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聽the virtual town hall on September 20, 2024, regarding the UW鈥檚 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鈥檚 new Diversity in Clinical Trials law (). This was followed by a Q&A session with attendees. A is now available聽along with a complete list of the 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.

  • . This guidance may be useful to researchers who are studying suicide prevention. It is also intended for the following categories of research:
  1. Studies that ask about suicide and will not collect identifiable information about participants;
  2. Studies that ask about suicidal ideation or intent even if it is not the focus of the research;
  3. Studies where participants are screened out for suicidal ideation; and
  4. Situations in which participants may disclose unsolicited information about suicidal thoughts or behavior.

罢丑别听 for helping researchers determine: 1) whether a Suicide Risk Mitigation Plan is required; and 2) what the 91探花IRB will generally expect to be included in the 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 鈥渃heck a box鈥� 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.
  • . 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 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 and the . We also solicited feedback from 91探花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 91探花researchers who provided feedback on what we hope will be an improved and streamlined approach to mitigating risk for this vulnerable population.

Questions. Contact with any questions about the new materials.

Changes to CITI Login

91探花Now Uses Single Sign On (SSO)

91探花now uses Single Sign On (SSO) with the . using your 91探花NetID and password.

If you are logging into 91探花CITI for the first time, your CITI account will be automatically created based on your 91探花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 91探花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 using your CITI username and password. To merge 2 existing accounts, email 聽for assistance.

91探花continues to offer free human subjects protections training to collaborators of 91探花researchers who are required to take the training. Review for step by step instructions.

To learn how to add courses to your CITI account, review .

Contact with any questions.