Guiding Ethical Principles and Explanation
The ethical foundations for preserving a subject’s privacy and protecting the confidentiality of information collected from subjects can be traced to two ethical principles-respect for persons and their relationships and the obligation to minimize the harm to subjects participating in research (beneficence). Establishing and maintaining a trusting subject-investigator relationship are also essential to ensuring that subjects will continue participating in human subjects research and protecting a subject’s privacy and confidential personal information helps maintain that trust.
Respect for persons and their relationships is achieved in the informed-consent process. This principle requires that subjects be allowed to exercise their autonomy to the fullest extent possible, including the sharing of personal information with whom they choose and to the extent they choose, as well as having this private information kept confidential to the degree committed to by the investigator during the consent process. The principle of beneficence requires that harm to subjects be minimized and benefits maximized. The maintenance of privacy and confidentiality helps to protect subjects from a variety of potential harms should their confidential information be disclosed, including damage to their financial standing, employability, insurability, or reputation. Finally, investigators enter into a pledge of confidentiality with research subjects during the consent process. Breaking this pledge would erode the level of trust and respect between subjects and investigators. If subjects are unable to trust investigators, they will refuse to participate in research, leaving investigators unable to conduct human subjects research and develop the generalizable knowledge that benefits all of society. Therefore it is essential that each investigator maintain a strong record of trust and respect for his/her research subjects.
Additional information on the ethical principles guiding research with human subjects is located in module #1.