1. Privacy and Confidentiality in Research
Renatha S. Joseph

2. 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

3. 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.

4. 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

5. 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

6. 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

7. 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

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

9. 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)

10. 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

11. Cases of confidentiality and research
Humphrey tea room study
Havasupai tribe

12. 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

13. 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

14. 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