Institutional Review Board - Key Documents and Processes
Information below is intended for WCWH Researchers already listed on the Cohort Study IRB:
Active IRB documents
IRB modifications
Required trainings new and current study personnel
Consent Documents
Last updated 3/17/2025
Folder name | Date of approval | Active/Inactive | Notes |
|---|---|---|---|
8/31/2023 | Active | Part 1 includes all study activities and signing agreement(s) covers mobile app and survey use as well as environmental measures (beacon, dust, water samples), and data linking to other WCWH projects | |
8/31/2023 | Active | Part 1 covers data linking to other WCWH projects and academic record access | |
8/31/2023 | Active | Part 2 covers Fitbit use and biological samples | |
8/31/2023 | Active | Part 2 covers biological samples only | |
8/31/2023 | Active | Part 3 includes LENA, Accelerometer, and Daily Check-ins (EMAs) | |
8/31/2023 | Active | Part 4 is medical record access | |
8/31/2023 | Active | Part 4 is medical record access | |
12/20/2024 | Active | Part 5 is 24-hour blood pressure monitoring | |
11/4/2021 | Active | Assent forms includes all study activities and is completed following parental consent | |
6/16/2022 | Active | Assent forms includes all study activities and is completed following parental consent | |
3/28/2022 | Inactive | Original consent form used through (MM/DD/YYYY) | |
3/28/2022 | Inactive | Original consent form used through (MM/DD/YYYY) |
Related IRB protocols and contact information
ID | Name | Date modified | State | PI first name | PI last name | Primary contact |
2019100034 | 3/6/2025 4:10 PM | Approved | Darla | Castelli | sarah.smith@austin.utexas.edu | |
2018070126 | Whole Communities - Whole Health Community Readiness Project | 8/29/2024 1:00 AM | Approved | Karla | Lawson | sarah.smith@austin.utexas.edu |
2020020150 | 7/22/2021 12:14 PM | Approved | Frances | Champagne | sarah.smith@austin.utexas.edu |
Reporting new information -
When a protocol deviation that meets the criteria for an unanticipated problem or incident of noncompliance (See Section 2 – Definitions) becomes known to a researcher, they must complete and submit a Protocol Deviation or Noncompliance Report via the Reportable New Information (RNI) submission pathway in UTRMS-IRB. It is expected that researchers and research staff promptly self-report events that may meet the criteria for an unanticipated problem or noncompliance to the IRB via the RNI pathway in UTRMS-IRB.
Allegations or reports of protocol deviations and incidents of noncompliance may be identified via monitoring visits or via communication by someone other than the researcher through telephone calls, letters, e-mails, or any other method of communication and may be made to the ORSC office, the ORSC Director, the IRB Chair, or to the University Compliance Services Hotline (877-507-7321). The identity of individuals making a report will remain confidential unless the individual provides permission to disclose his/her identity.
Policies & Guidance | Texas Research (utexas.edu) - see section 9 for reporting unanticipated problems
New information should be reported to the study coordinator who can initiate the RNI submission