HS-IRBs News May 2015
Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 5, May 2015
HS IRBs Office ClosureThe HS IRBs Office will be closed Monday, May 25th in observance of Memorial Day.
June Dates for IRB for Beginners
Are you new to the HS-IRBs review process? Consider signing up for one of the Summer 2015 IRB for Beginners Workshops.
The 90-minute workshops are held in the HSLC computer lab and are designed to 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 will also introduce participants to the IRB’s review process and procedures.
There are workshop openings on the following dates:
Space is limited and registration is required. Please email Jake Rome at email@example.com to reserve your spot in one of the future sessions.
Exemptions and Five Year Extensions
UW-Madison has a five year renewal policy for non-exempt human subjects research protocols. A similar but much simplified process for exempt projects has been developed. ARROW will send five year extension notifications to study teams for exempt projects that have been open for five years. If you receive an email notification that an exempt project has been open for five years, you may extend the project or close it as follows:
- If you wish to keep an exempt project open, please complete the Extend Exemption activity in the exempt project workspace. This activity is NOT reviewed by the IRB office and no replacement application is required. Completing the activity simply indicates in ARROW that the study team is keeping the exempt project open.
- If you wish to close an exempt project, please complete the Submit Study Completion Report activity in the exempt project workspace. The study completion report will be reviewed by the IRB office as with any other study completion report.
If you have any questions about the five year notifications for exempt projects and the extension or closure process, please email firstname.lastname@example.org.
Reminder: HS IRBs Reliance Team Formed to Support Collaborative Research
Along with the changes to multisite and IRB reliance resources on the website, the HS IRBs offices has a team of people to support study teams with IRB reliance issues. The team includes Mike Bingham, Molly Lumley, Carol Pech, and Brandy Stoffel. The Reliance Team is able to assist study teams with issues such as:
- Identifying what IRB oversight requirements may apply to studies involving multiple sites or personnel outside the UW, including community partners.
- Assisting study teams with navigating the review process for different IRB reliance partnerships (e.g., WIC, Meriter).
- Facilitating the processing of IRB authorization and independent investigator agreements.
- Fostering collaborative research by coordinating communication with other institutions regarding IRB oversight issues.
The Reliance Team encourages study teams to contact them with any questions about IRB reliance or multisite and collaborative research issues.
Please see below for some reminders regarding training requirements for human subjects researchers:
- Per campus policy, all personnel listed as study team members on an IRB application must complete human subjects research training.
- The HS and MR IRBs will accept biomedical and social-behavioral training courses completed via UW-Madison's CITI module as well as VA human subjects training.
- Only VA training can be accepted for study team members listed on VA human subjects protocols unless a waiver is granted by the VA.
- Personnel outside the UW for whom the HS IRBs are serving as IRB of record also must complete human subjects research training. The HS IRBs will accept CITI or equivalent training completed elsewhere in lieu of completion of UW-Madison CITI training. Please contact the HS IRBs' Reliance Team if you have questions about training requirements for non-UW personnel.
- Personnel transferring to UW-Madison may receive credit for CITI training completed elsewhere by following these instructions on the HRPP website.
- Study team members also may need to complete HIPAA training if they are members of the UW-Madison's health care component or if other criteria apply. Please see the HIPAA training page for more information.
ARROW Outage in JuneDue to upgrades and maintenance, ARROW will be unavailable June 27th from 1PM to 5PM. We apologize for any inconvenience.
- 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.