Privacy and Confidentiality
One of the primary ways the IRB evaluates projects is by the degree of risk to the privacy of the participant. The IRB considers these questions for research projects:
- Is there a risk of release of private information because the study population is too small and/or locally known?
- Who will have access to the data?
- How will the data be collected and maintained?
- How will the data be reported?
- How harmful will a breach of privacy be to a partcipant?
Because the John Carroll community is relatively small, the IRB is concerned with collection of demographic information that might identify a research participant when using the John Carroll community. Therefore, researchers are encouraged to limit the collection of demographic data for those studies in which John Carroll students or employees are employed as research participants.
Listed below are descriptions of important privacy-related topics:
Data are confidential if the researcher can link a data set to a particular participant but will protect the privacy of the participant from others.
Data are anonymous if there are no identifiers connected to the data and the researcher is unable to link data to any one individual.
Identifiers are types of data that can identify a research participant. Identifiers include gender, religion, birth month, salary range, city of origin, or ethnicity, especially if the participant pool is small. Focus groups or in-person interactions cannot be considered anonymous since visual recognition is an identifier. Dissemination of audio tapes is not confidential since voice recognition is an identifier.
The federal Office of Human Research Protections online guidebook defines privacy as “control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.” Loss of privacy is considered to be a risk factor.
- Manner of Data Collection
If the data are of a sensitive nature, the IRB would carefully examine the informed consent document to ensure that the participant is aware of study design. Projects may collect data in a confidential manner but analyze and/or report it in an anonymous manner. Individual data sets can be re-identified in some cases; reporting of aggregated data protects the privacy of the individual. Or the data may be collected and analyzed on an anonymous basis. Rarely are data collected, analyzed, and reported with the identity of participants disclosed. The consent form and IRB application should make these procedures clearly understood.
In some cases, the use of a consent form itself may lead to a loss of confidentiality.