July 2005

The Office for Human Research Protections (OHRP) recently released new guidance on coded private information or biological specimens. This article will discuss part of that guidance as it relates to research involving coded private information or specimens and when the research is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46).

For the purposes of this article, coded means:

1. identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., code); and
2. a key to decipher the code exists, enabling the linkage of the identifying information.

Private information or specimens 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 the information to constitute research involving human subjects.

However, when only coded private information or specimens are obtained, OHRP does not consider this human subjects research if the following conditions are both met:

1. the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
2. the investigator(s) cannot readily ascertain the identity of the individuals(s) to whom the coded private information or specimens pertain because, for example:
   1. the key to decipher the code is destroyed before the research begins;
   2. the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased
   3. there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
   4. there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

OHRP further recommends that institutions designate an individual or entity authorized to independently determine whether research involving coded private information or specimens constitutes human subjects research. The investigator does not have the authority to make this determination. At the University of Arizona, that entity would be the Human Subjects Protection Program office.

NOTE: Some HHS conducted or supported research involving coded private information or specimens may be subject to Food and Drug Administration (FDA) regulations. The FDA regulatory definitions of human subject (21 CFR 50.3(g), 21 CFR 56.102(e) and subject (21 CFR 312.3(b), 21 CFR 812.3(p)) differ from the definition for human subject under HHS regulations.

* Office for Human Research Protections. Guidance on Research Involving coded private information or biological specimens, 10 August 2004. Access date 21 June 2005. World Wide Web http://www.hhs.gov/ohrp/policy/index.html#topics.