October 8, 2024
For the Record- October 8, 2024: DCTI, Participants at Risk of Suicide, CITI Changes
In this Issue:
September 20th DCTI Town Hall
Update
Thank you to everyone who participated in the virtual town hall on September 20, 2024, regarding the UW’s Diversity in Clinical Trials Initiative. At this event information was presented about translation/interpreter services and community engagement resources that are being put in place to support researcher compliance with WA State’s new Diversity in Clinical Trials law (RCW 69.78). This was followed by a Q&A session with attendees. A recording of the event is now available along with a complete list of the questions and responses in summary format.
Participants at Risk of Suicide
New Guidance
On September 26, 2024, HSD published new materials for studies that may identify participants at risk of suicide. The new guidance and required supplement (for applicable studies) are intended to provide a more standardized approach for creating a risk mitigation plan for studies that may identify participants who are at risk of suicide.
- Participants at Risk of Suicide web guidance. This guidance may be useful to researchers who are studying suicide prevention. It is also intended for the following categories of research:
- Studies that ask about suicide and will not collect identifiable information about participants;
- Studies that ask about suicidal ideation or intent even if it is not the focus of the research;
- Studies where participants are screened out for suicidal ideation; and
- Situations in which participants may disclose unsolicited information about suicidal thoughts or behavior.
The guidance provides a framework for helping researchers determine: 1) whether a Suicide Risk Mitigation Plan is required; and 2) what the UW IRB will generally expect to be included in the Plan.
- SUPPLEMENT Suicide Risk Mitigation Plan. Submit this supplement if a Suicide Risk Mitigation Plan is required according to the framework in the web guidance. Many of the required elements described in the framework are listed in the supplement so that researchers can “check a box” if they will include that element in their Plan. If the research team has already developed a suicide risk mitigation plan as part of a larger data safety monitoring plan, they can submit that instead of the supplement.
- INFORMATION SHEET Mental Health Resources. HSD has provided a list of potential resources that can be provided to research participants experiencing mental health issues. Some of these resources are targeted to particular groups or demographics (e.g., LGBTQ+; veterans). Researchers are not required to use these resources.
Developing the framework. HSD collaborated with Dr. Katherine Comtois of UW Psychiatry to develop the guidance, and particularly the framework for determining when a suicide risk mitigation plan is necessary. Dr. Comtois has been working to prevent suicide for over 20 years and is the director of the UW Center for Suicide Prevention and Recovery (CSPAR) and the UW Suicide Care Research Center (SCRC). We also solicited feedback from UW researchers with relevant expertise in the departments of Psychiatry, Rehabilitation Medicine, Social Work, and the Addictions, Drug & Alcohol Institute (ADAI). HSD is grateful to Dr. Comtois and all the UW researchers who provided feedback on what we hope will be an improved and streamlined approach to mitigating risk for this vulnerable population.
Questions. Contact hsdinfo@uw.edu with any questions about the new materials.
Changes to CITI Login
UW Now Uses Single Sign On (SSO)
UW now uses Single Sign On (SSO) with the CITI Program. Login to the CITI Program using your UW NetID and password.
If you are logging into UW CITI for the first time, your CITI account will be automatically created based on your UW NetID credentials.
If you previously created a CITI account, your old CITI account has been automatically merged with your SSO login if possible. This means that when you login using your UW NetID and password, you should see your account information from your original CITI registration, including any previously completed courses. If you do not see your previously completed courses, you can still access them by logging in on the CITI website using your CITI username and password. To merge 2 existing accounts, email support@citiprogram.org for assistance.
UW continues to offer free human subjects protections training to collaborators of UW researchers who are required to take the training. Review CITI Registration for Users Without UW NetIDs for step by step instructions.
To learn how to add courses to your CITI account, review Web Based CITI Training.
Contact hsdinfo@uw.edu with any questions.