February 6, 2024
For the Record- February 6, 2024: RNI Reporting, Forms and Templates Reminder
In this Issue:
New Process for RNI Reporting to Sponsors
Effective February 1, 2024
HSD, in collaboration with the UW Office of Sponsored Programs (OSP), has revised the process for notification to study sponsors and others regarding Reports of New Information (RNI) that involve a reportable event (i.e., unanticipated problem, serious or continuing noncompliance, study suspension or termination).
HSD will continue to directly notify the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) of reportable events reviewed by the UW IRB. HSD will also be responsible for notifying any relying non-UW institution as specified in the reliance agreement.
Beginning February 1, 2024, OSP is responsible for completing any institutional obligations for reporting reportable events to funding agencies or other study sponsors under the terms of any research award, subaward or contract managed through its office. For funding that is not managed through OSP, the Principal Investigator (PI) is responsible for completing any reporting obligations to the study sponsor(s).
The UW PI (and applicable relying site PI) will be notified in advance by HSD of a reportable event, to allow the researcher the opportunity to alert any sponsor(s) prior to notification from OSP. The UW PI will be copied on any notification from OSP to the sponsor(s).
For questions about these changes, contact the HSD Regulatory Affairs team at hsdreprt@uw.edu.
New Process for External IRB Reportable Events
Effective February 1, 2024
When HSD relies on an external (non-UW) IRB for the review and oversight of a UW research project, the external IRB is responsible for reviewing Reports of New Information (RNI) and determining if any are a reportable event (i.e., unanticipated problem, serious or continuing noncompliance, study suspension or termination). The external IRB is responsible for any notification to the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). They are also responsible under the terms of the reliance agreement to notify HSD.
With the growing number of UW studies relying on an external IRB, HSD has implemented new procedures for how we process, track, and notify others when we receive a reportable event from an external IRB. Specifically, we look to ensure, where applicable:
- Notification to OHRP and/or FDA has occurred
- Other UW offices with interest in the incident have been made aware of the issue by the PI (e.g., UW Privacy notified of a data breach)
Additionally, HSD identifies if there is any funding associated with the study that is being managed through the UW Office of Sponsored Programs (OSP). If there is, the information is forward to OSP, who will make any necessary reporting to the study sponsor(s).
Finally, HSD will create a RNI in Zipline associated with the External IRB authorization request and upload a copy of the external IRB report. The RNI is created for the purpose of tracking receipt, notifications to others, and processing. HSD does not make any additional regulatory determinations and there is no IRB review. Researchers are not required to take any action.
For questions about these changes, contact the HSD Regulatory Affairs team at hsdreprt@uw.edu.
Old Consent Templates No Longer Accepted
Reminder
As of October 1st, 2023, HSD requires a participant-focused approach to the consent process and forms. This approach emphasizes: (1) providing prospective study participants with the key information most likely to influence their enrollment decision, (2) using plain language, and (3) presenting the information from the participants’ perspective. This means that new consent forms submitted on the old template are no longer accepted.
Requirements.
- The old consent template does not meet our participant-focused approach to consent so we no longer accept new forms submitted on the old template.
- For studies that are ongoing, you do not have to convert existing consent forms. However, any new forms that are submitted with a modification will not be accepted on the old template.
- The new consent templates are designed to help researchers create participant-focused consent forms. HSD does not require use of the new templates. Consent forms that do not use the new templates will be accepted provided they satisfy requirements for participant-focused consent forms.
HSD staff and our IRBs look forward to working in partnership with the UW research community to improve research consent at the UW. Contact hsdinfo@uw.edu with any questions.
Always Use the Most Recent Version of HSD Forms
Reminder
When you’re starting a new IRB application, it’s tempting to use a completed IRB protocol form from a previously submitted study to get started. However, because the IRB protocol and other HSD forms are revised regularly, it’s important to make sure that you’re always using the most recent version of the form so that you are providing all of the information required for review. If you use an out-of-date version of an application form, review may be delayed, and HSD may ask you to resubmit with the most recent version of the form.
Links to the most recent version of all HSD application forms can be found on our Application Forms page.