Confidentiality of Collected Data

Confidentiality of Collected Data

Committee on the Use of Human Research Subjects
Institutional Review Board (IRB)

This document outlines policies concerning

· Confidentiality of research data

· Discussion of research data

· Presentation and publication tips to preserve subject 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.

In most research, assuring confidentiality is a matter of following some precautionary practices: substituting codes for names or other personal identifiers, separately storing informed consent forms or face sheets (containing such items as names and addresses) from survey instruments containing the data itself, properly disposing of computer sheets and other papers, limiting access to identified data, impressing on the research staff the importance of confidentiality, and storing research records in locked cabinets. 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:

· Information relating to sexual attitudes, preferences, or practices;

· Information relating to the use of alcohol, drugs, or other addictive products;

· Information pertaining to illegal conduct;

· Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;

· Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;

· Information pertaining to 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.

As early as feasible, the data in studies like the above should be handled in coded form (i.e., the subject's name and information that would reveal his or her identity should be removed; consent forms separated from data, etc). Plans for the ultimate disposition of the data should also be made (i.e., after the three year retainment period, how will the data be destroyed). 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.

Feel free to contact the IRB chair for more ideas as needed for safe data collection and storage.