Procedure for Confidentiality of Data; HIPAA Authorization and Waiver
Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Protected Health Information refers to individually identifiable health information meeting the definition of protected health information under HIPAA privacy regulations at 45 CFR 160.103.
The Senior Staff:
The IRB or Experienced IRB reviewer for expedited review at the time of initial, continuing, or modification review:
Approved on April 26, 2010, by:
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP