally must satisfy this requirement through the completion of certain modules within the CITI training course.  For UW Hospital and Clinics personnel engaged in human subjects research, the UW-Madison’s CITI training courses must be completed. All personnel within the Health Care Component at the UW-Madison or with UW Health appointments also must complete HIPAA Privacy Rule training designed for researchers. For Individuals engaged in research that falls under the purview of the Madison VA Hospital, VA Good Clinical Practice and Human Subjects Protection Training must be completed.For individuals who are not UW-Madison faculty, staff, or students, VA personnel, or UW Health personnel, human subjects protection training must still be completed if a UW-Madison IRB will serve as their IRB of record.  These individuals can complete the UW-Madison CITI training or other human subjects protection training programs, such the National Institutes of Health Human Subjects Protection Training. 

        Under certain circumstances, a research team can propose alternative training for personnel engaged in human subjects research who are unaffiliated with UW-Madison, the Madison VA, or UW Health.  The reviewing IRB must approve this alternative training.

        For more information on human subjects training requirements, please see the Education and Training of HRPP Personnel Policy.  To access CITI training and for further practical details about training, please see the Graduate School’s training opportunities page.

        IRB Fee Updates

        In July 2008, a new IRB fee schedule was implemented.  Below are two clarifications regarding the assessment of IRB fees.  Please note that only researchers within the School of Medicine and Public Health (SMPH) are currently subject to IRB fees.

        Protocols Funded by Private Foundations

        If a private sponsor provides indirects (aka F&A) to support a research study, in most cases IRB fees will not be assessed.  Additionally, if a private sponsor has as a standing, publicly posted policy that it will not provide indirects for any research its supports, no IRB fee would be assessed. There are two cases when a privately sponsored study, however, could be assessed a fee:

        • If the indirect rate the sponsor provides is significantly under the current 28% rate the UW receives for most research (e.g., under 10%) and the study does not otherwise qualify for recusal from an IRB fee (e.g., the study is exempt human subjects research or is a medical records study) the protocol will be placed on a list of studies that have incurred fees that the IRB maintains, which is provided to the principal investigator’s department at the end of the fiscal year.  The department would be responsible for paying the IRB fee for the study.If the sponsor has a policy to provide indirects as part of its support for research studies but declined to provide them for a specific study and the study does not otherwise qualify for recusal from an IRB fee (e.g., the study is exempt human subjects research or is a medical records study), the protocol will be placed on a list of studies that have incurred fees that the IRB maintains, which is provided to the principal investigator’s department at the end of the fiscal year.  The department would be responsible for paying the IRB fee for the study. 

          Protocols for which Funding is Pending

          If a federal or private grant is not in place when the IRB receives a study for review and the study does not otherwise qualify for recusal from an IRB fee (e.g., the study is exempt human subjects research or is a medical records study), IRB fees will be assessed for any reviews that occur before the federal grant or other funding is awarded.  IRB fees that were incurred before any funds are awarded that qualify the study for recusal from IRB fees will not be refunded.

          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.




Keywords:Newsletter   Doc ID:18411
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-05-02 18:00 CSTUpdated:2015-10-13 14:11 CST
Sites:Health Sciences IRBs
Feedback:  0   0