Researchers, whether from academic, commercial, or clinical backgrounds, have a responsibility to uphold participant privacy when conducting human studies. This entails taking necessary measures to protect the sensitive and personal information that participants would not willingly disclose or make public. Respecting participant privacy can be achieved through two primary approaches: conducting anonymous research or conducting confidential research.
Anonymous Research refers to a research approach where the identity of participants is completely unknown to the researcher and all project associates. The collected information in anonymous research does not include any identifiable data, significantly reducing the risk of data attribution to specific individuals.
Confidential Research emphasizes the implementation of robust safeguards to protect participant privacy and their information from unauthorized access, use, disclosure, modification, loss, and theft. It ensures that proper measures are in place to maintain the confidentiality of participant data throughout the research process.
Anonymized information undergoes a process where all direct identifiers, such as names, social insurance numbers, and health numbers, are permanently removed. The remaining indirect identifiers carry a low risk of re-identification, and there are no existing codes that could potentially link the anonymized data back to individual participants. Even the researcher themselves cannot establish a link between the data and participants in anonymized information.
De-Identified Data refers to data that is provided to the researcher in a de-identified form. The existing key code, necessary for potential re-linkage, is accessible only to a custodian or trusted third party who operates independently from the researcher. This ensures an additional layer of protection for participant privacy.
Identifiable information encompasses both direct and indirect identifying data. Direct identifiers, such as names, social insurance numbers, and personal health numbers, uniquely identify specific individuals. Indirect Identifying Information refers to data elements, such as date of birth, place of residence, or unique characteristics, which in combination could reasonably identify an individual.
Coded Information involves replacing all direct identifiers with a code, allowing specific data to be attributed to individual participants while maintaining their anonymity. This coded approach ensures the confidentiality of participant identities while enabling the researcher to analyze and interpret the collected data.
