“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f))
Obtaining means receiving or accessing identifiable private information or identifiable specimens for research purposes. OHRP interprets obtaining to include an investigator's use, study, or analysis for research purposes of identifiable private information or identifiable specimens already in the possession of the investigator. http://www.hhs.gov/ohrp/policy/cdebiol.pdf
Under the definition of human subject at 45 CFR 46.102(f), obtaining identifiable private information or identifiable specimens for research purposes constitutes human subjects research.
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 that has been provided for specific purposes by an individual and that 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. 45 CFR 46.102(f).
According to the “Guidance on Research Involving Coded Private Information or Biological Specimens”(http://www.hhs.gov/ohrp/policy/cdebiol.pdf) OHRP generally considers private information or specimens to be individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Conversely, OHRP considers private information or specimens not to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
The Privacy Rule permits a covered entity to determine that health information is de-identified even if the health information has been assigned, and retains, a code or other means of record identification, provided that the code is not derived from or related to the information about the individual and could not be translated to identify the individual and the covered entity does not use or disclose the code for other purposes or disclose the mechanism for re-identification.
Under the HHS Protection of Human Subjects Regulations, if an investigator obtains private information about living individuals for research purposes and that private information retains a link to individually identifying information, such private information ordinarily would be considered by OHRP to be individually identifiable to the investigator. However, OHRP does not ordinarily consider such information to be individually identifiable to the investigator if (1) the investigator and the holder of the individually identifying information sign an agreement prohibiting the release of individually identifying information to the investigator under any circumstances, or (2) there are other legal requirements prohibiting the release of the link to the investigator.
An example of a legal requirement prohibiting the release of the key is the HIPAA Privacy Rule, which permits a covered entity to assign to de-identified health information a code for re-identification under specific conditions. One such condition prohibits a covered entity from disclosing the mechanism for re-identification (e.g., releasing the key or the mechanism for breaking the code).
Exemption 4 applies to retrospective studies of specimens and/or data that have already been collected. The materials must be “on the shelf” (or in the freezer) at the time the protocol is submitted to the IRB or other designated officials at your institution to determine whether the research is indeed exempt. Research that involves the ongoing collection of specimens and/or data does not meet the criteria for Exemption 4, even if they were destined to be discarded.
This language in the regulation was intended to apply to public sources of data, such as census data. Its meaning with respect to human tissue specimens is widely debated. Although there are organizations that make human cells and tissues broadly accessible to the research community, these materials are not usually available to the public at large and are not generally considered to be publicly available.
Examples of identifiers, would include names, social security numbers, medical record numbers, or pathology accession numbers, or any other “code” that permits specimens or data to be linked to individually identifiable living individuals and perhaps also to associated medical information.