Confidentiality and Limits to Confidentiality

"Confidentiality of the identity of subjects and of information from subjects is an important part of any research activity. Especially in behavioral research, but also in bio-medical research, breach of confidentiality and invasion of privacy may pose the greatest risks of harm associated with the research. Wherever possible, research data should be retained without any identifiers. When this is not possible, as in the case of longitudinal research or research which links data from several sets of data, investigators must take steps to protect the confidentiality of the subjects and the data."
--University of Washington Human Subjects Manual

Anonymity and confidentiality are mutually exclusive. When data are anonymous, they are not linked to the identity of individual subjects in any way that would make it possible to collect the information to the individual from whom it came. When participation is anonymous, it is not possible to tell whether or not an individual has participated in a study. When data are confidential, there is a link between information and the individuals who provide it, but the link is obscured by coding or other devices, so that even someone who has access to the raw data can not know from whom it came without also having access to the link between the subject code and the subject's identity. When participation is confidential, whether or not an individual has participated in a study is on record, but cannot be known by anyone except an investigator who has legitimate access to participation records.

In general, both data and participation should at least be confidential, when it is not possible for them to be anonymous. This should be clearly stated in the consent form (or other consent material), in the appropriate place under "Other Information", with some statement such as, "All of the information you provide will be confidential. Access to it will be restricted to members of the research staff [and .....].  Also, government or university staff sometimes review studies such as this one to make sure they are being done safely and legally. If a review of this study takes place, your records may be examined.  The reviewers will protect your privacy. The study records will not be used to put you at legal risk of harm."

There are, however, situations in which there are ethical or legal limits to confidentiality.

• immediate, grave danger to the subject or to others (if, for example, one has reason to believe that the subject is suicidal or homicidal)
• recent or ongoing child abuse
• recent or ongoing abuse of a dependent adult
• diagnosis of diseases or conditions subject to mandatory public health reporting

If it is likely that study procedures would obtain information subject to mandatory reporting, the fact that there are exceptions to confidentiality must be stated in the appropriate place (under "Other Information") in the consent form or other consent material. Examples of commonly used statements are:

• All of the information that you provide will be confidential. The only exceptions would be incidents of child abuse that you might report.
• All of the information that you provide will be confidential. The only exceptions would be incidents of elder abuse that you might report.
• All of the information that you provide will be confidential. The only exceptions would be information about risks of serious danger to others or to yourself.

However, there are many other situations in which confidentiality may be limited. For example, in a study of marital therapy, there might be individual sessions as well as couple sessions, and information collected during individual sessions might be brought up during the couple sessions. On the other hand, it might be that information will not be shared, when sharing might otherwise be expected. For example, a child might undergo certain types of cognitive testing for research purposes, but because the tests as administered are not clinically valid, the results may not be made available to parents or others. These limitations should all be considered by the investigators, and addressed in the consent materials.

There is a final set of situations in which investigators may feel some pressure to release information. Consider, for example:

• A study of anger management therapies in which a subject assaults one of the study staff (but not in a life-threatening fashion)
• A home visit during which a substantial sum of money disappears from an interviewer's purse
• A check for study participation is altered, or used as a model for forging additional checks, leading to an official inquiry about the identity of subjects

Under such circumstances, the promises made in the consent form will limit the actions the investigator can take. In general, investigators are obliged to provide the level of confidentiality that they have promised to provide, except in situations in which information subject to mandatory reporting is obtained even though there was no likelihood that it would be, and the issue was thus not addressed in the consent form.

It is thus very important for investigators to reflect on possible and likely events while they are designing their studies, drafting their consent materials, and providing training for study staff. While Human Subjects reviewers may query investigators about various procedures and materials, the focus of human subjects review is on risk to subjects, and on whether the consent process adequately informs prospective subjects of risks and burdens they can expect. It is not possible to rely on reviewers to consider all aspects of study design.