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HS-IRBs News - March 2011
Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 3, March 2011
Printer Friendly Newsletter March 2011
ARROW Mini Quick-Start Training and Open Lab Sessions
The HS-IRBs are offering brief introductions to ARROW. Sessions are held in the HSLC computer lab (HSLC 2121), with open lab time to follow for those who want assistance with using ARROW or just want to try out the system. The next session will be held on March 23rd from 2-3:30PM. To register, please email your request to firstname.lastname@example.org.
HS IRBs Staff News
Farewell: Jessica Johnson will be leaving our office at the end of March to take a position with the IRB at the Medical College of Wisconsin. Jessie has been a critical member of the review staff, overseeing both continuing review and reportable event submissions. We wish Jessie the very best and she will be sorely missed.
Welcome: We are very pleased to welcome to a new staff reviewer to the office. Gina Grumke will begin working with the HS-IRBs later this month.
FYI: With assistance from other IRB staff, Catherine Rogers (email@example.com) will be assuming Jessica Johnson’s review responsibilities for the time being.
Upcoming HS-IRBs Office Closure
The HS-IRBs Office will be closed for a mandatory furlough day on Friday, March 18th. The ARROW helpline also will not be staffed on March 18th.
Coming Soon: New and Improved ARROW Help Page
The ARROW help page is being migrated to a new platform that will include a robust search engine so study teams can find information more quickly. The new page also will incorporate screenshots in to the current FAQs. Please email any suggestions for the new help page to firstname.lastname@example.org. Please put Help Page in the subject line.
NEW: Personnel Change Guidance
The Health Sciences IRBs has posted new guidance regarding personnel changes, including changes to Principal Investigator (PI), on the Policies & Guidance page on its website. This guidance will be effective as of March 21, 2011. Highlights of the guidance include:
- Description of the process for reporting personnel changes and how the IRB handles personnel changes
- Clarification that PI changes now require full board review due to the level of review required to the assess the qualifications of the PI to conduct the study
- The information that should be communicated to research participants when a PI leaves a study
- The required timeframe for research teams to report changes of PI to the IRB
- When new personnel (other than new PIs) can begin performing activities related to a research study
- How to handle personnel who move to another institution and wish to continue performing activities related to a study under UW-Madison purview
- Clarification that personnel changes are not required for studies determined to be exempt
A new flow chart describing IRB requirements for studies that involve either personnel or sites external to the UW-Madison/UWHC/Madison has been posted to the multisite research page of the HS-IRBs website. The chart outlines when IRB approval and letters of support are required as well as when an IRB authorization agreement (IAA) or independent investigator (IIA) agreement might be needed. If you have any questions about this chart or IRB requirements for external personnel or sites, please contact Carol Pech (email@example.com).
Schedule IRB Consultations Online
To schedule a consultation with an IRB staff reviewer, please submit your request online via the online request form that is now posted on the home page of the HS-IRBs website. Consultations provide a good way for study teams to obtain expert assistance regarding the IRB submission and review process. Researchers planning complex projects or who are new to the IRB submission process may particularly benefit from the consultation service.
NEW: ARROW Consultations
ARROW consultations are now available. Consultations are available by appointment only and are held only at the HS-IRBs office in the University Bay Office Building (free 2 hour parking is available). If you would like in-person assistance with certain ARROW features or an individual quick-start session, please email your request to firstname.lastname@example.org. Small group demonstrations also are available by appointment only at the HS-IRBs office. When emailing your request, please put ARROW consultation or small group demonstration in the subject line.
ARROW Helpline Reminders
- If you do not reach someone when calling the ARROW helpline, please leave a message. We are able to return the majority of voicemails quickly, typically the same day.
- If you are calling about a particular submission, please provide the ID number or IRB protocol number. This is especially important when leaving a message.
- If you are calling for help with how to use ARROW (e.g., navigating different workspaces, responding to reviewer notes), please be at a computer and logged in to ARROW. This will allow helpline staff to walk you through whatever process you need help with.
- Please do NOT rely on the IRB point of contact system for ARROW questions that are not about how to answer questions in the ARROW application forms. All other questions should be directed to the helpline.
The HS-IRBs newsletter previously announced that the IRB drop box (basket) located within ICTR Client Services Center, room 2112 HSLC, would be discontinued due to the transition to ARROW. The IRB put out a call in a recent newsletter asking for feedback about this decision. Only three people requested the continuation of the drop box. The IRB has monitored the drop box for the month and on several days no paper submissions were received. The IRB will continue the drop box through May 2011, but will reduce the frequency with which materials placed in the drop box are picked up. Starting Monday March 21st the IRB will pick up items placed in the drop box on Mondays, Wednesdays, and Fridays (unless the IRB Office is closed due to a holiday or mandatory furlough day). In order to ensure a submission is picked up on these days, it must be in the drop box by 2 pm. We hope the continuation of this service assists those who requested the retention of the drop box.
Reminder: New Protocol Exceptions and Deviations Guidance
The HS-IRBs have issued revised guidelines for research teams regarding the reporting of protocol “exceptions” and “deviations” to the IRB. The new guidelines are posted on the HS IRBs website. If you have any questions about the new guidelines, whether a deviation falls under these guidelines, or whether the divergence from the protocol instead constitutes a change of protocol, noncompliance, or an unanticipated problem, please contact the HS-IRBs office.
- 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.