HRPP Newsletter February 2022
Latest Toolkit Updates Now Live!
Since the launch of the HRPP Toolkit last March, we have been collecting feedback on the Toolkit materials from the research community, IRB staff, and HRPP leadership and making revisions every 6 months. The latest round of revisions went live the week of January 24, 2022. Updates to the Investigator Manual, Reliance Manual, and various templates were made. Additionally, updates were made to Toolkit checklists and worksheets that IRB Staff have been using to conduct reviews for the past several months. As a reminder, we welcome feedback via the Toolkit Feedback Form that is linked throughout the IRB website or by email (firstname.lastname@example.org).
Sending Studies back to Pre-submission
Applications that are missing a significant amount of required information, as outlined in HRP-308, or ancillary approvals required for the pre-review process to be completed, may be sent back to pre-submission. This will allow the study team to continue to edit the application and supporting documents without delaying the review process and without the possibility of the study reaching a deadline and being auto-archived. These applications are identified by the IRB Analyst early in the pre-review process. The analyst will contact the study team and work to schedule a consult to discuss any outstanding issues.
IRB For Beginners Workshop
The UW-Madison IRBs office is hosting an IRB for Beginners Workshop on February 22nd at 2pm (Register here).
This workshop offers an overview of the IRB process and review procedures, including information on required training, steps to completing and submitting an IRB application with supporting documents, resources you can consult for more information, the IRB’s overall review process, and some tips and tricks to avoid delays in approval.
A recording will also be made available on the IRB website.
Revised guidelines for when UW-Madison's will serve as the single IRB or cede IRB review went into effect January 1st. The two main changes are:
- UW-Madison will consider serving as the sIRB or ceding IRB review only for non-exempt studies with external funding.
- UW-Madison will only cede IRB review to or serve as the sIRB for accredited sites or those with a robust HRPP.
- More information about the revised guidelines can be found in the appendix of the reliance manual.
Effective January 1st, a consultation with RELIANT is required for study teams asking the UW to serve as the single IRB (reviewing IRB) for a multisite, non-exempt study. Without prior consultation, the UW cannot agree it will serve as the single IRB. If the UW is unable to serve as the reviewing IRB, RELIANT will assist study teams in identifying another external IRB.
Please contact email@example.com with any questions about these changes.
RELIANT is Hiring
The UW Reliance and Navigation team (RELIANT) is hiring. The incumbent will use independent judgement to conduct institutional reliance reviews and support study teams engaged in multi-site human subjects research. Interested applicants can read more about the position and apply on the UW jobs site.
Upcoming PREP Course: Communicating with Empathy
Register here for PREP’s upcoming course on 3/1 at 11am.
Trying to explain your scientific research clearly to a potential study participant is a challenge. Trying to explain your study to someone who is scared or upset is even more challenging. Learning how to respond to these emotions in an empathetic way can ultimately help you and the potential participant communicate about your study more clearly. Join us to practice sensitively approaching people who have a difficult diagnosis or who are wary of a stressful procedure.
Update on MyChart Research Recruitment
The UW SMPH and UW Health are working to develop a mechanism for recruiting research subjects through MyChart, UW Health’s patient portal. This functionality is still under development and will be piloted this summer. Information about the projected timeline for broader use, including what studies will be eligible to use MyChart for recruitment, will be communicated as soon as the information is finalized. If you have more specific questions about MyChart for Recruitment, please contact Jomol Mathew (Associate Dean for Informatics and Information Technology), SMPH or Betsy Nugent (Chief Clinical Research Officer, UW Health).
NEW Continuing Review Submission Guidance
With the launch of Toolkit in early 2021, guidance on when to submit continuing reviews was updated:
If your study requires continuing review, you must submit your continuing review no later than 45 days (previously 60 days) prior to the study’s expiration date to allow sufficient time for IRB review. Unlike other IRB submissions, which are reviewed in order of submission, continuing reviews are reviewed based on the expiration date of the study. The change in submission guidance is being made to review continuing review applications sooner upon their submission to the IRB Office while not cutting off the study’s review period. This guidance applies to continuing reviews that require full committee review and those that qualify for review under expedited procedures.
The IRB makes every effort to review continuing review applications prior to a study’s expiration date. However, it is the study team’s responsibility to submit their continuing review application with sufficient time for IRB review.
Some additional continuing review reminders/notices:
- A continuing review application and a change of protocol can be submitted at the same time in ARROW and reviewed concurrently by the IRB.
- Continuing reviews for most Statistical Data Analysis Center (SDAC) studies, which previously could be expedited, now require review by the full committee at an IRB meeting.
- The guidance above applies to all continuing review applications, regardless of if the continuing review requires full committee review or can be reviewed under expedited procedures.
Change in Administrative Review Fee for Industry –Sponsored Studies Ceded to External IRBs
In January 2019, the OVCRGE discontinued charging fees for IRB review, but continues to charge an institutional review fee for industry-sponsored studies. IRB review of all industry-sponsored studies is ceded to external IRBs and these fees are included in clinical trials agreements and therefore paid by the industry sponsors. To align with our peer institutions and help cover the increased costs of these reviews, this fee will increase from $2,000 to $3,000 on March 1, 2022.