HS-IRBs News February 2012

Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 2, February 2012

New FAQs Now Posted

Several new FAQs have been posted to the HS-IRBs website, including some that provide brief overviews of key human research protection program (HRPP) policies. The new FAQs include the following:

Important Consent Form Language Reminders

On March 7, 2012, the FDA requirement to include language in consent forms about listing trials in clinicaltrials.gov goes into effect. We thought we would take this opportunity to remind you of other recent changes in language requirements that are frequently missed in consent forms submitted to the HS-IRBs:

Coming Soon to ARROW: Ability to Check Human Subjects Research/CITI Training for Study Team Members

This spring, a new activity will be added to ARROW that will allow study teams to check the human subjects research/CITI training status for all study team members listed in the IRB application. The information provided about training in ARROW will include whether a study team member has completed the training, which course was completed, and expiration date for training certification. After this functionality becomes available, study teams will be expected to check the training status of all study team members prior to submitting initial review applications or personnel changes to the HS-IRBs. A FAQ about how to use this new activity will be available soon.  If you have questions about this new ARROW feature in the interim, please contact Carol Pech at cap@medicine.wisc.edu.

Personnel Change Reminders

When submitting personnel changes, study teams should keep the following in mind:

IRBs are audited, too: The Office for Human Research Protections (OHRP) Begins Audit of UW-Madison

UW-Madison was recently informed that OHRP is beginning an audit of the institution. OHRP is the federal agency that regulates the protection of human subjects that participate in research funded by the Department of Health and Human Services (DHHS). The audit is “not for cause”, which means that OHRP will conduct a general inspection of the UW’s human research protection program. The audit will focus on IRB function and initially involve a review of HRPP-related documents (e.g., policies and guidelines, information about IRB members and staff, and a list of DHHS-supported studies). OHRP may conduct interviews of research teams as well as a site visit in future. The last time OHPR visited UW-Madison was in 2000.

In addition to the new OHRP audit, the HS IRBs have undergone 5 audits since 2006. Audits can affect what the IRBs ask for and how regulations are interpreted. Researchers frequently wonder why IRBs ask them to answer so many questions in the IRB application. These questions are to designed to help the IRB obtain sufficient information from study teams to assess and document whether a study meets the federal regulations governing human subjects research. Just like study teams, the IRB must be able to demonstrate to auditors the reason why it took the actions it did.

Reminder: Incarceration and Unanticipated Problem Reports

Study teams are reminded that if a subject enrolled in a research study becomes incarcerated, this must be reported to the IRB as an unanticipated problem in accordance with campus policy. For more information, see the campus Reporting Unanticipated Problems policy as well as the Unanticipated Problems/Adverse Event Reporting Decision Guide.

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.