Confidentiality and Privacy

Does the Common Rule demand confidentiality in research records?

The Common Rule addresses privacy of information about persons and confidentiality of data. A research project involving individual information about respondents can be exempt under two conditions:

• if the information either is not linked to the respondents' identity (§ 101 (b) (2)), e.g., it is anonymous, or
• the information is linked to the respondents' identity, but the nature of the information is such that disclosure will not be reasonably expected to cause harm (§ 101 (b) (2)). Non-anonymous data recording can be exempt if any breach of confidentiality will not cause harm beyond that encountered in everyday life. Historical or other research where the respondent is fully aware that publication will involve names, or where the information is in public records, is not of concern here.

The Common Rule explicitly allows social and behavioral science research involving minimal risk to record the identity of respondents in the data. Whether or not the research is exempt, professional ethics and respect for persons mandate confidentiality unless the participant agrees to release the information. (§ 111 (a) (7)).