Confidentiality

Confidentiality of Research Data

The anonymity and/or confidentiality of subject data must be preserved in studies collecting data, using archival data, or using information originally obtained for different purposes. Investigators and their personnel conducting research on human subjects must agree to maintain in strict confidence the names, characteristics, questionnaire scores, ratings, incidental comments, and/or other information on all subjects and/or subjects' data they encounter so as not to conflict with State and/or Federal laws and regulations.

Assuring Confidentiality

In most research, assuring confidentiality is a matter of following some precautionary practices:

  • Substituting Codes
  • Separately Storing Informed Consent Forms or Face Sheets
  • Limiting Access
  • Storing Research Records in Locked Cabinets

Confidentiality of Sensitive Research

More elaborate procedures may be needed in some studies, either to give subjects the confidence they need to participate and answer questions honestly, or to enable researchers to offer strong, truthful assurances of confidentiality. This may be particularly necessary for studies in which data are collected on sensitive matters.

Sensitive research can be defined as involving the collection of information falling into any of the following categories:

  • Sexual attitudes, preferences, or practices
  • Use of alcohol, drugs, or other addictive products
  • Illegal conduct
  • Information damaging to an individual's financial standing, employability, or reputation
  • A patient's medical record
  • An individual's psychological well-being or mental health

Information in other categories, not listed here, might also be considered sensitive because of specific cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation.

Data in studies like the above should be handled in coded form, and plans for the ultimate disposition of the data should also be made. The identity of subjects must not be released except with their expressed permission.


Discussion of Research Data

Researchers may not discuss nor divulge in any manner a subject's name or any identifying information or characteristics, scores, ratings, comments, or information about a subject with anyone who is not an authorized member of the research team.

Furthermore, investigators may not discuss confidential information in a place where such a discussion might be overheard. Neither will they discuss confidential information in a way that would allow an unauthorized person to associate (either correctly or incorrectly) an identity with such information.


Presentations and Publications of Research Data

Publications or reports based on the collected data must be written in such a way as to safeguard the identity of individual participants. For example, data can be reported collectively as a group or with subgroups.

Any reporting of individual data is done in such a way as to protect the subject’s identity. For example, in a counseling research article that includes an individual case study, a pseudonym, minor demographics alterations, and minor details of the case may be altered so as to preserve anonymity. In the article, the writer notes that some case details have been altered so as to preserve anonymity.