The privacy of subjects must be respected and ensured in research protocols. This requirement has been codified in various federal regulations but has its foundation in ethical principles outlined in the Belmont Report. Privacy refers to a subject’s right to control other people’s access to personal information about himself/herself. Generally speaking, it is the individual’s right to select the time and circumstances under which facts about him/her are shared with or withheld from others for nonclinical purposes.
Once a subject in a research protocol divulges private information to an investigator, this private information must remain confidential to the degree committed to by the investigator during the consent process. Investigators have a primary obligation to take precautions to protect private information obtained during the course of their research and to manage this information in accordance with the confidentiality standards established in the consent agreement. The release of subject’s confidential information could be harmful to subjects in a variety of ways. For example, release of a subject’s information concerning a negative impression of his/her community to other members of the community might lead to the subject experiencing a sense of insecurity or an erosion of trust. Release of a subject’s Human Immunodeficiency Virus (HIV) status might cause damage to his/her employability and financial standing, insurability, or reputation.
The harm from a breach of confidentiality may affect the subject, his/her close contacts (e.g., family members), or even his/her community. Subjects may be “wronged” - even if not harmed - if confidential information is released. Only under extreme situations, such as when a law requires disclosure or when disclosure will protect the subject or his/her close contacts from harm, should private information be disclosed without a subject’s consent. To the degree possible, these situations and other potential disclosures should be anticipated and described to the subject during the consent process as well as included in the informed consent document. It is during the consent process that subjects authorize investigators to collect private information from them and agree as to how it will be used, with whom this information will be shared, and how its confidentiality will be maintained, following HIPAA security requirements. Subjects have the right to expect that the private information and actions disclosed to an investigator will be used for their current research purposes, as outlined during the consent process.