Protection of Health Information
- Investigators are expected to keep any protected health information (PHI) in a secure database. Only the portion of the de-identified data that is required for analysis needs to be provided to the biostatistician.
- To ensure compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), please de-identify your data as per the Safe Harbor Method and export it into a CSV file for analysis. This process entails removing 18 specific identifiers, including contact information such as names, telephone numbers, and email addresses, as well as health-related information such as medical record numbers or health plan beneficiary numbers.
- For some projects, it may be necessary for core staff to work with limited data sets. With a limited data set, the following information may remain in the data disclosed:
- Dates such as admission, discharge, service, DOB, DOD
- City, state, five digit or more zip code
- Ages in years, months, days, or hours
- Use of a Box Health Data Folder (BHDF) is required for secure transfer of data of limited data sets.
- Clients are asked to discuss data security best practices with the biostatistician in the event that limited data sets must be used, as a data use agreement may be required.
- If you require assistance with HIPAA compliance after having consulted this document and the resources hyperlinked herein, please contact Gillian Cooke, (217) 300-6079.
- More information regarding University of Illinois HIPAA regulations can be found at hipaa.uillinois.edu.
Protection of Human Subjects
- For all research involving human subjects where identifiable data are to be reviewed or analyzed by core biostatisticians (including limited data sets), the core requires:
- Institutional Review Board (IRB) documentation (i.e., approval letter) prior to the commencement of biostatistical work
- The biostatistician be added to the research team, where the amendment identifying the biostatistician as a team member must also be received prior to the commencement of work
- If you are unsure whether your project involves identifiable data or whether the biostatistician needs to be added to your IRB application as a research team member, please contact your institution’s IRB staff for assistance. University of Illinois investigators can contact the Office for the Protection of Research Subjects (OPRS) at email@example.com with questions.