HS-IRBs News June 2015
Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 6, June 2015
HS-IRBs Staff Updates
A Final Farewell: Sherry Holcomb, MR IRB staff
reviewer, has been working part-time for the HS-IRBs Office remotely since
relocating in July 2014. Sherry will bid a final farewell to the office at the
end of June. We want to thank Sherry for
all of her hard work over the years. Sherry has been an invaluable member of
the HS IRBs Office and we wish her all the best.
Filling In: With Sherry's departure, Monica Esquibel will be taking over the review of exemptions previously covered by Sherry. Questions about any items that Sherry previously reviewed can be directed to Gretchen Anding (263-4170).
New: 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 firstname.lastname@example.org. Please include "informed consent feedback" in the subject line.
Tips for Handling Personnel Leaving or Joining UW-Madison
Since summer is often a time of transition on campus, please keep the following tips in mind for handling study team members leaving or joining UW-Madison:
- Per the HS IRBs' Personnel Change Guidance, study team members leaving UW-Madison must be removed from the IRB application within 1 month of departure from the study team.
- If personnel leaving UW-Madison will continue to be engaged in human subjects research for a study, please remember that the HS-IRBs cannot automatically remain the IRB of record for these personnel. Please contact the HS-IRBs Reliance Team to discuss what additional steps may need to be taken to ensure these personnel continue to have appropriate IRB oversight for their study activities.
- Any change in principal investigator (PI) requires a full change of protocol and must be submitted at least 14 business days prior to the current PI's departure. Please see How do you change the responsible principal investigator (PI)? for more information.
- New personnel should be added to the IRB application via a personnel change prior
to or at the time when the new personnel will engage in human subjects
research. Please see the Personnel Change Guidance linked to above for more information, including limited exceptions to this time frame.
- Personnel joining UW-Madison may be able to receive credit for human subjects research training completed at another institution. Please see Instructions for Linking Previous CITI Training to Your NetID for more information.
Continuing Review and Checking Training Certifications
To assist the campus human research protection program in ensuring that all study team members have current human subjects research training certification, HS IRBs staff are reviewing study team training certifications at the time of continuing review. If study team members are found to have expired training, the study team will be asked to request that they renew their training or remove them from the study team via a personnel change. Study teams also can help with monitoring training certifications by doing the following:
- Use the Record Human Subjects Training Snapshot activity in ARROW to check the current training certifications for your study team. Please see Using the Record Human Subjects Training Snapshot Activity in ARROW for more information.
- If the snapshot indicates someone has expired training certification and you wish to remove this person from the study team, please submit a personnel change to do so. Personnel changes can be submitted at the same time as a continuing review. For more information on submitting personnel changes, please see 19971.
- In future, ARROW will be able to check for personnel with expired netIDs and study teams will be requested to remove anyone with an expired netID from the study team. In anticipation of this and consistent with Personnel Change Guidance , please keep lists of study team members current by submitting personnel changes whenever someone leaves the study team.
ARROW Outage in JuneDue to upgrades and maintenance, ARROW will be unavailable June 27th from 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 email@example.com. 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 firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- WIRB updates, please sign up for the WIRB listsserv by emailing firstname.lastname@example.org 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.