Congenital Hyperinsulinism International (CHI) has strict rules to protect the privacy and identity of individuals who participate in the HI Global Registry (HIGR). These rules and principles apply to all data collected in the registry, including registry surveys, data from glucose monitoring devices, electronic health record (EHR) data, or any other data types that may be collected in the future. Here are some of the key points:
- Only authorized people can access registry data. CHI uses role-based access so staff only receive the level of access needed for their approved job responsibilities. Only members of the CHI research team can access any identifiable information (such as name), but even this access is limited to rare instances, such as needing to contact the respondent to clarify responses to survey questions. Data analysis is completed using only ID numbers.
- Staff must complete privacy and security training. CHI research personnel who work with registry data are required to complete training on ethical research practices, privacy, security, and HIGR policies.
- Data are stored in a secure cloud platform. HIGR operates through the Matrix platform by Across Healthcare, hosted in a Microsoft Azure production environment.
- Data sharing is limited and reviewed. Researchers or third parties must submit a formal data request, explain how they will use and protect the data, and receive approval before any data are shared.
- Only the minimum necessary data are shared. CHI reviews each request for data and limits data shared to the minimum information needed for the approved purpose.
- Data are de-identified before sharing. CHI works to reduce the chance that a participant could be identified, including removing all personally identifiable information (e.g. participant name and date of birth), reviewing small groups of participants, rare combinations of information, and sensitive variables.
- Higher-risk data receive extra review. Information that could increase privacy risk, such as detailed medical, genetic, demographic, or free-text information, requires additional scrutiny before being shared with researchers or included in a data report.
- Researchers must sign a Data Use Agreement. Approved recipients must agree to use the deidentified data only for the approved purpose, protect it appropriately, not try to identify participants, and destroy the data when required.
- Secure transfer methods are required. Deidentified data are transferred only through CHI-approved secure methods, with access limited to authorized recipients and removed after the transfer period.
