HRPP Newsletter December 2021

Review Flexibility for Single-Patient Expanded Access Requests

With the December ARROW patch, applications for Humanitarian Use Devices (HUDs) and Expanded Access Requests (emergency uses, single-patient, and patient group expanded access/compassionate uses) will be stand-alone application types in the Wizard. In addition, to take advantage of flexibility in the review process for non-emergent single-patient expanded access requests, the Expanded Access application will ask treating teams if they have requested a waiver from convened board review from the FDA. If the appropriate request has been made and documentation uploaded, these submissions will no longer require review by the convened board and can instead be reviewed by the Chair or designee.

Presentation on the Non-Protocol-Based Application (nPBA)

The UW-Madison IRBs is hosting a nPBA Information Session to cover the following topics:

An introduction to the IRB Efficiency Project (IEP)
Overview of using the nPBA
Resources
Q&A

Presentation on Revised Guidelines for Single (sIRB) Review

On December 15th at 11 AM, RELIANT will discuss recent changes to UW-Madison single IRB review guidelines. We will cover changes for both ceding IRB review and UW serving as IRB of record (sIRB). We also will be discussing some frequently asked reliance-related questions. Registration is required and available here.

Reminder: Single IRB Consultation Requirement

Staring January 1st, study teams will be required to have a consultation with RELIANT when asking the UW to serve as the reviewing IRB for external sites. This consultation must occur prior to grant or IRB application submission. If a consultation has not occurred, the UW cannot guarantee it will serve as the sIRB. If the UW is not the best option for serving as the sIRB, RELIANT will assist study teams in identifying a reviewing IRB for their study. Our consultation request form can be found here.

Updated ClinicalTrials.gov questions coming to ARROW

Beginning December 18, all new nPBA applications and all existing PBA applications will show new questions about registering studies with ClinicalTrials.gov. Historically, these questions have simply asked the PI to determine whether their study meets one or more of the registration criteria set out by a federal entity (FDA, NIH) or working group (ICMJE); these new questions attempt to break down these criteria into easier to understand pieces that will guide the PI through the determination process.

Don’t forget UW-Madison HRPP offers comprehensive support for ClinicalTrials.gov records as a free service to all study teams via the ClinicalTrials.gov Service Line.

To submit feedback on these new questions or for general ClinicalTrials.gov information, please email ClinicalTrials.gov_Support@research.wisc.edu.

FDA Now Enforcing Federal ClinicalTrials.gov Policies

The first Notices of Noncompliance for incomplete ClinicalTrials.gov records have been sent this year, signaling FDA’s willingness to use their enforcement powers to ensure record accuracy and completeness. Studies that meet the definition of an Applicable Clinical Trial as described in the Food and Drug Administration Amendments Act (2007) and/or a NIH clinical trial as described in the Final Rule (2017) are required to maintain an accurate record on ClinicalTrials.gov throughout the life of the study and report a summary of their results within one year of the end of data collection. Failure to comply with these policies include fines, suspension of HHS grant disbursement for the institution, and public ‘name and shaming’.

UW-Madison has a free service called the ClinicalTrials.gov Service Line to assist PIs in creating and maintaining study records; they have also developed resources for study teams that opt to handle their own records. Please feel free to contact them with any questions, record support needs, or to request an introductory session to ClinicalTrials.gov for your department or research group.