1. Privacy vs. Confidentiality Presentation for IRB Members

2. What is the difference between Privacy and Confidentiality? Privacy is about people. Confidentiality is about data.

3. Privacy vs. Confidentiality Privacy About peopleAbout people Sense of being in control of access that others have to ourselvesSense of being in control of access that others have to ourselves a Right to be Protecteda Right to be Protected Confidentiality Extension of privacy About identifiable data an Agreement about maintenance and who has access to identifiable data HIPAA - protects patients from inappropriate disclosures of "Protected Health Information" (PHI)

4. Definitions Privacy – about people and our sense of being in control of others access to ourselves or to information about ourselves with others.Privacy – about people and our sense of being in control of others access to ourselves or to information about ourselves with others. Confidentiality – treatment of identifiable, private information that has been disclosed to others; usually in a relationship of trust and with the expectation that it will not be divulged except in ways that have been previously agreed upon.Confidentiality – treatment of identifiable, private information that has been disclosed to others; usually in a relationship of trust and with the expectation that it will not be divulged except in ways that have been previously agreed upon.

5. Privacy and Confidentiality are supported by two principles of the Belmont Report Respect for PersonsRespect 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.

6. BeneficenceBeneficence –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; and criminal or civil liability.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; and criminal or civil liability.

7. Per HHS and FDA Regulations In order to approve human subjects research, the IRB shall determine that where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data. 45 CFR 46.111(a)(7) 21 CFR 56.111(a)(7)

8. When is it appropriate to require provisions to protect the privacy of the participants? Consider the following: Will the participants have an expectation of privacy?Will the participants have an expectation of privacy? YES – adequate provisions for maintaining privacy are required are required NO – Provisions not needed Will participants think that the information sought is any of the researcher’s business? If NO, provisions are required.Will participants think that the information sought is any of the researcher’s business? If NO, provisions are required. Will participants be comfortable in the research setting? If NO, provisions are required.Will participants be comfortable in the research setting? If NO, provisions are required.

9. Privacy Issues Consider the following: The proposed subject population?The proposed subject population?  What are the cultural norms of the proposed subject population? Some cultures are more private than others.  What are the ages of the proposed subject population? There may be age differences in privacy preferences (e.g., teenagers less forthcoming than older adults) (continued on next slide)

10. The proposed recruitment methods: How are potential participants identified and contacted?The proposed recruitment methods: How are potential participants identified and contacted? Acceptable methods ~  advertisements, notices, and/or media  Send introduction letter to colleagues to distribute to eligible individuals – interested individuals contact researcher  Primary care staff contact those patients that qualify to determine interest Unacceptable methods ~  search through medical records for qualified subjects or existing database (e.g., registry); then have a researcher with no previous contact with potential subject recruit; this method violates the individuals’ privacy  recruit subjects immediately prior to sensitive or invasive procedure (e.g., in pre-op room)  retain sensitive information obtained at screening without the consent of those who either failed to qualify or refused to participate for possible future studies participation (continued on next slide)

11. Sensitivity of the information being collected – greater sensitivity = greater need for privacySensitivity of the information being collected – greater sensitivity = greater need for privacy Method of data collection (focus group, individual interview, covert observation)Method of data collection (focus group, individual interview, covert observation)  Will subjects feel comfortable providing the information in this manner?  If passively observing the subject; could the individual have an expectation of privacy (e.g., chat room for breast cancer patients)?  Will the researcher collect information about a third party individual that is consider private (e.g., mental illness, substance abuse in family)? If yes, informed consent should be obtained from third party? Privacy is in the eye of the participant, not the researcher or the IRBPrivacy is in the eye of the participant, not the researcher or the IRB (continued on next slide)

12. When is it appropriate to require provisions to maintain the confidentiality of collected data? Will confidentiality of identifiable date be offered?Will confidentiality of identifiable date be offered? Are there legal/ethical requirements (e.g., HIPAA)?Are there legal/ethical requirements (e.g., HIPAA)? Will release of data cause risk of harm?Will release of data cause risk of harm? YES TO ANY – adequate provisions for maintaining confidentiality of data are required NO TO ALL – Not needed

13. Methods to Maintain Confidentiality Restrict access to data (password protect, lock)Restrict access to data (password protect, lock) If data stored on a computer; maintain on a standalone computer; no network connectionIf data stored on a computer; maintain on a standalone computer; no network connection Use encryption software, if data is accessed it is unable to be decipheredUse 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 stolenMinimize storage of subject identifiable data on a laptop computer which can be lost or stolen Certificates of Confidentiality – protects data from being subpoenaedCertificates of Confidentiality – protects data from being subpoenaed Waiver of Documentation of informed consent - the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (not applicable for research conducted under FDA regulations).Waiver of Documentation of informed consent - the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (not applicable for research conducted under FDA regulations).

14. Important Points! The IRB must decide on a protocol-by-protocol basis whether there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the identifiable data at each segment of the research…recruitment to maintenance of the data.The IRB must decide on a protocol-by-protocol basis whether there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the identifiable data at each segment of the research…recruitment to maintenance of the data. The committee must consider the sensitivity of the information collected and the protections offered the subjects.The committee must consider the sensitivity of the information collected and the protections offered the subjects. Especially in social/behavioral research the primary risk to subjects is often an invasion of privacy or a breach of confidentiality.Especially in social/behavioral research the primary risk to subjects is often an invasion of privacy or a breach of confidentiality. During the informed consent process, subjects must be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of the parties who will or may have access (e.g., research team, FDA, OHRP). This will allow subjects to decide about the adequacy of the protections and the acceptability of the possible release of private information to the interested parties.During the informed consent process, subjects must be informed of the precautions that will be taken to protect the confidentiality of the data and be informed of the parties who will or may have access (e.g., research team, FDA, OHRP). This will allow subjects to decide about the adequacy of the protections and the acceptability of the possible release of private information to the interested parties.

15. Questions? Please contact:  Karen Allen Director of Research Protections @ kallen@uci.edu or 949-824-1558 kallen@uci.edu This presentation was adapted from IRB 201 Presentation by Jeffrey Cooper, M.D., M.M.M., 2004 and the Institutional Review Board: Management and Function, Amdur and Bankert, 2002