Specimen Types, IRB, and Useful Links

Specimen Types/IRB

De-identified samples/or data have linking codes that may be kept by the tissue bank but cannot be revealed to the investigator. De-identified data may contain linking codes if such codes are not derived from any identifier (e.g., Social Security or Medical Record number) and are not used for any other purposes, provided that the covered entity does not disclose the code key to the researcher or anyone else. Although de-identified data may contain linking codes that meet the above criteria, a de-identified data set may not contain any of the 18 identifiers listed in the Privacy Rule.

Anonymous data have been stripped of all identifiers, including linking codes. Data may be anonymized to render a protocol "non-human subjects research" if the data source includes no identifiable information. The individual who anonymizes the data must be someone who has prior authorization to access the data (e.g., hospital or treating physician). A data source can be anonymized when someone outside the research study strips the data source of all identifiable information. Importantly, however, anonymized data are not considered de-identified data under the Privacy Rule.

A human subject is a living individual about whom an investigator collects data through direct intervention or interaction, or from sources such as medical records, clinical databases, billing records, and pathologic or diagnostic tissue specimens. Data from these sources are called "identifiable private information."

Additional information:

NYU Langone Medical Center IRB: