HRPP Newsletter January 2023
New Leadership Updates
We are very excited to announce that Lisa Wilson and Travis Doran have accepted leadership positions within the Office of Research Compliance.
As of January 9th, Travis Doran became the Associate Director of HRPP Quality, Compliance, and Reliance, a new position that will oversee the reliance and navigation team and the quality and compliance team. Prior to starting this position, Travis served as an HRPP Quality & Compliance Analyst since 2015. In that role, he conducted post-approval monitoring and engaged in a number of cross-campus committees and duties to support the HRPP.
On February 1st, Lisa Wilson will assume the interim IRB Director role. Lisa Wilson currently serves as Senior University Legal Counsel with a focus in HRPP/IRB/FDA regulations and in that capacity has worked with the IRB committees and office since 2003. She has also led and continues to lead a number of projects with intersections between the UW HRPP and UWHC.
We look forward to continuing to work with them in these new roles!
Records Retention Changes in ARROW
In order to comply with the UW Institutional records retention schedules for IRB applications, this spring, OVCRGE ARROW IT and IRB will begin the process of PERMENANTLY DELETING applications from ARROW that have reached their scheduled record retention period. The retention period is 7 years after a study is closed (which is 5 ½ years after a study is archived and cannot be modified by the study teams or the IRB). You will receive an automated email from ARROW ~ 30 days prior to deletion of these protocols. For studies that never required IRB oversight (studies certified to be not human subjects research, like PDAs, or those withdrawn prior to approval), the retention period is 3 years after certification or being withdrawn. As no human subjects activities were conducted on these studies, you will NOT RECEIVE any study-specific notification prior to deletion of these applications.
As with the paper applications for closed studies that have reached their retention period and been confidentially destroyed by the IRB, when the application is deleted from ARROW, all associated documents (protocol, stamped consents, approval letters, minutes, etc.) will also be deleted.
Detailed information will be sent prior to the official launch of the disposition process.
IRB for Beginners – Register now!
Register here for the IRB for Beginners Workshop, which will be held virtually on 2/8 from 10:00-11:00 am. 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.
It’s a new year, a great time to take a fresh look at your active protocols! One of the most common compliance findings is that changes have been made to the study without IRB approval. It is recommended that study teams regularly review their protocols to make sure practice and protocol are still aligned, and if they are not, steps should be taken to re-align them, submitting Reportable Events and Changes of Protocol as needed. Keeping aware of what’s in the protocol also helps prevent deviating from it and can help save time in the future to avoid needing to submit Reportable Events.
NIH Data Sharing Policy Implementation Tool
Ahead of the new NIH Data Management and Sharing policy changes, which go into effect January 25, 2023, DMPTool has released a new NIH template. This template is based on the NIH data management & sharing plan provided by the NIH and includes sections that help researchers answer questions about data types, related tools, software and/or code, standards, data preservation, considerations for access, distribution, and reuse, as well as oversight of data management and sharing.
As a reminder, Research Data Services will serve as the primary office for data management help, writing and review of data management plans, and data sharing/archiving. IRB protocol and consent templates will be updated to prompt study teams to include details relevant to the sharing of human subjects data.
ClinicalTrials.gov Service Line Updates
The latest version of the Investigator Guidance to CT.gov document is now live. Key updates include:
- Links to a few PRS Video Tutorials (also found on the first page of our website)
- Link to a ClinicalTrials.gov to NIH ASSIST document (modified from Duke)
- Link to UW resources for the NIH Data Management and Sharing Policy
- A new page “The Case for Voluntary Submission to ClinicalTrials.gov”
- Updated inflation adjusted (2022) federal fines for non-compliance ($13,237/day)