HS-IRBs News June 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 6, June 2013

HS-IRB Office Closures

The HS-IRBs office will be closed Thursday, July 4th and will close early at 12:30PM Friday, July 5th. The ARROW helpline also will not be staffed on the 4th or the afternoon of the 5th. Normal business hours resume on Monday, July 8th.

New Guidance on Investigational Software

The HS IRBs posted new guidance regarding software used, evaluated, or tested in a research study. This Investigational Software Guidance describes when software can be considered a medical device and thus FDA-regulated. In addition, the guidance indicates when such software is considered investigational and how to describe this to the IRB in the initial review application.

HS-IRBs Staff Updates

  • Farewell: Lauren Stockman, a staff reviewer for the Minimal Risk IRB, is leaving the HS IRBs Office in July.  Lauren will be working as an epidemiologist for the Wisconsin AIDS/HIV Program at the Wisconsin Department of Health Services.  Although Lauren was only with the HS IRBs Office for a short time, she will be greatly missed.  Good luck, Lauren!  
  • On Leave: Jessica Johnson is currently on leave until September. In her absence, please contact the following regarding reportable events and continuing reviews:
    • For reportable events, please contact Catherine Rogers (csr@medicine.wisc.edu) or Brooke Mechelke (263-8880 or bmechelke@medicine.wisc.edu).
    • For continuing reviews, please contact Carol Pech (cap@medicine.wisc.edu).

Human Subjects Research Training Tips

All study team members listed on a UW-Madison IRB application must complete human subjects research training through CITI. Please keep the following tips in mind regarding the human subjects research training requirement:

Reminder: IRB Approval Required Before Enrolling Vulnerable Populations 

A special consent process is often needed in order to enroll subjects who may be considered to be part of vulnerable population (e.g., individuals who are illiterate or who have physical limitations such as blindness or deafness). As a result, IRB approval must be obtained before enrolling such subjects in a study even if such populations are not targeted for enrollment. Please contact the HS-IRBs office for additional information if you considering enrolling members from such populations.

Tips for Preparing Personnel Changes

  • To allow for staff turnover or leaves of absence among study team members, the HS-IRBs office strongly encourages study teams to list more than 1 point of contact in the IRB application. Up to 4 points of contact may be designated.
  • All study team members must have current human subjects research training certification before a personnel change can be approved. To check the training status of study team members, please use the Record Human Subjects Training activity in ARROW. The snapshot displays the names of anyone on the study team who has not completed human subjects research training, has expired training certification, or has taken the required training without using a netID. The names will display in the history tab after the snapshot activity is used. Please see Using the Record Human Subjects Training Snapshot Activity in ARROW for additional instructions.
  • If you are trying to add someone to a study team and her/his name is not appearing in ARROW, please see this FAQ on How to Find Personnel in ARROW
  • Per the HS-IRBs' Personnel Change Guidance, study teams do NOT need to wait for a personnel change to be approved for new personnel to start study activities if ALL of the following are true:
    • A personnel change has been submitted to the IRB for review;
    • The personnel do not have a financial conflict of interest related to the study as defined under the UW-Madison Conflict of Interest Policy;
    • The personnel have completed the required human subjects research training as defined under UW-Madison policy or by Madison VA requirements;
    • The personnel have completed appropriate HIPAA Privacy Rule training, if applicable;
    • The personnel have received study-specific training and can adequately perform their study-related role(s); and
    • The personnel are engaged in human subject research under UW-Madison, UWHC, UWMF or Madison VA appointment of as a UW-Madison student.

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, training snapshot, human subjects research training, personnel changes, investigational software,   Doc ID:30847
Owner:Carol P.Group:Health Sciences IRBs
Created:2013-06-18 09:26 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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