Record-level birth, death, and fetal death data are confidential in Texas. These data cannot, per statute, be “de-identified” unless aggregated with suppression for small counts. When describing data management and security, treat all record-level data as sensitive.
The IRB requires clear justification for all requested variables. We suggest adding a sentence next to each variable as needed. Some can be as simple as “potential confounder” or “outcome of interest,” so long as the IRB understands their purpose.
All study collaborators, project partners, co-investigators, etc. who will have any access to study data must be listed as a “Project Partner” on the HRP-301 form with Human Subjects Training attached to the application.
Data Management section of the HRP-302
The IRB and CHS take data security very seriously. The data management section of the 202 should include all of the following:
- How and where data will be stored, and who will have access to it
- What steps will be taken to avoid identifying individuals in publications? Will data be aggregated?
- What suppression criteria will be applied to small counts?
- Clarify that only those listed on the 201 will have access to study data
- List the date of destruction along with destruction method. If you wish to hold on to data past the study end date, provide justification for the delay.