Privacy and Confidentiality in Research Renatha S. Joseph

Objectives of the session Overview of the privacy and confidentiality Importance of privacy and confidentiality Challenges of privacy in confidentiality in research How to maintain confidentiality

Overview of the privacy and confidentiality Whatsoever things I see or hear, in my attendance on the sick or even apart there from, which on no account one must spread abroad, I will keep to myself holding such things as sacred secrets - Hippocratic Oath, 4th Century, B.C.E.

Confidentiality: Is the non disclosure of private of information (data) disclosed in a trusting relationship Confidentiality is an agreement between parties made via the consent process

Privacy vs. Confidentiality About people Sense of being in control of access that others have to ourselves Right to be Protected Confidentiality About identifiable data Agreement about maintenance and who has access to identifiable data

Principle of bioethics Respect for Persons Individuals should be treated as autonomous agents Allows individuals to exercise their autonomy to the fullest extent possible, including the right to privacy and the right to have private information remain confidential

Principle of bioethics Beneficence Do not harm Minimize risk and maximize possible benefits Maintaining privacy and confidentiality helps to protect participants from potential harms including; Psychological harm such as embarrassment or distress Social harms such as loss of employment or damage to one‘s financial standing Legal such as criminal or civil liability

IRB determine that where appropriate there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data

Privacy: An individual’s control over the extent, timing, and circumstances of sharing him/herself (physically, behaviorally, or intellectually) with others Researchers must protect subjects’ privacy Researchers must safeguard subjects’ privacy during recruitment for the study and during data collection Data must be stored securely and in a form that prevents, where possible, the identification of individuals (anonymity)

Importance of confidentiality in research Build trust between participants and researchers and community at: Individual Community Honest data Minimizes stigma Minimizes stress like possible criminal liability

Cases of confidentiality and research Humphrey tea room study Havasupai tribe

Challenges of confidentiality in research Informed consent, full disclosure of the purpose and procedure is needed including how confidentiality is maintained Extent to which confidentiality can be breached in any Secondary data use Incidental and unexpected findings Result publication- criminal

How to maintain confidentiality Restrict access to data (password protect, lock) If data stored on a computer; maintain on a stand alone computer; no network connection Use encryption software, if data is accessed it is unable to be deciphered Minimize storage of subject identifiable data on a laptop computer which can be lost or stolen

Waiver of Documentation of informed consent – Certificates of Confidentiality – protects data from being subpoenaed from the authority as evidence Waiver of Documentation of informed consent – the only record linking the subject and the research would be the consent document principal risk would be potential harm resulting from a breach of confidentiality applicable for research conducted under FDA regulations