HS-IRBs News June 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 6, June 2016
HS IRBs Office Closure
The HS IRBs office will be closed Monday, July 4th, in observance of Independence Day.
NIH Single IRB Review Policy Now Final
NIH recently issued its final policy requiring single IRB review for multisite research funded by NIH. The effective date for this policy is May 25, 2017. This policy will apply only to studies where the same research protocol is conducted at all study sites. Multsite studies currently ongoing will not need to comply with this policy until a competing renewal applicatin is submitted. Guidance from NIH regarding key questions such as costs for single IRB review and what information about single IRB review needs to be included in grant applications and proposals is pending. The HS IRBs Office is very involved in the national discussions about implementation of this new policy, and we will provide further information when available. In the meantime, researchers are encouraged to contact the HS IRBs Reliance Team with any questions regarding IRB oversight for collaborative and multisite projects.
Improving IRB Processes for Researchers
As part of our continuing series on how the HS IRBs Office is working to improve IRB processes for researchers, we want to highlight improvements in handling funding deadlines. In the last month, the HS IRBs Office has seen many
Just-in-Time (JIT) requests as well as other tight timelines to fulfill
grant requirements. While the HS IRBs Office has always made every
effort to address funding constraints, we have started a new,
comprehensive process for tracking funding time-frames for newly
submitted applications, both initial reviews and changes. We are
implementing this process to better support researchers who are faced
with tight funding deadlines and to help ensure timely IRB approval for such projects.
In partnership with our colleagues in the Vice Chancellor for Research and Graduate Education's IT area, the HS IRBs Office is continually making improvements to ARROW to make the IRB review process easier for study teams. Planned and recent improvements include:
- Earlier and More Frequent Pre-Submission Notifications: ARROW currently sends an email notification to study teams to remind them that an application has been in pre-submission for 90 days and has not yet been submitted to the IRB office. Later this summer, this notification will be sent to study teams twice - at 14 and 30 days - to help researchers better manage pending IRB submissions
- Concurrent Changes Reminder: ARROW has been updated to now allow only one type of change of application (either a personnel or regular change of protocol) to be submitted at a time. This change eliminates inconsistencies between change forms in ARROW and will reduce the potential for noncompliance when listing study team members in ARROW. Study teams are still able to make changes to personnel as part of a change of protocol application and may submit a continuing review at the same time as a change application.
- Coming Soon: The HS IRBs and ED/SBS IRB offices are currently discussing ways to improve navigation for exiting and submitting applications to make it easier for study teams to know what steps to take to submit an application to the IRBs.
If you have questions about these changes to ARROW, please e-mail email@example.com.
Tips for Managing Study Team Transitions With the end of one academic year upon us, study teams may be undergoing transitions with personnel either leaving or joining the UW. Here are a couple tips for managing these changes:
- Submit a Personnel Change to Update List of the Study Team Members: Whether personnel are leaving or joining the UW, a personnel change must be submitted to keep the list of study team members current. For additional information, see our Principal Investigator Changes and Personnel Updates Guidance or contact us for assistance.
- Clarify IRB of Record Issues: UW-Madison IRB review does NOT automatically cover someone who leaves the UW but who continues to be involved in the conduct of a study open at the UW. Study teams who wish to keep someone on the study team after they leave the UW should contact the Reliance Team for assistance.
- Consider Whether a PI Change or Study Transfer Is Needed: Study teams may need to submit a change in PI if the current PI is leaving the UW or make arrangements for the PI to retain PI status at the UW for up to one year in order to complete the study. PIs leaving the UW also may wish to consider transferring IRB oversight for their study to another institution. To discuss options for transferring IRB oversight, please contact the Reliance Team.
Good Clinical Practice Training Reminder
In response to a
recent NIH mandate, UW-Madison now requires Good Clinical Practices
(GCP) training every 3 years for all members of a study team engaged in
research involving drugs, devices, biologics, or radiation. The
effective date for this training requirement is August 1, 2016. The
human subjects training snapshot activity in ARROW will include GCP
training data starting July 30th. The HS IRBs Office will begin
monitoring for GCP training starting August 1st. For more information
about GCP training, please visit this page. If you have any questions about this requirement, please contact the Office of Research Policy at firstname.lastname@example.org or 608-890-4399.
- 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.