1. Confidentiality Issues in Research with Human Subjects Sarah Frankel, Ph.D. Human Studies Committee Washington University

2. Confidentiality Pre-Test Name one method of protecting a participant’s confidentiality. Who are we protecting the participant’s confidentiality from? The researcher/research team, outside sources, NIH/FDA, the sponsor

3. Confidentiality Pre-Test What is the purpose of a Certificate of Confidentiality? Where does one obtain a Certificate of Confidentiality? How does the consent document protect confidentiality?

4. Importance of Confidentiality Protecting research participants - Ethical concerns Insurance coverage Federal legislation (HIPAA)

5. Measures of Protecting Confidentiality Consent Form Procedures (revealed on HSC forms) Certificate of Confidentiality

6. Consent Form Warrants an entire section. Includes explanation of: –type of data to be used –storage of data –period of time data will be active Risk of breach of confidentiality is to be included in the Risks section, especially for sensitive data

7. Procedures HSC is particularly concerned with... –What identifiers will be used? –How and when will data be coded/identified? –How will data be stored? –Who will have access to data? Particular concerns with audiotapes, videotapes, and photographs

8. Certificate of Confidentiality Issued by the NIH to protect data from subpoena. Granted for: studies using sensitive data, or for which a Certificate would promote participation –HIV status, illegal drug or alcohol use, sexual behaviors, STDs, genetic studies that may reveal a predisposition

9. HIPAA  Federal legislation concerning the confidentiality of Protected Health Information (PHI) used or created in research  For all research studies, a waiver of participant authorization or an authorization will be required.  Examples of research that might request a waiver: databases, repositories, chart reviews, preliminary searches to identify participants http://medicine.wustl.edu/~hsc/hipaa/ FOR MORE INFO...

10. Resources www.medicine.wustl.edu/hsc –Confidentiality guidelines (general and Certificate) –Model consent form statements –HIPAA information –Necessary forms HSC staff

11. Confidentiality Pre-Test Answers Name one method of protecting a participant’s confidentiality. De-identification, COC, randomly/code, remove all identifiers, behind two keys, identifiers kept separately from information. Who are we protecting the participant’s confidentiality from? The researcher/research team, outside sources, NIH/FDA, the sponsor. Outside sources - those not associate with the research.

12. Confidentiality Pre-Test Answers What is the purpose of a Certificate of Confidentiality? Protect the data from subpoena. Where does one obtain a Certificate of Confidentiality? NIH or FDA How does the consent document protect confidentiality? Outlines what will be used, with whom it will be shared, when and how the information will be shared, if a COC has been obtained.