Confidentiality Protection

Confidentiality issues need to be considered at every stage of the research process:

• Initial study design;
• Identification, recruitment and consent of subjects;
• Security, analysis and final disposition of the data;
• Publication or dissemination of the data and results.

Protections should be developed consistent with the study design and potential risk of harm from breaches of confidentiality. Considerations to minimize confidentiality issues that may influence research design include:

• Limiting the amount of personal information to the absolute minimum;
• Collecting information without unique identifiers attached to the data, or known to the researcher. Note: Some studies will require consent forms which identify the subject, but these names do not necessarily need to be linked to the data;
• Changing or aggregating other identifiers that may be used to identify the subject by deduction such as age, income and occupation.

In many studies, however, the use of unique identifiers is unavoidable. In these cases there are data collection procedures that can reduce the risk to confidentiality. Some of these are:

• Temporarily identifying responses and removing the subject names as soon as data are analyzed;
• Assigning codes to names and storing the identifying list in a safe or separate area from the study data. Some studies use aliases to protect identity.

Certificate of Confidentiality

A Certificate of Confidentiality protects participants by protecting research records from subpoena. Without the certificate, researchers can be required by a court-ordered subpoena to disclose research results, usually as part of a criminal investigation of the participants.

Certificates of Confidentiality help to minimize risks to subjects by adding an additional level of protection for maintaining confidentiality of private information.

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies under two conditions: the research is on a sensitive topic; and the protection is necessary to achieve the research objectives. These certificates are granted sparingly but are not limited to federally funded research.

Research can be considered ‘sensitive' if it involves the collection of:

• Information about sexual attitudes, preferences, practices;
• Information about the use of alcohol, drugs, or other addictive products;
• Information about illegal conduct; information that could damage an individual's financial standing, employability, or reputation within the community;
• Information in a participant's medical record that could lead to social stigmatization or discrimination; or
• Information about a participant's psychological well-being or mental health.

This list is not exhaustive. Researchers contemplating research on a topic that might qualify as sensitive should investigate the use of a Certificate of Confidentiality.

It must be understood that Certificates of Confidentiality protect participants from compelled disclosure of identifying information, but do not prevent the voluntary disclosure of identifying characteristics of participants. Researchers are not prevented from voluntarily disclosing certain information about research participants, such as evidence of child abuse or a participant's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, it should be clearly indicated in the consent form. See an Example Voluntary Disclosure Statement.

Additional information can be obtained at the web site of the Office for Human Research Protections (OHRP) and at the NIH web site. Visit the NIH Confidentiality Kiosk. The OSU IRB office is available to assist with questions about, or application for, a certificate.

Data Storage

Data storage and disposition are also important considerations. Data should be stored in files accessible only to the investigator and their assistants. If computers are used to store data, the investigator must be certain that access to sensitive files is limited, and if possible, the computer is isolated from any networks. Audio and video tapes may be particularly revealing and may require special precautions to maintain confidentiality when airing or viewing and for storage.