HS-IRBs News July 2015
Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 7, July 2015
August 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.
Space is limited to the first 20 interested participants and registration is required. Please email Jake Rome at jarome@medicine.wisc.edu to reserve your spot in on of the sessions.
Important Update on Changes to Human Subjects Research Regulations
In 2011, the Department of Health and Human Services (HHS) issued an advance notice of proposed rulemaking regarding revisions to the federal regulations governing human subjects research (i.e. the Common Rule). Following a period of public comment, the proposed revisions have been making their way through the administrative approval process at the federal level. The next step will be for HHS to post the revised Common Rule for a final round of public comment.
Although it is not yet known when the revised Common Rule will be made available for public comment, researchers are advised to look for this announcement. The revised Common Rule will likely include changes that will affect a broad range of research and study teams may wish to comment on the proposed changes. When the revised Common Rule is posted for public comment, an announcement will be sent via the HS IRBs listserv as well as being posted on our website.
Tips for Completing Personnel Changes
Remember to the use the Record Human Subjects Training Snapshot activity before submitting a personnel change. Running this activity will identify whether all study team members have current human subjects training certification and, if not, which personnel should update or take the required training. For help in using this activity, please see [Link for document 23550 is unavailable at this time.] .
Check to make sure the correct person is listed. This is a large campus with many people sharing the same or similar names, so please check to make sure the correct person is being listed. ARROW now displays a person's email address to help study teams better identify the correct person to list in the application.
Principal investigators and points of contact can only be listed on the first page of the ARROW application. If you receive an error message when updating the edit and read-only access page in the personnel change, this likely means the PI or POC are listed and need to be removed.
Personnel changes are reviewed within 1-2 business days of receipt, so study teams should not need to request priority review. In addition, some new study team personnel may begin study activities before a personnel change is approved. Please see Principal Investigator Changes and Personnel Updates Guidance for details.
Revised FAQ on Listing Study Team Members in ARROW
The FAQ on Listing Study Team Members in the Application has been substantially revised to provide more detailed guidance on how to list study team members in the initial review application, including more information about the differences between edit access and read-only access.
Reminder: HS IRBs Informed Consent Working Group Wants to Hear from You!
HS IRBs staff are working to revise and improve the informed consent form templates and informed consent-related guidance for the research community. We need your suggestions and ideas so we can create templates and guidance that are most helpful for you. Please provide your feedback and suggestions by emailing asktheirb@medicine.wisc.edu. Please include "informed consent feedback" in the subject line.
ARROW Outage
Due to upgrades and maintenance, ARROW will be unavailable August 8th, 1PM to 5PM. We apologize for any inconvenience.
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.