HS-IRBs News January 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 1, January 2013

New and Improved Reportable Events Page

The Reportable Events page on the HS-IRBs website has been revised to help make the guidance about reportable events more accessible. Several new documents have been posted to assist study teams with understanding what to report and when. Some current guidance documents have been revised to reflect changes in reporting time frames. A summary of the new and revised reportable events documents has been posted

HS-IRBs staff also will provide an overview of the most important changes to the reportable event guidance on February 19th from noon to 1PM in 1309 HSLC. This session is for study teams NOT in the UWCCC; a separate session is being held for UWCCC study teams on February 20th. Registration is required. Please mail Jessica Johnson at jjohnson@medicine.wisc.edu to register.

The new and revised guidance documents are effective immediately. Due to the number of changes, however, the HS-IRBs will offer a grace period until March 1, 2013. This grace period is to allow study teams sufficient time to become familiar with the new and revised reportable events guidance.  After March 1st, the HS-IRBs will expect study teams to adhere to the new reporting guidelines.

Reminder: Important Proposed Changes to the ARROW Helpline

The HS-IRBs office currently supports the ARROW helpline through both email and voicemail. Beginning in spring 2013, the office plans to phase out voicemail support and continue only email support for the ARROW helpline.
  • Why is voicemail support for the helpline being phased out? The reasons for this change include a significant decrease in the number of voicemails received by the helpline as well as the ability of the office to provide better and more timely responses to emails received by the helpline rather than voicemails.
  • What does this change mean for study teams? Email support for the helpline will still be provided Monday through Friday, 9AM to 3PM. HS-IRBs staff will still call study teams when needed to resolve an ARROW technical issue.
  • Will ARROW training still be available? ARROW training is available through the IRB for Beginners workshop and through the many resources available on the Health Sciences IRBs ARROW Help  page. Study teams can get additional in-person assistance at ARROW open labs.

If you have any concerns or questions regarding this proposed change, please email Carol Pech (cap@medicine.wisc.edu).

Last Call for the IRB for Beginners Workshop Until Summer 2013

The HS-IRBs Office is offering 1 additional session of the IRB for Beginners Workshop this month. We have a couple spots available for the January 28th session that starts at 11AM. The 90-minute workshop will be held in the HSLC computer lab (room 2121) 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 also will introduce participants to the IRB's review process and procedures. This workshop is designed for people who are new to the HS-IRBs review process.

Registration is required. Please email Brooke Mechelke (bmechelke@medicine.wisc.edu) to reserve your spot.

HS-IRBs Staff Update

Brandy Stoffel has joined the HS-IRBs office as a new IRB staff reviewer. Brandy comes to us from the University of Missouri IRB, where she served in a similar staff reviewer role. Brandy will be working with both the HS and MR IRBs, including assisting with expedited reviews. She also will assist with WIRB submissions. Welcome Brandy!

Revised: Updates to 2 Campus Human Subjects Research Policies

A new section has been added to the Defining Human Subjects Research Policy regarding defining UW-Madison's jurisdiction. The new section states that UW-Madison does not become engaged in research by allowing a non-UW-Madison investigator to use a UW-Madison resource, property, or facility to conduct his/her own human subjects research, although UW-Madison may still require the investigator to submit an application for UW-Madison IRB review. 

The Conflicts of Interest of Non-UW-Madison Key Personnel Participating in Human Subjects Research under the Purview of a UW-Madison IRB policy has been updated to reflect new federal requirements and changes to UW-Madison conflict of interest program practices. The documents now describes procedures for reviewing non-UW-Madison research personnel who identify a significant financial interest in the UW-Madison IRB application.

WIRB Update: Fee for Consent Addenda

WIRB now regards consent addenda as an additional new consent document for a protocol. As a result, WRIB will now be assessing a "New Consent Form" fee in conjunction with either a "Change to Research" or "Initial Review" fee. Please be aware that study teams will be charged two fees when submitting this type of document. WIRB will assess the fees after it approves the document. Please see the IRB Fee Policy for additional information and contact Colette Wagner (caw@medicine.wisc.edu) with any questions.

Continuing Review Reminders

  • Study teams should submit their continuing review applications 60 days prior to expiration of IRB approval. 
  • IRB staff review continuing review applications in order according to the expiration date for IRB approval for a study, not the date the continuing review was submitted to the IRB office. This is to help ensure that, when at all possible, IRB approval does not expire for studies for which a continuing review has been submitted.
  • Continuing review applications for studies that are minimal risk or in data analysis or long-term follow-up are typically reviewed under expedited procedures by an IRB member. Whether a continuing review can be reviewed under expedited procedures or requires review by the full IRB, however, is at the discretion of the IRB member reviewing the continuing review application.

Reminder: Clinical Trials Registration

The federal government recently issued various laws and directives regarding clinical trial registration. The registration effort began with the development of the Clinicaltrials.gov website with the goal of providing more transparency about clinical studies, especially regarding results of such research. The campus has developed detailed guidance for researchers about what studies need to be registered with Clinicaltrials.gov, who can assist with the registration, what information is required if the study must be registered, and the potential penalties for failing to register when required. This guidance can assist study team in answering the question within the ARROW initial review application regarding whether a study requires registration at Clinicaltrials.gov and who is responsible for the registration. 

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.

  • For 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.
  • For 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.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, 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, helpline, workshops, reportable events, continuing review, clinicaltrials.gov, conflict of interest,   Doc ID:27999
Owner:Carol P.Group:Health Sciences IRBs
Created:2013-01-10 11:08 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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