SOP 033: Research Involving Coded Private Information or Biological Specimens

1. Purpose

This SOP outlines WVU OHRP and WVU IRB procedures for guiding researchers when research is conducted involving coded private information or biospecimens.

2. Overview

WVU OHRP procedures are based on the federal OHRP guidance document entitled, “Coded Private Information or Specimens Use in Research, Guidance” (October 15, 2008, https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded- private-information/index.html).

3. General Information

3.1. For the purposes of this SOP, coded is defined as (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 that has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

3.2. Under the definition of human subject at 45 CFR 46.102(f), obtaining identifiable information or identifiable specimens for research purposes constitutes human subjects research. Obtaining identifiable private information or identifiable specimens includes, but is not limited to:

• Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens that have been provided to investigators from any source; and
• Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens that were already in possession of the investigator.

3.3. In general, private information or specimens are considered 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.

3.4. Conversely, private information or speciments are not individually identifable when they cannot be linkedto specific individuals by the investigator(s) directly or indirectly through coding systems. For example, research involving only coded private information or specimens does not involve human subjects as defined under 45 CFR 46.102(f) if the following conditions are met:

• The private information or specimens were not collected specifically for the current proposed research project through an interaction or intervention with living individuals; and
• The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
• 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 (i.e., note that HHS regulations do not require the IRB review and approve this agreement);
  
• Other legal requirement prohibit the release of the key to the investigators until the individuals are deceased.
  

3.5. In some cases, an investigator who obtains coded private information or specimens about living individuals under one of the conditions cited above may:

• Unexpectedly learn the identity of one or more living individuals, or
• For previously unforeseen reasons now believe that it is important to identify the individual(s).

If, as a result, the investigator knows, or may be able to readily ascertain, the identity of the individuals to whom the previously obtained private information or specimens pertain, then the research activity would now involve human subjects under the HHS regulations. Unless this human subjects research is determined to be exempt (See SOP 017: Exempt Review), IRB review of the research would be required. Informed Consent of the subjects also would be required unless the IRB approved a waiver of informed consent (See SOP 012: Informed Consent Requirements and SOP 016: Documentation of the Informed Consent Process).

4. Who Should Determine Whether Coded Private Information or Specimens Constitutes Human Subjects Research

4.1. The researcher (PI), in consultation with the WVU OHRP staff, will determine if the research involving coded information or specimens requires IRB review. If the request is verbal (by phone or in person) or by email, it is the researcher’s responsibility to maintain documentation of the decision. If the researcher submits a formal submission, the request must include sufficient documentation of the activity to support the determination. Formal requests for determinations will be responded to in writing and a copy of the submitted materials and determination letter/email will be kept on file (either in the form of paper, email, or other electronic/automated system records).

5. References

WVU Policies:
SOP 012: Informed Consent Requirements
SOP 016: Documentation of Informed Consent Process
SOP 017: Exempt Review

Federal Regulations:
45 CFR 46.102(f)

AAHRPP:
Element I.1.A