HS-IRBs News - December 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 12, December 2010
Printer Friendly Newsletter December 2010
REMINDER: All study teams must use ARROW for all new IRB submissions and most continuing reviews. Please see the FAQ on [Link for document 17172 is unavailable at this time.] for more information.
Upcoming HS-IRBs Office Closures
The HS-IRBs office will be closed the following days this December:
December 30th (Mandatory Furlough Day)
December 31st (University Holiday)
Modified ARROW Helpline Hours for December 23rd
In addition to the dates noted above, the ARROW helpline will not be staffed the afternoon of 12/23.
Update on PLUS and ARROW
An interface has recently been built between ARROW and PLUS. This means that PLUS is now being updated with data from studies in ARROW. Those who do not have access to studies in ARROW should be able to use PLUS to obtain basic study information.
ARROW Mini Quick-Start Training and Open Lab Sessions
The HS-IRBs will be offering brief introductions to ARROW for those who did not attend training earlier this fall. These sessions will be held in the HSLC computer lab, with open lab time to follow for those who want assistance with using ARROW or just want to try out the system.
Mini quick-start sessions will be offered in HSLC 2121 on:
- December 13th - FULL
- January 12th from 2-3:30PM
- January 17th from 10-11:30AM
ARROW Small Group Demonstrations for 2011
Research groups wanting a more detailed introduction to ARROW may request a small-group demonstration. Requests for demonstrations should be emailed to firstname.lastname@example.org. Please note that slots for demonstrations are limited, so please submit your requests as soon as possible.
2011 HS IRB and MR IRB Meeting Dates
Meeting dates for both the HS and MR IRBs have been posted on the IRB Meeting Dates page of the HS-IRBs website.
Deadlines for the Submission of Continuing Review Protocol Progress Reports
The HS-IRBs will no longer publish specific deadline dates for the submission of continuing review protocol progress reports. Research teams are responsible for monitoring when IRB approval of their studies expires, but will receive automated reminders from ARROW at 75, 60, and 30 days before IRB approval for a study expires.
To allow the IRB sufficient time to review and reapprove a study so that it does not expire, please follow the required submission timelines for continuing reviews noted below.
- The first continuing review submitted in ARROW for studies that were approved by the IRB prior to the implementation of ARROW needs to be provided to the IRB 2 months before the study expires.
- For studies that were submitted and approved as initial reviews through ARROW, the continuing review protocol progress report needs to be provided to the IRB 1 month before the study expires.
- For studies that have not been migrated into ARROW yet, which are those set to expire between November 17, 2010 and February 15, 2011, continuing reviews should be submitted to the IRB 1 month before the study expires via the interim process.
To help the HS-IRBs better serve you, please keep the following in mind when calling us:
- Please call the ARROW helpline (262-0041) for questions about ARROW (including how to get started, whether a continuing review should be submitted in paper or in ARROW, technical issues, etc.). Expert ARROW is available via the helpline, so please do not call the main office number with ARROW questions.
- For general IRB questions or to speak to the point of contact for the day, please call the main office (262-2362).
- For questions about a particular submission (e.g., questions about modifications), please contact the staff person listed on IRB correspondence (if the submission is in paper) or in the submission workspace in ARROW (look at the author in the history tab or the staff reviewer listed near the top right side of the submission workspace).
- For questions about the status of a submission submitted in paper, please call 265-2304.
- For questions about the status of an ARROW submission, please check the submission’s History tab or its current state (displayed in the yellow bar on the left side).
The HS-IRBs Office currently has a drop off basket within ICSC, room 2112 of the Health Sciences Learning Center. Because of the transition to ARROW, this drop box will be eliminated in March 2011. Until March 2011, the IRB Office will continue to pick up items from the ICSC drop box, but will pick up only once a day at approximately 2:30 pm.
REMINDER: UW-Madison HRPP Five Year Renewal Policy
Important guidance about how the campus Five Year Renewal policy will be implemented in conjunction with final rollout of ARROW has been posted to the HS-IRBs website. Please review the Five Year Renewal Policy and Replacement Studies in ARROW for details.
New ARROW FAQs Posted
Several new ARROW FAQs have been posted to the HS-IRBs website, including FAQs on how to complete the funding pages, the special procedures page, and the study location section of the initial review application. New FAQs for the UWCCC on submitting changes with a 90-day review period and handling new information during pre-review also have been posted. Please see the Health Sciences IRBs ARROW Help page on the HS-IRBs website for a complete list of FAQs.
New Form: Requesting IRB Documents
For studies migrated in to ARROW, study teams must complete both a continuing review and legacy application at the time of the next continuing review for those studies. When completing the legacy application, study teams will be asked to upload several study documents within the application. These documents may include the study protocol, consent/assent documents and information sheets, data collection sheets, and survey instruments or questionnaires.
Study teams are expected to exercise due diligence in locating whatever documents need to be uploaded to ARROW as part of the legacy application. In the event that a study team is unable to locate a document(s), a Request IRB Documents must be submitted to request a copy of the document(s) from the IRB file. This form and additional instructions can be found on both the Health Sciences IRBs ARROW Help and Forms pages of the HS-IRBs website.
- 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.