HS-IRBs News - January 2011
Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 1, January 2011
Printer Friendly Newsletter January 2011
REMINDER: All study teams must use ARROW for all new IRB submissions and most continuing reviews. Please see the Health Sciences IRBs ARROW Help page on the HS-IRBs website for more information.
Upcoming HS-IRBs Office Closure
The HS-IRBs office will be closed on Monday, January 17th for a university holiday. The ARROW helpline also will not be staffed on January 17th.
ARROW Mini Quick-Start Training and Open Lab Sessions
The HS-IRBs are offering brief introductions to ARROW. 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:
Space is limited, so registration for these sessions is required. To register, please email your request to firstname.lastname@example.org. Please include the date for the session you wish to attend.
- January 18th from 2-3:30PM
- February 7th from 10-11:30AM
- February 16th 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 email@example.com. Please note that slots for demonstrations are limited, so please submit your requests as soon as possible.
REMINDER: 2011 Meeting Dates
Meeting dates for both the HS and MR IRBs have been posted on the Meeting Dates page of the HS-IRBs website.
UPDATE: Guidance on When to Select the Non-Exempt Medical Records Application Type: Radiological Imaging
As mentioned in the November HS IRBs newsletter, the second section of the new IRB application form in ARROW allows study teams to select the most appropriate application type for their study. The Initial Review: Non-Exempt Medical Records application type must be used only for studies involving the collection and use of medical information from medical records and databases, including studies analyzing radiological images collected for medical purposes. However, do NOT select Initial Review: Non-Exempt Medical Records for studies involving use of clinical images to test newly developed imaging software or tools. If study activities include using the images to test new software or imaging tools and are not limited to re-reading of radiological images, the Initial Review Application: Full Review option must be selected.
How to Update the Point of Contact for Legacy Studies in ARROWTo update the point of contact for existing studies that have been migrated in to ARROW (also called legacy studies) AND for which the continuing review has not yet been approved in ARROW, study teams should use one of the following options:
Option 1: If the new point of contact is already listed as key personnel in the IRB file (e.g., on the list of key personnel in the continuing review application or initial review application, whichever is most recent), email the requested update to firstname.lastname@example.org. Be sure to include the IRB protocol number in the subject line.
Option 2: If the new point of contact is NOT already listed as key personnel in the IRB file, submit a personnel change form in paper to the HS-IRBs office.After the request or personnel change form has been reviewed and approved, the HS-IRBs office will then update the POC in ARROW.
NEW: Community-Based Research Working Group
The Health Sciences IRBs Office continues to see an increase in community-based and type 2 translational research requiring IRB review and oversight. This type of research can pose unique regulatory challenges. As a result, the HS IRBs Office has formed a working group that will focus on improving the HS IRBs review processes for community-based research that involves health care interventions or occurs in health care settings. The working group consists of individuals from the research community with varying expertise in community-based research as well as representatives from the HS IRBs office. In the coming year, the working group has plans to solicit feedback from the research community regarding the IRB review process for community-based research. Updates on the progress of the working group and opportunities for providing feedback will be included in future newsletters.
Updates to the Protocol Exceptions and Deviations Reporting Guidance
The HS-IRBs will issue updated guidelines for research teams regarding the reporting of protocol “exceptions” and “deviations” to the IRB, which will replace the guidelines first issued March 31, 2003. The new guidelines will be posted on the HS IRBs website on the “Policies and Guidance” page by January 24, 2011 and a link will be included in the February newsletter. The Health Sciences IRBs recognize that research teams cannot always adhere to protocol requirements and developed these guidelines to clarify the threshold for reporting deviations to the IRB.
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 Health Sciences IRBs Office at 608-263-2362.
Multisite Webpage Updates
Several new FAQs have been posted to the HS-IRBs multisite webpage, including guidelines for IRB of record and IRB deferral requests as well as how to submit IRB of record and deferral requests in ARROW. Additional revisions to the multisite webpage will be made in the coming weeks and will be announced in future newsletters. If you have suggestions for information you would like to see posted to the multisite webpage, please email them to Carol Pech at email@example.com.
Legacy Application Tips
- To enter a legacy application in ARROW, first search for the IRB protocol number to locate the record for that study in ARROW. Do NOT create a new IRB application to enter a legacy study.
- Legacy studies must be submitted 2 months prior to the expiration of IRB approval.
- If you need to submit a change of protocol while a legacy application is under review, please contact the HS-IRBs office first for guidance.
- For additional guidance on preparing legacy applications, several FAQs and guidance are posted on the Health Sciences IRBs ARROW Help .
- 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
- 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
- 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 email@example.com.
- 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.
- 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.