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Confidentiality Protection

Confidentiality Protection

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

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:

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:

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:

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.

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