Confidentiality Issues in Confidentiality Issues in Research with Human SubjectsResearch with Human Subjects

Sarah Frankel, Ph.D.

Human Studies Committee

Washington University

Confidentiality Pre-TestConfidentiality 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

Confidentiality Pre-TestConfidentiality 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?

Importance of ConfidentialityImportance of Confidentiality

Protecting research participants - Ethical concerns

Insurance coverageFederal legislation (HIPAA)

Measures of Protecting Measures of Protecting ConfidentialityConfidentiality Consent Form

Procedures (revealed on HSC forms)

Certificate of Confidentiality

Consent FormConsent 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

Procedures 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

Certificate of ConfidentialityCertificate 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

HIPAAHIPAA

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...

ResourcesResources

www.medicine.wustl.edu/hsc– Confidentiality guidelines (general and

Certificate)– Model consent form statements– HIPAA information– Necessary forms

HSC staff

Confidentiality Pre-Test AnswersConfidentiality 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.

Confidentiality Pre-Test AnswersConfidentiality 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.