HRPP Newsletter – September 2024

New Guidance on Enrolling Subjects with Limited English Proficiency (LEP)

Various Toolkit documents, including the Investigator Manual and Protocol template, have been updated to provide study teams with additional guidance and resources on enrolling non-English speakers and those with limited English proficiency, including the use of interpreters and who can serve as a witness, as well as campus resources available for oral interpretation and written translation of study materials.

Upcoming PREP Course on Building Community-Academic Partnerships

Best of Both Worlds: A Community-Academic Partnership Addressing Mental Health and Incarceration
This presentation will describe a community-academic partnership focused on mental health and well-being among currently and formerly incarcerated individuals. The presentation will describe the process of developing this partnership with key lessons learned, from the perspective of an academic partner (Dr. Koenigs) and a community partner (Mr. Hicks).

Interested in Serving as an IRB Member?

If you have ever considered serving as an IRB member, our website includes information to consider, including answers to frequently asked questions, such as how much time is required, what it means to be an affiliated or unaffiliated member, and who to contact if you are interested. Feel free to pass this along to anyone (including friends or family who are not affiliated with the UW!) who may be interested in this unique opportunity to serve the research community.

Exemption Reminders

Changes

While not all exemption changes require IRB review, study teams need to submit changes under certain circumstances in order for the IRB to confirm that the exemption status remains unchanged. Examples of exempt changes that require IRB review: adding questions to an instrument, new procedures, or new study materials; the addition of external data sharing; the addition of a new study population.

See the Exemption Change Guidance Table for information about whether specific revisions or updates to exempt studies may require a change of protocol in ARROW. If you are unsure after consulting the table, please email the IRB analyst that reviewed the application.

If you wish to make a change to a study that was determined to be Not Human Subjects Research, please email the IRB analyst of the original application. The analyst will review the change in relation to the original application and determine whether the change affects its status, requiring a new application.

Renewals

Study teams should expect to receive renewal email notifications for exempt studies that have been open for three years (except for projects certified as Not Human Research). Reminders are sent 90, 60 and 30 days prior to the set expiration date. If the exempt project is on-going, the study team should complete the Renew Exemption activity in the study workspace prior to the expiration date.

If you wish to close an exempt project, please complete the Submit Study Completion Report activity in the study workspace (please see How to Close Studies for help).

If no action is taken, the project will automatically be closed in ARROW on the expiration date.