HRPP Newsletter – March 2025

Adding Federal Funding to Approved Studies

Adding new federal funds, particularly NIH funds, to an already approved study may require additional modifications beyond just adding the funding. For example, NIH funding requires data sharing and management plans, and the use of a single IRB for multi-site studies; if applicable to your study in general, these should also be addressed in the change of protocol.  Please review our new guidance, here.

Email Recruitment Reminders

All recruitment materials, including emails using the UW Research Email Service, should include the following email caution language when potential participants are invited to contact the study team via email, if the study may collect sensitive OR health related information:

• Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email.

Please see the Investigator Manual for additional information on recruiting via email.

Updated Reporting Timeframes for Reportable Events

Please review updated requirements for reporting certain events to the IRB.  Changes include a new section specific to reporting timeframes for studies involving investigational devices, including a new 5 day reporting requirement for any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency.