Privacy & Subject Protection
The Duke-IGSP Biorepository is committed to ensuring patient privacy through compliance with the Health Insurance Portability and Accountability Act (HIPAA) and requires Institutional Review Board (IRB) approval before banking or receiving specimens for their research.
HIPAA Privacy Rule: Enacted by Congress in 1996, HIPAA requires that the Department of Health and Human Services (HHS) establish national standards for electronic health care transactions. The Privacy Rule, issued by HHS, implements the requirements of HIPAA establishing sets of national standards for the protection of certain health information, called protected health information (PHI). The Privacy Rule was enacted to ensure the privacy and confidentiality of PHI, and to regulate known and unanticipated risks to privacy that may accompany the use and disclosure of such information. The Privacy Rule does not apply to specimens per se, but does apply to some of the health information that may be associated with the specimen. The Duke-IGSP Biorepository protects the identity of patients from whom specimens are obtained, and does not provide patient identity or other identifiers to investigators.
IRB Approval: The function of the Institutional Review Board (Duke IRB) is to protect the rights (including privacy) and welfare of human subjects and to minimize risks (including risks to confidentiality). The Duke-IGSP Biorepository requires researchers to agree to follow the provisions of the Common Rule (45CFR46) federal human subjects regulations and obtain IRB approval and appropriate Informed Consent before banking or receiving specimens for their research.
Informed Consent: Informed Consent data will be associated with every human specimen stored within the Biorepository with the ability to remove specimens and data upon withdrawal or expiration of consent.
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