HS-IRBs News December 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 12, December 2012
Health Sciences IRBs Office Closures
The HS-IRBs office will be closed the following days in December and early January:
- December 24th and 25th
- December 26th: closed in the afternoon
- December 31st and January 1st
The ARROW helpline also will not be staffed on these days.
Important Proposed Changes to the ARROW Helpline
The HS-IRBs office currently supports the ARROW helpline through both email and voicemail. Beginning in spring 2013, the office plans to phase out voicemail support and continue only email support for the ARROW helpline.
- Why is voicemail support for the helpline being phased out? The reasons for this change include a significant decrease in the number of voicemails received by the helpline as well as the ability of the office to provide better and more timely responses to emails received by the helpline rather than voicemails.
- What does this change mean for study teams? Email support for the helpline will still be provided Monday through Friday, 9AM to 3PM. HS-IRBs staff will still call study teams when needed to resolve an ARROW technical issue.
- Will ARROW training still be available? ARROW training is available through the IRB for Beginners workshop and through the many resources available on the Health Sciences IRBs ARROW Help page. Study teams can get additional in-person assistance at ARROW open labs.
If you have any concerns or questions regarding this proposed change, please email Carol Pech (firstname.lastname@example.org).
HS-IRBs Presentations and Workshops on Hiatus in Spring 2013
Due to expected staffing levels, the HS-IRBs office will not be offering any workshops or presentations in spring 2013 (March through June). Educational programs will resume in summer 2013. Please note:
- Several IRB for Beginners workshops will be offered between now and March 2013 (please see below for additional information).
- If you wish to request a presentation before the spring hiatus, please submit a request by February 15th. Presentation requests should be submitted through [Link for document 18204 is unavailable at this time.] .
- IRB consultations will still be available during spring 2013.
New Dates for IRB for Beginners Workshop
By popular demand, the HS-IRBs Office is offering additional sessions of the IRB for Beginners Workshop. The 90-minute workshop will be held in the HSLC computer lab (room 2121) and will give participants a first-hand view of the resources available on the HS-IRBs website as well as basic tools and tips for the ARROW electronic application submission system. The workshop also will introduce participants to the IRB's review process and procedures. This workshop is designed for people who are new to the HS-IRBs review process.
Additional workshops are scheduled on the following dates:
***Registration Full*** December 19th 3:00-4:30PM
January 8th (Tuesday) 12:30-2:00PM
January 24th (Thursday) 9:00-10:30AM
January 28th (Monday) 11:00-12:30PM
Registration is required. Please email Brooke Mechelke (email@example.com) to reserve your spot. Space is limited.
Coming Soon: Revised Expedited Change Guidance
Revisions to the expedited change guidance will be posted to the HS-IRBs website in January. The guidance has been revised to clarify what types of changes may qualify for expedited review. In addition, a new document has been developed that describes common types of changes as well as when those changes can be expedited and when full IRB review is required.
New Guidance Documents Available
The HS-IRBs have developed 2 new guidance documents available on the Policy and Guidance page.
- Guidance Regarding Types of Supporting Materials that Require IRB Review and Approval provides guidance on which materials always require IRB review (e.g., consent documents, protocol) and which may require IRB review depending on their content.
- Guidance Regarding Research that Involves the Collection of Information about Illegal Substance or Alcohol Abuse was developed for studies that screen or otherwise collect information about illegal substance or alcohol abuse. The guidance addresses when data should not be retained, when a Certificate of Confidentiality might be required, and special considerations to address when this information is collected about pregnant women.
HS-IRBs Staff Update: Patricia "Trica" Kalscheur to Retire
Trica Kalscheur, the HS IRBs Office Manager, will retire on December 30, 2012 after more 27 years of service to the State of Wisconsin. She joined the HS- IRBs Office in August 2003 from Dr. Jerry Dempsey’s laboratory, bringing strong organizational skills with her and a keen sense of humor. Many in the research community worked with Trica on issues related to the assessment of IRB fees. We will miss Trica. Happy retirement!
Coming Soon: Revised Reportable Events Webpage
The reportable events page for the HS-IRBs website is in the process of being revised to help make the information more accessible to study teams. In addition, several revised and new documents will be posted, including new guidance on submitting new information reports and a new reporting time frames table. HS-IRBs staff will provide an overview of the revised reportable events page during presentations to be scheduled in early 2013. Please stay tuned to the listserv and newsletter for further details.
Revised Personnel Change Guidance
Principal Investigator Changes and Personnel Updates Guidance has been revised to 1) clarify what steps study teams need to take should a Principal Investigator become temporarily unavailable (e.g., due to illness or sudden leave of absence); and 2) provide more flexibility regarding personnel changes for certain types of research (i.e., non-exempt medical records research and reading center studies).
New: FAQ on Working with Closed, Completed, Withdrawn, and Archived Studies
A new FAQ on Working with Closed, Completed, Withdrawn, and Archived Studies has been posted to the ARROW guidance page of the HS-IRBs website. This FAQ describes when studies are closed, withdrawn, and archived as well as what actions study teams may need to take to reactivate or reopen a study.
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 firstname.lastname@example.org. 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 email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- WIRB updates, please sign up for the WIRB listsserv by emailing email@example.com 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.