HS-IRBs News - May 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 5, May 2010
Reminder: New HS-IRBs Office Location
Just a reminder that the HS-IRBs Office moved on March 31, 2010. Our new mailing address is:
Health Sciences IRBs Office
University Bay Office Building
800 University Bay Drive, Suite 105
Madison, WI 53705
Our phone numbers and email addresses remain unchanged.
Submission materials may be dropped off either at our new location, or at the new IRB drop box, room 2112 of the Health Sciences Learning Center (HSLC) within the Institute for Clinical & Translational Research Client Services Center (ICSC). ICSC drop box hours are 8:30 am to 4 pm. Please note that due to limitations in office space, IRB staff will NOT be available at this location and researchers should contact the office directly with any questions about submissions. The drop box is checked at approximately 10-10:30 am and 2-2:30 pm on weekdays. For submissions that are particularly large, please contact the IRB office at 263-2362 for advice rather than using the ICSC drop box.
New HS-IRBs User Survey Coming in June
In early 2008, the HS-IRBs conducted a survey of IRB users. About 300 people responded to the survey and the feedback we received was very helpful. Since 2008, a number of significant changes have been made to the IRB review process (e.g., weekly meetings for the HS-IRB, development of a formal pre-review process). A revised version of the survey will soon be sent to IRB users to get their feedback on these changes as well as other aspects of the IRB review process. We hope study teams will take a few moments to provide us with their thoughts and help the HS-IRBs continue to improve its services to study teams... Please check your email and the HS-IRBs website for more details on the survey this June.
- Since ARROW went live on 3/31, the study teams piloting the system have submitted several applications. The first approval letter for a continuing review was issued earlier this month and the first submissions requiring full IRB review are on an IRB agenda for late May. Our thanks to the early ARROW adapters for their hard work and patience as everyone learns the new system. To help prepare for ARROW, please ensure that the person listed as point of contact (POC) for legacy studies (i.e., studies that have already been approved by the IRB outside of ARROW) is current
- A Health Sciences IRBs ARROW Help has been added to the HS-IRBs website with information for ARROW users on how to get help as well as frequently asked questions. Online training videos for study teams will be coming soon, so stay tuned.
- Have questions about ARROW? Please email firstname.lastname@example.org.
UWHC Personnel Human Subjects Training Requirements
A reminder that UWHC personnel involved in human subjects research must complete the same CITI training module as UW-Madison personnel (VA personnel must meet separate, more stringent VA requirements). Information about CITI training can be found on the Graduate School website. Please note that CITI training alone does not meet HIPAA training requirements, which are described on the HIPAA Privacy Rule Guidance website.
Continuing Review and Noncompliance
Federal regulations require that IRBs review all approved studies at least annually to ensure studies continue to meet all regulatory and local policy requirements. This process is called continuing review and federal regulations do not allow for any grace period regarding the date IRB approval expires. Studies for which IRB approval has expired are no longer in compliance with either federal regulations or UW-Madison campus policy. No research activities may occur on studies for which IRB approval has expired.
- Several changes have recently been made to campus policy (see January 2010 newsletter for more details) to address issues regarding expiration of IRB approval. The HS-IRBs will be implementing these changes as follows:
- Per the revised campus policy, studies which have been expired for 3 months will automatically be closed by the IRB office.
- If IRB approval for a study has expired, the study team will be asked to provide a corrective action plan to ensure that no future lapses in IRB approval will occur. The study team also will be advised that future lapses may be regarded as noncompliance.
- If multiple expirations of IRB approval have occurred on a single study OR across multiple studies for the same PI, the IRB may review these lapses to determine whether serious and/or continuing noncompliance has occurred.
- 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.