An issue of primary importance is the protection of both the privacy of research subjects and maintaining the confidentiality of data. Federal regulations [45 CFR 46.111(a)(7) (DHHS) and 21 CFR 56.111(a)(7) (FDA)] require that the IRB only approve research where there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Although related, the concepts of privacy and confidentiality are distinct from one another. Confidentiality means the ethical or legal right that information is considered private and will be held secret unless consent is provided permitting disclosure.
Privacy is the freedom from unauthorized intrusion or the state of being let alone and able to keep certain personal information to oneself. Research may require the collection, use, or access to identifiable information that would otherwise not be shared with others. When this is required for the purposes of the research, the private information involved should be the minimum necessary to accomplish the goals of the research.
The investigator must have sound plans to protect the subject's identity, must collect only the necessary identified information to conduct the study, and must have procedures in place to maintain the confidentiality of the research records. Care should be taken to explain the mechanisms that have been devised, for example, the use of numbering or code systems or safely locked files in private offices. Furthermore, the investigator should describe who has access to the data and under what circumstances a code system may be broken. Without appropriate safeguards, problems may arise from long-term retention of records.
The term anonymous is sometimes confused with the term confidential. In human subjects research, anonymous means that at no time during the data collection could someone determine who provided the information. If a link existed at any time, even if the link is subsequently destroyed, the IRB cannot consider the information anonymous.