HS-IRBs News - September 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 9, September 2010
REMINDER: Final ARROW Rollout Coming in November
The final phase of ARROW rollout (the new electronic submission and review system for the HS-IRBs) will happen this November. All study teams will begin using ARROW on November 17, 2010. Please plan to attend a quick-start training session in October or schedule a demonstration for your group so you are ready to use ARROW on November 17th.
ARROW Quick-Start Training Sessions
Three large group training sessions have been scheduled to provide study teams with a quick overview of ARROW and its key features. Attendees can try out ARROW in the HSLC computer lab immediately following sessions held in the CSC. No registration is required. Quick-start sessions will be offered on:
- October 6th from 10-11AM at CSC G5/119
- October 13th from 10-11AM at 260 Bascom
- October 27th from 12-1PM at CSC G5/119
Research groups wanting a more detailed introduction to ARROW may request a small-group demonstration. NOTE: Very few slots remain for demonstrations in October and slots in November are limited, so please submit your request soon. Requests for demonstrations should be emailed to email@example.com.
Questions about Going Live with ARROW?
For more information on what going live with ARROW means, please see the [Link for document 17172 is unavailable at this time.] . For more information about ARROW – including brief training videos as well as FAQs – check out Health Sciences IRBs ARROW Help of the HS-IRBs website.
Tips for Current ARROW Users
- Close Studies When Possible: Before completing a continuing review and legacy application for a study migrated in to ARROW, please review the study to determine whether it can be closed. Creating and reviewing legacy applications takes a lot of effort on the part of study teams and IRB staff alike, so closing studies when possible will reduce everyone’s workload. For guidance on when a study can be closed, see the HS-IRBs Protocol Closure Guidance and call us if you have questions. NOTE: For studies already migrated in to ARROW, closure reports will need to be submitted in both paper and electronically.
- Do NOT Add New Key Personnel to Legacy Applications: When creating legacy applications in ARROW, do NOT add personnel who are not already on the list of key personnel in the currently approved version of the IRB application. A personnel change can be submitted after the continuing review and legacy applications have been approved. For the list of currently approved key personnel, please review the last continuing review or initial review application, whichever is most recent.
- Timing Continuing Reviews and Changes: Please avoid submitting changes of protocol for studies for which a continuing review and legacy applications are currently under review in ARROW. If you must submit a change of protocol before the continuing review and legacy applications are approved, please call the ARROW helpline at 262-0041 or email firstname.lastname@example.org before submitting the change in paper to discuss the prioritization of the submissions.
Use of Records or Databases to Identify Potential Subjects and Waivers of Informed Consent
Current Office for Human Research Protections (OHRP) guidance indicates that under the Common Rule, the use of records or databases to identify potential subjects constitutes human subjects research. Thus, researchers must disclose to the IRB any records or databases they may use to identify potential subjects so that the IRB can determine whether a waiver of documentation of informed consent can be granted for this activity. Please note that in contrast to the HIPAA Privacy Rule, the Common Rule does not include a preparatory to research provision.
- In May 2010, the Madison VA underwent an audit by the VA Office for Research Oversight. This audit included a review of IRB files and operations. The audit was generally favorable, but will result in the IRB Office contacting some research teams about required changes to VA consent and authorization forms. A revised VA consent form template and other guidance will be issued in October.
- Under VA policy, research teams are prohibited from making initial contact with potential research participants via the telephone. First contact can be made in-person or by mail. (VHA Handbook 1200.12).
- The VA interprets the preparatory to research provision under the HIPAA Privacy Rule differently than the University of Wisconsin-Madison. For non-VA research University of Wisconsin-Madison policy indicates that the review of records or databases to identify potential subjects is considered a preparatory to research activity under the HIPAA Privacy Rule. In contrast, VA regulations require that the IRB grant a waiver of authorization for such activities.
- 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.