HS-IRBs News October 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 10, October 2015

Important: Proposed Changes to Human Subjects Research Regulations Announced

The Department of Health and Human Services has released its notice of proposed rulemaking (NPRM) regarding significant changes to the Common Rule, the federal regulations that govern human subjects research. The proposed revisions affect a broad range of research and study teams are encouraged to review the proposed changes and provide comments. The revised Common Rule and supporting documents are are available on the OHRP website.

The campus HRPP (Human Research Protection Program) is developing a webpage with resources regarding the proposed changes to the Common Rule as well as way for the research community to submit comments or questions to the HRPP. When this page becomes available, we will announce it in a future newsletter and via the HS IRBs listserv.

November Dates for IRB for Beginners Workshop

The Health Sciences IRBs for Beginners Workshop provides training on the HS IRBs' processes and ARROW application system. The two-hour workshop gives participants an introduction to the HS IRBs structure, regulatory approval process, HS IRBs Office resources, and ARROW electronic submission system.The workshop is meant for individuals new to the UW IRB process or for those looking for help on how to effectively submit an IRB application.

The next sessions of workshop will be held:

Monday, November 2nd from 9:00 to 11:00 AM (HSLC 2121)

Tuesday, November 3rd from 2:00 to 4:00 PM (HSLC 2121)

Space is limited to the first 20 interested participants and registration is required.  To register, click on the date you would like to attend and complete the registration process through the Office of Talent Management.  If you have questions or issues with registration, please email Jake Rome.

Tips for Preparing a Protocol Development Activities (PDA) Application

Study teams are encouraged to keep the following tips in mind when preparing a PDA application:

Changes to Studies Excepted from the Five Year Renewal Policy

When considering making a significant change or funding update to a study that has been open for five years or longer and for which a replacement application has NOT been required (e.g., the study is in data analysis or long-term followup only), please contact the IRB office for guidance before submitting the change of protocol. In keeping with campus policies, significant changes (e.g., adding new aims, collecting new data or specimens, reopening the study to enrollment) or funding updates (e.g., adding a new grant) may require a new application be submitted instead of a change of protocol. Our staff can assist you in determining whether a change to the existing study is appropriate and if not, what type of new application may be needed.

HS IRBs Office Staff Updates


Filling In

  • 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@hsirb.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@hsirb.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.
  • 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.